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with the development of water dilutable insecticides , such as ffast ™ insecticides , came the need for a process for diluting and dispensing the water - based formulation by the use of an injector system that would properly mix and dilute the concentrated insecticide with water and that would dispense the water diluted insecticide into the application equipment . the present invention is directed to the process of mixing a formulation of a water dilutable insecticides , accurately diluting with water and dispensing the water diluted formulation , and the injector system . the present invention is directed to a process that includes the steps of : agitating , recirculating , mixing or re - suspending the water dilutable insecticide formulation within a container ; drawing the water dilutable formulation from the container and accurately diluting the insecticide with water at concentrations selected to meet the manufacturer &# 39 ; s label application specifications ; and dispensing the water diluted insecticide directly into the application equipment ( for example , aircraft , truck mounted or portable ) selected for use . the present invention is also directed to a specific type of injector system that is used to mix , dilute and dispense an insecticide with water . the injector system includes : a container and a mixing system for mixing the concentrated insecticide ; a water source and a water stream through the injector system ; a water injection pump for accurately injecting a predetermined amount of the insecticide into the water stream ; and a dispensing system for dispensing the water diluted insecticide into application equipment . the injector system can properly mix the concentrated insecticide , properly dilute the insecticide with water and dispense the water diluted insecticide into the application equipment . this is accomplished by providing a means for mixing , agitating , re - circulating or re - suspending the concentrated formulation to assure a homogeneous state , and then diluting the insecticide by injecting the insecticide into a water stream at a specified rate , which results in a pre - selected concentration of the insecticide . once mixed and diluted , the injector system provides a means for dispensing the solution into application equipment for subsequent dispersal . the injector system can optionally include a tamper - evident container . the container of the injector systems can also optionally be returnable to the manufacturer for refilling with the concentrated insecticide . the injector system of the present invention for preparing a water dilutable insecticidal formulation includes : a container having an inlet and an outlet for holding the water dilutable insecticidal formulation prior to dilution with water ; a mixing system for mixing the water dilutable insecticidal formulation in the container prior to dilution ; a water source ; a water injection pump ; a water line connecting the water outlet port of the water injector pump to a dispensing system ; a fluid line connecting the water dilutable insecticidal formulation outlet of the water injection pump and the water line , whereby the water injector pump injects a predetermined amount of the water dilutable insecticidal formulation into the water stream forming a final water diluted insecticidal formulation ; and a dispensing system connected to the water line for dispensing the final water diluted insecticidal formulation into application equipment . prior to each dispensing event utilizing the injector system , the insecticide concentrate may need to be re - circulated within its container to assure proper performance of the formulation of the concentrate . the amount of time of recirculation will vary according to the amount of concentrate remaining in the container and the manufacturer &# 39 ; s instructions . recirculation insures that the concentrated insecticide ( for example , aqua - reslin ® or other ffast ™ formulated insecticides ) is uniformly mixed prior to being drawn out of the container to the injector and injected into the water stream . the injector system of the present invention may include a re - circulation loop for recirculating or agitating the insecticide . the injector system may include a water stream , a concentrate injector to inject concentrate into the water stream and a dispensing system to allow for filling of the application equipment . as a further embodiment , the injector system may include a concentrate recirculation loop incorporating the insecticide concentrate container , a recirculation pump , and a three - way valve to divert the flow of the concentrate from the recirculation loop to the injector . the injector system requires a water source that can be from a standard water line . the connection between the water source and the injector systems may include a check valve to prevent the backflow of the water after injection of the concentrated insecticide , a pressure reducer if required , an inlet or shut - off valve for restricting the water flow when the injector is not in operation , a pressure gauge , and a water line allowing the water stream to pass to the dispensing system of the injector system . the injector system allows for the injection of concentrate into the water stream for mixing and prior to dispensing . in the injector system with a three way valve in the recirculation loop , the valve is oriented to allow the concentrate to be injected into the water stream by diverting flow from the recirculation loop to the injector in the injector system . the injector would inject concentrated insecticide at a pre - selected rate into the water stream , thereby diluting and mixing the insecticide with water . a dispensing system on the outlet side of the injector system allows the water / insecticide solution to pass through the dispensing system into the application equipment . the dispensing system may include a nozzle and valve , and a flow meter . the dispensing system of the injector system may optionally include a bypass loop to be used for flushing the system after use . the injector system may also include an agitation system that includes a mixing unit is incorporated into the concentrated insecticide container . one example of a mixing unit that is an integral part of the container includes a rotary mixer with the shaft of the mixer extending outward from the inside of the container . in this example , the end of the shaft of the rotary mixer inside the container includes a mixing head . the operator would then attach a mixing motor onto the shaft of the mixing unit on the outside of the container to turn the rotary mixer . this allows the concentrated insecticide to be mixed in the container without the use of a recirculation loop and pump . the motor could be connected with a standard quick connect coupling between the shaft of the mixer and the drive shaft of the motor . if the mixing unit is incorporated into the container , the container would require only one outlet since the inlet port and the outlet port required for a recirculation loop would not be required . a tamperproof or tamper - evident device could be included in a container with only one port . these containers with a single outlet can also be designed to be product specific , whereby different concentrated insecticides could be assigned different container port configurations . this avoids the potential of using the wrong concentrated insecticide for a given application . other mixing apparatus could be used to provide specific modes of agitation by modifying the mixing unit . another injector system could include a shaker platform to agitate the concentrate in the container prior to dilution . the concentrate container would be placed on the shaker unit and the container would be shaken to agitate the contents of the concentrate container prior to dilution . in another injector system , the container could be designed for refilling with concentrated insecticide by the supplier of the insecticide . a preferred embodiment of the injector system for water dilutable insecticidal formulations is described in fig1 . this injector system uses standard components and includes , for example , an optional recirculation pump , a container for the concentrated insecticide , a three way valve , an injector , a water stream and a water line for mixing , a dispensing nozzle with flow meter , and associated electrical connections , valving and hoses . additionally , the system could include a selector switch controlling the three - way valve in the recirculation loop ( to select between recirculation and dispensing ) and a pressure gauge to monitor the water inlet pressure . the injector system described in fig1 includes two water injection pumps . these could include a dosmatic ® injector available from dosatron international , rue pascal — bp - 6 , 33370 tresse ( bordeaux ), france . the setting on the water injector pump is selected to correspond to the desired final concentration of water / insecticide to be prepared . for example , if a 10 % volume / volume solution is desired , the injector pump is set according to the manufacturer &# 39 ; s instructions . following re - circulation to mix the concentrated insecticide , the water source coming to the injector system is turned on at the water inlet . the injector system is set to produce the desired concentration for the water / insecticide solution following the manufacturer &# 39 ; s instructions for use of the water injector pump selected . the water injection pump continuously injects the proper amount of concentrated insecticide into the water stream . as the water stream exits the nozzle into the application equipment reservoir , the water diluted insecticide is ready for use . by incorporating two water injector pumps into the injection system , the concentration of the insecticide in water can be increased to twice the concentration possible utilizing a single water injection pump . the injector system is designed to inject liquid into water and can be applied to a variety of other applications . other chemicals can also be applied in a wide range of other applications , including irrigation , livestock hygiene and crop spraying . the injector system mixes the concentrated insecticide , such as the ffast ™ formulated insecticide aqua - reslin ®, in proper proportions with water , and then dispenses the water diluted insecticide into application containers . end users then spray this water diluted insecticide to kill mosquito and other insects . the injector system can be portable and can be placed in a location convenient for connection to a standard electrical outlet and water source . the insecticidal formulations that can be used with the injector system are those insecticides that are suitable for dilution with water to form a space sprayable preparation . these insecticidal formulations generally comprise an active ingredient , an emulsifier and an evaporation retardant . the formulation can optionally contain a carrier or solvent for the active ingredient . the active ingredient in the formulation may be a pyrethroid or natural pyrethrins or other insecticide classes possibly combined with a synergist . other active ingredients can include both non - biologically and biologically active compounds . for example , the active ingredients may be selected from insecticides alone or in combination with insecticides or biological larvicides or other active ingredients . carriers and solvents may include lower alkyl esters , lower ketones , lower alkanols , lower alkanes , kerosene , mineral oil , heptyl acetate , 4 - methylpentan - 2 - one , or butane . emulsifier may include anionic compounds , such as calcium dodecyl benzene sulphate or sodium diisopropyl naphthalene sulphonate , and non - ionic compounds , such as polyoxyethylene stearyl ethers , polyoxyethylene monolaurates , polyoxyethylene mono - oleates , sorbitan mono - oleates , nonylphenol ethoxylate , polyethylene glycol , and blends of olyel ethoxylate and peg20 glyceryl oleate . an evaporation retardant may include any film - forming compound , preferably an alkanol and is preferably a primary alcohol with no more than one or two side substituents selected from methyl , ethyl , trifluoromethyl and halogen , with such substitutions preferably remote from the alcohol group ( preferably at least 7 carbon atoms away from the hydroxyl group ,) and preferably the alkanol is not substituted at all , preferably c 16 - 20 , preferably saturated . hexadecan - 1 - ol ( also known as cetyl alcohol ) is usually available commercially as a mixture with a minor proportion of octadecan - 1 - ol ( stearyl alcohol ) and such cetostearyl alcohol is satisfactory . heptadecan - 1 - ol performs adequately . other effective film forming agents include 1 - hexadecylamine , 1heptadecylamine and 1 - octodecylamine . less preferred film - forming agents include hexadecan - 2 - ol , 1 , 2 - hexadecandiol , methyl stearate , stearyl acetate , methyl palmirate , and 1 , 2 - octadecandiol . n - alkoxyalkanols may be used , for example ch 3 ( ch 2 ) 2 oc 2 h 4 oh , ch 3 ( ch 2 ) 21 och 3 h 6 oh , ch 3 ( ch 2 ) 17 oc 2 h 4 oh , or ch 3 ( ch 2 ) 15 och 2 h 4 oh , as may oxyethylene - docosanol and mixtures of any of the said evaporation retardants . such a formulation allows droplets to remain stable while drifting over a given swath area necessary to obtain effective coverage and to obtain and to maintain an optimum droplet size . for maximum impact , the droplets need to be sized within tight parameters : too big and they fall to the ground before reaching the target , too small and they may not impact the intended target , such as an insect . an example of such a formulation that allows water dilutable insecticide droplets ( for example , the mosquito adulticide aqua - reslin ®) to remain stable with less evaporative loss is currently available under the name ffast ™. the mosquito adulticide aqua - reslin ® utilizes anti - evaporant technology which allows for the use of water as a diluent while maintaining a stable ulv droplet of an insecticide which allows the water droplets to perform the same , or very similar to the oil based solvent droplets . the benefits are many , including the almost complete elimination of oil as an environmental insult . the aqua - reslin ® insecticide is a concentrated formulation of a water dilutable mosquito adulticide that can be provided by the manufacturer in a container can be installed onto the injector system . the process of the present invention mixes the formulation in its container , dilutes the insecticide , such as the aqua - reslin ® insecticide , by injecting the concentrated insecticidal formulation into a water stream to achieve a predetermined concentration , and dispenses the diluted insecticide into application equipment for subsequent dispersal . the container is connected to the injector system of the present invention , whereby the outlet of the container may or may not be connected to the recirculation loop of the injector system which is used for mixing the insecticide prior to dilution . agitation and resuspension can be achieved by drawing the concentrated formulation out of the container , passing it through a recirculation pump , and then returning the concentrated formulation back into the container , or by any of the other methods previously described . once homogenized , the insecticide is injected and mixed into the water stream of the injector system through the use of a water injection pump , which accurately dilutes and mixes the formulation with water . the water diluted insecticide is then dispensed by the injector system into application equipment for subsequent spraying . in addition to the aqua - reslin ® insecticide , other ffast ™ insecticide formulations can include products such as aqua - pyrenone ™, esbiol ®, aqua - scourge ™, and other products where the active ingredient in the formulation may be a pyrethroid or natural pyrethrins or other insecticide classes . aqua - pyrenone ™ contains the active ingredient pyrethrins synergized with piperonyl butoxide , which can be applied undiluted or diluted with water and can be used for structural insect and pest control and as a ulv mosquito adulticide over crops . esbiol ™ contains the active ingredient s - bioallethrin combined with piperonyl butoxide and is also formulated in such a way as to be dilutable with water and can be used for structural pest control , food protection and as a ulv mosquito adulticide . aqua - scourge ™ contains synergized resmethrin for ulv mosquito control . as described above , oil was used in the past as a diluent for these formulations in order to prevent evaporation of the diluent during the application of droplets during spraying of the insecticide . the present invention includes formulations that allow for dilution with water and for forming stable droplets that remain intact during application without significant loss of water due to evaporation . these water diluted droplets further eliminate problems associated with the use of oils in general , such as the difficulty in handling , additional storage requirements for the oil , environmental concerns associated with handling of oils and safety issues . accordingly , the present invention overcomes the problems inherent in insecticide formulations that must be diluted with oil . the present invention further improves upon the prior art in that it includes a complete injector system for mixing , diluting and dispensing the water diluted formulations directly into the application equipment used to disperse insecticides . some of the more notable benefits of the process and the injector system include : environmental , since the process and formulation minimizes oil in the environment and insures consistent dilution and minimizes the chance of over - application ; economic , since the process and the formulation no longer requires the purchase of large quantities of oil for dilution , and the easy dilution using this process results in manpower time savings . there is also a quick turn around of trucks and aircraft tank refilling ; and safety , since the closed system minimizes worker contact with the insecticide and eliminates the hazards of storing flammable oils . it will thus be seen that the objects set forth above , among those made apparent from the preceding description , are effectively attained . since certain changes may be made in the injector systems detailed herein , as well as in carrying out the process described above , without departing from the scope of the invention , it is intended that all matter contained in this specification shall be interpreted as illustrative and not in a limiting sense . all attachments , exhibits and referenced appended to provisional application ser . no . 60 / 175 , 548 filed jan . 11 , 1999 are hereby incorporated by reference . [ 0055 ] fig1 is a schematic of the injector system in accordance with one embodiment of the present invention . the overall operation of the injector system of one of the embodiments of the present invention will be described with reference to fig1 . this particular embodiment of the injector system includes : a container ( 1 ) for holding the water dilutable insecticide formulation ; a recirculation loop including insecticide lines ( 2 ), ( 4 ), and ( 6 ), a recirculation pump ( 5 ) for mixing the concentrate by recirculation , and a three way valve ( 3 ) connected to the recirculation loop to divert flow of the concentrated water dilutable insecticide after mixing from the recirculation loop and container ; two water injection pumps ( 11 a ) and ( 11 b ) connected to a water source ( 13 ) and the three way valve ( 3 ) of the recirculation loop ; a water stream flowing through the water injector pumps ( 11 a ) and ( 11 b ) and passing into water line ( 23 ), which includes individual connections for water dilutable insecticide lines ( 22 a ) and ( 22 b ) and wherein the water dilutable insecticide is mixed with water ; and a hose ( 24 ) and dispensing nozzle ( 26 ) through which the water diluted insecticide is dispensed into the target tank ( 27 ) of the application equipment . the process begins by mixing the concentrated water dilutable insecticidal formulation in the container ( 1 ). in the injector system depicted in fig1 mixing is accomplished by recirculating the concentrate in the recirculation loop connected to the container ( 1 ). the recirculation loop includes insecticide line ( 2 ) connected to the outlet of the container ( 1 ) and the three - way valve ( 3 ). the three - way valve ( 3 ) can be oriented to keep the flow of concentrated water dilutable insecticide in the recirculation loop by directing flow to insecticide line ( 4 ) or can be oriented to divert the flow of the concentrated water dilutable insecticide from the recirculation loop into the injector system through insecticide line ( 7 ). when the three - way valve ( 3 ) is oriented to keep the flow of insecticide formulation in the recirculation loop , the insecticide is pumped through this loop by recirculation pump ( 5 ). the recirculation pump ( 5 ) is connected to the inlet of the container through insecticide line ( 6 ). recirculation continues until mixing is complete and the three - way valve ( 3 ) is switched from the recirculation flow direction to the bypass flow direction . once the water dilutable insecticide has been mixed according to the manufacturer &# 39 ; s instructions , the three - way valve ( 3 ) is set to divert the flow of the insecticide into the remainder of the injector system for dilution with water . a water source ( 13 ) is connected to the injector system and can be any pressurized water source including a standard connection to a municipal water supply . water provided by the water source ( 13 ) is directed into one inlet of a water injection pump . the concentrated water dilutable insecticide from container ( 1 ), which is diverted from the recirculation loop through the three - way valve ( 3 ), is directed to the other inlet of a water injection pump . water is directed through the water injection pump and passes through a water outlet port which is connected to a water line ( 23 ) and dispensing hose ( 24 ). the water dilutable insecticide is simultaneously metered from the water injection pump by a water driven piston through a water dilutable insecticide outlet port and is injected into the water line ( 23 ) connected to dispensing hose ( 24 ). at this point , the water dilutable insecticide is diluted with water as the formulation is injected into the water stream in water line ( 23 ). the embodiment detailed in fig1 includes two water injector pumps ( 11 a ) and ( 11 b ), each with individual water dilutable insecticide inlet ports ( 10 a ) and ( 10 b ) and outlet ports ( 21 a ) and ( 21 b ), water inlet ports ( 19 a ) and ( 19 b ) and outlet ports ( 20 a ) and ( 20 b ), and water driven pistons ( 12 a ) and ( 12 b ). in the injector system depicted in fig1 a single water stream passes through the two water injection pumps ( 11 a ) and ( 11 b ) which are connected in series . the water source ( 13 ) is connected to the injector system such that a water stream passes through the water inlet ( 19 a ) of the first water injection pump ( 11 a ). the water stream flows from the water outlet ( 20 a ) into the water inlet ( 19 b ) of the second water injection pump ( 11 b ) and passes through the water outlet ( 20 b ) of the second injection pump ( 11 b ) into water line ( 23 ). the insecticide fluid streams passing through water injection pumps ( 11 a ) and ( 11 b ) are not connected in series and include individual water dilutable insecticide lines ( 22 a ) and ( 22 b ) connected to the water line ( 23 ). these individual insecticide lines ( 22 a ) and ( 22 b ) are used to inject the water dilutable insecticide into the water stream . check valves ( 9 a ) and ( 9 b ) can be placed in insecticide line ( 7 ) between the three - way valve ( 3 ) and the insecticide inlet ports ( 10 a ) and ( 10 b ) of the water injection pumps ( 11 a ) and ( 11 b ). additionally , a check valve ( 16 ) can be placed between the water source ( 13 ) and the water inlet port ( 19 a ) of the first water injection pump ( 11 a ). after injecting the water dilutable insecticide formulation into the water stream in water line ( 23 ), the final water diluted insecticide passes through the dispensing hose ( 24 ) and is ready for dispensing into a variety of target tanks ( 27 ). the configuration of the target tank is determined by the application equipment for the final water diluted insecticide . the dispensing nozzle ( 26 ) can be designed to accommodate a variety of target tank ( 27 ) configurations . optional process control and measurement equipment utilized in the injector system depicted in fig1 includes : a tank empty sensor ( 8 ) for sensing concentrated water dilutable insecticide in insecticide line ( 7 ) coming from the container ( 1 ); a manual valve ( 14 ) isolating the water source ( 13 ) from the injector system ; a water bypass line ( 17 ) coupled to a pressure switch ( 18 ) and an electric valve ( 15 ), to further control the water pressure and flow from the water source ( 13 ); and a flow meter totalizer ( 25 ) connected to the dispensing hose ( 24 ) for measuring the amount of water diluted insecticide dispensed into the target tank ( 27 ). all of the components of the injector systems described in fig1 are commercially available and require no additional description herein . while the present invention has been disclosed in terms of a preferred embodiment in order to facilitate a better understanding thereof , it should be appreciated that the invention can be embodied in various ways without departing from the principle of the invention . therefore , the invention should be understood to include all possible embodiments and modifications to the shown embodiment without departing from the principle of the invention as set forth in the appended claims .

a process for mixing an insecticide formulation with an injector system that uses water to mix , dilute and dispense the insecticide . an injector system that includes a water dilutable formulation , a means of mixing or agitating the concentrated formulation , a water source , an injector for the purpose of diluting and mixing the formulation with water at pre - selected ratios , and a means for delivering the mixed and diluted formulation to application equipment used to reduce populations of insects , pests or other nuisance organisms of public health importance . a water dilutable formulation , an injector system and a process are combined in the present invention to provide an optional means of recirculating the insecticide concentrate in its container , drawing concentrate insecticide from the container and diluting and mixing it with water at selected concentrations which are calculated to meet the insecticide label application stipulations , and dispensing the correctly mixed solution directly into the application equipment selected for use . end - users then spray this mixture to mitigate infestations .

fig1 is a perspective view , partly in cross section , of a distal end of an endoscopic stapling device or assembly 8 for use in inserting a staple 10 deeply into internal organic tissues of a patient . staple 10 includes a pair of legs or prongs 10 a and 10 b each provided with a staple notch , aperture , or recess 13 for enabling a locking of the staple in a closed post - firing configuration . staple 10 is locked in the closed configuration by a backbone 12 ( see fig2 - 5 ) comprising a pair of legs or prongs 12 a and 12 b projecting parallel to one another from a body portion 12 c . body portion 12 c has opposing planar faces 12 d and is provided at a rear or proximal end with a cutout 12 e serving as a seat for the distal end of a push bar 22 . as discussed below , backbone 12 is disposed back behind the staple 10 until the staple is inserted into the tissues and is ready to be locked . in addition to staple 10 , backbone 12 and pushbar 22 , endoscopic stapling assembly 8 includes a staple holder 16 , an elongate tube 14 , and one or more drive wires or rods 26 . staple 10 initially sits within the jaws 16 a and 16 b of the staple holder 16 with the backbone 12 positioned at a proximal end of the staple 10 and contained within the staple holder 16 and elongate tube 14 . jaws 16 a and 16 b of staple holder 16 are formed along inner surfaces ( not labeled ) with respective longitudinally extending grooves or recesses 16 c and 16 d for removably receiving legs 10 a and 10 b of staple 10 . grooves 16 c and 16 d may be approximately the same size and shape as staple legs 10 a and 10 b , for seating the staple so as to prevent a forward or lateral displacement of the staple from the staple holder 16 prior to completion of a staple closing operation . staple 10 is biased to an open position angle greater than the open position angle of staple holder 16 , thus exerting outward pressure on staple holder 16 and serving to maintain staple 10 within staple holder 16 in an open configuration of the staple and the staple holder . this force contributes to staple retention and maintaining staple 10 in position inside the staple holder 16 when staple 10 and staple holder 16 are inserted into the targeted tissue to be secured . backbone 12 contributes to staple 10 maintaining the preferred position inside staple holder 16 jaws by providing resistance against staple 10 and keeping staple 10 from sliding proximally as these components are inserted into tissue . staple holder 16 is connected to elongate tube 14 and an actuation assembly , which includes drive wires or rods 26 that activate the jaws 16 a and 16 b of the staple holder 16 . elongate tube 14 contains push bar 22 which slides distally to push backbone 12 over staple 10 after the staple and the holder 16 have been inserted into tissues , as discussed below with reference to fig6 - 9 . push bar 22 is operatively connected to a component of a handle mechanism 24 ( fig1 a - 10e ) which controls the forward motion of the push bar 22 . fig2 is a cross sectional view of the distal end of endoscopic stapling assembly 8 , showing staple 10 with staple notches 13 a and 13 b in legs 10 a and 10 b , backbone 12 with two protrusions 15 a and 15 b extending inwardly from respective legs or prongs 12 a and 12 b , staple holder 16 , elongate tube 14 , drive wires 26 , and push bar 22 , with staple 10 and holder 16 disposed in a closed position . after the insertion of holder 16 and staple 10 into target tissues inside a patient , backbone 12 is slid forward over the closed staple 10 and locked into position by means of staple notches 13 a and 13 b and backbone protrusions 15 a and 15 b . staple holder 16 is made from a rigid metal with opposing jaws that meet and align when closed . the closing of staple holder 16 jaws results in the closing of staple 10 and alignment of staple legs 10 a and 10 b . fig3 is a perspective view of staple 10 which is composed of a flexible metal that allows for repeat opening and closing of staple 10 . legs 10 a and 10 b of staple 10 are joined at the proximal end or formed by bending or folding a single metal component at a center point . staple legs 10 a and 10 b have preformed channels 11 a and 11 b on the outside surfaces of the legs . notches 13 a and 13 b communicate with the respective channels or grooves 11 a and 11 b . channels 11 a and 11 b serve to guide legs 12 a and 12 b of backbone 12 over legs 10 and 10 b of staple 10 during a distally directed staple - closing stroke of push bar 22 , while notches 13 a and 13 b serve to guide and secure the backbone 12 and , more specifically , backbone protrusions 15 a and 15 b when backbone 12 is slid over the closed staple 10 in the target organic tissues . backbone 12 is composed of rigid metal whose structural force is greater than the open angle force of staple 10 . channels 11 a and 11 b may be opposite end portions of a single channel or groove in the backside or outwardly facing surface ( not separately labeled ) of staple 10 . fig4 is a perspective view of staple 10 and backbone 12 in proximal position to staple 10 . the configuration of fig4 occurs when staple holder 16 and staple 10 are partially opened after insertion of the distal end portion of assembly 8 into a patient during an endoscopic or laparoscopic surgical procedure . fig5 is a perspective view of the backbone 12 with legs or prongs 12 a and 12 b disposed in the staple closed position over respective legs 10 a and 10 b of staple 10 . backbone 12 is slid from the proximal end of staple 10 toward the distal end of staple 10 along the preformed channels 11 a and 11 b in the outer walls of staple 10 . backbone protrusions 15 a and 15 b have diameters that match the diameters of channels 11 a and 11 b and of notches 13 a and 13 b formed in the outside surfaces or faces of staple 10 . backbone protrusions 15 a and 15 b lock into the respective notches 13 a and 13 b when backbone 12 is fully pushed down channels 11 a and 11 b of staple 10 in the closed position . backbone 12 locks in place , maintaining staple 10 in a fully closed position over the captured tissue . fig6 is a perspective view of the distal end of endoscopic stapling device or assembly 8 as the device is passed through a working channel 30 of an endoscope 32 and approaches target tissue ts . staple holder 16 is opened by manipulation of handle 24 ( fig1 a - 10e ) after the holder emerges from the distal end of the endoscope 32 . in the opened configuration of holder 16 shown in fig7 , the staple 10 and the backbone 12 have the configurations and relative positions shown in fig4 . it is to be noted that staple holder 16 has a pointed distal end for penetrating the targeted tissue . more particularly , holder jaws 16 a and 16 b have pointed tips 16 e and 16 f that enable a deep penetration of jaws 16 a , 16 b and concomitantly staple 10 into the target tissue ts . fig7 is a perspective view of the distal end of endoscopic stapling device 8 as the jaws 16 a and 16 b , together with staple 10 , penetrate the targeted tissue ts . when the tissue ts is located by the endoscopist , staple holder 16 , in the open position , is pushed into the tissue . staple 10 and backbone 12 still have the configurations and relative positions of fig4 . fig8 is a perspective view of the distal end of the endoscopic stapling device 8 as the staple holder 16 is closed over the captured tissue ts . the closure of holder 16 causes staple 10 to close as well . staple holder 16 is closed by manipulation of the device handle 24 , capturing the targeted tissue ts . more specifically , this closure may be effectuated , for instance , by drawing wires or rods 26 in a proximal direction . handle 24 is then manipulated in a second movement , which shifts the push bar 22 in the distal direction and consequently advances the backbone 12 over the closed staple 10 that is inside the staple holder 16 . backbone 12 locks in place on the closed staple 10 , as discussed above with references to fig2 and 5 , and secures the captured tissue ts . staple holder 16 is then opened by a reverse manipulation of the handle 24 and removed from the tissue . staple 10 and backbone 12 remain on the captured tissue . fig9 is a perspective view of the distal end of the endoscopic stapling device 8 after deployment of staple 10 and backbone 12 . staple holder 16 is closed by manipulation of handle 24 and pulled back through the endoscope working channel 30 . fig1 a - 10e are partially schematic elevational views of the handle mechanism 24 at a proximal end of an endoscopic stapling device 34 . fig1 a - 10e are also partially schematic cross - sectional views of a stapling mechanism 36 at a distal end of the endoscopic stapling device 34 . fig1 a - 10e shows successive steps in the utilization of the device . as shown in fig1 a - 10e , stapling device 34 includes elongate tube 38 fixed at a proximal end to handle mechanism 24 . a staple holder 40 similar to staple holder 16 is connected to elongate tube 38 and an actuation assembly which includes a drive wire or rod 42 that activates jaws 40 a and 40 b of the staple holder 40 . this actuation mechanism is connected at its proximal end to handle mechanism 24 . handle mechanism 24 is composed of formed plastic or metal components that slide within each other . one set of components 44 controls the opening and closing of the staple holder jaws 40 a and 40 b another set of components 46 controls the sliding of a push bar 48 that advances a backbone 50 over a staple 52 once the staple has been inserted and closed in target tissue . backbone 50 and staple 52 have interacting locking structures as described above particularly with references to fig3 - 5 . drive wire or rod 42 effectuates the closing of jaws 40 a and 40 . like jaws 16 a and 16 b , jaws 40 a and 40 b may be provided with a biasing spring ( not shown ) tending to open the jaws upon an ejection thereof into a body cavity . alternatively , drive wire or rod 42 may be used to both open and close the jaws 40 a and 40 b in response to distal and proximal movement of actuation component 44 under the direct control of the operator . jaws 40 a and 40 b may be connected to another tube ( not shown ) internal to tube 38 . fig1 a shows staple 52 and staple holder 40 disposed within the distal end of tube 38 prior to ejection therefrom during an endoscopic or laparoscopic stapling procedure . fig1 b shows staple 52 and staple holder 40 opened by a controlled distal movement of actuation components 44 and 46 ( arrows 45 and 47 in fig1 a and 10b ). staple 52 is now opened with backbone 50 disposed proximally thereof , as discussed above with reference to fig4 . after an insertion of the opened staple holder 40 and staple 52 into a desired tissue site ( see fig7 and 8 , actuation component 44 is manipulated to close jaws 40 a and 40 b and actuation component 46 is pushed in the distal direction , as indicated by an arrow 54 to cause push bar 48 to advance backbone 50 over staple 50 ( fig1 c and 10d ), as discussed above with reference to fig5 and 8 . after the locking of staple 52 by backbone 50 , actuation components 44 and 46 are moved in opposing directions , as indicated by arrows 56 and 58 in fig1 e , to eject backbone 50 and close jaws 40 a and 40 b . fig1 is a perspective view of a staple tray 18 , which is a formed holder that contains additional staples 10 ( or 52 ) and backbones 60 and facilitates in the reloading of staple holder 16 ( or 40 ). staple tray 18 has a base 62 formed with a series of holes or slots 64 , which accept the distal tips of staples 10 in the open configuration thereof . a second level 68 of staple tray 18 is positioned securely over the base 62 of the staple tray 18 and has a series of aligned holes 66 that securely hold backbones 60 in proximal contact to staples 10 . the second tray level 68 thus serves as an orientation structure for maintaining a plurality of backbones 60 at proximal ends of the staples 10 in the base 62 of the tray 18 . when reloading staple holder 16 , the staple holder is placed at the proximal end of backbone 60 , push bar 22 ( or 48 ) is retracted and staple holder 16 is slid over staple 10 capturing staple 10 in the opposing slots 16 c , 16 d on the inside surfaces of the staple holder jaws 16 a and 16 b . since other modifications and changes varied to fit particular operating requirements and environments will be apparent to those skilled in the art , the invention is not considered limited to the example chosen for purposes of disclosure , and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention . having thus described the invention , what is desired to be protected by letters patent is presented in the subsequently appended claims .

an endoscopic staple and related stapling device that can be used in conjunction with flexible or rigid endoscopy . the staple can also be used for other surgical procedures . the invention relates to performing a stapling operation on internal body tissues as part of a surgical procedure , diagnostic procedure or therapeutic procedure . this invention includes a surgical staple , an associated staple holder , and an associated staple delivery and deployment device . the staple holder and delivery system have a design iteration whereby the holder can be reloaded with additional staples to be used on the same patient . there is another design iteration whereby the staple holder and stapler are reusable after appropriate cleaning and sterilization .

the curing solutions used in the method of this invention are prepared by dissolving the nitrite composition and sodium free additives in water . the water soluble , inorganic , nitrite compositions employed herein include potassium nitrite , ammonium nitrite , nitrous acid and mixtures thereof . the concentration of the water soluble , nitrite composition in the aqueous curing solution is generally in the range of about 0 . 005 to about 0 . 40 % by weight and preferably in the range from about 0 . 05 to about 0 . 25 % by weight . the nitrite composition provides the chemical constituent which reacts with the meat to produce the cured meat color . at the present time , the legal limit for nitrite is 2 pounds per 100 gallons of curing solution and the completely processed primal cuts may not contain more than 200 parts of nitrite per million parts of meat . ascorbic acid , erythorbic acid , potassium and ammonium salts of these acids and mixtures thereof are advantageously included in the curing solution in an amount from about 0 . 1 to about 0 . 9 % by weight in order to shorten the curing time and add stability to the cured meat pigment . the present legal limit for the acids is 75 ounces per 100 gallons of curing solution while the legal limit for the salts of the acids is 87 . 5 ounces per 100 gallons of curing solution . ( erythorbic acid is the trivial name adopted officially for d - erythroascorbic acid , formerly called isoascorbic acid .) sugar may also be included in the curing solution in an amount from about 1 to about 8 % by weight in order to improve the flavor and taste of the cured product . the term sugar as used herein and in the claims includes sucrose , honey , dextrose , corn syrup solids and the like . the curing solution may be further formulated with flavorings and spices to provide special flavor and taste . the curing solution , which is usually at ambient temperature , is injected into hams by arterial pumping and into bacon , corned beef and pastrami by stitch pumping in an amount corresponding to about 1 to about 20 % of the weight of the primal cut . the primal cuts during the pumping step are at a temperature between about 33 ° and 100 ° f . following the pumping step , the primal cuts may be refrigerated for several days and then further processed by heating or by heating and smoking in accordance with procedures well known in the art . the internal temperatures must reach the minimum prescribed by usda standards . primal cuts cured in accordance with the method of this invention have texture and taste suitable for individuals on a low sodium diet . ______________________________________ quantityingredients a b c______________________________________water 55 gal . 55 gal . 55 gal . kno . sub . 2 10 oz . 10 oz . 10 oz . erythorbic acid 11 oz . 11 oz . sugar 25 lb . ______________________________________ samples of medium size hams , sides of bacon , rounds and briskets of corned beef , and trimmed navels for pastrami are pumped separately with curing solutions a , b , and c to 110 % of their green weight . the hams are injected with the curing solutions by arterial pumping and the other primal cuts are injected with the solutions by stitch pumping . after the pumping step , the primal cuts are refrigerated at 40 ° f . for 3 days . following refrigeration , the primal cuts are further processed by heating or heating and smoking . the hams , comprising first and second sets of 4 hams each , are heated at 130 ° f . for four hours without smoking after which one set is heated at 140 ° f . for 8 hours with heavy smoking and the other set is heated at 165 ° f . for 10 hours without smoking . the bacon slabs are smoked at approximately 135 ° f . for about ten hours at which time the internal temperature reaches 128 ° f . in the case of pastrami , the primal cuts are hung in the smokehouse and rubbed with a pastrami spice mixture in which no sodium chloride is present . the temperature is elevated in stages , with smoking to 125 ° f ., 150 ° f . and 180 ° f . in accordance with the usual procedure . corned beef was further processed by heating it in a steam oven at 160 ° f . until the internal temperature reaches 152 ° f . the primal cuts produced by the method of this example have color , taste and texture suitable for individuals on a low sodium diet , although they are somewhat drier and more bland tasting than primal cuts cured with conventional sodium chloride brines . this example illustrates curing solutions having from 10 to 32 ounces of kno 2 per 100 gallons of curing solution , as follows : ______________________________________ quantityingredients e f g______________________________________water 100 gal . 100 gal . 100 gal . kno . sub . 2 32 oz . 10 oz . 10 oz . erythorbic acid 75 oz . ascorbic acid 75 oz . potassium erythorbate 87 . 5 oz . sugar 25 lbs . corn syrup solids 50 lbs . ______________________________________ in this example , the curing solutions are based on 5 ounces of kno 2 per 100 gallons of curing solution , as follows : ______________________________________ quantityingredients i j k______________________________________water 100 gal . 100 gal . 100 gal . kno . sub . 2 5 oz . 5 oz . 5 oz . erythorbic acid 15 oz . ammonium erythorbate 15 oz . ammonium ascorbate 15 oz . sugar 50 lbs . 25 lbs . ______________________________________ samples of medium size hams , sides of bacon , rounds and briskets for corned beef , and the boned out shoulders for pastrami are pumped separately with the curing solutions identified in examples ii and iii to 110 % of their green weight . the hams are injected with the curing solutions by arterial pumping and the other primal cuts are injected with the solutions by stitch pumping . thereafter , the primal cuts are processed in accordance with the procedure described in example i . the primal cuts treated with the curing solutions of examples ii and iii have color , taste and texture suitable for individuals on a low sodium diet . having thus provided a written description of the invention , it should be understood that no undue limitations are to be imposed by reason of the specific examples but that the present invention is defined by the appended claims .

a method is provided for curing fresh primal cuts of meat intended for consumption by those on a low sodium diet which includes the step of subjecting a fresh primal cut to an aqueous curing solution substantially free of organic nitrites and chloride , phosphate , nitrate and sodium ions and containing from about 0 . 005 to about 0 . 40 percent by weight of a nitrite selected from the group consisting of potassium nitrite , ammonium nitrite , nitrous acid and mixtures thereof .

described herein is a mattress cover with hinged , foam edge rails . however , it will be appreciated that the principles of the system described herein may be adapted to a wide range of applications where a cushioned surface is constructed with edges of foam or other material . for example , the principles of this disclosure may be applied to couches or padded seats with reinforced foam edges , or to mattresses having a row of spring coils attached to the outer perimeter of a foam mattress core . these and other applications not specifically described below are intended to fall within the scope of the systems and methods described herein . fig1 shows a perspective view of an assembly for a mattress cover with edge rails in an unassembled position . the assembly 100 includes an upholstery layer 102 with one or more flaps 104 , one or more edge rails 106 , and one or more hinges 108 . the assembly 100 may be for use with , for example , a queen size mattress , a king size mattress , a twin mattress , or any other mattress of conventional or unconventional dimensions . the assembly 100 may be shaped and sized to fit over a mattress core ( not shown ) of any general construction . the mattress core may be , for example , a foam core , an open spring core , or a pocket spring core , or any combination of these constructed to provide a suitable sleeping surface . a mattress using the assembly 100 and a mattress core may be designed for use in varying orientations , or the mattress may be a no - flip mattress that is designed for use in one or two orientations with a single upper surface . the upholstery layer 102 may include one or more upholstery layers useful in mattress construction . this may include , for example , batting , quilting , padding , or other materials used to enhance comfort , strength , thickness , or some other desirable property of an assembled mattress . the upholstery layer 102 may include reinforcing materials such as plastic sheets or fibers . it may also include functional layers such as a moisture barrier , or exterior quilting and any associated stitching or labeling . more generally , combinations of these layers corresponding to the layers desired for an assembled mattress may be included within the upholstery layer 102 . the upholstery layer 102 may include one or more flaps 104 which overlap the ends of adjacent edge rails 106 when the edge rails 106 are in an assembled position ( see fig2 ). this configuration permits a convenient point of attachment for the edge rails using , for example , glue , two - sided adhesive tape , or one - sided tape around the outside of each corner . the edges may also be secured with staples , hog rings , ultrasonic welds , or any other attachment means that is suitable strong to support the assembled mattress when in use . it will be appreciated that , while the flaps 104 are shown on only two of the sides with the edge rail 106 centered between the flaps , other arrangements are possible , such as one flap 104 on each edge extending from a single side of each edge rail 106 . in this arrangement , each edge rail 106 would extend to one of the corners of the assembled mattress , with a flap on an opposing end for attachment to an adjacent edge rail 106 that extends to the adjacent corner . the edge rails 106 may be foam edges fashioned from , for example , a viscoelastic foam or a latex foam rubber . they may be of any desired firmness according to the intended properties of the assembled mattress , and may be firmer than the mattress core , the same firmness as the mattress core , or less firm than the mattress core , or some combination of these , such as firmer side edge rails 106 and less firm head and foot edge rails 106 . the edge rails 106 may be , for example , the depth of a mattress , and two to six inches wide in the plane of the mattress surface . while foam edges are useful in mattress construction , the edge rails 106 may include other materials , such as a row of spring coils or pocket coils , reinforcing edge materials such as border wires or plastic , adjustable air bladders , or any other materials useful in constructing mattress edges , and combinations of these . it will also be appreciated that , while four edge rails 106 are shown , the assembly 100 may also be constructed with one , two , or three edge rails 106 according to the desired construction of the assembled mattress . other numbers of edge rails 106 may also be used where , for example , the mattress has an unusual geometric shape ( e . g ., an octagonal mattress ) or multiple sections of different materials are to be used on one of the edge rails 106 . the hinges 108 may run along each side of the upholstery layer 102 where each edge rail 106 is to be folded around a mattress core . any number of constructions may be used for the hinges 108 . two examples are provided below with reference to fig4 and 5 . however , it will be appreciated that other hinge means or techniques may be employed provided they accommodate movement of the edge rails 106 between unassembled and assembled positions , and that they are sufficiently strong , or reinforceable in a manner to become sufficiently strong , to support the assembled mattress during use and wear . in use , the assembly 100 may be placed on a work surface in the unassembled position . a mattress core ( not shown ) may then be placed on the assembly 100 , and each edge rail 106 may be hinged into position as a rail for the mattress core . the edge rails 106 may then be secured to each other and / or the mattress core to provide an assembled mattress that includes a reinforced edge . prior to use , the assembly 100 may be left in its unassembled state , which may have a lower profile than the assembled state that is more suitable for stacking , storage , and transportation . fig2 shows a perspective view of an assembly for a mattress cover with edge rails in an assembled position . the assembly 200 may include an upholstery layer 202 and edge rails 206 surrounding a mattress core 210 . the edge rails 206 may be , for example , any of the edge rails 106 discussed above with reference to fig1 . the upholstery layer 202 enclosing the edge rails 206 may be , for example , the upholstery layers 102 described above with reference to fig1 . it should further be appreciated that , while the upholstery layer 202 may be conveniently extended to serve as an upholstery for the sides of an assembled mattress , in certain constructions the upholstery layer 202 may not extend around the exterior edge as depicted in fig2 . for example , where one or more of the hinges ( not shown ) are formed of a tape joint between the edge rail 206 and the upholstery layer 202 , the upholstery layer 202 may not extend around the perimeter of the mattress . such a hinge is depicted , for example , in fig4 below . the mattress core 210 may be of any conventional or unconventional construction suitable for use in a mattress . although coils are commonly used in mattress cores , it will be appreciated that any material or materials may be used including open coils , pocket coils , a monolithic or composite foam ( such as viscoelastic foam ), foams of varying densities and firmness , fluids or gasses in one or more bladders , or any combination of these . a mattress using the assembly 200 and a mattress core 210 may be designed for use in varying orientations , or the mattress may be a no - flip mattress that is designed for use in one or two orientations with a single upper surface . the assembly 200 may be attached to the mattress core 210 and to itself using , for example , glue , tape , two - sided tape , adhesive patches such as duon , staples , hog rings , ultrasonic welds , or any other technique that will maintain the assembled mattress in its assembled state during use and wear . as another example , an additional upholstery layer ( not shown ) may extend around the four sides of the perimeter of the assembly 200 to hold the edge rails securely about the mattress core 210 . thus , it will be appreciated that in one respect , there is disclosed herein a method for assembling a mattress . the method may include providing the assembly 100 , 200 , and positioning the mattress core 210 adjacent to the assembly 100 , with either the mattress core 210 or the assembly 100 , 200 placed on a work surface , and the other piece placed on top . alignment marks may be provided on the assembly 100 , 200 to assist in properly aligning the mattress core 210 before hinging the edge rails 206 into their assembled position . the edge rails 206 may then be rotated on their hinges into the assembled position , and the edge rails 206 secured in place using any of the techniques described above . fig3 shows a plan view of an assembly for a mattress cover with edge rails . the assembly 300 may include an upholstery layer 302 , edge rails 304 , flaps 306 , and hinges 308 , substantially as described above with reference to fig1 and 2 . fig4 shows a hinge that may be used with the assembly . the hinge 400 may connect an upholstery layer 402 to an edge rail 406 using , for example , a tape 408 . the upholstery layer 402 and the edge rail 406 may be any of the upholstery layers and edge rails described above . the tape 408 may be any tape of sufficient tear strength to support the hinge 400 , and having sufficient adhesive strength to adhere to the edge rail 406 and the upholstery layer 402 during assembly and use of a mattress . it will be appreciated that if the tape bond is sufficiently strong , then the tape 408 may only be required on one side of the hinge 400 , i . e ., on the inside or on the outside . it will also be appreciated that the tape hinge 400 need not extend along an entire edge rail , as depicted in , for example , the plan view of fig3 . in certain embodiments , the hinge 400 may be formed by a number of separate joints along the edge rail 406 . in one embodiment , a single piece of tape may extend from one surface of the upholstery layer 402 completely around the edge rail 406 to the other , opposing surface of the upholstery layer 402 . this may be particularly useful where the tape - to - edge rail bond is weak . fig5 shows a hinge that may be used with the assembly . the hinge 500 may join an upholstery layer 508 to an edge rail 506 . in this embodiment , the upholstery layer 508 is a foam upholstery layer , and includes a notch 508 to prevent compression of foam around the hinge 500 when the edge rail 506 is rotated . this notch 508 may also be employed , for example , when the upholstery layer 502 and the edge rail 506 are formed of a single , integral piece of foam . a tape 510 may be included to strengthen and reinforce the hinge 500 . although depicted in a certain location within the hinge 500 , it will be appreciated that the tape 510 may be provided at one or more of a number of locations , such as along the outside of the hinge 500 ( the bottom surface , as depicted ), or along the inside of the hinge 500 ( i . e ., along the right side of the edge rail 506 as depicted , and then bending perpendicular to join the surface of the upholstery layer 502 ). these and other possible arrangements employing tapes , glues and other attachment techniques are intended to fall within the scope of the term “ hinge ” as used herein . while particular embodiments of the present invention have been shown and described , it will be apparent to those skilled in the art that changes and modifications may be made without departing from the scope of the invention , and therefore , the following claims are to be interpreted in the broadest sense allowable by law .

edge rails for a mattress core are combined with an upholstery layer to provide a pre - assembled work piece that provides a perimeter about a mattress core . the edge rails , which may be foam , may be attached to the upholstery layer with hinges that permit each edge rail to rotate relative to the upholstery layer between an unassembled , flat position and an assembled , upright position . in the unassembled position , the work piece may present a relatively flat profile for more convenient bulk storage . in the assembled position , the edge rails are positioned to closely surround a mattress core of suitable size .

referring initially to fig1 illustrated is one embodiment of a mop head constructed according to principles of the present invention . the mop head , generally designated 100 , comprises absorbent material 110 , a central headband 120 and a bag 130 . in the illustrated embodiment , the bag 130 comprises an impervious flexible plastic material such as polyethylene . the bag 130 is physically attached to the headband 120 by such means as melting or stitching . in one embodiment , a tear line 140 and a reclosable ( perhaps a ziplock ®- type ) seal 150 are manufactured into the bag 130 . during manufacture , a predetermined quantity of germicide is impregnated within or applied to the surface of at least some of the absorbent material 110 . the germicide may be in either a liquid or dry form as desired . the dry germicide may be activated upon contact with a liquid such as water or a detergent solution . in an alternative embodiment , the dry germicide may include a detergent which is likewise activated by water . the application of germicide assures that the germicide concentration is adequate to disinfect the desired or floor area . the bag 130 serves to contain the germicide during shipping and storage , preventing evaporation of the germicide . the bag 130 may also be used as a disposal container for the contaminated mop head 100 . in the preferred embodiment , the plastic material of the bag 130 is clear to permit easy identification of a soiled mop head versus an unused mop head 100 . in the illustrated embodiment , the bag 130 is constricted ( clamping area 135 ) about the headband 120 to allow the mop head 100 to be joined to a mop handle without requiring the bag 130 to be opened . in this embodiment , a clamping - type mop handle ( perhaps a rubbermaid quickdrop ®) is applied to the headband 120 over the bag 130 at the clamping area 135 . the plastic bag 130 is opened by tearing at the tear line 140 exposing the mop head 100 . thus the cleaning staff can expose the clean mop head 100 without handling the absorbent material 110 impregnated with germicide . after use , the mop head 100 may be dropped in the disposable contaminated waste or returned to the bag 130 and resealed with the reclosable seal 150 . referring now to fig2 illustrated is the mop head of fig1 during manufacture . the absorbent material 110 is a plurality of fiber pieces 210 arranged parallel to one another . in a particularly advantageous embodiment , the fiber pieces are yarn . the yarn pieces 210 may be pre - cut to the desired length or may be drawn simultaneously from a corresponding plurality of spools ( not shown ). a headband 120 is wrapped about the plurality of yarn pieces 210 at the desired midpoint of the mop head 100 and held in place with stitches 222 . the yarn pieces 210 are cut to the desired length and the cut ends 211 are left exposed . this construction technique encourages fraying of the yarn pieces 210 should the mop head 100 be laundered or used over an extended period of time , and therefore discourages reuse of the mop head 100 . in the illustrated embodiment , a predetermined quantity of germicide is impregnated within at least some of the plurality of the yarn pieces 210 , and the mop head 100 is attached to and sealed within the bag 130 ( see fig1 ). referring now to fig3 illustrated is an isometric view of a single piece of yarn of the mop head of fig1 . the yarn 210 is formed from a plurality of fiber pieces 310 by twisting . in the illustrated embodiment , the plurality of fiber pieces 310 ( herein numbering four ) is composed of fibers selected from the group containing cotton and rayon ®. the choice of cotton or rayon ® fibers ( or a combination of both ) is made based upon the liquid pick - up , holding and release characteristics desired for the mop head 100 . in an alternative embodiment , the fiber pieces 310 may be pieces of woven material such as cloth or other suitable mop material . one skilled in the art will recognize that other fibers may readily be substituted for cotton or rayon ® while remaining within the greater scope of the present invention . referring now to fig4 illustrated is one embodiment of a fantail mop head constructed according to principles of the present invention . in a fantail ( also called a web foot ) mop head 400 , a tailband 460 is stitched in place at a location near , but short of , the cut ends 411 of the yarn 410 . the tailband 460 joins the plurality of yarn pieces 410 in a spread configuration to form a fantail 470 . some customers prefer a mop head with a fantail 470 , as the mop head 400 covers a larger floor area than the conventional mop head 100 of fig1 . however , note that the tailband 460 is located short of the free ends 411 of the yarn pieces 410 , thus encouraging the yarn 410 to fray if the mop head 400 is subjected to laundering or reuse . as stated above , this construction technique of exposing cut ends 411 of the yarn 410 discourages reuse of the mop head 400 . referring now to fig5 a and 5b , illustrated is an alternative embodiment of the mop head and bag of fig1 . as in the embodiment of fig1 the bag 530 is constricted ( clamping area 535 ) about the headband 520 to allow the mop head 500 to be gripped by clamping jaws 560 . the plastic bag 530 is opened by tearing at the tear line 540 . with the seal 550 open , the mop is placed in service by pulling the bag 530 from around the mop head 500 to a position circumferentially about the mop stick 570 as shown in fig5 b . the cleaning staff can expose the clean mop head 500 and re - cover the used mop head by handling only the clean exterior of the bag 530 . when the mopping has been completed , the cleaning staff slides the bag 530 back around the mop head 500 and closes the seal 550 . the attachment of the plastic bag 530 to the mop head 500 encourages resealing of a contaminated mop head and proper disposal rather than reuse . referring now to fig6 illustrated is an alternative embodiment of a mop head constructed according to principles of the present invention . the mop head 600 comprises nonwoven absorbent material 610 , a support surface 620 , a bag 630 and an attach bolt 660 . the nonwoven material 610 is natural chamois or a similar man - made material . the support surface 620 may be made of any suitable material , such as metal or plastic , which will sustain storage in contact with the germicide and retain sufficient strength to perform the intended mopping task . the nonwoven material 610 is cut into a plurality of flat strips which are mechanically attached to the support surface 620 by any suitable method , such as stitching , fusing or adhesion . the nonwoven material 610 is impregnated with germicide in the manner described above and is sealed within the bag 630 . although the illustrated embodiment shows a circular support surface 620 , one skilled in the art will recognize that the support surface 620 may be of any shape suitable to perform the mopping function and to facilitate manufacture . the male threaded attach bolt 660 is firmly affixed to the support surface 620 and provides the means to attach a mop handle of suitable corresponding design to the mop head 600 . surrounding the mop head 600 is an impervious bag 630 affixed to the support surface 620 and allowing the attach bolt 660 to protrude through the bag 630 . the bag 630 is fused or otherwise firmly attached to the support surface 620 . the bag 630 is equipped with a tear line 640 and a reclosable seal 650 . the mop head 600 is placed in service in a manner similar to the mop head of fig5 a and 5b . the bag 630 , tear line 640 and reclosable seal 650 function in manners analogous to the bag 530 , tear line 540 and reclosable seal 550 , respectively , of fig5 a and 5b . referring now to fig7 illustrated is one embodiment of a sponge mop head constructed according to principles of the present invention . the mop head 700 comprises absorbent material in the form of a sponge 710 , a support surface 720 , a bag 730 and an attach bolt 760 . the sponge 710 may be of natural or man - made materials . the sponge 710 is impregnated with germicide in the manner described above and is sealed within the bag 730 . the sponge 710 is mechanically attached to the support surface 720 by any suitable method such as adhesion . one skilled in the art will recognize that the support surface 720 may be of any suitable shape necessary to accommodate the sponge or may be a fixed shape for ease of manufacture . the mop head 700 is placed in service in a manner similar to the mop head 600 of fig6 . the bag 730 , tear line 740 , reclosable seal 750 and attach bolt 760 function in manners analogous to the bag 630 , tear line 640 , reclosable seal 650 and attach bolt 660 , respectively , of fig6 . although the present invention has been described in detail , those skilled in the art should understand that they can make various changes , substitutions and alterations herein without departing from the spirit and scope of the invention in its broadest form .

the present invention provides a germicidal mop head and a method of manufacturing the same . in one embodiment , the mop head includes : absorbent material capable of retaining a germicide , a predetermined quantity of germicide contained in or residing on at least a portion of the absorbent material and a container , located about at least a portion of the absorbent material , that retains the germicide about the germicidal mop head . the present invention therefore introduces a mop head that is germicide - impregnated for convenience and efficacy .

referring to fig1 , a motorised umbrella 1 includes an upright support tube assembly 2 having a crown 3 fixed at an outer end thereof . a plurality ribs 4 for supporting the umbrella canopy ( not shown ) are connected at one end to the crown 3 by pivots 5 to extend radially from the support tube assembly 2 . a yoke 6 is in external sliding relationship to the support tube assembly 2 received therein . the yoke 6 is moveable relative to the support tube assembly 2 between the extended ( upper ) position shown and a retracted position . note that the terms “ inner ” and “ outer ” are used to describe relationships relative to both of the two longitudinally opposing ends of the central tube assembly of the umbrella . references in brackets relate to the upright orientation shown in the figures and are added for clarity . a plurality of struts 7 are pivotally connected to the yoke 6 , each strut 7 being connected to an associated one of the ribs 4 . when moving the yoke 6 from the retracted position to the extended position , the struts 7 cause the ribs 4 to splay outwardly of support tube assembly 2 . the struts 7 cause the ribs 4 to collapse inwardly in response to movement of the yoke 6 to the retracted position ( shown in dashed outline ). the support tube assembly 2 includes lower support tube 2 a which , for instance , may be received in an aperture in a table , or the like , and upper support tube 2 b to which the crown 3 is mounted . a winch 10 mounted in the lower support tube 2 a provides drive means for moving the sleeve between the extended and retracted positions . a line 11 engaged with the winch 10 extends longitudinally within lower support tube 2 a , around a pulley 12 and through an aperture 13 in the upper support tube 2 b , to connect to the yoke 6 . as seen in fig2 , a winch drum 14 and threaded shaft 15 are integrally formed from an elongate member mounted coaxially with the central longitudinal axis 16 a of the lower tube 2 a . a journal 17 engages a bearing block 18 fixed inside the tube 2 a , to support the drum 14 and shaft 15 for rotation about axis 16 a . a nut 19 is engaged with the treaded shaft 15 and has a longitudinally aligned slot 21 . a bar 20 fixed to the inner wall of the tube 2 a extends axially and is received in the slot 21 to block rotation of the nut 19 . the line 11 approaches the nut in the longitudinal direction , passes about a roller guide 22 fixed to the nut 19 and is fed generally transversely into the drum 14 . one end of the line 11 is fixed to the drum 14 , such that the line is wound in a helix of the same pitch as that of the screw threads . on the nut 19 , opposite the slot 21 , a pair of axially spaced wheels 23 a , 23 b engage the inner wall of the tube 2 a . the drum 14 and shaft 15 are rotated by a motor 24 , driven through a primary gearbox 25 , a clutch 26 and then a secondary gearbox 27 . the primary gearbox 25 serves to reduce the speed and increase the torque supplied to the clutch 26 . the primary gearbox 25 is mounted within the lower tube 2 a coaxially with the adjacent motor 24 . the clutch 26 and secondary gearbox 27 cooperate to allow the umbrella to be operated using either the motor 24 or a crank handle 28 to rotate the drum 14 and shaft 15 . the secondary gearbox 27 includes opposing driving and driven bevel gears 30 , 31 mounted coaxially with the axis 16 and connected by a pinion 32 . the pinion 32 is mounted on a transversely extending axle 33 which includes a socket 34 for receiving the crank handle 28 . the driven bevel gear 31 is connected to the winch drum 14 and threaded shaft 15 by a coupling shaft 35 mounted for rotation in a bearing sleeve 36 fixed inside the support tube assembly . the clutch 26 is mounted between the output 37 from the primary gearbox 25 and the driving bevel gear 30 . as best seen in fig4 , the clutch 26 includes an actuating member extending transversely through the lower tube 2 a and having button portions 38 , 39 on opposing ends thereof which protrude from either side of the support tube 2 a and are pressed to release and engage the clutch 26 respectively . a spring 40 is mounted ( around a hub 41 fixed to the driving bevel gear 30 ) to bear against an axially sliding collar 42 , which through the abutting thrust plate 43 and pins 44 in turn holds balls 45 in recesses in a flange portion 39 of the rotating output 37 . in this manner the torque is transmitted through the thrust plate 43 to the hub 41 and thus to the driving bevel gear 30 . when the button portion 38 is pressed ( fig5 ) inclined faces ( not shown ) on the actuating member 30 and collar 42 cooperate to move the collar 42 axially so as to compress the spring 40 , thereby allowing the balls 45 to ride up out of the recesses in the output 37 , disengaging the drive from the primary gearbox 25 . in the released position ( fig2 and 4 ) the button portion 38 protrudes from the lower tube 2 a at a position circumferentially aligned with the crank - receiving socket 34 . in this manner the button portion 38 projects into the path traced in use by rotation of the crank handle 28 providing a visual clue to the user that , in order to crank the handle 28 , it is necessary to press the button 38 , not only to release the clutch but to allow the handle 28 to pass the button 38 . stacked within the support tube 2 a , below the motor 24 are five rechargeable batteries for powering the motor . a socket in the support tube assembly is provided for plugging in a power supply ( not shown ) for charging the batteries . fig6 - 10 illustrate a joint assembly 50 between the upper and lower support tubes 2 a , 2 b , each of which are fixed to a respective upper an lower joint member 51 , 52 joined by a transverse pivot 53 . protruding from an end of the upper joint member 51 is a central tongue 56 with a semicircular edge 59 . the tongue 56 is received between flanges 57 , 58 protruding from the end of the lower joint member 52 , the pivot 53 extending between both flanges 57 , 58 . three recesses 54 a , 54 b , 54 c are provided in the edge of the flange 56 , recesses 54 a and 54 c being equally angularly spaced either side of the central recess 54 b . a detent 61 is mounted to slide longitudinally in the lower joint member 52 and includes a nub portion 55 and a button portion 60 . the button portion 60 is exposed externally and for manual release of the detent , for instance , sliding the button longitudinally against the urging of spring 62 withdraw the nub 55 from one of the recesses 54 , allowing the members to be inclined relative one another for tilting the umbrella . the outer edge of the flange 58 has a convex face 64 complementary to an adjacent concave face 65 on the upper joint member 51 . a pin 66 is received in a longitudinally aligned recess in the extending through the convex face 65 . a beam spring 67 engages one end of the pin 66 to bias the opposing end outward toward the concave face 65 . a recess 68 in the concave face 65 is longitudinally aligned with the axis 16 . an interlock switch 63 is provided in the electrical circuit controlling the operation of the motor 24 , the switch 63 being mounted adjacent the pin 66 in the lower joint member 52 . an actuating lever 69 extends from the switch 63 below the beam spring 67 . in use , with the upper and lower portions of the support tube aligned , as shown in fig9 , the pin 66 is received in the recess 68 and the switch is in a first state , for instance , an electrically closed position . any rotation of the portions of the support tube , as shown in fig1 , displaces the pin 66 from the recess 68 , pushing the pin 66 against the actuating lever 69 to move the switch to a second state , for instance , an electrically open position . in this manner the switch 63 is used to prevent operation of the motor 24 when the upper and lower support tubes 2 a , 2 b are inclined . aspects of the present invention have been described by way of example only and it should be appreciated that modifications and additions may be made thereto without departing from the scope thereof .

a winch for opening and closing an umbrella includes a winch drum mounted within an elongate support tube of the umbrella , to rotate about a longitudinal axis thereof . a threaded shaft is coaxial and rotationally fast with the drum . a line is fixed at one end to the drum and at other end to a sleeve , to which struts are pivotally connected , each strut being associated with a canopy - supporting rib . a travelling nut is engaged with the threaded shaft and blocked for rotation relative to the tube . a guide is fixed to the nut for guiding the line onto the drum , and a motor is also enclosed in the support tube and drivingly connected to the winch drum .

the present invention consists of methods and apparatus of use in the monitoring and determination of stock or plant performance during the normal milking process . the methods and apparatus may be used independently or used in combination . in one embodiment of the present invention the use of the combined methods and apparatus the results in a system that monitors and determines alerts for abnormal stock performance including indicators of milk with mastitis , milk flow , milk volume yield and end of milking . it also monitors and determines alerts for abnormal plant performance including abnormal bail equipment operation and cleaning characteristics . in this embodiment of the present invention , the system comprises a bail unit for each milking cluster and a single central command unit . a common 2 - wire bus for power distribution and communication connects all units . of relevance to the first and second aspects of the present invention is a manifold that connects in series with the long milking tube from the milking cluster . solution is transported in the milking tube under differential vacuum and subsequently flows through the manifold as shown in fig1 . solution enters the manifold through the entry pipe ( 1 ) and passes into an entry chamber ( 2 ). air and solution are separated in the entry chamber by a whirlpool and / or settling effect with solution outflow from the outer peripheral of the rotating mass and / or from the bottom of the entry chamber . from the entry chamber outflow the separated solution passes into an accumulation chamber ( 3 ). chamber walls or baffles are used to improve air solution flow ( 2 a ) and define the boundary between the entry and accumulation chambers ( 3 a ). solution is able to build - up in the accumulation chamber and provides short periods of continuous supply to an attached conductivity tube or tubes ( 6 ). the conductivity tube or tubes define the physical arrangement for conductivity sensing . a high length to sectional area ratio and a co - ordinated external electrode configuration ( 12 ) is used to enhance solution conductivity effects and reduce solution dielectric effects . this allows for the extraction of a useful conductivity measurement from the otherwise dominating solution capacitance . in one embodiment of the present invention useful performance was achieved with a single plastic tube of about length 120 mm , diameter 9 mm , and wall thickness 0 . 9 mm and electrodes of about 50 mm length . to ensure the same potential at each end of the tube to prevent erroneous effects from currents in solution external to the tube , one of the electrodes was split into two parts located at each end of the tube and the other electrode was located in the centre of the tube . the conductivity tube or tubes incorporate a mechanical or fluid dynamic exit restriction ( 8 ) to extend solution residence time under conditions of low flow . the size of a mechanical restriction is a compromise between extended residence time and the ability to pass dense or solid components in the solution flow without blockage . in one embodiment of the present invention the exit restriction was achieved by the disturbed fluid dynamic flow where solution the conductivity and bypass tubes re - combine ( 10 ). the conductivity tube or tubes also receive preferential supply from the accumulation chamber to extend performance under low flow conditions . the preferential supply is due to the separation and settling of solution within the entry ( 2 ) and accumulation ( 3 ) chambers and the lower position of conductivity tube entry orifice ( 4 ) compared to entry orifice ( 5 ) of the alternative solution passageway through a bi - pass tube or tubes ( 7 ). the bi - pass tube or tubes ( 7 ) carry overflow solution from the accumulation chamber mixed with the separated air stream from the entry chamber . the tube dimensions including the entry ( 5 ) and exit ( 9 ) orifices ensure that the over - all manifold causes minimal head loss . in a preferred embodiment of the present invention the bi - pass tube or tubes are fitted with electrodes and used to measure fluid mass within the tube . this can be used together with the measurements from the conductivity tubes to determine flow rate and volume yield from the measured mass and mass time dependency , which indicates velocity . here the tube requires a relatively high surface to sectional area ratio and a co - ordinated external electrode configuration ( 13 ) to enhance both dielectric and conductivity effects associated with fluid mass . in one embodiment of the present invention useful performance was achieved with four parallel plastic tubes of about length 120 mm , diameter 12 mm , and wall thickness 0 . 9 mm and electrode of about 50 mm length . one of the electrodes was split into two parts located at each end of the tube and the other electrode was located in the centre of the tube as for the conductivity tube above . solution velocity is obtained from the time dependence of the measured mass . this is most easily illustrated by considering asymmetric electrodes as an example . fluid often arrives in large “ plugs ” in sympathy with the pulsation of the milking machine . with an asymmetric electrode , the “ plug ” first moves past the smaller electrode and then causes a time dependent ramp in mass measurement as it moves past the large electrode . the known electrode length divided by the ramp time gives velocity . filtering over many “ plugs ” gives practical results with minimum uncertainty . other similar methods for obtaining velocity using time dependent mass measurement with symmetrical or split electrodes are equally as effective . in a preferred embodiment of the present device split electrodes were used . an exit chamber ( 10 ) collects the outflow from both the conductivity and bi - pass tube or tubes . the solution exits the manifold through an exit pipe ( 11 ) one physical implementation of a manifold arrangement is illustrated in fig2 a and 2 b where the entry pipe ( 1 ) is tangential to entry chamber ( 2 ) to produce the “ whirlpool ” effect . like integers have like numbers to those used in fig1 . of relevance to the third and fourth aspects is conductivity sensing and signal conditioning circuitry that can operate in conjunction with the manifold and attached electrodes described herein or with some other arrangement . fig3 and 4 show the signal sensing block diagram and phasor addition method used to improve the conductivity measurement . the sensing system is driven by an oscillator ( 50 ) producing a high frequency sine - wave excitation voltage ( 51 ). the oscillator frequency is selected for a particular fluid tube and electrode arrangement . in one embodiment of the present invention the manifold described herein a frequency of about 5 mhz was high enough to give a satisfactory performance . the excitation voltage ( 51 ) is fed to a conductivity measuring circuit section ( 53 - 60 ) for solution in the conductivity tube or tubes ( 52 ). the excitation voltage is also fed to a duplicate conductivity measurement circuit section ( 53 a - 60 a ) and an additional low ion mass measuring circuit ( 62 - 69 ) section for solution in the bi - pass tube or tubes ( 61 ). for solutions with high ion concentration a compensated conductivity measurement is used to determine mass whereas for solutions with low ion conductivity the low ion mass measurement is used . the excitation voltage is impressed across a conductivity sensor assembly ( 52 ) by a coupling circuit ( 53 ). the sensor assembly represents a load that can be considered as a fixed capacitance due to the tube wall in series with a parallel combination of fixed capacitance due to the solution dielectric and a variable resistance ( conductance ) due to ion solutes in the solution . however , because of the physical design of the conductivity tube and electrode assembly described herein , the capacitance due to the solution can be neglected and the load , simplified to a fixed capacitance and variable resistance series circuit . the current in this capacitance - resistance series circuit is shown in the phasor diagram of fig4 ( a ). the reference phasor is the excitation voltage ( 101 ). the circuit current leads this voltage with a phase angle that depends on the variable resistance component . at high resistance ( low ion concentration ) the current is small and has a small phase lead ( 102 ). at a standard resistance ( typical ion concentration ) the current is moderate with a phase lead of about 45 degrees ( 103 ). at low resistance ( high ion concentration ) the current is large and with a phase lead approaching 90 degrees ( 104 ). with the ion concentration range found in healthy to mastitis infected cows the practical variation in phase is rather less than the 0 to 90 degree limit points above . in addition , the current amplitude is small for practical excitation voltage amplitudes and therefore sensitive to interference from electrical noise . the phase of the current does however represent conductivity and is the fundamental output of the sensor ( 54 ) ( fig3 ). in order to improve both the range of phase shift and amplitude of the conductivity sensor , a second development current is employed . this is derived from the excitation voltage ( 51 ) using a development current circuit ( 55 ). the circuit is designed to produce a current that is equal in magnitude but opposite in phase to the imaginary component of the sensor current output at a standard ion concentration . the development current output ( 56 ) and conductivity sensor current output ( 54 ) are summed ( 57 ) to give the improved performance . the phasor diagrams in fig4 ( a ) and ( b ) illustrate the effect of employing the development current . the development current as designed lags the excitation voltage ( 101 ) by − 90 degrees ( 105 ). when added to the sensor current the resulting output amplitude is maintained a moderate level and the phase shift range is doubled . at high resistance ( low ion concentration ) the current is moderate with a lag approaching − 90 degrees ( 107 ). at a standard resistance ( typical ion concentration ) the current is moderate and about the same phase as the excitation voltage ( 108 ). at low resistance ( high ion concentration ) the current is moderate with a lead approaching 90 degrees ( 109 ). the sensor and development current summer ( 57 ) also converts the current to an ac coupled output voltage ( 58 ). this is fed to a phase detector circuit ( 59 ) to give an unfiltered conductivity measurement output ( 60 ). in one embodiment of the present invention the excitation voltage coupling , current phase - shift response , development current summation and ac coupled output are performed by a compact circuit segment shown in fig5 . a high frequency transformer ( 121 to 123 ) shown in the equivalent circuit form of an ideal transformer ( 121 , 122 ) and magnetising inductance ( 23 ) is used to couple the excitation voltage ( 51 ) to the sensor arrangement ( 52 ). the sensor response current flows in the transformer secondary ( 121 ) and is reflected in the transformer primary ( 122 ). the development current flows in the magnetising inductance of the transformer ( 123 ). in a real transformer the primary and magnetising inductance are one , and the response and development currents are summed intrinsically . a resistor ( 126 ) is used to convert the resulting current ( 125 ) to a voltage which is ac coupled using a coupling capacitor ( 127 ) to provide the required output voltage ( 58 ). the use of a transformer as a coupling device also provides a large common - mode impedance caused only by transformer inter - winding and stray capacitance ( 124 ). this reduces spurious behaviour due to stray fields coupling into the sensor fluid and surrounding environment . for one implementation of the sensor arrangement discussed herein the transformer was designed with a magnetising inductance of about 13 uh . in a preferred embodiment of the present invention the excitation voltage ( 51 ) is also impressed across a bi - pass tube or tubes and sensor assembly ( 61 ) by a coupling circuit ( 62 ). the sensor assembly represents a load that can be considered a capacitor in series with a parallel combination of capacitor and resistor as for the conductivity sensor . with a solution of low ion concentration , the resistance due to the solution is small and the load can be simplified to a fixed capacitance and variable capacitance series circuit . the current in this capacitance - capacitance series circuit leads the excitation voltage by 90 degrees and has an amplitude that depends on the solution mass within the bi - pass tube . the current has zero amplitude for an empty tube and reaches a maximum when the tube is completely full . the current amplitude when the tube is full is relatively small for practical excitation voltage amplitudes and becomes increasingly sensitive to interference from electrical noise as the tube empties . the current does however represent mass as amplitude and is the fundamental low ion concentration mass sensor output ( 63 ) ( fig3 ). to prevent interference from electrical noise an offset current is used . the offset current is derived from the excitation voltage ( 51 ) using an offset current circuit ( 64 ). the circuit is designed to produce constant amplitude current in phase with the sensor current output . the offset current ( 65 ) and mass sensor current ( 63 ) are summed ( 66 ) so that an empty bi - pass tube gives a current equal to the offset current . the mass sensor and offset current summer ( 66 ) also converts the current to an ac coupled output voltage ( 67 ). this is fed to an amplitude detector circuit ( 68 ) to give an unfiltered mass measurement ( 69 ). mass flow , volume and yield are determined from the time dependence of mass within the sensor tube . in one embodiment of the present invention the excitation voltage coupling , current amplitude response , offset current summation and ac coupled output are performed by the same compact circuit as with the conductivity measurement in fig5 . when the solution has a high ion concentration the situation is similar to that for the conductivity sensor assembly and a duplicate signal conditioning circuit is used to represent mass as phase shift as the unfiltered high ion concentration mass sensor output . since this operates in identical fashion to the conductivity sensor no further explanation is given here . the measurement from the conductivity sensor defines the ion concentration of the solution and is used to determine the most appropriate mass sensor output . in one embodiment of the present invention the phase detector ( 59 ) and amplitude detector ( 68 ) are as set out in fig5 . the approach used gives an accurate and cost effective solution to detecting the phase and amplitude of the high frequency sine - wave signals . the phase detector compares a zero phase reference output ( 72 ) to the improved conductivity output ( 68 ). the reference output is used to give a phase reference that tracks the improved conductivity output . the reference output is derived from the excitation voltage ( 51 ) using a reference current circuit ( 70 ). the output from the reference current circuit ( 71 ) is fed to a current to voltage converter with an ac coupled output ( 72 ) to give the required zero phase reference ( 73 ). in one embodiment of the present invention the zero phase reference output is obtained using a resistance - capacitance phase shift circuit and an ac coupling capacitor . subsequent signal conditioning for the zero phase output ( 72 ) and the improved conductivity output ( 68 ) is through identical pathways to ensure the relative phase relationships are accurately maintained . a precision squaring circuit is formed by the dc restoration circuit ( 74 ), high - speed comparator ( 75 ) and 50 % duty cycle integrator ( 76 ). the squaring circuit operates as a feedback regulator for the dc restoration level that produces a square - wave output with a precise 50 % duty cycle . squared - up forms of the two input waveforms ( 56 and 54 ) are fed into a high - speed digital phase comparator ( 80 ) to give the unfiltered conductivity measurement ( 60 ). the amplitude detector also utilises a precision squaring circuit . this is formed by the dc restoration circuit ( 81 ) high - speed comparator ( 82 ), duty cycle reference ( 83 ), and programmable duty cycle integrator ( 84 ). again the squaring circuit operates as a feedback regulator for the dc restoration level but in this case produces a rectangular - wave output with a duty cycle equal to the duty cycle reference ( 83 ) which is set for a low value . when the amplitude of the mass sensor output ( 67 ) is small the output of the integrator will produce a dc value slightly less than the switching threshold of the high - speed comparator to maintain a low duty cycle . when the amplitude of the mass sensor output ( 67 ) is large the output of the integrator will produce a dc value significantly less than the switching threshold of the high - speed comparator to maintain the same low duty cycle . in this way the dc restoration level represents amplitude and is the unfiltered low ion mass output ( 69 ). of relevance to the third and fourth aspects is the use of information in the determination of stock and plant performance during a normal milking session . fig7 shows the information flow . multiple measurements are made by multiple units ( 150 ) during the milking process . within each unit the measurements are filtered , combined and qualified by analysing trends as a cow is milked to provide derived parameters with improved reliability or accuracy . the derived parameters are made available over a communications network ( 152 ). the information from the communications network is collected and used to incrementally construct statistical profiles for each derived parameter ( 152 ) and at the end of the milking process the set of profiles is saved for later use ( 154 ). at some stage near the start of the milking process a determination is made as to which of the stored set of profiles best matches the current milking situation ( 155 ). the best match set together with user or pre - determined standards of performance ( 156 ) and the current incremental profiles ( 152 ) are used to calculate performance assessment criteria ( 157 ). these are made available on a communications network or used locally . the assessment criteria are used to determine performance by comparison with measurements during the milking ( 158 ). the use of best match profiles allows performance to be monitored and assessed relative to the norms of a particular herd and plant . performance determined in this way is of the most practical value as farm management is performed within parameters determined by local conditions . it allows performance to track with local variation such as farm location , changes in feed , and stage of lactation . this prevents excessive alerts from absolute measurement not relevant to the local situation . in addition , the selection of best match profiles including frequency of occurrence distributions allows for management with performance standards defined by a number of stock . a standard of this kind can be used with the best match profile distribution to calculate performance criteria for measurements to separate out the desired number of stock . this is in sympathy with on farm management practices and rather more useful than management based on an absolute thresholds . in one embodiment of the present invention a bail unit is used for making measurements ( 151 ). the bail unit incorporates a microcontroller for signal processing of measurements , operation of local interface outputs and communication over a common power bus . signal processing combines conductivity and mass measurements with additional measurements of solution temperature , ambient temperature and time . processing includes range and mean filtering to remove noise and improve accuracy , linearisation and scaling to give corrected values , and qualification by analysing trends as a cow is milked to provide derived parameters with improved reliability or accuracy . time and frequency domain analysis are used to determine rates and periodicity . known heat transfer models can be used to relate temperature information to mixed air and solution to provide an alternative mass - flow estimation . the information from the low level measurements and derived parameters from signal processing are used to define application level measurements of flow rate , indicative mastitis , volume yield , flow periodicity , flow temperature , cycle time , cycle state ( start , mid , end ), and cycle type ( milking or cleaning ). the application level measurements are compared with calculated performance criteria ( 157 ) to determine stock and plant performance . stock performance includes indicators of milk with mastitis , milk flow , milk volume yield and end of milking . plant performance includes abnormal bail equipment characteristics including milking time , air solution ratio , pulsator rate . abnormal cleaning characteristics include correct hot or cold cycles , cleaning phases ( rinse , wash ) cleaning volume , cleaning temperature and detergent use . in one embodiment of the present invention performance criteria and measurements are compared in the bail unit and indicated through a local interface . one arrangement includes a display with lights ( led &# 39 ; s ) for performance level and parameter type and an audible sounder and relay output for an unsatisfactory performance alert . alerts include mastitis ( mastitis alert ), low yield ( yield alert ), abnormal bail equipment ( plant alert ) and abnormal cleaning ( clean alert ). application level parameters are also indicated through the local interface . these include current milk flow , mass , volume , yield and end of milking . in one embodiment of the present invention the communications network ( 151 ) is provided for using modems on a power distribution bus . connected to the same bus is a command unit . in the command unit measurements are collected and parameter profiles built ( 152 ), sets of profiles stored ( 152 ), settings for user and pre - determined standard of performance are provided ( 158 ) and performance assessment criteria are calculated . in one arrangement sets of profiles are stored for two previous milkings ( normally the previous morning and evening ). the best match profile set is that which corresponds to the current milking based on an elapsed time of about 24 hours . user input is set through a function ( parameter type ) and threshold ( standard of performance ) switch stored in the command unit with a save switch . lights ( led &# 39 ; s ) are used to give an indication of the current settings . functions can be disabled by special threshold values . the sensor technology described herein provides for a sufficiently accurate measurement of milk conductivity under the conditions of low flow milk mixed with air to be of practical use in detecting mastitis . it is possible to make accurate conductivity measurements because of the sensor manifold design that provides at least partial separation of milk and air and a conductivity tube geometry with coordinated electrode arrangement for sensing through the tube wall that is sensitive to conductivity . measurements are further improved by signal conditioning that uses a phasor addition method to cancel unwanted effects caused by sensing through the tube wall . this increases output range and noise immunity . the bi - pass portion of the sensor manifold is used with similar electrode arrangements and sensing circuits enable the solution mass to be measured and therefore mass , flow , volume and yield to be determined . the sensor manifold , electrode arrangement and signal conditioning circuits form a simple , reliable , and low cost sensor with no moving parts , no electrodes in solution , no hygiene traps and minimal head loss . placement in the top of the long milking tube provides protection from the harsh milking environment and enables automatic measurements . preferred arrangements include additional sensing and signal processing that provides for additional measurements of stock and plant performance . implementation using multiple bail units communicating over a network to a single command unit allows for profiles of measurement parameters to be constructed and stored . this enables standards of performance to be defined in terms of on farm stock and plant norms using levels or number of stock in contrast to other systems that enforce absolute standards . using standards within an on farm context is in keeping with farm management as is actually practised . the bail unit and command unit implementation provides an effective low cost solution well suited to the practical farm environment . the basic system can be extended for other dairy automation requirements including remote display , cow identification and counting , automatic cluster removal , supplement feeding and automatic cow drafting . a preferred communications interface on the command unit together with support software enables remote access using standard telecommunications infrastructures including the internet to provide farm or industry based computer systems and services . where in the foregoing description reference has been made to integers or components having known equivalents then such equivalents are herein incorporated as if individually set forth . although this invention has been described by way of example it is to be appreciated that improvements and / or modifications may be made thereto without departing from the scope or spirit of the present invention .

a measurement sensor where a mixed solution enters a manifold and is separated in an entry chamber by a whirlpool and / or setting effect . an accumulation chamber and outflow positioned in the lower peripheral of the entry chamber causes the separated solution to preferentially flow to a sensing tube with surface to sectional area dimensions optimised for high frequency electric field measurement of solution parameters used to determine capacitance and conductivity . overflow of mixed solution enters similar sensing tubes , for mixed flow measurements used to determine mass and flow rate . the number and size of the overflow tubes give minimal head loss through the manifold . solution is recombined in an exit chamber that causes fluid dynamic restrictions to extend solution residence time in measurement tube before exiting the manifold . also disclosed is measurement of a fluid parameter by improving the measurement sensitivity by at least partially canceling the effect of dielectric properties of the containment wall through which the parameter is sensed , and a method for determining plant performance using stored performance profiles .

fig1 and fig2 illustrate , respectively , the bowling table 1 taught by this invention rom the side and from above . the alley 2 can , in general , be divided into four portions : a ball launching portion 3 , which corresponds in general to the area of a full scale bowling alley from which the bowler launches the ball ; a flat portion 4 , which may be of various lengths without adversely affecting the function of the invention ; a troughed portion 5 , which produces effects similar to those produced by the spin of the ball in full scale bowling ; and a pin bearing portion 6 , which is flat and somewhat triangular in outline . the approximate boundary between portions 4 and 5 is indicated by the broken line &# 34 ; a &# 34 ;. the approximate boundary between portions 5 and 6 is indicated by broken line &# 34 ; b &# 34 ;. the line between the ball launching portion 3 and the flat portion 4 designates the first edge 7 of those portions of the alley 2 that corresponds with the lane of full scale bowling : flat portion 4 and troughed portion 5 , together with pin bearing portion 6 . the second edge 8 indicates the boundary of the alley 2 opposite the first edge 7 . a bin 9 is located adjacent to and below the second edge 8 to catch any balls 10 that cross the second edge 8 as well as any pins 11 that may be knocked over . ( only pin 11 is labelled to avoid a confusing duplication of reference numbers and crowding of the figures ; however , it will be understood that all of the circles inscribed in portion 6 represent pins 11 ). the table 1 is also provided with gutters 12 ( as in full scale bowling ) which open into the bin 9 and are inclined such that a ball 10 crossing over one of the side edges of the alley 2 and entering the gutter 12 will roll down towards , and be emptied into the bin 9 . a return gutter 13 is provided below the table 1 with its entry 14 at the end of the table adjacent to the second edge 8 . the return gutter 13 slopes downward to a ball rack 15 located below and adjacent to the ball launching portion 3 such that a ball entering the return gutter 13 at its entry 14 will automatically roll down into and be contained by the ball rack 15 where it is easily accessible to game players . models have been made where the bin 9 is constructed so as to automatically funnel the ball 11 to the entry 14 ; however , where manual pin spotting techniques and mechanisms are used and provided , it has been determined that the configuration shown is just as suitable . the ball may be manually launched ; however , it has been found that this invention can be more simply and effectively utilized when some simple , aimable launching means is provided . this launching means needs to be freely aimable , and capable of providing a freely adjustable impetus to the ball so that the player can , by propelling the ball at varying speeds and angles , fully exploit the variety of shots that are available for bowlers on a full scale lane . in the instant embodiment , a ramp 16 is provided which may be rotated freely on a pivot 17 . the pivot 17 is slidably anchored in a slot 18 so that the ramp 16 may be moved from side - to - side in the ball launching portion 3 . for each position chosen , the ramp 16 may also be freely rotated on its pivot 17 so as to allow the ball to be launched from varying angles . the velocity of the ball can be simply and efficiently controlled by releasing it from different heights on the ramp 16 . for ease in placement (&# 34 ; spotting &# 34 ;) of pins 11 , a pin spotter 19 is provided . as illustrated in fig1 and 2 , the pin spotter 19 is a flat , relatively thin member having circular perforations 20 slightly greater in diameter than the pins utilized . ( only one perforation 20 if labelled to avoid a confusing proliforation of reference numbers ; however , it will be understood that all of the circles in pin spotter 19 represent perforations 20 ). when not in use , it is rotated back on the spotter pivot 21 so as to cover the bin 9 . to put it into use , it is raised and rotated forward on the spotter pivot 21 so that it is above the pin bearing portion 6 . from this position , it may be dropped directly downward to a resting position only slightly above the pin bearing portion 6 . guiding rods 22 are provided on each side of the pin spotter 19 to assure that the pin spotter 19 moves straight up and down for at least the distance necessary to bring it above the pins 11 before it can be rotated backward on the spotter pivot 21 . these rods 22 enter the slots 23 located in the sides of the bin section 24 when the pin spotter 19 is allowed to drop down over the pin bearing portion 6 . with the pin spotter 19 in this position , the pins 11 can be quickly and easily returned to their positions on the pin bearing portion 6 by inserting their base through the perforations 20 and leaving them standing on the pin bearing portion 6 . the pin spotter 19 is then returned to its resting position over the bin 9 . handles 25 have also been provided at the sides of the pin spotter to assist the user . the simple manual system illustrated can , of course , be replaced by more complex mechanical and electronic pin spotting and scoring mechanisms of the type well known in the art . however , the system illustrated has the virtue of simplicity and is easy to manufacture and use . lighting has also been added in some models to illuminate the pins 11 in their standing location . this also adds to the realism of the format . fig3 , 5 , and 6 illustrate the unique and novel cross - section given to the concave portions of the alley 2 of the instant invention . as previously noted , the flat portion 4 may be of various lengths without adversely affecting the function of the invention . in the embodiment shown , it is approximately 24 inches in length . it can be shortened considerably or even eliminated . however , in full scale bowling , the effect of spin on the ball &# 39 ; s trajectory is not generally obvious until the ball has traveled some distance down the alley . thus , including a flat portion 4 in the alley 2 allows the invention to more closely replicate the experience of full scale bowling . in the embodiment shown and discussed , the alley 2 ( as measured between the first edge 7 and the second edge 8 ) is approximately 96 inches long . it is 9 1 / 8 inches wide . the weight and dimensions of the various components should , ideally , be proportionate to those utilized in full scale bowling . thus , the pins should be in substantially the same proportion to the size and weight of the ball used as the size and weight of full - scale pins are to full - scale bowling balls . likewise , the length and width of the alley 2 should be in the same proportions as the length and width of a full - scale bowling alley . however , wide variation in dimension is possible without exceeding the ambit of this invention . as shown in fig3 the troughed portion 5 has a central concavity 26 which begins at a point adjacent to the flat portion 4 , and gradually develops in the center of the alley 2 . as it moves away from the flat portion 4 , the concavity 26 becomes both wider and deeper . at a point approximately 80 inches from the first edge 7 , it reaches a maximum depth of approximately one quarter inch ( 1 / 4 &# 34 ;). as illustrated in fig4 the width of the concavity 26 gradually expands until it completely spans the distance between the gutters 12 . the bottom of the concavity 26 gradually becomes flatter as it reaches its maximum depth . thus , as illustrated in fig5 the concavity 26 begins to develop a more &# 34 ; bowl - like &# 34 ; shape with steeper sides ( than those shown in fig3 or 4 ) as it approaches the pin bearing portion 6 . in the embodiment shown , the depth of the concavity 26 then begins to gradually decrease as it approaches the triangle shaped pin bearing portion 6 , which is at the same level as the flat portion 4 . as it advances toward the second edge 8 , the bottom of the concavity 26 must rise first to meet the point of the pin bearing portion 6 which is closest to the first edge 7 . this results , as illustrated in fig6 in the creation of two subtroughs 30 adjacent to the sides of the pin bearing portion 6 . the pin bearing portion 6 need not , however , be at the same level as alley 2 for this invention to function properly . further , numerous other changes can be made to the contour and configuration of the concavity 26 without exceeding the spirit and scope of this invention and the claims . the inventive concept embodied herein comprehends any bowling - type games with an alley having a bilaterally symmetrical central concavity running from a point proximate to the first edge 7 to a point proximate the second edge 8 , where the central concavity gradually expands in width and depth as it moves toward the second edge 8 until it reaches a maximum depth , and has a bottom that becomes progressively flatter and sides that become progressively steeper as it moves toward the second edge . in addition to the foregoing features , the bowling table 1 may be advantageously provided with adjustable ( screw threaded ) pads 27 that allow it to be tilted or inclined . bubble - type levels 28 are also a useful addition as they assist in both leveling the table 1 and in monitoring the degree and informity of the tilt or incline given to the table 1 via pads 27 . finally , spotting markers 29 , which may consist of circular indentations in the surface of the ball launching portion 3 as shown , are provided in this embodiment to assist visually handicapped players to correctly position the ramp 16 . ( not all of the markers 29 are numbered to avoid needless duplication of reference numerals ; however , it will be understood that all of the small circles in the ball launching portion 3 which are identical to those labelled &# 34 ; 29 &# 34 ; are markers 29 ).

a bowling game table featuring a lane surface having a bilaterally symmetrical central trough which , beginning at a point proximate the edge from which the ball is rolled toward the pins , gradually expands in width and increases in depth until it reaches a maximum depth , and continues expanding in width until it spans the entire width of the lane surface while maintaining said maximum depth .

referring to fig1 a presently preferred embodiment of pressure equalizing apparatus 10 according to the present invention includes activation means 12 , compressor 14 and nostril plug 16 . referring to fig2 activation means 12 includes power source 18 , switch 20 and power variation device 22 . compressor 14 is activated by activation means 12 . more specifically , compressor 14 includes motor 24 having motor shaft 26 . motor shaft 26 is connected to piston 28 through pivoting linkage 30 . pivoting linkage 30 includes rotating disk 32 having pin 34 extending transversely therefrom , and arm 36 . pin 34 pivotally engages arm 36 . arm 36 pivotally drives piston 28 upon rotary motion of shaft 26 and disk 32 . oscillation of piston 28 effects operation of flutter valves 38 and 40 . deflection of flutter valves 38 and 40 operate to create air flow through exit port 42 . exit port 42 communicates with channel 44 in nostril plug 16 . referring to fig3 during the downward stroke of piston 28 , flutter valve 38 operates to allow air to be drawn into chamber 46 through port 48 . more specifically , shoulder 50 , having radially extending ridges and channels , prevents disk 52 from sealing off port 48 during the downward stroke of piston 28 . simultaneously , flutter valve 40 prevents the drawing of air through exit port 42 . shoulder 54 is relatively smooth , allowing disk 56 to provide a seal to prevent the drawing of air through exit port 42 . referring to fig4 during the upward stroke of piston 28 , air which was previously drawn into chamber 46 during the downward stroke of piston 28 , is expelled through exit port 42 by operation of flutter valve 40 . during the upward stroke of piston 28 , shoulder 58 and disk 56 operate similar to disk 52 and shoulder 50 during the downward stroke . simultaneously , flutter valve 38 prevents the expulsion of air through port 48 . during the upward stroke of piston 28 , disk 52 and shoulder 60 operate similar to disk 56 and shoulder 54 during the downward stroke of piston 28 . compressor 14 provides a rapid succession of pulses of air as a function of the rotational speed of the motor . the succession of pulses is therefore so rapid that a continuous air flow is delivered in this context . in use , the air flow is continuous for the period of the procedure which may vary from a few seconds to several minutes . the apparatus should provide the user with sufficient control over the duration of the continuous air flow period to minimize difficulties associated with the timing of the delivery of air to the patient and swallowing . the requisite duration may be either user - defined by turning the device on or off , or apparatus - defined , i . e ., intermittently providing continuous air flow over a timed interval . while the air flow provided is continuous , the air flow rate need not be constant and is likely to vary as a function of the back - pressure created in the patient &# 39 ; s nasal cavity . activation means 12 and compressor 14 are combined to provide a constant air flow which is bounded by a maximum constant air pressure . as used herein , the term &# 34 ; air pressure &# 34 ; is intended to mean the constant air pressure as measured by a bourdon - spring type pressure gage . switch 20 may include a locking element to hold switch 20 in the on position . in an alternate embodiment , switch 20 may be spring biased and thus , require pressure to maintain the on position . additionally , power variation device 22 acts to vary the power supplied to motor 24 , thereby varying the rotational speed of shaft 36 and thus , regulating air pressure supplied through exit port 42 and nostril plug channel 44 . power source 18 may include batteries . pressure equalizing apparatus 10 is operated by inserting nostril plug 16 into a first nostril . the operator creates a seal by inserting nostril plug 16 into the first nostril . the operator &# 39 ; s second nostril is collapsed using a free hand to prevent leakage therethrough . activation means 12 is used to control compressor 14 . accordingly , air is supplied through nostril plug 16 into the first nostril . the operator may then adjust the air pressure delivered to the first nostril by adjusting power variation means 22 . the operator then swallows , opening the eustachian tube to allow equalization of middle ear pressure with the ambient pressure . nostril plug 16 has an outer shape to accommodate various nostril sizes . nostril plug 16 may be conically tapered , having an angle of inclination , θ , of approximately 70 °, a base diameter of approximately of 1 . 0 inch tapering to a tip diameter of approximately 0 . 375 inches . the diameter of channel 44 is preferably approximately 0 . 0938 inches . referring to fig5 and 6 , nostril plug 16 may be cylindrically shaped having a spherically shaped top accommodate various nostril sizes . the compressor 14 must generate sufficient air pressure at the exit of channel of 42 to operate effectively . the preferred minimum air pressure which the device must be able to create is approximately 0 . 5 pounds / inch 2 ( p . s . i .). while the upper limit of pressure which the device can create may exceed the limit specified herein , it is believed , for the safety of the patient , that the pressure created by the device should not exceed approximately 3 . 5 p . s . i . preferably , the maximum air pressure is approximately 2 . 0 p . s . i . the peak flow rate of air should be within the range of 0 . 5 liter / minute to 4 . 0 liters / minute . preferably , the peak flow rate should be between 1 . 5 liters / minute and 2 . 0 liters / minute . referring to fig5 an alternate embodiment of pressure equalizing apparatus 10 includes nostril plug 16 , handle 66 , multi - position switch 20a and operating display 68 . multi - position switch 20a replaces switch 20 and power variation device 22 previously discussed . multi - position switch 20a is positioned relative to handle 66 to allow manipulation using a thumb which is associated with the hand which is used to hold apparatus 10 . as a result , the user may support and control apparatus 10 using one hand . referring to fig7 multi - position switch 20a may occupy one of three positions . in the first position , switch 20a contacts first element 21 a to occupy a first operating state . the value of resistor 23a is selected to achieve the characteristics associated with the first operating state of the air flow source . in one embodiment , resistor 23a is a 3 . 3 ohm resistor intended to achieve an air flow rate of 1 . 0 liter / min . and maximum air delivery pressure of 1 . 5 p . s . i . in the second position , switch 20a contacts second element 21b to occupy a second operating state . the value of resistor 23b is selected to achieve the characteristics associated with the second operating state . in one embodiment , resistor 23b is a 1 . 0 ohm resistor selected to achieve an air flow rate of 2 . 0 liters / min . and a maximum air delivery pressure of 3 . 0 p . s . i . preferably , the first and second operating states are selected to achieve incremental operating states , i . e ., the first operating state has an operating characteristic which is lower than that of the second operating state . operating display 68 may include any number of indicators which inform the operator of the status of the apparatus 10 . for example , operating display 68 may provide an indicator which indicates that the switch 20 occupies the on position . in an embodiment having a multi - position switch 20a , any number of indicators may be provided to indicate which position is being occupied by switch 20a . for example , referring to fig7 first and second positions of switch 20a cause leds 69a and 69b , respectively , to emit light . in addition to multi - position switch 20a and associated indicators 69a , 69b , the circuitry provides for a battery low indicator . a commercially available chip , max666 , two 1 kohm resistors and an led are connected as illustrated in fig7 to achieve the desired configuration of one embodiment . referring to fig5 nostril plug 16 is removable from apparatus 10 . nostril plug 16 is fictionally fit into opening 70 of apparatus 10 . alternatively , plug 16 is in threaded engagement with mating threads on apparatus 10 . referring to fig6 nostril plug 16 includes shoulder 72 which , when inserted into opening 70 , engages rim 74 of opening 70 . a spring 76 is biased between nostril plug 16 and apparatus 10 . nostril plug removal element 78 is provided to disengage shoulder 72 and rim 74 . as a result , spring 76 expels plug 16 from opening 70 once shoulder 72 disengages rim 74 . preferably , nostril plug 16 is constructed from material making disposal and replacement thereof inexpensive . in an alternate embodiment , an inhalable gas , stored in a container under pressure may be used in conjunction with a valve to provide a relatively constant flow of gas to a nostril plug . in a further embodiment , a motorized fan may be used to replace the compressor to generate the necessary pressure or air flow . while preferred embodiments of the present invention have been shown and described , it will be understood by those skilled in the art that various changes and modifications , could be made without varying from the scope of the present invention , including the incorporation of features discussed with respect to one embodiment into a device according to a different embodiment .

an apparatus for equalizing pressure in a middle ear includes a hand held air source for providing a continuous flow of air at a predetermined rate and a tapered sealing nostril plug adapted to be inserted into a nostril . the tapered nostril plug has a channel therethrough for delivering the continuous flow of air . the channel of the tapered plug is adapted to be placed in communication with the air source , and a controller is coupled to the air source to limit the pressure provided at the channel of the nostril plug to substantially no more than 3 . 0 pounds per square inch .

although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention , the physical embodiments herein disclosed merely exemplify the invention , which may be embodied in other specific structure . while the preferred embodiment has been described , the details may be changed without departing from the invention , which is defined by the claims . referring to fig1 , the preferred embodiment 10 of the present invention is depicted . the present invention comprises a substantially tubular structure 12 having at least one internal pocket 14 and at least one internal resilient object 20 . as disclosed in the view of fig1 , a preferred embodiment utilizes three objects or orbs 20 a , 20 b and 20 c , located in the left end pocket 14 a , the right end pocket 14 b and the centrally located pocket 14 c , respectively . the opening or openings 22 are of a size permitting access of an orb 20 a , 20 b , 20 c to a respective internal pocket 14 a , 14 b and 14 c . the openings 22 may further include resealable fasteners 24 for retaining the resilient object 20 within a respective pocket 14 during use . the tubular structure 12 may be constructed from any suitable web - like material 26 including , but not limited to , cloth , silk , canvas or mesh . the web - like material 26 is preferably strong but soft , flexible , absorbent and able to provide some amount of friction to aid in grip . the material 26 will preferably be an absorbent material , such as “ terry cloth ” commonly used in the manufacture of toweling and capable of being washed and dried by machine . the apparatus 10 may be made from a single web 26 folded lengthwise to provide an enclosing crease 13 substantially coextensive with the length of the structure 12 . the fold is preferably sewn shut at spaced intervals 17 along the side 19 opposite the crease 13 . the end portions 30 of the tubular structure 12 are closed to provide at least one internal pocket 14 formed within the structure 12 . the pockets 14 are each formed by conventional sewing thread stitching 32 , or by adhesive or heat fusion techniques to join the facing internal surfaces of the folded web 26 surfaces at longitudinally spaced intervals , and lying transversely relative to the lengthwise crease 13 to defined pocket dividers 32 . various embodiments of the present invention may contain different numbers and arrangements of the internal pockets 14 . the preferred embodiment 10 includes three internal pockets 14 , including two end pockets 14 a , 14 b and a centrally located pocket 14 c . contained within at least one of said internal pockets 14 a , 14 b , 14 c is at least one resilient object or orb 20 . the object 20 may serve multiple purposes , such as providing a means of gripping the device and providing a substantially rigid shape that is conducive to massage and accupressure therapy . a preferred object or orb 20 is in the form of a conventional tennis ball . the primary purpose of the centrally located object 20 c is to provide a fairly rigid , but flexible localized area to aid in the transfer of pressure to a pressure point region . a secondary function of the centrally located object 20 c is to provide a gripping area for use when manipulating the invention 10 . although these resilient objects 20 have preferred functions , based on location , each is capable of performing other functions , as well . because the preferred function of any given resilient object 20 may change with its location along the length of the tubular structure 12 , different objects 20 may be chosen for having different properties . properties that may affect the choice may be size , shape , hardness , resilience or flexibility . for example , in the preferred embodiment 10 , the end objects 20 a and 20 b may be fairly large , but somewhat soft , capable of contouring to a user &# 39 ; s hand quickly during a given exercise . the central object 20 c may be a smaller , harder , spherical object that transfers pressure more effectively . it should be noted that no two objects 20 are required to be substantially alike . the objects 20 may also be custom selected for the individual user . additionally , individual pockets 14 may or may not contain an object 20 . individual pockets 14 may also contain multiple objects . the invention preferably utilizes at least one pocket opening 22 . each opening 22 provides reclosable access to an internal pocket 14 , and may be located anywhere on the device 10 . the openings 22 allow the resilient objects 20 to be removed and exchanged , permitting the device 10 to more easily serve multiple functions . the objects 20 may also be removed while the device 10 is being washed . each opening 22 preferably includes a resealable fastener 24 as a means of securing an object , or objects 20 within a respective pocket 14 a , 14 b , 14 c for opening and resealing during use . the resealable fasteners 24 may be of any appropriate type , such as zippers , buttons or snaps . the fasteners 24 will preferably be fairly soft , flexible , and allow an internal connection . the preferred embodiment 10 uses a hook and loop style fastener 24 of the variety commonly known as “ velcro ”®. referring to fig4 , the device is shown used for a muscle stretching exercising usage . the length of the structure 12 is essential to achieving the proper stretching and motion techniques . therefore , various users require a structure 12 of various lengths . as illustrated in fig3 , the device 10 , including an object 20 c , provides a useful , and comfortable , acupressure apparatus . as will be observed , a person being treated for headaches or stiff neck , or difficulty turning the head , merely grips the end portions 30 , containing orbs 20 a and 20 b , and longitudinally stretches the material of the web structure 12 to tighten the area of the orb 20 c and press the orb 20 c against a selected acupressure treating area 35 a or 35 b , known respectively as “ anmian points ”, in the case of treatment for emotional stress which may cause restlessness , tight muscles of the neck , and headaches , or at a centrally located neck muscular area ( not specifically shown ), commonly known as the “ ashi point .” acupressure and massage of a respective anmian or ashi point has been found to reduce tense muscles and also helps to soothe stressful emotions . another use for the device is rotational exercise techniques . such techniques are used to strengthen , stabilize and challenge pre - selected muscle groups that are used in various activities . rotational exercise techniques also increase joint health , muscle flexibility and agility , as well as eye hand coordination . one or more gripping portions of the device are grasped by the user and moved in a predetermined pattern . fig5 demonstrates one of many possible exercise techniques using the device 10 . the demonstrated exercise is one of several warm - up exercises incorporated into an exercise routine , with the warm - up exercises lasting about 10 - 15 minutes . these exercises will warm up the core muscles of the user 100 , as well as increase the range of motion of the user 100 . the user 100 grasps the device 10 at or near one of the end portions 30 and begins to move the device 10 back and forth across the body in a “ figure 8 ” pattern , which will help in warming up the muscles of the user 100 . other warm - up movements may be incorporated as well . the user 100 may also decide to switch the device from one hand 102 a or 104 a to the other 104 a or 102 a , and may also decide to incorporate movement of the legs 106 , 108 into the exercises . for instance , the user 100 may decide to pass the device 10 from one hand 102 a to the other 104 a underneath one of the user &# 39 ; s legs , while lifting that leg 106 . the user 100 can incorporate sideways movement of the legs 106 , 108 into this movement . other movements include moving the device 10 around the body while passing it from one hand to the other . sports style movements , such as practicing a batter &# 39 ; s or golfer &# 39 ; s swing , can be incorporated into the warm - up . any of these movements , and other movements , can be used together in various fashions to provide a warm - up routine . because of the design of the device 10 and the placement of the objects 20 a and 20 b within the pouches 14 a and 14 b , respectively , the device 10 and the exercises provide enough resistance for the user 100 to have an efficient warm - up routine . fig6 depicts further exercises for use with the present invention . the user 100 grabs device 10 on or near one of the objects 20 a or 20 b with one hand 102 a and used the other hand 104 a to grab the device 10 on or near the other object 20 a or 20 b . one of the arms is extended outwards in an archer &# 39 ; s type of pose , which allows the arm muscles to be properly stretched . the arms can be switched to stretch the other arm , as well . along with stretching , the opposing , pulling movement of the arms will assist in strengthening the arms 102 , 104 . the shape and design of the device 10 provides proper length and resistance so that the muscles can be adequately stretched . likewise , the design of the device 10 allows for the length of the device to be changed to accommodate shorter or taller users . the device 10 can be used for various stretching routines , by grasping one end of the device in one hand and securing and positioning the other end of the device 10 near or with one of the user &# 39 ; s other appendages , i . e . the user &# 39 ; s other hand or feet . the user 100 will pull the device 10 taut , as necessary , to perform various stretching exercises . the depicted stretching exercise of fig6 is one of several stretching exercises incorporating the device 10 . as an example of another exercise , one of the end portions 30 can be placed under the user &# 39 ; s foot 106 a , while the other end portion 30 will be gripped by the user 100 to stretch the side muscles . either hand can grip the end portion , in the front or the back of the user 100 , to further stretch and twist various muscles , such as the spine muscles . in another example , the device 10 can be gripped with both hands 102 a , 104 a behind the back to stretch chest and back muscles . other standing and kneeling positions can incorporate use of the device 10 . examples of other stretching drills or exercises were previously shown in fig3 and 4 , which can also incorporate using the “ anmian points ” to further provide an overall stretching regime . these stretching exercises can be incorporated into a routine along with the warm - ups demonstrated according to fig5 . fig7 depicts further uses of the device 10 that help in strengthening the user &# 39 ; s muscles . the user 100 holds the device 10 on a surface and forms a push - up type position . the position specifically shown is sometimes referred to as a “ kung fu ” push - up . the user 100 balances on the objects 20 , which allows the user 100 to perform a push - up that requires more balance than a normal push - up , thereby strengthening the user &# 39 ; s muscles . also , the ability to be able to grasp the objects 20 incorporated in the device 10 , as shown , assists the user in keeping the proper spacing when doing the push - ups and other exercises . the objects 20 are preferably ergonomically designed to fit within the user &# 39 ; s hands . the user 100 can incorporate other movements , such as leg lifts , into this exercise , to provide a work - out for the entire body . similarly , the user 100 could perform the push - ups with the knees on the ground , if more comfortable for the user . other similar exercises include using the device 10 and the objects 20 b to lift one &# 39 ; s self in the sitting position , with the user &# 39 ; s legs either crossed out extended outward . this will assist in strengthening the stomach and related core muscles . alternatively , the device 10 can be placed behind the neck ( see fig3 ), and sit - ups or crunches can be performed . the sit - ups can incorporate movements , such as rowing movements used with a kayak , or martial art style thrusts , all the while holding the ends portions 30 of the device to provide resistance while performing the basic exercise movements . these strengthening exercises address the muscles of the body together and not in an isolated manner , which strengthens the muscles and the body in an efficient manner . fig8 provides a further exercise that not only strengthens muscles , but treats the core muscles , as well . there are many core muscles , including the abdominal muscles , gluteus muscles , as well as back and abductor muscles . the user 100 stretches the device 10 behind his head , holding the device at the objects 14 a and 14 b with a hand 102 a and 104 a connected to each of his arms 102 and 104 . the user 100 rests on his side , while crossing his legs 106 and 108 and feet 106 a and 108 a . the user 100 keeps one hand 102 a and one foot 106 a on the floor , while lifting the user &# 39 ; s body and leg 108 off of the ground . this will strengthen the core muscles of the user 100 . other exercises that treat the core muscles include sit - ups and stretches , previously discussed . the device 10 is designed to keep a proper distance between the hands 102 a and 104 a when doing the various exercises , which helps in more efficient exercises and , also , less stress on the neck and other parts of the body . likewise , any of the other described movements , such as the martial arts moves , can be incorporated into these exercises for treating the core muscles . the device 10 and the described exercises provide an easy and efficient workout process that can be tailored to a specific user &# 39 ; s needs and abilities , such as using heavier objects 20 for more strenuous activities . fig9 provides an exercise that will also strengthen the body and treat the core muscles for the user 100 . the user 100 is sitting or lying on a surface in a basic sit - up position . as done with several of the exercises , the user 100 grabs the device 10 at each end portion 30 with each of the user &# 39 ; s hands 102 a and 104 a . the user 100 raises his legs 106 and 108 in the air and can perform sit - ups while moving the legs 106 and 108 inwardly and outwardly from the body or , alternatively , holding the leg 106 in the position of fig9 while performing sit - ups . the device 10 can also be used to improve the coordination of the user 100 . the design and weight of the device 10 allows the user 100 to improve hand - eye coordination . for example , the exercise in fig5 could incorporate a movement , wherein the user 100 twists the device 10 with one hand 102 a and catches the device with the other hand 104 a , similar to movements that a martial artist would do when using nunchucks . other movements , such as rotating the device 10 and stopping the device 10 with a foot 106 a or 108 a , would mimic the movements of a soccer player dribbling a ball . these and many other movements will assist the user 100 to gain improved coordination . it should be noted that the device 10 and method of the present invention incorporates exercises that treat and train the entire body . for example , fig3 - 9 demonstrate various exercises that help the user 100 warm - up , stretch , strengthen the user &# 39 ; s muscles , as well as treating the core muscles and providing a system for improving coordination . the various exercises are designed to address more than one of these areas of note . for example , the warm - up exercises discussed specifically with respect to fig5 , will also address the coordination issues addressed more specifically with respect to fig9 . likewise , the strengthening exercises discussed with respect to fig7 will also address the core muscle groups related to fig8 . the present invention provides a device 10 that will easily adapt from one exercise to the next to address all of these concerns quickly and efficiently . the foregoing is considered as illustrative only of the principles of the invention . furthermore , since numerous modifications and changes will readily occur to those skilled in the art , it is not desired to limit the invention to the exact construction and operation shown and described . while the preferred embodiment has been described , the details may be changed without departing from the invention , which is defined by the claims .

a flexible exercising and massaging apparatus formed from tubular , flexible , web - like material and having a plurality of internal pockets , along with an exercise regimen that includes the apparatus . the pockets located at opposite ends of the tubular material may hold objects such as resilient , hand - graspable orbs , including tennis balls , that aid in gripping the apparatus , and which have also been found to be conducive to self - massage therapy . the objects located within an intermediate pocket or pockets may be removed , and alternative objects inserted , through openings that allow access to a preselected pocket or pockets . the openings may be enclosed with resealable fasteners .

described herein is a novel antibiotic first identified from a strain of streptococcus mutans designated jh1140 . the antibiotic , here termed mutacin 1140 , like other lantibiotics , is a polycyclic peptide which is the product of post translational modification of a precursor protein translated from a single gene transcript in the host organism . the identified molecular structure of mutacin 1140 is illustrated in fig1 seq . id no . 5 . lactate - dehydrogenase deficient mutants of streptococcus mutans have been studied for their potential use in replacement therapy for dental caries . without the trait of ldh , fermentation of carbohydrates by this microorganism employs alternate pathways for pyruvate metabolism that yields significant amounts of neutral end products , and thus ldh deficient strains exude less total acids into the environment . as a result , ldh deficient mutants of this bacteria are less cariogenic . thus , these bacterias are being studied as an effector strain for replacement therapy for dental caries . however , in order to be an effective replacement strain , strains must demonstrate superior competitive colonization properties in order to compete against other strains of the species and to prevent subsequent recolonization by wild - type strains . accordingly , effort has been conducted to find strains which have both superior colonization properties as well as an ldh - deficiency phenotype . one of the evolutionary strategies utilized by microorganisms for enhanced competitiveness with competing strains is the synthesis of antibiotic agents to which competitive strains are sensitive . it was found here that a strain of s . mutans , previously called jh1000 , an ethyl methane sulfonate - induced mutant called jh1005 , and a spontaneous mutant of that strain , known as jh1140 , which have been previously reported to have good colonization properties , produced a potent broad spectrum bacteriocin - like inhibitory substance , referred to as a blis . as described below , the blis was found to inhibit the growth of representative strains of a wide variety of bacterial species . in addition , virtually all known streptococcus mutans strains tested were sensitive to the blis substance . analysis of isogenic mutants of these strains demonstrated good correlation between blis production and colonization potential in both a rodent model and human subjects . utilizing genetic methods , the transcript responsible for the blis activity has been identified and sequenced . presented as sequence id no : 1 below is the genomic copy of the single transcript encoding the peptide responsible for the blis activity , the gene being named here lana . identified as sequence id no : 2 below is the deduced amino acid sequence of the transcript produced by an open reading frame present in sequence id no : 1 . sequence id no : 2 is the pre - protein form which , after proteolytic cleavage and other processing by other factors present in the host organism , results in the synthesis of mutacin 1140 as shown in fig1 seq . id . no : 5 . the proper synthesis of mutacin 1140 in the host microorganism requires the presence of other enzymes to properly process the precursor form of the protein into the effective and active form of the peptide antibiotic . the gene encoding one of those enzymes , here designated lanb , has also been cloned and sequenced and is presented as sequence id no : 3 below . sequence id no : 4 below presents the deduced amino acid sequence of the open reading frame contained in sequence id no : 3 . as used herein , the term &# 34 ; mutacin 1140 &# 34 ; is intended to apply to the peptide antibiotic produced by streptococcus mutans strain 1140 , as well as related peptides produced by minor insertions , deletions or other variants which do not detract from the biological efficacy of the lantibiotic . it should be understood that while the chemical structure presented in fig1 seq id no : 5 , is believed correct , that due to limitation in the analytical techniques used to date to elucidate the structure of the molecule , it is possible that there may be some minor differences between the structure of fig1 seq id no : 5 , and the actual structure of the molecule produced by the bacteria , particularly at the carboxyl - end of the peptide . it is intended that the term mutacin 1140 describes the actual molecule in the event there are such minor differences . it is also anticipated that other evolutionarily - related strains of streptococcus mutans , or closely related strains of other species , could produce allelic variations of this same lantibiotic and the term mutacin 1140 is intended to cover those as well . it has been found that mutacin 1140 is an antibiotic with an evolutionary relationship to another antibiotic known as epidermin produced by staphylococcus epidermidis . the genetic sequence presented below , derived from a mutant strain jh1005 derived from jh1000 , includes sequences with a high degree of homology to epia , b and d , which are genes previously sequenced from staphylococcus epidermidis and found to be involved in the biosynthesis of the antibiotic epidermin . the lana and lanb genes presented herein are believed to be roughly analogous to the epia and epib genes associated with the antibiotic epidermin . the antibiotic polypeptide mutacin 1140 of the present invention can be isolated from the culture medium in which its native host organism , i . e ., a streptococcal organism , has been grown in culture , followed by isolation of the polypeptide antibiotic from the culture medium . in addition , the presentation of the lana and lanb coding sequences below allows for the construction of artificial genes encoding these sequences which can be transformed into other streptococcal species or strains of other bacterial species . two streptococcal strains which produce the mutacin 1140 antibiotic have been deposited with the american type culture collection , rockville , md ., as accession numbers 55676 ( jh1140 ) and 55677 ( jh1000 ) . the mutacin 1140 antibiotic can be recovered from these strains , or other related strains of streptococcal species into which the genetic capability to synthesize mutacin 1140 is introduced using the information from sequence id nos : 1 through 4 below . a potential complexity in the introduction of the phenotype of production of mutacin 1140 into a new strain is the fact that the peptide undergoes post - translational modifications by other genetic elements in the host strain . as mentioned above , the lanb gene presented below is a necessary , but not sufficient , genetic component for the post translational modification . the other post translational modification genes are contained within the genome of strain jh1140 as deposited above . by performing a random - type genetic transfer experiment of dna from mutacin 1140 - competant hosts into other streptococcal strains , one can readily identify what other genetic components are necessary , in addition to lana and lanb presented below , to achieve the fully mature and biologically active form of mutacin 1140 produced by the native producing streptococcal host strains . such procedures are within the ordinary level of skill in the art . once identified , these other genetic components can be transferred together with lana and lanb into a new host which would then produce mutacin 1140 . it is also specifically envisioned that mutacin 1140 can be synthesized ex vivo . a number of techniques exist for the synthesis of peptide molecules by a relatively conventional organic chemical techniques . for example , solid phase polypeptide synthesis permits the creation of peptides , and that technology has evolved to the point where peptides of the size of mutacin 1140 can readily be synthesized outside of a microbial host . it is envisioned that the mutacin 1140 antibiotic will be useful generally as an antibiotic . since the antibiotic is produced by a common streptococcal strain present in human mouths , it is expected to be relatively non - toxic to human species . this conclusion is further buttressed by its analogous characteristic to existing antibiotics , such as epidermin , which are known to be quite non - toxic to mammals . in its method of use , the mutacin 1140 is applied to the area in which it is desired to inhibit microbial growth . a carrier may be used to assist delivery of the antibiotic . in such delivery , it is desired to deliver an effective amount of the lantibiotic , such an effective amount being readily determinable by empirical testing to determine what amount of lantibiotic achieves the desired level of microbial inhibition . a lantibiotic was purified from streptococcus mutans jh1140 using the following procedure : four liter batches of todd - hewitt broth ( thb ; difco ) containing 0 . 5 % le agarose ( seakem ) were sterilized and poured into 90 mm petri plates . the plates were dried overnight at 37 ° c . a pure culture of jh1140 on a brain - heart infusion starter plate was used to inoculate 3 ml of thb and the cell suspension was vortexed for 10 sec . about 0 . 3 ml of the cell suspension was spread on the surface of a bhi agar plate and incubated overnight at 37 ° c . in a candle jar . a 10 - pronged inoculator was ethanol - flame sterilized and used to inoculate jh1140 from the spread plate prepared as above into evenly spaced stabs in the plates prepared as above . the plates were incubated in candle jars at 37 ° c . for 72 hours . the agar was scraped from the plates entirely and placed into centrifuge bottles . the bottles were stored overnight at - 20 ° c . the bottles were then centrifuged at room temperature for 60 min . at 4 , 000 rpm in a sorvall rc2b centrifuge and then for an additional 30 min . at 8 , 000 rpm . the supernatant was recovered and passed through whatman # 1 filter paper in a buchner funnel . to the filtered extract ( ca . 3 , 000 ml ) in a 4 l beaker , 100 ml of chloroform was added . the solution was placed on a magnetic stirrer and agitated at high speed for 120 min . the stir bar was removed and the solution was allowed to stand overnight undisturbed . the aqueous ( upper ) phase was aspirated off and discarded . the chloroform layer , containing a milky white flocculent , was divided into 50 ml conical centrifuge tubes and centrifuged at ca . 4 , 000 rpm for 8 min . residual aqueous material was removed by aspiration . the clear chloroform layer was removed using a pasteur pipette , leaving the flocculent which was washed 2 times with 5 ml of chloroform . chloroform was evaporated from the flocculent using a stream of nitrogen gas ; the tube was placed in a 45 - 50 ° c . water bath during this process to promote evaporation . the dried residue was dissolved in 0 . 5 ml of 50 % ethanol ; undissolved material was removed by centrifugation at 13 , 000 × g for 2 min . at room temperature . the clarified fraction including the lantibiotic was then stored at - 20 ° c . until further use . 5 ml of thb were inoculated with s . rattus strain bht - 2 ( resistant to 1 mg / ml streptomycin ); and grown overnight standing at 37 ° c . 0 . 02 ml of fractions to be tested for lantibiotic activity were serially 2 - fold diluted in distilled water in microtiter wells . top agar was prepared containing bhi broth , 0 . 75 % agar , 1 mg / ml streptomycin , and 1 : 10 , 000 diluted overnight s . rattus bht - 2 culture from above at 42 ° c . ; 0 . 2 ml was pipetted into each microtiter well . after 5 min . at room temperature to allow agar to set , the plate was incubated at 37 ° c . overnight . the minimal inhibitory concentration ( mic ) was determined as the reciprocal of the highest dilution of the test fraction which inhibited growth of s . rattus bht - 2 by visual inspection . single colonies of the strain producing mutacin 1140 were stab inoculated into brain heart infusion medium and incubated overnight in candle jars at 37 ° c . three drops of an overnight todd - hewitt broth culture of the indicator strain were mixed with 3 ml of molten top agar and poured evenly over the surface of the plate . after an additional 24 hours of incubation , clear zones surrounding the test strain were measured . representative strains of various bacteria were tested for their sensitivity to the inhibitory activity of the mutacin 1140 produced by the jh1140 strain by using the overlay technique . in addition to s . mutans , most gram positive organisms were found to be sensitive , including streptococcus mitis , streptococcus pyogenes , staphylococcus aureus , and actinomyces species . the inhibitory factor inhibited 124 of 125 s . mutans strains tested . gram - negative bacteria were invariably resistant to inhibition by mutacin 1140 . the following table summarizes the spectrum of activity found for the lantibiotic . the partially purified mutacin 1140 had the same spectrum of activity displayed by jh1140 , as demonstrated by spotting 5 μl samples on lawns of target strains prepared as described above . this is also shown in the table . table 1______________________________________mutacin sensitivity assay . sup . a test strainsindicator strain target strain jh1140 strain jh1005______________________________________mutans streptococci fa1 ( a ) + +/- bht - 2 ( b ) + + lm7 ( e ) + + ingbritt ( c ) + + mt - 3 ( c ) + + 10449 ( c ) + + jc2 ( c ) + + gs5 ( c ) + + pk1 ( c ) + + streptococcus salivarius ss2 + + o2 + + o4 + + streptococcus sanguis fc - 1 + + kj3 + + challis - + streptococcus mitis mt + + re - 7 + + 26 + + streptococcus pyogenes sta628 + + streptococcus faecalis rf - streptococcus aureus dc3 + + lactobacillus casei lac - 6 - + lactobacillus salivarius ucl - 37 + antinomyces israelii x523 + 10048 + antinomyces naeslundii 12104 + + n16 + + 6 - 60b + + antinomyces viscosus w1528 + t6 + m100 + micrococcus luteus 207 - 79 - bacteroides gingivalis 381 - wolinella recta 371 - capnocytophaga sputigena 4 - ______________________________________ . sup . a sensitivity to mutacin was determined as described . indicator strains were evaluated as sensitive (+) showing zones of 10 - 15 mm in diameter , insensitive (-), or slightly sensitive (+/-) with zones & lt ; 5 mm in diameter to test strain . the inhibitory factor was produced in detectable amounts only during early stationary phase and could be recovered from todd - hewitt broth cultures of jh1140 . the inhibitory factor &# 39 ; s effect on other strains of s . mutans was bacteriocidal , since loopfuls of agar taken from clear zones were found to be sterile . the inhibitory activity in cell - free culture liquors was completely inactivated by treatment with trypsin under the conditions tested . incorporation of trypsin inhibitor into the reaction mixture at a concentration of 100 μg / ml prevented this inactivation . the inhibitory activity was inactivated ca . 50 % by treatment with 100 mg / ml pronase . higher concentrations of pronase ( 250 μg / ml ) or more prolonged treatment ( 1 h ) resulted in complete inactivation of the bacteriocin activity . it appeared to be completely resistant to inactivation by dnase i , rnase a , lipases , thermolysin , and lysozyme . the proteinaceous nature of the inhibitor indicated by this experiment , plus its biological activity , formally qualify it for inclusion in the broad family of bacteriocins . the amino acid sequence of the subject bacteriocin polypeptide was determined . information on the total number of modified amino acids in a lantibiotic can be determined by a combination of a chemical derivatization and electrospray ionization mass spectroscopy . edman degradation of ethane thiol - derivatized mutacin 1140 gave the results shown in the following table . this procedure was performed as described by mezer et al ., ( 1994 ) analyt . biochem . 223 : 185 - 190 . table 2__________________________________________________________________________edman sequencing of mutacin 1140 derivatized with ethanethiolcycle predicted residue identified residue__________________________________________________________________________ 1 phe phe 2 lys lys 3 ser s -- ec . sup . a 4 trp trp 5 ser s -- ec 6 leu leu 7 cys s -- ec 8 thr β - m -- s -- ec . sup . a 9 pro pro10 gly gly11 cys s -- ec12 ala ala13 arg arg14 thr β - m -- s -- ec15 gly gly16 ser s -- ec17 phe phe18 asn asn19 ser s -- ec20 tyr tyr21 cys nd . sup . b22 cys nd__________________________________________________________________________ . sup . a thioethyl cysteine ( s -- ec ) and methylthioethyl cysteine ( m -- s -- ec ) derived from ethanethiol derivatization of lanthionine ( lan ), 3methyllanthionine ( melan ), 2 , 3didehydroalanine ( dha ) and 2 , 3didehydro - 2 - aminobutyric acid ( dhb ) according to the scheme of myers a presented below : ## str1 ## ## str2 ## 2 ## str3 ## 3 . sup . b not detected these analyses suggested the chemical structure shown in fig1 seq id no : 5 . a genetic analysis of a strain producing the lantibiotic was performed . the analysis utilized a plasmid ptv1 - ok which is a repa ( ts ) derivative of the lactococcus lactis cryptic plasmid pwv01 for temperature - dependent replication in both streptococcus mutans and escherichia coli . the plasmid possesses the transposon tn917 which confers erythromycin resistance in streptococci . transposon mutagenesis was performed on lantibiotic - producing strain jh1005 harboring ptv1 - ok . erythromycin resistant clones were selected on bhi agar using 15 μg / ml antibiotic and were then stab inoculated into the same medium without antibiotic . after incubation overnight in candle jars at 37 ° c ., the plates were overlaid with 3 ml of top agar containing about 106 colony forming units per ml of bht - 2 . stabbed clones which failed to produce growth inhibition of the bht - 2 lawn were recovered and purified by streaking on a medium with erythromycin . from these mutants , which now had the transposon in the genetic elements responsible for lantibiotic production , chromosomal dna was isolated and dna flanking the tn917 insert was cloned into escherichia coli strain mc1061 . the flanking dna was sequenced by the university of florida icbr using taq dye deoxy terminator and dye primer cycle sequencing protocols as published by applied biosystems , using an applied biosystems model 373a dna sequencer . homology searches were conducted on the recovered sequences using the blast program . the recovered sequences , designated lana and lanb are presented as seq : id no : 1 and seq : id no : 3 below . these sequences were found to have homology to epia and epib . the open reading frames of these dna sequences produce the proteins presented in seq : id no : 2 and seq : id no : 4 below . the compounds , polypeptides , and polynucleotides of the invention are useful for various non - therapeutic and therapeutic purposes . it is apparent from the testing that the compounds , polypeptides , and polynucleotides of the invention are effective for biochemical probes or controlling bacterial growth . therapeutic application of the new compounds and compositions comprising them can be contemplated to be accomplished by any suitable therapeutic method and technique presently or prospectively known to those skilled in the art . further , the compounds of the invention have use as starting materials or intermediates for the preparation of other useful compounds and compositions the dosage administration to a host in the above indications will be dependent upon the identity of the infection , the type of host involved , its age , weight , health , kind of concurrent treatment , if any , frequency of treatment , and therapeutic ratio . the compounds of the subject invention can be formulated according to known methods for preparing pharmaceutically useful compositions . formulations are described in detail in a number of sources which are well known and readily available to those skilled in the art . for example , remington &# 39 ; s pharmaceutical science by e . w . martin describes formulations which can be used in connection with the subject invention . in general , the compositions of the subject invention will be formulated such that an effective amount of the bioactive compound ( s ) is combined with a suitable carrier in order to facilitate effective administration of the composition . it should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and the scope of the appended claims . __________________________________________________________________________ # sequence listing - ( 1 ) general information :- ( iii ) number of sequences : 5 - ( 2 ) information for seq id no : 1 :- ( i ) sequence characteristics :# pairs ( a ) length : 1316 base ( b ) type : nucleic acid ( c ) strandedness : double ( d ) topology : linear - ( ii ) molecule type : dna ( genomic )- ( ix ) feature : 35 . sub .-- - # signalkey : ( b ) location : 738 .. 742 - ( ix ) feature : 10 . sub .-- - # signalkey : ( b ) location : 757 .. 763 - ( ix ) feature : ( a ) name / key : rbs ( b ) location : 784 .. 791 - ( ix ) feature : ( a ) name / key : cds ( b ) location : 796 .. 987 - ( xi ) sequence description : seq id no : 1 :- aatctatttt gtagagaatt tagagaaatt attaaattac caagatatgt tt - # gcaataac 60 - atttttaaaa tttttaaaaa aaattattac ttactttcat gataagtcag ta - # gatatgtc 120 - tgaattagaa cattatatta atatagttga agaaataaat cctacgattg ct - # tcaattct 180 - taaatctaat ttgaatcagc ttttataaag ttttagccat taaagccatc tt - # gataaatt 240 - ttatatcttt catattcatt aaatgtggag ataatgaaaa agcaacggtt at - # gctatcgc 300 - tgcttttttt gtgattagaa gctatgttat catggagtta tagtaatgaa ac - # atagtgac 360 - agttcatcct ttcttattat aaaagtggta ataagagaag tggtaaacaa ag - # agttagta 420 - aaataatacg tttaaccata atatttcctc ctttaattta ttataagatt ca - # aaaaggta 480 - atattcctat atttgcaaat atgggataaa ataattttaa aaaagcagat tt - # gcaatttt 540 - aaaaaaatag aggctaatgg tggtattata ttattgtaaa tatatgttta ct - # cagtaata 600 - gtgatttact attacaacag attttgttgt tatcttagat atttctgcta gc - # attagtta 660 - tctgtagatg tactacttaa taagtatata attataatta tataataact at - # tatcagat 720 - taccgttaaa agttttctga tatgcttcta ctgaacaatt tatgttcagt ta - # cacacatg 780 # gaa gtc ctt ggt act 831ac aca caa tta tta # ser asn thr gln leu leu glu val leu gly t - # hr # 10 - gaa act ttt gat gtt caa gaa gat ctc ttt gc - # t ttt gat aca aca gat 879glu thr phe asp val gln glu asp leu phe al - # a phe asp thr thr asp # 25 - act act att gtg gca agc aac gac gat cca ga - # t act cgt ttc aaa agt 927thr thr ile val ala ser asn asp asp pro as - # p thr arg phe lys ser # 40 - tgg agc ctt tgt acg cct ggt tgt gca agg ac - # a ggt agt ttc aat agt 975trp ser leu cys thr pro gly cys ala arg th - # r gly ser phe asn ser # 60 - tac tgt tgc tga ttgtataaaa gatttagatt gtgccgcatg tt - # agcggcac1027tyr cys cys *- aatcttttga tattagaggt attaatatgt taaatacaca attattagaa gt - # ccttggta1087 - ctaaaacttt tgatgttcaa gaagatttat ttgagtttaa tataacagat ac - # tattgtac1147 - tgcaggctag tgatagtcca gatactcata gtaggggtcc cgagcgctta gt - # gggaattt1207 - gtatcgataa ggggtacaaa ttcccactaa accaatgttt caaggcctat tt - # atttttta1267 # 1316agtgt ttaggaatag ataacaagtc aaatttata - ( 2 ) information for seq id no : 2 :- ( i ) sequence characteristics : ( a ) length : 63 amin - # o acids ( b ) type : amino acid ( d ) topology : linear - ( ii ) molecule type : protein - ( xi ) sequence description : seq id no : 2 :- met ser asn thr gln leu leu glu val leu gl - # y thr glu thr phe asp # 15 - val gln glu asp leu phe ala phe asp thr th - # r asp thr thr ile val # 30 - ala ser asn asp asp pro asp thr arg phe ly - # s ser trp ser leu cys # 45 - thr pro gly cys ala arg thr gly ser phe as - # n ser tyr cys cys # 60 - ( 2 ) information for seq id no : 3 :- ( i ) sequence characteristics :# pairs ( a ) length : 1323 base ( b ) type : nucleic acid ( c ) strandedness : double ( d ) topology : linear - ( ii ) molecule type : dna ( genomic )- ( ix ) feature : 35 . sub .-- - # signalkey : ( b ) location : 177 .. 182 - ( ix ) feature : 10 . sub .-- - # signalkey : ( b ) location : 191 .. 196 - ( ix ) feature : ( a ) name / key : rbs ( b ) location : 218 .. 224 - ( ix ) feature : ( a ) name / key : cds ( b ) location : 228 .. 782 - ( xi ) sequence description : seq id no : 3 :- tagtaaagtg ggtagtttca atatctgccc tcctcgaaag atctccgtca gt - # ttcaatag 60 - ttactgttgt taactataaa ttatacttaa attgatagga aacttggtcg tg - # acattatc 120 - atatgttgat attggaagag aatcaaattt ataaagacaa ttaaatctaa at - # ttgatgaa 180 # aac gat 236attact aggttgacag tcatgttagg agaagag atg # asn asp met # 65 - ttt caa ttt caa gat tat ttt atg tac aga aa - # a cca tta ggc aac ttt 284phe gln phe gln asp tyr phe met tyr arg ly - # s pro leu gly asn phe # 80 - tct aat ttt ttt agt ata act gat acg atg ga - # t ccc att gag tta cta 332ser asn phe phe ser ile thr asp thr met as - # p pro ile glu leu leu # 95 - cat agt gat ccg ata ttt gct gaa gga gta ta - # t ttg gcc tct tca tct 380his ser asp pro ile phe ala glu gly val ty - # r leu ala ser ser ser100 1 - # 05 1 - # 10 1 -# 15 - ctt aga gca gcc ata aat aaa ctt aag aat ca - # t act gcg agt act aag 428leu arg ala ala ile asn lys leu lys asn hi - # s thr ala ser thr lys # 130 - gat aaa aag aat gca aga gag act att ttt ca - # a tac tat gcc cgt tat 476asp lys lys asn ala arg glu thr ile phe gl - # n tyr tyr ala arg tyr # 145 - aac acg aga tca act ccg ttt ggc ttg ttt tc - # g tcc atc gga gta ggt 524asn thr arg ser thr pro phe gly leu phe se - # r ser ile gly val gly # 160 - gct ttt tcg gct tac ctt aaa aaa gaa aag tc - # t cgt tat gaa aaa tct 572ala phe ser ala tyr leu lys lys glu lys se - # r arg tyr glu lys ser # 175 - att aat att gat ctt ttt tgg gct tat aaa gt - # a gca gat aaa cta gaa 620ile asn ile asp leu phe trp ala tyr lys va - # l ala asp lys leu glu180 1 - # 85 1 - # 90 1 -# 95 - agt atg cct gaa att tta aat act tta aaa gt - # a gtt gct aat aat gct 668ser met pro glu ile leu asn thr leu lys va - # l val ala asn asn ala # 210 - ttg caa aag tca gat aat ttt tgg ctt ttg ga - # t acg cga agt cat ttt 716leu gln lys ser asp asn phe trp leu leu as - # p thr arg ser his phe # 225 - ggt ctt atg aat tct ttt cat ttt atc ttg ta - # c gac ttc tat tct ttc 764gly leu met asn ser phe his phe ile leu ty - # r asp phe tyr ser phe # 240 - ctt caa gat aga cca taa gaattgatat atcagctgga tt - # cacaccag 812leu gln asp arg pro * 245 - aaatacggct agcttgacca atagtttctg ggttaatttt cttaaatttc tg - # acgtgctt 872 - cggtcgcaat agaatcaatg gcatcccaat cgatattctt aggaattcga gc - # tcggtacc 932 - cggggatcct ctagagtcga cctgcaggca tgcaagcttg gcactggccg tc - # gttttaca 992 - acgtcgtgac tgggaaaacc ctggcgttac ccaacttaat cgccttgcag ca - # catccccc1052 - tttcgccagc tggcgtaata gcgaagaggc ccgcaccgat cgcccttccc aa - # cagttgcg1112 - cagcctgaat ggcgaatggc gcctgatgcg gtattttctc cttacgcatc tg - # tgcggtat1172 - ttcacaccgc atatggtgca ctctcagtac aatctgctct gatgccgcat ag - # ttaagcca1232 - gccccgacac ccgccaacac ccgctgacgc gccctgacgg gcttgtctgc tc - # ccggcatc1292 # 1323 gtga ccgtctccgg g - ( 2 ) information for seq id no : 4 :- ( i ) sequence characteristics : ( a ) length : 184 ami - # no acids ( b ) type : amino acid ( d ) topology : linear - ( ii ) molecule type : protein - ( xi ) sequence description : seq id no : 4 :- met asn asp phe gln phe gln asp tyr phe me - # t tyr arg lys pro leu # 15 - gly asn phe ser asn phe phe ser ile thr as - # p thr met asp pro ile # 30 - glu leu leu his ser asp pro ile phe ala gl - # u gly val tyr leu ala # 45 - ser ser ser leu arg ala ala ile asn lys le - # u lys asn his thr ala # 60 - ser thr lys asp lys lys asn ala arg glu th - # r ile phe gln tyr tyr # 80 - ala arg tyr asn thr arg ser thr pro phe gl - # y leu phe ser ser ile # 95 - gly val gly ala phe ser ala tyr leu lys ly - # s glu lys ser arg tyr # 110 - glu lys ser ile asn ile asp leu phe trp al - # a tyr lys val ala asp # 125 - lys leu glu ser met pro glu ile leu asn th - # r leu lys val val ala # 140 - asn asn ala leu gln lys ser asp asn phe tr - # p leu leu asp thr arg145 1 - # 50 1 - # 55 1 -# 60 - ser his phe gly leu met asn ser phe his ph - # e ile leu tyr asp phe # 175 - tyr ser phe leu gln asp arg pro *# 185 - ( 2 ) information for seq id no : 5 :- ( i ) sequence characteristics :# acids ( a ) length : 21 amino ( b ) type : amino acid ( d ) topology : linear - ( ii ) molecule type : protein - ( ix ) feature : ( a ) name / key : mod . sub .-- - # res ( b ) location : 3didehydroalanineher information :- ( ix ) feature : ( a ) name / key : mod . sub .-- - # res ( b ) location : 8didehydrobutyrineer information :- ( ix ) feature : ( a ) name / key : mod . sub .-- - # res ( b ) location : 14 # xaa = abud ) other information :- ( xi ) sequence description : seq id no : 5 :- phe lys xaa trp ala leu ala xaa pro gly al - # a ala arg xaa gly ala # 15 - phe asn ala tyr ala 20__________________________________________________________________________

antimicrobial compounds and compositions and uses thereof , including the treatment and prevention of bacterial infections are described . the compounds and compositions include lantibiotic polypeptides and the nucleic acid sequences encoding the polypeptides . the compounds and compositions are useful as antimicrobials in antibiotic pharmaceutical preparation and as an antimicrobial or antiseptic dentifrice .

the following descriptions are exemplary embodiments only , and are not intended to limit the scope , applicability or configuration of the invention in any way . rather , the following description provides a convenient illustration for implementing exemplary embodiments of the invention . various changes to the described embodiments may be made in the function and arrangement of the elements described without departing from the scope of the invention as set forth in the appended claims . as shown in fig2 , 3 , and 4 , a belt buckle 2 according to an embodiment of the present invention has an indentation 21 on the front surface of the body of the belt buckle 2 . the bottom surface of the indentation 21 is divided into two parts of substantially equal sizes , a first bottom 22 having a greater depth and a second bottom 23 having a smaller depth . a magnet 3 is fixedly positioned in the center of the indentation 21 at where the first and second bottoms 22 and 23 interface with each other . the indentation 21 allows the accommodation of a cap element 4 . another magnet 41 is fixedly embedded on the bottom surface of the cap element 4 . the magnet 41 has a polarity opposite to that of the magnet 3 and is positioned such that , when the cap element 4 is placed inside the indentation 21 , the magnets 3 and 41 are next to each other . the magnetic attraction between the magnets 3 and 41 therefore removably holds the cap element 4 inside the indentation 21 . the front surface of the cap element 4 can have an ornamental pattern 42 such as a company , club , or team logo or even a picture for enhanced appearance . as shown in fig4 and 5 , when the cap element 4 is placed inside the indentation 21 , a gap is reserved between the bottom surface of the cap element 4 and the first bottom 22 . as such , by pressing the part of the cap element 4 above the gap , the other part of the cap element 4 will be raised out of the indentation 21 . the cap element 4 therefore can be easily removed from the indentation 21 . in the present embodiment , the cap element 4 is very much like a coin and therefore can be used in various occasions as a substitute . for example , on the golf course , it can be used by a golfer to mark the position of the golf ball . for another example , in the supermarket , it can be used as a substitute for a coin to retrieve a chained shopping cart . as shown in fig6 , 6 a and 7 , in another embodiment of the present invention , the indentation 21 is formed of two intersecting circles and dimensioned to receive the cap element 4 . the bottom surface of the indentation 21 again contains a deeper first bottom 22 and a shallower second bottom 23 . in addition , the bottom surface of the indentation 21 further contains a narrow third bottom 24 between the first bottom 22 and the circumference of the indentation 21 . the third bottom 24 is as high as the second bottom 23 . the magnet 3 is configured slightly close to the third bottom 23 , i . e . the magnet 3 is not mounted at the center of the indentation 21 . as such , when the cap element 4 is placed inside the indentation 21 , the magnetic attraction would automatically draw the cap element 4 to rest on the second and third bottoms 23 and 24 . in this way , the cap element 4 will not be accidentally removed from the indentation 21 as its edge is supported by the third bottom 24 . to remove the cap element 4 in the present embodiment , the user slides the cap element 4 away from the third bottom 24 so that a part of the cap element 4 is entirely above the first bottom 22 . then , by pressing the part of the cap element 4 above the first bottom 22 , as shown in fig8 , the other part of the cap element 4 is raised out of the indentation 21 for easy removal of the cap element 4 . in another embodiment of the present invention as shown in fig9 and 10 , the indentation 21 has a flat bottom surface , instead of a stepwise bottom surface as in the previous embodiments . a rod 28 having an embedded magnet ( not shown ) is provided in the center of the indentation 21 . as such , the cap element 4 can be held on top of the rod 28 . a user can press any part of the cap element 4 other than the center to raise an opposite part of the cap element 4 for easy removal . in yet another embodiment of the present invention as shown in fig1 and 12 , the belt buckle 2 has an indentation 25 on the front surface of the body . the indentation 25 is extended to two opposing sides of the belt buckle 2 via two aligned troughs 26 , respectively . on the flat bottom surface of the indentation 25 , at least a magnet 27 is provided so as to attract and hold a carrier member 5 inside the indentation 25 . the carrier member 5 can also be held inside the indentation 25 by other means such as clamping in alternative embodiments . the carrier member 5 has an indentation 51 on the front surface . the bottom surface of the indentation 51 is , like the previous embodiments , divided into two parts of substantially equal sizes , a first bottom 52 having a greater depth and a second bottom 53 having a smaller depth . a magnet 6 is fixedly positioned in the center of the indentation 51 at where the first and second bottoms 52 and 53 interface with each other . the indentation 51 allows the accommodation of a cap element 7 . another magnet 71 is fixedly embedded on the bottom surface of the cap element 7 . the magnet 71 has a polarity opposite to that of the magnet 6 and is positioned such that , as shown in fig1 , when the cap element 7 is placed inside the indentation 51 , the magnets 6 and 71 are next to each other . the magnetic attraction between the magnets 6 and 71 therefore removably holds the cap element 7 inside the indentation 51 . the front surface of the cap element 7 can have an ornamental pattern 72 . the removal of the cap element 7 from the carrier member 5 can be conducted in the same way described earlier . to remove the carrier member 5 out of the indentation 25 , a user could use the finger to reach the rim of the carrier member 5 through the trough 26 and lift the carrier member 5 out of the indentation 25 . the carrier member 5 itself can have other integrated functions . for example , the carrier member 5 can contain an electronic clock 53 with the readings shown on the back surface . as shown in fig1 , when the cap element 7 is removed , the carrier member 5 can be flipped with its back surface facing outwards . a user therefore can enjoy the various timing functions of the electronic clock 54 . for another example , as shown in fig1 , a remote control 55 ( e . g ., for the garage door ) is integrated to the carrier member 5 with its control buttons on the back surface so that the user will never forget to bring remote control or where the remote control is placed . these are only two examples and various other utility functions can be integrated to the carrier member 5 . it will be understood that each of the elements described above , or two or more together may also find a useful application in other types of methods differing from the type described above . while certain novel features of this invention have been shown and described and are pointed out in the annexed claim , it is not intended to be limited to the details above , since it will be understood that various omissions , modifications , substitutions and changes in the forms and details of the device illustrated and in its operation can be made by those skilled in the art without departing in any way from the spirit of the present invention .

a belt buckle which has an indentation on the front surface accommodating a removable cap element held by magnetic attraction . the indentation has a stepwise bottom surface for easy removal of the cap element . in an alternative embodiment , the indentation accommodates a removable carrier member capable of integrating various functions such as electronic clock or remote control . the carrier member in turn has an indentation for removably holding a cap element by magnetic attraction . the carrier member &# 39 ; s indentation has a stepwise bottom surface for easy removal of the cap element .

referring to fig1 , the device 10 and it &# 39 ; s components can be seen . the device 10 comprises a longitudinally extending strap 11 and a centrally located button , 12 . the strap 11 has at least one opening 13 along it &# 39 ; s length located to either side of the button 12 . the strap 11 is made form a flexible material such as elastic banding , cloth or leather . the strap 11 may be provided with plurality of openings 13 along it &# 39 ; s length to provide for adjustment and accommodate sandal straps of different sizes . the strap 11 may also be constructed to include decoration on the strap itself such as sequins , embroidery or printing . the device 10 is removable and re - attachable so that it may be taken off and transferred between shoes or to facilitate washing . in the preferred embodiment the device 10 is constructed of materials that are washable and may be immersed in water without damage . referring to fig2 , the device 10 can be seen in a side view . the button 12 is centrally located on strap 11 . the button 12 may be attached by any means to the strap 11 as long as there is sufficient clearance between the attachment point and the circumference of the button 12 so that the opening 13 in the ends of the strap 11 may be placed over the button 12 and secure against its underside . in the preferred embodiment of the invention the strap 11 is made from a stretchy elastic material . the button 12 may be a utilitarian device such as a plain button , or it may incorporate a design itself . referring to fig3 and 4 a through 4 d , the device 10 can be seen as installed on a sandal 14 . each side of the strap 11 is wound around a side strap of the sandal 15 , the straps 15 attaching to the sandal at the front and back in the normal fashion , and secured by inserting the button 12 through the opening 13 . the device 10 then serves to provide a structure to secure a decoration to the sandal 14 . referring to fig5 , a clip 16 is shown which is used to secure a decorative object to the device 10 . the clip 16 has an upper arm and a lower arm that are joined with a hinge at one end and are open at the other end , allowing the upper arm of the clip to be placed through a loop on the decorative object . the open end of the clip 16 is provided with means for securing the upper and lower arms together such as a snap . the clip 16 as shown is a barrette such as the type used to hold women &# 39 ; s hair in place . barrettes come in many decorative designs and the use of a barrette will accentuate the attractiveness of the device 10 . although a barrette is shown in the preferred embodiment of the device 10 , any number of devices can be used to secure the decorative object to the device 10 such as a safety pin , a length of ribbon which could be tied in a decorative bow , or a length of elastic material having the mating parts of a snap at either end . the device 10 , as previously recited , is made from a flexible or elastic material that allows sufficient room for a may be secured to the device 10 by sliding a pin or clip between the strap 11 of the device 10 , and the side straps of the sandal .

a device for removable securing decorative objects to a thong type sandal and a sandal system incorporating such a device .

reference will now be made in greater detail to a preferred embodiment of the invention , an example of which is illustrated in the accompanying drawings . wherever possible , the same reference numerals will be used throughout the drawings and the description to refer to the same or like parts . fig1 and 2 are schematic diagrams of adjustable footwear system 10 in accordance with the teachings of the present invention . adjustable footwear system 10 is shown in an un - activated state . footwear 11 includes upper 12 . preferably , upper 12 is formed of an elastic material . for example , upper 12 can be formed of one or more materials having elastic properties . suitable materials include , but are not limited to , lycra , elastic , spandex , neoprene , or pvc . upper 12 can also include one or more materials which are more rigid . suitable rigid materials include , but are not limited to , plastic , polyurethane and polypropylene . the rigid material can provide support of upper 12 or decoration . cavity 13 is formed between upper 12 and insole 14 . adjustable footwear system 10 includes extensor system 20 . extensor system 20 can be activated by pressure activation device 30 to provide a rigid infra - structure . extensor system 20 includes a one or more extensors 22 . in this embodiment , extensors 22 are formed of extensor arms 23 . extensor arms 23 can be positioned to extend from one side 24 of upper 12 to the other side 25 of upper 12 . width w 1 adjacent of respective extensor arms 23 positioned adjacent side 24 or side 25 can be greater than width w 2 at end 26 of extensor arms 23 . extensor arms 23 can extend from width w 2 to point 27 . extensors 22 are coupled to pressure activation device 30 . pressure activation device 30 controls pressure within extensors 22 . in the un - activated state shown in fig1 and fig2 zero pressure is used in extensor system 20 . extensor arms 23 in the un - activated state are substantially flat within upper 12 . pressure activation device 30 can be hydraulic and use fluids or air with device 32 to manually increase the pressure in extensor system 20 as shown in fig3 . coupling lines 34 can be used to couple device 32 to pressure button actuator 36 . device 32 can be a pump . alternatively , device 32 can be a crank and ratchet device or a battery powered device to regulate the desired pressure . activation of pressure button actuator 36 increases pressure in extensor system 20 to increase rigidity of extensor system 20 . referring to fig4 and 5 , in one embodiment , increasing of pressure in extensor system 20 extends extensor arms 23 in a substantially vertical direction to extend upper 12 away from insole 14 thereby increasing the size of cavity 13 . in the activated state extensor arms 23 are no longer flat . referring to fig6 and 7 , in one embodiment , extensor arms 23 expand in both a horizontal and vertical direction to extend upper 12 away from insole 14 thereby increasing the size of cavity 13 . in the activated state extensor arms 23 are no longer flat . referring to fig8 and 9 , in one embodiment , extensor system 20 includes extensor mesh 50 formed of overlapping extensors 22 . pressure activation device 30 can be activated for increasing of pressure to extends mesh 50 away from insole 14 thereby increasing the size of cavity 13 as shown in fig1 . activation of pressure button actuator 36 by finger 60 of a user can increase pressure in extensor system 20 to a maximum pressure to expand cavity 13 to its largest volume and allow for easy entry of foot 70 into cavity 13 , as shown in fig1 and 12 . once foot 70 is in cavity 13 , finger 60 of the user can activate pressure button actuator 36 to decrease pressure in extension system 20 , which decreases volume of cavity 13 , and allows for the elastic upper 13 to apply the pressure on foot 70 . fig1 - 15 are schematic diagrams of adjustable article system 100 in accordance with the teachings of the present invention . article 101 can be for example a band or a sleeve such as a watch band , headband or medical band . adjustable article system 100 is shown in an un - activated state in fig1 and 14 . article 101 has diameter d 1 between sides 103 . article 101 includes embedded extensor system 20 and pressure activation device 30 . extensor system 20 can be activated by pressure activation device 30 to provide a rigid infra - structure . in the activated state shown in fig1 , diameter d 2 is increased from diameter d 1 to enlarge opening 105 . fig1 is a schematic diagram of adjustable footwear system 200 which includes extensor system 202 . extensor system 202 includes first group 204 a of extensors 22 positioned at front 205 of footwear 11 and second group 204 n of extensors 22 positioned at rear 206 of footwear 11 . extensors 22 of first group 204 a can be activated by pressure activation device 30 a to provide a rigid infra - structure . extensors 22 of second group 204 n can be activated by pressure activation device 30 n to provide a rigid infra - structure . in the embodiment shown in fig1 , pressure activation device 30 a is activated to activate first group 204 a of extensors 22 . it will be appreciated that any number of groups of extensors can be positioned in footwear and activated by a corresponding number of pressure activation devices to control pressure in different positions of the footwear . fig1 is a schematic diagram of adjustable footwear system 350 which includes extensor system 352 . extensor system 352 includes first mesh 50 a positioned at front 205 of footwear 11 and second mesh 50 n positioned at rear 206 of footwear 11 . first mesh 50 a can be activated by pressure activation device 30 a to provide a rigid infra - structure . second mesh 50 n can be activated by pressure activation device 30 n to provide a rigid infra - structure . in the embodiment shown in fig1 , pressure activation device 30 b is activated to activate second mesh 50 n . it will be appreciated that any number of portions of mesh can be positioned in footwear and activated by a corresponding number of pressure activation devices to control pressure in different positions of the footwear . fig2 is a schematic diagram of adjustable article system 400 includes embedded extensor system 402 . extensor system 402 includes first group 404 a of extensors 22 positioned at side 405 of article 401 and second group 404 n of extensors 22 positioned at side 406 of article 401 . extensors 22 of first group 404 a can be activated by pressure activation device 30 a to provide a rigid infra - structure . extensors 22 of second group 404 n can be activated by pressure activation device 30 n to provide a rigid infra - structure . fig2 is a schematic diagram of adjustable article system 500 which includes extensor system 502 . extensor system 502 includes first mesh 50 a positioned at side 505 of article 501 and second mesh 50 n positioned at side 506 of article 501 . first mesh 50 a can be activated by pressure activation device 30 a to provide a rigid infra - structure . second mesh 50 n can be activated by pressure activation device 30 n to provide a rigid infra - structure . it will be appreciated that any number of groups of extensors can be positioned in the article and activated by a corresponding number of pressure activation devices to control pressure in different positions of the article . alternatively , mesh 50 a and mesh 50 n can be formed in a spiral configuration . fig2 is a schematic diagram of adjustable article system 600 which includes extensor system 602 . extensor system 602 can be activated by device lever 610 to provide a rigid infra - structure . extensor system 602 can be in the form of a flexible clip . extensor system 602 includes extensor base 604 . one or more extensor arms 605 can extend from extensor base 604 . extensor system 602 can be positioned within sides 24 of upper 12 from end 607 to end 608 . device lever 610 can be moved to squeeze extensor system 602 to enlarge cavity 13 to open upper 12 . device lever 610 can be locked in place . device lever 610 can be moved again to release extensor system 602 to provide a rigid infra - structure and reduce cavity 13 and upper 12 creating a snug fit around a foot inserted into cavity 13 . it will be appreciated that any number of groups of extensors can be positioned in the article and activated by a corresponding to control pressure in different positions of the article . fig2 a is a schematic diagram of adjustable article system 700 which includes extensor system 702 . extensor system 702 can be activated by pressure activation device 708 . pressure activation device 708 can include device lever 710 device lever 710 to provide a rigid infra - structure . device lever 710 can include arms 711 extending from central portion 709 . arms 711 can be grasped by a user to activate device lever 710 . extensor system 702 includes air chamber 704 . air chamber 704 is connected to device lever 710 with connection 712 as shown in fig2 b . referring to fig2 a , extensor system 702 can be positioned within side 24 of upper 12 from end 707 to end 708 . device lever 710 can be activated to create a vacuum within air chamber 704 to provide a rigid infra - structure and reduce cavity 13 and upper 12 . device lever 710 can be locked in place . device lever 710 can be moved again to activate air valve 716 of extensor system 702 to inflate upper 12 creating a larger opening of cavity 13 . it will be appreciated that any number of groups of extensors can be positioned in the article and activated by a corresponding to control pressure in different positions of the article . fig2 and 25a - c are schematic diagrams of adjustable article system 1200 which includes extensor system 1202 . extensor system 1202 includes extensor chamber 1204 . extensor chamber 1204 can be a hydraulic extensor chamber . chamber bracket 1205 is attached to one or more ends 1207 as shown in fig2 a . panel 1206 can be attached to chamber bracket 1205 . panel 1206 can be formed of fabric . hydraulic path connector 1208 connects extensor chamber 1204 to hydraulic path 1210 as shown in fig2 . hydraulic path connector 1208 can receive hydraulic fluid 1210 . hydraulic fluid 1210 can include for example water or air . extensor material 1220 houses extensor chamber 1204 . in one embodiment , extensor material 1220 is includes edge 1230 as shown in fig2 b . edge 1230 is substantially straight . in an alternate embodiment , extensor material 1220 includes edge 1232 . edge 1232 includes one or more curvatures 1233 as shown in fig2 c . edge 1232 is substantially curved . fig2 a - 26d are schematic diagrams of variations of extensor system 1202 to provide an array of functions for various shoe types or activities . extensor system 1240 includes extensor chamber 1204 having extensor material 1220 formed into cylindrical body 1242 as shown in fig2 a . extensor system 1250 includes a plurality of extensor chambers 1252 as shown in fig2 b . extensor chambers 1252 extend longitudinally between panels 1256 . extensor chambers 1252 are substantially adjacent to one another . extensor chambers 1252 can extend vertically within an adjustable article . extensor chambers 1252 have a width which can vary with the application . extensor system 1260 includes a plurality of extensor chambers 1262 as shown in fig3 c . extensor chambers 1262 extend laterally between panels 1266 . extensor chambers 1262 have space 1264 between one another . extensor chambers 1262 can extend horizontally within an adjustable article . extensor system 1270 includes a plurality of extensor chambers 1272 as shown in fig2 d . extensor chambers 1272 extend longitudinally between panels 1276 . extensor chambers 1272 are substantially adjacent to on to one another . extensor chambers 1252 can extend vertically within an adjustable article . extensor chambers 1272 have a width which can vary with the application . fig2 a and 27b are schematic diagrams of adjustable footwear system 2000 in accordance with the teachings of the present invention . adjustable footwear system 2000 includes extensor system is shown in an un - activated state . footwear 2001 includes heel upper 2002 coupled to heel component compartment 2004 at upper portion 2003 of heel upper 2002 . toe upper 2005 is coupled to heel component compartment 2004 at lower portion 2006 of component compartment . sole 2007 is positioned at bottom 2008 of compartment 2004 . insole 2009 is positioned at top 2010 of heel component compartment 2004 . heel component compartment 2004 can be in the shape of a wedge with length l 1 which is greater than length l 2 . adjustable footwear system 2000 includes extensor system 2020 . extensor system 2020 can be coupled to heel upper 2002 . strap 2012 connects end 2021 of extensor system 2020 to toe upper 2005 . heel upper 2002 , strap 2012 and toe upper 2005 can be formed of an elastic material . suitable materials include , but are not limited to , lycra , elastic , spandex , neoprene , or pvc . extensor system 2020 can be activated by pressure activation device 2030 to enlarge one or more openings between heel upper 2002 , strap 2012 and toe upper 2005 and insole 2009 of footwear 2001 for easy insertion of a foot . extensor system 2020 includes upper extensor 2021 and one or more lower extensors 2022 . upper extensor 2021 is attached to either side 2009 of heel upper 2002 . upper extensor 2021 is coupled with hydraulic path 2022 to path connector 2024 . one or more lower extensors 2022 are positioned in lower portion 2025 of heel component compartment 2004 . one or more lower extensors 2022 are connected with hydraulic path 2026 to path connector 2024 . fluid reservoir 2028 is connected by hydraulic path 2027 to hydraulic path 2026 . hydraulic path connector 2029 connects path connector 2024 to pressure activation device 2030 . pressure activation device 2030 controls pressure within upper extensor 2021 and one or more lower extensors 2022 . in the un - activated state shown in fig2 a zero pressure is used in extensor system 2020 . upper extensor 2021 and one or more lower extensors 2022 in the un - activated state are substantially flat . pressure activation device 2030 can be hydraulic and use fluids or air with device 2032 to manually increase the pressure in extensor system 2030 . upper extensor 2021 in the activated state provides an easy opening between upper extensor 2021 and heel upper 2002 for receiving a foot . after insertion of the foot , upper extensor 2021 can be un - activated to provide a snug fit of heel upper 2002 , strap 2012 and the foot . lower extensors 2022 in the activated state provides an easy opening between lower extensor 2022 and toe upper 2005 for receiving a foot . after insertion of the foot , lower extensors 2022 can be un - activated to provide a snug fit of toe upper 2005 and the foot . one or more upper flexors 2040 can be positioned at sides 2042 of heel upper 2002 . upper flexor 2040 is an elastic material . suitable materials include , but are not limited to , lycra , elastic , spandex , neoprene , or pvc . the one or more upper flexors 2040 can be used to pull strap 2012 , upper extensors 2021 and toe upper 2005 for a tight fit of adjustable footwear system 2000 . activation of upper extensor 2021 and lower extensor 2022 creates sufficient force when extended under pressure to create a stronger counter force against upper flexor 2040 to open the cavity of footwear 2001 between heel upper 2002 and strap 2012 . after insertion of the foot , upper flexor 2040 can be un - activated to provide a snug fit of upper flexor 2040 and the foot . fig2 a and 28b are schematic diagrams of adjustable footwear system 3000 in accordance with the teachings of the present invention . adjustable footwear system 3000 is shown in an un - activated state . footwear 3001 includes upper 3012 . preferably , upper 3012 is formed of an elastic material . for example , upper 3012 can be formed of one or more materials having elastic properties . suitable materials include , but are not limited to , lycra , elastic , spandex , neoprene , or pvc . upper 3012 can also include one or more materials which are more rigid . suitable rigid materials include , but are not limited to , plastic , polyurethane and polypropylene . the rigid material can provide support of upper 3012 or decoration . cavity 3013 is formed between upper 3012 and sole 3014 . adjustable footwear system 3000 includes extensor system 3020 . extensor system 3020 can be activated by pressure activation device 3330 . extensor system 3020 includes a one or more heel extensors 3021 and one or more upper extensors 3022 . in one embodiment , heel extensors 3021 can be formed individually . alternatively , heel extensors 3021 can be formed of plenum 3023 which is divided by one or more baffles 3015 . in one embodiment , upper extensors 3022 can be formed individually . alternatively , upper extensors 3022 can be formed of plenum 3016 which is divided by one or more baffles 3017 . hydraulic path 3025 connects one or more upper extensors 3022 to fluid reservoir 3024 . hydraulic path 3026 connects fluid reservoir 3024 to pressure activation device 3030 . fluid reservoir 3024 can be positioned within cavity 3027 between bottom sole 3028 and insole 3014 . hydraulic path 3028 connects one or more heel extensors 3021 to one or more upper extensors 3022 . one or more flexors 3040 can be positioned at top 3042 of upper 3012 . pressure activation device 3030 controls pressure within one or more heel extensors 3021 and one or more upper extensors 3022 . pressure activation device 3030 includes pressure button actuator 3036 . in the un - activated state shown in zero pressure is used in extensor system 3020 . one or more heel extensors 3021 and one or more upper extensors 3022 in the un - activated state are substantially flat within upper 3012 . pressure activation device 3030 can be hydraulic and use fluids or air with pressure button actuator 3036 to manually increase the pressure in extensor system 3020 . activation of pressure button actuator 3036 increases pressure in extensor system 3020 to expand one or more heel extensors 3021 and one or more upper extensors 3022 to create a larger cavity 3013 for easy insertion of a foot into upper 3012 . in the activated , one or more heel extensors 3021 and one or more upper extensors 3022 are no longer flat . fig2 a and 29b are schematic diagrams of adjustable footwear system 4000 in accordance with the teachings of the present invention . adjustable footwear system 4000 is shown in an un - activated state . footwear 4001 includes upper 4012 . preferably , upper 4012 is formed of an elastic material . for example , upper 4012 can be formed of one or more materials having elastic properties . suitable materials include , but are not limited to , lycra , elastic , spandex , neoprene , or pvc . upper 4012 can also include one or more materials which are more rigid . suitable rigid materials include , but are not limited to , plastic , polyurethane and polypropylene . the rigid material can provide support of upper 4012 or decoration . cavity 4013 is formed between upper 4012 and sole 4014 . heel portion 4015 is positioned at rear 4016 of footwear 4001 . strap 4008 can be positioned at rear of 4011 of cavity 4013 . adjustable footwear system 4019 includes extensor system 4020 . extensor system 4020 can be activated by pressure activation device 4030 . extensor system 4020 includes a one or more heel extensors 4021 positioned at heel portion 4015 . one or more upper extensors 4022 are positioned at upper portion 4012 . one or more heel extensors 4021 can extend radially around heel portion from edge 4016 to an opposite edge 4017 on the opposite side of footwear 4001 . one or more upper extensors 4022 can extend radially around upper portion 4012 from edge 4016 to an opposite edge 4017 on the opposite side of footwear 4001 . hydraulic path 4023 connects one or more heel extensors 4021 and one or more upper extensors 4022 to outlet 4025 . inlet 4032 of pressure activation device 4030 can be connected to outlet 4025 . hydraulic path 4034 connects fluid reservoir 4036 to inlet 4032 . fluid reservoir 4036 can be positioned within housing 4035 . pressure activation device 4030 includes pressure button actuator 4036 . hydraulic path 4038 connects fluid reservoir 4036 to pressure button actuator 4039 . one or more flexors 4040 can be positioned at top 4042 of upper 4012 . pressure activation device 4030 controls pressure within one or more heel extensors 4021 and one or more upper extensors 4022 . in the un - activated state shown in zero pressure is used in extensor system 4020 . one or more heel extensors 4021 and one or more upper extensors 4022 in the un - activated state are substantially flat within upper 4012 . pressure button activation device 4030 can be pumped to activate fluid reservoir 4036 to manually increase the pressure in extensor system 4020 . activation of pressure button actuator 4036 increases pressure in extensor system 4020 to expand one or more heel extensors 4021 and one or more upper extensors 4022 to create a larger cavity 4013 for easy insertion of a foot into upper 4012 . in the activated state one or more heel extensors 4021 and one or more upper extensors 4022 are no longer flat . it is to be understood that the above - described embodiments are illustrative of only a few of the many possible specific embodiments , which can represent applications of the principles of the invention . numerous and varied other arrangements can be readily devised in accordance with these principles by those skilled in the art without departing from the spirit and scope of the invention .

the present invention is directed to an adjustable footwear system to provide varying degrees of tightness in different areas of the footwear before and after the footwear is received on the foot . an extensor system is activated to open or close a cavity of the footwear between the upper and an insole . the extensor system can provide loosen the footwear to the foot .

the apparatus represented in the figures is designed for uniformly positioning disjointed legs 2 - 5 of slaughtered poultry , suspended by the ankles from the hooks 1 of an overhead conveyor ( not shown ). in the embodiment shown , the first part of the apparatus comprises a horizontal conveyor belt 6 positioned under the overhead conveyor , which moves at a greater speed 7 than the transport speed 8 of the overhead conveyor . the conveyor belt 6 is placed under the hooks 1 at a distance such that the legs 2 - 5 touch the conveyor belt 6 . due to the difference in speed between the conveyor belt 6 and the hooks 1 , the legs are lifted slightly from their original position ( fig2 leg 2 ) in the hooks 1 ( to the position of leg 3 in fig2 ), such that they are no longer jammed therein . this facilitates the rotation of the legs in the hooks as described later . also extending under the overhead conveyor and succeeding the conveyor belt 6 is a substantially horizontal plate 9 . this horizontal plate 9 is again placed under the hooks 1 at a distance such that the legs 2 - 5 transported by the overhead conveyor touch said plate 9 . as the legs are dragged by the hooks over said plate 9 , the gravitational force and the frictional force between the legs and the plate 9 will rotate the legs into a position in which they will point sideways in relation to the ( arbitrary ) vertical plane through the overhead conveyor . this may , for example , be a vertical plane through the suspension points of the ankles . basically it means that the knees are pointed perpendicularly to the transport direction of the overhead conveyor . as indicated in fig1 by means of a vertical plane of symmetry 10 , each leg can assume two positions . the knee of a leg 4 points toward this plane of symmetry 10 , while the knee of a leg 5 points away from this plane of symmetry . the legs 4 and 5 are suspended from a traditional double hook 1 , equipped to carry two legs next to each other at right angles to the transport direction of the overhead conveyor . each double hook 1 carries on the same side always a left or right leg respectively . of course , each of the legs 4 and 5 may also have the opposite orientation . this means that the knee of leg 4 may also point away from the plane of symmetry 10 and that the knee of leg 5 may point toward said plane of symmetry 10 . the position of the legs illustrated by means of the legs 4 and 5 in fig1 is , as already mentioned , caused by the horizontal plate 9 . in this position the legs will arrive at a first direction check 11 which will only engage those legs whose knees point away from the plane of symmetry 10 . after all , the thigh of these legs projects more in the opposite direction , so that said thigh will be able to engage the respective first direction check 11 . in fig1 this means that leg 4 will not engage the first direction check 11 , whereas leg 5 will . as a result of the interaction between the leg 5 and the direction check 11 , leg 5 will rotate into a position where the knee points substantially in the direction of transport ( and at the same time slightly downward ). after having passed the direction check 11 , the leg 5 will again hang free on the hook 1 and point its knee into the direction of transport . the first direction check 11 is double - sided , that is to say that both its surfaces pointing away from the plane of symmetry 10 function as direction check , and are thus able to engage passing legs . when an overhead conveyor is involved comprising hooks from which only one leg is suspended , the direction check 11 needs to be only one - sided . succeeding the direction check 11 are two second direction checks 12 . said second direction checks 12 can swivel about vertical axes 13 , and their free end is spring - activated in the direction of the plane of symmetry 10 by means of a spring means which is not further illustrated . with their free end they are able to engage an extension 14 of the first direction check 11 . each leg will pass between the free end of a second direction check 12 and the extension 14 of the first direction check 11 . to this end , said second direction check 12 will swivel about the vertical axis 13 counter to the spring force . if the knee of the respective leg has already been positioned into the direction of transport by the first direction check 11 , the second direction check 12 will fulfil no further function . if , however , a leg passes whose knee was initially pointed toward the plane of symmetry 10 ( such as leg 4 ) and has therefore passed the first direction check 11 without hindrance , said leg will be rotated under the influence of the second direction check 12 into a position in which the knee will point again into the overhead conveyor &# 39 ; s direction of transport . it should be noted , that a rotation of the legs in the hooks 1 caused by the first direction check 11 is relatively simple . for each left or right leg respectively this rotation occurs in an anatomically corresponding ( opposite ) direction . anatomically , the shape of the ankle joint engaging the hook 1 readily permits such a rotation . in contrast , a reverse rotation of a leg in the hook 1 will be impeded by joint knuckles on the ankle . however , the fact that the second direction checks 12 , which effect such a reverse rotation , are spring activated allows a greater force to be exerted on the passing legs , so that the desired rotation can still be effected . the apparatus further includes guides 15 and angled feed guides 16 for optimally guiding the leg to effect an interaction with the various direction checks 11 , 12 . in addition , a central guide plate 17 is applied on top of the first direction check 11 provided with a suitably profiled rim . the invention is not limited to the above - described embodiment which , within the scope of the appended claims , may be varied in a numerous of ways .

the invention relates to a method and apparatus for uniformly positioning legs of slaughtered poultry . initially the legs are rotated in such a way that their knees end up pointing sideways in relation to a vertical plane passing through the overhead conveyor , subsequent to which the legs are rotated in such a way that the knees preferably end up pointing in the direction of transport . the apparatus for carrying out the method is provided with first and second direction checks .

the present invention provides , inter alia , bazedoxifene acetate formulations and compositions thereof having improved properties relating to reduction , elimination or prevention of polymorphic conversion of bazedoxifene acetate . in some embodiments , the compositions are prepared by a non - aqueous process , for example dry granulation , roller compaction or direct blend processes . in some embodiments , the present invention provides a direct blend formulation of bazedoxifene acetate that can reduce the potential for polymorphic conversion of bazedoxifene acetate , such as from form a to form b , compared to other more complex formulations . the use of a direct blend formulation is simple and cost - efficient compared to other more time consuming processes such as wet granulation or roller - compaction , although roller compaction processes can be utilized in some embodiments of the invention . many of the complex formulations such as roller compaction require large power inputs during mixing , milling and compaction . in addition , a process with power input for an extended period of time can also increase potential polymorphic conversions . thus , another advantage associated with a direct blend formulation is to use lower power in the process . while not wishing to be bound by any particular theory , it is believed the use of water in a wet granulation has the potential of increasing polymorphic conversion during processing and storage because of the potential for solubilization of the bazedoxifene acetate . upon drying , recrystallization of the bazedoxifene acetate can result in polymorphic conversion , such as from form a to form b . accordingly , in one aspect , the present invention provides non - aqueous processes ( i . e . processes that do not utilize water ) for producing the pharmaceutical compositions described herein . examples of such non - aqueous processes include dry granulation and roller compaction processes , as are known in the art . in one particular embodiment , the non - aqueous process is a direct blend process , which is used to prepare direct blend formulations of bazedoxifene acetate , and which does not require contacting the bazedoxifene acetate with water . such non - aqueous processes can be advantageous where it is desired to minimize conversion from one polymorphic form of bazedoxifene acetate to another , for example to minimize the conversion of the form a polymorph to the form b polymorph . a further advantage of the present compositions is that there is no need to employ a surfactant , such as sodium lauryl sulfate . while not wishing to be bound by any particular theory , it is believed the use of a surfactant can increase wetting , solubility and dissolution , and the increased solubility can facilitate potential polymorphic conversion between the different polymorphic forms . in some embodiments , the present invention provides pharmaceutical compositions comprising a pharmaceutically effective amount of bazedoxifene acetate , and a carrier or excipient system , the carrier or excipient system comprising : a pharmaceutical composition comprising a pharmaceutically effective amount of bazedoxifene acetate and a carrier or excipient system , the carrier or excipient system comprising : a ) a first filler / diluent component comprising from about 5 % to about 85 % by weight of the pharmaceutical formulation ; b ) an optional second filler / diluent component comprising from about 5 % to about 85 % by weight of the pharmaceutical formulation ; c ) an optional antioxidant component comprising up to about 15 % by weight of the pharmaceutical formulation ; d ) a glidant / disintegrant component comprising from about 0 . 01 % to about 10 % by weight of the pharmaceutical formulation ; and e ) a lubricant component comprising from about 0 . 01 % to about 10 % by weight of the pharmaceutical formulation . in some embodiments , the compositions are prepared by a non - aqueous process , for example a dry granulation , roller compaction or direct blend process . in some embodiments , the compositions of the invention contain bazedoxifene acetate substantially in one pure crystalline polymorph , preferably substantially in the a polymorph form . in further embodiments , at least about 90 % of the bazedoxifene acetate is present in the a polymorph form . in some further embodiments , at least about 80 % of said bazedoxifene acetate is present in the a polymorph form . the direct blend formulations of the present invention have improved properties relating to reduction , elimination or prevention of polymorphic conversion of bazedoxifene acetate , such as from form a to form b , during preparation of the compositions , and during storage thereafter . therefore , the formulations of the present invention more effectively maintain advantages associated with a single polymorph form . those of skill in the art will be able to readily ascertain pharmaceutically effective amounts of bazedoxifene acetate . generally , on a percentage basis , the bazedoxifene acetate is present in an amount of from about 0 . 1 % to about 30 % by weight of the pharmaceutical compositions of the present invention . in some embodiments , the bazedoxifene acetate is present in an amount of from about 10 % to about 30 % by weight of the composition . in some embodiments , the bazedoxifene acetate is present in an amount of from about 10 % to about 25 % by weight of the composition . as will be appreciated , the compositions of the invention can be prepared as , or incorporated into , a variety of dosage forms , for example tablets and capsules . in some embodiments , the invention provides tablets that contain , or are composed of a composition of the invention . generally , tablet dosage forms of the invention can contain bazedoxifene acetate in an amount of from about 0 . 1 mg to about 300 mg . in further embodiments , the dosage forms can include bazedoxifene acetate in an amount of from about 0 . 5 to about 230 mg , from about 1 to about 170 mg , from about 5 to about 115 mg , or from about 1 to about 30 mg . in some embodiments , the invention provides dosage forms , for example tablets , containing a composition of the invention that includes bazedoxifene acetate in an amount of from about 15 mg to about 25 mg . generally , the first filler / diluent component , and the optional second filler / diluent component , when present , can be present in an amount of from about 5 % to about 85 % by weight of the pharmaceutical formulation , or from about 25 % to about 50 % by weight of the pharmaceutical formulation . in one embodiment the first filler / diluent component , and the optional second filler / diluent component are present in an amount of from about 25 % to about 40 % or more , e . g . to about 42 %, by weight of the pharmaceutical formulation . both the first filler / diluent component and the optional second filler / diluent component can be selected from fillers and diluents known to be useful in the art , including for example one or more of sugars , for example sucrose , mannitol , lactose , and the like , and / or other fillers such as powdered cellulose , malodextrin , sorbitol , xylitol , carboxymethyl cellulose , carboxyethyl cellulose , hydroxyethyl celluloses , microcrystalline celluloses , starches , calcium phosphates , for example anhydrous dicalcium phosphate , sodium starch glycolates , metal aluminosilicates , for example magnesium aluminometasilicate ( neusilin ), and a mixture thereof . in some embodiments , the first filler / diluent component includes or consists of microcrystalline cellulose , for example avicel ph101 , and the second filler / diluent includes or consists of lactose , for example lactose nf . as used herein , the term “ sugar ” refers to any type of simple carbohydrate , such as a mono or disaccharide , either naturally obtained , refined from a natural source , or artificially produced , and includes , without limitation , sucrose , dextrose , maltose , glucose , fructose , galactose , mannose , lactose , trehalose , lactulose , levulose , raffinose , ribose , and xylose . the term “ sugar ,” as used herein , also includes various “ sugar substitutes ” widely known to those of ordinary skill in the art of preparing solid dosage forms , such as the polyhydric alcohols ( sometimes referred to as “ sugar alcohols ” or hydrogenated saccharides ), for example sorbitol , mannitol , xylitol , and erythritol , and the sugar derivatives of polyhydric alcohols , such as maltitol , lactitol , isomalt , and polyalditol . accordingly , the recitation of the term “ sugar ” generically should be interpreted to include such specific compounds , as well as others not expressly recited . in certain embodiments , the sugar is a mono - or disaccharide , for example , sucrose , dextrose , maltose , glucose , fructose , galactose , mannose , or lactose . in some embodiments , the second filler / diluent component of the compositions of the invention include or consist of lactose . generally , the glidant / disintegrant component is present in an amount of from about 0 . 01 % to about 10 % by weight of the pharmaceutical formulation , or from about 1 % to about 10 % by weight of the pharmaceutical formulation , or from about 3 % to about 5 % by weight of the pharmaceutical formulation . the glidant / disintegrant can be selected from glidants and disintegrants know to be useful for pharmaceutical formulations . examples of suitable glidant / disintegrants include croscarmellose sodium , modified cellulose , pregelatinized starch , sodium starch glycolate , crospovidone , starch , alginic acid , sodium alginate , clays , cellulose floc , ion exchange resins , effervescent systems based on food acids , aerosil 200 , talc , lactose , stearates , dibasic calcium phosphate , magnesium carbonate , magnesium oxide , calcium silicate , silica , silicon dioxide , silicon dioxide aerogels and mixtures thereof . in some embodiments , the glidant / diluent includes or consists of sodium starch glycolate . the lubricant component is generally present in an amount of from about 0 . 01 % to about 10 % by weight of the pharmaceutical formulation , from about 0 . 01 % to about 3 % by weight of the pharmaceutical formulation , or from about 0 . 01 % to about 2 % by weight of the pharmaceutical formulation . in some embodiments , the lubricant component is present in an amount of about 1 % by weight of the pharmaceutical formulation . the lubricant component can be selected from the many lubricants useful in the pharmaceutical arts . examples of suitable lubricants include metal stearates , fatty acid esters , fatty acids , fatty alcohols , glyceryl behenate , mineral oil , paraffins , hydrogenated vegetable oils , leucine , polyethylene glycols , aerosil 200 , sodium chloride and mixtures thereof . in some preferred embodiments , the lubricant is a metal stearate , for example , magnesium stearate . in some embodiments , the pharmaceutical formulations and excipient systems of the invention also contain an antioxidant component , which can be a single compound , such as ascorbic acid , or a mixture of antioxidants . a wide variety of antioxidant compound are known in the art , and are suitable for use in the present invention . examples of such antioxidants that can be used in the present invention include sodium ascorbate , ascorbyl palmitate , bht ( butylated hydroxytoluene ) and bha ( butylated hydroxyanisole ), each optionally in conjunction with an amount of ascorbic acid . generally , the antioxidant component , when present , is used in an amount of up to about 15 % by weight of the pharmaceutical formulation , for example from about 1 % to about 10 % by weight of the pharmaceutical formulation , or from about 2 % to about 8 % by weight of the pharmaceutical formulation . additional suitable filler / diluents , antioxidants , glidant / disintegrants and lubricants can be found in , for example , remington &# 39 ; s pharmaceutical sciences , 17th ed ., mack publishing company , easton , pa ., 1985 , which is incorporated herein by reference in its entirety . in some embodiments , the first filler / diluent component includes one or more of sugars , mannitol , lactose , sucrose , powdered cellulose , microcrystalline cellulose , malodextrin , sorbitol , starch , xylitol , carboxymethyl cellulose , carboxyethyl cellulose , hydroxyethyl celluloses , anhydrous dicalcium phosphate , sodium starch glycolates , or metal aluminosilicates ; the optional second filler / diluent component includes one or more of sugars , mannitol , lactose , sucrose , powdered cellulose , microcrystalline cellulose , malodextrin , sorbitol , starch , xylitol , carboxymethyl cellulose , carboxyethyl cellulose , hydroxyethyl celluloses , anhydrous dicalcium phosphate , sodium starch glycolates , or metal aluminosilicates ; the optional antioxidant component , when present , includes one or more of ascorbic acid , sodium ascorbate or ascorbyl palmitate ; the glidant / disintegrant component includes one or more of croscarmellose sodium , modified cellulose , pregelatinized starch , sodium starch glycolate , crospovidone , starch , alginic acid , sodium alginate , clays , cellulose floc , ion exchange resins , effervescent systems based on food acids , aerosil 200 , talc , lactose , metal stearates , dibasic calcium phosphate , magnesium carbonate , magnesium oxide , calcium silicate , silica , silicon dioxide and silicon dioxide aerogels ; and the lubricant component includes one or more of metal stearates , fatty acid esters , fatty acids , fatty alcohols , glyceryl behenate , mineral oil , paraffins , hydrogenated vegetable oils , leucine , polyethylene glycols , aerosil 200 , and sodium chloride . in some preferred embodiments , the first filler / diluent component includes or consists of microcrystalline cellulose , for example avicel ph101 ; the optional second filler / diluent component is present , and includes or consists of a sugar , for example lactose nf ; the optional antioxidant component is present , and includes or consists of ascorbic acid ; the glidant / disintegrant component includes or consists of sodium starch glycolate ; and the lubricant component includes or consists of a metal stearate , for example magnesium stearate . in some embodiments , the invention further provides non - aqueous processes for preparing a pharmaceutical composition comprising a pharmaceutically effective amount of bazedoxifene acetate and a carrier or excipient system , the carrier or excipient system comprising : a ) a first filler / diluent component comprising from about 5 % to about 85 % by weight of the pharmaceutical formulation ; b ) an optional second filler / diluent component comprising from about 5 % to about 85 % by weight of the pharmaceutical formulation ; c ) an optional antioxidant component comprising up to about 15 % by weight of the pharmaceutical formulation ; d ) a glidant / disintegrant component comprising from about 0 . 01 % to about 10 % by weight of the pharmaceutical formulation ; and e ) a lubricant component comprising from about 0 . 01 % to about 10 % by weight of the pharmaceutical formulation . examples of suitable non - aqueous processes include direct blending , dry granulation and roller compaction . in some embodiments , the non - aqueous process is a direct blend process . in some such embodiments , the process comprises : i ) combining the bazedoxifene acetate , first filler / diluent , second filler / diluent , glidant , and , optionally , the antioxidant to form a first mixture ; iii ) adding the lubricant to the blended first mixture to form a second mixture ; and iv ) optionally blending the second mixture to form a blended second mixture ; and compressing at least a portion of said second mixture , or said blended second mixture , to form a tablet therefrom ; or filling a capsule with said second mixture , or said blended second mixture , to provide a capsule filled with said second mixture , or said blended second mixture . generally , it is preferred that the bazedoxifene acetate is micronised prior to combination with the other components of the formulation . the order of addition of the components ( i . e ., the bazedoxifene acetate , first and second filler / diluents , antioxidant , lubricant and glidant ) is not critical , although it is generally preferred that the bazedoxifene acetate , first and second filler / diluents , antioxidant and glidant be combined and blended prior to blending with the lubricant . the tablets can further include one or more surface coatings , for example clear coatings and / or color coatings . numerous coatings and procedures for their application are known in the art , including those disclosed in remington &# 39 ; s pharmaceutical sciences , supra . the processes of the invention are useful , inter alia , to provide compositions of the invention , and dosage forms containing the compositions , that include a preponderance of one polymorphic form of bazedoxifene acetate . in some embodiments , the bazedoxifene acetate is present substantially in a crystalline polymorphic form . in some embodiments , the bazedoxifene acetate is present substantially in form a polymorph ; i . e ., there is no detectable b polymorph present , as determined by raman spectroscopy or x - ray diffraction . in some embodiments , at least about 90 % of the bazedoxifene acetate is present in the a polymorph form . in further embodiments , at least about 80 % of the bazedoxifene acetate is present in the a polymorph form . the determination of the amount of the a or b polymorphic form can be accomplished by , for example , raman spectroscopy or x - ray diffraction . the present invention also provides products of the processes described herein . it will be understood that the weight percentages set forth for the bazedoxifene acetate , first filler / diluent component , the optional second filler component , antioxidant component , glidant / disintegrant component , and lubricant component of the compositions disclosed herein are the percentages that each component will comprise of a final pharmaceutical composition , without reference to any surface covering , such as a tablet coating ( for example any clear or color coating ) or capsule . oral formulations containing the present solid dispersions can comprise any conventionally used oral forms , including tablets , capsules , buccal forms , troches , lozenges , suspensions , and the like . in some embodiments , the dosage form is a tablet . capsules or tablets of containing the present solid dispersion can also be combined with mixtures of other active compounds or inert fillers and / or diluents such as the pharmaceutically acceptable starches ( e . g . corn , potato or tapioca starch ), sugars , artificial sweetening agents , powdered celluloses , such as crystalline and microcrystalline celluloses , flours , gelatins , gums , etc . in some preferred embodiments , the formulations are direct blend solid dispersions compressed into tablets . tablet formulations can be made by conventional compression , wet granulation , or dry granulation methods and utilize pharmaceutically acceptable diluents ( fillers ), binding agents , lubricants , disintegrants , suspending or stabilizing agents , including , but not limited to , magnesium stearate , stearic acid , talc , sodium lauryl sulfate , microcrystalline cellulose , carboxymethylcellulose calcium , polyvinylpyrrolidone , gelatin , alginic acid , acacia gum , xanthan gum , sodium citrate , complex silicates , calcium carbonate , glycine , dextrin , sucrose , sorbitol , dicalcium phosphate , calcium sulfate , lactose , kaolin , mannitol , sodium chloride , talc , dry starches and powdered sugar . oral formulations used herein may utilize standard delay or time release formulations or spansules . suppository formulations may be made from traditional materials , including cocoa butter , with or without the addition of waxes to alter the suppositories melting point , and glycerin . water soluble suppository bases , such as polyethylene glycols of various molecular weights , may also be used . in some embodiments , the dosage forms of the invention are direct blend tablets . such tablets can generally range from about 50 mg to about 1000 mg , depending upon the dosage required for therapeutic use . in some embodiments , the dosage forms are 200 mg tablets , containing a sufficient amount of bazedoxifene acetate to provide 20 mg of bazedoxifene , based on the weight of the free acid . in some further embodiments , the compositions and dosage forms of the invention include a sufficient amount of bazedoxifene acetate to provide 10 mg , 20 mg , 50 mg , 75 mg , 100 mg , 120 mg , 125 mg , 150 mg , 175 mg , 200 mg , 225 mg or 250 mg of bazedoxifene , based on the weight of the free acid . film coatings useful with the present formulations are known in the art and generally consist of a polymer ( usually a cellulosic type of polymer ), a colorant and a plasticizer . additional ingredients such as sugars , flavors , oils and lubricants can be included in film coating formulations to impart certain characteristics to the film coat . the compositions and formulations herein may also be combined and processed as a solid , then placed in a capsule form , such as a gelatin capsule . as will be appreciated , some components of the formulations of the invention can possess multiple functions . for example , a given component can act as both a diluent and a disintegrant . in some such cases , the function of a given component can be considered singular , even though its properties may allow multiple functionality . additional numerous various excipients , dosage forms , dispersing agents and the like that are suitable for use in connection with the solid dispersions of the invention are known in the art and described in , for example , remington &# 39 ; s pharmaceutical sciences , 17th ed ., mack publishing company , easton , pa ., 1985 , which is incorporated herein by reference in its entirety . the materials , methods , and examples presented herein are intended to be illustrative , and are not intended to limit the scope of the invention . all publications , patent applications , patents , and other references mentioned herein are incorporated by reference in their entirety . procedure for preparation of 100 mg tablets containing 20 mg of bazedoxifene ( as acetate ) a . bazedoxifene acetate ( 2 , 256 g ), avicel ph101 ( 3 , 276 g ), lactose nf ( fast flow ; 3 , 276 g ), ascorbic acid ( 680 g ) and sodium starch glycolate ( 412 g ) are combined in a tumble blender and blended to form a mixture ; b . magnesium stearate ( 100 g ) is added to the blended first mixture to form a second mixture , which is then blended again ; c . the blended mixture is then compressed to form tablets having final weight of 100 mg . ingredient % wt / wt mg / tablet avicel ph101 32 . 76 32 . 76 lactose , nf ( fast flow ) 32 . 76 32 . 76 ascorbic acid , usp 6 . 80 6 . 80 mg sodium starch glycolate 4 . 12 4 . 12 magnesium stearate 1 . 00 1 . 00 bazedoxifene acetate ( 88 . 68 % 22 . 56 22 . 56 mg bazedoxifene free base ) a , b total 100 . 00 100 mg a the potency of bazedoxifene acetate may vary , and the amount in the formula must be adjusted accordingly with a corresponding adjustment in the amount of avicel b 22 . 56 mg of bazedoxifene acetate provides 20 mg of bazedoxifene . procedure for preparation of 200 mg tablets containing 20 mg of bazedoxifene ( as acetate ) the procedure is similar to that of example 1 , except that the amounts of the components used are : bazedoxifene acetate ( 1 , 128 g ), avicel ph101 ( 4 , 036 g ), lactose nf ( fast flow ; 4 , 036 g ), ascorbic acid ( 300 g ), sodium starch glycolate ( 400 g ) and magnesium stearate ( 100 g ). ingredient % wt / wt mg / tablet avicel ph101 40 . 36 80 . 72 lactose , nf ( fast flow ) 40 . 36 80 . 72 ascorbic acid , usp 3 . 00 6 . 00 mg sodium starch glycolate 4 . 00 8 . 00 magnesium stearate 1 . 00 2 . 00 bazedoxifene acetate ( 88 . 68 % 11 . 28 22 . 56 mg bazedoxifene free base ) a , b total 100 . 00 200 mg a the potency of bazedoxifene acetate may vary , and the amount in the formula must be adjusted accordingly with a corresponding adjustment in the amount of avicel b 22 . 56 mg of bazedoxifene acetate provides 20 mg of bazedoxifene . a 2 gal hydrogenation vessel with agitator was charged with hexamethyleneimino benzyloxyindole ( 250 g , 0 . 3841 mol ; see u . s . pat . no . 5 , 998 , 402 for a preparation ), ethanol ( denatured with 5 % by volume ethyl acetate ) ( 1578 g , 2000 ml ), and palladium on carbon 10 % ( 25 g ). the reactants were hydrogenated at 25 ° c . and 50 psi for 20 hours . reaction progress was monitored by hplc ( column : csc - s ods 2 , 25 cm ; mobile phase : 20 % 0 . 02 m nh 4 h 2 po 4 ( 2 ml tea / l , ph = 3 ) and 80 % mecn ; flow : 2 ml / min ; detector : 220 nm ). the reaction was considered complete when less than 1 % of either the hexamethyleneimino benzyloxyindole ( 18 . 2 min retention time ) or mono - debenzylated derivative thereof ( 5 . 1 min retention time ) was detected . the mixture was filtered through a cartridge which was subsequently rinsed with ethanol ( denatured with 5 % by volume ethyl acetate ) ( 2 × 198 g , 2 × 250 ml ). the filtrate was transferred to a 5 l multi - neck flask with agitator charged with l - ascorbic acid ( 2 . 04 g , 0 . 0116 mols ) under nitrogen . acetic acid ( 34 . 6 g , 0 . 5762 moles ) was added at 20 ° c . while stirring . the resulting reaction mixture was stirred for 2 hours ( ph was about 5 and crystallization began within about 10 minutes of addition of acetic acid ). the reaction mixture was then cooled to 0 ° c . and maintained at this temperature for 2 hours . the resulting solid was collected by filtration on a buchner funnel and washed with ethanol ( denatured with 5 % by volume ethyl acetate ) ( 2 × 150 g , 2 × 190 ml ) at 0 ° c . the solid product was further purified by charging a 3 l multineck flask ( with agitator , thermometer , and condenser under nitrogen ) with the filtered solid , ethanol ( denatured with 5 % by volume ethyl acetate ) ( 1105 g , 1400 ml ), and l - ascorbic acid ( 1 . 73 g , 0 . 01 mols ). the resulting mixture was heated to 75 ° c . and cooled to 20 ° c . over the course of 2 hours . the resulting suspension was further cooled to 0 ° c . and held at this temperature for 2 hours . the resulting solid product was collected by filtration with a buchner funnel and washed with ethanol ( denatured with 5 % by volume ethyl acetate ) ( 2 × 79 g , 2 × 100 ml ) at 0 ° c . the product was dried in vacuo at 60 ° c ., 5 mm hg for 24 hours giving 151 . 3 g bazedoxifene acetate form a ( 74 . 2 % yield ). xrpd analyses were carried out on a ( scintag x2 ) x - ray powder diffractometer using cu k α radiation . the instrument was equipped with tube power , and amperage was set at 45 kv and 40 ma . the divergence and scattering slits were set at 1 ° and the receiving slit was set at 0 . 2 mm . a theta - two theta continuous scan at 3 °/ min ( 0 . 4 sec / 0 . 02 ° step ) from 3 to 40 ° 2θ was used . xrpd data are provided in the table below . the corresponding xrpd pattern is provided in fig1 . xrpd data for form a intensity , degree ( 2θ ) counts per second ( cps ) 9 . 8 180 12 . 7 3111 15 . 2 683 16 . 0 1347 17 . 1 591 17 . 4 220 18 . 5 1964 18 . 8 970 19 . 6 482 20 . 4 894 20 . 7 1440 22 . 3 1373 23 . 5 822 24 . 9 145 25 . 6 231 26 . 1 346 27 . 4 147 28 . 0 152 28 . 7 153 29 . 6 202 29 . 9 307 30 . 7 268 ir spectra ( e . g ., see fig2 ) were acquired as follows . samples were prepared as potassium bromide ( kbr ) discs ( or pellets ). a small amount of each sample ( about 3 mg ) was ground in a hard surface mortar until glossy in appearance . one half gram ( 0 . 5 g ) of kbr was added to the sample and the mixture was continuously ground until well mixed . the mixture was then transferred to a die and pressed into a disc using a hydraulic press . the ir spectrum of fig2 was obtained using a digilab excalibur series fts - 4000 ft - ir spectrometer operated at 4 cm − 1 resolution and 16 scans between 400 - 4000 cm − 1 . dsc measurements ( see fig3 ) were carried out in both sealed pan and vented pan at a scan rate of 10 ° c ./ min from 25 ° c . to 200 ° c . under nitrogen purge using a pyris i dsc from perkin - elmer . to a stirred solution of 594 g of ethanol ( denatured with 5 % of acetone and with 3 % of cyclohexane ) and 184 g of ethyl acetate , 400 g of pure bazedoxifene acetate form a were added under nitrogen ( e . g ., see example 2 ). the heterogeneous mixture was kept at 30 ° c . and stirred overnight under nitrogen . the completion of the crystalline transformation was determined by dsc analysis . the mixture was cooled to 0 ° c . and stirred for 2 hrs under nitrogen . the product was filtered , washed with a mixture of denatured ethanol and ethyl acetate as above and dried overnight at 60 ° c . under vacuum giving 391 g ( 97 . 7 % yield ) of bazedoxifene acetate form b polymorph . a substantially identical result was obtained using absolute ethanol or ethanol denatured with 5 % toluene . preparation of bazedoxifene acetate form b from a mixture of form a and form b bazedoxifene acetate form a ( 298 g ) and bazedoxifene acetate form b ( 2 g ) were suspended in a degassed mixture of ethyl acetate ( 400 ml ) and ethyl alcohol ( 2400 ml ). the resulting mixture was heated at reflux temperature for 2 hours . the suspension was cooled to 50 ° c . over the course of 1 hour and then to 20 ° c . over the course of 3 hours . the mixture was maintained at 20 ° c . for 13 hours and the product was recovered by filtration and washing with ethyl alcohol ( 78 . 9 g divided in 2 portions ). the wet material was dried under vacuum at 60 ° c . resulting in 276 . 8 g of bazedoxifene acetate form b . xrpd analyses were carried out on a ( scintag x2 ) x - ray powder diffractometer using cu k a radiation . the instrument was equipped with tube power , and amperage was set at 45 kv and 40 ma . the divergence and scattering slits were set at 1 ° and the receiving slit was set at 0 . 2 mm . a theta - two theta continuous scan at 3 °/ min ( 0 . 4 sec / 0 . 02 ° step ) from 3 to 40 ° 2θ was used . xrpd data are provided in the table below . the corresponding xrpd pattern is provided in fig4 . xrpd data for form b intensity , degree ( 2θ ) counts per seconds ( cps ) 12 . 1 1530 13 . 3 3174 13 . 4 1758 14 . 5 1034 15 . 6 814 15 . 9 1249 16 . 9 710 18 . 8 700 19 . 4 1605 20 . 8 6982 21 . 6 2193 22 . 7 1225 22 . 8 1045 24 . 2 756 25 . 0 1809 26 . 0 705 29 . 9 833 30 . 5 994 34 . 2 1269 ir spectra ( e . g ., see fig5 ) were acquired as follows . samples were prepared as potassium bromide ( kbr ) discs ( or pellets ). a small amount of each sample ( about 3 mg ) was ground in a hard surface mortar until glossy in appearance . one half gram ( 0 . 5 g ) of kbr was added to the sample and the mixture was continuously ground until well mixed . the mixture was then transferred to a die and pressed into a disc using a hydraulic press . the ir spectrum of fig5 was obtained using a digilab excalibur series fts - 4000 ft - ir spectrometer operated at 4 cm − 1 resolution and 16 scans between 400 - 4000 cm − 1 . dsc measurements ( see fig6 ) were carried out in both sealed pan and vented pan at a scan rate of 10 ° c ./ min from 25 ° c . to 200 ° c . under nitrogen purge using a pyris i dsc from perkin - elmer . pharmacokinetic analysis of a direct blend formulation of the invention in dogs a direct blend tablet formulation in accordance with example 1 , supra , was compared in female beagle dogs to a tablet formulation prepared by a wet granulation process . the composition of the wet granulation formulation is shown in the table below : ingredient % wt / wt mg / tablet bazedoxifene acetate , micronized 4 . 843 a 20 . 00 a lactose , nf ( fast flow ) 35 . 206 145 . 40 avicel ph101 33 . 898 140 . 00 pregelatinized starch nf ( starch 1500 ) 13 . 559 56 . 00 sodium lauryl sulfate nf 1 . 453 6 . 00 sodium starch glycolate nf 5 . 811 24 . 00 ascorbic acid , usp fine powder 1 . 453 6 . 00 silicon dioxide ( syloid 244 fp ) 0 . 145 0 . 60 magnesium stearate nf 0 . 484 2 . 00 white opadry 1 ( ys - 1 - 18027 - a ) 3 . 148 13 . 00 water , usp , purified qs qs total 100 . 00 413 . 0 mg a as the free base , quantity is adjusted based on actual potency . corresponding adjustment was made with lactose each of six female dogs ( 7 . 2 - 11 . 0 kg ), received a single 10 mg dose of bazedoxifene acetate from both formulations following an overnight fast in a non - randomized crossover design . 20 mg wet granulation tablets as described above were broken in half for the 10 mg dose from that formulation . blood samples were drawn at 0 ( predose ), 0 . 5 , 1 , 2 , 3 , 4 , 6 , 8 , 12 and 24 hours after dosing , plasma was separated and assayed for bazedoxifene acetate content . individual dog plasma bazedoxifene concentration - time profiles were subjected to noncompartmental pharmacokinetic analyses ( winnonlin , model 200 ). the following pharmacokinetic parameters were determined for each dog and descriptive statistics were calculated for comparison between the two formulations : auc 0 - t , c max , t max . the results are summarized in the following table : pharmacokinetic parameters of bazedoxifene acetate in female dogs following single oral dose administration of 10 mg as direct blend tablet and tablet prepared by wet granulation procedure wet granulation individual dog parameter direct blend tablet tablet ratios auc 0 - t 79 . 3 88 . 2 0 . 90 ( ng · hr / ml ) 171 149 1 . 14 61 . 6 106 0 . 58 65 . 4 139 0 . 47 112 48 . 0 2 . 33 82 . 2 158 0 . 52 mean 95 . 2 115 0 . 99 sd 41 . 0 42 . 2 0 . 71 c max 20 . 7 26 . 6 0 . 78 ( ng / ml ) 12 . 3 14 . 5 0 . 85 5 . 10 13 . 7 0 . 37 6 . 74 20 . 0 0 . 34 18 . 7 12 . 9 1 . 45 8 . 99 14 . 2 0 . 63 mean 12 . 1 17 . 0 0 . 74 sd 6 . 42 5 . 36 0 . 41 t max 1 . 00 0 . 50 ( hr ) 4 . 00 1 . 00 2 . 00 0 . 50 4 . 00 1 . 00 0 . 50 0 . 50 0 . 50 1 . 00 mean 2 . 00 0 . 75 sd 1 . 64 0 . 27 because of the variability in the plasma bazedoxifene levels typically observed in this protocol , terminal elimination half - lives could not be determined for the majority of the plasma bazedoxifene concentration - time profiles ; therefore auc 0 - t values were compared between the two tablet formulations . also , the exposure levels of bazedoxifene from the direct blend tablet appeared to be slightly lower than those from the wet granulation tablet . fig7 shows the mean ( sd ) plasma bazedoxifene levels in female dogs following single oral dose administration of 10 mg bazedoxifene as direct blend tablet of example 1 , and the wet granulated tablet described above . fig8 shows individual dog plasma bazedoxifene levels following single oral dose administration of the 10 mg bazedoxifene direct blend tablets , and fig9 shows individual dog plasma bazedoxifene levels following single oral dose administration of 10 mg bazedoxifene via the wet granulated tablet described above . as can be seen from these data , the direct blend formulation prepared in accordance with the present invention provides administration of bazedoxifene that is comparable to that provided by the tablets prepared by the wet granulation process . various modifications of the invention , in addition to those described herein , will be apparent to those skilled in the art from the foregoing description . such modifications are also intended to fall within the scope of the appended claims . each of the publications and , references , including books and patents , cited in the present application is incorporated herein by reference in its entirety .

the present invention is directed to formulations of bazedoxifene acetate that have reduced polymorph conversion , compositions containing the same , preparations thereof , and uses thereof .

wherein a is a heterocyclic moiety optionally substituted by one or more substituents selected from the group consisting of alkyl , aryl , halogen , trihalomethyl , trihalomethoxy , trialkylsilyl , s ( o ) r , so 2 r , so 2 nrr ′, so 3 r , sr , no 2 , nrr ′, or , cn , c ( o ) r , oc ( o ) r , nhc ( o ) r , co 2 r and conrr ′, wherein r and r ′ are independently hydrogen , alkyl or aryl ; b 1 and b 2 are independently hydroxy or oconr 1 r 2 , provided that b 1 and b 2 are not simultaneously hydroxy , and r 1 and r 2 are independently selected from the group consisting of hydrogen , hydroxy , alkyl , alkoxy , alkylaryl , arylalkyl , aryl and aryloxy , and their enantiomers , as well as enantiomeric mixtures , and pharmaceutically acceptable salts thereof . a preferred group of compounds of the present invention are compounds of formula ( i ) wherein a is selected from the group consisting of wherein r 3 , r 4 and r 5 , each independently , is selected from the group consisting of hydrogen , alkyl and aryl , and x is selected from sulfur , oxygen and nitrogen . a more preferred compounds of according to the present invention are compounds of formula i wherein a is wherein r 3 , r 4 and r 5 are as previously described . (±)-( 2 -( 5 - chloro - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide . (+)-( 2r )-( 2 -( 5 - chloro - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; (−)-( 2s )-( 2 -( 5 - chloro - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; ( 2 -( 5 - trifluoromethyl - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; ( 2 -( 5 - bromo - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; ( 2 -( 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; n - methyl -( 2 -( 5 - chloro - 2 - thienyl )- 2 - n - methylcarbamoyloxyethyl ) oxocarboxamide ; ( 2 -( 5 - phenyl - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; ( 2 -( 3 , 4 , 5 - trichloro - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; ( 2 -( 5 - methyl - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; ( 2 -( 2 , 5 - dichloro - 3 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; ( 2 -( 2 - benzothienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ; and ( 2 -( 5 - tert - butyl - 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide . as used herein , the term “ lower alkyl ” is to be understood to mean a straight - or branched - chain alkyl group of 1 to 6 carbon atoms , such as methyl , ethyl , isopropyl , butyl , pentyl , hexyl , and the like with methyl being preferred . the term “ halogen ” is to be understood to mean all of the halogens , that is , bromine , chlorine , fluorine and iodine ; with bromine and chlorine being preferred . the term “ lower alkoxy ” is to be understood to mean a lower alkyl ether group in which the lower alkyl moiety is as described above , such as methoxy , ethoxy , propoxy , butoxy and the like with methoxy being preferred . additional examples of the heterocyclic groups represented by a in formula ( i ) include the following : and the like , wherein each r 10 is the same or different and represents a substituent selected from the group consisting of hydrogen , alkyl , aryl , halogen , trihalomethyl , trihalomethoxy , trialkylsilyl , s ( o ) r , so 2 r , so 2 nrr ′, so 3 r , sr , no 2 , nrr ′, or , cn , c ( o ) r , oc ( o ) r , nhc ( o ) r , co 2 r and conrr ′, m is 1 - 3 ; and r and r ′ are independently selected from the group consisting of hydrogen , alkyl and aryl . the starting materials for the compounds of the present invention are represented by the general formula wherein a is a heterocyclic ring as defined above . these 2 - heterocyclic - 1 , 2 - ethanediols are known per se or can be conveniently prepared by a dihydroxylation reaction of the corresponding styrenic compound . optically active diols can be prepared according to the procedure given in k . sharpless et . al ., j . org . chem 56 : 4585 ˜ 8 ( 1991 ). the compounds of formula i above wherein only one of b 1 and b 2 is a carbamate group can be prepared by the synthetic method described in scheme 1 , a detailed description of which follows . the 2 - heterocyclic - 1 , 2 - ethanediol starting material is reacted with dimethyl carbonate in the presence of catalytic amount of sodium methoxide . the by - product that forms is removed by vacuum distillation and the residual product dried in vacuo . the crude reaction product is subsequently dissolved in a lower alkanol , such as methanol , and an excess amount of an amine is added to the reaction solution at room temperature to provide two regioisomeric forms of a monocarbamate of 2 - heterocyclic - 1 - 2 - ethanediol . the compounds of the present invention wherein both of b 1 and b 2 are carbamate groups and the carbamate groups are the same may be prepared directly from the 2 - heterocyclic - 1 - 2 - ethanediol starting material according to the reaction of reaction scheme 2 as described below . the 2 - heterocyclic - 1 - 2 - ethanediol is dissolved in dichloromethane and is treated with about 2 equivalents of carbonyl diimidazole . the resulting mixture is stirred until the starting material is not observed by thin layer chromatography analysis , and the mixture is then treated with excess amounts of amine ( r 1 r 2 nh wherein r 1 and r 2 are as defined above ). it takes more than 24 hours to complete the reaction . after a routine aqueous wash , the crude reaction product is purified by flash column chromatography or recrystallization to provide the desired compound of formula i . the compounds of the present invention wherein both of b 1 and b 2 are carbamate groups and the carbamate groups are different may be prepared from the corresponding monocarbamate compound represented by formula i in accordance with reaction scheme 3 . the 2 - heterocyclic - 1 - 2 - ethanediol monocarbamate is treated with about 1 equivalent of carbonyl diimidazole . the resulting mixture is stirred until the starting material is not observed by thin layer chromatography analysis , after which the mixture is treated with an excess amount of amine ( r 1 r 2 nh wherein r 1 and r 2 are as defined above , but are different in at least one particular from those of the starting material ). exemplary of the 2 - heterocyclic - 1 , 2 - ethanediols starting materials in accordance with the present invention are the following : 1 -( 2 - thienyl )- 1 , 2 - ethanediol ; 1 -( 5 - chloro - 2 - thienyl )- 1 , 2 - ethanediol ; 1 -( 5 - phenyl - 2 - thienyl )- 1 , 2 - ethanediol ; 1 -( 3 , 4 , 5 - trichloro - 2 - thienyl )- 1 , 2 - ethanediol ; 1 -( 2 - benzothienyl )- 1 , 2 - ethanediol ; 1 -( 5 - cyano - 2 - thienyl )- 1 , 2 - ethanediol ; 1 -( 2 - furanyl )- 1 , 2 - ethanediol ; and the like . the compounds of the invention contain chiral centers . the compounds of formula ( i ) contain an asymmetric carbon atom at the position , which is the aliphatic carbon adjacent to the heteroaromatic ring . the scope of the invention includes pure enantiomeric forms and enantiomeric mixtures , wherein one of the enantiomer predominates in the compound of formula ( i ). preferably , one of the enantiomers predominates to the extent of about 90 % or greater , and most preferably , about 98 % or greater . the compounds of formula ( i ) of the invention , which have basic amine functional group like as amino , pyridyl or imidazolyl can form salts with inorganic and organic acids including , for example , hydrochloric acid , hydrobromic acid , methanesulfonic acid , and the like . these salts are prepared following procedures well known to those skilled in the art . in utilizing the compounds of the invention for the treatment of diseases of the central nervous system , particularly the treatment of convulsions , epilepsy , neurogenic pain , stroke and muscle spasm , it is preferred to administer the compounds orally . moreover , since the compounds of formula ( i ) are absorbed orally , it will not be necessary to resort to parenteral administration . for oral administration , the compounds of formula ( i ) are preferably combined with a pharmaceutical carrier . the ratio of the carrier to a compound of formula ( i ) is not critical to achieve the desired effects on the central nervous system of the host requiring such treatment , and can vary considerably , depending on whether the composition is to be filled into capsules or formed into tablets . in tableting , it is usually desirable to employ at least as much pharmaceutical carrier as the pharmaceutically active ingredients . various pharmaceutical carriers or mixtures thereof can be used . suitable carriers , for example , comprise mixtures of lactose , dibasic calcium phosphate and corn starch . other pharmaceutically acceptable ingredients can be further added , including lubricants such as magnesium stearate . the compounds of formula ( i ) can be formulated , using conventional inert pharmaceutical adjuvant materials , into dosage forms that are suitable for oral or parenteral administration . such dosage forms include tablets , suspensions , solutions , and the like . furthermore , the compounds of the invention can be administered in the form of hard or soft capsules . examples of suitable inert adjuvant materials that can be used in formulating the compounds of formula ( i ) into oral and parenteral dosage forms will be immediately apparent to persons skilled in the art . these adjuvant materials include , for example , water , gelatin , lactose , starch , magnesium stearate , talc , vegetable oils , gums , polyalkylene glycols , and the like . moreover , preservatives , stabilizers , wetting agents , emulsifying agents , salts for altering osmotic pressure , buffers , and the like , can be incorporated , if desired , into such formulations . the therapeutic use of the compounds of formula i as anticonvulsants has been established by the “ maximal electroshock ( mes )” test , which is a well - established pharmacological screening method for anticonvulsants against partial seizures , and the results are presented in table i . the procedure employed in the mes test for anticonvulsants is as follows . the dosing solutions of the compounds to be tested were prepared in saline . the subjects , namely , mice ( icr strain ), were dosed i . p . after the designated number of hours , maximal electroshock was induced in mice via corneal electrodes using iitc life science model 11a shocker at 50 ma - 60 hz for 0 . 2 second . anticonvulsant activity is demonstrated by the elimination of hindlimb tonic extension upon inducing maximal electroshock . median efficacy dose ( ed 50 ) levels were determined using three different dose levels with at least 6 mice in each group . compounds with smaller ed 50 value are more potent as anticonvulsants . the “ pentylenetetrazol ( ptz )” test for anticonvulsant activity was also carried out . compounds that antagonize the effects of subcutaneous ptz - induced seizures are known to elevate the threshold for seizures , hence are generally useful in preventing such seizures . the procedure employed in the ptz test for anticonvulsants follows . the compound dosing solutions were prepared in saline , and mice ( icr strain ), were dosed i . p . after the designated number of hours , each animal was injected subcutaneously with 100 mg / kg of ptz ( cd 97 dose ) and observed for up to 30 minutes for the presence or absence of threshold clonic seizures of 2 second duration or longer . median efficacy dose ( ed 50 ) levels were determined using three different dose levels with 8 mice in each group . the compounds with a smaller ed 50 value are more potent as anticonvulsants . test results obtained with the compounds of formula i of the invention are set forth in table i . table i compound mes ptz of ed 50 ed 50 example ( mg / kg ) ( mg / kg ) hour 4 16 . 9 31 . 3 2 5 8 . 4 47 . 2 2 6 36 . 9 42 . 7 2 7 37 . 4 — 1 14 12 . 6 — 1 17 14 . 9 50 1 18 19 . 6 — 1 the data presented in table 1 demonstrate that the compounds of formula ( i ) of the invention possess anticonvulsant activity by preventing the occurrence of electroshock seizures , and also protecting the host against convulsions produced by pentylenetetrazole . the amount of a compound of formula ( i ) which is present in any of the above - described dosage forms is variable . in the systemic treatment of cns diseases with a active amount of compounds of the formula ( i ), the dosage is typically from about 0 . 02 mg to about 250 mg / kg / day ( 0 . 001 ˜ 12 . 5 g / day in a typical human weighing 50 kg ) in single or divided doses , regardless of the route of administration . a more preferred dosage range is from about 0 . 15 mg / kg / day to about 250 mg / kg / day . of course , depending upon the exact compound and the exact nature of the individual illness , doses outside this range may be prescribed by the attending physician . the examples , which follow further , illustrate the invention . all parts are by weight and all temperatures are in degrees centigrade , unless otherwise mentioned . moreover , unless otherwise stated , nmr spectra were obtained at 200 mhz , melting points are uncorrected , and optical rotations were measured with a automatic polarimeter . 1 , 1 ′- carbonyldiimidazole ( 4 . 5 g ) was added to a solution of 1 -( 2 - thienyl )- 1 , 2 - ethanediol ( 1 . 0 g 6 . 9 mmol ) in dichloromethane ( 15 ml ) at 5 °. the reaction mixture was allowed to come to room temperature with stirring over one hour . ten ml of an aqueous solution of ammonium hydroxide ( 28 % nh3 in water ) was added at 5 °. the reaction mixture was stirred for 1 hour at room temperature , extracted with ethyl acetate , washed with 0 . 5n aqueous hydrochloric acid , saturated sodium bicarbonate and brine . the extracts were dried over sodium sulfate , filtered , concentrated and purified by recrystallization from dichloromethane to yield the title compound as a white solid ( 1 . 2 g , yield 74 %). m . p . 158 - 159 ° ( from dichloromethane ). [ α ] d 24 ′ = 0 ′ ( c = 0 . 005 , methanol ). the title compound was prepared in accordance with the procedure of example 1 , except that (+)-( 1r )- 1 -( 2 - thienyl )- 1 , 2 - ethanediol ( m . p . 48 ˜ 50 ° from carbon tetrachloride ) was used instead of (±)- 1 -( 2 - thienyl )- 1 , 1 - ethandiol . m . p . 183 - 184 ° ( from dichloromethane ). [ a ] d 24 ′ =+ 63 ( c = 0 . 005 , methanol ). the title compound was prepared in accordance with the procedure of example 1 , except that (−)-( 1s )- 1 -( 2 - thienyl )- 1 , 2 - ethanediol ( m . p . 48 ˜ 50 ° from carbon tetrachloride ) was used instead of (±)- 1 -( 2 - thienyl )- 1 , 1 - ethandiol . m . p . 184 - 185 ° ( from dichloromethane ). [ a ] d 24 ′ =− 56 ( c = 0 . 005 , methanol ). the title compound was prepared in accordance with the procedure of example 1 , except that (±)- 1 -( 5 - chloro - 2 - thienyl )- 1 , 2 - ethanediol ( m . p . 50 ˜ 51 ° from carbon tetrachloride ) was used instead of (±)- 1 -( 2 - thienyl )- 1 , 1 - ethandiol . m . p . 154 - 156 ° ( from dichloromethane ). [ a ] d 24 ′ = 0 ′ ( c = 0 . 005 , methanol ). the title compound was prepared in accordance with the procedure of example 1 , except that (+)-( 1r )- 1 -( 5 - chloro - 2 - thienyl )- 1 , 2 - ethanediol ( m . p . 78 ˜ 80 ° from carbon tetrachloride ) was used instead of (±)- 1 -( 2 - thienyl )- 1 , 1 - ethandiol . m . p . 185 - 186 ° ( from dichloromethane ). [ α ] d 24 ′ =+ 55 ( c = 0 . 005 , methanol ). the title compound was prepared in accordance with the procedure of example 1 , except that (−)-( 1s )- 1 -( 5 - chloro - 2 - thienyl )- 1 , 2 - ethanediol ( m . p . 77 ˜ 78 ° from carbon tetrachloride ) was used instead of (±)- 1 -( 2 - thienyl )- 1 , 1 - ethandiol . m . p . 185 - 186 ° ( from dichloromethane ). [ α ] d 24 ′ =− 52 ( c = 0 . 005 , methanol ). the title compound was prepared in accordance with the procedure of example 1 , except that methylamme was used instead of ammonium hydroxide . m . p . 104 - 106 ° ( from hexane : ethyl acetate = 5 : 1 ). the title compound was prepared in accordance with the procedure of example 1 , except that 1 -( 5 - chloro - 2 - thienyl )- 1 , 2 - ethanediol ( m . p . 77 ˜ 78 ° from carbon tetrachloride ) was used instead of (±)- 1 -( 2 - thienyl )- 1 , 1 - ethandiol . m . p . 202 - 203 ° ( from methanol ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 3 , 4 , 5 - trichloro - 2 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 193 - 197 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 5 - methyl - 2 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 172 - 173 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 2 , 5 - dichloro - 3 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 137 - 138 ° ( from ether ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 3 - chloro - 2 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 153 - 155 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 2 - benzothienyl )- 1 , 2 - ethanediol as the starting material . m . p . 195 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 5 - trifluoromethyl - 2 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 159 - 160 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 5 - tert - butyl - 2 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 132 - 155 ° ( from carbon tetrachloride ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 5 - cyano - 2 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 149 - 151 ° ( from dichloromethane ). n - bromosuccinimide ( 1 . 79 g ) was added in portions to a solution of (±)-( 2 -( 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ( 2 . 2 g 9 . 5 mmol ) in 40 ml of a 1 : 1 mixture of chloroform and acetic acid . the resulting suspension was stirred for 24 hours . the reaction mixture was then diluted with an equal volume of water and the separated organic layer was recovered , and sequentially washed with potassium hydroxide solution and water . the extracts were dried over sodium sulfate , filtered , concentrated and purified by recrystallization from dichloromethane to yield the title compound as a white solid ( 2 . 2 g ). m . p . 160 - 161 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 17 , utilizing (+)-( 2r )-( 2 -( 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide as the starting material . m . p . 181 - 1820 ( from dichloromethane ). [ a ] d 24 ′ =+ 46 ′ ( c = 0 . 005 , methanol ). the title compound was prepared in accordance with the procedure of example 17 , except that the starting material was (−)-( 2s )-( 2 -( 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide instead of (±)-( 2 -( 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide . m . p . 181 - 1820 ( from dichloromethane ). [ a ] d 24 ′ =− 46 ′ ( c = 0 . 005 , methanol ). in 4 ml of acetic anhydride there was suspended ( 2 -( 2 - thienyl )- 2 - carbamoyloxyethyl ) oxocarboxamide ( 0 . 50 g ) and the resulting mixture was cooled to 0 °. a mixture of nitric acid ( 60 % in water 0 . 37 g ) in 4 ml of acetic acid was added dropwise and the mixture was stirred at room temperature for 1 . 5 hours , poured into 100 ml of ice water , extracted with ethyl acetate and washed with saturated brine . the extracts were dried over sodium sulfate , filtered , concentrated and purified by recrystallization from ether to yield the title compound as a yellow solid ( 0 . 07 g , yield 12 %). m . p . 145 - 1847 ( from ether ). 1 , 1 ′- carbonyldiimidazole ( 1 . 13 g ) was added to a solution of 1 -( 2 - thienyl )- 1 , 2 - ethanediol ( 1 . 0 g ) in 20 ml of dichloromethane at 5 °. the reaction mixture was allowed to warm to room temperature , stirred for one hour and then concentrated in vacuo to yield 1 -( 2 - thienyl )- 1 , 2 - ethanediol carbonate ( 1 . 07 g , 90 . 7 % yield ) as a colorless oil after chromatographic purification . the product was dissolved in 20 ml of tetrahydrofuran and 2 g of ammonium hydroxide ( equivalent to 28 % ammonia in water ) was added thereto at 0 °. the reaction mixture was slowly warmed to room temperature and was stirred thereafter for a further hour and then concentrated in vacuo to yield ( 2 -( 2 - thienyl )- 2 - hydroxyethyl ) oxocarboxamide ( 0 . 30 g , yield 25 %) as a white solid after chromatographic purification . m . p . 71 - 73 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 21 , utilizing 1 -( 5 - chloro - 2 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 68 - 72 ° ( from benzene ). imidazole ( 0 . 45 g ) was added to a solution of 1 ( 5 - chloro - 2 - thienyl )- 1 , 2 - ethanediol ( 1 . 0 g , 5 . 6 mmol ) and tert - butyldimethylsilyl chloride ( 0 . 80 g ) in n , n - dimethylformamide ( 5 ml ) at 5 °. the reaction mixture was allowed to come to room temperature and stirred 1 hour , extracted with ethyl acetate , washed with 0 . 5n aqueous hydrochloric acid , saturated sodium bicarbonate and brine . the extracts were dried over sodium sulfate , filtered , concentrated in vacuo . 1 - tert - butyldimethylsilyloxy - 2 -( 5 - chloro - 2 - thienyl ) ethan - 1 - ol ( 1 . 14 g ) was obtained as a colorless oil after a chromatographic purification . 1 , 1 ′- carbonyldiimidazole ( 0 . 95 g ) was added to a solution of the foregoing alcohol ( 1 . 14 g 3 . 9 mmol ) in dichloromethane ( 20 ml ) at 5 °. the reaction mixture was allowed to come to room temperature and stirred 1 hour . ammonium hydroxide ( equivalent to 28 % ammonia in water , 10 ml ) was added at 5 °. the reaction mixture was stirred for 1 hour at room temperature , extracted with ethyl acetate , washed with 0 . 5n aqueous hydrochloric acid , saturated sodium bicarbonate and brine . the extracts were dried over sodium sulfate , filtered , concentrated in vacuo . 1 - tert - butyldimethylsilyloxy - 2 ( 5 - chloro - 2 - thienyl )- 2 - carbamoyloxyethane ( 0 . 47 g ) was obtained as a colorless oil after a chromatographic purification . tetrabutylammonium fluoride ( 1 . 0m solution in tetrahydrofuran 2 ml ) was added to a solution of the carboxamide formed above ( 0 . 47 g 1 . 6 mmol ) in tetrahydrofuran ( 10 ml ) at 5 °. the reaction mixture was stirred 1 hour , extracted with ethyl acetate , washed with 0 . 5n aqueous hydrochloric acid , saturated sodium bicarbonate and brine . the extracts were dried over sodium sulfate , filtered , concentrated in vacuo . ( 2 -( 5 - chloro - 2 - thienyl )- 2 - carbamoyloxy ) ethan - 1 - ol ( 0 . 14 g ) was obtained as a white solid after a chromatographic purification . m . p . 117 - 120 ° c . ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 2 - pyridyl )- 1 , 2 - ethanediol as the starting material in place of 1 -( 2 - thienyl )- 1 , 2 - ethanediol . m . p . 173 - 174 ° c . ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 21 utilizing 1 -( 2 - pyridyl )- 1 , 2 - ethanediol as the starting material . m . p . 116 - 120 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 23 utilizing 1 -( 2 - pyridyl )- 1 , 2 - ethanediol as the starting material . m . p . 123 - 124 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing methylamine in place of ammonium hydroxide . m . p . 114 - 115 ° ( from chloroform / ether ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 2 - furanyl )- 1 , 2 - ethanediol as the starting material . m . p . 155 - 560 ° ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 4 - methyl - 5 - thiazolyl )- 1 , 2 - ethanediol as the starting material . m . p . 166 - 168 ° c . ( from dichloromethane ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 2 - indolyl )- 1 , 2 - ethanediol as the starting material . m . p . 145 - 146 ° ( from diethyl ether ). the title compound was prepared in accordance with the procedure of example 1 utilizing 1 -( 5 - trimethylsilyl - 2 - thienyl )- 1 , 2 - ethanediol as the starting material . m . p . 138 - 140 ° c . ( from dichloromethane ).

carbamate compounds of 2 - heteroaryl - 1 , 2 - ethanediol are described . the compounds are effective in the treatment of disorders of the central nervous system , especially as anti - convulsive or anti - epileptic agents .

the pharmaceutical formulation according to the present invention is effective in prevention and reduction and / or treatment of symptoms such as pain , inflammation and / or fever and osteoarthritis wherein said composition comprises combination of an nsaid and diacerein . these symptoms also include those of musculoskeletal and joint disorders such as ankylosing spondylitis , osteoarthritis and rheumatoid arthritis , soft tissue injuries such as sprains and strains , post - operative pain , dolorous and difficult menstruation migraine pains and all forms of headaches . the present invention relates to a new solid oral dosage form comprising a pharmaceutically effective amount of nsaid and a pharmaceutically effective amount of diacerein . the solid oral dosage form according to the present invention is preferably in the form of tablet and more preferably in the form of multi - layer tablet . the present invention relates to a solid oral multi - layer tablet formulation comprising the followings : i ) a first layer containing an nsaid molecule as the first active agent and pharmaceutically acceptable excipient or excipients ; ii ) a second layer containing diacerein molecule as the second active agent and pharmaceutically acceptable excipient or excipients ; and iii ) a barrier layer positioned between said two layers and containing pharmaceutically acceptable excipient or excipients ( fig1 ). in the tablet , these 3 layers are provided in the form of sandwich . barrier layer is provided in the intermediate portion so as to separate nsaid and diacerein layers from each other and nsaid and diacerein layers are provided on both sides of the barrier layer on the outside portion . negative interaction of nsaid and diacerein molecules are prevented by means of the barrier layer provided in the intermediate portion . the nsaid in the multi - layer tablet formulation according to the present invention is a propionic acid derivative wherein it can be given as ibuprofen , naproxen , ketoprofen , fenoprofen , benoxaprofen , suprofen , flurbiprofen , ibuproxam , alminoprofen , dexibuprofen , dexketoprofen , indoprofen and mixture thereof and preferably said nsaid is flurbiprofen , dexketoprofen and mixture thereof . on the other hand , nsaid and diacerein in the multi - layer tablet formulation according to the present invention can be present as pharmaceutically acceptable salts , enantiomers , racemates , polymorphs , esters and / or hydrates thereof . nsaid group molecules and diacerein are molecules wherein its absorption occurs in the gastrointestinal system . the multi - layer tablet according to the present invention , as per tablet shape , provides disintegration of both molecule layers when taken into the body . nsaid and diacerein layers starts to disintegrate when taken into the body as it doesn &# 39 ; t contain any coating or top layer . resulting from said disintegration , nsaid and diacerein molecules solubilizes . thus , formulation of said molecules having very low solubility in the multi - layer tablet according to the present invention positively affects the dissolution profiles of said molecules . another positive effect of the multi - layer tablet formulation according to the present invention is the prevention of adverse physical and chemical interaction of nsaid and diacerein molecules , provided in two separate layers and thus , a more stable formulation is provided . the pharmaceutically acceptable excipients provided in the multi - layer tablet formulation according to the present invention can be selected from , but not limited to , diluents , binders , disintegrants , glidants , lubricants , plasticizers , surfactants , preservatives or mixtures thereof . diluents according to the present invention include , but not limited to , lactose , microcrystalline cellulose , corn starch , modified corn starch , calcium phosphate , sugar , dextrose , mannitol , sorbitol , starch , pregelatinized starch and mixtures thereof . binders according to the present invention include , but not limited to , lactose , polymethacrylate , polyvinylpyrrolidone ( povidone ), hydroxypropyl methyl cellulose ( hpmc ), hydroxypropyl cellulose ( hpc ), carboxymethyl cellulose ( cmc ), methyl cellulose ( mc ), hydroxyethyl cellulose , sodium carboxy methyl cellulose ( nacmc ), carboxymethyl cellulose calcium , ethyl cellulose , polyethylene oxide , gelatin , starch , pregelatinized starch , xanthan gum , guar gum , alginate , carrageenan , pectin , carbomer , cellulose acetate phthalate , hydroxy propyl starch , polaxomer , polyethylene glycol and mixtures thereof . disintegrants according to the present invention include , but not limited to , microcrystalline cellulose , croscarmellose sodium , xylitol , polyplasdone ( 1 - ethenylpyrrolidin - 2 - one ), crospovidone , hydroxypropyl cellulose , low - substituted hydroxypropyl cellulose ( l - hpc ) and sodium starch glycolate or mixtures thereof . glidants according to the present invention include , but not limited to , silicon dioxide , magnesium trisilicate , starch , talc , colloidal silicon dioxide or silicon hydrogel or mixtures thereof . lubricants according to the present invention include , but not limited to , magnesium stearate , sodium stearyl fumarate , polyethylene glycol , stearic acid , metal stearates , boric acid , sodium chloride benzoate and acetate , sodium or magnesium lauryl sulfate or mixtures thereof . plasticizers according to the present invention include , but not limited to , triethyl citrate , triacetin , citric acid esters , phthalic acid esters , dibutyl sebacate , cetyl alcohol , polyethylene glycol , polysorbate or mixtures thereof . surfactants according to the present invention may include , but not limited to , dioctyl sulfosuccinate , polysorbates and polyoxyethylene alkyl esters and ethers thereof , glyceryl monolaurate saponins , sorbitan laurate , sodium lauryl sulfate , magnesium lauryl sulfate or mixtures thereof . preservatives according to the present invention include , but not limited to , methyl paraben , propyl paraben and salts thereof ( e . g . sodium or potassium salts ), sodium benzoate , citric acid , benzoic acid , butylated hydroxytoluene and butylated hydroxyanisole or mixtures thereof . the present invention , in a preferred embodiment thereof , also include at least one or a mixture in the suitable amount of polyvinyl alcohol - polyethylene glycol copolymer , polyoxyethylene - polyoxypropylene block copolymer , stearyl macrogol glyceride , polyethylene glycol , povidone , cationic methacrylate , copovidone , derivatives of methacrylic acid copolymer , cellulose acetate phthalate , acetylated monoglyceride , dibutyl tartrate , diethyl phthalate , dimethyl phthalate , glycerine , propylene glycol , stearic acid , triacetin , triacetin citrate and tripropionin . excipients comprised within the content of the multi - layer tablet according to the present invention is selected and formulated so as to optimize disintegration rate of said tablet . in the formulation according to the present invention , disintegrant agent provided in each layer containing the active ingredients is in the range of 0 . 5 % to 30 % by weight of the layer . with disintegrant agent present in such amount , formulation gains the hardness required for the sandwich form as well as disintegrates quickly . according to another embodiment of the present invention , nsaid and diacerein layers comprise croscarmellose sodium and hydroxypropyl cellulose as disintegrant . said disintegrant agents swell by absorbing the water upon contact therewith and provide rapid disintegration of the tablet . it has been found out that the first and second layers comprising active ingredient provided in the multi - layer tablet formulation according to the present invention with croscarmellose sodium agent about 3 % to 7 % by weight of the layer and hydroxypropyl cellulose agent about 2 % to 10 % by weight of the layer causes synergistic effect on the disintegration time . higher amounts can lead to adverse effects on the mechanical resistance of the formula while lower amounts can worsen the disintegration time . in said ranges , layers containing croscarmellose sodium and hydroxypropyl cellulose disintegrate rapidly as well as they are hard enough to take the multi - layer tablet form according to the present invention . according to another embodiment , the present invention concerns inclusion of glidant in the layers of the multi - layer tablet formulation comprising nsaid and diacerein wherein said glidant is preferably colloidal silicon dioxide . colloidal silicon dioxide provided in the layers is in the range of approximately 0 . 01 % to 1 % by weight of the layers . it has been found out that the effectiveness of the disintegrant agents increase with the colloidal silicon dioxide provided in said range in each layer . colloidal silicon dioxide is a hydrophobic substance . thus , large amount of said substance being present delays the contact of the disintegrant agents with water and leads to delayed disintegration of the tablet . according to another embodiment , the present invention concerns multi - layer tablet formulation comprising nsaid and diacerein wherein lactose and derivatives thereof are comprised therein as excipient . total lactose amount provided in the tablet according to the present invention is in the range of 14 % to 43 % by weight of total tablet weight . thus , potential side effects that may be observed in the patient ( e . g ., lactose intolerance ) are reduced . when nsaid and diacerein preparations available in the prior art are used separately , total lactose intake of the patient increases . when these two molecules are brought together in the form of multi - layer tablet , lactose intake decreases in the range of approximately 30 % to 60 % and thus , potential side effects that can be observed in the patient reduces . according to another embodiment , in the multi - layer tablet formulation according to the present invention , lactose amount comprised in the layer containing nsaid is in the range of 7 % to 43 % by weight of respective layer and lactose amount comprised in the layer containing diacerein is in the range of 50 % to 60 % by weight of respective layer . with lactose being present in said ranges , multi - layer tablet is not affected by environmental conditions such as humidity in particular and becomes more stable . in addition , compressibility property of the tablet is at the optimum level with lactose provided in such ranges . pharmaceutically acceptable lactose according to the present invention is selected from the group comprising spray - dried lactose , beta - lactose , alpha lactose monohydrate , lactose anhydride or mixtures thereof , preferably , said lactose is spray - dried lactose . the multi - layer tablet according to the present invention comprises pharmaceutically acceptable lactose having 98 % of particles thereof with size in the range of approximately 300 μm to 350 μm . from another perspective , the amount of nsaid group molecules provided in the multi - layer tablet formulation according to the present invention is in the range of 5 mg to 1000 mg and preferably , among said molecules , flurbiprofen is provided in the range of approximately 50 mg to 300 mg and dexketoprofen is provided in the range of approximately 5 mg to 100 mg and more preferably , flurbiprofen amount is 100 mg or 50 mg and dexketoprofen amount is 25 mg . from another perspective , the amount of diacerein provided in the multi - layer tablet formulation according to the present invention is in the range of approximately 10 mg to 100 mg and preferably , diacerein amount is 50 mg . the present invention concerns a multi - layer tablet comprising nsaid layer wherein it includes , but may not be limited to , the following substances by weight of the respective layer : a ) approximately 5 % to 60 % by weight of nsaid , b ) approximately 5 % to 60 % by weight of diluent , c ) approximately 0 . 5 % to 30 % by weight of disintegrant , d ) approximately 2 % to 10 % by weight of binder , e ) approximately 0 . 1 % to 10 % by weight of glidant , f ) approximately 0 . 1 % to 10 % by weight of lubricant . the present invention concerns a multi - layer tablet comprising diacerein layer wherein it includes , but may not be limited to , the following substances by weight of the respective layer : a ) approximately 5 % to 50 % by weight of diacerein , b ) approximately 30 % to 75 % by weight of diluent , c ) approximately 0 . 5 % to 30 % by weight of disintegrant . d ) approximately 1 % to 10 % by weight of binder , e ) approximately 0 . 01 % to 5 % by weight of glidant , f ) approximately 1 % to 10 % by weight of lubricant . from another perspective , the present invention concerns a multi - layer tablet in the form of sandwich comprising a barrier layer separating a first layer containing nsaid and a second layer containing diacerein wherein the barrier layer constitutes the middle layer of the multi - layer tablet and comprises pharmaceutically suitable excipients . incompatibility of nsaid and diacerein molecules within the formulation is minimized or prevented by means of said barrier layer . the pharmaceutically acceptable excipients provided in the barrier layer according to the present invention include binders , disintegrants , glidants , lubricants , plasticizers , surfactants , preservatives or mixtures thereof . multi - layer tablet formulation according to the present invention can be prepared by various conventional methods known in the respective technical field . said methods can be given as , but not limited to , wet granulation , dry granulation , direct compression , melt granulation and double compression . nsaid containing layer provided in the multi - layer tablet formulation according to the present invention can be prepared by various conventional methods known in the respective technical field wherein it is preferably prepared by wet granulation or dry granulation methods . thus , potential flowability problems that can be encountered with nsaid molecules are resolved . diacerein containing layer provided in the multi - layer tablet formulation according to the present invention can be prepared by various conventional methods known in the respective technical field wherein it is preferably prepared by dry granulation or direct compression methods . barrier layer provided in the multi - layer tablet formulation according to the present invention can be prepared by various conventional methods known in the respective technical field wherein it is preferably prepared by direct compression method . finally , 3 layers obtained by methods according to the present invention are compressed together so as to form a tablet where the barrier layer is positioned in the middle . the term formulation may refer to formulation as well as both the packaging or blisters in which the formulation is stored . multi - layer tablet formulation according to the present invention is preferably stored in opaque pvc / pvdc packaging and the formulation thus becomes more stable . the main reason for this is the light sensitivity of the diacerein molecule . the following examples show the preferred oral pharmaceutical formulations of the present invention . multi - layer tablet formulation , manufacturing method of which is described below , contains 100 mg flurbiprofen and 50 mg diacerein . a ) preparation of the first layer containing flurbiprofen is carried out as follows : i . flurbiprofen , a portion of microcrystalline cellulose , lactose , croscarmellose sodium and hydroxypropyl cellulose are provided ; ii . colloidal silicon dioxide and rest of the microcrystalline cellulose are sieved , added into the mixture obtained in step i and mixed ; iii . tablets are compressed into bricks , crushed and sieved ; iv . magnesium stearate is added into the mixture obtained in step iii and mixed . b ) preparation of the second layer containing diacerein is carried out as follows : i . diacerein , a portion of lactose , croscarmellose sodium and hydroxypropyl cellulose are provided ; ii . colloidal silicon dioxide and rest of the lactose are sieved , added into the mixture obtained in step i and mixed ; iii . sodium stearyl fumarate is added into the mixture obtained in step ii and mixed . c ) preparation of the barrier layer is carried out as follows : i . sodium carboxymethyl cellulose , polyvinylpyrrolidone , a portion of microcrystalline cellulose and yellow iron oxide are provided ; ii . rest of the microcrystalline cellulose and colloidal silicon dioxide are sieved , added into the mixture obtained in step i and mixed ; iii . magnesium stearate is added into the mixture obtained in step ii and mixed . d ) homogeneous mixtures obtained in steps a , b , and c are compressed so as to obtain a tablet in the form of sandwich with the barrier layer provided in the middle thereof . multi - layer tablet formulation , manufacturing method of which is described below , contains 100 mg flurbiprofen and 50 mg diacerein . a ) preparation of the first layer containing flurbiprofen is carried out as follows : i . flurbiprofen , microcrystalline cellulose , lactose and a portion of the hydroxypropyl cellulose are picked up and loaded into the fluidized bed dryer ; ii . an aqueous solution is prepared with the rest of the hydroxypropyl cellulose ; iii . mixture obtained in step i . in the fluidized bed dryer is granulated with said solution , dried and milled ; iv . mixture obtained in step iii is transferred into the container ; v . croscarmellose sodium and colloidal silicon dioxide are added into the same container and mixed ; vi . magnesium stearate is added into the mixture obtained in step v and mixed . b ) preparation of the second layer containing diacerein is carried out as follows : i . diacerein , a portion of lactose , croscarmellose sodium and hydroxypropyl cellulose are mixed ; ii . colloidal silicon dioxide and rest of the lactose are sieved , added into the mixture obtained in step i and mixed ; iii . sodium stearyl fumarate is added into the mixture obtained in step ii and mixed . c ) preparation of the barrier layer is carried out as follows : i . sodium carboxymethyl cellulose , polyvinylpyrrolidone , a portion of microcrystalline cellulose and yellow iron oxide are mixed ; ii . rest of the microcrystalline cellulose and colloidal silicon dioxide are sieved , added into the mixture obtained in step i and mixed ; iii . magnesium stearate is added into the mixture obtained in step ii and mixed . d ) homogeneous mixtures obtained in steps a , b , and c are compressed so as to obtain a tablet in the form of sandwich with the barrier layer provided in the middle thereof . a ) preparation of the first layer containing dexketoprofen is carried out as follows : i . dexketoprofen , lactose monohydrate and corn starch are picked up and loaded into the fluidized bed dryer ; ii . mixture obtained in step i in the fluidized bed dryer is granulated with water , dried and milled ; iii . mixture obtained in step ii is transferred into the container ; iv . sodium starch glycolate is added into the same contained and mixed ; v . sodium stearyl fumarate is added into the mixture obtained in step iv and mixed . b ) preparation of the second layer containing diacerein is carried out as follows : i . diacerein , a portion of lactose , croscarmellose sodium and hydroxypropyl cellulose are mixed ; ii . colloidal silicon dioxide and rest of the lactose are sieved , added into the mixture obtained in step i and mixed ; iii . sodium stearyl fumarate is added into the mixture obtained in step ii and mixed . c ) preparation of the barrier layer is carried out as follows : i . sodium carboxymethyl cellulose , polyvinylpyrrolidone , a portion of microcrystalline cellulose and yellow iron oxide are mixed ; ii . rest of the microcrystalline cellulose and colloidal silicon dioxide are sieved , added into the mixture obtained in step i and mixed ; iii . magnesium stearate is added into the mixture obtained in step ii and mixed . d ) homogeneous mixtures obtained in steps a , b , and c are compressed so as to obtain a tablet in the form of sandwich with the barrier layer provided in the middle thereof .

the present invention relates to a combined pharmaceutical formulation having therapeutic anti - inflammatory , analgesic , antipyretic and osteoarthritis activities . from another perspective , the present invention relates to a new solid oral dosage form comprising a pharmaceutically effective amount of nsaid and a pharmaceutically effective amount of diacerein and the solid oral dosage form according to the present invention is preferably in the form of tablet and more preferably in the form of multi - layer tablet .

the instant invention is directed to a method of converting fodder to silage by ensiling with a new preservative . the amount of preservative must be controlled to between 0 . 5 and 4 . 0 percent of the treated fodder . all percentages and parts given herein are by weight unless otherwise specified . ensiling with less than 0 . 5 percent preservative does not prevent mold growth on the silage , and more than 4 . 0 percent reduces the number of live bacteria colonies to a point where they are no longer able to ferment the sugars contained in the fodder , as required in the ensiling process . the use of between 1 . 0 and 2 . 0 percent preservative is preferred . in this range the production of nutritionally desirable lactic acid by fermentation of the contained sugars is maximized and low molecular weight carboxylic acids , such as citric are minimized . to inhibit mold growth , preserve the natural protein content of the ensiled fodder without sterilizing the bacteria required for fermentation , the preservative must be specifically selected and carefully prepared . it was found that methylolurea , in practical concentrations required to preserve the natural protein and increase crude protein content in the silage , reduces the number of live bacteria colonies in treated fodder to a point where fermentation and the ensiling process virtually cease . the same effect was found with mixtures of urea , and ammonia with methylolurea . the sterilizing effect of methylolurea was especially strong when it was freshly formed from urea and formaldehyde . it has now been discovered that these unacceptable properties of methylolurea may be changed to produce an effective new silage preservative by admixing methylolurea with methylenediurea in a methylolurea to methylenediurea ratio between about 1 and 20 to 1 . the mixture of methylolurea and methylenediurea may be prepared by a simple blending of the chemical compounds , or it may be prepared by the reaction of urea and formaldehyde to produce the compounds in the necessary concentrations . it was found necessary to include free urea in the preservative in an amount sufficient to prevent the reversion of methylolurea to free formaldehyde because methylolurea will revert to free formaldehyde and urea particularly in the presence of water unless some chemical is added to prevent it . formaldehyde is a strong bactericide which substantially stops fermentation even at low concentrations . free urea amounting to less than 33 percent of the urea combined as methylolurea and methylenediurea does not shift the reaction equilibrium far enough from formaldehyde and undesirably allows the presence of some free formaldehyde to exist in the ensiling process , and free urea amounting to more than 150 percent of the combined urea allows excessive loss of urea by urease degradation . it has been found that the desired free urea concentrations may be formed from 1 . 3 to 2 . 5 urea moieties per formaldehyde moiety . this formation may be achieved by a simple blending of the requisite compounds , or by reacting urea and formaldehyde raw materials . the maximum nitrogen concentration in the preservative found to be practical is 32 percent . higher concentrations have high viscosities when liquid , and may not be handled and distributed onto the fodder effectively , and undesirably have saltout temperatures above normal ambient temperatures . preservatives containing below about 10 percent nitrogen are economically undesirable to ship or store . nitrogen concentration between 20 and 30 percent are preferred . the preservative may be diluted and blended with wetting agents prior to its use to improve mixing with the treated fodder . the methylolurea and methylenediurea components of the preservative have a tendency to react with each other to form polymeric chain compounds which are insoluble . it has now been found that the use of a small amount of an ammonia compound in the silage preservative is sufficient to act as a chain stopper and to prevent polymer precipitation in the preservative . the ammonia compounds found to function effectively are : ammonia , hexamethylene tetramine , ethanolamine and ethylamine . ammonia is preferred because of its economical availability and the small amount required . ammonia in amounts of less than 0 . 5 percent was found to provide storage stability in the preservative for less than 30 days , and concentrations above 1 . 5 percent , although providing long stabilities , undesirably caused strong ammonia odor in the treated silage . concentrations between about 0 . 8 and 1 . 2 percent provided more than 6 months storage stability without causing undesirable ammonia odors in the treated silage . the storage stability of the methylolurea and methylenediurea components of the preservative may be ruined in relatively short periods of time by the tendency of these compounds to form organic acids , which decrease ph of the preservative and cause the formation of insoluble solids . it has been found that an alkaline , ph modifying substance can be used to adjust the ph of the preservative solution to between 6 and 10 so that ph is substantially unchanged and no insoluble solids are formed in the preservative even if it is stored for 3 months or longer . the alkaline ph modifying substance is used to adjust ph to between 8 . 5 and 9 . 0 to achieve 6 months or longer storage stability . the ph modifying substances found to be especially effective are the salts of alkali metals , including potassium and sodium carbonates , and bicarbonates ; potassium and sodium formates ; and potassium and sodium phosphates . these buffering agents may be added during or after the reaction or may be formed in - situ . it was also found that alkali metal hydroxides could be used to control ph , but it was necessary to control the amount of these materials used more accurately than the salts . the use of alkaline earth carbonates , particularly calcium and magnesium carbonates were effective also , and provided a method of introducing these elements into the silage . in the method of producing silage , it is necessary that the preservative be substantially blended with the fodder , and the use of the preservative in the liquid form was found to be the most effective way to achieve complete mixing . it is therefore necessary to include in the preservative composition , sufficient water to dissolve its methylolurea , methylenediurea , free urea , ammonia compound and ph modifying substance . the preservative may be sprayed onto the fodder while it is being chopped or while it is being transported into the ensiling container , or after it reaches its storage point in the ensiling container . surprisingly , the preservative has been found to be effective when it is applied to fodders prior to their ensiling . the preservative may be sprayed onto fodders as they are cut in a field . it has also been found possible to apply the preservative when it is applied to fodders still standing in a field , prior to harvesting . supplementary nutrients such as phosphates and minor elements are frequently added to silage to improve its nutritive value . it has been found that these materials may be effectively added to the silage by combining them with the preservative . it has been found best to add the supplementary materials shortly before the preservative is applied to the fodder . although the preservative used in the instant invention may be prepared by a simple blending of the necessary chemical compounds , it has been found that it may be prepared more economically by a process by which a mixture of water , caustic alkali ( meaning alkali metal carbonates or hydroxides ), urea , formaldehyde , and an ammonia compound are heated to a temperature of about 75 ° to 100 ° c ., preferably 88 ° to 93 ° c ., and holding those temperatures for 20 to 300 minutes , preferably between 45 and 75 minutes , while maintaining ph between 8 . 0 and 11 . 0 , preferably between 8 . 5 and 9 . 5 , until no free formaldehyde remains and methylenediurea has been formed in amounts so that the ratio of contained methylolurea and methylenediurea is between 1 and 20 to 1 , and the sterilizing activity of the preservative is reduced to the point so that a 4 percent concentration will not substantially eliminate the live colonies of bacteria in the silage . it was discovered that carrying out the reaction until the indicated distribution between methylolurea and methylenediurea was reached was an effective way of achieving the desired reduced level of sterilizing activity . the reduced level of sterilizing activity was confirmed by counting the live bacterial colonies in samples of the treated silage . it was found that reduction of the live bacteria colonies to levels below 10 percent of those in silage not treated with preservative caused fermentation to proceed at an unsatisfactory rate and failure of the ensiling process . where more than 10 percent of the bacterial colonies remained live , the ensiling method was successful . substantial reduction in live bacterial colonies occurred when mold growth was inhibited and substantially eliminated . it is difficult and impractical to measure the reduction of live bacterial colonies present in each batch of material being ensiled , so that it is a considerable advancement in the art to be able to carry the process for making the preservative to the point where the readily measured and analyzed preservative solution has the desired strength . in the process for the preservative , the amounts of urea and formaldehyde used are controlled so that the free urea concentration in the preservative amounts to between 33 and 150 percent of the urea combined into methylolurea and methylenediurea , and so that the total nitrogen content of the preservative is not less than 10 percent and not more than 32 percent . the ph of the preservative is finally adjusted to between 7 . 5 and 10 . 5 by means of a ph modifying substance . the caustic alkali used in the process may be added as a base buffering material and is preferably potassium carbonate in amounts between 1 and 6 percent of the preservative solution . the caustic alkali may be added incrementally as the process proceeds , to maintain ph in the desired range . the ph modifying material controlling the ph of the final preservative may be formed during the reaction from the caustic alkali used in the process . for example , buffer potassium bicarbonate may be readily formed during the reaction from potassium carbonate . it may be , if desired , be added as a ruminant nutrient such as potassium phosphate after the preservative preparation process is completed . having described the basic concepts of the instant invention , reference is now made to the following examples which are provided to illustrate the best method for carrying out the invention . a silage preservative was prepared batchwise in a stirred stainless steel reactor equipped with a jacket and internal coils for heating and cooling . to this reactor were added , in the order listed , the following ingredients : ______________________________________ingredients wt % ______________________________________water 8 . 8na . sub . 2 co . sub . 3 3 . 5ammonia 2 . 3urea 52 . 650 % hcho solution 32 . 8______________________________________ these blended ingredients , including commercial urea and formaldehyde in a mol ratio of 1 . 6 , had a ph of 10 . 7 . the ingredients were agitated and heated until all ingredients were in solution , and the temperature reached 89 ° c . cooling was applied as needed to maintain the temperature between 88 ° and 95 ° c . for a period of 60 minutes . at the end of this period the reaction mixture was cooled to ambient temperature of 32 ° c . in 27 minutes , and samples were withdrawn for evaluation . the ph was maintained between 8 . 5 and 10 . 5 during the reaction and stabilized at 9 . 1 by adding 1 . 0 percent of potassium phosphate at the completion of the reaction . tests for the presence of free formaldehyde by the bisulfite method were negative after the 60 minute period . a sample was withdrawn and analyzed by wet chemical and high pressure liquid chromatographic means , with the components found in the preservative listed as follows : ______________________________________components wt % ______________________________________ammonia 1 . 1methylolurea 36 . 1methylenediurea 4 . 0urea 28 . 1sodium bicarbonate 5 . 5water ( by difference ) 25 . 2______________________________________ another four gram sample was blended with 100 grams of freshly chopped corn plant , and the mixture was enclosed in a plastic bag for 24 hours . a comparison was made of the number of live bacteria colonies in the blended sample with the number in a 100 gram sample of untreated chopped corn plant . the sample contained 1 . 5 × 10 7 live colonies per milliliter compared to 10 × 10 7 live colonies in the untreated fodder . thus , although the number of live bacteria colonies was significantly reduced , the live colonies were not substantially eliminated . the weight ratio of methylolurea to methylenediurea was 9 . 02 to 1 . the free urea content amounted to 98 percent of the urea combined as methylolurea and methylenediurea , and was sufficient to prevent any reversion of those compounds to free formaldehyde during storage . total nitrogen concentration was 26 . 7 percent in the preservative product . the preservative was stored in a steel tank and found to be clear and virtually unchanged in appearance , properties , and analysis after a period of 12 months . the silage preservative from example 1 was used in a method of ensiling fodder . whole corn plants were selected as the fodder . they were cut from a single field in central ohio and taken to three plastic - lined pits , each having a capacity of about 50 tons . there the whole corn plant was chopped into approximately 1 / 4 &# 34 ; diameter pieces and conveyed directly , in about equal amounts , to the three plastic - lined pits for ensiling . no preservative was added to the fodder sent to the first pit . the liquid preservative from example 1 was sprayed onto the fodder sent to the second pit . it was thoroughly blended with the chopped fodder as it was moved by a screw conveyor to the pit , the liquid preservative amounting to 1 percent of the fodder ( 20 pounds per ton ). to the fodder sent to the third pit , 3 percent liquid preservative was in a like manner added . polyethylene sheets were then used to cover the plastic - lined pits to form ensiling containers which limited air intrusion . because of the relatively large surface to volume ratio , and the low integrity of the ensiling containers , air intrusion was significantly higher than in a conventional silo . the whole corn plant fodder was thus ensiled and each pit warmed significantly after about 7 hours as fermentation of the contained sugar proceeded . warming was most evident in the pit receiving no preservative , and least evident where 3 percent preservative was added . seven days after charging , counts were made of live colonies of bacteria in samples taken from each pit silo . the number of live colonies found per milliliter of the untreated fodder in the first pit , the fodder treated with 1 percent preservative in the second pit , and the fodder treated with 3 percent preservative in the third pit were : 14 × 10 7 , 4 × 10 7 , and 2 × 10 7 , respectively . the ensiled fodders in each pit were monitored by visual inspection . mold began to form on the untreated ensiled fodder within two weeks in pit silo 1 , particularly near the outside of the polyethylene covering sheet where air intrusion was most pronounced . no mold formation was noted in the pits containing preservative . after 6 months storage , the ensiled corn plant silage was heavily covered with mold so that its market value was reduced . the pit receiving 1 percent silage preservative contained only small amounts of mold on the edge of the pile , amounting to 5 percent or less of the mold on the untreated fodder . the fodder receiving 3 percent of the preservative contained virtually no mold even in areas where significant penetration of air and moisture occurred . analyses were performed on the six - month old silage in each pit for natural protein using the tungstic acid precipitation method . the silage receiving no preservative contained 4 . 06 percent natural protein , on a dry basis ; the silage treated with 1 percent preservative contained 6 . 9 percent natural protein ; and the silage treated with 3 percent preservative contained 7 . 5 percent natural protein . total available crude protein contents of the same silages were : 7 . 5 , 9 . 5 , and 13 . 4 percent , respectively , on dry bases . total dry matters in the three silages were 33 . 0 , 33 . 3 , and 33 . 5 percent . carboxylic acid analyses were made on the silages from the three treatments by gas chromatography . the silage receiving no preservative contained 2 . 6 percent acetic acid , the silage receiving 1 percent preservative contained 1 . 1 percent acetic acid , and the silage receiving 3 percent preservative contained 0 . 5 acetic acid . the untreated silage contained 6 . 1 percent lactic acid compared to 7 . 7 and 8 . 1 dry basis percents , respectively , in the samples treated with 1 and 3 percent preservative . analyses were made by high pressure liquid chromatograph for methylolurea and methylenediurea in each of the silage piles . neither compound was found in either the treated or untreated silage . the detection limit of the method is not known exactly , but when 50 parts per million of the compounds were added , they were readily determined quantitatively . silage prepared in pit 3 of example 2 , treated with 3 percent preservative , was used to feed a group of heifers and the performance of these heifers was compared with a group fed the same silage without preservative . two groups of 15 heifers were fed the silages four times per week on monday , tuesday , thursday , and saturday . the heifers fed the silage from example 2 each received 675 pounds of silage and 50 pounds of vitamin and mineral supplement d - 656 , while the heifers receiving the untreated silage received 625 pounds silage , 50 pounds of the same supplement d - 656 , and 50 pounds of soybean meal to balance the protein content of each feed regimen , throughout the 10 week feeding period . the results obtained in the feeding tests , after 1 week period for feed accommodation , are listed as follows : ______________________________________ examplesilage source untreated 2 silage______________________________________amount of n , lbs / ton 0 18initial weight of heifers , avg . lbs 856 856final weight , avg . lbs 925 931number of days 63 63numbers of animals 15 15average daily weight gain , lbs / day 1 . 10 1 . 19______________________________________ feed palatability of the silage from example 2 was good and no difficulty was encountered in getting the heifers to consume it . blood plasma derived from blood withdrawn from both herds was analyzed by high pressure liquid chromatography at maximum sensitivity and neither methylolurea or methylenediurea were found . the preservative from example 1 was applied to alfalfa in the field to preserve it through subsequent ensiling . the preservative from example 1 was sprayed onto alfalfa as it was cut and thrown into wind rows near scottsdale , ariz ., in april at 74 ° f . and conditions of high relative humidity . in a test area containing 3 long wind rows , 43 . 8 pounds of the preservative , containing 11 . 7 pounds nitrogen was applied per acre to 7500 pounds of alfalfa which formed 70 bales . the three wind rows on each side of the treated wind rows were not treated but were bailed and stored . after 6 months stacked storage , the alfalfa bales ensiled with the preservative were free of mold and were readily accepted by feeding cattle . the untreated bales contained enough black mold to significantly reduce its acceptability as a feed . total crude protein content of the preservative - treated bales averaged 23 . 6 percent compared to 20 . 2 percent for the untreated bales .

an improved method of producing silage for use as ruminant feed , whereby green fodders are ensiled with about 1 percent of an additive containing methylolurea and methylenediurea in a weight ratio between 1 and 20 to 1 , sufficient free urea to prevent reversion to free formaldehyde , a buffering agent to maintain ph , and water . the method preserves contained natural protein , substantially prevents growth of mold , and increases crude protein content , palatability , and feed efficacy . operative feature of the method is the discovery that a methylolureamethylenediurea - urea solution may be reacted to a point where it will not sterilize the bacteria needed to ferment contained sugars to carboxylic acids , but will protect the silage against mold formation and natural protein degradation . a process for producing the required silage additive from urea , formaldehyde , ammonia , alkali , and water is provided .

for oral use the preferred composition of the invention which produces rapid , painless hemostasis is comprised of 250 micron aluminum sulfate granules encapsulated with a biologically inert and non - allergenic hemostatic polymer such as ethyl cellulose . it is desirable for the hemostasis time to be as short as possible . for dermatological or other hemostatic use the preferred composition of the invention which produces rapid , painless hemostasis is comprised of 250 micron aluminum sulfate granules encapsulated with a biologically inert and non - allergenic hemostatic polymer such as ethyl cellulose . it is desirable for the hemostasis time to be as short as possible to reduce excessive hemorrhage . conventional techniques for preparing astringent particles microencapsulated with a biologically compatible polymer are well known in the art . teachings of microencapsulation techniques are provided in “ microencapsulation ” by herbig in the encyclopedia of chemical technology , 2nd edition , volume 13 , published by kirk - othmer . 100 to 350 micron microcapsules are the preferred size for use in the method of the present invention and are prepared with a conventional coacervation technique , such as found in u . s . pat . no . 4 , 394 , 287 ; u . s . pat . no . 3 , 878 , 121 ; u . s . pat . no . 3 , 872 , 024 ; and u . s . pat . no . 3 , 869 , 406 . the term coacervation describes the phenomenon of phase separation . from a homogeneous solution of polymer , droplets of a polymer in liquid form , rather than solid aggregates . this phase , separated in the form of liquid and amorphous droplets , is the coacervate . in preparing the preferred microcapsules used in the present invention , the aluminum sulfate is milled and sieved to obtain granule size of less than 350 microns , and tumbled with the ethyl cellulose and a solvent to form the encapsulated granules . other astringent materials that may be microencapsulated in accordance with the invention include aluminum chloride , ferric sulfate , ferric subsulfate , ferric chloride , zinc chloride , aluminum chlorohydrate , aluminum acetate , alum , tannins , permanganates and mixtures thereof . any other astringents such as those disclosed in u . s . pat . no . 5 , 250 , 569 may also be used in the methods of the present invention . the preferred wall forming encapsulation material , ethyl cellulose , is biologically inert ; is compatible with human tissue ; is non - allergenic ; and has hemostatic properties . ethyl cellulose granules contributes to blood clotting by acting as a situs for clot formation . preferably , the ethyl cellulose is water insoluble and hydrophobic . in addition to intraoral applications of the novel composition of the invention , the novel compositions of the invention have applicability for hemostasis for dermatological purposes . astringent hemostatic compositions of the invention suitable for dermatological purposes include 100 to 350 micron microencapsulated aluminum sulfate as above and can include additionally other microencapsulated astringent hemostatic materials . for example , microencapsulated aluminum sulfate and microencapsulated aluminum chloride are suitable astringent hemostatic agents of the invention for dermatological purposes . in addition to ethyl cellulose , other cellulose - based polymeric materials soluble in body fluids may serve as coatings for encapsulation of the selected astringent hemostatic agent . ethyl cellulose is an ethyl ether of cellulose . other related ethers such as methyl cellulose may also be used for encapsulation of the astringent hemostatic agent to produce a composition having time - release properties . other cellulose ethers have inherent hemostatic properties similar to ethyl cellulose . in general , oxidized cellulose is a useful class of hemostatic materials . generally , hemostatic oxidized cellulose materials are also absorbed by body fluids as when used to pack wounds . some commercial absorbable hemostatic cellulose materials are sold under the names of oxycel and hemo - pak . although a wide variety of sizes of astringent hemostatic particles and polymer coating thicknesses of encapsulation material may be used , satisfactory compositions of the invention have been obtained by encapsulating micron - mesh astringent with a 3 %- 6 % solution of ethyl cellulose to create granules having a predominant particle size of less than 350 micron , preferably less than 250 micron and more preferably less than 200 micron clotting times under one minute can be achieved . in practice , excess 100 to 350 micron hemostatic granules could be applied to a wound without any concern of overdose since the active principle of hemostatic granules is presented to the bleeding tissue on demand and the action ceases when bleeding stops . however , it is preferable to irrigate the wound once hemostatic action is complete and to apply a protective dressing . the color indication properties of the last layer of microcapsules allow the practitioner to observe when hemostasis is complete , and so unnecessary material is not applied and excess microcapsules are not wasted . in the preferred 250 micron composition , clotting times of under one minute were achieved in a 2 cm 2 cut rat liver lobe . it is desirable for the hemostasis time to be as short as possible while still balancing the handling and aesthetic property aspects . the 250 micron size has desirable handling properties , good aesthetics and rapid clotting times . additionally , the 250 micron size granule can be obtained in economically satisfactory quantities while still achieving rapid clotting times . balancing of size vs . desirable properties can be achieved with routine experimentation , in view of the present specification . in another use of the compositions of the invention , the 100 to 350 micron microencapsulated astringent hemostatic agents can be used in conjunction with gingival retraction cord to further enhance retraction and hemostasis . this can be accomplished in two ways : either the microencapsulated astringent hemostatic agent is applied immediately superior to the subgingivally - placed retraction cord after placement in the sulcus , or microencapsulated astringents are contacted with the surface of a previously dampened gingival retraction cord prior to placement of the cord into subgingival areas . the powdered microencapsulated astringent hemostatic agents of the invention may be used by locally applying an appropriate amount thereof on a bleeding part . for example , if a skin wound were a relatively shallow abrasion over a relatively large skin surface , the practitioner may apply a relatively small amount of a composition of the invention having relatively small amounts of the astringent hemostatic agent because of the relatively small amounts of blood flow . on the other hand , if the skin wound was a deep laceration or tear , a more highly concentrated formulation may be applied by the practitioner to treat the more localized blood flow of a relatively high rate . in both cases , in accordance with the invention , the release of the microencapsulated astringent hemostatic agent from the microcapsules is upon demand depending upon contact with body liquids such as blood and the observation that the last layer of microcapsules remain white indicate that the application is complete . if the use of the composition of the invention is merely for a short period of time such as for first aid purposes , the practitioner may desire a rapidly released composition of the invention . however , if the applied material is expected to be in use for a considerable length of time , then a formulation having longer time release properties may be employed . the practitioner may vary the microcapsules size to adjust the rate of hemostatic action . accordingly , the invention provides a painless and rapid method for providing an active astringent and hemostatic agent on demand for contact with body tissues and , by virtue of its color characteristics , signals when the hemostatic action is complete . since astringent is presented on demand , delicate tissue is not subjected to excess reagent and tissue irritation is avoided . yet another advantage of the invention is the provision of a method and composition for controlling the amount of active hemostatic agent which contacts tissues . another advantage of the invention is the provision of a composition and method for applying hemostatic astringent in adequate quantities to tissues or wounds so that the amount is precisely the amount that is needed to effect hemostasis without excess micro - capsules being wasted . the invention provides for a safe and easy to handle , rapid hemostatic composition which is aesthetically pleasing and which can be manufactured consistently and economically . additionally the microcapsules of the invention possess bactericidal and bacteriostatic activity against several micro - organisms , including some of those most commonly present in surgical wound infections . in the foregoing and in the following examples , all temperatures are set forth uncorrected in degrees celsius ; and , unless otherwise indicated , all parts and percentages are by weight . the entire disclosure of all applications , patents and publications , cited above and below are hereby incorporated by reference . the coagulation times listed below are obtained on liver cuts in anesthetized rats . following anesthesia , the tip of a liver lobe is cut creating a wound approximately 2 cm 2 . immediately following the cut , the wound is blotted with gauze and a layer of hemostatic 250 micron microcapsules are applied . the microcapsules rapidly turn red with the coagulating blood and additional layers are applied until the outermost layer of mircocapsules remain white , at which point hemostasis is established and the time is noted . [ 0039 ] % coating microcapsule diameter ( microns ) 150 250 350 4 38 . 7 44 . 2 63 . 8 6 41 . 4 48 . 5 73 . 9 8 55 . 7 63 . 3 96 . 2 10 76 . 9 95 . 2 124 . 4 250 micron microcapsules ( ethyl cellulose 6 %/ aluminum sulfate 94 % ) of the present invention are evaluated on skin shave and punch biopsies on human patients . following tissue sampling , the micro - capsules are sprinkled on the wound and allowed to remain in place until hemostasis is assured . at this point , the time for hemostasis is noted , and the micro - capsules are flushed from the wound and the wound area blotted . in each case the wound remains free of blood and serious fluid after treatment with granules . the wound is dressed with an antibiotic ointment and bandage . the wounds all heal normally without scabbing . the clinical evaluation is presented below . bleeding patient age procedure location time white 49 shave biopsy right cheek & lt ; 60 seconds female black 36 shave biopsy right abdomen & lt ; 45 seconds female white 42 shave biopsy right chin & lt ; 60 seconds female white male 58 shave biopsy right forehead & lt ; 45 seconds black male 32 punch biopsy right hand = 85 seconds * a punch biopsy is about one - quarter of one inch deep . additional time is required for the microcapsules to reach the source of bleeding . in this case , as well as others , the application of light pressure enhances the rate of hemostasis . ability of 250 micron micro - capsule and kaltostat to stop minor bleeding twenty two rats weighing 142 - 148 gms are anesthetized with 50 mg / kg b . w . intraperitoneally . the abdominal area is shaved and a midline incision is made through the skin and muscle from the lower abdomen up to the xyphoid process . the liver is exposed , isolated with gauze and the tip of the most prominent lobe is cut , producing a wound of approximately 3 cm long and 0 . 6 cm wide . blood from the cut surfaces is collected in capillary tubes for control bleeding evaluation . the cut surface is then blotted and either 250 micron micro - capsule or kaltostat , sufficient to just cover the wound , is applied . the time to stop bleeding is measured and the number of kaltostat applications required are noted . the results of this test are shown in table v . the average bleeding time of 10 determination with 250 micron micro - capsule is 48 seconds ( 35 - 80 ). six kaltostat estimates average 5 minutes : 10 seconds ( 4 : 15 - 6 : 10 ) and require 5 - 8 applications and six controls average 9 minutes : 57 seconds ( 7 : 25 - 12 : 10 ). the data reveal that a single application of 250 micron micro - capsules is six times more effective at stopping minor bleeding than five to eight applications of kaltostat . ability of 250 micron micro - capsules and kaltostat to stop minor bleeding [ 0048 ] bleeding times 250 micron microcapsules kaltostat controls animal date min : sec min : sec min : sec rt - f - s8 9 / 25 0 : 45 rt - f - s9 9 / 25 0 : 45 8 : 40 rt - m - s11 9 / 25 0 : 35 10 : 15 rt - f - k1 10 / 2 4 . 55 ( 7 ) rt - m - k4 10 / 2 0 : 35 rt - m - c7 9 / 25 0 : 45 rt - f - s14 10 / 2 6 : 10 ( 7 ) rt - m - s19 9 / 18 5 : 10 ( 6 ) rt - f - c5 9 / 25 0 : 40 7 : 25 rt - f - k6 9 / 25 0 : 35 rt - m - d 9 / 25 0 : 45 12 : 10 rt - f - s21 9 / 13 1 : 15 rt - f - s22 9 / 13 4 : 15 ( 6 ) rt - f - k10 9 / 13 1 : 20 rt - m - k14 9 / 19 5 : 40 ( 8 ) rt - m - k15 9 / 19 11 : 35 rt - m - k16 9 / 13 4 : 50 ( 6 ) rt - f = a 9 / 25 9 : 40 () = number of kalostat 0 : 48 5 : 10 9 : 57 applications ( 6 . 5 ) [ 0049 ] amt . of 250 micron microcapsules organism ( g / 30 ml media ) mode of action cidal time p . aeruginosa 0 none n / a p . aeruginosa 0 . 179 bactericidal 60 p . aeruginosa 1 . 416 bactericidal & lt ; 5 e . fecalis 0 none n / a e . fecalis 0 . 129 none n / a e . fecalis 1 . 403 bactericidal 240 s . aureus 0 none n / a s . aureus 0 . 149 bacteriostatic n / a s . aureus 1 . 373 bacteriostatic n / a e . coli 0 none n / a e . coli 0 . 314 bactericidal 60 e . coli 1 . 529 bactericidal & lt ; 5 mrsa 1 . 50 bactericidal & lt ; 30 mrsa 0 . 15 bacteriostatic n / a cidal time represents the approximate number of minutes of exposure to 250 micron micro - capsules an organism undergoes a 4 log reduction in colony forming units per ml in those instances where bactericidal activity is observed . mrsa ia 4 - methicillin resistant staph . aurcus indiana university hospital isolate number 202634 . concentrations resulting from the dilution of micorcapsules in 30 ml . of media are considerably less than those resulting form direct application of microcapsules to wounds . thus , the cidal times listed are significantly prolonged . the embodiments of the invention set forth above are only representative of broad aspects of the invention , and the invention is not to be deemed limited to the particular embodiments set forth . the scope of the invention is to be defined by the claims appended below .

this invention relates to hemostatic therapeutic compositions and , more particularly to methods for bringing about rapid , painless hemostasis intraorally , for dermatological applications or all other hemostasis applications . 100 to 300 micron microcapsules comprising a granular astringent hemostatic agent micro - encapsulated with a biocompatible polymer are applied to a wound . the microcapsules are applied to the wound until the outermost layer of microcapsules remain white , a visible indication that the hemostatic action is complete . upon observation that the hemostatic action is complete the microcapsules are flushed from the wound , the wound blotted and dressed . the rapid clotting times achieved with the 100 to 300 micron size microcapsules together with the visual indication that hemostasis is complete gives the practitioner the ability to irrigate the wound and apply a protective dressing much more quickly than the prior art and excess microcapsules are not wasted .

the following detailed description and the accompanying drawings are intended to describe some , but not necessarily all , examples or embodiments of the invention only and does not limit the scope of the invention in any way . the following detailed description and the accompanying drawings are intended to describe some , but not necessarily all , examples or embodiments of the invention only and does not limit the scope of the invention in any way . a number of the drawings in this patent application show anatomical structures of the male reproductive and / or urinary system . in general , these anatomical structures are labeled with the following reference letters : fig1 a shows a sagittal section of a male human body through the lower abdomen showing the male urinary tract . the male urinary tract comprises a pair of tubular organs called ureters ( ur ) that conduct urine produced by the kidneys . the ureters empty into the urinary bladder . the urinary bladder is a hollow muscular organ that temporarily stores urine . it is situated posterior to the pubic bone . the inferior region of the urinary bladder has a narrow muscular opening called the bladder neck which opens into a soft , flexible , tubular organ called the urethra . the muscles around the bladder neck are called the internal urethral sphincter . the internal urethral sphincter is normally contracted to prevent urine leakage . the urinary bladder gradually fills with urine until full capacity is reached , at which point the sphincter relaxes . this causes the bladder neck to open , thereby releasing the urine stored in the urinary bladder into the urethra . the urethra begins at the bladder neck , terminates at the end of the penis , and allows for urine to exit the body . the region of the urethra just inferior to the urinary bladder is completely surrounded by the prostate gland . the prostate gland is part of the male reproductive system and is usually walnut shaped . clinically , the prostate is divided into lobes . the lateral lobes are located lateral to the urethra ; the middle lobe is located on the dorsal aspect of the urethra , near the bladder neck . most commonly in bph , the lateral lobes become enlarged and act like curtains to close the urethral conduit . less commonly , the middle lobe grows in size and becomes problematic . because of its superior location near the bladder neck with respect to the urethra , an enlarged middle lobe acts like a ball valve and occludes fluid passage . fig1 b shows a coronal section through the lower abdomen of a human male showing a region of the male urinary system . the prostate gland ( pg ) is located around the urethra at the union of the urethra and the urinary bladder . fig2 a through 2h show various alternate approaches to deploy implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . specific examples of implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) useable in this invention are shown in other figures of this patent application and are described more fully herebelow . fig2 a shows a first trans - urethral approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland pg . in fig2 a , an introducing 200 is introduced in the urethra through the urethral opening of the penis . introducing 200 comprises an elongate body 202 comprising a lumen that terminates distally in a distal opening 204 . one or more working device ( s ) 206 is / are then introduced through distal opening 204 into the urethra . the working device ( s ) 206 penetrate the urethral wall and thereafter one or more lobes of the prostate gland . in some applications of the method , working device ( s ) 206 may further penetrate the prostate capsule and enters the pelvic cavity . working device ( s ) 206 are also used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig2 b shows a second trans - urethral approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland pg . in fig2 b , an introducing 210 is introduced in the urethra through the urethral opening uo of the penis . introducing 210 comprises an elongate body 212 comprising a lumen that terminates distally in a distal opening 214 . one or more working device ( s ) 216 is / are insertable through distal opening 214 into the urethra . working device ( s ) 216 penetrate ( s ) the urethral wall inferior to the prostate gland and enters the pelvic cavity . thereafter , working device ( s ) 216 penetrate ( s ) the prostate capsule cp and thereafter one or more lobes of the prostate gland . in some applications of the method the working device ( s ) 216 may further penetrate the urethral wall enclosed by the prostate gland eg and enters the urethral lumen . working device ( s ) 216 may then be used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig2 c shows a third trans - urethral approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland pg . in fig2 c , an introducing 220 is introduced in the urethra through the urethral opening uo of the penis . introducing 220 comprises an elongate body 222 comprising a lumen that terminates distally in a distal opening 224 . introducing 220 is positioned such that distal opening 224 is located in the urinary bladder ub . thereafter , a one or more working device ( s ) 226 is / are introduced through distal opening 224 into the urinary bladder ub . working device ( s ) 226 penetrate ( s ) the wall of the urinary bladder ub and thereafter penetrate ( s ) one or more lobes of the prostate gland pg . in some applications of the method , the working device ( s ) 226 may further penetrate the prostate capsule and enter the pelvic cavity . working device ( s ) 226 may then be used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig2 d shows a transperineal approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland pg . in fig2 d , an introducing 230 is introduced in the pelvic cavity percutaneously through the perineum . introducing 230 comprises an elongate body 232 comprising a lumen that terminates distally in a distal opening 234 . introducing 230 is positioned such that distal opening 234 is located in the pelvic cavity adjacent to prostate gland . thereafter , one or more working device ( s ) 236 is / are introduced through distal opening 234 into the prostate gland pg . working device ( s ) 236 penetrate ( s ) the prostate capsule cp and thereafter penetrate ( s ) one or more lobes of the prostate gland pg . in some applications of the method , the working device ( s ) 236 may further penetrate the urethral wall surrounded by the prostate gland pg and enter the urethral lumen . working 236 may then be used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig2 e shows a percutaneous / transvesicular approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland pg . in fig2 e , an introducing 240 is introduced percutaneously through the abdominal wall . introducing 240 comprises an elongate body 242 comprising a lumen that terminates distally in a distal opening 244 . after passing through the abdominal wall , introducing 240 is advanced through the wall of the urinary bladder ub such that distal opening 244 is located in the urinary bladder ub . thereafter , one or more working device ( s ) 246 is / are introduced through distal opening 244 into the urinary bladder ub . one ore more working device ( s ) 246 are advanced through the wall of the urinary bladder ub and into the prostate gland pg . in some applications of the method , working device ( s ) 246 may further penetrate through the prostate gland capsule and enter the pelvic cavity . working device ( s ) 246 is / are then used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig2 f shows a percutaneous trans - osseus approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland pg . in fig2 f , an introducing 250 is introduced percutaneously through the abdominal wall . introducing 250 comprises an elongate body 252 comprising a lumen that terminates distally in a distal opening 254 . introducing 250 is used to penetrate a pelvic bone ( e . g . the pubic bone pb ). thereafter , introducing 250 is positioned such that distal opening 254 is located adjacent to the prostate gland pg . thereafter , one or more working device ( s ) 256 is / are introduced through distal opening 254 into the prostate gland pg . working device ( s ) 256 penetrate the prostate capsule and thereafter penetrate one or more lobes of the prostate gland pg . in some applications of the method , working device ( s ) 256 may further penetrate the urethral wall surrounded by the prostate gland and enter the urethral lumen . working device ( s ) 256 is / are then used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig2 g shows a percutaneous suprapubic approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland pg . in fig2 g , an introducing 260 is introduced in the pelvic cavity percutaneously in a trajectory that passes superior to the pubis bone . introducing 260 comprises an elongate body 262 comprising a lumen that terminates distally in a distal opening 264 . introducing 260 is then positioned such that distal opening 264 is located in the pelvic cavity adjacent to prostate gland . thereafter , one or more working device ( s ) 266 is / are introduced through distal opening 264 into the prostate gland pg . working device ( s ) 266 penetrate the prostate capsule cp and thereafter penetrate one or more lobes of the prostate gland pg . in some applications of the method , working device ( s ) 266 may further penetrate the urethral wall surrounded by the prostate gland and enter the urethral lumen . working device ( s ) 266 is / are then used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig2 h shows a percutaneous infrapubic approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland . in fig2 h , an introducing 270 is introduced in the pelvic cavity percutaneously in a trajectory that passes inferior to the pubis bone . introducing 270 comprises an elongate body 272 comprising a lumen that terminates distally in a distal opening 274 . introducing 270 is introduced percutaneously in the pelvic cavity in a trajectory that passes inferior to the pubic bone . introducing 270 is then positioned such that distal opening 274 is located in the pelvic cavity adjacent to prostate gland . thereafter , one or more working device ( s ) 276 is / are introduced through distal opening 274 into the prostate gland pg . working device ( s ) 276 penetrate the prostate capsule cp and thereafter penetrate one or more lobes of the prostate gland pg . in some applications of the method , working device ( s ) 276 may further penetrate the urethral wall surrounded by the prostate gland pg and enter the urethral lumen . working device ( s ) 276 is / are then used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig2 shows a trans - rectal approach that may be used to implant tissue compression devices ( s ) to compress the prostate gland pg . in fig2 , an introducing 280 is introduced in the rectum . introducing device 280 comprises an elongate body 282 comprising a lumen that terminates distally in a distal opening 284 . introducing device is then advanced such that it penetrates the rectal wall and enters the pelvic cavity . introducing device 280 is then positioned such that distal opening 284 is located in the pelvic cavity adjacent to prostate gland . thereafter , one or more working device ( s ) 286 is / are introduced through distal opening 284 into the prostate gland pg . working device ( s ) 286 penetrate the prostate capsule cp and thereafter penetrate one or more lobes of the prostate gland . in some applications of the method , working device ( s ) 286 may further penetrate the urethral wall surrounded by the prostate gland and enter the urethral lumen . working device ( s ) 286 is / are then used to deploy and implant implantable tissue compression device ( s ) ( e . g ., one or more clips , anchoring elements , tensioning members , etc .) to compress the prostate gland pg , thereby relieving constriction of the urethra . fig3 a to 3f show various examples of devices and systems that are useable to treat conditions where the prostate gland pg is compressing a region of the urethra such that the urethra does not expand normally during micturition and urine outflow is impeded . fig3 a shows the perspective view of an introducer 300 . introducer 300 comprises an outer body 301 constructed from suitable biocompatible materials including , but not limited to pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel and fluoropolymers like ptfe , pfa , fep , eptfe etc . body 301 comprises a working device lumen 302 . distal end of working device lumen 302 emerges out of the distal end of body 301 . in one embodiment , distal end of working device lumen 302 has a bent or curved region . proximal end of working device lumen 302 emerges out of a first flexible tube 304 . the proximal end of first flexible tube 304 comprises a stasis valve 306 . body 301 further comprises a cystoscope lumen 308 . distal end of cystoscope lumen 308 emerges out of the distal end of body 301 . proximal end of cystoscope lumen 308 emerges out of a second flexible tube 310 . the proximal end of second flexible tube 310 comprises a stasis valve 312 . cystoscope lumen 308 may comprise one or more side ports e . g . a first side port 318 for the introduction or removal of one or more fluids . working device lumen 302 may comprise one or more side ports e . g . a second side port 320 for the introduction or removal of one or more fluids . fig3 b shows a perspective view of an injecting needle . injecting needle 330 is used for injecting one or more diagnostic or therapeutic substances . in some applications of the invention , the injecting needle 330 may be used to inject local anesthetic in the urethra , prostate gland and / or tissues near the prostate gland . specific examples of target areas for injecting local anesthetics are the neurovascular bundles , the genitourinary diaphragm , the region between the rectal wall and prostate , etc . examples of local anesthetics that can be injected by injecting needle 330 are anesthetic solutions e . g . 1 % lidocaine solution ; anesthetic gels e . g . lidocaine gels ; combination of anesthetic agents e . g . combination of lidocaine and bupivacaine ; etc . injecting needle 330 comprises a hollow shaft 332 made of suitable biocompatible materials including , but not limited to stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . in this example , the distal end of hollow shaft 332 comprises a sharp tip 334 . the proximal end of hollow shaft 332 has a needle hub 336 made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . ; polymers e . g . polypropylene , pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , ptfe , pfa , fep , eptfe etc . in one embodiment , needle hub 336 comprises a luer lock . fig3 c shows an example of an introducing device or introducing sheath 340 . introducing sheath 340 comprises a hollow , tubular body 342 made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . or polymers e . g . pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , ptfe , pfa , fep , eptfe etc . tubular body 342 further comprises two marker bands : a proximal marker band 344 and a distal marker band 346 . the marker bands can be seen by a cystoscope . in one embodiment , proximal marker band 344 and distal marker band 346 are radiopaque . the position of proximal marker band 344 and distal marker band 346 is such that after introducing sheath 340 is placed in an optimum location in the anatomy , proximal marker band 344 is located in the urethra where it can be seen by a cystoscope and distal marker band 346 is located in the prostrate gland or in the wall of the urethra where it cannot be seen by a cystoscope . tubular body 342 further comprises a series of distance markers 348 on the outer surface of tubular body 342 . the proximal end of tubular body 342 further comprises a hub 350 made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . or polymers e . g . pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , ptfe , pfa , fep , eptfe etc . in one embodiment , hub 350 comprises a luer lock . fig3 d shows a perspective view of a trocar . trocar 360 comprises a tubular trocar body 362 . the proximal end of trocar body 362 comprises a hub 364 . trocar body 362 and hub can be constructed from suitable biocompatible materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . or polymers e . g . pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , ptfe , pfa , fep , eptfe etc . distal end of trocar body 362 ends in a sharp trocar tip 366 . fig3 e shows a perspective view of an anchor delivery device . anchor delivery 370 comprises a body 372 having a distal opening 373 . a section of the distal region of body 372 has been removed to show a view of the anchor assembly . body 372 encloses a distal anchor 374 and a proximal anchor 376 . proximal anchor 376 and distal anchor 374 can have a variety of designs including , but not limited to the designs disclosed elsewhere in this patent application . proximal anchor 376 and distal anchor 374 can be constructed from suitable biocompatible materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . or polymers e . g . pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , ptfe , pfa , fep , eptfe etc . in one embodiment , shown in fig3 f and 3g , proximal anchor 9976 and distal anchor 9974 comprise splayable elements that expand in a radially outward direction when a radial compression force , as enacted by body lumen 9972 , on proximal anchor 9976 and distal anchor 9974 is removed . the splayable elements can be made of suitable super - elastic materials such as nickel - titanium alloys etc . proximal anchor 9976 and distal anchor 9974 are connected to each other by a tension element 9978 . tension element 9978 can be made of suitable elastic or non - elastic materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , suture materials , titanium etc . or polymers such as silicone , nylon , polyamide , polyglycolic acid , polypropylene , pebax , ptfe , eptfe , silk , gut , or any other braided or mono - filament material . tension element 9978 can have a variety of designs including the designs shown in fig5 a through 5f . as shown in fig3 e , the proximal end of proximal anchor 9976 is connected by an attachment mechanism 9980 to a torquable shaft 9982 . the proximal end of torquable shaft 9982 is attached to a control button 9984 . control button 9984 can be used to deploy proximal anchor 9976 by sliding control button 9984 along groove 9985 in the distal direction . control button 9984 is then used to deploy distal anchor 9974 by turning control button 9984 in the circumferential direction along groove 9985 . fig3 h shows a perspective view from the proximal direction of a particular embodiment of the attachment mechanism of fig3 e . attachment mechanism 380 comprises a circular plate 386 made from suitable biocompatible materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . or polymers e . g . polycarbonate , pvc , pebax , polyimide , polyurethane , nylon , hytrel , hdpe , peek , ptfe , pfa , fep etc . the proximal face of circular plate 386 is connected to torquable shaft 382 . circular plate 386 further comprises a semicircular groove 388 . one end of semicircular groove 388 comprises an enlarged region 390 . a knob 392 located on the proximal portion of proximal anchor 376 slides on semicircular groove 388 . the size of knob 322 is larger than the size of semicircular groove 388 but smaller than size of enlarged region 390 . this keeps proximal anchor 376 attached to circular plate 386 . when control button 384 is turned in the circumferential direction along groove 385 , torquable shaft 382 is turned . this turns circular plate 386 causing knob 392 to slide on the groove 388 . ultimately , knob 392 reaches enlarged region 390 . this releases knob 392 from circular plate 386 thereby releasing proximal anchor 376 from anchor delivery 370 . fig4 a through 4h show a coronal section through the prostate gland showing the various steps of a method of treating prostate gland disorders by compressing a region of the prostate gland using the kit shown in fig3 a through 3f . in fig4 a , introducer 300 is introduced in the urethra through the urethral opening at the tip if the penis . a cystoscope is inserted in introducer 300 through cystoscope lumen 308 such that the lens of the cystoscope is located in the distal opening of cystoscope lumen . the cystoscope is used to navigate introducer 300 through the urethra such that the distal region of introducer 300 is located in a target region in the prostatic urethra . thereafter in fig4 b , injecting needle 330 is advanced through working device lumen 302 such that the distal tip of injecting needle 330 penetrates into a region of the urethral wall or the prostate gland . injecting needle 330 is then used to inject one or more diagnostic or therapeutic agents into the urethral wall or the prostate gland . this step may be repeated one or more times to inject one or more diagnostic or therapeutic agents in one or more regions of the urethral wall and / or the prostate gland . in one method embodiment , injecting needle 330 is used to inject an anesthetic in one or more regions of the urethral wall and / or the prostate gland . in another embodiment , injecting needle 330 is used to deliver energy in the form of radiofrequency energy , resistive heating , laser energy , microwave energy etc . in another embodiment , injecting needle 330 is used to deliver alpha antagonist agents , such as phenoxybenzamine , prazosin , doxazosin , terazosin , tamsulosin , alfuzosin etc . in another embodiment , injecting needle 330 is used to deliver anti - androgen , such as flutamide or 5 - alpha reductase inhibitors , such as finasteride , dutasteride , 3 - oxosteroid compounds , 4 - aza - 3 - oxosteroid derivatives of testosterone etc . in another embodiment , injecting needle 330 is used to deliver anti - inflammatory agents , such as rapamycin , paclitaxel , abt - 578 , everolimus , taxol etc . in another embodiment , injecting needle 330 is used to deliver ablative agents such as methyl alcohol etc . in another embodiment , injecting needle 330 is used to deliver energy in the form of radiofrequency energy , resistive heating , laser energy , microwave energy etc . in another embodiment , injecting needle 330 is used to deliver alpha antagonist agents , such as phenoxybenzamine , prazosin , doxazosin , terazosin , tamsulosin , alfuzosin etc . in another embodiment , injecting needle 330 is used to deliver anti - androgen , such as flutamide or 5 - alpha reductase inhibitors , such as finasteride , dutasteride , 3 - oxosteroid compounds , 4 - aza - 3 - oxosteroid derivatives of testosterone etc . in another embodiment , injecting needle 330 is used to deliver anti - inflammatory agents , such as rapamycin , paclitaxel , abt - 578 , everolimus , taxol etc . in another embodiment , injecting needle 330 is used to deliver ablative agents such as methyl alcohol etc . in step 4 c , injecting needle 330 is withdrawn from introducer device 300 . thereafter , introducer sheath 340 and trocar 360 are advanced through working device lumen 302 . in the example shown , introducer sheath 340 and trocar 360 are advanced till the distal tip of trocar 360 penetrates the capsule of the prostate gland and the distal end of introducer sheath 340 is located outside the prostate gland in the pelvic cavity . thereafter , trocar 360 is withdrawn from working device lumen 302 leaving introducer sheath 340 in place . in fig4 d , anchor delivery 370 is introduced through the lumen of introducer sheath 340 till the distal end of body 372 protrudes through the distal tip of introducer sheath 340 . in step 4 e , distal anchor 374 is deployed . it should be noted that the anchor may be carried to the site and deployed from within an introducer , on the outside of an introducer , or it may be the distal tip of the introducer itself . thereafter , anchor deliver 370 is pulled in the proximal direction along with introducer sheath 340 so that distal anchor 374 is anchored on the outer surface of the prostate capsule . this step may be used to create tension in the tension element 378 . in one method embodiment , anchor deliver 370 is pulled in the proximal direction along with introducer sheath 340 such that the distal end of anchor delivery 370 is located in the prostate gland . in another method embodiment , anchor deliver 370 is pulled in the proximal direction along with introducer sheath 340 till the distal end of anchor delivery device 370 is located in the urethral wall or the urethral lumen . in step 4 f , proximal anchor 376 is deployed . proximal anchor 376 may be deployed in the prostate gland , in the urethral wall or in the urethral lumen . proximal anchor 376 is still attached by attachment mechanism 380 to anchor delivery 370 . the proximal anchor may be pre - loaded on the tension element , or may subsequently be loaded by the operator on the tension element . fig4 g through 4h show the steps of deploying proximal anchor 376 in the prostate gland . in fig4 g , proximal anchor 376 is separated from anchor delivery 370 . this separation may be achieved via numerous means including cutting , melting , un - locking a link , or breaking the tensioning element at a desired location . ideally this residual end of the tensioning element will not protrude substantially into the lumen of the urethra . thus proximal anchor 376 and distal anchor 374 are anchored in the anatomy . thereafter , anchor delivery 370 and introducer sheath 340 are both pulled in the proximal direction and are withdrawn into introducer 300 . thereafter , introducer 300 is pulled in the proximal direction to pull it out of the urethra . in fig4 h , the steps from fig4 a through 4g are repeated in a second region of the prostate gland if desired to implant two or more sets of anchoring devices . alternatively , fig4 g ′ through 4 h ′ show the steps of deploying proximal anchor 376 in the urethra . after the step in fig4 f , in fig4 g ′, proximal anchor 376 is separated from anchor delivery 370 in the urethra . thus proximal anchor 376 and distal anchor 374 are anchored in the urethra and the prostate capsule respectively . thereafter , anchor delivery 370 and introducer sheath 340 are both pulled in the proximal direction and are withdrawn into introducer 300 . thereafter , introducer device 300 is pulled in the proximal direction to pull it out of the urethra . in fig4 h ′, the steps from fig4 a through 4 g ′ are repeated optionally in a second region of the prostate gland to implant two or more sets of anchoring devices . it should be understood that this method and devices may be applied to any lobe ( middle or lateral lobes ) of the prostate and further more may be used multiple times in the same lobe to achieve the desired effect . fig4 h ″ shows a coronal section through the prostate gland showing the final deployed configuration of an embodiment of bone anchoring devices for treating prostate gland disorders by compressing a region of the prostate gland . in the method of deploying this device , introducer sheath 340 and trocar 360 are advanced till the distal tip of trocar 360 penetrates a bone in the abdomen ( e . g . the pelvic bone , etc .) and the distal end of introducer sheath 340 is located outside the bone . thereafter , trocar 360 is withdrawn from working device lumen 302 leaving introducer sheath 340 in place . thereafter , anchor delivery 370 is introduced through the lumen of introducer sheath 340 until the distal end of body 372 touches the bone through the distal tip of introducer sheath 340 . thereafter , distal anchor 374 is implanted in the bone . distal anchor 374 may comprise a variety of designs including , but not limited to designs of distal tips of kirschner wires . examples of such kirschner wire distal tips are spiral drill tips , lancer tips , threaded trocar tips , lengthwise knurled tips , 3 - sided trocar tips , 4 - sided trocar tips , thereafter , anchor deliver 370 is pulled in the proximal direction along with introducer sheath 340 . this step creates tension in the tension element 378 . in another method embodiment , anchor deliver 370 is pulled in the proximal direction along with introducer sheath 340 till the distal end of anchor delivery 370 is located in the urethral wall or the urethral lumen . the remaining method steps are similar to steps 4 f through 4 h . one or more anchors disclosed in this patent application may be implanted in anatomical locations that include , but are not limited to : a location within prostatic lobe ; a location within peripheral zone of prostate ; a location within prostatic capsule ; a location between prostatic capsule and pubic fascia ; a location within the pubic fascia ; a location within the levator ani muscle a location within the obturator internus muscle ; a location within the pelvic bone ; a location within the periostium of pelvic bone ; a location within the pubic bone ; a location within the periostium of pubic bone ; a location within the symphysis pubica ; a location within the urinary bladder wall ; a location within the ischiorectal fossa ; a location within the urogenital diaphragm ; and a location within the abdominal fascia . fig4 i and 4j show a crossection of the urethra through the prostate gland pg showing the appearance of the urethral lumen before and after performing the method shown in fig4 a through 4h . fig4 i shows a crossection of the urethra through the prostate gland showing the appearance of the urethral lumen in a patient with bph . fig4 j shows a crossection of the urethra through the prostate gland pg showing the appearance of the urethral lumen after performing the procedure shown in fig4 a through 4h . the urethral lumen shown in fig4 i is larger than the urethral lumen in fig4 j . fig5 a through 5f show perspective views of some designs of the tension elements that can be used in the embodiments disclosed elsewhere in this patent application . fig5 a shows a perspective view of a tension element 500 comprising a single strand of an untwisted material . examples of materials that can be used to manufacture tension element 500 include but are not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . fig5 b shows a perspective view of a tension element 502 comprising one or more serrations 504 or notches . serrations 504 may be aligned in a particular direction to allow relatively easy movement of an outer body along tension element 502 in one direction and offer significant resistance to movement of the outer body along the tension element in the other direction . fig5 c shows a perspective view of a tension element 506 comprising multiple filaments 507 of a material twisted together . examples of materials that can be used include to manufacture multiple filaments 507 include but are not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . multiple filaments 507 may be coated with a coating 508 including , but not limited to a lubricious coating , antibiotic coating , etc . it is also possible for the tension element to comprise a composite braided structure in a plastic / metal or plastic / plastic configuration to reduce profile and increase strength . such materials could have preset levels of elasticity and non - elasticity . fig5 d shows a perspective view of a tension element 509 comprising a flexible , elastic , spiral or spring element . examples of materials that can be used include to manufacture tension element 509 include but are not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . fig5 e shows a perspective view of a tension element 510 comprising a screw threading 511 on the outer surface of tension element 510 . screw threading 511 enables tension element 510 to be screwed through an outer element to advance or withdraw tension element through the outer element . fig5 f shows a perspective view of a tension element 512 comprising a hollow shaft 514 comprising one or more collapsible regions 516 . a collapsible region 516 comprises one or more windows 518 . windows 518 are cut in hollow shaft 514 in such a way that several thin , collapsible struts 520 are created between adjacent windows 518 . when tension element 512 is compresses along its length , collapsible struts 520 are deformed in the radially outward direction to create one or more anchoring regions . fig5 g shows a perspective view of an anchoring 522 comprising a tension element and two anchors . distal end of a tension element 524 is attached to a distal anchor 526 . proximal end of tension element 524 is attached to a proximal anchor 528 . fig5 h shows a perspective view of a tensioning element device comprising a detachable region . anchoring 530 comprises a first anchor 532 and a second anchor 534 . first anchor 532 and second anchor 534 may comprise a variety of anchor designs disclosed elsewhere in this patent application . in one embodiment , one or both of first anchor 532 and second anchor 534 comprise a substantially flat plate . the substantially flat plate may be made from various materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . first anchor 532 and second anchor 534 are connected to a tensioning element . the tensioning element comprises two flexible members : a first tensioning member 536 and a second tensioning member 538 . the distal end of first tensioning member 536 is connected to first anchor 532 and the proximal end of second tensioning member 538 is connected to second anchor 534 . proximal end of first tensioning member 536 and distal end of second tensioning member 538 are connected to a releasable member 540 . releasable member 540 can be releasably connected to a deploying device . in one embodiment of a method using anchoring 530 , first anchor 532 is deployed out of an anatomical tissue ( e . g . the prostate gland ) into a first anatomical cavity ( e . g . the pelvic cavity ). thereafter , second anchor 534 is deployed into a second anatomical cavity ( e . g . the urethral lumen ). thereafter , releasable member 540 is released from the deploying device to deliver anchoring 530 in a target region . fig5 i shows a perspective view of a tensioning element comprising telescoping tubes . tensioning element 544 may comprise two or more telescoping tubes . in this example , tensioning element 544 comprises three telescoping tubes : a first telescoping tube 546 , a second telescoping tube 548 and a third telescoping tube 550 . second telescoping tube 548 slidably fits into a lumen of first telescoping tube 546 . similarly third telescoping tube 550 slidably fits into a lumen of second telescoping tube 548 . the telescoping tubes have a locking mechanism to prevent a telescoping tube from completely disengaging from another telescoping tube . the telescoping tubes may be made from a variety of biocompatible materials including , but not limited to plastics , metals etc . all the components of the systems disclosed herein ( including but not limited to the tensioning elements , inner and outer anchor members ) may be coated or embedded with therapeutic or diagnostic substances ( e . g ., drugs or therapeutic agents ) or such therapeutic or diagnostic substances may be introduced into or near the prostate or adjacent tissue through a catheter , cannula needles , etc . examples of therapeutic and diagnostic substances that may be introduced or eluted include but are not limited to : hemostatic agents ; antimicrobial agents ( antibacterials , antibiotics , antifungals , antiprotozoals ; antivirals ; antimicrobial metals ( e . g ., silver , gold , etc . ); hemostatic and / or vasoconstricting agents ( e . g ., pseudoephedrine , xylometazoline , oxymetazoline , phenylephrine , epinephrine , cocaine , etc . ); local anesthetic agents ( lidocaine , cocaine , bupivacaine , ); hormones ; anti - inflammatory agents ( steroidal and non - steroidal ); hormonally active agents ; agents to enhance potency ; substances to dissolve , degrade , cut , break , weaken , soften , modify or remodel connective tissue or other tissues ; ( e . g ., enzymes or other agents such as collagenase ( cgn ), trypsin , trypsin / edta , hyaluronidase , and tosyllysylchloromethane ( tlcm )); chemotherapeutic or antineoplastic agents ; substances that prevent adhesion formation ( e . g ., hyaluronic acid gel ); substances that promote desired tissue ingrowth into an anchoring device or other implanted device ; substances that promote or facilitate epithelialization of the urethra or other areas ; substances that create a coagulative lesion which is subsequently resorbed causing the tissue to shrink ; substances that cause the prostate to decrease in size ; phytochemicals that cause the prostate to decrease in size ; alpha - 1a - adrenergic receptor blocking agents ; 5 - alpha - reductase inhibitors ; smooth muscle relaxants ; agents that inhibit the conversion of testosterone to dihydrotestosterone , etc . specific examples of antitumor agents ( e . g ., cancer chemotherapeutic agents , biological response modifiers , vascularization inhibitors , hormone receptor blockers , cryotherapeutic agents or other agents that destroy or inhibit neoplasia or tumorigenesis ) that may be delivered in accordance with the present invention include but are not limited to ; alkylating agents or other agents which directly kill cancer cells by attacking their dna ( e . g ., cyclophosphamide , isophosphamide ), nitrosoureas or other agents which kill cancer cells by inhibiting changes necessary for cellular dna repair ( e . g ., carmustine ( bcnu ) and lomustine ( ccnu )), antimetabolites and other agents that block cancer cell growth by interfering with certain cell functions , usually dna synthesis ( e . g ., 6 mercaptopurine and 5 - fluorouracil ( 5fu ), antitumor antibiotics and other compounds that act by binding or intercalating dna and preventing rna synthesis ( e . g ., doxorubicin , daunorubicin , epirubicin , idarubicin , mitomycin - c and bleomycin ) plant ( vinca ) alkaloids and other anti - tumor agents derived from plants ( e . g ., vincristine and vinblastine ), steroid hormones , hormone inhibitors , hormone receptor antagonists and other agents which affect the growth of hormone - responsive cancers ( e . g ., tamoxifen , herceptin , aromatase inhibitors such as aminoglutethamide and formestane , trriazole inhibitors such as letrozole and anastrazole , steroidal inhibitors such as exemestane ), antiangiogenic proteins , small molecules , gene therapies and / or other agents that inhibit angiogenesis or vascularization of tumors ( e . g ., meth - 1 , meth - 2 , thalidomide ), bevacizumab ( avastin ), squalamine , endostatin , angiostatin , angiozyme , ae - 941 ( neovastat ), cc - 5013 ( revimid ), medi - 522 ( vitaxin ), 2 - methoxyestradiol ( 2me2 , panzem ), carboxyamidotriazole ( cai ), combretastatin a4 prodrug ( ca4p ), su6668 , su11248 , bms - 275291 , col - 3 , emd 121974 , imc - 1c11 , im862 , tnp - 470 , celecoxib ( celebrex ), rofecoxib ( vioxx ), interferon alpha , interleukin - 12 ( il - 12 ) or any of the compounds identified in science vol . 289 , pages 1197 - 1201 ( aug . 17 , 2000 ) which is expressly incorporated herein by reference , biological response modifiers ( e . g ., interferon , bacillus calmette - guerin ( bcg ), monoclonal antibodies , interluken 2 , granulocyte colony stimulating factor ( gcsf ), etc . ), pgdf receptor antagonists , herceptin , asparaginase , busulphan , carboplatin , cisplatin , carmustine , cchlorambucil , cytarabine , dacarbazine , etoposide , flucarbazine , flurouracil , gemcitabine , hydroxyurea , ifosphamide , irinotecan , lomustine , melphalan , mercaptopurine , methotrexate , thioguanine , thiotepa , tomudex , topotecan , treosulfan , vinblastine , vincristine , mitoazitrone , oxaliplatin , procarbazine , streptocin , taxol , taxotere , analogs / congeners and derivatives of such compounds as well as other antitumor agents not listed here . additionally or alternatively , in some applications such as those where it is desired to grow new cells or to modify existing cells , the substances delivered in this invention may include cells ( mucosal cells , fibroblasts , stem cells or genetically engineered cells ) as well as genes and gene delivery vehicles like plasmids , adenoviral vectors or naked dna , mrna , etc . injected with genes that code for anti - inflammatory substances , etc ., and , as mentioned above , macrophages or giant cells that modify or soften tissue when so desired , cells that participate in or effect the growth of tissue . fig6 a through 11a show various examples of anchor designs and / or anchoring device designs . fig6 a and 6b show examples of a crumpling anchor 600 . in fig6 a , crumpling anchor 600 comprises a substantially flattened body 602 . body 602 can be made of a variety of materials including , but not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . further , in any of the implantable tissue compression devices , any or all of the anchors , the tensioning element ( s ) and any other components may be coated , impregnated , embedded or otherwise provided with substance ( s ) ( e . g ., drugs , biologics , cells , etc .) to reduce the likelihood of infection , inflammation , treat the prostatic adenoma directly or enhance the likelihood of endothelialization , deter adhesion formation , promote healing or otherwise improve the likelihood or degree of success of the procedure . such substance ( s ) may be released primarily at the time of delivery or may be released over a sustained period . examples of such substances are listed above and include but are not limited to certain metals with bacteriostatic action ( i . e . silver , gold , etc . ), antibiotics , antifungals , hemostatic agents ( i . e . collagen , hyaluronic acid , gelfoam , cyano - acrylate , etc . ), anti - inflammatory agents ( steroidal and non - steroidal ), hormonally active agents , stem cells , endothelial cells , genes , vectors containing genes , etc . body 602 may be non - woven or woven . body 602 may have a variety of shapes including , but not limited to square , rectangular , triangular , other regular polygonal , irregular polygonal , circular etc . body 602 may have a substantially one dimensional , two dimensional or three dimensional shape . the material chosen for this device may have hemostatic properties to reduce bleeding from the implantation tract or site . distal end of body 602 is connected to the distal end of tension element 604 . body 602 further comprises one or more attachment means 606 . attachment means are used to create a channel in the body 602 through which tension element 604 passes . crumpling anchor 600 is introduced through a region of tissue ( e . g . through prostate gland tissue ) into a cavity or lumen e . g . pelvic cavity , urethral lumen etc . in fig6 b , tension element 604 is pulled in the proximal direction . the causes crumpling ( e . g ., collapsing ) of the crumpling anchor 600 between the tissue and the distal end of tension element 604 . this process prevents tension element 604 in the tissue and prevents further movement of tension element 604 in the proximal direction . fig7 a and 7b show an example of a deployable anchor 700 in an undeployed configuration and a deployed configuration , respectively . this deployable anchor 700 comprises one or more anchoring arms 702 . anchoring arms 702 may be made from a variety of elastic , super - elastic or shape memory materials etc . typical examples of such materials include but are not limited to metals e . g . stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . anchoring arms 702 are connected to a central hub 704 . central hub in turn is connected to the distal end of a tension element 706 . in fig7 a , anchoring arms 702 are folded inside a hollow deploying sheath 708 . this reduces the undeployed diameter of anchoring arms 702 and also prevents unwanted anchoring of anchoring arms 702 . in fig7 b , deploying sheath 708 is pulled in the proximal direction . this releases anchoring arms 702 from the distal end of deploying sheath 702 . this causes anchoring arms 702 to open in the radially outward direction . anchor 700 can then anchor to tissue and resist movement of tension element 706 in the proximal direction . fig8 a and 8b show sectional views of an undeployed configuration and a deployed configuration respectively of a “ t ” shaped deployable anchor . anchor 8110 comprises an elongate region 802 . elongate region 802 may be made from a variety of elastic , super - elastic or shape memory materials etc . typical examples of such materials include but are not limited to metals e . g . stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc ; polymers e . g . polypropylene , teflon etc . middle section of elongate region 802 is connected to the distal end of a tension element 804 to form a “ t ” shaped anchor . in one embodiment , middle section of elongate region 802 is connected to the distal end of a tension element 804 by a hinge . in fig8 a , elongate region 802 is folded inside a hollow deploying sheath 806 . this reduces the undeployed diameter of the distal region of anchor 8110 and also prevents unwanted anchoring of elongate region 802 to tissue . in fig8 b , deploying sheath 806 is pulled in the proximal direction . this releases elongate region 802 from the distal end of deploying sheath 806 . this in turn causes elongate region 802 to twist and orient itself perpendicular to the distal end of a tension element 804 . anchor 800 can then anchor to tissue and resist movement of tension element 804 in the proximal direction . anchoring arms 702 in fig7 a and 7b can have a variety of configurations including , but not limited to configurations shown in fig9 a through 9d . fig9 a shows a distal end view of an embodiment of an anchor comprising two triangular arms . anchor 900 comprises two anchor arms 902 . anchor arms 902 can be made of a variety of materials including , but not limited to metals e . g . stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc ; polymers e . g . polypropylene , teflon etc . anchor arms 902 are connected to a tension element 904 . in one embodiment , anchor arms 902 are connected to a central hub , which in turn is connected to tension element 904 . the arms in each of these devices may be folded or contained prior to deployment through the use of a sheath or grasping or mounting device . fig9 b shows a distal end view of an embodiment of an anchor comprising four rectangular arms . anchor 906 comprises four anchor arms 908 . anchor arms 908 can be made of a variety of materials including , but not limited to metals e . g . stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc ; polymers e . g . polypropylene , teflon etc . anchor arms 908 are connected to a tension element 910 . in one embodiment , anchor arms 908 are connected to a central hub , which in turn is connected to tension element 910 . fig9 c shows a distal end view of an embodiment of an anchor comprising a mesh or a woven material . anchor 912 comprises four anchor arms 914 . anchor arms 914 can be made of a variety of materials including , but not limited to metals e . g . stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc ; polymers e . g . polypropylene , teflon etc . anchor arms 914 are connected to a tension element 916 . in one embodiment , anchor arms 914 are connected to a central hub , which in turn is connected to tension element 916 . a layer of porous material 918 is located between anchor arms 914 . porous material 918 comprises a plurality of pores that allow for tissue ingrowth . porous material 918 may also help to distribute the pressure on anchor arms 914 over a wider area . porous material 918 can be made of variety of materials including , but not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . porous material 918 may be non - woven or woven . any of the arms or struts in one or more anchoring devices may comprise bent or curved regions . for example , fig9 d shows a distal end view of an embodiment of an anchor comprising four curved arms . anchor 920 comprises four curved anchor arms 922 . curved anchor arms 922 can be made of a variety of materials including , but not limited to metals e . g . stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc ; polymers e . g . polypropylene , teflon etc . curved anchor arms 922 are connected to a tension element 924 . in one embodiment , curved anchor arms 922 are connected to a central hub which in turn is connected to tension element 924 . fig1 a shows a distal end view of an anchor comprising a spiral element having a three dimensional shape . anchor 1000 comprises a three dimensional spiral element 1002 . diameter of spiral element 1002 may be substantially constant or may substantially vary along the length of spiral element 1002 . spiral element 1002 may be made of an elastic , super - elastic or shape memory materials . spiral element 1002 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . spiral element 1002 is connected to a central hub 1004 , which in turn is connected to a tension element . in one embodiment , spiral element 1002 is directly connected to a tension element without using central hub 1004 . fig1 a ′ shows a side view of the anchor in fig1 a . fig1 a ′ shows anchor 1000 comprising spiral element 1002 connected to central hub 1004 which in turn is connected to a tension element 1006 . fig1 b shows a distal end view of an anchor comprising a spiral element having a two dimensional shape . anchor 1000 comprises a two dimensional spiral element 1010 . spiral element 1010 may be made of an elastic , super - elastic or shape memory materials . spiral element 1010 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . spiral element 1010 is connected to a central hub 1012 which in turn is connected to a tension element . in one embodiment , spiral element 1010 is directly connected to a tension element without using central hub 1012 . fig1 b ′ shows a side view of the anchor in fig1 b . fig1 b ′ shows anchor 1008 comprising spiral element 1010 connected to central hub 1012 which in turn is connected to a tension element 1014 . fig1 c shows a distal end view of an anchor comprising one or more circular elements . in fig1 c , anchor 1016 comprises an inner circular element 1018 and an outer circular element 1020 . a series of radial arms or struts 1022 connect inner circular element 1018 to outer circular element 1020 and to a central hub 1024 . central hub 1024 may have a lumen 1026 . anchor 1016 may be substantially two dimensional or three dimensional . fig1 c ′ shows a perspective view of the anchor in fig1 c . fig1 c ′ shows an anchor 1016 comprising an inner circular element 1018 , an outer circular element 1020 and series of radial arms or struts 1022 connecting inner circular element 1018 to outer circular element 1020 and to a central hub 1024 . central hub 1024 is connected to a tension element . fig1 d shows a perspective view of an embodiment of an anchoring device comprising an outer ring . anchor 1040 comprises a central hub 1042 and an outer ring 1044 . in one embodiment , central hub 1042 acts as a plug to plug an opening in the anatomy to reduce or prevent bleeding or leakage of fluids . central hub 1042 is connected to outer ring 1044 by one or more bars or struts 1046 . in one embodiment , central hub 1042 is connected to an inner ring 1048 which in turn is connected to outer ring 1044 by one or more bars or struts 1046 . central hub 1042 further comprises a locking element 1050 . locking element 1050 comprises a lumen 1052 through which a tension element can slide . after positioning anchor 1040 in a desired position with respect to the tension element , locking element 1050 is used to securely attach anchor 1040 on the tension element . locking element 1050 may comprise a design disclosed including various locking designs disclosed elsewhere in this patent application . anchor 1040 may be made from a variety of materials including , but not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . fig1 e shows a partial perspective view of an anchoring device comprising a hemostatic element . anchor 1060 comprises a central hub 1062 . in one embodiment , central hub 1062 acts as a plug to plug an opening in the anatomy to reduce or prevent bleeding or leakage of fluids . central hub 1062 comprises a cinching mechanism to allow central hub 1062 to cinch on to a tension element 1064 passing through central hub 1062 . the free end 1066 of tension element 1064 is severed to minimize the presence of tension element 1064 in the anatomy . anchor 1060 further comprises an outer ring 1068 . central hub 1062 is connected to outer ring 1068 by one or more struts 1070 . anchor 1060 further comprises a mesh or porous element 1072 between outer ring 1068 and struts 1070 . the mesh or porous element 1072 may be concave shaped as shown in fig1 e . mesh or porous element 1072 allows for tissue ingrowth over a period of time thus providing additional securing of anchor 1060 to tissue . fig1 a shows a perspective view of a device having a set of anchors comprising a curved sheet . anchoring 1100 may comprise one or more anchors comprising a curved sheet . in this example , anchoring 1100 comprises a first anchor 1102 and a second anchor 1104 . first anchor 1102 and second anchor 1104 may comprise elastic , super elastic or shape memory materials . first anchor 1102 and second anchor 1104 may be made from various materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . the concave surface of first anchor 1102 is connected to a first end of a tension element 1106 . second end of tension element 1106 is connected to the convex surface of second anchor 1104 . in one embodiment of a method to deploy anchoring 1106 , first anchor 1102 is deployed out of an anatomical tissue ( e . g . the prostate gland ) into a first anatomical cavity ( e . g . the pelvic cavity ). thereafter , second anchor 1104 is deployed into a second anatomical cavity ( e . g . the urethral lumen ). this method embodiment has the advantage of using the natural curvature of first anchor 1102 and second anchor 1104 to distribute pressure on first anchor 1102 and second anchor 1104 over a large area . fig1 a through 17i show further examples of anchor designs and / or anchoring device designs . fig1 a shows a perspective view of an anchor comprising an arrowhead . anchor 1200 comprises an arrowhead 1202 . arrowhead 1202 may be made from various materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; rubber materials e . g . various grades of silicone rubber etc . arrowhead 1202 may comprise a sharp distal tip . arrowhead 1202 may have a three dimensional or a substantially two dimensional design . proximal region of arrowhead 1202 is wider that the distal region of arrowhead 1202 to resist motion of arrowhead 1202 along the proximal direction after it is deployed in a tissue . proximal region of arrowhead 1202 is connected to a tension element 1204 . fig1 b shows a crossectional view of an anchor comprising a cup - shaped element that encloses a cavity . anchor 1208 comprises a cup - shaped element 1210 . proximal , concave surface of cup - shaped element 1210 encloses a cavity . cup - shaped element 1210 may be made from various materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; rubber materials e . g . various grades of silicone rubber etc . proximal region of cup - shaped element 1210 is connected to a tension element 1212 . fig1 c shows a perspective view of an anchor comprising a screw . anchor 1216 comprises a screw 1218 . screw 1218 may be made from various materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . screw 1218 may comprise a sharp distal tip . proximal region of screw 1218 may be wider that the distal region of screw 1218 to resist motion of screw 1218 along the proximal direction after it is deployed in a tissue . screw 1218 comprises a thread rolled thread including , but not limited to wood screw style thread , double lead thread , tapping style thread , tapered wood thread etc . proximal region of arrowhead 1202 is connected to a tension element 1204 . fig1 a and 13b show perspective views of an uncollapsed state and a collapsed state respectively of an anchor comprising a collapsible region . in fig1 a , anchor element 1300 is in an uncollapsed state . anchor element 1300 comprises a hollow shaft 1302 comprising one or more collapsible regions . a collapsible region comprises one or more windows 1304 . windows 1304 are cut in hollow shaft 1302 in such a way that several thin , collapsible struts 1306 are created between adjacent windows 1304 . in fig1 b , anchor element 1300 is in a collapsed state . when anchor element 1300 is compresses along its length , collapsible struts 1306 are deformed in the radially outward direction to create one or more anchoring regions . fig1 c and 13d show perspective views of an undeployed state and a deployed state respectively of an anchor comprising radially spreading arms . in fig1 c , anchor 1312 comprises a hollow tube 1314 . hollow tube 1314 is made from suitable elastic , super - elastic or shape memory materials such as metals including , but not limited to titanium , stainless steel , nitinol etc . ; suitable elastic polymers etc . u - shaped slots 1316 are cut in hollow tube 1314 in such a way that arms 1318 are created within u - shaped slots 1316 . in this embodiment , u - shaped slots are substantially parallel to the axis of hollow tube 1314 . in absence of an external force , arms 1318 tend to spread in a radially outward direction . anchor 1312 is kept in an undeployed state by enclosing anchor 1312 in a sheath . anchor 1312 is deployed by removing the sheath to allow arms 1318 to spread in a radially outward direction as shown in fig1 d . hollow tube 1314 may comprise one or more cinching elements . cinching elements may be located on the proximal region , distal region or a middle region of hollow tube 1314 . the cinching element or elements may comprise cinching mechanisms including , but not limited to cinching mechanisms disclosed in fig2 a through 29p . fig1 e shows perspective views of an alternate embodiment of an undeployed state of an anchor comprising radially spreading arms . in fig1 c , anchor 1320 comprises a hollow tube 1322 . hollow tube 1322 is made from suitable elastic , super - elastic or shape memory materials such as metals including , but not limited to titanium , stainless steel , nitinol etc . ; suitable elastic polymers etc . u - shaped slots 1324 are cut in hollow tube 1322 in such a way that arms 1326 are created within u - shaped slots 1324 . in this embodiment , u - shaped slots are at an angle to the axis of hollow tube 1322 as shown in fig1 e . fig1 a and 14b show perspective views of anchoring devices comprising an adhesive delivering element . fig1 a shows a perspective view of an anchoring 1400 comprising a hollow shaft 1402 with a shaft lumen . hollow shaft 1402 can be made of suitable biocompatible materials including , but not limited to pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel and fluoropolymers like ptfe , pfa , fep and eptfe etc . distal end of shaft lumen ends in a delivery opening 1404 . when an adhesive is injected through the shaft lumen , it emerges out of anchoring 1400 through delivery opening 1404 . hollow shaft 1402 may also comprise an attachment element 1406 such as a porous woven or non - woven circular sleeve securely attached to hollow shaft 1402 . the circular sleeve may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . the adhesive flowing out through delivery opening comes into contact with attachment element 1406 and securely attaches attachment element 1406 to surrounding tissue . fig1 b shows a perspective view of an anchoring 1408 comprising a hollow shaft 1410 with a shaft lumen . hollow shaft 1410 can be made of suitable biocompatible materials including , but not limited to pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel and fluoropolymers like ptfe , pfa , fep and eptfe etc . distal end of shaft lumen ends in a delivery opening 1412 . when an adhesive is injected through the shaft lumen , it emerges out of anchoring 1408 through delivery opening 1412 . hollow shaft 1410 may also comprise an attachment element 1414 such as porous foam securely attached to hollow shaft 1410 . the porous foam may be made of a variety of materials including , but not limited to polymers e . g . polypropylene , teflon etc . ; synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; rubber materials e . g . various grades of silicone rubber etc . the adhesive flowing out through delivery opening comes into contact with attachment element 1414 and securely attaches attachment element 1414 to surrounding tissue . typical examples of adhesives that can be used with anchoring 1400 and anchoring 1408 include but are not limited to cyanoacrylates , marine adhesive proteins , fibrin - based sealants etc . fig1 a and 15b show two configurations of an anchoring device comprising a ratcheted tension element . anchoring 1500 comprises a distal anchor . distal anchor may comprise a design selected from the variety of designs disclosed elsewhere in this document . in this particular example , distal anchor comprises a series of radial arms 1502 connected to a central hub 1504 . the proximal end of central hub is attached to a ratcheted tension element 1506 . a proximal anchor is located on ratcheted tension element 1506 proximal to the distal anchor . proximal anchor may comprise a design selected from the variety designs disclosed elsewhere in this document . in this particular example , distal anchor comprises a series of radial arms 1508 connected to a central hub 1510 . central hub 8368 has a central lumen through which ratcheted tension element 1506 can slide . ratcheted tension element 1506 has ratchets arranged such that proximal anchor can slide easily over ratcheted tension element 1506 in the distal direction but cannot slide easily in the proximal direction . in fig1 b , proximal anchor slides over ratcheted tension element 1506 in the distal direction . this causes a compression of tissue between distal anchor and proximal anchor . the compression of tissue can be maintained since proximal anchor cannot slide easily in the proximal direction . in one embodiment of a method using anchoring 1500 , distal anchor is introduced via an anatomical lumen ( e . g . the urethral lumen ) and through a tissue ( e . g . the prostate gland ) into an anatomical cavity ( e . g . the pelvic cavity ). thereafter , proximal anchor is advanced along ratcheted tension element 1506 till it encounters a wall ( e . g . the urethral wall ) of the anatomical lumen . anchoring 1500 may be made from various materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . fig1 shows a perspective view of an anchor comprising a trocar lumen . anchor 1600 comprises a hollow shaft 1602 comprising a lumen . a trocar 1604 or a penetrating device can pass through hollow shaft 1602 such that the distal tip of trocar 1604 emerges out through the distal end of hollow shaft 1602 . distal end of hollow shaft 1602 comprises a tapering region 1606 with a smaller distal diameter and a larger proximal diameter . tapering region 1606 further comprises a series of sharp projections 1608 located on the proximal end of tapering region 1606 . projections 1608 may be projecting in the proximal direction , radially outward direction etc . projections 1608 prevent the movement of anchor 1600 in the proximal direction after it has penetrated through a tissue . anchor 1600 may also comprise a sleeve 1610 located proximal to tapering region 1606 . sleeve 1610 is made of a porous material that has a plurality of pores that allow for tissue ingrowth thus anchoring sleeve 1610 firmly in tissue . sleeve 1610 may also help to distribute the pressure on tapering region 1606 over a wider area . sleeve 1610 may be non - woven or woven . sleeve 1610 can be made of variety of materials including , but not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . fig1 a shows a perspective view in the undeployed state of an anchor comprising a rigid or partially flexible t element and a crumpling element . in fig1 a , anchoring 1700 comprises a distal , t element 1702 . the t element 1702 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; rubber materials e . g . various grades of silicone rubber etc . further it may be a composite material or have cut out sections to allow it to be flexible in certain dimensions but rigid in other dimensions . in this example , t element 1702 is in the form of a hollow cylinder . the proximal end of t element 1702 is in contact with the distal end of a delivery rod 1704 . delivery rod 1704 is hollow and is used to deliver t element 8266 in a target anatomical region . a trocar 1705 can pass through delivery rod 1704 and through t element 1702 such that the distal tip of trocar emerges through the distal end of rigid element 1702 . the t - element could also be contained within a lumen of the trocar or may be the trocar itself . of the t element 1702 is connected to the distal end of a flexible tension element 1706 . various connection means are possible such as the tension element being tied or crimped to the t element , or passing through a loop in the t element , or being adhered by adhesive or weld , or by being made of a continuous material which becomes the t element . although the t element is shown as a t , any shape which is larger in at least one dimension compared to its other dimensions could appropriately be released and cause to change it &# 39 ; s orientation to produce an anchoring effect . examples of materials that can be used to manufacture tension element 1706 include but are not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . a substantially flattened body 1708 is located on the distal region of tension element 1706 . tension element 1706 is threaded through body 1708 in such a way that tension element 1706 can slide through body 1708 . body 1708 may be non - woven or woven . body 1708 can be made of a variety of materials including , but not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . body 1708 may have a variety of shapes including , but not limited to square , rectangular , triangular , other regular polygonal , irregular polygonal , circular etc . body 1708 may have a substantially one dimensional , two dimensional or three dimensional shape . fig1 b and 17c show various steps of a method to deploy the anchoring device shown in fig1 a . in fig1 b , anchoring 1700 is introduced in an anatomical cavity ( e . g . the pelvic cavity ) through a tissue ( e . g . the prostate gland ). thereafter , trocar 1705 is withdrawn by pulling trocar 1705 in the proximal direction . thereafter , delivery rod 1704 is withdrawn by pulling delivery rod 1704 in the proximal direction . thereafter , tension element 1706 is pulled in the proximal direction . tension element 1706 in turn pulls t element 1702 in the proximal direction . in fig1 c , rigid element 1702 is pulled against a wall of the tissue ( e . g . the prostate gland ) but is unable to penetrate the tissue because of its size . this causes body 1708 to crumple because of compression of body 1708 between the wall of the tissue and rigid element 1702 . crumpled body 1708 may be designed to cause tissue ingrowth or epithelialization in body 1708 as well as healing , hemostasis or a more even force distribution . fig1 d and 17e show perspective views of an undeployed and deployed configuration of an anchor comprising a rigid or partially flexible t element with one or more openings or perforations . fig1 d shows a perspective view of an anchoring 1720 comprising an anchor 1722 . anchor 1722 comprises a tubular body . the tubular body may comprise one or more openings or perforations 1724 in the tubular body . openings or perforations 1724 increase the flexibility of anchor 1722 . this makes it easier to navigate anchoring 1720 through the anatomy before reaching its target location . further it enables anchoring 1720 to be passed through a tight bend in the anatomy or through a delivery device . within tubular body of anchor 1722 is trocar tip 1727 that is fixedly attached to tensioning element 1728 . in the embodiment shown in fig1 d , anchor 1722 comprises a lumen . a length of the distal end of deployment element 1726 passes through the proximal end of the lumen and abuts trocar tip 1727 that enables anchor 1722 to puncture tissue . in an alternate embodiment trocar tip is fixedly attached to elongate deployment element 1726 and is retracted fully into element 1729 upon anchor deployment . in an alternate embodiment , distal tip of deployment 1726 is not exposed through the distal end of anchor 1722 . distal end of anchor 1722 comprises a sharp tip to enable anchor 1722 to puncture tissue . anchoring element 1720 further comprises a tension element 1728 attached to tubular body 1722 . in this embodiment , distal end of tension element 1728 attached to the inner surface of the trocar tip 1727 . proximal region of tension element 1728 passes through deployment element 1726 . anchor 1722 is deployed by pushing in a distal direction one elongate deployment element 1726 , that runs within lumen of anchor 1722 abutting trocar tip 1727 distally , in tandem with another elongate deployment element 1729 that abuts the proximal end of anchor 1722 . anchoring 1720 punctures tissue to transport anchor 1722 through a first anatomical location ( e . g . a prostate gland ) to a second anatomical location ( e . g . the pelvic cavity , urethra etc .). thereafter , deployment element 1726 is withdrawn by pulling deployment element 1726 in the proximal direction . thereafter , tension element 1728 is pulled in the proximal direction . this causes anchor 1722 to anchor in tissue as shown in fig1 e . proximal portion of tension element 1728 emerges out of anchor 1722 through a lengthwise groove in anchor 1722 to create a t shaped anchor as shown in fig1 e . tension on tensioning element 1728 causes trocar tip 1727 to retract into lumen 1722 . in the example shown , the first anatomical location is the prostate gland pg and the second anatomical location is the pelvic cavity . anchoring 1720 can be made from a variety of materials including , but not limited to metals such as synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . tension element 1728 may then be connected to any one of the other anchoring elements such as anchor 10 d . fig1 f and 17g show perspective views of an undeployed and deployed configuration of an anchor comprising a stent . anchor 1730 comprises a self - expanding stent 1732 and a tension element 1734 . distal end of tension element 1734 is attached to stent 1732 . in one embodiment , distal end of tension element 1734 is attached on the mid section of stent 1732 . stent 1732 may comprise various designs including , but not limited to metallic tube designs , polymeric tube designs , spiral designs , chain - linked designs , rolled sheet designs , single wire designs etc . stent 1732 may have an open celled or closed celled structure . a variety of fabrication methods can be used for fabricating stent 1732 including but not limited to laser cutting a metal or polymer element , welding metal elements etc . a variety of materials can be used for fabricating stent 1732 including but not limited to metals , polymers , foam type materials , super elastic materials etc . a variety of features can be added to stent 1732 including but not limited to radiopaque coatings , drug elution mechanisms etc . anchor 1730 is introduced through a sheath 1736 into a target anatomy . thereafter , sheath 1736 is withdrawn . this causes stent 1732 to revert to its natural shape as shown in fig1 g and act as an anchor . fig1 h and 17i show perspective views of an undeployed and deployed configuration of an anchor comprising a spring . anchor 1740 comprises an elastic spring 1742 and a tension element 1744 . distal end of tension element 1744 is attached to spring 1742 . in one embodiment , distal end of tension element 1744 is attached on the mid section of spring 1742 . a variety of materials can be used for fabricating spring 1742 including but not limited to metals , polymers , foam type materials , super elastic materials etc . a variety of features can be added to spring 1742 including but not limited to radiopaque coatings , drug elution mechanisms etc . anchor 1740 is introduced through a sheath 1746 into a target anatomy to reduce the profile of spring 1742 . thereafter , sheath 1746 is withdrawn . this causes spring 1742 to revert to its natural shape as shown in fig1 i and act as an anchor . fig1 a through 22e show various embodiments of mechanisms to deploy one or more anchors . fig1 a shows a crossection of an anchor deploying mechanism comprising a screw system . fig1 a shows an anchor deploying mechanism comprising an anchor 1800 comprising an anchor body 1802 and anchoring elements 1804 attached to anchor body 1802 . anchor body 1802 comprises an inner lumen . inner lumen of anchor body 1802 comprises screw threading . anchoring elements 1804 may have various designs including , but not limited to anchor designs disclosed elsewhere in this document . anchor body 1802 and anchoring elements 1804 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; rubber materials e . g . various grades of silicone rubber etc . the anchor deploying mechanism further comprises a deploying shaft 1806 . distal region of deploying shaft 1806 comprises a screw threading such that deploying shaft 1806 can be screwed into anchor body 1802 . fig1 b shows the method of deploying an anchor comprising a screw mechanism . deploying shaft 1806 is rotated to release the distal region of deploying shaft 1806 from anchor body 1802 after positioning anchor 1800 in a desired location . such a mechanism can be used to deploy one or more anchors . in one embodiment , more than one anchors are located on deploying shaft 1806 . the anchors can be sequentially deployed by rotating deploying shaft 1806 . deploying shaft 1806 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . in one embodiment , the anchor deploying mechanism is located inside an outer sheath . fig1 a and 19b show a crossectional view of an anchor deploying system comprising an electrolytic detachment element . fig1 a shows a crossection of an anchor deploying mechanism comprising a deployable anchor 1900 . deployable anchor 1900 comprises an anchor body 1902 and anchoring elements 1904 attached to anchor body 1902 . anchoring elements 1904 may have various designs including , but not limited to anchor designs disclosed elsewhere in this document . anchor body 8402 and anchoring elements 8404 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; rubber materials e . g . various grades of silicone rubber etc . proximal region of deployable anchor 1900 further comprises an electrolyzable element 1906 . electrolyzable element 1906 is made of a length of metallic wire e . g . steel wire . proximal region of electrolyzable element 1906 is electrically connected to a deploying shaft 1908 . proximal region of deploying shaft 1908 is further connected to a first electrode . the anchor deploying system further comprises a second electrode 1910 connected to a bodily region of the patient to be treated . in fig1 b , the first electrode is connected to a positive terminal of a power supply and the second electrode is connected to the negative terminal of the power supply to form an electrical circuit . electrical current flowing between electrolyzable element 1906 and second electrode 1910 causes metallic ions from electrolyzable element 1906 to dissolve into surrounding anatomy . this causes electrolyzable element 1906 to detach from deploying shaft 1908 . fig2 shows a perspective view of an anchor deploying system comprising a looped ribbon . the anchor deploying system comprises a deployable anchor 2000 . deployable anchor 2000 comprises an anchor body 2002 and anchoring elements 2004 attached to anchor body 2002 . anchoring elements 2004 may have various designs including , but not limited to anchor designs disclosed elsewhere in this document . anchor body 2002 and anchoring elements 2004 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; rubber materials e . g . various grades of silicone rubber etc . proximal region of deployable anchor 2000 further comprises a looping lumen 2006 . a looped ribbon 2008 is looped through looping lumen 2006 . looped ribbon 2008 may be made of a variety of materials including , but not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . looped ribbon 2008 extends to a proximal region where it can be cut by a user . in a method of deploying deployable anchor 2000 , a single cut is made in looped ribbon 2008 at a proximal region . this turns looped ribbon 2008 into a straight ribbon . the straight ribbon can then be pulled in the proximal direction to remove it from deployable anchor 2000 . looped ribbon 2008 may also be in the form of a looped monofilament or multifilament wire or suture . fig2 a shows a crossectional view of an anchor deploying system comprising a locked ball . the anchor deploying system comprises a deployable anchor 2100 . deployable anchor 2100 comprises an anchor body 2102 . deployable anchor 2100 may have various designs including , but not limited to anchor designs disclosed elsewhere in this document . proximal end of anchor body 2102 is connected to a thin shaft 2104 . proximal end of thin shaft 2104 comprises a locking ball 2106 . anchor body 8428 , thin shaft 2104 and locking ball 2106 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; rubber materials e . g . various grades of silicone rubber etc . the anchor deploying system further comprises an outer locking sheath 2108 . distal end of locking sheath 2108 comprises an opening 2110 . diameter of opening 2110 is greater than the diameter of thin shaft 2104 but greater than diameter of locking ball 2106 . thus , locking ball 2106 is locked in locking sheath 2108 . the anchor deploying system further comprises a deploying shaft 2112 located within locking sheath 2108 . deploying shaft 2112 can be pushed in the distal direction within locking sheath 2108 by a user . locking sheath 2108 and deploying shaft 2112 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . in one embodiment , distal region of locking sheath 2108 comprises one or more longitudinal grooves or windows to allow distal region of locking sheath 2108 to expand easily in the radial direction . fig2 b and 21c show a method of deploying an anchor comprising a locked ball . in fig2 b , deploying shaft 2112 is pushed in the distal direction by a user . this causes distal end of deploying shaft 2112 to push locking ball 2106 in the distal direction . this in turn causes locking ball 2106 to exert a force on the distal end of locking sheath 2108 . this force causes opening 2110 to enlarge and release locking ball 2106 . in fig2 c , locking ball 2106 is released by locking sheath 2108 thus releasing deployable anchor 2100 . fig2 a through 22c show various views of an anchor deploying system comprising two interlocking cylinders . the anchor deploying system comprises a proximal interlocking cylinder and a distal interlocking cylinder . the distal interlocking cylinder is located on an anchor to be deployed . fig2 a shows a perspective view of a proximal interlocking cylinder 2200 comprising a locking element 2202 located on the distal end of proximal interlocking cylinder 2200 . in this example , locking element 2202 comprises a solid cylinder with a ninety degree bend . proximal interlocking cylinder 2200 and locking element 2202 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . fig2 b shows a crossectional view of the anchor deploying system comprising proximal interlocking cylinder 2200 interlocked with a distal interlocking cylinder 2204 . distal interlocking cylinder 2204 comprises a groove 2206 which locks locking element 2202 . locking element 2202 can be unlocked from distal interlocking cylinder 2204 by turning proximal interlocking cylinder 2200 . distal interlocking cylinder 2204 may be made of a variety of materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; polymers e . g . polypropylene , teflon etc . ; rubber materials e . g . various grades of silicone rubber etc . fig2 c shows a crossectional view through plane a - a in fig2 b . fig2 c shows distal interlocking cylinder comprising groove 2206 . also shown is locking element 2202 located in groove 2206 . turning proximal interlocking cylinder 2200 turns locking element 2202 . at a particular orientation , distal region of locking element 2202 can pass easily through groove 2206 unlocking proximal interlocking cylinder 2200 from distal interlocking cylinder 2204 . fig2 d and 22e show the steps of a method of unlocking the two interlocking cylinders from the anchor deploying systems of fig2 a through 22c . in fig2 d , locking element 2202 of proximal interlocking cylinder 2200 is locked in groove 2206 of distal interlocking cylinder 2204 . in fig2 e , proximal interlocking cylinder 2200 is turned in a clockwise or counterclockwise direction to unlock locking element 2202 from groove 2206 . thereafter , proximal interlocking cylinder 2200 is pulled in the proximal direction to separate proximal interlocking cylinder 2200 from distal interlocking cylinder 2204 . fig2 a shows a perspective view of a distal end of an anchoring device that has an imaging modality . anchoring 2300 comprises an elongate shaft 2302 comprising a lumen . elongate shaft 2302 can be made of suitable biocompatible materials such as metals , polymers etc . the lumen of shaft 2302 terminates in a window 2304 located on the distal region of shaft 2302 . anchoring device further comprises an imaging modality such as a cystoscope , an ultrasound imaging system etc . in this example , the imaging modality is a cystoscope 2306 . distal end of cystoscope 2306 is located in window 2304 to allow visualization of the anatomy adjacent to window 2304 . in one embodiment , cystoscope 2306 is permanently fixed to anchoring 2300 . in another embodiment , cystoscope 2306 can be introduced through the proximal region of anchoring 2300 . anchoring 2300 further comprises a puncturing 2308 . puncturing 2308 comprises a sharp distal tip and a lumen that holds an anchor . anchoring 2300 further comprises an anchor deployment 2310 . distal end of anchor deployment 2310 is detachably attached to the anchor . fig2 b through 23g show various steps of a method for compressing an anatomical region using the anchoring device of fig2 a . in fig2 b , anchoring 2300 is introduced in an anatomical region such that distal end of anchoring 2300 is located adjacent to a target anatomical region to be treated . in one method embodiment , anchoring 2300 is introduced transurethrally into the prostatic urethra . thereafter , puncturing 2308 is advanced to puncture the anatomical region . in this example , puncturing 2308 punctures the prostate gland pg such that distal end of puncturing 2308 is located in the pelvic cavity . puncturing device comprises an anchor located in the lumen of puncturing 2308 . the anchor comprises a distal anchor 2312 , a tension element 2314 connected at one end to distal anchor 2312 and a proximal anchor 2316 that can slide over tension element 2314 . puncturing 2308 comprises a groove at the distal end such that tension element exits puncturing device 2308 through the groove . puncturing 2308 further comprises a pusher 2318 that can push distal anchor 2312 out of puncturing 2308 . proximal anchor 2316 is detachably attached to the distal region of anchor deployment 2310 . proximal anchor 2312 , distal anchor 2316 and tension element 2314 may comprise designs including , but not limited to the designs disclosed elsewhere in this patent application . the imaging modality may be used to verify the accurate placement and working of anchoring 2300 . in fig2 c , pusher 2318 is pushed in the distal direction to push distal anchor 2312 out of puncturing 2308 . distal anchor 2312 is thus deployed in the anatomy e . g . in the pelvic cavity surrounding the prostate gland pg . thereafter , in step 23 d , puncturing 2308 is withdrawn by pulling it in the proximal direction . in step 23 e , tension element 2314 is pulled in the proximal direction through anchor deployment 2310 . thereafter , in step 23 f , tension element 2314 is pulled further in the proximal direction such that the anatomical region between proximal anchor 2316 and distal anchor 2312 is compressed . thereafter , in step 23 g , proximal anchor 2316 is securely locked on to tension element 2314 . further in step 23 g , proximal anchor 2316 is detached from anchor deployment 2310 . the detachment can be performed by a variety of mechanisms including , but not limited to the anchor detachment mechanisms disclosed elsewhere in this patent application . further in step 23 g , excess length of tension element 2314 is removed . this removal can be done using a variety of methods including , but not limited to the methods disclosed elsewhere in this patent application such as cutting , delinking , melting , and breaking . thereafter , anchoring 2300 is withdrawn from the anatomy . it should be understood that these deployment steps may be repeated in the same , opposing or neighboring tissues to essentially tack up the encroaching tissue ( i . e . prostatic tissue , tumor , relaxed tissue , expanded tissue or growth ). it may be desired that over time both anchors become completely embedded within the tissue and covered to prevent encrustation , clotting or other tissue or body - fluid interaction — this may be facilitated by the processes , therapeutic agents and coatings described elsewhere in the application . although these anchors are shown on either side of the tissue , it may be possible to deploy either or both of them within the body of the tissue itself to help bury them and eliminate the possibility that they may interact with other parts of the body . it should further be noted that in the case of application to the prostate , that this technique may be used on any of the lateral or middle lobes to compress or hold the prostate gland pg away from the lumen of the urethra . if removal of the intra or para luminal anchor is required , it may be possible to resect that region completely , capturing the anchor embedded within the tissue and removing it en - bloc , severing the tether in the process . in the case of prostate applications , such removal may be accomplished with a standard resectoscope system . in other regions , and energized rf or sharp curette or blade may be used to resect the anchor minimally invasively . alternatively if engagement with the locking mechanism is still achievable , it may be possible to simply unlock the tether , releasing the anchor . lastly , if applying additional tension at some point after the procedure is required , it may be possible to engage and grasp the tether as it exits the locking device in the anchor and apply additional tension . fig2 a through 24 c ′ show various steps of a method of compressing an anatomical region using a device with deploying arms deployed through a trocar . in fig2 a , an anchoring 2400 is introduced in an anatomical region . anchoring 2400 comprising a distal anchor 2402 is introduced in the anatomy . distal anchor 2402 comprises a hollow shaft . distal end of distal anchor 2402 comprises one ore more outwardly curling or spreading arms 2404 . curling or spreading arms 2404 are made of an elastic , springy , super - elastic or shape memory material such that they tend to curl or spread in a radially outward direction in absence of an external force . anchoring 2400 further comprises a proximal anchor comprising a variety of designs including , but not limited to the designs disclosed elsewhere in this patent application . in this example , proximal anchor is designed similar to anchor 1040 in fig1 d . anchor 1040 can slide along proximal region of distal anchor 2402 . anchor 1040 can also be attached to distal anchor 2402 after a desired positioning between anchor 1040 and distal anchor 2402 is achieved . anchoring 2400 is delivered through a trocar 2406 . trocar 2406 comprises a sharp distal tip 2408 that can penetrate through tissue . the proximal region of distal tip 2408 comprises one ore more grooves or notches such that distal ends of curling or spreading arms 2404 can be temporarily held together by distal tip 2408 to allow for easy introduction into a target anatomy . anchoring 2400 is introduced into a target tissue to be compressed such that curling or spreading arms 2404 are distal to the target tissue and anchor 1040 is proximal to the target tissue . fig2 a ′ shows the distal end view of the anchoring 2400 . in fig2 b , trocar 2406 is pushed in the distal direction relative to proximal anchor 2402 . this releases the distal ends of curling or spreading arms 2404 causing them to curl or spread outwards . fig2 a ′ shows the distal end view of the anchoring 2400 with released curling or spreading arms 2404 . in fig2 c , anchor 1040 is pushed in the distal direction over distal anchor 2402 to compress tissue between anchor 1040 and distal anchor 2402 . thereafter , anchor 1040 is attached to the hollow shaft of distal anchor 2402 . thereafter trocar 2406 is withdrawn from the anatomy . in the above embodiment , the tethering function is performed by the shaft of the distal anchor , and the force is created by the curling arms . this tension may be pre - set into the arms through heat forming . it should be noted that any mechanism capable of expanding from within a tubular shape and capable of applying retrograde forces on the tissue are within the scope of this invention such as expandable flanges , balloons , cages , molly - bolt - like structures , stent - like structures and springs . fig2 d shows a crossection through the deployed anchoring 2400 of fig2 a . in one anchoring device embodiment , anchoring 2400 comprises a distal anchor such as the distal anchor described in fig1 a instead of distal anchor 2412 . fig2 a shows a perspective view of a spring clip that can be used to spread the anatomy . clip 2500 comprises two or more spreading arms 2502 . spreading arms 2502 may be curved or straight . distal ends of spreading arms 2502 may comprise a flattened region . the proximal ends or curved arms 2502 are connected to each other by a heel region 2504 . heel region 2504 may be made from the same material as curved arms 2502 . in an undeployed configuration , spreading arms 2502 are held close to each other . when clip 2500 is deployed , spreading arms 2502 tend to expand away from each other thus spreading the anatomical region or regions between spreading arms 2502 . clip 2500 can be made of suitable elastic , super - elastic or shape memory biocompatible materials including , but not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , etc . fig2 b through 25f show various steps of a method of spreading an anatomical region or regions using the spring clip of fig2 a . in fig2 b , a delivery tool 2506 comprising a clip 2500 is introduced in the anatomy and positioned near the target anatomy to be spread . delivery tool 2506 comprises an elongate hollow body 2508 comprising a lumen . distal end of body 2508 may comprise a blunt , atraumatic end . distal region of body 2508 comprises a slot 2510 that is in fluid communication with the lumen of body 2508 . delivery tool may further comprise an outer sheath 2512 and an imaging modality 2514 . imaging modality 2514 may be permanently attached to delivery tool 2506 or may be introduced into delivery tool 2506 by a user . in this example , imaging modality 2514 is a cystoscope . in fig2 c , clip 2500 is introduced into the anatomy by pushing clip 2500 out of slot 2510 such that the distal ends of spreading arms 2502 emerge first . slot 2510 is designed such that spreading arms 2504 are biased towards each other as they emerge out of slot 2510 . in fig2 d , clip 2500 is further advanced such that distal tips of spreading arms 2502 penetrate into the tissue to be spread . in fig2 e , clip 2500 is advanced further such that the biasing forces on spreading arms 2502 are removed . spreading arms 2502 tend to spread away from each other thus spreading the tissue between them . clip 2500 is detachably attached to delivery tool 2506 by a detaching mechanism 2516 including , but not limited to the several detaching mechanisms disclosed elsewhere in this patent application . in fig2 f , detaching mechanism 2516 is used to detach clip 2500 from delivery tool 2506 or deploy clip 2500 in the target anatomy . in this example , distal region of delivery tool 2506 is inserted transurethrally into the prostatic urethra . clip 2500 is then delivered into the anterior commissure to spread the two lateral lobes of the prostate gland pg apart . in one method embodiment , an opening in the commissure is made prior to the method of fig2 b through 25g . in another embodiment , the spreading force exerted by spreading arms 2502 cause cutting of the anterior commissure . clip 2500 may be placed completely sub - urethrally or a small amount of heel region 2504 remains in the urethra . the embodiments of anchoring devices wherein a sliding anchor is slid over a tension element may comprise one or more cinching elements . these cinching elements may be present on the sliding anchors , on the tension elements etc . a cinching element may be a separate device that cinches to a tension element . in doing so , it increases the effective diameter of that region of the tension element and prevents the tension element from sliding through a sliding anchor . cinching elements may allow only unidirectional motion of the sliding anchor over the tension element or may prevent any substantial motion of the sliding anchor over the tension element . typical examples of such cinching mechanisms include , but are not limited to mechanisms described in the fig2 series . for example , fig2 a and 26b show a crossectional view and a perspective view respectively of a mechanism of cinching a tension element or tether to an anchor . in fig2 a , cinching mechanism 2600 comprises an outer base 2602 . outer base 2602 comprises one or more grooves created by the presence of two or more leaflets 2604 . leaflets 2604 are biased along a first axial direction as shown in fig2 a . when a tension element 2606 is located in the one or more grooves , cinching mechanism 2600 allows motion of tension element 2606 only along the first axial direction and prevents substantial movement of tension element 2606 in the opposite direction . fig2 c and 26d show a partial section through a cinching mechanism comprising a cam element . in fig2 c , cinching mechanism 2610 comprises an outer body 2612 made of suitable biocompatible metals , polymers etc . body 2162 comprises a cam 2614 located on a pivot 2616 . cam 2614 may comprise a series of teeth to grip a tension element 2618 passing through body 2612 . in one embodiment , body 2162 comprises an opening 2620 located proximal to cam 2614 . proximal region of tension element 2618 passes out of body 2612 through opening 2620 . cinching mechanism 2610 allows movement of body 2162 over tension element 2618 in the proximal direction . in fig2 d , body 2162 is moved over tension element 2618 in the distal direction . motion of tension element 2618 over cam 2614 causes cam 2614 to turn in the anti - clockwise direction . this causes tension element 2618 to be pinched between cam 2614 and body 2612 . this in turn prevents further motion of body 2162 over tension element 2618 . fig2 e shows a sectional view of an embodiment of a cinching mechanism comprising a locking ball . cinching mechanism 2630 comprises an outer body 2632 comprising a lumen . a tension element 2634 passes through the lumen of outer body 2632 . the lumen of outer body gradually reduces in the proximal direction as shown in fig2 e . a locking ball 2636 is present in the lumen . motion of outer body 2632 over tension element 2634 in the distal direction pushes locking ball 2636 in the proximal region of outer body 2632 . a proximal end region 2638 of a small diameter prevents locking ball 2636 from falling out of outer body 2632 . the large lumen diameter in the proximal region of outer body 2632 allows free motion of locking ball 2636 . thus , presence of locking ball 2636 does not hinder the motion of outer body 2632 over tension element 2634 in the proximal direction . when outer body 2632 is moved over tension element 2634 in the proximal direction , locking ball 2636 is pushed in the distal region of outer body 2632 . the small lumen diameter in the proximal region of outer body 2632 constricts motion of locking ball 2636 . this causes a region of tension element 2634 to be pinched between anchoring ball 2636 and outer body 2632 . this in turn prevents further motion of outer body 2632 over tension element 2634 in the proximal direction . this mechanism thus allows unidirectional motion of outer body 2632 is over tension element . fig2 f shows a side view of an embodiment of a cinching mechanism comprising multiple locking flanges . in this embodiment , cinching mechanism 2644 comprises a body 2646 comprising a lumen lined by a first locking flange 2648 and a second locking flange 2650 . first locking flange 2648 and second locking flange 2650 are biased in the proximal direction as shown . a tension element 2652 passes through the lumen of body 2646 . first locking flange 2648 and second locking flange 2650 together allow the movement of body 2646 over tension element 2652 in the distal direction , but prevent movement of body 2646 over tension element 2652 in the proximal direction . similar cinching mechanisms may be designed comprising more than two locking flanges . fig2 g shows an end view of body 2646 comprising a lumen lined by first locking flange 2648 and second locking flange 2650 . body 2646 may be made of suitable biocompatible metals , polymers etc . fig2 h shows a side view of an embodiment of a cinching mechanism comprising a single locking flange . in this embodiment , cinching mechanism 2656 comprises a body 2658 comprising a lumen lined by a locking flange 2660 . locking flange 2660 is biased in the proximal direction as shown . a tension element 2662 passes through the lumen of body 2658 . locking flange 2660 allows the movement of body 2658 over tension element 2662 in the distal direction , but prevents movement of body 2658 over tension element 2662 in the proximal direction . fig2 i shows an end view of body 2658 comprising a lumen 2662 lined by locking flange 2660 . body 2658 may be made of suitable biocompatible metals , polymers etc . fig2 j shows an end view of a cinching mechanism comprising a crimping lumen . cinching mechanism 2670 comprises a body 2672 comprising a crimping lumen 2674 . crimping lumen 2674 is in the form of an arc with a gradually reducing size as shown in fig2 j . a tension element 2676 passes through crimping lumen 2674 . in fig2 j , tension element 2676 is locked in a region of crimping lumen 2674 of a diameter smaller than the diameter of tension element 2676 . tension element 2676 can be unlocked from crimping lumen 2674 by rotating body 2672 in the anti - clockwise direction . similarly , rotating body 2672 in the clockwise direction causes an unlocked tension element 2676 to be locked into crimping lumen 2674 . in an alternate embodiment , cinching mechanism comprises a disk shaped body comprising a central lumen . central lumen is large enough to allow a tension element to slide easily through the central lumen . one or more radially oriented slits emerge from the central lumen . the radially oriented slits have a diameter that is of the same size or is slightly smaller than the diameter of the tension element . to lock cinching mechanism to the tension element , the tension element is forced through one of the radially oriented slits . the friction between the disk shaped body and the tension element prevents or resists sliding of tension element through the disk shaped body . to unlock cinching mechanism from the tension element , the tension element is moved back to the central lumen . in another alternate embodiment , cinching mechanism comprises a disk shaped body comprising a small central lumen . the central region of the body comprises three or more triangular flaps biased together out of the plane of the body . the ends of the triangular flaps together form the central lumen that is of the same size or is slightly smaller than the diameter of the tension element . tension element can pass easily through the central lumen in the direction of the bias of the triangular flaps . but , tension element cannot pass or encounters substantial resistance when the tension element is pulled through the central lumen in the opposite direction . fig2 k and 26l show crossections of an embodiment of a cinching mechanism comprising a crimping anchor in the undeployed and deployed configurations respectively . cinching mechanism 2680 comprises a crimping anchor 2680 comprising a lumen . crimping anchor 2680 can be made of a variety of biocompatible materials including , but not limited to metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc ., polymers , etc . a tension element 2684 passes through the lumen of crimping anchor 2680 . the lumen of an undeployed crimping anchor 2680 is larger than the diameter of tension element 2684 . in fig2 l , crimping anchor 2680 is deployed by compressing the middle section of crimping anchor 2680 such that crimping anchor 2680 compresses tension element 2684 . friction between crimping anchor 2680 and tension element 2684 prevents relative motion between crimping anchor 2680 and tension element 2684 . crimping anchor 2680 may be a component of a sliding anchor or may be a stand - alone device used to prevent or restrict motion of a sliding anchor over a tension element . fig2 m shows a perspective view of an embodiment of a cinching mechanism comprising an element providing a tortuous path to a tension element . in this example , cinching mechanism 2686 comprises a spring 2688 . a tension element 2690 is passed through spring 2688 such that the path of tension element 2690 through spring 2688 is tortuous . when spring 2688 is moved over tension element , motion of tension element 2690 through the tortuous path generates high frictional forces that prevent or reduce motion of spring 2688 over tension element 2690 . the frictional forces are strong enough to resist motion of spring 2688 over tension element 2690 after deploying cinching mechanism 2686 in the anatomy . a user can move spring 2688 over tension element 2690 by applying a force that overcomes the resistive frictional forces that prevent movement of spring 2688 over tension element 2690 . similarly , other cinching mechanisms comprising a tortuous path can be used instead of spring 2688 . examples of such mechanisms are solid elements comprising tortuous lumens , elements comprising multiple struts or bars that provide a tortuous path etc . in another embodiment the cinching mechanism comprises a knot on one or more tensioning element . said knot can be advanced fully tightened or can be loose when advanced and tightened in situ . fig2 n shows a crossectional view of an embodiment of a locking mechanism comprising a space occupying anchor securely attached to a tension element . locking mechanism 2692 comprises a hollow element 2694 comprising a lumen . hollow element 2694 is a component of a sliding anchor that slides over tension element 2696 . tension element 2696 comprises a space occupying anchor 2698 comprising a tapering distal end 2699 . anchor 2698 is securely attached to tension element 2696 . diameter of anchor 2698 is larger than the diameter of the lumen of hollow element . due to this , anchor 2698 cannot pass through hollow element 2694 effectively locking the position of tension element 2696 with respect to the position of hollow element 2694 . fig2 o and 26p shows a partial sectional view and a perspective view of an embodiment of a cinching mechanism comprising a punched disk . cinching mechanism 2602 ′ comprises a disk 2604 ′ comprising a punched hole 2606 ′. punched hole 2606 ′ is made by punching disk 2604 ′ along the proximal direction such that the punching action leaves an edge that is biased along the proximal direction as shown in fig2 o . disk 2604 ′ can slide over a tension element 2608 ′ along the distal direction . however , motion of disk 2604 ′ over tension element 2608 ′ along the proximal direction is substantially resisted by the proximally biased edges of punched hole 2606 ′. excess lengths of tension elements or other severable regions of one or more devices disclosed in this patent application may be cut , severed or trimmed using one or more cutting devices . for example , fig2 q and 26r show a perspective view of a first embodiment of a cutting device before and after cutting an elongate element . in fig2 q , cutting device 2610 ′ comprises an outer sheath 2612 ′ comprising a sharp distal edge 2614 ′. outer sheath 2612 ′ encloses an inner sheath 2616 ′. inner diameter of outer sheath 2612 ′ is slightly larger than outer diameter of inner sheath 2616 ′ such that inner sheath 2616 ′ can slide easily through outer sheath 2612 ′. inner sheath 2616 ′ comprises a lumen that terminates distally in an opening 2618 ′. an elongate severable device passes through the lumen and emerges out of opening 2618 ′. an example of an elongate severable device is a tension element 2620 ′. in the method of cutting or trimming tension element 2620 ′ the desired area of tension element 2620 ′ to be cut or severed is positioned near opening 2618 ′ by advancing or withdrawing cutting device 2610 ′ over tension element 2620 ′. thereafter , outer sheath 2612 ′ is advanced over inner sheath 2616 ′ to cut tension element 2620 ′ between sharp distal edge 2614 ′ and an edge of opening 2618 ′. inner sheath 2616 ′ and outer sheath 2612 ′ may be substantially rigid or flexible . they may be made of suitable materials including , but not limited to pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel and fluoropolymers like ptfe , pfa , fep and eptfe etc . fig2 s show a crossectional view of a second embodiment of a cutting device for cutting an elongate element . cutting device 2622 ′ comprises an outer sheath 2624 ′ comprising a lumen that opens in an opening 2626 ′ in outer sheath 2624 ′. outer sheath 2624 ′ encloses an inner sheath 2628 ′ that comprises a lumen and a sharp distal edge 2630 ′. inner diameter of outer sheath 2624 ′ is slightly larger than outer diameter of inner sheath 2628 ′ such that inner sheath 2628 ′ can slide easily through outer sheath 2624 ′. an elongate severable device passes through the lumen of inner sheath 2628 ′ and emerges out of distal end of inner sheath 2628 ′ and out of outer sheath 2624 ′ through opening 2626 ′. an example of an elongate severable device is a tension element 2632 ′. in the method of cutting or trimming tension element 2632 ′ the desired area of tension element 2632 ′ to be cut or severed is positioned near opening 2626 ′ by advancing or withdrawing cutting device 2622 ′ over tension element 2632 ′. thereafter , inner sheath 2628 ′ is advanced through outer sheath 2624 ′ to cut tension element 2632 ′ between sharp distal edge 2630 ′ and an edge of opening 2626 ′. inner sheath 2628 ′ and outer sheath 2624 may be substantially rigid or flexible . they may be made of suitable materials including , but not limited to pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel and fluoropolymers like ptfe , pfa , fep and eptfe etc . in a third embodiment of a cutting device for cutting an elongate element , the cutting device comprises an outer hollow sheath . outer hollow sheath has a distal end plate comprising a window . an elongate severable device passes through the window . an example of an elongate severable device is a tension element . an inner shaft can slide and rotate within outer hollow sheath . distal end of inner shaft comprises a blade that is usually located away from the window and adjacent to the distal end plate of the outer hollow sheath . in the method of cutting or trimming tension element the elongate severable device , the desired area of the elongate severable device to be cut or severed is positioned near the window . this is done by advancing or withdrawing the cutting device over the elongate severable device . thereafter , the inner shaft is rotated within outer hollow sheath such that the blade cuts the elongate severable device between a sharp edge of the blade and an edge of the window . inner shaft and outer hollow sheath may be substantially rigid or flexible . they may be made of suitable materials including , but not limited to pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel and fluoropolymers like ptfe , pfa , fep and eptfe etc . the end plate and the blade are preferentially rigid . they may be made of suitable materials including , but not limited to metals like stainless steel , polymers like polycarbonate , polyimide , pvc , hytrel , hdpe , peek and fluoropolymers like ptfe , pfa , fep etc . the anchoring devices disclosed herein may be used in a variety of configurations depending on the location of the disease process , ease of procedure etc . fig2 a through 27d show axial sections through the prostate gland pg showing various configurations of anchoring devices comprising distal anchors 2700 and a tension element 2702 that is anchored at a suitable location such that a sufficient tension exists in tension element 2702 . fig2 and 28a show perspective views of an embodiment of an anchoring device comprising an elongate element comprising multiple barbs or anchors . fig2 shows a perspective view of anchoring device 2800 comprising an elongate element 2802 . elongate element 2802 can be made of several biocompatible materials including , but not limited to synthetic fibers e . g . various grades of nylon , polyethylene , polypropylene , polyester , aramid etc . ; metals e . g . various grades of stainless steel , titanium , nickel - titanium alloys , cobalt - chromium alloys , tantalum etc . ; natural fibers e . g . cotton , silk etc . ; rubber materials e . g . various grades of silicone rubber etc . elongate element 2802 may comprise natural or artificial suture materials . examples of such materials include but are not limited to polyamide ( nylon ), polypropylene , polyglycolic acid ( pga ), polylactic acid ( pla ) and copolymers of polylactic acid , polyglycolic acid and copolymers of polyglycolic acid , copolymers of pla and pga , silk , polyester , silicone , collagen , polymers of glycolide and lactide . a particular example of a suture is the nordstrom suture which is a highly elastic silicone suture . in one embodiment , the suture material is bioabsorbable . elongate element 2802 comprises two sets of projections such as barbs , anchors or hooks . in the example shown , elongate element 2802 comprises a set of distal barbs 2804 and a set of proximal barbs 2806 . distal barbs 2804 are oriented in the proximal direction and proximal barbs 2806 are oriented in the distal direction as shown in fig2 . fig2 a shows a magnified view of the region 28 a of anchoring device 2800 showing proximal barbs 2806 . fig2 b through 28e show a coronal section through the prostate gland pg showing various steps of a method of treating the prostate gland pg using the device of fig2 . in fig2 b , introducer device 300 of fig3 a comprising a working device lumen and a cystoscope lumen 308 is introduced into the urethra such that the distal end of introducer device 300 is located in the prostatic urethra . thereafter , a hollow puncturing device 2808 is inserted in the working device lumen of introducer device . puncturing device 2808 is advanced such that distal end of puncturing device 2808 penetrates the prostate gland pg . in fig2 c , anchoring device 2800 is introduced through puncturing device 2808 into the prostate gland pg . thereafter , puncturing device 2808 is pulled in the proximal direction . simultaneously , anchoring device 2800 is pulled in the proximal direction to anchor distal barbs 2804 in the anatomy . in fig2 d , puncturing device 2808 is pulled further in the proximal direction to expose the entire anchoring device 2800 . thereafter , in step 28 e , the proximal end of anchoring device 2800 is detached to deploy anchoring device 2800 in the anatomy . thus , tissue between distal barbs 2804 and proximal barbs 2806 is anchored to anchoring device 2800 . fig2 a shows an axial section of the prostate gland pg showing a pair of implanted magnetic anchors . in fig2 a , a first magnetic anchor 2900 and a second magnetic anchor 2902 are implanted in the prostate gland pg on either side of the urethra . like poles of first magnetic anchor 2900 and second magnetic anchor 2902 face each other such that there is magnetic repulsion between first magnetic anchor 2900 and second magnetic anchor 2902 . this causes the urethral lumen to widen potentially reducing the severity of bph symptoms . fig2 b through 29d show a coronal section through the prostate gland pg showing the steps of a method of implanting magnetic anchors of fig2 a . in fig2 b , a deployment device 2904 is advanced trans - urethrally . deployment device 2904 comprises a sharp distal tip 2906 and first magnetic anchor 2900 . distal tip 2906 of deployment device 2904 penetrates prostatic tissue and implants fist magnetic anchor 2900 in the prostate gland pg . similarly , another deployment device 2908 comprising a sharp distal tip 2920 is used to implant second magnetic anchor 2902 in the prostate gland pg . first magnetic anchor 2900 and second magnetic anchor 2902 are implanted on opposite sides of the urethra such that like poles of first magnetic anchor 2900 and second magnetic anchor 2902 face each other . this causes magnetic repulsion between first magnetic anchor 2900 and second magnetic anchor 2902 . this causes the urethral lumen to widen potentially reducing the severity of bph symptoms . in one embodiment , deployment device 2904 can be used to deploy multiple magnetic anchors . fig3 a shows a coronal section of a region of the male urinary system showing the general working environment of a method of treating prostate disorders by cutting prostrate tissue using a device inserted into the prostate gland pg from the urethra . cutting device 3000 comprises an outer body 3002 comprising a side port 3004 . outer body 3002 can be made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers e . g . etc . cutting device 3000 further comprises an access device 3006 that can be deployed out of side port 3004 . access device 3006 can be retracted back into side port 3004 . typical examples of elements that can be used as access device 3006 are needles , trocars etc . access device 3006 may be made from suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers e . g . etc . access device 3006 penetrates the walls of the urethra and enters the prostate gland pg by creating an access channel in the prostate gland pg . cutting device 3000 further comprises a cutting element 3008 that is introduced into the prostate gland pg through the access channel in the prostate gland pg . in one embodiment , cutting element 3008 enters the prostate gland pg through access 3006 . cutting element 3008 comprises one or more cutting modalities such as electrosurgical cutter , laser cutter , mechanical cutter e . g . a knife edge etc . cutting element 3008 may be moved through prostate tissue by several mechanisms including one or more deflecting or bending elements located on cutting element 3008 ; one or more articulating elements located on cutting element 3008 ; motion of cutting device 3000 along the urethra etc . cutting element 3008 is used to cut one or more regions of the prostate gland pg including peripheral zone , transition zone , central zone or prostatic capsule . after the desired region or regions of the prostate gland pg are cut , cutting element 3008 and access device 3006 are withdrawn into cutting device 3000 . thereafter , cutting device 3000 is withdrawn from the urethra . in one device embodiment , cutting device 3000 comprises an endoscope or means for inserting an endoscope . fig3 b shows a coronal section of a region of the male urinary system showing the general working environment of a method of treating prostate disorders by cutting prostrate tissue using a device that accesses outer surface of the prostate gland pg by passing through the walls of the urethra distal to the prostate gland pg . cutting device 3020 comprises an outer body 3022 comprising a side port 3024 . outer body 3022 can be made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers e . g . etc . cutting device 3020 is advanced into the urethra such that side port 3024 is located distal to the prostate gland pg . cutting device 3020 further comprises an access device 3026 that can be deployed out of side port 3024 . access device 3026 can be retracted back into side port 3024 . typical examples of elements that can be used as access device 3026 are needles , trocars etc . access device 3026 may be made from suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers e . g . etc . access device 3026 is deployed from side port 3024 in a desired orientation such that access device 3026 penetrates the wall of the urethra . access device 3026 is advanced further such that distal end of access device 3026 is located near the prostate gland pg . thereafter , a cutting element 3028 is introduced through access device 3026 to the outer surface of the prostate gland pg . cutting element 3028 comprises one or more cutting modalities such as electrosurgical cutter , laser cutter , mechanical cutter e . g . a knife edge etc . cutting element 3028 is used to cut one or more regions of the prostate gland pg including prostatic capsule , peripheral zone , transition zone or central zone . cutting element 3028 may be moved relative to prostate tissue by several mechanisms including one or more deflecting or bending elements located on cutting element 3028 ; motion of cutting element 3028 along access device 3026 etc . in one method embodiment , cutting element 3028 cuts prostatic capsule while being withdrawn into access device 3026 . after the desired region or regions of the prostate gland pg are cut , cutting element 3028 and access device 3026 are withdrawn into cutting device 3020 . thereafter , cutting device 3020 is withdrawn from the urethra . in one device embodiment , cutting device 3020 further comprises an endoscope or means for inserting an endoscope . fig3 c shows a coronal section of a region of the male urinary system showing the general working environment of a method of treating prostate disorders by cutting prostrate tissue using a device that accesses outer surface of the prostate gland pg by passing through the wall of the urinary bladder . cutting device 3040 comprises an outer body 3042 comprising a side port 3044 . outer body 3042 can be made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers e . g . etc . cutting device 3040 is advanced into the urethra such that side port 3044 is located inside the urinary bladder . cutting device 3040 further comprises an access device 3046 that can be deployed out of side port 3044 . access device 3046 can be retracted back into side port 3044 . typical examples of elements that can be used as access device 3046 are needles , trocars etc . access device 3046 may be made from suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers e . g . etc . access device 3046 is deployed from side port 3044 in a desired orientation such that access device 3046 penetrates the wall of the urinary bladder . access device 3046 is advanced further such that distal end of access device 3046 is located near the prostate gland pg . thereafter , a cutting element 3048 is introduced through access device 3046 to the outer surface of the prostate gland pg . cutting element 3048 comprises one or more cutting modalities such as electrosurgical cutter , laser cutter , mechanical cutter e . g . a knife edge etc . cutting element 3048 is used to cut one or more regions of the prostate gland pg including prostatic capsule , peripheral zone , transition zone or central zone . cutting element 3048 may be moved relative to prostate tissue by several mechanisms including one or more deflecting or bending elements located on cutting element 3048 ; motion of cutting element 3048 along access device 3046 etc . in one method embodiment , cutting element 3048 cuts prostatic capsule while being withdrawn into access device 3046 . after the desired region or regions of the prostate gland pg are cut , cutting element 3048 and access device 3046 are withdrawn into cutting device 3040 . thereafter , cutting device 3040 is withdrawn from the urethra . in one device embodiment , cutting device 3040 further comprises an endoscope or means for inserting an endoscope . fig3 d shows a coronal section of a region of the male urinary system showing the general working environment of a method of treating prostate disorders by cutting prostrate tissue using a device that accesses outer surface of the prostate gland pg by passing through the walls of the urethra enclosed to the prostate gland pg . cutting device 3060 comprises an outer body 3062 comprising a side port 3064 . outer body 3062 can be made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers e . g . etc . cutting device 3060 is advanced into the urethra such that side port 3064 is located in the region of the urethra enclosed by the prostate gland pg . cutting device 3060 further comprises an access device 3066 that can be deployed out of side port 3064 . access device 3066 can be retracted back into side port 3064 . typical examples of elements that can be used as access 3066 are needles , trocars etc . access device 3066 may be made from suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers e . g . etc . access device 3066 is deployed from side port 3064 in a desired orientation such that access device 3066 penetrates the prostate . thereafter , a cutting element 3068 is introduced through access device 3066 such that the distal region of cutting element can access the outer surface of the prostate gland pg . cutting element 3068 comprises one or more cutting modalities such as electrosurgical cutter , laser cutter , mechanical cutter e . g . a knife edge etc . cutting element 3068 is used to cut one or more regions of the prostate gland pg including prostatic capsule , peripheral zone , transition zone or central zone . cutting element 3068 may be moved relative to prostate tissue by several mechanisms including one or more deflecting or bending elements located on cutting element 3068 ; motion of cutting element 3068 along access device 3066 etc . in one method embodiment , cutting element 3068 cuts prostatic capsule while being withdrawn into access device 3066 . after the desired region or regions of the prostate gland pg are cut , cutting element 3068 and access device 3066 are withdrawn into cutting device 3060 . thereafter , cutting device 3060 is withdrawn from the urethra . in one device embodiment , cutting device 3060 further comprises an endoscope or means for inserting an endoscope . fig3 shows a coronal section of a region of the male urinary system showing the general working environment of a method of treating prostate disorders by cutting prostrate tissue by a percutaneous device that accesses the prostate gland pg through an incision in the abdomen . in this method , a cannula 3100 is introduced percutaneously into the lower abdomen . cannula 3100 can be made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers etc . cannula 3100 is advanced into the abdomen such that it passes below the pubic bone . the distal end of cannula 3100 is positioned near the prostate gland pg . thereafter , a cutting device 3102 is advanced through distal end of cannula 3100 to the outer surface of the prostate gland pg . cutting device 3102 can be retracted back into cannula 3100 . cutting device 3102 comprises one or more cutting modalities such as electrosurgical cutter , laser cutter , mechanical cutter e . g . a knife edge etc . cutting device 3102 is used to cut one or more regions of the prostate gland pg including prostatic capsule , peripheral zone , transition zone or central zone . cutting device 3102 may be moved relative to prostate tissue by several mechanisms including one or more deflecting or bending elements located on cutting device 3102 ; motion of cutting device 3102 along cannula 3100 etc . in one method embodiment , cutting device 3102 cuts prostatic capsule while being withdrawn into cannula 3100 . after the desired region or regions of the prostate gland pg are cut , cutting device 3102 is withdrawn into cannula 3100 . thereafter , cannula 3100 is withdrawn from the urethra . in one device embodiment , cannula 3100 further comprises an endoscope or means for inserting an endoscope . fig3 shows a coronal section of a region of the male urinary system showing the general working environment of a method of treating prostate disorders by cutting prostrate tissue by a percutaneous device that penetrates the urinary bladder and accesses the outer surface of the prostate gland pg through an incision in the urinary bladder . in this method , a cannula 3200 is introduced percutaneously into the lower abdomen . cannula 3200 can be made of suitable biocompatible materials including , but not limited to metals e . g . stainless steel , nickel - titanium alloys , titanium etc . ; polymers etc . cannula 3200 is advanced into the abdomen such that it passes above the pubic bone . the distal end of cannula 3200 enters the urinary bladder . thereafter , an access device 3202 is advanced through cannula 3200 such that access device 3202 penetrates the urinary bladder wall as shown in fig4 . thereafter , a cutting 3204 is advanced through distal end of access device 3202 to the outer surface of the prostate gland pg . cutting device 3202 can be retracted back into access device 3202 . cutting device 3202 comprises one or more cutting modalities such as electrosurgical cutter , laser cutter , mechanical cutter e . g . a knife edge etc . cutting device 3202 is used to cut one or more regions of the prostate gland pg including prostatic capsule , peripheral zone , transition zone or central zone . cutting device 3202 may be moved relative to prostate tissue by several mechanisms including one or more deflecting or bending elements located on cutting device 3202 or access device 3202 ; motion of cutting device 3202 along access device 3202 etc . in one method embodiment , cutting device 3202 cuts prostatic capsule while being withdrawn into access device 3202 . after the desired region or regions of the prostate gland pg are cut , cutting device 3202 is withdrawn into access device 3202 . access device 3202 is then withdrawn into cannula 3200 . thereafter , cannula 3200 is withdrawn from the urinary bladder . in one device embodiment , cannula 3200 further comprises an endoscope or means for inserting an endoscope . fig3 series shows a perspective view of a prostate treatment kit to cut prostate tissue . fig3 a shows a perspective view of an introducer device . introducer 3300 comprises a first tubular element 3302 enclosing a working device lumen 3304 . first tubular element 3302 can be made of suitable biocompatible materials such as pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel and fluoropolymers like ptfe , pfa , fep and eptfe etc . the proximal end of working device lumen 3304 comprises a first stasis valve 3306 . the distal end of working device lumen 3304 comprises a deflection mechanism . the deflection mechanism is used to bend the distal region of working device lumen 3304 . one example of deflection mechanism is a pull wire and a deflection dial 3310 to adjust the magnitude and / or the direction of deflection caused by the pull wire . similarly , other deflection mechanisms can be used in the introducer device instead of a pull wire . introducer 3300 further comprises a second tubular element 3312 which encloses a cystoscope lumen 3314 . a cystoscope can be introduced through cystoscope lumen 3314 into the urethra . typical examples of cystoscopes that can be used with introducer device are those manufactured by olympus , pentax , storz , wolf , circon - acmi , etc . these may have pre - set angles ( i . e . 0 , 30 , 70 , 120 degrees ) or may be flexible scopes where in the tip may be deflectable . the proximal end of cystoscope lumen 3314 comprises a second stasis valve 3316 . the cystoscope is inserted through the proximal end of cystoscope lumen 3314 and emerges out into the urethra from the distal end of cystoscope lumen 3314 . the cystoscope can then be used to visualize the anatomy and various instruments during a procedure . working device lumen 3314 may comprise one or more side ports e . g . a first side port 3318 for the introduction or removal of one or more fluids . cystoscope lumen 3314 may comprise one or more side ports e . g . a second side port 3320 for the introduction or removal of one or more fluids . fig3 b shows a perspective view of an injecting needle . injecting needle 3330 is used for injecting one or more diagnostic or therapeutic agents in the anatomy . in one method embodiment , injecting needle 3330 is used to inject local anesthetic in the urethra and / or prostate gland pg . specific examples of target areas for injecting local anesthetics are the neurovascular bundles , the genitourinary diaphragm , the region between the rectal wall and prostate , etc . examples of local anesthetics that can be injected by injecting needle 3330 are anesthetic solutions e . g . 1 % lidocaine solution ; anesthetic gels e . g . lidocaine gels ; combination of anesthetic agents e . g . combination of lidocaine and bupivacaine ; etc . injecting needle 3330 comprises a hollow shaft 3332 made of suitable biocompatible materials including , but not limited to stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . the length of hollow shaft 3332 can range from to centimeters . the distal end of hollow shaft 3332 comprises a sharp tip 3334 . the proximal end of hollow shaft 3332 has a needle hub 3336 made of suitable biocompatible materials including , but not limited to metals e . g . like stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . ; polymers e . g . polypropylene etc . in one embodiment , needle hub 3336 comprises a luer lock . fig3 c shows a perspective view of a guiding device . guiding 3338 comprises an elongate body 3340 comprising a sharp distal tip 3342 . in one embodiment , guiding device 3338 is a guidewire . distal end of elongate body 3340 may comprise an anchoring element to reversibly anchor guiding device 3338 into tissue . examples of suitable anchoring elements are barbs , multipronged arrowheads , balloons , other mechanically actuable members ( e . g . bendable struts ), screw tips , shape memory elements , or other suitable anchor designs disclosed elsewhere in this patent application . fig3 d shows a perspective view of a rf cutting device . cutting device 3343 comprises an inner sheath 3344 and an outer sheath 3346 . inner sheath 3344 comprises a lumen of a suitable dimension such that cutting device 3343 can be advanced over guiding device 538 . outer sheath 3346 can slide on inner sheath 3344 . outer sheath 3346 also comprises two marker bands : a proximal marker band 3348 and a distal marker band 3350 . the marker bands can be seen by a cystoscope . in one embodiment , proximal marker band 3348 and distal marker band 3350 are radiopaque . the position of proximal marker band 3348 and distal marker band 3350 is such that after cutting device 3343 is placed in an optimum location in the anatomy , proximal marker band 3348 is located in the urethra where it can be seen by a cystoscope and distal marker band 3350 is located in the prostrate gland pg or in the wall of the urethra where it cannot be seen by the cystoscope . cutting device 3343 further comprises a cutting wire 3352 that is capable of delivering electrical energy to the surrounding tissue . the distal end of cutting wire 3352 is fixed to the distal region of outer sheath 3344 . the proximal end of cutting wire 3352 is connected to a distal region of outer sheath 3346 and is further connected to a source of electrical energy . in fig3 d , cutting wire 3352 is in an undeployed configuration . fig3 d ′ shows the distal region of cutting device 3343 when cutting wire 3352 is in a deployed configuration . to deploy cutting wire 3352 , inner sheath 3344 is moved in the proximal direction with respect to outer sheath 546 . this causes cutting wire 3352 to bend axially outward thus deploying cutting wire 3352 in the surrounding anatomy . fig3 e shows a perspective view of an embodiment of a plugging device to plug an opening created during a procedure . plugging 3354 comprises a tubular shaft 3356 comprising a distal opening 3358 . distal opening 3358 is used to deliver one or more plugging materials 3360 in the adjacent anatomy . plugging material 3360 may comprise a porous or non - porous matrix formed of a biodegradable or non - biodegradable material such as a flexible or rigid polymer foam , cotton wadding , gauze , hydrogels , etc . examples of biodegradable polymers that may be foamed or otherwise rendered porous include but are not restricted to polyglycolide , poly - l - lactide , poly - d - lactide , poly ( amino acids ), polydioxanone , polycaprolactone , polygluconate , polylactic acid - polyethylene oxide copolymers , modified cellulose , collagen , polyorthoesters , polyhydroxybutyrate , polyanhydride , polyphosphoester , poly ( alpha - hydroxy acid ) and combinations thereof . in one embodiment , plugging material 3360 comprises biocompatible sealants including but not limited to fibrin sealants , combination of natural proteins ( e . g . collagen , albumin etc .) with aldehyde cross - linking agents ( e . g . glutaraldehyde , formaldehyde ) or other polymeric , biological or non - polymeric materials capable of being implanted with the body , etc . plugging 3354 may be introduced in the anatomy by various approaches including the approaches disclosed elsewhere in this patent application . plugging device 3354 may be introduced in the anatomy through a cannula , over a guiding device such as a guidewire etc . in the embodiment shown in fig3 e , plugging material 3360 is preloaded in plugging device 3354 . plugging material 3360 is introduced through distal opening 3358 by pushing plunger 3362 in the distal direction . in another embodiment , plugging device 3354 comprises a lumen that extends from the proximal end to distal opening 3358 . plugging material 3360 may be injected through the proximal end of the lumen such that it emerges out through distal opening 3358 . fig3 f through 33n show various alternate embodiments of the electrosurgical cutting device in fig3 d . fig3 f and 33g show perspective views of the distal region of a first alternate embodiment of an electrosurgical cutting device in the undeployed and deployed states respectively . fig3 f show an electrosurgical cutting device 570 comprising an elongate shaft 3372 . shaft 3372 is made of an electrically insulating material . electrosurgical cutting device 3370 further comprises an electrosurgical cutting wire 3374 . electrosurgical cutting wire 3374 can be made of a variety of materials including , but not limited to tungsten , stainless steel , etc . distal end of cutting wire 3374 is attached to distal region of shaft 3372 . the proximal region of cutting wire 3374 can be pulled in the proximal direction by an operator . in one embodiment , electrosurgical cutting device 3370 is introduced in the target anatomy through a sheath 3376 . in fig3 f , electrosurgical cutting device 3370 is deployed by pulling cutting wire 3374 in the proximal direction . this causes distal region of shaft 3372 to bend . thereafter , electrical energy is delivered through cutting wire 3374 to cut tissue . this may be accompanied by motion of electrosurgical cutting device 3370 along the proximal or distal direction . fig3 h and 33i show perspective views of the distal region of a second alternate embodiment of an electrosurgical cutting device in the undeployed and deployed states respectively . electrosurgical cutting device 3380 comprises an elongate sheath 3382 comprising a lumen . distal region of sheath 3382 has a window 3384 . electrosurgical cutting device 3380 further comprises an electrosurgical cutting wire 3386 located in the lumen . distal end of cutting wire 3386 is fixed to the distal end of sheath 3384 . proximal end of cutting wire 3386 can be pushed in the distal direction by a user . in fig3 i , cutting wire 3386 is deployed by pushing cutting wire 3386 in the distal direction . this causes a region of cutting wire 3386 to bend in the radially outward direction and thus emerge out of window 3384 . thereafter , electrical energy is delivered through cutting wire 3386 to cut tissue . this may be accompanied by motion of electrosurgical cutting device 3380 along the proximal or distal direction . fig3 j through 33l show perspective views of the distal region of a second alternate embodiment of an electrosurgical cutting device showing the steps of deploying the electrosurgical cutting device . electrosurgical cutting device 3390 comprises an elongate sheath 3391 comprising a lumen 3392 . in fig3 j , an electrosurgical cutting wire 3394 is introduced through lumen 3392 such that it emerges out through the distal opening of lumen 3392 . in fig3 k , cutting wire 3394 is further advanced in the distal direction . distal end of cutting wire 3394 has a curved region so that cutting wire 3394 starts to bend as it emerges out of lumen 3392 . in fig3 l , cutting wire 3394 is further advanced in the distal direction to fully deploy cutting wire 3394 . thereafter , electrical energy is delivered through cutting wire 3394 to cut tissue . this may be accompanied by motion of electrosurgical cutting device 3390 along the proximal or distal direction . fig3 m through 33n show perspective views of the distal region of a third alternate embodiment of an electrosurgical cutting device showing the steps of deploying the electrosurgical cutting device . electrosurgical cutting device 3395 comprises an elongate sheath 3396 comprising a lumen . cutting device 3395 further comprises a cutting wire 3398 located in the lumen of elongate sheath 3396 . the proximal end of cutting wire 3398 is connected to a source of electrical energy . distal end of cutting wire 3398 is connected to the inner surface of the distal region of elongate sheath 3396 . cutting wire 3398 may be made from suitable elastic , super - elastic or shape memory materials including but not limited to nitinol , titanium , stainless steel etc . in fig3 n , electrosurgical cutting device 3395 is deployed by pushing the proximal region of cutting wire 3398 in the distal direction . this causes a distal region of cutting wire 3398 to emerge from the distal end of elongate sheath 3396 as a loop . thereafter , electrical energy is delivered through cutting wire 3398 to cut tissue . this may be accompanied by motion of electrosurgical cutting device 3395 along the proximal or distal direction . electrosurgical cutting device 3395 can be used to cut multiple planes of tissue by withdrawing cutting wire 3398 in elongate sheath 3396 , rotating elongate sheath 3396 to a new orientation , redeploying cutting wire 3398 and delivering electrical energy through cutting wire 3398 . the devices 33 h through 33 n may be introduced by one or more access devices such as guidewires , sheaths etc . fig3 shows a perspective view of the distal region of a balloon catheter comprising a balloon with cutting blades . balloon catheter 3400 can be introduced into a lumen or in the tissue of an organ to be treated using one or more of the introducing methods disclosed elsewhere in this patent application . balloon catheter 3400 comprises a shaft 3402 . shaft 3402 may comprise a lumen to allow balloon catheter 3400 to be introduced over a guidewire . in one embodiment , shaft 3402 is torquable . shaft 3402 comprises a balloon 3404 located on the distal end of shaft 3402 . balloon 3404 can be fabricated from materials including , but not limited to polyethylene terephthalate , nylon , polyurethane , polyvinyl chloride , crosslinked polyethylene , polyolefins , hptfe , hpe , hdpe , ldpe , eptfe , block copolymers , latex and silicone . balloon 3404 further comprises one or more cutter blades 3406 . balloon catheter 3400 is advanced with balloon 3404 deflated , into a natural or surgically created passageway and positioned adjacent to tissue or matter that is to be cut , dilated , or expanded . thereafter , balloon 3404 is inflated to cause cutter blades 3406 to make one or more cuts in the adjacent tissue or matter . thereafter balloon 3404 is deflated and balloon catheter 3400 is removed . cutter blades 3406 may be energized with mono or bi - polar rf energy . balloon catheter 3400 may comprise one or more navigation markers including , but not limited to radio - opaque markers , ultrasound markers , light source that can be detected visually etc . fig3 shows a perspective view of the distal region of a balloon catheter comprising a balloon with cutting wires . balloon catheter 3500 can be introduced into a lumen or in the tissue of an organ to be treated using one or more of the introducing methods disclosed elsewhere in this patent application . balloon catheter 3500 comprises a shaft 3502 . shaft 3502 may comprise a lumen to allow balloon catheter 3500 to be introduced over a guidewire . in one embodiment , shaft 3502 is torquable . shaft 3502 comprises a balloon 3504 located on the distal end of shaft 3502 . balloon 3504 can be fabricated from materials including , but not limited to polyethylene terephthalate , nylon , polyurethane , polyvinyl chloride , crosslinked polyethylene , polyolefins , hptfe , hpe , hdpe , ldpe , eptfe , block copolymers , latex and silicone . balloon 3504 further comprises one or more radiofrequency wires 3506 . balloon catheter 3500 is advanced with balloon 3504 deflated , into a natural or surgically created passageway and positioned adjacent to tissue or matter that is to be cut , dilated , or expanded . thereafter , balloon 3504 is inflated and an electrical current is delivered through radiofrequency wires 3506 to make one or more cuts in the adjacent tissue or matter . thereafter the electrical current is stopped , balloon 3504 is deflated and balloon catheter 3500 is removed . radiofrequency wires 3504 may be energized with mono or bi - polar rf energy . balloon catheter 3500 may comprise one or more navigation markers including , but not limited to radio - opaque markers , ultrasound markers , light source that can be detected visually etc . fig3 a and 36b series show perspective views of an undeployed state and a deployed state respectively of a tissue displacement device . fig3 a shows a tissue anchoring device 3600 in the undeployed state . anchoring device 3600 comprises an elongate body having a proximal end 3602 and a distal end 3604 . anchoring device 3600 may be made of a variety of elastic or super - elastic materials including , but not limited to nitinol , stainless steel , titanium etc . anchoring device 3600 is substantially straight in the undeployed state and has a tendency to become substantially curved in the deployed state . anchoring device 3600 is maintained in the undeployed state by a variety of means including , but not limited to enclosing anchoring device 3600 in a cannula or sheath , etc . fig3 b shows tissue anchoring device 3600 in the deployed state . anchoring device 3600 comprises a curved region . when anchoring device 3600 changes from an undeployed state to a deployed state , the anatomical tissue adjacent to the central region of anchoring device 3600 is displaced along the direction of motion of the central region . anchoring device 3600 can be deployed by a variety of methods including , but not limited to removing anchoring device 3600 from a sheath or cannula , etc . in one embodiment , anchoring device 3600 is made from a shape memory material such as nitinol . in this embodiment , anchoring device 3600 is maintained in the undeployed state by maintaining anchor device 3600 in a temperature lower than the transition temperature of the super - elastic material . anchoring device 3600 is converted to the deployed state by implanting anchoring device 3600 in a patient such that the device is warmed to the body temperature which is above the transition temperature of the super - elastic material . fig3 c and 36d show a coronal view and a lateral view respectively of a pair of deployed tissue displacement devices of fig3 a and 36b implanted in the prostate gland pg . in fig3 c , two anchoring devices are implanted in the prostate gland pg near the prostatic urethra in a patient with bph . a first anchoring device 3600 is introduced on a first side of the urethra and is deployed there as shown . similarly , a second anchoring device 3606 comprising a proximal end 3608 and a distal end 3610 is introduced on the other side of the urethra and is deployed there as shown . first anchoring device 3600 and second anchoring device 3606 change into the deployed curved configuration . this causes prostate gland pg tissue near the central regions of first anchoring device 3600 and second anchoring device 3606 to be displaced radially away from the urethra . this displacement of prostate gland pg tissue can be used to eliminate or reduce the compression of the urethra by an enlarged prostate gland pg . fig3 d shows a lateral view of the urethra enclosed by the prostate gland pg showing deployed first anchoring device 3600 and second anchoring device 3606 . the various cuts or punctures made by one ore more cutting devices disclosed in this patent application may be plugged or lined by a plugging or space filling substance . fig3 e through 36h show an axial section through a prostate gland showing the various steps of a method of cutting or puncturing the prostate gland and lining or plugging the cut or puncture . fig3 e shows a section of the prostate gland showing the urethra , the lateral lobes and the middle lobe surrounded by the prostatic pseudocapsule . in fig3 f , one or more cuts are made in a region of the prostatic pseudocapsule . in addition , one or more cuts may be made in a region of between two lobes of the prostate gland . in fig3 g , a plugging material 3619 is introduced in the one or more regions of the prostate gland that are cut or punctured . plugging material 3619 may be delivered through one or more delivery devices including , but not limited to the device disclosed in fig3 e . plugging material 3619 may comprises a material such as plugging material 3360 . the various cuts or punctures made by one ore more cutting devices disclosed in this patent application may be spread open by a clipping device . for example , fig3 h shows an axial section through a prostate gland showing a clip for spreading open a cut or punctured region of the prostate gland . spreading device 3620 comprises a body having a central region and two distal arms . spreading device 3620 may be made of a variety of elastic or super - elastic materials including , but not limited to nitinol , stainless steel , titanium etc . spreading device 3620 has a reduced profile in the undeployed state by maintaining distal arms close to each other . spreading device 5000 is maintained in the undeployed state by a variety of means including , but not limited to enclosing spreading device 3620 in a cannula or sheath , etc . when spreading device 3620 changes from an undeployed state to a deployed state , the distance between the two distal arms increases . this causes any anatomical tissue between two distal arms to spread along the straight line between two distal arms spreading device 3620 can be deployed by a variety of methods including , but not limited to removing spreading device 3620 from a sheath or cannula , etc . in one embodiment , spreading device 3620 is made from a shape memory material such as nitinol . in this embodiment , spreading device 3620 is maintained in the undeployed state by maintaining anchor device 3620 in a temperature lower than the transition temperature of the super - elastic material . spreading device 3620 is converted to the deployed state by implanting spreading device 3620 in a patient such that the device is warmed to the body temperature which is above the transition temperature of the super - elastic material . stretching of prostate gland tissue can be used to eliminate or reduce the compression of the urethra by an enlarged prostate gland or to prevent cut edges of a cut from rejoining . more than one spreading device 3620 may be used to treat the effects of an enlarged prostate or to eliminate or reduce the compression of the urethra by an enlarged prostate gland or to prevent cut edges of a cut from rejoining . fig3 a through 37k show an embodiment of a method of treating prostate gland disorders by cutting a region of the prostate gland using the devices described in fig3 a through 33e . in fig3 a , introducer device 3300 is introduced in the urethra . it is advanced through the urethra such that the distal tip of introducer device 3300 is located in the prostatic urethra . thereafter , injecting needle 3330 is introduced through introducer device 3300 . the distal tip of injecting needle 3330 is advanced such that injecting needle 3330 penetrates the prostate gland . injecting needle 3330 is then used to inject a substance such as an anesthetic in the prostate gland . thereafter , in fig3 b , injecting needle 3330 is withdrawn from the anatomy . the distal region of introducer 3300 is positioned near a region of the prostate gland to be punctured . thereafter , in fig3 c , first tubular element 3302 is bent or deflected with a bending or deflecting mechanism such as the bending mechanism in fig3 c ″ and 37 c ′″ to align the distal region of first tubular element 3302 along a desired trajectory of puncturing the prostate gland . fig3 c ′ shows the proximal region of introducer 3300 . a cystoscope 3700 is introduced through second stasis valve 3316 such that the distal end of cystoscope 3700 emerges through the distal end of introducer device 3300 . cystoscope 3700 is then used to visualize the anatomy to facilitate the method of treating prostate gland disorders . fig3 c ″ shows a perspective view of the distal region of an embodiment of introducer device 3300 comprising a bending or deflecting mechanism . in this embodiment , first tubular element 3302 comprises a spiral cut distal end and a pull wire . in fig3 c ′″, the pull wire is pulled by deflection dial 3310 . this deflects the distal tip of first tubular element 3302 as shown . after the step in fig3 c , guiding device 3338 is introduced through first tubular element 3302 . guiding device 3338 is advanced through first tubular element 3302 such that the distal tip of guiding device 3338 penetrates into the prostate gland . in one method embodiment , guiding device 3338 is further advanced such that the distal tip of guiding device 3338 penetrates through the prostate gland and enters the urinary bladder . in one embodiment , distal region of guiding device 3338 comprises an anchoring element 3702 . anchoring element 3702 is deployed as shown in fig3 e . thereafter , guiding device 3338 is pulled in the proximal direction till anchoring element 3702 is snug against the wall of the urinary bladder . cystoscope 3700 can be used to visualize the steps of penetrating the prostate gland by guiding device 3338 and deploying anchoring element 3702 . if guiding device 3338 is not positioned in a satisfactory position , guiding device 3338 is pulled back in introducer 3300 . the deflection angle of distal end of first tubular lumen 3302 is changed and guiding device 3338 is re - advanced into the urinary bladder . fig3 e ′ shows a perspective view of an embodiment of anchoring element 3702 . anchoring element comprises a hollow sheath 3704 . distal region of hollow sheath 3704 is attached to distal region of guiding device 3338 . a number of windows are cut in the distal region of hollow sheath 3704 such that several thin , splayable strips are formed between adjacent windows . pushing hollow sheath 3704 in the distal direction causes splayable strips to splay in the radially outward direction to form an anchoring element . in fig3 f , cutting device 3343 is advanced over device guiding 3338 into the prostate gland . in fig3 g , cutting device 3343 is positioned in the prostate gland such that proximal marker band 3348 can be seen by cystoscope 3700 but distal marker band 3350 cannot be seen . thereafter , in fig3 h , relative motion between outer sheath 3343 and inner sheath 3344 causes cutting wire 3352 to deploy outward in the axial direction . in one embodiment , this step is carried out by moving outer sheath 3343 in the distal direction while the inner sheath 3344 is stationary . in another embodiment , this step is carried out by moving inner sheath 3344 in the proximal direction while outer sheath 3343 is kept stationary . also during step , electrical energy is delivered through cutting wire 3352 to cut tissue . in fig3 i , cutting device 3343 is pulled in the proximal direction such that the deployed cutting wire 3352 slices through tissue . thereafter , cutting wire 3352 is withdrawn again in cutting device 3343 . cutting device 3343 is then removed from the anatomy . in fig3 j , plugging device 3354 is introduced over guiding device 3338 through the puncture or opening in the prostate gland . thereafter , in fig3 k , anchoring element 3702 is undeployed and guiding device 3343 is withdrawn from the anatomy . thereafter , plugging device 3354 is used to deliver one or more plugging materials in the adjacent anatomy . the plugging materials can be used to plug or line some or all of the cuts or punctures created during the method . fig3 a to 38d show various components of a kit for treating prostate gland disorders by compressing a region of the prostate gland . fig3 a shows the perspective view of an introducer 3800 . introducer device 3800 comprises an outer body 3801 constructed from suitable biocompatible materials including , but not limited to metals like stainless steel , nichol plated brass , polymers like pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek and fluoropolymers like ptfe , pfa , fep , eptfe etc . body 3801 comprises a working device lumen 3802 . distal end of working device lumen 3802 emerges out of the distal end of body 3801 . proximal end of working device lumen 3802 incorporates lock thread 3803 such that introducer device may join with other devices . device lumen 3802 may comprise one or more side ports e . g . a first side port 3804 and a second side port 3805 for the introduction or removal of one or more fluids . fig3 b shows a perspective view of a bridge device 3806 constructed from suitable biocompatible materials including , but not limited to metals like stainless steel , nichol plated brass , polymers like pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek and fluoropolymers like ptfe , pfa , fep , eptfe etc . bridge device may insert into introducer lumen 3802 and lock into place by threadably mating thread lock 3807 with thread 3803 . bridge may incorporate port 3808 for cystoscope with locking means 3809 that joins to cystoscope when inserted . bridge device may incorporate one or more working lumens . working lumen 3810 emerges out of the distal end of body 3806 . in one embodiment , distal end of working device lumen 3810 has a bent or curved region . proximal end of lumen 3810 emerges from port 3811 that may incorporate fluid stasis valve 3812 and a luer lock . working lumen 3813 emerges distally in straight fashion through blunt obturator 3814 at distal end of body 3806 and emerges proximally through second port that may incorporate fluid stasis valve and luer lock . fig3 c shows a perspective view of a distal anchor deployment device 3815 constructed from suitable biocompatible materials including , but not limited to polymers like polycarbonate , pvc , pebax , polyimide , braided pebax , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel , nichol plated brass , and fluoropolymers like ptfe , pfa , fep , eptfe etc . deployment 3815 comprises handle 3816 , which incorporates movable thumb ring pusher 3817 and anchor deployment latch 3818 ; and distal shaft 3819 which has trocar point 3820 at distal end . mounted on distal shaft 3819 is distal anchor 3821 that incorporates tether 3822 . tether 3822 can be made of suitable elastic or non - elastic materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , suture materials , titanium etc . or polymers such as silicone , nylon , polyamide , polyglycolic acid , polypropylene , pebax , ptfe , eptfe , silk , gut , or any other monofilament or any braided or mono - filament material . proximal end of tether 3822 may incorporate hypotube 3823 . distal anchor 3821 is constructed from suitable biocompatible materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . or polymers e . g . pebax , braided pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , ptfe , pfa , fep , eptfe etc . deployment device 3815 is inserted into bridge working lumen 3810 . advancement of thumb ring 3817 extends distal shaft 3819 through distal end of working lumen 3810 , preferably into tissue for deployment of distal anchor 3821 . depth of distal shaft deployment can be monitored on cystoscope by visualizing depth markers 3824 . once distal shaft 3819 is deployed to desired depth , anchor deployment latch 3818 is rotated to release distal anchor 3821 . retraction of thumb ring 3817 then retracts distal shaft 3819 while leaving distal anchor 3821 in tissue . bridge 3806 is then disconnected from introducer device 3800 and removed . fig3 d shows the proximal anchor delivery tool 3825 constructed from suitable biocompatible materials including , but not limited to polymers like polycarbonate , pvc , pebax , polyimide , braided pebax , polyurethane , nylon , pvc , hytrel , hdpe , peek , metals like stainless steel , nichol plated brass , and fluoropolymers like ptfe , pfa , fep , eptfe etc . proximal anchor delivery tool 3825 comprises handle 3826 , which incorporates anchor deployment switch 3827 in slot 3828 and tether cut switch 3829 ; and distal shaft 3830 which houses hypotube 3831 . lumen of hypotube 3831 emerges proximally at port 3832 which may incorporate a luer lock . mounted on the hypotube and distal shaft is the proximal anchor 3833 with cinching hub 3834 . proximal anchor 3833 is constructed from suitable biocompatible materials including , but not limited to metals e . g . stainless steel 304 , stainless steel 306 , nickel - titanium alloys , titanium etc . or polymers e . g . pebax , braided pebax , polyimide , braided polyimide , polyurethane , nylon , pvc , hytrel , hdpe , peek , ptfe , pfa , fep , eptfe or biodegradable polymers e . g . polyglycolic acid , poly ( dioxanone ), poly ( trimethylene carbonate ) copolymers , and poly ( ε - caprolactone ) homopolymers and copolymers etc . fig3 e shows a close - up perspective view of proximal anchor 3833 mounted on hypotube 3831 and distal shaft 3830 of proximal anchor delivery tool 3825 . hypotube 3831 biases open the cinching lock 3835 of cinching hub 3834 . in order to deploy proximal anchor 3833 , hypotube 3823 is loaded into hypotube 3831 until it exits proximal port 3832 . hypotube 3823 is then stabilized while proximal anchor delivery tool 3825 is advanced into introducer device lumen 3802 and advanced to tissue target . because hypotube 3831 biases open cinching lock 3835 , the proximal anchor delivery tool travels freely along tether 3822 . once proximal anchor 3833 is adequately apposed to urethral wall of prostate , anchor deployment switch 3827 is retracted . during retraction of switch 3827 , hypotube 3831 is retracted proximal to cinching hub 3834 and tether 3822 is tightened . when switch 3827 is fully retracted or desired tension is accomplished , tether 3822 is cut within cinching hub 3834 by advancing cutting switch 3829 . any of the anchoring devices disclosed herein may comprise one or more sharp distal tips , barbs , hooks etc . to attach to tissue . various types of endoscopes can be used in conjunction with the devices disclosed herein such as flexible scopes that are thin , flexible , fibre - optic endoscopes and rigid scopes that are thin , solid , straight endoscopes . the scopes may have one or more side channels for insertion of various instruments . further they may be used with in conjunction with standard and modified sheaths intended for endoscopic and transurethral use . local or general anesthesia may be used while performing the procedures disclosed herein . examples of local anesthetics that can be used are anesthetic gels e . g . lidocaine gels in the urethra ; combination of anesthetic agents e . g . combination of lidocaine and bupivacaine in the urethra ; spinal anesthetics e . g . ropivacaine , fentanyl etc . ; injectable anesthetics e . g . 1 % lidocaine solution injected into the neurovascular bundles , the genitourinary diaphragm , and between the rectal wall and prostate ; etc . an optional trans - rectal ultrasound exam may be performed before and / or during the procedures disclosed herein . in this exam , a device called ultrasound transducer is inserted into the rectum . the ultrasound transducer is then used to image the prostate gland pg using ultrasound waves . the devices may be modified so that they are more visible under ultrasound such as etched surfaces . other imaging devices may also be optionally used such as mri , rf , electromagnetic and fluoroscopic or x - ray guidance . the anchoring devices or delivery devices may contain sensors or transmitters so that certain elements may be tracked and located within the body . the tethering devices may be used as cables to temporarily transmit energy to the distal and / or proximal anchors during deployment . the invention has been described hereabove with reference to certain examples or embodiments of the invention but various additions , deletions , alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention . for example , any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example , unless to do so would render the embodiment or example unsuitable for its intended use . also , where the steps of a method or process are described , listed or claimed in a particular order , such steps may be performed in any other order unless to do so would render the embodiment or example un - novel , obvious to a person of ordinary skill in the relevant art or unsuitable for its intended use . all reasonable additions , deletions , modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims .

devices , systems and methods for compressing , cutting , incising , reconfiguring , remodeling , attaching , repositioning , supporting , dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures . in some applications , the invention may be used to used to improve patency or fluid flow through a body lumen or cavity .

a description of the preferred embodiments of the present invention will now be presented with reference to fig1 - 10 . the present invention is directed in a particular embodiment to a hand - held atmospheric pressure cold plasma device 10 ( fig1 - 4 ) that produces multiple - frequency cold plasma 11 without the use of internal ground electrodes . the cold plasma 11 is induced through the use of multiple - frequency energy wavelengths , which are created through an electrode 12 comprising a plurality , here , seven , different - sized square brass plates 13 having a range of thicknesses from 0 . 001 to 0 . 007 in ., and arranged in substantially parallel fashion , with a common central axis . the electrode 12 is positioned within an interior space 14 of a housing 15 that can have a “ gun ”- type shape , although this is not intended as a limitation , with a lower portion comprising a downwardly depending handle 16 meeting at a top end 17 thereof an upper portion comprising a housing body 18 that is substantially cylindrical at a proximal end 19 and tapers downward to a discharge nozzle 20 at a distal end 21 . in a particular embodiment , the housing 15 has a 2 . 25 - in . outer diameter and a 1 . 75 - in . inner diameter in a central portion comprising the primary 22 and a secondary 33 chamber . the plates 13 are connected together in a primary chamber 22 within the housing 15 with a substantially central brass support rod 59 connected to an rf source to maintain a predetermined distance , for example , approximately 0 . 125 in ., between the plates 13 for multiple frequency generation . the multiple frequency electrode 12 is nickel , silver , and gold plated to induce a capacitance of energy before releasing a multiple - frequency output in the primary chamber 22 with helium gas to gain maximum separations of electrons . the helium gas is introduced into the primary chamber 22 via a gas inlet 23 positioned adjacent the proximal end 19 of the housing 15 . the gas inlet 23 comprises the terminus of a tube 24 that runs through the handle 16 and terminates at a gas port 25 adjacent a bottom end 26 of the handle 16 . gas flow is controlled with a “ trigger ” 27 , which is connected in operative relation to a gas flow valve 28 within the tube 24 . the energized gas is channeled from the primary chamber 22 through a substantially cylindrical orifice 29 in a first magnet comprising a north alignment permanent magnet 30 , and exits into a space 31 . the magnetic field in a secondary chamber 33 comprises a compressed magnetic field created by a second magnet comprising a south alignment permanent magnet 34 , which creates a south - to - south alignment compression magnetic field . inside the secondary chamber 33 , in a position approximately in the middle of the compressed magnetic field , is positioned a magnetically inert support plate 35 comprising , for example , polymethyl methacrylate ( acrylic ), that contains , on a proximal side , a multiple - frequency grid system 36 ( fig3 ) that is energized through induction . in a particular embodiment , the acrylic support plate 35 comprises a disc approximately 0 . 25 in . thick . the acrylic support plate 35 has a plurality , here , four ports 39 therethrough , evenly spaced about and adjacent the circumference 37 . the acrylic support plate 35 further has affixed thereto a plurality , here , four , grid supports 40 , which in this exemplary embodiment are positioned approximately 90 ° apart , each terminating in spaced relation at their inner ends 41 from a centerpoint of the support plate 35 , and in spaced relation at their outer ends 42 from the disc &# 39 ; s circumference 37 . the “ working ” elements of the grid system 36 itself comprise a plurality of , here , 28 , nickel , silver , and gold - plated brass capacitance spheres 43 affixed at opposed ends 44 of a plurality of , here , 14 , nickel , silver , and gold - plated solid brass rods 45 . in this embodiment , the rods 45 each have two substantially equal - length arms 81 and a central , inwardly facing 90 ° bend 46 . the rods 45 are arrayed in pairs so that the spheres 43 of one rod 45 are closely opposed to the spheres 43 of a partner rod 45 . there are in this embodiment seven such pairs . each adjacent pair is arrayed so that an opposing set of spheres 43 is adjacent at least one bend 46 of the closest rod 45 , so that , in plan view , the grid 36 appears as a set of nested squares with alternately interrupted corners , at the spheres &# 39 ; locations . the spheres 43 decrease in size from the outermost to the innermost spheres 43 . at the center of the grid 36 is positioned a unitary central sphere 47 , which is larger than the spheres 43 to which it is most closely adjacent . the grid system 36 is powered by an rf power feed 48 that enters the housing 15 adjacent the housing &# 39 ; s proximal end 19 thereof through a coupling 20 . the rf power feed 48 terminates at the center sphere 47 , and also at the outermost , seventh - level , bends 46 . it is believed that this type of frequency induction grid is superior in capacitance to the commonly used concentric rings of capacitance because it contains more than twice as many electrical capacitance spheres to hold and release rf energy signals , and can produce a multiple - frequency wave output . the grid 36 is constructed in frequency harmony with the multiple frequency electrode 12 positioned within the primary chamber 22 , which work in concert to create a multiple - frequency harmonics . as the energized gas comes in contact with the grid 36 , more electrons are energized . this highly energized gas is forced through the quad ports 39 in the acrylic plate 35 . as the energized gas travels through the quad ports 39 , the electron orientation is reversed 180 ° in south - to - south compression magnetic fields to establish a higher kinetic energy value of 15 vdc and forced through the south - to - north magnetic field alignment to be discharged from the secondary chamber 33 . the energized gas is forced out through a graduated 5 - in . nozzle 20 . in use , the cold plasma can be applied directly ( at a distance of 1 - 1 . 5 in .) to a living body of capacitance ( e . g ., laboratory specimens ) to complete the circuit . the multiple - frequency cold plasma 11 that comes in contact with the tissue ranges between 65 and 69 ° f . the device 10 of the present invention , which is believed at the time of filing to represent the best embodiment , can produce an atmospheric pressure cold plasma without the use of internal negative electrodes , allowing the device to operate for extended periods of time without overheating . with the length of the discharge nozzle 20 and the composition of the multiple - frequency harmonic field , a cold plasma stream 11 can be realized that can be utilized in the treatment of animal flesh wounds to accelerate healing ( wound healing time in a laboratory setting has been reduced by two - thirds of normal healing time ) and substantially eliminate bacterial wound infections . another feature of the present device 10 is its ability to remove physical pain from animal and human flesh wounds . the ability of accelerated healing time in animal flesh wounds , and the substantial elimination of bacterial infection and pain in wounds , demonstrates a novel path that may be pursued in health care for animals and humans . to achieve a low - temperature dense ( cold ) plasma electron population , a dual - chamber device with a positive multiple - frequency electrode configuration allows for electron population production to create the conductive plasma flow to a body having a capacitance . in an alternate embodiment 60 of the invention ( fig5 - 7 ), a plurality of , here seven , plates 61 comprise non - insulated nickel - plated discs having decreasing diameters from the proximal to the distal end of the stack . the plates 61 are positioned within a first chamber 62 within a housing 63 . the generated cold plasma 64 passes into a second chamber 80 containing a first , north magnet 65 , a harmonic ring system 66 , and a second , south magnet 67 before passing out the orifice 68 . in this embodiment 60 , the resonator comprises a concentric ring resonator that includes an acrylic support plate 69 surrounded by a 0 . 25 - in . acrylic tube wall 77 . four outlet ports 70 are positioned around the periphery 71 of the support plate 69 , and a ring support 72 extends across the support plate 69 generally through the center thereof . a plurality of , here , six , concentric brass partial rings 73 are positioned on the support plate 69 , each again having a nickel - plated brass sphere 74 affixed to ends 75 thereof that are closely opposed . the rings 73 are positioned so that each adjacent ring &# 39 ; s ends 75 are 180 ° opposed to each other . a central unitary sphere 76 is also positioned on the support plate 69 . radio frequency input 48 is supplied to the central sphere 76 and to the outermost ring 73 . fig8 and 9 are frequency calculations of the first 62 and second 80 chambers in the plasma device 60 . for fig8 , frequency # 1 = 12 v at 2 μsec = 500 khz ; frequency # 2 = 3 to 9 v at 1 . 5 to 2 μsec = 750 - 500 khz . the dielectric static voltage = 150 kv . for fig9 , frequency # 1 = 15 v at 2 μsec = 500 khz ; frequency # 2 = 0 to 13 v at 1 . 5 to 2 μsec = 750 - 500 khz . the dielectric static voltage = 150 kv . in the second chamber 80 , there is an increase in energy by 3 vdc at the plasma quad ports 70 . there is an energy gain , as the electron spin rotation is changed 180 ° at the ports 70 in the compressed magnetic field , allowing a kinetic energy increase for the plasma flow , as illustrated schematically in fig1 . in the foregoing description , certain terms have been used for brevity , clarity , and understanding , but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art , because such words are used for description purposes herein and are intended to be broadly construed . moreover , the embodiments of the device illustrated and described herein are by way of example , and the scope of the invention is not limited to the exact details of construction and use . having now described the invention , the construction , the operation and use of preferred embodiments thereof , and the advantageous new and useful results obtained thereby , the new and useful constructions , and reasonable mechanical equivalents thereof obvious to those skilled in the art , are set forth in the appended claims .

a device for generating atmospheric pressure cold plasma inside a hand - held unit discharges cold plasma with simultaneously different rf wavelengths and their harmonics . the device includes an rf tuning network that is powered by a low - voltage power supply connected to a series of high - voltage coils and capacitors . the rf energy signal is transferred to a primary containment chamber and dispersed through an electrode plate network of various sizes and thicknesses to create multiple frequencies . helium gas is introduced into the first primary containment chamber , where electron separation is initiated . the energized gas flows into a secondary magnetic compression chamber , where a balanced frequency network grid with capacitance creates the final electron separation , which is inverted magnetically and exits through an orifice with a nozzle . the cold plasma thus generated has been shown to be capable of accelerating a healing process in flesh wounds on animal laboratory specimens .

the response and remission rates to first - line ssri treatment of ptsd and ied are poor in veterans ; thus , different or augmentation treatment is needed to improve outcomes . in one embodiment , the methods of the present invention using a combination of antidepressant and compound of formula i , or a compound of formula i alone , results in a synergistic effect on ptsd and / or icd . that is , the combination of antidepressant such as ssri and a compound of formula i results in a complementary mechanism of action that is better than either class of drug alone . ptsd is listed as diagnosis 309 . 81 in the diagnostic and statistical manual of mental disorders , fourth edition , text revision ( dsm - iv - tr ), published by the american psychiatric association in 2000 . examples of icd include compulsive gambling , compulsive shopping , pyromania , kleptomania , trichotillomania , and ied . the majority of the cases of ied occur when the individual is between late adolescence and late twenties . ied is characterized by frequent and often unpredictable episodes of extreme anger or physical outbursts ; between episodes there is typically no evidence of violence or physical threat . ied is listed in the dsm - iv - tr as diagnosis 312 . 34 . specific diagnostic criteria are listed in the dsm - iv - tr for both ptsd and ied . the compounds of the formula i and their pharmaceutically acceptable salts may be made using the methods as described and exemplified in any of the following patents or applications : u . s . pat . nos . 6 , 548 , 493 ; 7 , 238 , 690 ; 6 , 552 , 017 ; 6 , 713 , 471 ; u . s . re39680 ; u . s . re39679 ; pct / us08 / 03340 ; u . s . application ser . no . 10 / 786 , 935 ; wo 2011 / 133224 a1 , and u . s . provisional application no . 61 / 036 , 069 . if not commercially available , starting materials for these processes may be made by procedures , which are selected from the chemical art using techniques which are similar or analogous to the synthesis of known compounds . all references cited herein are hereby incorporated in their entirety by reference . the words “ treatment ” and “ treating ” are to be understood accordingly as embracing prophylaxis and treatment or amelioration of symptoms of disease as well as treatment of the cause of the disease . in free or pharmaceutically acceptable salt form . also , other specific compounds of the invention are where y is — c ( h )( oh )— and x is — o —, — n ( h )—, or — n ( ch 3 )—. a specific compound of the invention is compound a which is the compound of formula i wherein x is — n ( ch 3 )— and y is — c ( o )—. the terms “ compounds of formula i ” and “ compounds of the invention ” may be used interchangeably and may be used as a sole therapeutic agent , or they may also be used in combination or for co - administration with other active agents . also , in the methods of the present invention the phrase “ a compound of formula i ” includes more than one of the compounds of formula i . unlike dopamine receptor antagonists , compounds of formula i normalize brain dopamine activity , particularly in the prefrontal cortex . the compounds of formula i bind to 5 - ht 2a and dopamine d 2 receptors . compounds of formula i also exhibit nanomolar binding affinity for sert compared to known antidepressants . therefore , in addition to treating ptsd and / or icd , the compounds of formula i are useful for the treatment of depression and , in certain embodiments , the treatment of depression in patients suffering from psychosis and for the treatment of psychosis in patients suffering from depression . in a further embodiment , the invention provides a method of treating ptsd by administering an antidepressant and a compound of formula i . ( method i - a ). in another embodiment , the invention provides a method of treating icd by administering an antidepressant and a compound of formula i . ( method ii - a ). in such methods the antidepressant may be an adjunctive to the compound of formula i or the compound of formula i may be an adjunctive to the antidepressant . as used herein the term “ adjunctive ” refers to any treatment that is used in conjunction with another to increase the chance of cure , or to increase the first treatment &# 39 ; s efficacy . in other words , adjunctive therapy acts as an aid to the primary treatment . 3 . 1 method i - a or ii - a , wherein the antidepressant is selected from amitriptyline , amoxapine , bupropion , citalopram , clomipramine , desipramine , doxepin , duloxetine , escitaloprame , fluoxetine , fluvoxamine , imipramine , isocarboxazid , maprotiline , mirtazapine , nefazodone , nortriptyline , paroxetine , phenelzine sulfate , protiptyline , sertraline , tranylcypromine , trazodone , trimipramine , and velafaxine ; 3 . 2 method i - a or ii - a , wherein the antidepressant ( s ) is a selective serotonin reuptake inhibitor ( ssri ); 3 . 3 method i - a or ii - a or 3 . 1 , wherein the ssri compound is selected from the group consisting of citalopram , escitalopram oxalate , fluoxetine , fluvoxamine maleate , paroxetine , sertraline , and dapoxetine . the combination compositions of the invention can include mixtures of the combined drugs , as well as two or more separate compositions of the drugs , which individual compositions can be , for example , co - administered together to a patient at the same of different times . dosages employed in practicing the present invention will of course vary depending , for example , on the particular disease or condition to be treated , the particular compound of the invention used , the mode of administration , and the therapy desired . unless otherwise indicated , an amount of the compound of the invention for administration ( whether administered as a free base or as a salt form ) refers to or is based on the amount of the compound of the invention in free base form ( i . e ., the calculation of the amount is based on the free base amount ). compounds of the invention may be administered by any suitable route , including orally , parenterally or transdermally , but are preferably administered orally . the dosages of a compound of formula i and / or the antidepressant of method i - a and ii - a can be the same as or lower than the approved dosage for the drug , the clinical or literature test dosage or the dosage used for the drug as a monotherapy . for example the daily dosage of compound of formula i to be administered in combination with an antidepressant is about 1 mg to about 140 mg , in another embodiment about 1 mg to about 100 mg , in another embodiment about 10 mg to about 100 mg , in another embodiment about 10 mg to about 50 mg , in another embodiment about 10 mg to about 40 mg , in another embodiment about 20 mg to about 40 mg and in another embodiment about 1 mg to about 10 mg . the amount of antidepressant to be administered in combination with the compound of formula i is about 0 . 01 mg to about 2000 mg , in another embodiment about 0 . 1 mg to about 200 mg , in another embodiment about 10 mg to about 200 mg . in particular embodiments , the second therapeutic agent , that is antidepressant ssri of method i - a and ii - a is sertraline and the daily dosage of sertraline is between about 20 mg and 100 mg . in a specific embodiment , the dosages of a compound of formula i and / or the second therapeutic agents of method i - a and ii - a are lower than when used in a monotherapy . therefore , in a particular embodiment , the daily dosage of a compound of formula i is lower than 100 mg once daily , or less than 50 mg , or less than 40 mg , or less than 30 mg , or less than 20 mg , or less than 10 mg . in another preferred embodiment , the dosages of both the compound of formula i and the antidepressant agent of method i - a and ii - a are lower than the dosages used for the individual drug as a monotherapy . therefore , in a particular embodiment , for example , method i - a or ii - a comprises administering ( 1 ) a compound of formula i at a dosage lower than 100 mg once daily , preferably less than 50 mg , more preferably less than 40 mg , still more preferably less than 30 mg , still more preferably less than 20 mg , still more preferably less than 10 mg ; and ( 2 ) antidepressant , for example a ssri such as sertaline , at a daily dosage of less than 50 mg , more preferably , less than 20 mg , still more preferably , less than 10 mg , most preferably less than 6 mg , in free or pharmaceutically acceptable salt form . in some embodiments , the methods of the invention also encompass additional methods for treating other disorders . such additional disorders include , but are not limited to , sleep disorders associated with psychosis , e . g ., sleep disorders associated with schizophrenia or parkinson &# 39 ; s disease . more specific disorders which may co - exist with agitation , icd and / or ptsd and may be treated using the methods of the invention include ( a ) psychosis with a co - morbid disorder of depression and / or sleep disorder ; ( b ) depression with a co - morbid disorder of psychosis ; ( c ) sleep disorder in patients suffering from psychosis , parkinson disease , and / or depression ; ( d ) disorders associated with cognition impairment , including mild cognition imparment , and dementing illnesses including senile dementia , alzheimer &# 39 ; s disease , pick &# 39 ; s disease , frontotemporal dementia , parasupranculear palsy , parkinson &# 39 ; s dementia , dementia with lewy bodies , vascular dementia , huntington &# 39 ; s disease , parkinson &# 39 ; s disease , multiple sclerosis , amyotrophic lateral sclerosis , down syndrome , elderly depression , wernicke - korsakoffs syndrome , corticobasal degenerations , and prion disease ; or ( e ) any combinations thereof . optionally , the compounds of formula i may be simultaneously , sequentially , or contemporaneously administered with another antidepressant ( methods i - a and ii - a ), or additional therapeutics may also be administered in either methods , i , ii , i - a , or ii - a , for example , anti - psychotic , hypnotic agents , and / or agents used to treat parkinson &# 39 ; s disease or mood disorders . in another example , side effects may be reduced or minimized by administering a compound of formula i in combination with one or more second therapeutic agents in free or salt form , wherein the dosages of the second therapeutic agent ( s ) or both compound of formula i and the second therapeutic agents are lower than if the agents / compounds are administered as a monotherapy . as mentioned above , dosages of the compound of the invention will vary depending , e . g . on the particular disease or condition to be treated , the particular compound of the invention used , the mode of administration , the therapy desired , as well as specific patients &# 39 ; needs , other therapeutic agents administered , disorders to be treated , and the like . other daily doses contemplated to be within the scope of the invention are about 1 mg , 2 mg , 2 . 5 mg , 3 mg , 4 mg , 5 mg , 10 mg , 20 mg , 30 mg , 40 mg , or 50 mg . if additional therapeutic agents are used in methods i , ii , i - a , or ii - a , the daily doses of such agents can vary considerably depending the specific agent chosen as well as other factors mentioned above , for example , daily doses of about 0 . 001 mg to about 2000 mg , 0 . 1 mg to about 200 mg , 1 mg to about 100 mg , 10 mg to about 100 mg , 10 mg to about 50 mg , 20 mg to about 50 mg , and the like . other therapeutic agents which can be optionally administered to a patent in need thereof include compounds that modulate gaba activity ( e . g ., enhances the activity and facilitates gaba transmission ), a gaba - b agonist , a 5 - ht modulator ( e . g ., a 5 - ht 1a agonist , a 5 - ht 2a antagonist , a 5 - ht 2a inverse agonist , etc . ), a melatonin agonist , an ion channel modulator ( e . g ., blocker ), a serotonin - 2 antagonist / reuptake inhibitor ( saris ), an orexin receptor antagonist , an h3 agonist , a noradrenergic antagonist , a galanin agonist , a crh antagonist , human growth hormone , a growth hormone agonist , estrogen , an estrogen agonist , a neurokinin - 1 drug , and an antipsychotic agent , e . g ., an atypical antipsychotic agent , in free or pharmaceutically acceptable salt form . the term “ gaba ” refers to gamma - aminobutyric acid . the gaba compounds are compounds which bind to the gaba receptor , and include , but are not limited to one or more of doxepin , alprazolam , bromazepam , clobazam , clonazepam , clorazepate , diazepam , flunitrazepam , flurazepam , lorazepam , midazolam , nitrazepam , oxazepam , temazapam , triazolam , indiplon , zopiclone , eszopiclone , zaleplon , zolpidem , gabaxadol , vigabatrin , tiagabine , evt 201 ( evotec pharmaceuticals ) or estazolam . other optional therapeutic agents are 5ht 2a antagonists such as ketanserin , risperidone , eplivanserin , volinanserin ( sanofi - aventis , france ), pruvanserin , pimavanserin ( acp - 103 ), mdl 100907 ( sanofi - aventis , france ), hy10275 ( eli lilly ), apd125 ( arena pharmaceuticals , san diego , calif . ), or ave8488 ( sanofi - aventis , france ). other optional therapeutic agents are 5ht 1a agonists such as repinotan , sarizotan , eptapirone , buspirone or mn - 305 ( medicinova , san diego , calif .). other optional compounds are melatonin agonists such as melatonin , ramelteon ( rozerem ®, takeda pharmaceuticals , japan ), vec - 162 ( vanda pharmaceuticals , rockville , md . ), pd - 6735 ( phase ii discovery or agomelatine . other optional therapeutic agents are ion channel blockers such as lamotrigine , gabapentin or pregabalin . other optional therapeutic agents are orexin receptor antagonists such as orexin , a 1 , 3 - biarylurea , sb - 334867 - a ( glaxosmithkline , uk ), gw649868 ( glaxosmithkline ) or a benzamide derivative , for example . other optional therapeutic agents are serotonin - 2 antagonist / reuptake inhibitors ( sari ) such as org 50081 ( organon - netherlands ), ritanserin , nefazodone , serzone or trazodone . other optional therapeutic agents are neurokinin - 1 drugs such as casopitant ( glaxosmithkline ). specific examples of additional therapeutic agents include modafinil , armodafinil , doxepin , alprazolam , bromazepam , clobazam , clonazepam , clorazepate , diazepam , flunitrazepam , flurazepam , lorazepam , midazolam , nitrazepam , oxazepam , temazapam , triazolam , indiplon , zopiclone , eszopiclone , zaleplon , zolpidem , gabaxadol , vigabatrin , tiagabine , evt 201 ( evotec pharmaceuticals ), estazolam , ketanserin , risperidone , eplivanserin , volinanserin ( sanofi - aventis , france ), pruvanserin , mdl 100907 ( sanofi - aventis , france ), hy10275 ( eli lilly ), apd125 ( arena pharmaceuticals , san diego , calif . ), ave8488 ( sanofi - aventis , france ), repinotan , sarizotan , eptapirone , buspirone , mn - 305 ( medicinova , san diego , calif . ), melatonin , ramelteon ( rozerem ®, takeda pharmaceuticals , japan ), vec - 162 ( vanda pharmaceuticals , rockville , md . ), pd - 6735 ( phase ii discovery ), agomelatine , lamotrigine , gabapentin , pregabalin , orexin , a 1 , 3 - biarylurea , sb - 334867 - a ( glaxosmithkline , uk ), gw649868 ( glaxosmithkline ), a benzamide derivative , org 50081 ( organon - netherlands ), ritanserin , nefazodone , serzone , trazodone , casopitant ( glaxosmithkline ), amitriptyline , amoxapine , bupropion , citalopram , clomipramine , desipramine , doxepin , duloxetine , escitaloprame , fluoxetine , fluvoxamine , imipramine , isocarboxazid , maprotiline , mirtazapine , nefazodone , nortriptyline , paroxetine , phenlzine sulfate , protiptyline , sertraline , tranylcypromine , trazodone , trimipramine , velafaxine , chlorpromazine , haloperidol , droperidol , fluphenazine , loxapine , mesoridazine molidone , perphenazine , pimozide , prochlorperazine promazine , thioridazine , thiothixene , trifluoperazine , clozapine , aripiparazole , olanzapine , quetiapine , risperidone , ziprasidone and paliperidone , asenapine , lurasidone , iloperidone and cariprazine , in free or pharmaceutically acceptable salt form . the compounds to be administered in the methods of the present invention can be in the form of free acid or free base or as pharmaceutically acceptable salts . the phrase “ pharmaceutically acceptable salts ” refers to derivatives of the above disclosed compounds wherein the parent compound is modified by making acid or base salts thereof . examples of pharmaceutically acceptable salts include , but are not limited to , mineral or organic acid salts of basic residues such as amines ; alkali or organic salts of acidic residues such as carboxylic acids ; and the like . the pharmaceutically acceptable salts include the conventional non - toxic salts or the quaternary ammonium salts of the parent compound formed , for example , from non - toxic inorganic or organic acids . for example , such conventional non - toxic salts include those derived from inorganic acids such as hydrochloric , hydrobromic , sulfuric , sulfamic , phosphoric , nitric and the like ; and the salts prepared from organic acids such as acetic , propionic , succinic , glycolic , stearic , lactic , malic , tartaric , citric , ascorbic , pamoic , maleic , hydroxymaleic , phenylacetic , glutamic , benzoic , salicylic , sulfanilic , 2 - acetoxybenzoic , fumaric , toluenesulfonic , methanesulfonic , ethane disulfonic , oxalic , isethionic , and the like . the pharmaceutically acceptable salts of the compounds to be used in the methods of the invention can be synthesized from the parent compound which contains a basic or acidic moiety by conventional chemical methods . generally , such salts can be prepared by reacting the free base forms of these compounds with a stoichiometric amount of the appropriate acid in water or in an organic solvent , or in a mixture of the two ; generally , nonaqueous media like ether , ethyl acetate , ethanol , isopropanol , or acetonitrile are preferred . further details for the preparation of these salts , e . g ., toluenesulfonic salt in amorphous or crystal form , may be found in pct / us08 / 03340 and / or u . s . provisional appl . no . 61 / 036 , 069 and wo 2009 / 114181 . pharmaceutical compositions comprising the compounds of the invention may be prepared using conventional diluents or excipients and techniques known in the galenic art . for example the compounds can be administered in a wide variety of different dosage forms , i . e ., they may be combined with various pharmaceutically - acceptable inert carriers in the form of tablets , capsules , lozenges , troches , hard candies , powders , sprays , aqueous suspension , injectable solutions , elixirs , syrups , and the like . for oral administration , the pharmaceutical compositions may take the form of , for example , tablets or capsules prepared by conventional means with pharmaceutically acceptable excipients such as binding agents ( e . g . pregelatinised maize starch , polyvinylpyrrolidone or hydroxypropyl methylcellulose ); fillers ( e . g . lactose , microcrystalline cellulose or calcium phosphate ); lubricants ( e . g . magnesium stearate , talc or silica ); disintegrants ( e . g . potato starch or sodium starch glycolate ); or wetting agents ( e . g . sodium lauryl sulphate ). the tablets may be coated by methods well known in the art . liquid preparations for oral administration may take the form of , for example , solutions , syrups or suspensions , or they may be presented as a dry product for constitution with water or other suitable vehicle before use . such liquid preparations may be prepared by conventional means with pharmaceutically acceptable additives such as suspending agents ( e . g . sorbitol syrup , methyl cellulose or hydrogenated edible fats ); emulsifying agents ( e . g . lecithin or acacia ); non - aqueous vehicles ( e . g . almond oil , oily esters or ethyl alcohol ); and preservatives ( e . g . methyl or propyl p - hydroxybenzoates or sorbic acid ). for buccal administration the composition may take the form of tablets or lozenges formulated in conventional manner . the active compounds may be formulated for parenteral administration by injection , including using conventional catheterization techniques or infusion . formulations for injection may be presented in unit dosage form , e . g . in ampules or in multi - dose containers , with an added preservative . the compositions may take such forms as suspensions , solutions or emulsions in oily or aqueous vehicles , and may contain formulating agents such as suspending , stabilizing and / or dispersing agents . alternatively , the active ingredient may be in powder form for reconstitution with a suitable vehicle , e . g . sterile pyrogen - free water , before use . the active compounds may also be formulated in rectal compositions such as suppositories or retention enemas , e . g ., containing conventional suppository bases such as cocoa butter or other glycerides . for intranasal administration or administration by inhalation , the active compounds are conveniently delivered in the form of a solution or suspension from a pump spray container that is squeezed or pumped by the patient or as an aerosol spray presentation from a pressurized container or a nebulizer , with the use of a suitable propellant , e . g . dichlorodifluoromethane , trichlorofluoromethane , dichlorotetrafluoroethane , carbon dioxide or other suitable gas . in the case of a pressurized aerosol , the dosage unit may be determined by providing a valve to deliver a metered amount . the pressurized container or nebulizer may contain a solution or suspension of the active compound . capsules and cartridges ( made , for example , from gelatin ) for use in an inhaler or insufflator may be formulated containing a powder mix of an active compound and a suitable powder base such as lactose or starch . when aqueous suspensions and / or elixirs are desired for oral administration , the essential active ingredient ( s ) therein may be combined with various sweetening , or flavoring agents , coloring matter or dyes and , if so desired , emulsifying and / or suspending agents as well , together with such diluents as water , ethanol , propylene glycol , glycerin and various like combinations thereof . the following example is to illustrate the invention but should not be interpreted as a limitation thereon . a single - site , prospective , open label pilot study is performed of compound a ( formula i wherein x is — n ( ch 3 )— and y is — c ( o )—; tosylate salt ) as adjunctive treatment to the selective serotonin - reuptake inhibitor ( ssri ) in veterans with non - remitting posttraumatic stress disorder . this study focuses on subjects who fail to remit to sertraline , the first - line fda indicated medication for ptsd . male and female subjects ( n = 20 ) from active duty , reserves , national guard and / or veterans between the ages of 19 and 65 years , inclusive , with a diagnosis of non - remitting ptsd as defined by failing an adequate trial of a ssri are prospectively treated with adjunctive compound a for 12 weeks . participants are recruited from outpatient clinics , residential treatment programs , and nearby us military reserve or active units , as potential subjects present for medical / psychiatric evaluation . of the 16 , 000 total patients in the network studied , approximately 18 % ( n = 2880 ) have a diagnosis of ptsd ; 88 % are male , ˜ 59 % caucasian and 41 % minorities . of the 1 , 200 or more oif / oef veterans treated at tvamc , 63 % have a mental illness diagnosis and 42 % have ptsd . ( 1 ) signed informed consent ( i . e . subject can read and understand the procedures , alternatives , risks and benefits and agrees to visit frequency ) ( 5 ) diagnosis of ptsd by mini - international neuropsychiatric inventory ( mini ) and clinician administered ptsd scale ( caps ) using rule of fours and total caps score greater or equal to 45 ( 6 ) inadequate response to standard ssri therapy (& gt ; 6 wk duration ; citalopram 40 mg / d , sertraline 150 mg / d , fluoxetine 40 mg / d , paroxetine 40 mg / d , or equivalent ) ( 7 ) caps score ≧ 45 for the past week prior to randomization ( defines an inadequate response ) ( 8 ) at least moderate severity on cgi - severity scale ( defines an inadequate response ) ( 9 ) no substance use disorders ( except for nicotine and caffeine ) in the previous 1 month ( 10 ) free of other psychotropic medications ( mood stabilizers , neuroleptics , benzodiazepines , non - ssri medications , prazosin ) for 2 wks prior to randomization . subjects can be tapered off excluded medication if not responding to or having intolerable side effects to the medication . ( 1 ) lifetime history of bipolar i , schizophrenia , schizoaffective disorders ( assessed by the mini ) ( 2 ) actively considering plans of suicide or homicide ( assessed by clinical interview ) ( 3 ) psychotic symptoms that in the investigator &# 39 ; s opinion impair the subject &# 39 ; s ability to give informed consent or make it unsafe for subject to be maintained without a neuroleptic ( 5 ) nonresponse to & gt ; 3 adequate trials of psychotropic medication ( s ), i . e . treatment - refractory ( 7 ) pregnant women or women planning to become pregnant or breastfeed during the study ( 8 ) clinically significant unstable or severe medical condition that would contraindicate study participation or expose them to an undue risk of a significant adverse event , including but not limited to : unstable or severe hepatic , renal , respiratory , cardiovascular , endocrine , neurologic , or hematologic disease ; hypo - or hyper - thryoidism , unless the condition has been stabilized for 3 months ; or a history of seizures ( except for a single childhood febrile seizure , post - traumatic , or alcohol withdrawal ). the following are exclusionary : platelets & lt ; 75 , 000 / mm ; hemoglobin & lt ; 9 g / dl ; neutrophils , absolute & lt ; 1000 / mm ; sgot & gt ; 3 × upper limit ; sgot & gt ; 3 × upper limit ; creatine & gt ; 2 mg / dl ; diastolic bp & lt ; 60 or & gt ; 110 mmhg ; ekg qtc & gt ; 475 msec . ( 9 ) in regard to vulnerable patient populations , persons with dementia , minors (& lt ; age 19 ), the elderly (& gt ; age 65 ), prisoners and the terminally ill are excluded . after providing signed informed consent , 1 - 14 day screening and baseline assessment includes a psychiatric and general medical evaluation , psychiatric history , family psychiatric history , psychotropic medication history , demographics , disability status , a diagnostic evaluation ( the mini and the caps ), an inventory of general medication conditions , a physical , ekg , and laboratory tests ( complete blood count , liver and thyroid function tests , blood chemistry , urinalysis , urine screen for drugs of abuse , and fasting glucose and lipid profile ). women of child - bearing potential have a negative urine pregnancy test . after eligibility is determined , the subject receives compound a . compound a is initiated at 20 mg / day for the first 7 days , then increased to 40 mg / d . the target dose is 40 mg / d , but the dose is reduced to 20 mg / d as needed due to side effects . the study medication is stored and dispensed by the tvamc pharmacy . the baseline ssri medication is continued throughout the 12 - wks study . except for the ssri and study medication , no other psychotropic medications are allowed during the study ( including mood stabilizers , other antidepressants , neuroleptics , benzodiazepines , prazosin ). pain medications ( narcotics , gabapentin , acetaminophen , nonsteriodal anti - inflammatory agents ) for pain conditions are allowed as long as doses are stable for 4 wks prior to randomization . due to the potential confounding therapeutic effects of some types of psychotherapy , concurrent cognitive behavioral therapy , cognitive processing therapy or exposure therapy is not allowed during the study . subjects are assessed by the investigators or trained clinical research coordinators with telephone contacts every two weeks and the assessments ( indicated in the table below ) every four weeks . a structured clinician - administered interview that assesses current and lifetime dsm - iv axis i disorders . the mini has good reliability and validity . selected for its reduced burden on the research participant , the mini takes ˜ 30 min to administer compared to 45 - 60 min for the structured clinical interview for dsm - iv . a structured clinician - administered interview is used to assess frequency and intensity of 17 symptoms of ptsd . the caps is further subdivided into three clusters to allow scoring for criterion b ( re - experiencing ), criterion c ( avoidant behaviors ) and criterion d ( hyper - arousal ). caps is advantageous in that : 1 ) it is a standard rating scale in ptsd studies ; 2 ) it allows comparison of the results of the this study to studies of other medications ( i . e . ssris ) for ptsd that used the caps , and 3 ) it gives reliable scores for the 3 ptsd symptom clusters for more detailed analysis of the ptsd b , c , and d clusters . a 16 - item self report rating scale for depression used extensively in clinical trials ; has good internal consistency , reliability , and is sensitive to change . an assessment of depression is selected because depression occurs frequently in ptsd patients . a 30 - item clinician - administered scale to assess the positive and negative syndromes in psychotic disorders ; good reliability and validity ; sensitive to treatment changes . 7 - point clinician scales that are used in rcts to measure severity of illness & amp ; improvement . a frequently used self - rated sleep questionnaire that has been validated in healthy and psychiatric patients with an addendum has been developed to assess sleep disturbances more specific to ptsd . sheehan disability scale ( sds ): a 3 - item of the degree to which psychiatric symptoms are disruptive of occupational , family / home , and social function ; has high internal consistency ( 0 . 89 ), good validity , and is sensitive to change . intent - to - attend : a 2 - item scale that asks the subject at baseline “ how likely is it that you will complete the study ?” and asks the subjects at follow - up “ how likely is it that you will attend next assessment session ?” and scores from zero to 10 . these data could change non - ignorable dropout to ignorable or be used clinically to discuss identifiable barriers and encourage follow - up . treatment satisfaction questionnaire for medication ( tsqm ): a 14 - item likert - type self - report ; psychometrically valid ; measures major dimensions of patients &# 39 ; satisfaction with medication . adverse event monitoring : frequency , intensity , and burden of side effects rating ( fibser ): a self - report ; measures side effect global frequency , intensity , and overall burden . abnormal involuntary movement scale ( aims ): 65 12 - item clinician admin scale that assesses the presence and severity of dyskinetic movements , used widely for assessment of tardive dyskinesia ; has established inter - rater reliability . barnes akathisia scale ( bas ): a 4 - item clinician admin validated scale to assess presence and severity of drug - induced akathisia . simpson - angus scale ( sas ): a 10 - item validated scale to assess presence and severity of dystonia or parkinsonism symptoms . sheehan suicidality tracking scale ( ssts ), is an 8 - item self - report scale ; tracks treatment - emergent suicidal ideation ( items 2 , 3 , 4 plus score from item 5 if & lt ; 1 ) and behaviors ( items 6 , 7a , 8 , plus item 5 if & gt ; 1 ); sensitive to change in frequency or intensity of suicidal thoughts or behaviors over time ; maps directly to the suicidality classification coding system used by the fda . at each visit , the subject completes the ssrs and one of the investigators reviews it . positive endorsements are handled by the investigator ( see suicide prevention plan ). procedures for training research staff are outlined by tracy k ., et al . ( 1997 ). “ inter - rater reliability issues in multicenter trials , part i : theoretical concepts and operational procedures used in department of va csp # 394 .” psychopharm bull 33 : 1 : 53 - 57 ; which are specific guidelines for establishing and preserving inter - rater reliability . past inter - rater reliability coefficient ranged from 0 . 75 to 1 . 0 for the caps total and subscales . prior to study initiation , training for all scales are conducted and inter - rater reliability coefficients in the range of 0 . 90 to 0 . 95 are established and will be repeated annually . as much as possible , each subject is evaluated by the same rater during the study . subjects are evaluated at every 2 weeks by phone ( or more frequently if needed ) and every 4 weeks in clinic . the subject completes the ssts self report at the clinical visit and the ssts is reviewed by the md or nurse practitioner . the investigator explores all positive endorsements with the subject and judges the clinical state and risk of suicide . at baseline , the investigator and subject agree on a detailed suicide prevention plan , which includes 24 hr access to one of the investigators ( paging ) in the event of suicidal thoughts , plans or behaviors , 24 hr access to the vamc emergency room , knowing the va suicide prevention crisis and va suicide prevention coordinators &# 39 ; phone numbers ( cards and flyers are given to subjects ), identifying a significant other who can assist during a crisis , removal of all lethal weapons from the immediate access of the subject , and subject &# 39 ; s agreement to abstain from drugs and alcohol . if positive endorsements are made on the ssts , the investigator reviews and modifies the suicide prevention plan with the subject . should the investigator deem the subject to be at heightened risk of suicide , the subject is treated in the most clinically appropriate setting ( outpatient , residential or inpatient ), the study medication may be discontinued and other treatments provided , and appropriate ae or sae reports are filed with irb . in addition to treatment - ermergent suicidal thoughts and behaviors described above , the patients are monitored for all possible side effects and adverse events on a regular basis ( i . e . face - to - face monthly clinic visits with telephone contact in the intervening weeks ). laboratory tests and ekg are repeated at week 12 to evaluate medical and / or cardiac outcomes . adverse events , weight , and vital signs are evaluated at each visit . all adverse events are recorded at each visit ( description , severity , relationship to study medication , intervention , date onset , date resolution ) regardless of relationship to study medication . serious adverse events ( as defined by crf 312 . 32 ) that are unanticipated and related to the study medication are expeditiously reported to the irb and all regulatory agencies . side effects are listed in the informed consent and reviewed carefully with the subject . most adverse events of compound a are mild to moderate and include headache , dizziness , postural tachycardia , dry mouth , gastrointestinal complaints , and somnolence . importantly , compound a lacks potent off - target interactions that may be associated with unwanted side effects . at doses where target receptors are engaged , compound a is not likely to exhibit sedation associated with h1 antagonism ( h1 ki & gt ; 1000 nm ), weight gain , or metabolic liability associated with h1 or 5 - ht2c receptor antagonism ( 5 - ht2c ki = 173 nm ). compound a has no affinity for muscarinic receptors and is not anticipated to be associated with anticholingeric side effects . the closest off - target activity is adrenergic alpha 1a ( ki = 73 nm ). to date , this has not been associated with any cardiovascular side effects , such as postural hypotension , but subjects are closely monitored . compound a is safe and well - tolerated across a range of doses ( 1 - 140 mg ) in healthy volunteer and clinical populations . a randomized , double - blind , placebo - controlled single oral dose escalation study to demonstrate the safety , tolerability and pharmacokinetics of compound a in 30 young , healthy volunteers demonstrated that single oral doses of 2 . 5 mg , 5 . 0 mg , 10 . 0 mg , 20 . 0 mg and 30 . 0 mg are safe and tolerated in healthy male volunteers . there are no serious adverse events in this study . there are no dose - related clinically relevant changes in vital signs or clinical laboratory . there are no significant increase in qtc and no clinically significant changes in any 12 - lead ecg or 24 - hour holter - ecg . most adverse events are mild to moderate , and included headache , dizziness , postural tachycardia , dry mouth , gastrointestinal complaints , and somnolence . in another placebo - controlled study in 24 healthy male volunteers , multiple oral doses of 5 , 10 and 20 mg compound a once daily for 5 days were safe and well tolerated . pharmacokinetics of compound a on day 5 of dosing is similar to that observed on day 1 , suggesting no accumulation in plasma with repeated administration . oral administration of increasing compound a doses results in dose - proportional linear pharmacokentics and tmax occurs around 1 h after compound a administration . pregnant or nursing women are excluded and men and women of childbearing potential use birth control . compound a does not produce hyper - prolactinemia and there are no reports of sexual dysfunction . compound a is metabolized predominantly by cytochrome p450 3a4 ( cyp3a4 ). it is not a potent inhibitor of any cyp enzyme . subjects are informed to avoid the use of strong cyp450 inhibitors ( e . g macrolide antibiotics , verapamil , aprepitant , grapefruit juice ) and strong cyp450 inducers ( e . g . phenytoin , carbamazepine oxcarbazepine , phenobarbital , modafinil , rifampicin , saint john &# 39 ; s wort ) during study . ssris may elevate the concentration of concomitantly administered compound a due to the common cyp450 metabolic pathway ( paroxetine & gt ; fluoxetine & gt ; sertraline & gt ; citalopram ); thus , conservative introduction of compound a and careful safety monitoring is conducted . the common side effects risks of ssri antidepressants are well described elsewhere and are included in the informed consent . one rare potentially serious adverse event is a serotonin syndrome . this syndrome typically occurs within 24 hours of initiation , overdose , or change in dose . symptoms include : nausea , diarrhea , autonomic instability , elevated temperature , changes in blood pressure , twitching and increased muscle tone , tremor , hyperreflexia , and confusion . to minimize the risk of serotonin syndrome , the investigators provide education to study staff and participants to aid in early recognition and treatment of this syndrome . other serotonergically active medications ( i . e ., triptans ) are not used during the study . experienced study physicians , familiar with serotonin syndrome , are available 24 hr / d , 7 d / wk in the event of emergency . in order to minimize drop - out , the investigators provide thorough pre - enrollment education for all prospective subjects and confirm the subjects &# 39 ; commitment to and feasibility for follow - up . the investigators also provide ongoing education during the study to reinforce the subjects &# 39 ; commitment . the subject receives a modest payment for participation at each visit to offset the inconvenience of the follow - up appointments and transportation cost . a one - item scale called “ intent - to - attend ” is administered at each study visit . if a subject expresses low intent ( i . e ., & lt ; 5 ), the assessor queries as to the reasons for low intent and attempts to accommodate that subject &# 39 ; s needs ( e . g ., more convenient time of day for appointment ) to decrease the chance of losing the subject during follow - up . also , the clinical research coordinator conducts the study visit in the subject &# 39 ; s community if needed . at the end of study ( week 12 or premature exit ), all week 12 procedures and assessments are conducted and the subject is started on the most appropriate treatment in the most appropriate setting and referred to his / her previous or newly assigned long - term provider for follow - up . a post - study visit with the research team is scheduled as a routine clinic visit to ensure that the subject has made or scheduled the appropriate follow - up appointments and to address any clinical problems that may have occurred related to previous study procedures , study medication , or any new medication that may have been started at study exit . the sample size is based on the pragmatics of recruitment based on experience of ability to screen 2 - 3 subjects / month per site . during an 8 month enrollment period , approximately 3 subjects per month are enrolled in order to start at least 20 subjects on study mediation . unless stated otherwise below , analyses adhere to the intention to treat ( itt ) principle by including all subjects who take at least one dose of the study medication and return for at least one post - baseline assessment visit . the clinical and demographic characteristics of the sample at baseline are examined . frequency distributions are calculated for all variables . the mean , median , standard deviation , minimum and maximum are calculated on each continuous measure . categorical variables are presented as frequencies and proportions . graphical displays including histograms and box plots are produced . these analyses examine baseline caps score , gender , age , presence / absence of mdd , disability status , length of illness , and number of past failed adequate medication treatments and all post baseline assessments . medians and mean ± and standard deviation ( sd ) of the caps ( primary outcome ), qids - sr , cgi - i , panss , and sds by treatment group are determined over time . there is a significant decline in rating scale scores from baseline to the end of the 12 - week compound a treatment period . in addition to change scores , rates of response (≧ 30 % decrease in caps ) and remission (≧ 45 on caps ) are determined within - group effect sizes using cohen &# 39 ; s d for the continuous outcomes is determined . the number needed to treat ( nnt ) for response and remission rates is determined . the effect size is a descriptive , not inferential , measure of change ; i . e . no significance tests are directly associated with it . the effect size conveys a description of magnitude of change that is independent of sample size . a 95 % confidence interval accompanies each effect size to guide their interpretation . in addition , analyses for each outcome variable consist of paired t - tests . evaluation of tolerability , safety and side effects of compound a in a ptsd sample : the safety analyses includes all subjects who have taken at least one dose of study medication and have at least one post - baseline safety evaluation . these analyses include those subjects who have reported an adverse event as well as those who do not report an adverse event . the incidence of treatment emergent adverse events , type of adverse events , and frequency of withdrawals due to an adverse event are summarized . tolerability by the rate of study medication discontinuation due to medication side effect is evaluated . pre - post change on the fib ser , aims , sas , bas , and ssts are also evaluated and presented descriptively mean , medians , sd , 95 % ci . the reason ( s ) for prospective participants to decline the study are maintained in the database with a link to an assigned number ( i . e . no personal identifiers ). in addition , the reason ( s ) for the prospective subjects to agree to participate in the study , he / she is asked to give a reason ( s ) for their decision and these reason ( s ) are also maintained in the database with a link to the assigned number as well as linked to the subject &# 39 ; s assigned study number that is given after he / she signs informed consent . all reasons for screen failure and reasons for drop - out prior to starting study medication also are maintained . all reasons for early exit from the treatment study are collected , including side effect , lost to follow - up , non adherence to study protocol , etc . rates ( and 95 % cis ) for starting medication and study completion are calculated : 1 ) the number of subjects approached is divided by the number of subjects enrolled in the study and 2 ) the number of subjects completed is divided by the number who were started on medication . the rates of scale completion are calculated for each of the assessments over the course of the study . the database is tested and examined for frequency of missing data . the treatment satisfaction questionnaire for medication ( tsqm ) is completed by each subject at study visits . the means ( and 95 % ci ), medians , and sd is calculated . every effort is made to prevent attrition , e . g ., telephone reminders prior to visits , participation fees , meeting with subject in community if needed , reinforcing adherence at each visit , being available to subject if change in appointment time is needed . however , some attrition is inevitable . the analyses will includes all available observations ( i . e . from the various assessment times ) from each subject . no imputation processes is used to replace missing data . analyses examine the intent - to - attend variable by treatment group over time . at baseline subjects rate their intent to complete the trial . the ratings are used in two ways . first , effect size estimates of the treatment effect ( described above ) also are calculated separately for those who provide higher vs . low rating of baseline intent to attend ( 5 + vs . & lt ; 5 ). second , in an effort to reduce risk of attrition , the clinical research coordinator attempts to accommodate the needs of the subject who reports low self - rated intent , ( e . g ., changing time of day for next assessment ). month 1 : study start - up training , procure study medication and supplies , and conduct inservices to initiate enrollment . enroll first subject . start data entry . month 2 - 8 : continue enrollment of approximately 3 subjects per month to start 20 subjects on study medication . meet 50 % enrollment ( n = 10 ) by end of month 4 and 100 % enrollment ( n = 20 ) by end of month 8 . data entry is completed within 48 hours of collection . month 9 - 11 : all final enrolled subjects complete follow - up assessments . enrollment closes at month 9 . all data are entered and checked . this single - site , prospective , open label trial study of compound a as adjunctive treatment to an inadequate response to an ssri shows that compound a is effective for the treatment for ptsd . the combination of an ssri and compound a offers a complementary mechanism of action that is better than either drug alone . the effect of compound a on reversal of social isolation resulted from repeated stress mice are tested for social isolation behavior after repeated exposure ( once daily for 10 days ) to an aggressive resident intruder mouse in the social defeat / resident intruder paradigm as describe by berton et al ., science ( 2006 ) 311 : 864 - 868 , the contents of which are incorporated by reference . mice are then dosed chronically , once daily for 30 d , with either vehicle ( 5 % dmso / 5 % tween - 20 / 15 % peg400 / 75 % water , 6 . 7 ml / kg volume ) or compound a ( 1 mg / kg , ip ) in vehicle solution . on the day after the last drug or vehicle treatment , the mice are placed in the open field in the presence of a resident intruder mouse and the animal &# 39 ; s behavior recorded by videotape for 10 min . the videotapes are then scored for the total time each mouse spent during a 10 min period in specified open - field quadrants . the total time ( sec ) spent by mice representing each drug treatment group in the interaction zone in proximity to the resident intruder mouse or , in the corner zones , at a distance from the intruder mouse is expressed as a mean (± sem ). decreased social function is a core feature of the ‘ negative ’ symptoms of schizophrenia that are poorly addressed by existing antipsychotic medications . the social defeat / resident intruder model can be used to measure social isolation behavior in rodents . isolation behavior has been shown to be reversed using this model , after chronic administration of anti - depressant medications with potent sert activity , including fluoxetine ( berton et al ., science ( 2006 ) 311 : 864 - 868 ). neither acute administration of anti - depressant medications or chronic treatment with anti - anxiety medications , like chlordiazepoxide , are similarly effective in this paradigm ( berton et . al ., science ( 2006 ) 311 : 864 - 868 ). thus , the model has been proposed for the identification of compounds to address social isolation behavior , such as social isolation behavior resulted from repeated stress . this assay is therefore used to demonstrate reversal of social isolation behavior . in the experiment described or similarly described above , mice are subjected to exposure to an aggressive resident intruder mouse in the social defeat / resident intruder paradigm as described in berton et al ., science ( 2006 ) 311 : 864 - 868 . they are then dosed chronically , once daily for 30 d , with either vehicle or compound a ( 1 mg / kg , ip ) in vehicle . on the day after the last drug or vehicle treatment the mice are placed in the open field in the presence of a resident intruder mouse and the total time each mouse spent during a 10 min period in defined open - field quadrants in close proximity to the intruder or in isolation to the intruder is measured . as anticipated , exposure to the aggressor mouse significantly reduced the amount of time resident mice spent in proximity to the intruder ( p & lt ; 0 . 0 . 05 compared with vehicle ). however , mice treated with compound a following exposure to the intruder paradigm , showed no significant reduction in time spent in proximity to the intruder ( ns , compared with compound a alone ). compound a treatment alone did not result in differences in time spent in the interaction zone , compared with untreated control mice . the data indicate that chronic treatment with compound a results in a reversal of social defeat behavior comparable to that seen after chronic treatment with anti - depressant medications such as fluoxetine . this experiment shows that compound a is effective in reversing social isolation resulted from repeated stress . this experiment also shows that compound a has functional anti - depressant activity .

use of particular substituted heterocycle fused gamma - carboline compounds as pharmaceuticals for the treatment of agitation , aggressive behaviors , posttraumatic stress disorder or impulse control disorders .

the operating environment of the present invention is described with respect to a four - slice computed tomography ( ct ) system . however , it will be appreciated by those of ordinary skill in the art that the present invention is equally applicable for use with single - slice or other multi - slice configurations . moreover , the present invention will be described with respect to the detection and conversion of x - rays . however , one of ordinary skill in the art will further appreciate , that the present invention is equally applicable for use with other imaging modalities , such as magnetic resonance imaging ( mri ), positron emission tomography ( pet ), or x - ray . referring to fig1 and 2 , a computed tomography ( ct ) imaging system 10 is shown as including a gantry 12 representative of a “ third generation ” ct scanner . gantry 12 has an x - ray source 14 that projects a beam of x - rays 16 toward a detector array 18 on the opposite side of the gantry 12 . detector array 18 is formed by a plurality of detectors 20 which together sense the projected x - rays that pass through a medical patient 22 . each detector 20 produces an electrical signal that represents the intensity of an impinging x - ray beam and hence the attenuated beam as it passes through the patient 22 . during a scan to acquire x - ray projection data , gantry 12 and the components mounted thereon rotate about a center of rotation 24 . rotation of gantry 12 and the operation of x - ray source 14 are governed by a control mechanism 26 of ct system 10 . control mechanism 26 includes an x - ray controller 28 that provides power and timing signals to an x - ray source 14 and a gantry motor controller 30 that controls the rotational speed and position of gantry 12 . a data acquisition system ( das ) 32 in control mechanism 26 samples analog data from detectors 20 and converts the data to digital signals for subsequent processing . an image reconstructor 34 receives sampled and digitized x - ray data from das 32 and performs high speed reconstruction . the reconstructed image is applied as an input to a computer 36 which stores the image in a mass storage device 38 . computer 36 also receives commands and scanning parameters from an operator via console 40 that has a keyboard . an associated cathode ray tube display 42 allows the operator to observe the reconstructed image and other data from computer 36 . the operator supplied commands and parameters are used by computer 36 to provide control signals and information to das 32 , x - ray controller 28 and gantry motor controller 30 . in addition , computer 36 operates a table motor controller 44 which controls a motorized table 46 to position patient 22 and gantry 12 . particularly , table 46 moves portions of patient 22 through a gantry opening 48 . the present invention provides an apparatus and method of simulating cardiac motion for use with an imaging scanner , such as a ct system . referring to fig3 the cardiac motion simulator 100 includes a phantom 102 . phantom 102 is formed of an expandable material and includes a hollowed center region 104 and a number of tubular protrusions 106 . in a preferred embodiment , there are four tubular protrusions 106 corresponding to the four chambers of a human heart . protrusions 106 may be fastenly connected to an outer surface of the center region 104 or seamlessly connected , i . e ., the protrusions 106 and the center region 104 formed as a single unitized structure . however , the inlets 108 of the tubular protrusions must be in fluid communication with the outlets 110 of the center region 104 . phantom 102 further includes a fluid inlet 112 that fluidly communicates with center region 104 . simulator 100 further includes a pump 114 configured to supply fluid to the phantom 102 from a fluid reservoir 116 via supply / discharge pipe 118 . to mimic cardiac motion , the pump cyclically circulates fluid between the phantom 102 and the reservoir 116 . in a preferred embodiment , the cyclical circulation of fluid between phantom 102 and reservoir 116 are such that the volume changing phases of the heart are simulated . that is , the pump circulates the fluid to mimic a slow empty phase , a rapid empty phase , a change - over to filling phase or pause phase , a rapid filling phase , a slow filling phase , and a change - over to empty phase or pause phase . typically , the rapid filling phase fills the phantom with fluid at a speed twice that of the slow filling phase . conversely , the rapid empty phase discharges fluid from the phantom at a speed 50 % slower than the fast filling phase . these values are simply one preferred embodiment and are used for illustrative purposes only and are not intended to limit the scope nor the breadth of the present invention . simulator 100 further includes a controller 118 configured to transmit modulating signals to the pump thereby instructing the pump to circulate fluid between phantom 102 and reservoir 116 . the controller 118 may include a computer program that automatically causes the pump to circulate fluid to the phantom and reservoir , but also may transmit operator entered parameters to the pump 114 . for example , controller 118 may include a computer program that automatically randomly varies the aforementioned phases to more accurately reflect cardiac motion . additionally , a user such as a researcher or design engineer may wish to simulate varied cardiac motion and therefore may input cardiac motion data directly to the controller using a keypad and / or keyboard . other known data input techniques and modules are contemplated and are within the scope of the present application . accordingly , the present invention includes an algorithm for simulating cardiac motion for use with an imaging system . the present invention contemplates both a method of simulating cardiac motion and a computer program implementing the steps of the method , and both will be discussed with reference to fig4 . the algorithm begins at 150 with positioning of the phantom within a field - of - view of the scanner 152 . once positioned in the scanner 152 , the phantom is filled with fluid such as water at 154 . a data acquisition sequence is then initialized at 156 followed by a slow emptying of the water from the phantom at 158 . in a preferred embodiment the slow emptying phase 158 lasts for 100 ms . per 1 , 000 ms . of total phase time . following the slow emptying phase 158 , water is rapidly drained fromm the phantom at 160 for a period of 150 ms . per 1 , 000 ms . after rapidly emptying the phantom at 160 , the algorithm pauses at 162 for a period of 50 ms . per 1 , 000 ms . as the algorithm changes over fromm the emptying phase to the filling phase . thereafter at 164 , the phantom is rapidly filled with water for a period of 100 ms . per 1 , 000 ms . followed at 166 by a slow filling phase lasting 500 ms . per 1 , 000 ms . at 168 , the algorithm determines if simulation of cardiac motion is to continue . that is , if simulation is complete 168 , 170 , an image is reconstructed of the phantom at 172 in accordance with known imaging techniques whereupon the algorithm ends at 174 . however , if cardiac motion simulation is not complete and is to be repeated 168 , 176 , the algorithm pauses at 178 for a period of 100 ms . per 1 , 000 ms . to accommodate changing over to the emptying phase fromm the filling phase . following pausing 178 , the algorithm begins anew at 158 with the slowly emptying of water from the phantom . it should be noted that imaging data is continuously acquired during emptying / filling phases 158 - 166 . the time period associated with each phase 158 - 166 is for illustrative purposes only and is not intended to limit the scope or breadth of the instant application . moreover , the present invention contemplates varying of circulation phases 158 - 166 fromm cycle to cycle , and such variation may be as much as 20 % in a preferred embodiment to more precisely simulate cardiac motion of a patient &# 39 ; s heart . the amount of variation however is preferably random and based upon a uniform distribution . additionally , the algorithm of fig4 contemplates using analyzed ekg traces from a real patient to determine the phase times for acts 158 - 166 . by using actual ekg data , the algorithm may more accurately reflect actual cardiac motion thereby providing more reliable and resourceful data for image reconstruction and subsequent software development . that is , the final reconstructed image of the cardiac phantom is analyzed to determine what changes , if any , should be made to the imaging protocol so that artifact free images result . the present invention contemplates evaluation of the imaging protocols using the cardiac phantom during the protocol development stage as well as during onsite clinical trials of the imaging protocol . in accordance with one embodiment of the present invention , a dynamic cardiac phantom is provided and includes a hollow chamber made of a pliable material to expand and contract based on an injection and discharge of fluid therein . the dynamic cardiac phantom further includes at least one inlet connected to the hollow chamber at one end and having another end connectable to a fluid source to inject and discharge fluid into the hollow chamber in a manner to simulate cardiac motion . in accordance with another embodiment of the present invention , a cardiac motion simulator for use with an imaging system is provided and includes a balloon having an inlet and a plurality of outlets . the inlet is configured to at least receive fluid and preferably discharge fluid as well . a plurality of tubes corresponding in number to the plurality of outlets of the balloon is also provided . each tube includes an inlet connected to an outlet of the balloon wherein the plurality of tubes is further configured to receive fluid exiting the plurality of balloon outlets . further , the balloon is configured to expend upon receipt of fluid and retract upon discharge of fluid to mimic cardiac motion . in accordance with yet another embodiment of the present invention , a computer program for mimicking cardiac motion has instructions to supply fluid to an expandable chamber having a number of expandable tubes connected thereto . the computer program further includes instructions to slowly empty fluid from the expandable chamber and rapidly empty fluid from the expandable chamber . the computer program has further instructions to rapidly supply fluid to the expandable chamber and slowly supply fluid to the expandable chamber . in a further embodiment of the present invention , a method of phantomming cardiac motion for use with a scanner is provided . the method includes the step of connecting a balloon having an inlet and a number of tubular protrusions to a fluid reservoir . the method further includes the steps of filling the balloon with fluid and circulating fluid to and fro the balloon . imaging data is then acquired of the balloon during circulation of the fluid to and from . in yet a further embodiment of the present invention , a computer tomography system having a rotatable gantry having an opening is provided . the ct system further includes a high frequency electromagnetic energy projection source configured to project high frequency energy toward an object and a scintillator ray having a plurality of scintillators to receive high frequency electromagnetic energy attenuated by the object . a photodiode ray is also provided and includes a plurality of photodiodes wherein the photodiode ray is coupled to the scintillator ray and configured to detect light energy emitted therefrom . a plurality of electrical interconnects are configured to transmit photodiode outputs to a data processing system and a computer is also provided to produce a visual display based upon the photodiode outputs transmitted to the data processing system . the object is defined to include an expandable balloon having a number of tubular protrusions and an inlet configured to receive circulating fluid such that circulation of the fluid simulates cardiac motion . the present invention has been described in terms of the preferred embodiment , and it is recognized that equivalents , alternatives , and modifications , aside from those expressly stated , are possible and within the scope of the appending claims .

an apparatus and method for simulating cardiac motion for use with an imaging system are provided . the apparatus includes an expandable balloon - like member having a number of protrusions fluidly connected thereto . fluid is circulated between the pump and a fluid reservoir by a pump which is controlled by a programmable controller . imaging data is acquired during circulation of the fluid between the reservoir and the phantom and subsequently analyzed to determine the effectacy and efficiency of the imaging protocol .

as hydrophilic , non - biodegradable polymers , polyethyleneoxide and / or copolymer of peo / ppo of m . w . 600 - 30 , 000 , preferably 2 , 000 - 10 , 000 , can be used . the polymers less than m . w . 2 , 000 show low flexibility and processiblility , and the polymers more than m . w . 10 , 000 are hard to be excreted through kidney . to synthesize the peo multi - block linked by biodegradable chemical linkage ( x ), polyethylene glycol ( peg ) derivatives substituted by various functional groups are used , for example , ho --( ch 2 ch 2 o ) n -- h , o 2 nc 6 h 4 oco -- o --( ch 2 ch 2 o ) n -- co 2 c 6 h 4 no 2 , ho 2 cch 2 ch 2 o --( ch 2 ch 2 o ) n -- ch 2 ch 2 co 2 h , ho 2 cch 2 o --( ch 2 ch 2 o ) n -- ch 2 co 2 h , ho --( ch 2 ch 2 o ) n -- ch 2 co 2 h , ho --( ch 2 ch 2 o ) n -- conhch 2 co 2 h , h 2 n --( ch 2 ch 2 o ) n h , h 2 nnhcoch 2 --( ch 2 ch 2 o ) n -- h , and h 2 nch 2 coo --( ch 2 ch 2 o ) n -- h . by coupling the above peg derivatives , the biodegradable peo multi - block is synthesized . as hydrophobic , biodegradable , crystallizable and non - swellable polymers , polylactide ( pla ), polyglycolide ( pga ), polycaprolactone ( pcl ), and / or their copolymers can be used . copolymers having various number of branches can be obtained by the chemical linkage ( y ) between block ( a ) and block ( b ). the preferred type of block copolymers of the present invention can be shown as following formula ( i ) and ( i &# 39 ;) [ h --( ochr . sub . 1 coochr . sub . 2 co ). sub . m -- o ( ch . sub . 2 ). sub . z ]. sub . l -- y -- a -- y &# 39 ;--[( ch . sub . 2 ). sub . z o --( cochr . sub . 1 oc (= o ) chr . sub . 2 o ). sub . m -- h ]. sub . l ( i ) a shows hydrophilic multi - block copolymer as --[--( och 2 ch 2 ) n -- x ] k --( ch 2 ch 2 o ) n --; x shows -- o ( co ch 2 o ) x --, -- o [ coch ( ch 3 ) o ] x --, -- och 2 conh --, -- och 2 ch 2 conh --, or -- oconh --; r 1 and r 2 shows each independently hydrogen or methyl ; k shows the integer 0 to 50 . the weight of the peo block lies between five ( 5 ) and ninety five ( 95 ) percent ( w / w ) of the multiblock copolymer . the preparation method of multi - block copolymers of the present invention can be explained as follows . 1 eq . of carboxymethyl polyethylene glycol [ ho 2 cch 2 o ( ch 2 ch 2 o ) n -- ch 2 co 2 h ] of m . w . 600 - 30 , 000 , 2 eq . of polyethylene glycol ( peg ) of m . w . 600 - 30 , 000 and 2 eq . of dicyclohexanediamine are laid on well dried reactor , and reacted in the presence of proper organic solvent . after filtration , filtered material is precipitated in non - polar solvent . finally , hydrophilic multi - block copolymer ( a ) having ester linkage ( x ) is obtained . 1 eq . of peg of m . w . 600 - 30 , 000 and 2 . 5 eq . of p - nitrophenylchloroformate ( npc ) or carbonyl di imidazole ( cdi ) are dissolved in organic solvent , and 2 . 5 eq . of base , such as , triethylamine or pyridine is added and reacted . reacted material is filtered arid added to non - polar solvent . polyethylene glycol , both ends hydroxyl groups of which are protected by npc , ( npc - peg - npc ) is precipitated . 1 eq . of dried npc - peg - npc and 2 eq . of α - amino - ω - hydroxy polyethylene glycol ( h 2 n - peg - oh ) are reacted and filtered . after precipitating in non - polar solvent , hydrophilic multi - block copolymer ( a ) having carbamate linkage ( x ) is obtained . the same process described above is repeated , using the peg derivatives , both ends hydroxyl groups of which are replaced by various functional groups . the hydrophilic multi - block copolymers ( a ) having various biodegradable linkages , such as , amide , ester , carbonate and / or carbamate linkage are obtained . both ends hydroxyl groups of hydrophilic multi - block copolymers obtained above are activated by p - nitrophenylchloroformate ( npc ) or carbonyl diimidazole ( cdi ). after activation , obtained copolymer is reacted with tris ( hydroxyalkyl ) aminomethane in polar solvent , and reacted material is precipitated in non - polar solvent . three ( 3 ) hydroxyl groups in both ends of polymer are introduced , which can be detected by nmr proton peaks ( 3 . 22 ppm ). 1 eq . of peo multi - block copolymer having both ends hydroxyl groups obtained above is laid on well - dried reactor , and dissolved in thf solvent . and , 0 . 05 - 0 . 5n of potassium - naphthalene solution is added to tile reactor . when the potassium - naphthalene solution is added in the same equivalent amount of hydroxyl groups of the copolymer , the color of the solution disappears from pale green . at the same time of color disappearance , a required amount of glycolide or lactide , monomer of hydrophobic block , is added and polymerized . finally , the biodegradable hydrogel copolymer of the present invention is obtained . as described above , the multi - block copolymer of the present invention comprises i ) hydrophilic middle block which is linked by biodegradable linkage among peos or copolymers of peo / ppo , and ii ) hydrophobic both end blocks comprise pla , pga , pgla , pcl and / or their copolymers . by changing the m . w . or components of each block , various type of thermoplastic , biodegradable hydrogel copolymers can be prepared . therefore , various copolymers can be easily synthesized according to the present invention . the present invention can be explained more specifically by following examples , but it is not limited by following examples . 1 mmole of polyethylene glycol ( peg ) of m . w . 3 , 400 , 2 . 5 mmole of p - nitrophenylchloroformate ( npc ), 200 ml of thf and 2 . 5 mmole of pyridine were laid on well - dried reactor , and stirred for 24 hours . after filtration , filtered material was precipitated in ether . polyethylene glycol , both ends hydroxyl groups of which are protected by npc , ( npc - peg - npc ) was obtained . 1 mmole of dried npc - peg - npc and 2 mmole of α - amino - ω - hydroxy polyethylene glycol ( h 2 n - peg - oh ) were laid on well - dried reactor , and reacted for 48 hours . finally , triblock peo was obtained . the yield of transformation detected by gpc is 79 . 2 %. 1 mmole of triblock peo obtained above , 3 mmole of npc and thf or dmso as solvent were mixed , and 3 mmole of pyridine as base was added with stirring . after stirring for 24 hours at room temperature , the reacted material was filtered , and precipitated in ether . triblock peo , both ends of hydroxyl groups of which are protected by npc , ( npc - peo - peo - peo - npc ) was obtained . 0 . 1 mmole of dried npc - multiblock peo , 0 . 2 mmole of tris ( hydroxymethyl ) aminomethane and dmso as solvent were mixed and reacted for 24 hours . reacted material was precipitated in ether , and obtained polymer was washed by excessive water to remove the unreacted tris ( hydroxymethyl ) aminomethane . the obtained copolymer showed proton peak of hydroxyl group at 3 . 22 ppm by nmr ( dmso - d 6 ) analysis . and , the amount of hydroxyl end group measured by neutralization method showed 4 . 8 - 5 . 2 meq ./ g , and m . w . of obtained copolymer was 10 , 600 . the tris - multiblock peo was obtained as the same process of example 1 except that 1 mmole of peg of m . w . 2 , 000 and 2 mmole of α - amino - ω - hydroxy polyethylene glycol ( h 2 n - peg - oh ) were used . the obtained copolymer showed proton peak of hydroxyl group at 3 . 22 ppm by nmr analysis , and the amount of hydroxyl end group showed 5 . 0 - 5 . 5 meq ./ g . ( m . w .= 6 , 500 ) the tris - multiblock peo was obtained as the same process of example 1 except that 1 mmole of peg of m . w . 3 , 000 and 2 mmole of α - amino - ω - hydroxy polyethylene glycol ( h 2 n - peg - oh ) were used . the obtained copolymer showed proton peak of hydroxyl group at 3 . 22 ppm by nmr analysis , and the amount of hydroxyl end group showed 5 . 0 - 5 . 5 meq ./ g . ( m . w .= 9 , 500 ) the tris - multiblock peo was obtained as the same process of example 1 except that 1 mmole of peg of m . w . 5 , 000 and 2 mmole of α - amino - ω - hydroxy polyethylene glycol ( h 2 n - peg - oh ) were used . the obtained copolymer showed proton peak of hydroxyl group at 3 . 22 ppm by nmr analysis , and the amount of hydroxyl end group showed 4 . 0 - 4 . 5 meq ./ g . ( m . w .= 15 , 600 ) 0 . 1 mmole of tris - multiblock peo ( m . w .= 10 , 600 ) obtained in example 1 was laid on well - dried reactor , and dissolved in thf solvent . and , 0 . 6 mmole of 0 . 1n - potassium naphthalene solution was added . when the color of the solution disappeared from pale green , l - lactide as same weight of tris - multiblock peo was added . after reaction for 30 minutes , small quantity of acetic acid dissolved in ether was added for finishing the reaction . after precipitating in cool methanol , the precipitated material was laid in a refrigerator for one day , and obtained material was filtered and dried in vacuum . the composition of above obtained copolymer showed tris - multiblock peo : pla = 1 : 1 . 06 . the proton peaks of lactide in nmr showed at 5 . 16 and 1 . 56 ppm , and the proton peak of oxyethylene (-- ch 2 ch 2 o --) showed at 3 . 64 ppm . number average molecular weight was 22 , 000 . the copolymer was obtained as the same process of example 5 except that tris - multiblock peo obtained in example 2 ( m . w .= 6 , 500 ) and l - lactide were used in weight ratio ( 1 : 1 . 7 ). number average molecular weight of obtained copolymer was 18 , 000 . the copolymer was obtained as the same process of example 5 except that tris - multiblock peo obtained in example 3 ( m . w .= 9 , 500 ) and l - lactide were used in weight ratio ( 1 : 1 . 2 ). number average molecular weight of obtained copolymer was 22 , 000 . the copolymer was obtained as the same process of example 5 except that tris - multiblock peo obtained in example 4 ( m . w .= 15 , 600 ) and l - lactide were used in weight ratio ( 1 : 0 . 7 ). number average molecular weight of obtained copolymer was 17 , 000 . 3 mmole of polyethylene glycol ( peg ) of m . w . 3 , 400 , 1 . 5 mmole of α , ω - carboxy methyl peg [ ho 2 cch 2 o ( ch 2 ch 2 o ) n -- ch 2 co 2 h ] and thf as solvent were laid on well - dried reactor , and stirred for 24 hours at room temperature . after filtration , filtered material was precipitated in ether . triblock peo linked by ester linkage was obtained . 1 mmole of dried triblock peo , 2 mmole of p - nitrophenyl chloroformate ( npc ), 2 mmole of pyridine and thf as solvent were mixed and stirred for 48 hours . reacted material was filtered , and precipitated in ether . triblock peo , both ends of hydroxyl groups of which are protected by npc , ( npc - peo - peo - peo - npc ) was obtained . 0 . 1 mmole of dried npc - multiblock peo , 0 . 2 mmole of tris ( hydroxymethyl ) aminomethane and dmso as solvent were mixed and reacted for 24 hours . reaction mixture was precipitated in ether , and obtained polymer was washed by excess water to remove the unreacted tris ( hydroxymethyl ) aminomethane . the obtained copolymer showed proton peak of hydroxyl group at 3 . 22 ppm and proton peak of -- och 2 c -- at 5 . 19 ppm by nmr ( dmso - d 6 ) analysis . and , the amount of hydroxyl end group measured by neutralization method showed 4 . 7 - 5 . 0 meq ./ g , and m . w . of obtained copolymer was 10 , 500 . the tris - multiblock peo was obtained as the same process of example 9 except that peg of m . w . 2 , 000 and α , ω - carboxy methyl peg of m . w . 2 , 000 were used . the obtained copolymer showed proton peak of hydroxyl group at 3 . 21 ppm and proton peak of -- och 2 c -- at 5 . 20 ppm by nmr analysis , and the amount of hydroxyl end group showed 5 . 8 - 6 . 2 meq ./ g . ( m . w .= 6 , 600 ) the tris - multiblock peo was obtained as the same process of example 9 except that peg of m . w . 3 , 000 and α , ω - carboxy methyl peg of m . w . 3 , 000 were used . the obtained copolymer showed proton peak of hydroxyl group at 3 . 21 ppm and proton peak of -- och 2 c -- at 5 . 21 ppm by nmr analysis , and the amount of hydroxyl end group showed 4 . 6 - 5 . 1 meq ./ g . ( m . w .= 9 , 300 ) the tris - multiblock peo was obtained as the same process of example 9 except that peg of m . w . 5 , 000 and α , ω - carboxy methyl peg of m . w . 5 , 000 were used . the obtained copolymer showed proton peak of hydroxyl group at 3 . 21 ppm and proton peak of -- och 2 c -- at 5 . 21 ppm by nmr analysis , and the amount of hydroxyl end group showed 4 . 0 - 4 . 5 meq ./ g . ( m . w .= 15 , 400 ) 0 . 1 mmole of tris - multiblock peo ( m . w .= 10 , 500 ) obtained in example 9 was laid on well - dried reactor , and dissolved in thf solvent . and , 0 . 6 mmole of 0 . 1n - potassium naphthalene solution was added . when the color of the solution disappeared from pale green , l - lactide as 1 . 5 times weight of tris - multiblock peo was added . after reaction for 30 minutes , small quantity of acetic acid dissolved in ether was added for finishing the reaction . after precipitating in cool methanol , the precipitated material was laid in a refrigerator for one day , and obtained material was filtered and dried in vacuum . the composition of above obtained copolymer showed tris - multiblock peo : pla = 1 : 1 . 57 . the proton peaks of lactide in nmr showed at 5 . 20 and 1 . 56 ppm , and the proton peak of oxyethylene (-- ch 2 ch 2 o --) showed at 3 . 64 ppm . number average molecular weight was 27 , 000 . the copolymer was obtained as the same process of example 13 except that tris - multiblock peo obtained in example 10 ( m . w .= 6 , 600 ) and l - lactide were used in weight ratio ( 1 : 2 . 6 ). number average molecular weight of obtained copolymer was 17 , 000 . the copolymer was obtained as the same process of example 13 except that tris - multiblock peo obtained in example 11 ( m . w .= 9 , 300 ) and l - lactide were used in weight ratio ( 1 : 1 . 7 ). number average molecular weight of obtained copolymer was 25 , 000 . the copolymer was obtained as the same process of example 13 except that tris - multiblock peo obtained in example 12 ( m . w .= 15 , 400 ) and l - lactide were used in weight ratio ( 1 : 1 ). number average molecular weight of obtained copolymer was 32 , 000 .

this invention concerns the thermoplastic , biodegradable and nontoxic block copolymer which is easily degraded and excreted in human body by the hydrolysis of intramolecular ester and amide bond . the structure of present copolymer comprises i ) hydrophilic and swellable soft domain consisting of polyethyleneoxide , and ii ) hydrophobic , biodegradable , crystallizable and non - swellable hard domain consisting of polylactide , polyglycolide , polylactideglycolide and polycaprolactone .

the present invention relates to a method and system for quantitatively estimating the cardiovascular performance reserve of a patient , a method to measure it , according which it may indicate the cardiovascular performance status and predict the cardiovascular performance related diagnosis . the invention in at least one exemplary embodiment includes a device and method capable of calculating in real time a cardio - vascular reserve index ( cvri ) which indicates quantitatively how much cardio - vascular performance reserve is left to an individual subject at the exact moment and condition of measurement — either at rest or under enhance physical activity or under any provocative intervention or during a disease or other medical condition . this allows gaining more timely information indicating the patient &# 39 ; s cardiovascular performance reserve condition . the cvri can also provide a trend indication whether an individual is improved , deteriorated or even approaching a cardiovascular collapse ( shock ). the present invention is adaptable for use by medical emergency personnel or medics in any setting , such as road accident , disaster sites , combat zones , caregiver office , sport medicine or hospitals . the systems and methods of the present invention allow better , simpler , immediate and more accurate evaluation and diagnosis of any of the above mentioned settings . the systems and methods of the present invention also enable decision making support by health care providers confronting mass casualty event , regarding triage , namely which patient to treat or to evacuate earlier than the others . an additional advantage provided by the invention is the real time displaying and documenting the cvri of a patient or of a plurality of patients . this is important in many cases inasmuch as there is a plurality of injured patients , rendering it difficult for the medical crew to determine which patient they should treated earlier . the figures and the following description relate to embodiments of the present invention by way of illustration only . it should be noted that from the following discussion , alternative embodiments of the structures and methods disclosed herein will be readily recognized as viable alternatives that may be employed without departing from the principles of the claimed invention . cardiovascular reserve is a term frequently used but the meaning was inconclusive . the embodiments of the present invention provides a novel cardiovascular paradigm according which healthy subjects , heart failure patients of diverse severities and shock of different types represent different placing along the cardiovascular performance reserve scale . the method of the present invention is based on our conceptual insight of what cardiovascular performance related morbidities are . the underlying assumption is that the cardiovascular reserve at rest of a healthy subject is maximal . heart failure patient may have reduced cardiovascular reserve at rest ( proportional to the heart failure severity ). each subject at rest can perform physical activity and may increase it until reaching cardiovascular exhaustion . exhaustion is , according our paradigm , a reversible debilitating condition that disabled further increase or even maintaining the present physical activity level . healthy subject reaches that exhaustion level only following intensive physical activity while heart failure patient will reach exhaustion level at milder efforts which we may refer to as premature cardiovascular exhaustion . in order to determine the best course of therapy , physicians often assess the stage of heart failure according to the new york heart association ( nyha ) functional classification system ( the criteria committee of the new york heart association , “ nomenclature and criteria for diagnosis of disease of the heart and great vessels ”, 9th edition , boston , mass . : little , brown & amp ; co ; 1994 : 253 - 256 ). this classification relates symptoms to the patient capability to perform everyday activities ( i . e . based on the patient anamnesis ). we expect heart failure patient nyha class i to be capable of performing considerable effort very closed to healthy subject before reaching exhaustion , while nyha class iv patient is expected to be capable to perform only mild exercise before reaching exhaustion . in general we refer to “ heart failure ” as “ reduced cardiovascular performance reserve ” proportional to the severity of heart failure which reaches exhaustion earlier ( premature exhaustion ). under the same conceptual assumption the term “ shock ” with respect to the cardiovascular performance reserve is further deterioration on the cardiovascular reserve scale which had reached cardiovascular insufficiency . shock is an unsustainable condition , non reversible spontaneously , i . e . unless intervene to correct would undergo a devastating chain of events until death . we assumed that each of these conditions can be placed in ordinal order on the cardiovascular performance reserve scale . fig1 presents graphically the dependence of the expected cardiovascular performance reserve on heart failure severity and exercise intensity according our conceptual hypothesis . the graphical expression of the conceptual hypothesis of cardiovascular performance reserve resembles low frequency heart rate variability ( lf - hrv ) power decrease on physical activity and with morbidity ( heart failure ) [ malpas s c , neural influences on cardiovascular variability : possibilities and pitfalls in am j physiol heart circ physiol . 2002 ; 282 : h6 - h20 ]. the overall principle can be summarized as the severer the morbidity the lower the cardiovascular reserve and the intensified the physical activity the lower the cardiovascular reserve left . we assume that given our conceptual hypothesis is true , then there must be an underlying measurable hemodynamic characteristic or parameter which its respective values place these conditions accordingly on the cardiovascular performance reserve scale as the conceptual hypothesis had predicted . before further describing our work we recall some relevant hydrodynamic variables , their definitions and relationships which are already known : svr [ dynes * sec − 1 * cm − 5 ]— systemic vascular resistance ( also known as tpr total peripheral resistance ) cvp [ mmhg ]— central vein pressure ( which is considered as approximation of rap ] in which p ( t ) is the instantaneous actual arterial blood pressure as measured in invasive blood pressure measurements , dynamically ranges between sbp and dbp , and t is the time span . simpler estimates of mabp may be used as regard with non - invasive blood pressure measurements . it is common to assume that mabp is approximated by the following formula : ( 1 ) mabp ≈ dbp +( sbp − dbp )/ 3 ( see cardiovascular physiology concept . editor klabunde r e , second edition , lippincott williams & amp ; wilkins , 2011 ) it should be noted that mabp approximation depends on the pulse pressure curve shape and on heart rate ( see murray w b , gorven a m , “ invasive v . non - invasive blood pressure measurements — the influence of the pressure contour ”, s . afr . med . j . 1991 ; 79 : 134 - 9 ) so the approximation of mabp in formula ( 1 ) may be deviated . some relationships between the hemodynamic parameters are already known based on physical principles . by simplifying darcy &# 39 ; s law ( darcy h . les “ fontaine publiques de la ville de dijon ”, dalmont , paris . 1856 ), we get the equation : there are several approximate expressions of bsa , for example mosteller formula ( mosteller r d , “ simplified calculation of body surface area ”, n . engl . j . med . 1987 ; 317 : 1098 ): it is a common practice to normalize some of the hemodynamic parameters by bsa . in order to identify the above mention underlying parameter according to our conceptual hypothesis we had allocated the specific hemodynamic parameter representative / average value for a diversity of conditions ( such as healthy subject at rest , heart failure patients of different severity levels , different levels of exercise of healthy subjects and heart failure patients , as well as different types of shock ). we evaluated each of the hemodynamic parameters &# 39 ; capability to discriminate and organized the conditions on ordinal order ( by morbidity level and physical activity intensity as predicted ) by which , at rest , healthy subject is placed on one end and shock on the other hand ( as shock patient can be considered incapable of exercise ). as for exercise , healthy subject is placed on one end and the severer heart failure on the other end . moreover we expect ordinal decrease by exercise intensity . we evaluated each hemodynamic parameter in order to realize whether it can solely places the above mention conditions on the cardiovascular reserve scale according our conceptual hypothesis . some of which are for example co and ef which frequently considered predictive to cardiovascular performance : fig2 presents cardiac output ( co ) dependency by physical activity intensity and by heart failure severity . as can be clearly evident co failed to play the role of cardiovascular performance reserve measure since it failed to discriminate and place the different conditions in ordinal order as expected by the conceptual hypothesis . fig3 presents ejection fraction ( ef ) dependency by physical activity intensity and by heart failure severity . as can be clearly evident ef failed to play the role of cardiovascular reserve measure since it failed to discriminate and place the different conditions in ordinal order . as neither of the individual hemodynamic parameters complied with our cardiovascular reserve hypothesis we analyzed the combination of hemodynamic parameters . reference will now be made to several embodiments of the present invention , examples of which are illustrated in the accompanying figures . wherever practicable similar or like reference numbers may be used in the figures and may indicate similar or like functionality . the figures depict embodiments of the present invention or show relevant graphs for purposes of illustration only . one skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the invention described herein . while plotting the different conditions according their representative sv values on y axis and their representative svr values on x axis , we had realized that the different types of shock were located differently though not randomly , but rather draw a hyperbolic like curve ( as shown in fig4 ). taking the insight of the hyperbolic curves further we realized that the product sv * svr defined various hyperbolic iso - product ( i . e . sv * svr ) curves . at rest a healthy subject is on the highest iso - product curve and all types of shock are on different locations on the lowest . while exercising a healthy subject moves from right to left and accordingly from a higher iso - product curve to a lower one . a heart failure patient at rest is already on a lower iso - product curve ( lower than the healthy one ) and he moves further to a lower iso - product curve while exercising . the intensified the exercise , the lower the placing on a sv * svr iso - product curve until reaching an exhaustion &# 39 ; s curve . a heart failure patient that is anyhow on a lower iso - product curve at rest reaches exhaustion curve earlier ( premature exhaustion ) following milder physical activity intensity ( which is reciprocal to his heart failure severity ). however the exhaustion curve is identical to all conditions . hence , we had concluded that the cardiovascular reserve measure may be proportional to the product of both sv × svr . interestingly this product ( sv × svr ) is proportional to the “ open loop gain ” of the baro - receptor control loop model ( dvir h , bobrovsky b z , gabbay u . “ a novel heart rate control model provides insights linking lf - hrv behavior to the open loop gain components ”. accepted for publication by ijc ). the decisive role of the “ open loop gain ” on the mechanism and behavior of the low frequency heart rate variability ( lf - hrv ) was also pointed out there , showing that high open loop gain results in high lf - hrv power . since lf - hrv power is believed to be associated with favored prognosis and vise versa , lack of lf - hrv at rest predicts bad prognosis ( kleiger r e , miller j p , bigger j t , moss a j , “ decreased heart rate variability and its association with increased mortality after acute myocardial infarction ” am . j . cardiol . 1987 ; 59 : 256 - 62 ). the importance of the open loop gain in the cardiovascular performance was further discussed in ( gabbay u , bobrovsky b z , “ hypothesis : low frequency heart rate variability ( lf - hrv ) is an input for undisclosed yet biological adaptive control , governing the cardiovascular regulations to assure optimal functioning ”, medical hypotheses . 2012 ; 78 : 211 - 12 ). an intermediate parameter z which is the product of sv by svr ( z = sv * svr ), is presented in fig5 presenting z dependency by physical activity intensity and by heart failure severity . z may play the role of cardiovascular performance reserve measure since it discriminate and place the different conditions in ordinal order as had been predicted by the conceptual hypothesis in fig1 . at rest normal subject is on one end and shock on the other end . in exercise of whatever intensity a healthy subject is on one end and heart failure on the other end . moreover the changes with exercise intensity are according to the expected . following empirical and statistical experiments we found that the cardiovascular performance reserve is best discriminated when z ( the product of sv and svr ) was also divided by respiratory rate ( rr ). cardiovascular reserve ( none standardized ) cvr is given by : while evaluating heterogeneous population , even better discrimination is gained by standardized cvr by dividing cvr by bsa and in order to normalize the measure to a scale of 1 by further dividing by 4 ( empirically ) to obtain cvri — cardiovascular reserve index as given by : if the measurement of sv and svr are known , then formula ( 6 ) may be the bottom - line formula . in most cases both sv and svr measurements are unfeasible . however , even though each of the parameters ( sv and svr ) is very difficult to be measured , we found that the product ( sv * svr ) can be calculated by using alternative parameters , thus the product sv * svr ( i . e ., the intermediate parameter z ) can be obtained and replaced by the formula [ z = 80 *( mabp − cvp )/ hr ], as will be further explained hereinafter . all the above will be better understood through the following illustrative and non - limitative description and examples . for the sake of brevity , however , the cvri calculations that were found to yield the best results and examples will be described hereinafter . the following is an exemplary method for determining an index for a patient according to an embodiment of the present invention . the method begins by receiving ( or recording depending upon the implementation ) the data from an individual that are required to obtain the following parameters : the mean arterial blood pressure ( mabp ), hr , rr and bsa . the data from the individual can be measured or obtained by different types of existing healthcare medical devices , or alternatively by a dedicated device configured to measure such data and accordingly to calculate crvi as described in further details hereinafter . substitute sv in formula ( 5 ) using formula ( 3 ) and substitute svr in formula ( 5 ) using formula ( 6 ), we get : in case of intensive care patient or any patient with both arterial line and cvp line which measure directly arterial pressure and central vein pressure respectively , then ( 7 ) may be the bottom line formula . the cvri calculations employ the cvp measurements yielded the best results and , therefore , this is one preferred method to carry out our invention , although of course less precise results can be obtained using alternative calculations , all of which are encompassed by the invention . however , given cvp is not routinely measured and given its value is generally small in comparison with mabp , the difference ( mabp − cvp ) may be estimated in several ways such as fraction ( e . g . 0 . 95 × mabp ) yielding cvri estimate as indicated by the following formula : cvp may be entirely neglected yielding cvri estimate as indicated by : or cvp may be estimated as constant ( e . g . 4 mmhg ) yielding cvri estimate as indicated by : note that in order to estimate the index despite lacking respiratory rate , rr may be estimated through hr e . g . rr = hr / 5 at rest , revealing cvri estimate : the cardiovascular index for the individual is calculated according to one of the above formulas ( 6 or 7 or 8 or 9 or 10 or 11 ) to obtain a number representing the cardio vascular performance reserve which carries diagnostic and severity estimation capabilities . the cardiovascular index is an indication of how much cardio - vascular performance reserve is preserved at the exact moment of measurement — either at rest or under enhance physical activity or under any provocative intervention or during a disease or other medical condition . the quantitative index provides a momentary diagnostic prediction ( at different conditions such as rest and different physical activity intensities ) either of being entirely preserved ( healthy subject ) or indicating reduced cardiovascular performance ( heart failure and its severity ) or cardiovascular insufficiency ( shock ) which sometimes called circulatory insufficiency , cardiovascular collapse or circulatory collapse . the quantitative index enables monitoring cardiovascular dynamics in the short term such as severely ill sepsis patient , myocardial infarction or acute heart failure patient in which severity dynamic evaluation is essential . in these patients monotonous decrease may represent a deterioration which may be the beginnings of an approaching shock even before such deterioration is manifested . it may however indicate circulatory improvement among shock patients , steady state or deterioration . the quantitative index enables long term cardiovascular performance follow - up indicating improvement , deterioration , steady state or fluctuations over time such as in chronic heart failure patient for example . in these patients identification of the overall trend may enable intervention such as replacing the existing medication or adjust dosing , which may be considered as a step forward towards personalized medication . unless otherwise indicated , the cvri calculation as described herein may be performed by executable code and instructions stored in computer readable medium and running on one or more processor - based systems as described in further details hereinafter . however , state machines , and / or hardware electronic circuits can also be utilized . similarly , while certain examples may refer to a health care monitoring systems or data health care devices , electronic medical record as well as other computer or electronic systems can be used , such as , without limitation , a network - enabled personal digital assistant ( pda ), a smart phone ( e . g ., with an operating system and on which a user can install applications ) and so on . the following is an exemplary method for determining an index for a patient based on sv , svr , rr and bsa as of formula ( 6 ) according to an embodiment of the present invention . the method begins by receiving ( or recording depending upon the implementation ) the data from an individual that are required to obtain the following parameters : the sv , svr , rr and bsa . the data from the individual can be measured or obtained by different types of existing healthcare medical devices , or alternatively by a dedicated device configured to measure such data either directly or through indirect estimation and accordingly to calculate the cvri . the index for the individual is calculated by taking the product sv * svr divided by rr , bsa and 4 to obtain cvri a number representing the cardio vascular performance diagnostic and severity estimation capabilities . the following is an exemplary method for determining an index for a patient based on mabp , cvp , hr , rr and bsa , as of formulas 7 , 8 , 9 , 10 , 11 according to an embodiment of the present invention . the method begins by receiving ( or recording depending upon the implementation ) the data from an individual that are required to obtain the following parameters : the arterial blood pressure , hr , rr and bsa . the data from the individual can be measured or obtained by different types of existing healthcare medical devices , or alternatively by a dedicated device configured to measure such data and accordingly to calculate the cvri . the index for the individual is calculated by taking the difference ( mabp − cvp ) or its estimate as in formulas 7 , 8 , 9 , 10 , 11 multiply by 20 , divided by the hr , rr and bsa to obtain cvri a number representing the cardio vascular performance reserve which carries diagnostic and severity estimation capabilities . the cardiovascular reserve index suggested by the method of the present invention as described by the above examples hereinabove is universally , normalized ( regardless of the individual age , body built , health status or gender ), quantitative , and can be computed on the basis of easy to measure , available medical measurements in any setting this evaluation is needed ( medical office , intensive care facility , hospitals , sport arena , street or battle field triage or self assessment ). an isolated cvri measurement reveals cardio vascular performance reserve which carry diagnostic and severity prediction . repeated cvri measurements over time reveal cardio vascular performance dynamics ( which indicates stability , deterioration or improvement of the cardiovascular performance reserve ). cvri may be implemented in continuous monitoring as for patient in shock , severely ill patient , or the patient in risk to deteriorate ( e . g ., acute heart failure in intensive care unit ). cvri provides long term cardio - vascular performance evaluation as for chronic heart patients on cardiologic follow - up . cvri provides home monitoring solution ( with sampling intervals according the severity ) for heart failure patients under tele - medicine care , self assessment , etc . fig6 and 7 ( bar diagram ) describe the actual cardiovascular reserve index ( cvri ) dependency by physical activity intensity and by heart failure severity , according to an embodiment of the present invention putting the respective average values of each condition for each of the invention formula variables . fig8 describes cvri dependency by different levels of hypovolemia , according to an embodiment of the present invention putting the respective average values for each of the invention formula variables . receiver operating characteristics roc is an acceptable method to evaluate diagnostic prediction (“ receiver operating characteristics curves and related decision measures : a tutorial ”, chemometrics and intelligent laboratory systems , 2006 ; 80 : 24 - 38 ). as was evident in our cases study ( based on case reports published in the literature ) cvri revealed excellent roc curve for shock prediction which was superior to si ( fig9 ). we found in our study that cvri revealed excellent roc curve for heart failure prediction ( fig1 ). throughout this description the term “ medical system ” is used to indicate an essentially medical data device / system adapted to analysis physiological measurement data . this term does not imply any particular medical field , construction material or geometry , and the invention is applicable to all suitable medical systems in any field such as intensive care unit , medical office , sport medicine , operation and intervention facilities , mass casualty arena , medical rescue team , remote evaluation , evaluation during training self assessment , inspected assessment or remote inspection , etc . as will be appreciated by the skilled person the medical system can be implemented as a dedicated standalone device or it can be embedded within common devices , such as an ambulatory electrocardiography device . the below mentioned devices are examples of existing devices which may be adapted to measure cvri . these devices measure , collect , archive or display all or some of the physiological parameters and vital signs which are utilized in cvri formula . utilizing the existing data while accomplishing the missing parameters essential to compute cvri may indeed enable calculating cvri . the missing parameters can be accomplished by diverse methods either through adding measuring unit ( for example respirometer to measure respiration rate to an automated blood pressure device ), keypad interface to input missing measurements ( weight and height to compute bsa for example ), analyzing existing data to reveal the missing parameter ( such as for example analyzing existing ecg data to reveal the respiratory rate ) etc . a combination of two bolter types : existing ecg bolter and existing blood pressure bolter produce hr and bp but lacks rr , weight and height . rr may be derived by external respiration detector or through ecg analyzing algorithm to detect respiration out of the ecg . height and weight may be input through an input interface to a processing unit . this existing test system is a combination of ecg stress test ( ergometry ) with existing pulmonary functional test which together produce hr , rr but lacks bp , weight and height . bp may derived by external automatic blood pressure device that export measurements to a processing unit . height and weight may be input through an input interface to a processing unit . this existing ecg stress test ( ergometry ) produces hr , but lacks rr , bp , weight and height . rr may be derived by external respiration detector or through ecg analyzing algorithm to detect respiration out of the ecg . bp may be derived by external automatic blood pressure device that export measurements to a processing unit . height and weight may be input through an input interface to a processing unit . this existing automated bp device produces hr , sbp and dbp but lacks mabp , rr , weight and height . rr may be derived by external respiration detector or best estimated through hr ( for example rr ≈ hr / 5 at rest ). mabp may be calculated by sbp and dbp . height and weight may be input through an input interface to a processing unit . this existing monitoring device detects hr , rr ( by different methods , such as ( i ) impedance , ( ii ) inspirium / experium detections or measurements , e . g ., co 2 measurements through the nose , temperature differences , etc . ), mabp ( e . g ., through arterial line ), and cvp ( e . g ., through central vein line ). it may lack anthropometric data such as weight and height which may be input through an input interface to the monitor processing unit . this existing monitoring device detects hr , rr , nibp ( non invasive blood pressure ) which compute mabp through sbp and dbp . it may lack anthropometric data such as weight and height which may be input through an input interface to the monitor processing unit . multi - parametric tests , such as polysomnography ( psg ), can also be adapted to calculate the cvri , if required , by adding complementary measurements such as for example rr . fig1 schematically illustrates a conceptual design of a medical system 10 that can be used in conjunction with the invention for performing the methods discussed above . the illustrated medical system 10 includes a vital sign source 11 and an analysis unit 12 in communication with the vital sign source 11 . the system 10 although illustrated with one vital sign source 11 may be expanded to include a plurality of vital sign sources connected to one individual and / or multiple individuals . in at least one exemplary embodiment , an individual would have multiple vital sign sources connected to monitor different vital signs for the system 10 . according to some embodiments of the present invention , the system can be designed or configured to handle monitoring of multiple individuals . the method of the present invention provides a simple quantitative cardiovascular measure which is unique as it can be easily computed either through invasive measurement routinely performed in intensive care facilities or through routine non - invasive vital signs . this measure indicates cardiovascular performance status and may utilized in cvri derived predictive test as for example for shock prediction and for heart failure prediction . as will be appreciated by the skilled person the arrangement described in fig1 results in an enhanced medical device , such that the implementation of at least part of the above calculations makes it possible to effectively analyze the patient condition or to provide indication of its cardiovascular status . exemplary vital sign sources ( such as the vital sign source 11 of fig1 ) may include a vital sign monitor ( or sensor ) or similar devices as described below : implementation within a monitor which displays cvri numerically ( which is physiologically meaningful ), and possibly with explicit diagnostic prediction ( such as text of “ shock ” or “ heart failure ” or “ normal ” etc .) and trends with or without graphical presentation of cvri versus time , with explicit text notification ( such as “ deterioration ” or “ improvement ” over time ). cardiovascular performance quantification and diagnostic prediction are unique and no other method had ever succeeded with . fig1 - 15 show variations of an ambulatory device that can be used in conjunction with the invention ( e . g . for medical offices or self assessment at home ). the device illustrated in these figures is particularly convenient because it can be adapted or modified to provide the cvri without the need to carry out major ( or any ) alterations in the structure . the device generally indicated by numeral 14 in the fig1 - 13 can be a traditional automatic noninvasive blood pressure / pulse measuring device , which comprises a common blood pressure cuff 18 ( fig1 ) and a data entry interface ( e . g ., a keypad 15 , or a touch sensitive screen 17 , etc . as shown in fig1 ) to enter hemodynamic and / or anthropometric related data ( such as height , weight ) and the respiratory rate ( rr ), which through embodiment of the invention output cvri and indicates the cardiovascular status . the device 14 may further comprise a display unit 17 , a control panel 16 ( which alternatively may be included in the touch sensitive element 17 ) or other common operating means as shown in fig1 . referring now to fig1 , the above device 14 is adapted to communicate also with a respiration rate detection unit counter ( e . g ., a respirometer 19 ), either via wired ( fig1 - a ) or wireless ( fig1 - b ) communication link , in order to automatically feeds the respiration rate into the device 14 . the wired connection as in fig1 - a can also supply power to the respirometer 19 . in fig1 , a traditional automatic noninvasive blood pressure / pulse measuring device 20 is shown , which interface into a portable computing device 21 ( e . g ., a pda , smart - phone , etc ). the portable computing device 21 enables : data entry of anthropometric variables manually , additional data entry such as but not limited to the patient and setting identification , medical history etc . or other relevant data ( e . g ., via i / o data port 22 ). the control function may be similar as element 16 in fig1 either directly by the pda 21 or through 20 or both . in this figure , the portable computing device 21 is in communication with the respirometer 19 . fig1 schematically illustrates an implementation of the cvri for self assessment during sporting , according to an embodiment of the present invention . in this embodiment , an extended pulse rate sport device 23 which enables input ( e . g . manually ) of height and weight and the initial blood pressure , in which the respiration rate rr is given either through an existing ecg unit 24 through dedicated analysis or through a dedicated respiratory sensor 25 ( e . g . strain gage ) embedded in the elastic band of the existing chest strap 26 . each of the above may include memory , output transmission to a control center , external computer either directly or through a network , archive or printer . flash memory enables manual transmission and direct viewing through a self operating viewer . the vital sign monitor will be in communication with an individual where in communication includes having the monitor affixed , attached , implanted , coupled , abutting the individual &# 39 ; s tissue , resident in clothing or equipment worn by the individual , and proximate to the individual . the analysis unit 12 is in communication with the vital sign source 11 through a wired connection or wireless connection such as infrared , radio , bluetooth , wi - fi , etc . where the connection can be continual , intermittent ( or on a predetermined schedule ), as needed or as permitted by the circumstances . the analysis unit 12 may be a separate component not present on the individual on whom the vital sign source 11 is present or in communication with , for example , to allow remote monitoring of the individual or monitoring during a medical event such as triage , transport , or treatment . in this implementation , the vital sign source 11 is connected to a transmitter ( and / or receiver ) 13 that allows vital sign data to be communicated to the analysis unit 12 as illustrated in the figure . alternatively , the analysis unit 12 may be located on ( or proximate to ) the individual whom the vital sign source 11 is in communication , and in this implementation an exemplary system for the analysis unit 12 to be configured as part of a given monitoring system that is capable of communicating with a remote user . if the analysis unit 12 is located on the individual , then in at least one exemplary embodiment the analysis unit 12 is connected to a corresponding transmitter ( and / or receiver ). the analysis unit 12 processes received vital sign data from the vital sign source 11 and enable anthropometric data entry either directly or through an intermediate component . it may or may not enable identification of the patient and the settings . depending upon the implementation , the set of vital sign data includes heart rate , respiratory rate and blood pressure to be able to determine the cvri . the term blood pressure refers to any measuring method of blood pressure that enable output of mabp , either invasive which compute mabp directly or non invasive which estimate mabp through sbp and dbp . the analysis unit 12 can be implemented as software on a variety of hardware computing devices including computers and pdas . the software includes the ability to process the received vital signs signals to provide as an output the desired indicators relating to cardiovascular status and to adjust cut - point level for certain predictive test aims . the software when used to implement the method of the present invention , may include notification / alarm unit to provide notification to the operator / user with an audio notification , a mechanical notification such as vibration , a visual notification including activation of a light ( s ) or via a display , either as signal , number or text ( indicate the exact status such as normal , heart failure ( which may or may not indicates its severity ) and shock . signal to another entity or device , or any combination of these if predetermined conditions occur or predetermined thresholds are exceed by a vital sign or the indicator . the analysis unit 12 in at least one exemplary embodiment is connected to a storage unit ( e . g ., a buffer , ram and disk storage , etc .) for storing data associated with its operation . it may be also transmitted through wired or wireless communication to remote location or from remote location either for telemedicine , central monitoring control or remote archiving . the invention can take the form of an entirely hardware embodiment , an entirely software embodiment or an embodiment containing both hardware and software elements . in at least one exemplary embodiment , the invention is implemented in software , which includes but is not limited to firmware , resident software , microcode , etc . furthermore , the invention can take the form of a computer program product accessible from a computer - usable or computer - readable medium providing program code for use by or in connection with a computer or any instruction execution system . for the purposes of this description , a computer - usable or computer readable medium can be any apparatus that can contain , store , communicate , propagate , or transport the program for use by or in connection with the instruction execution system , apparatus , or device . the present invention provides a comprehensive alarm system which carries physiological insight and hence it meets the need of intensive care units regarding the alarm : “ to be accurate ” and that “ it carries intelligence ” as such need is well described in the article “ alarms in the intensive care unit : too much of a good thing is dangerous : is it time to add some intelligence to alarms ?” by blum j m et . al ., crit . care med . 2010 february ; 38 ( 2 ): 451 - 6 . according to the embodiments described hereinabove the system of the present invention provides a quantified cardiovascular performance reserve measure and methods of how to measure it . moreover , the system of the present invention carries capability of diagnosis prediction ( such as normal , heart failure and its severity and shock ). cardiovascular performance quantification and diagnostic prediction are unique and no other method had ever succeeded with . the terms , “ for example ”, “ e . g .”, “ optionally ”, as used herein , are intended to be used to introduce non - limiting examples . while certain references are made to certain example system components or services , other components and services can be used as well and / or the example components can be combined into fewer components and / or divided into further components . moreover , the appearance and terminology as depicted and described herein , are intended to be illustrative and exemplary , and in no way limit the scope of the invention as claimed . while some embodiments of the invention have been described by way of illustration , it will be apparent that the invention can be carried into practice with many modifications , variations and adaptations , and with the use of numerous equivalents or alternative solutions that are within the scope of persons skilled in the art , without departing from the spirit of the invention or exceeding the scope of the claims .

the invention relates to a method for determining a cardiovascular performance reserve for each individual patient , comprising the steps of : a ) receiving input physiological data from the patient for obtaining a parameter z which is or approximates the product of the stroke volume by the systemic vascular resistance ; b ) providing a value representing the respiratory rate of said patient , wherein the respiratory rate value is provided by measurements using dedicated device , calculations from the input physiological data or manually by using best estimate ; c ) providing anthropometric data of said patient for calculating the body surface area of said individual , wherein the anthropometric data includes at least body dimensions of said patient ; d ) calculating the cardiovascular reserve by using said z parameter and said rr according to following formula : cvr =; e ) calculating a cardiovascular reserve index by standardizing said cvr and normalizing it to a scale of 1 according to the following formula : cvri = cvr /; and outputting said cardiovascular reserve index .

now with reference to the invention illustrated in the drawings and specifically fig1 an apparatus for creating a mold or template for the head , shoulder and torso region extending down to the mid thigh of the human body is shown generally by numeral 10 . the template forming apparatus consists generally of an essentially planar base 12 with an extension 42 , a head and shoulder form 14 , a pair of chest side forms 16 , a pair of side rails 24 ( shown in fig3 ), a flexible bag or container 50 , and a foaming mixture 52 . base 12 , as shown in fig2 is essentially rectangular in shape and has an upper surface 18 , although it is appreciated that a variety of alternative shapes are possible . in the preferred embodiment planar base 12 is composed of an extruded polystyrene material sufficient to support the weight of a patient for which the mold is being created . numerous other materials would be recognized as suitable by those of ordinary skill in the art . in fig2 a head and shoulder form 14 , preferably made from an expanded polystyrene material and having a width substantially equal to the width of base 12 , is attached to the upper surface 18 of planar base 12 at or near its top 20 . head and shoulder form 14 is attached to base 12 by means known in the art but preferably contact adhesive or double - sided tape products . head and shoulder form 14 may be fabricated from several pieces of polystyrene but in the preferred embodiment is fabricated from a single piece . a substantially rectangular block of polystyrene material with the appropriate forms cut out comprises head and shoulder form 14 . in one embodiment of head and shoulder form 14 , a head cavity 30 generally shaped as a human head when positioned in the supine position is created by removing a section of polystyrene from the substantially rectangular block of polystyrene . additionally , symmetrical arm channel regions 32 are formed in head and shoulder form 14 which allow a patient to place his arms above his head comfortably . depending on the goals of the therapy , different head and shoulder forms 14 can be used which have arm channel regions 32 formed for different arm positions and elevations . for further patient comfort , symmetrical arm rests 34 are formed in head and shoulder form 14 at a tangential angle to that of arm channel regions 32 . when a patient is required to maintain his arms above his head the natural reaction is to bend ones arms thereby forming a v shape from each elbow . without arm channel regions 32 and arm rests 34 , patients would experience discomfort when trying to maintain a steady position under their own strength . the most important considerations for proper patient positioning is the safety and comfort of the patient . head and shoulder form 14 serves as a support which cradles the patient in the desired set - up position . by increasing the level of comfort for the patient , the patient is less likely to move during treatment . several other contemplated embodiments of head and shoulder form 14 are shown in fig5 through 9 . referring now to fig5 and 6 , head and shoulder form 14 is constructed and attached to planar base 12 in the same manner as described earlier for fig1 through 4 . this alternative embodiment of head and shoulder form 14 is designed for treating patients undergoing any number of types of breast therapy . head and shoulder form 14 has a head cavity 30 with one arm channel region 32 which then extends away from head cavity 30 to form an integral chest side form 28 . head cavity 30 , arm channel region 32 , and integral chest side form 28 are only formed on whichever side the breast to be treated is located . depending on the needs of the patient , head and shoulder form 14 may be equipped with an arm rest 34 as shown in fig8 or without one as shown in fig7 . for breast therapy , the top 20 of planar base 12 has an angled corner 46 and head and shoulder form 14 has an angled corner 48 . the two angled corners , 46 and 48 respectively , compliment one another and provide a simple means of alignment when head and shoulder form 14 is attached to planar base 12 . the angled corners 46 and 48 are located on the side opposite the side of the breast to be treated , that being the same side that arm channel region 32 and integral chest side form 28 are located . this modification to the preferred embodiment allows immobilized patients to fit through the tunnel of most treatment equipment . it is to be understood that many different variations of head and shoulder form 14 are contemplated by the applicant and the specific shapes and configurations described are not to limit the scope of the claimed invention . referring back to fig2 a pair of chest side forms 16 are attached to upper surface 18 of planar base 12 by means similar to those used to attach head and shoulder form 14 , preferably by means of adhesive . chest side forms 16 are substantially elongated rectangular blocks with shoulder relief cutouts 36 on one side . shoulder relief cutout 36 begins at the top 38 of each chest side form 16 and ends at a predetermined distance which in the preferred embodiment is less than half the length of chest side form 16 . the length and size of shoulder relief cutouts 36 are different for different patients and as such the inventor contemplates variations such as shoulder relief cutouts 36 which are approximately the full length of the chest side forms 16 . because there are many variations depending on the patient , the treatment , and the physician , the invention is not to be limited by the specific configuration described . chest side forms 16 are attached to the upper surface 18 and along the sides 56 of planar base 12 so that the tops 38 of shoulder relief cutouts 36 are abutted with angled edges 40 of head and shoulder form 14 . the tops 38 of shoulder relief cutouts 36 are angled complimentary to angled edges 40 of head and shoulder form 14 in order to provide for proper mating and positioning when chest side forms 16 are attached to planar base 12 . the angled edges make proper alignment during production easier as there is only one position that will fit correctly which ensures that shoulder relief cutouts 36 are always located along the sides 56 and facing towards the center of planar base 12 . less time and supervision is necessary while maintaining correct and quality production of template forming or patient repositioning apparatus 10 . fig6 shows an alternate embodiment of apparatus 10 with different side forms used for breast therapy . head and shoulder form 14 comprises integral chest side form 28 extending from arm channel region 32 . chest side form 28 could be a separate component but it is preferred that it be integral with head and shoulder form 14 for easier assembly and consistent positioning accuracy . to immobilize the patient properly , a short chest side form 26 is attached through known means to planar base 12 on the opposite side of and parallel with integral chest side form 28 . patient repositioning systems have been used in medical treatment for several years and while providing satisfactory results the present invention has an advantage by providing improved control of torso rotation through apparatus 10 &# 39 ; s extended base 42 as shown in fig1 through 6 and 9 . referring to fig2 extended base 42 is the region of planar base 12 that extends past the bottoms 44 of chest side forms 16 . in the preferred embodiment the total length of planar base 12 is approximately five feet and may vary depending upon the patient and the specific treatment prescribed . earlier immobilization forms without extended base 42 caused difficulties in patient set up . by extending planar base 12 caudally to the mid thigh , extended base 42 immobilizes the patients pelvis and thighs when the template forming apparatus 10 is molded to the individual patient . extended planar base 12 provides complete immobilization of the torso region , hips and internal anatomy of the peritoneal cavity of a patient . fig3 shows side rails 24 which are attached to planar base 12 in the same manner as other components previously described and are aligned so as to act as extensions of and from the bottom 44 of chest side forms 16 . side rails 24 act as retaining walls which force foaming mixture 52 in toward the patient &# 39 ; s torso . in a study done for applicant to assess the effect of extended base 42 , the number of patient misalignments observed on port films was compared with that of the same number of patients treated using a template forming or immobilization form without an extended base . review of the port films revealed that the misalignment rate for the form without an extended base was greater than the test group which had the extended base . in addition the tests also showed that the size of the misalignment errors was larger in the test group which did not have the extended bases . fig9 shows an alternative embodiment of apparatus 10 used for breast therapy having extended base 42 and side rails 24 . similar testing of this embodiment lead to the same results , that being improved misalignment rates and much more aggressive patient immobilization . the extended base apparatus not only performed better but the technologists who performed the tests reported that they could set up treatments faster when patients are positioned in a body mold which is the result of having extended base 42 and side rails 24 for inferior or lower portions of the human body . the extended base 42 and side rails 24 reduced the number of repeat port films which also saves time , both in terms of taking and developing the films , and it also reduces the physicians &# 39 ; time because there are less port films to review . other savings are recognized in terms of amount of films needed and in space required for film storage . the most important gain however , lies with the fact that the patients feel comfortable , relaxed and are secure on what are normally narrow treatment couches . once the head and shoulder form 14 , chest side forms 16 , and side rails 24 are positioned and attached on the upper surface 18 of planar base 12 , a foam mixture 52 is applied to apparatus 10 . foam mixtures that are suitable for practice of the present invention are not in themselves particularly unique and may include the polyurethane family . various formulations of the polyurethane family are employed to provide foams having widely disparate , ultimate characteristics . for example , some formulations provide foam that is hydrophilic and are , therefore , eminently suited to be used for supports for floral displays . other formulations provide foam that possesses antipodal characteristics , and which are , therefore , eminently suited to be used in , or as , flotation devices . in order to be suitable for use in medical applications , such as the present , foam compositions must exhibit a low foaming temperature so as not to create a potential of causing a burn to the patient . further , it is desirable that any foam composition have a quick hardening time and have sufficient integrity to immobilize the particular body portion as well as support the necessary weight of the patient . one specific formulation which is well suited to this method and apparatus is the polyurethane foam composition set out in u . s . pat . no . 4 , 771 , 082 . this polyurethane foam composition has a maximum foaming temperature of 45 degrees celsius and hardens in approximately 8 - 10 minutes . the basic reaction is that of mixing a polyol and a polyisocyanate such as follows : ## str1 ## surfactants , catalysts and blowing agents are generally added in various amounts selectively to provide the desired properties from the wide range available , including such characteristics as hydrophilia rate of rise , rate of cure , amount of heat release , cell size and rigidity . the preferred polyisocyanate for practice of the subject invention is polymethylenepolyvinyl isocyanate , whereas the preferred polyol is a mixture of various polyols such as ethylene glycol , glycerin 2 , 2 dimethyl - 1 , 3 - butanediol , 1 , 2 , 4 butanetriol , 1 , 2 , 6 hexanetriol and the like . a typical application of the present invention to mold a template for any selected portion of a patient &# 39 ; s anatomy would employ the addition of approximately 100 ml to 350 ml of the polyol to 75 ml to 240 ml of the polyisocyanate . the chemicals required to form the foam are then mixed together . typically the polyisocyanate is provided in a bottle larger than that required , and the bottle in which the polyol is provided is emptied into the bottle containing the polyisocyanate . the bottle now contains the mixed polyisocyanate and polyol is then capped and vigorously shaken for approximately 35 seconds . thereafter , the bottle is opened and the contents are poured onto base 12 . the foam mixture 52 is spread as evenly as possible over the base . a barrier means is then placed over the entire upper surface 18 of the foam - containing apparatus 10 . the barrier means is illustrated in fig1 as a flexible container or bag 50 with the entire apparatus 10 contained therein . ideally , air is allowed to circulate inside the bag until bubbles are noted in the foam ( 1 - 3 minutes ). the air is then forced out , the bag is sealed and the patient is placed in the foam . however , a sheeted material placed over the entire upper surface of apparatus 10 and insulating the patient from any contact with the foam mixture can be used . the barrier means must be tear - resistant , flexible and must not react with the selected foam mixture . a suitable barrier means may be fabricated from a pliable , sturdy material such as polyvinyl - chloride ( pvc ). even though pvc has proven to be a perfectly acceptable material , it should be appreciated that the wall thickness of the bag should be no less than approximately 1 . 5 mils . hence , some standard refuse bags , even though made of pvc , cannot be used because their wall thickness if too thin . some industrial refuse bags , and certain brands of those home refuse bags advertised as having &# 34 ; double wall &# 34 ; thickness , or the like , as well as certain brands of waste compactor bags , however , do possess the requisite wall thickness , and they may be employed . this minimal wall thickness is required to accomplish two objectives . first , a wall thickness of less than 1 . 5 mils is too subject to tearing or rupturing . the flexible container 50 must provide a controlled confinement for the foam mix , if the invention is to be satisfactorily employed , and the objective cannot be achieved if the flexible container 50 ruptures , or tears . second , a wall thickness of less than 1 . 5 mils is too susceptible to wrinkling and could cause an undesirable fold where it might not be visually detectable . such unobserved folds can capture the foam mixture before it fully foams to create localized &# 34 ; hot spots &# 34 ; that could make the patient uncomfortable , at the least , or , at the worst , burn the patient . such localized hot spots have been observed to melt the pvc bag at , and around , such a fold . employing a pvc bag having sufficient wall thickness , however , has been found to obviate this potential problem . a flattened bag measuring approximately 54 × 246 inches ( 137 . 2 by 61 cm ) provides a convenient size that can be readily adapted to virtually any situation , as will become apparent from the hereinafter described exemplary usage . it is to be understood that the foam mixture 52 can be applied to apparatus 10 as previously explained , after the apparatus has been placed with a flexible container or bag 50 . after the foam has been applied to the upper surface 18 of base 12 and the barrier means applied , that portion of the patient &# 39 ; s body for which the template or mold is to be made is placed into contact with the apparatus 10 as shown in fig1 . as the foam begins to expand and rise , it begins to pull a portion of the barrier means 50 away from apparatus 10 and into conforming contact with the patient &# 39 ; s body portion . as the patient remains in a stable non - moving state , the foam hardens to form an impression of the particular body part . the foaming action typically subsides after about fifteen minutes , and thereafter , the patient can be carefully extricated from the newly formed mold . the mold should then be permitted to harden for a period of five to thirty minutes . therefore , upon reinsertion into the mold the particular portion of the patient &# 39 ; s body to be examined will be returned or repositioned just as it was at the time of mold formation . the resulting apparatus or mold can be used in successive procedures involving the same portion of the body to consistently duplicate the previous positioning and immobilization . the template made in accordance with this invention can also be further modified for the type of treatment desired , for example , by cutting access holes directly through the template . in the preferred embodiment of the present invention , planar base 12 , side rails 24 , head and shoulder form 14 , and chest side forms 16 are made from extruded or expanded polystyrene materials because of the material &# 39 ; s light weight , durability for this intended purpose and affordability . even more importantly , polystyrene products are substantially radiolucent . in this way , transmission of irradiation treatment can take place through the apparatus and / or hardened foam with minimal , if any , interference or distortion . however , numerous other material could be used to accomplish the purposes of this invention . the elements of the present invention can be supplied in the form of a single kit for use with patients of varying size . it should be apparent that the invention accomplishes the objects thereof . as stated , a variety of boards , supports , spacers , foam mixtures and methods of attaching to the base can be employed in the practice of this invention . it is to be understood that such variations are intended to fall within the scope of the claimed invention and that the subject invention is not to be limited by the specific method of operation described and / or depicted by the drawings nor is the invention to be limited by the specific chemical and mechanical components identified and described herein . there have been designated merely to provide a demonstration of operability and the selection of mechanically equivalent arrangements is not deemed a departure from the spirit of the invention being limited solely by the scope of the attached claims .

an apparatus for immobilizing and positioning the head , shoulder , and torso region extending down to the mid thigh of the human for radiographic examination or treatment . the device consists of a base board with an extension , a head and shoulder form , a pair of chest side forms and a pair of side rails . a foam mixture is applied to the upper surface of the baseboard and the entire device is placed into a large flexible container or bag . a patient &# 39 ; s head , shoulder and torso region are placed on the device in a supine position . the patient remains in a fixed position while the foam mixture expands around the patient &# 39 ; s body and the apparatus . after a brief period of time , the foam sets or hardens and a mold or template is formed . this mold serves to immobilize the head , shoulder and torso region extending down to the mid thigh of the body during radiographic examinations and treatment as well as other procedures . the form can be utilized repeatedly with the same patient in subsequent procedure for duplicating the initial examination or treatment posture .

looking next at fig1 , there is shown a safety needle 3 formed in accordance with the present invention . safety needle 3 generally comprises a handle assembly 100 , a needle assembly 200 and an obturator 300 . in general , and as will hereinafter be discussed in further detail , during use , needle assembly 200 is mounted to handle assembly 100 , and obturator 300 extends through handle assembly 100 and needle assembly 200 , in substantially the manner shown in fig1 . more particularly , and looking now at fig1 and 18 , handle assembly 100 generally comprises a tubular housing 103 having a distal end 106 , a proximal end 109 and a central lumen 112 extending therebetween . an annular wall 115 is formed intermediate the length of tubular housing 103 . a side port 116 ( fig1 ) extends through the side wall of tubular housing 103 , proximal to distal end 106 and distal to annular wall 115 . a trigger opening 118 extends through the side wall of tubular housing 103 , distal to proximal end 109 and proximal to annular wall 115 . a fluid conduit 121 is captured within tubular housing 103 between a mount 124 and a front cap 127 . o - rings 130 are disposed on either end of fluid conduit 121 so as to form ( i ) a watertight seal between fluid conduit 121 and mount 124 and ( ii ) a watertight seal between fluid conduit 121 and front cap 127 . leaf springs 133 bias mount 124 against annular wall 115 . a thumb lever 136 permits mount 124 to be urged distally toward front cap 127 , thereby shortening the chamber holding fluid conduit 121 and o - rings 130 , whereby to radially expand o - rings 130 and thereby cause the o - rings to seal against obturator 300 . as a result , when thumb lever 136 urges mount 124 toward front cap 127 , obturator 300 will be secured to handle assembly 100 . conversely , thumb lever 136 may be released , so that leaf springs 133 urge mount 124 proximally against annular wall 115 , whereby to ease the compression of o - rings 130 and thereby release the aforementioned seal on obturator 300 . as a result , when thumb lever 136 is released , obturator 300 is no longer secured to handle assembly 100 and may be removed from the handle assembly . front cap 127 comprises a longitudinal bore 137 for receiving needle assembly 200 , and a transverse bore 139 for receiving a locking pin 142 . more particularly , transverse bore 139 includes an annular flange 145 , and locking pin 142 includes a locking nut 148 , whereby leaf spring 151 can yieldably bias locking nut 148 against annular flange 145 . a longitudinal bore 154 extends through locking pin 142 so that when the head of locking pin 142 is pressed inwardly , against the bias of leaf spring 151 , longitudinal bore 154 of locking pin 142 can be aligned with longitudinal bore 137 of front cap 127 ; conversely , when the inward force on the head of locking pin 142 is released , leaf spring 151 causes the locking pin &# 39 ; s longitudinal bore 154 to move out of alignment with the front cap &# 39 ; s longitudinal bore 137 . in this way , locking pin 142 can be used to selectively capture needle assembly 200 to handle assembly 100 . a trigger carriage 157 ( fig1 ) is slidably disposed within tubular housing 103 , between annular wall 115 ( fig1 ) and proximal end 109 ( fig1 ). a trigger 160 is pivotally mounted to trigger carriage 157 , with a spring 163 biasing trigger 160 in a distal direction . a finger 166 ( fig1 ) is pivotally mounted to trigger carriage 157 , so as to selectively engage a notch 301 formed in obturator 300 . a release button 172 ( fig1 ), having a peripheral flange 175 , is captured between trigger carriage 157 and an end cap 178 . more particularly , a spring 181 biases trigger carriage 157 and peripheral flange 175 away from one another . first , trigger 160 is pinned to trigger carriage 157 , with trigger spring 163 in place , and then the components are inserted into tubular housing 103 until the trigger &# 39 ; s finger 184 ( fig1 ) extends out the bottom of trigger opening 118 . next , spring 181 and release button 172 are introduced into the back of tubular housing 103 , and then end cap 178 is screwed into place . then mount 124 ( fig1 ), fluid conduit 121 and o - rings 130 are inserted into the distal end of tubular housing 103 , and thereafter secured in place using front cap 127 . next , locking pin 142 is pressed inwardly so that its longitudinal bore 154 is moved into alignment with the front cap &# 39 ; s longitudinal bore 137 . then needle assembly 200 is inserted into longitudinal bore 137 of front cap 127 and through longitudinal bore 154 of locking pin 142 . then locking pin 142 is released , thereby locking needle assembly 200 to handle assembly 100 , with the interior of needle assembly 200 communicating with the interior of tubular housing 103 via an opening 179 formed in the proximal end of cap 127 . finally , obturator 300 is advanced through ( i ) an opening 180 formed in release button 172 , ( ii ) an opening 182 formed in the proximal end of finger 166 , ( iii ) an opening 183 formed in trigger carriage 157 , ( iv ) the interior of tubular housing 103 , ( v ) an opening 185 formed in mount 124 , ( vi ) the proximal o - ring 130 , ( vii ) the interior of fluid conduit 121 , ( viii ) the distal o - ring 130 , ( ix ) opening 179 formed in the proximal end of front cap 127 , and ( x ) needle assembly 200 , until notch 301 ( fig1 ) is engaged by finger 166 , whereby to releasably secure obturator 300 to handle assembly 100 . at this point , safety needle 3 is disposed in the condition shown in fig1 and 20 . more particularly , the trigger &# 39 ; s proximal arm 186 is in engagement with the proximal end 187 of trigger opening 118 ( fig1 ), and obturator 300 is in its extended position ( fig2 ), whereupon the sharp distal tip 201 of needle assembly 200 is proximal to , and shielded by , the projecting distal tip 302 of the extended obturator 300 . the safety needle may now be sterilized and packaged for shipping . during use , safety needle 3 is first removed from its sterile package . then end cap 178 ( fig1 ) is screwed towards or away from tubular housing 103 so as to set the appropriate tension on trigger carriage 157 via spring 181 . next , safety needle 3 is “ cocked ” by pulling trigger finger 184 proximally , so as to rotate the complete trigger 160 in a clockwise direction . as this occurs , trigger finger 184 is first disposed intermediate trigger opening 118 , with the trigger &# 39 ; s proximal arm 186 and distal arm 188 substantially parallel to obturator 300 , and with distal tip 302 of obturator 300 approximately aligned with distal tip 201 of needle assembly 200 ( see fig2 and 22 ). trigger finger 184 is pulled further back until the safety needle is placed into its “ cocked ” position ( fig2 and 24 ), with distal arm 188 of trigger finger 184 engaging the distal end 189 of trigger opening 118 , and with distal tip 302 of obturator 300 residing just proximal to , yet protruding slightly out of , distal tip 201 of needle assembly 200 . with safety needle 300 in this condition , the safety needle is advanced into the patient . as the safety needle is forced through the tissue of the patient , obturator 300 is urged proximally , further into needle assembly 200 , by virtue of the engagement of the distal tip of the obturator with the tissue . at the same time , trigger carriage 157 is urged proximally due to the engagement of finger 166 with notch 301 of obturator 300 . this action causes the trigger &# 39 ; s distal arm 188 to pivot counterclockwise , releasing distal arm 188 from its engagement with the distal end 189 of trigger opening 118 ( see fig2 and 26 ). the safety needle is held in this equilibrium condition as the safety needle is advanced through the tissue , by virtue of the proximally - directed force imposed on the advancing obturator by the intervening tissue . as soon as safety needle 3 penetrates through the tissue , so that there is no longer a proximally - directed force acting on distal tip 302 of obturator 300 , trigger carriage 157 “ pops ” forward , carrying obturator 300 with it by virtue of the engagement of finger 166 with notch 301 . trigger carriage 157 and obturator 300 move forward as a unit until the trigger &# 39 ; s distal arm 188 encounters annular wall 115 , whereupon obturator 300 will project out the distal end of needle assembly 200 ( fig2 and 28 ). as this occurs , the trigger &# 39 ; s proximal arm 186 rotates counterclockwise to engage proximal end 187 of trigger opening 118 ( fig2 ). this action locks obturator 300 in its extended position ( fig2 ), whereupon sharp distal tip 201 of needle assembly 200 resides proximal to blunt distal tip 302 of obturator 300 , and is as such prevented from engaging tissue due to the shielding tip of obturator 300 . it will be appreciated that , at this point , safety needle 3 will have returned to the “ starting position ” shown in fig1 and 20 , i . e ., the condition it was in when it was removed from the sterile packaging . at this point , needle assembly 200 can be disassembled from handle assembly 100 ( i . e ., by depressing locking pin 142 ), and then handle assembly 100 and obturator 300 can be removed from the surgical site , thereby leaving needle assembly 200 extending from a point outside the body down to the surgical site . tissue dilators may then deployed over needle assembly 200 so as to dilate the tissue disposed between the skin and the interior of the joint . then an access cannula may be inserted over needle assembly 200 . thereafter , the needle assembly 200 may be withdrawn , leaving the access cannula available for passing instruments and the like down to the surgical site . during hip surgery , it can be helpful to introduce fluids into the interior of the hip joint and / or to remove fluids from the interior of the hip joint . by way of example but not limitation , a saline flush can be used at the surgical site to improve visibility ( e . g ., to remove blood ) and to flush away particles ( e . g ., surgical debris ). furthermore , fluids can be used to administer therapeutic agents ( e . g ., pharmaceuticals , growth factors , etc .) to the surgical site . in addition , fluids can be used to help “ break ” the suction seal which normally exists between the ball of the femur and the acetabular cup . safety needle 3 is constructed so as to facilitate ( i ) the delivery of fluids into the interior of the hip joint and / or ( ii ) the withdrawal of fluids from the interior of the hip joint . more particularly , obturator 300 is preferably formed so that it has an interior lumen 305 ( fig1 ). lumen 305 extends between ( i ) an opening 310 ( fig2 ) formed just proximal to distal tip 302 of obturator 300 , and ( ii ) the proximal end 320 ( fig1 ) of obturator 300 . as a result , fluid can be passed to and from the surgical site via the proximal end 320 of obturator 300 . in this respect it should also be appreciated that , by forming the obturator &# 39 ; s distal tip 302 with a “ closed wall ” configuration , and by positioning opening 310 in the sidewall of the obturator just proximal to distal tip 302 of the obturator , tissue coring during safety needle insertion will be prevented while still preserving fluid access to and from the surgical site . in addition to the foregoing , and looking now at fig1 , obturator 300 preferably is also provided with one or more sidewall openings 325 . sidewall openings 325 communicate with openings 190 formed in the sidewall of fluid conduit 121 . as a result , fluid from the interior of lumen 305 communicates ( via sidewall openings 325 and openings 190 ) with the chamber formed between annular wall 115 and front cap 127 . side port 116 ( fig1 ), equipped with a removable closure , is formed in the sidewall of tubular housing 103 so as to permit fluid to be selectively passed to and from the surgical site via side port 116 , openings 190 in fluid conduit 121 , sidewall openings 325 in obturator 300 and lumen 305 in obturator 300 . o - rings 130 prevent any fluid within the interior of fluid conduit 121 from escaping along the exterior of obturator 300 . in many situations , surgical instruments and / or implants may be introduced to , and / or removed from , the surgical site by ( i ) forming the surgical instruments and / or implants with a cannulated construction , and ( ii ) running the cannulated instruments and / or implants coaxially down a guidewire to the surgical site . by way of example but not limitation , such an approach is commonly used in many minimally - invasive surgical procedures . in accordance with the present invention , obturator 300 can be formed and utilized so as to provide both obturator function and guidewire function . more particularly , in one form of the present invention , after safety needle 3 has been introduced into the interior of the hip joint , handle assembly 100 and needle assembly 200 may be withdrawn ( preferably as a unit ) over the distal end of obturator 300 , thereby leaving obturator 300 extending from a point outside of the body down to the surgical site . cannulated surgical instruments and / or cannulated surgical implants may then be introduced to , and / or removed from , the surgical site by running those cannulated devices coaxially over obturator 300 . thus , for the purposes of the present invention , obturator 300 may be considered to be a guidewire as well as an obturator . it should be appreciated that safety needle 3 may also be used for accessing joints in addition to the hip joint , e . g ., safety needle 3 may be used to access the knee joint , the shoulder joint , etc . furthermore , safety needle 3 may also be used to access other interior bodily spaces , e . g ., regions around the spine , the abdominal cavity , the chest cavity , etc . in essence , safety needle 3 may be used in any circumstance where it is desired to safely advance a sharp needle into the body through intervening tissue . it should be understood that many additional changes in the details , materials , steps and arrangements of parts , which have been herein described and illustrated in order to explain the nature of the present invention , may be made by those skilled in the art while still remaining within the principles and scope of the invention .

a safety needle comprising a handle ; a hollow needle ; a trigger carriage ; an obturator ; a spring ; a trigger ; a first latch and a second latch ; the first latch , second latch and trigger being configured so that when the trigger carriage is in a distal position and the first latch set , and the trigger is thereafter pulled proximally , the first latch is released and the trigger carriage moves proximally into a proximal position , and thereafter releasing the trigger causes the trigger carriage to move into an intermediate position and set the second latch ; and further wherein , when the trigger carriage is in its intermediate position and the distal end of the obturator engages tissue , the trigger carriage is moved proximally so as to release the second latch .

in the following description , specific details are set forth in order to provide a thorough understanding of the invention . however , it will be apparent that the invention may be practiced without these specific details . without departing from the generality of the invention disclosed herein and without limiting the scope of the invention , the discussion that follows , will refer to the invention as depicted in the drawings . as shown in fig1 and 2 , a wide - span mower assembly 10 includes a rectangular tube chassis 12 . the chassis 12 is composed of front tube element 14 , a rotary head mounting tube 16 , and a rear tube element 18 . a plurality of cross tubes connect the front tube element 14 to the , a rotary head mounting tube 16 and the rear tube element 18 . the cross tubes include left and right cross tubes 20 , 22 flanking a center tube 24 , and left and right end tubes 26 , 28 . the end tubes 26 , 28 extend longitudinally beyond the rear tube element 18 . a tongue 30 extends forwardly from the front tube element 14 in approximate line with the center tube 24 . the tongue 30 includes a pair of elongated slots 32 to which is bolted an engine mounting plate 34 . the engine mounting plate 34 is formed as a box open at the front and back . a power source 36 , here shown as an internal combustion engine , is secured to the mounting plate 34 . the power source 36 can be provided as any power source capable of providing sufficient mechanical energy in a form adaptable for use with the present invention . it is contemplated that an engine such as a regular push lawn mower &# 39 ; s engine , for example , a 3 . 5 hp briggs & amp ; stratton having a bottom output shaft , will suffice . in the place where a cutting blade would be on a regular lawn mower engine shaft is a drive pulley 38 , adapted to drive a driven v - belt 40 . the driven v - belt 40 is adapted to impart rotary movement to a central drive element 44 ( fig3 ). the central drive element 44 includes a central shaft 46 secured for rotation to the central tube 24 of the chassis 12 , for example , via upper and lower bearing assemblies 48 , 50 . the central shaft 46 is secured to the chassis by a bracket 52 . a pulley 54 is secured to the shaft 46 , and is adapted to engage the driven v - belt 40 . a chain sprocket 56 is secured for rotation with the shaft 46 , for example , via one or more screws , and is set at a desired height by a spacer 58 . the shaft 46 extends through the central tube 24 , and is secured by an end cap 50 and pull - pin 62 . a drive chain is woven in a serpentine manner through the other eleven sprocketed rotary cutting head assemblies . a manually adjustable chain tensioner is used to control the tension of the drive chain . the rotary cutting head assemblies extend through the bottom surface of a rotary head mounting tube . the lightweight frame structure and cutting heads facilitate the construction of wide - span mower assemblies . the illustrated examples are constructed to have 11 - foot spans , but it is contemplated that wider spans are easily accomplished using the principles of the present invention . the illustrated engine employs an “ on / off ” switch that must be engaged before the pull starter is used to actuate the engine . a manually operated belt tensioner is used to engage the drive pulley . a user grasps the t - handle and pushes the lever to its stop position , causing the t - handle to drop into a hole and apply pressure to the main drive belt . rotation of the central drive element causes movement of the drive chain , thus imparting rotation to the cutting heads . when use of the mowing assembly is complete , the t - handle is lifted and put into its “ stop ” position , releasing belt tension , and the engine is turned off . in an embodiment , the mower assembly is adapted for propulsion by means of a push - handle assembly . the push - handle assembly includes a pair of wheels mounted on an axle in a conventional manner . the axle extends through a pair of mounting brackets adapted for attachment to the tongue assembly of the chassis . the brackets are also used to secure a shaft , on which is secured a handle assembly having a pair of grip elements . the construction of the mower assembly in accordance with the principles of the present invention allows one person to easily push and maneuver the entire mower assembly , despite its wide span . it is also contemplated that the mower assembly can be used in conjunction with any conventional utility vehicle , such as a tractor or atv . once the push handle is removed , an attachment mechanism , here illustrated as a ½ ″ bolt , is used to secured the mower assembly to a conventional towing tongue . the use of a spacer allows the mower assembly chassis to be leveled with the ground while the assembly is in use by being towed with any of a wide variety of vehicles . in an illustrated embodiment , the power source for the mower assembly is provided by the pto shaft on a tractor or other vehicle . a pto connector is provided for this purpose , and is connected to the drive shaft in a manner similar to the connection of the engine shaft . each of the rotary heads includes a central shaft secured for rotation to the chassis , for example , via upper and lower bearing assemblies . a double - pulley element is in turn secured for rotation with the shaft , for example , via screws . the shaft extends through the rotary head mounting tube . a cutting head element , here illustrated as a 3 ″ cutting head element , is fastened to the shaft by a pull pin . a cutting whip , here shown as a twelve - inch length of ¼ ″ plastic - coated cable , extends through a bore in the cutting head element . the cutting whip can be secured in any desired manner , such as a set - screw . the illustrated pull - pin arrangement facilitates fast and easy replacement of the cutting head element for maintenance or replacement . when the pull - pin is removed , the cutting head element slides off of the bottom of the shaft the mowing height of the mower assembly can be adjusted by setting the height of the ground - engaging wheels . for this purpose , pluralities of holes at different heights are provided in the wheel supports of the chassis , and in the handle mounting brackets , if used . in the illustrated example , holes are provided to facilitate either a 2 ″ or 3 ″ cutting height , but it is contemplated that higher and lower mounting holes can also be provided as desired . the wide - span mower assembly is also advantageous in that it is easily and compactly storable . the engine mounting plate is secured to the tongue in elongated slots to allow position adjustment of the engine , and to accommodate engines from various manufacturers . thus , for storage , the engine and mounting plate are easily unbolted and removed from the mower assembly , and can be transported separate from the mower assembly , for example , for winter maintenance . with the engine and push handle assembly removed , the chassis and components that remaining mounted thereto can easily be raised to a vertical position for storage against a wall or similar support structure . while this invention has been described in connection with the best mode presently contemplated by the inventor for carrying out his invention , the preferred embodiments described and shown are for purposes of illustration only , and are not to be construed as constituting any limitations of the invention . modifications will be obvious to those skilled in the art , and all modifications that do not depart from the spirit of the invention are intended to be included within the scope of the appended claims . those skilled in the art will appreciate that the conception upon which this disclosure is based , may readily be utilized as a basis for the designing of other structures , methods and systems for carrying out the several purposes of the present invention . it is important , therefore , that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention . the invention resides not in any one of these features per se , but rather in the particular combinations of some or all of them herein disclosed and claimed and it is distinguished from the prior art in these particular combinations of some or all of its structures for the functions specified . with respect to the above description then , it is to be realized that the optimum dimensional relationships for the parts of the invention , including variations in size , materials , shape , form , function and manner of operation , assembly and use , and all equivalent relationships to those illustrated in the drawings and described in the specification , that would be deemed readily apparent and obvious to one skilled in the art , are intended to be encompassed by the present invention . therefore , the foregoing is considered as illustrative only of the principles of the invention . further , since numerous modifications and changes will readily occur to those skilled in the art , it is not desired to limit the invention to the exact construction and operation shown and described , and accordingly , all suitable modifications and equivalents may be resorted to , falling within the scope of the invention .

a wide - span lawn mowing mechanism includes a chassis assembly having a front tube element , a rear tube element , and a plurality of cross tubes connecting the front tube element to the rear tube element . a plurality of rotary cutting heads are suspended from the chassis assembly . a power source is included for imparting rotary motion to the cutting heads . a selectively actuatable drive system operatively connects the cutting heads to the power source .

the following detailed description is merely exemplary in nature and is not intended to limit the described embodiments or the application and uses of the described embodiments . as used herein , the word “ exemplary ” or “ illustrative ” means “ serving as an example , instance , or illustration .” any implementation described herein as “ exemplary ” or “ illustrative ” is not necessarily to be construed as preferred or advantageous over other implementations . all of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure which is defined by the claims . furthermore , there is no intention to be bound by any expressed or implied theory presented in the preceding technical field , background , brief summary or the following detailed description . the present disclosure is generally directed to a facial movement measurement and stimulation apparatus and method for measuring and / or stimulating movement of facial muscles in a variety of applications . in some applications , the apparatus and method may determine a person &# 39 ; s ability to make facial movements or assume facial expressions by measuring the electrical activity or movement of the person &# 39 ; s facial muscles . in some applications , the apparatus and method may be implemented in a therapeutic context in which a person is trained to assume facial expressions that accurately reflect the person &# 39 ; s underlying thoughts and emotions or the person is trained to change facial expressions to accurately reflect the person &# 39 ; s changing thoughts and emotions . alternatively , the stimulation can be provided at a low enough level to cause sensory stimulation without causing firing of the muscles . in some applications , the apparatus and method may be used to train a person in mimicking facial expressions in response to staged situations . in some applications , the goals of the apparatus and method may be attained by facilitating the sharing or transfer of facial movements or expressions between two or more subjects . referring initially to fig1 and 2 of the drawings , an illustrative embodiment of the facial movement measurement and stimulation apparatus , hereinafter apparatus , is generally indicated by reference numeral 100 in fig1 . in some applications , the apparatus 100 may function as an electromyographic measurement system to measure movements of facial muscles ( not illustrated ) in the face 107 of a subject 106 for any of a variety of purposes . for example , lack or impairment of movement of the facial muscles in the face 107 of the subject 106 , as interpreted by the apparatus 100 , may reveal a medical condition ( such as facial paralysis due to a stroke , for example ) and provide the basis for a medical diagnosis and / or therapeutic treatment regimen for the medical condition . accordingly , the apparatus 100 may include multiple electrodes 110 , which in some applications may function as facial movement sensors that may be placed on the skin ( not illustrated ) at various locations on the face 107 of the subject 106 to measure movement of the musculature ( not illustrated ) in the face 107 . the locations of the electrodes 100 may correspond in position to individual muscles ( not illustrated ) of the facial musculature , which underlies the skin in the face 107 . in some applications , the electrodes 100 may be confined to a portion of the face 107 . in some applications , the electrodes 100 may be placed over the entire face 107 and may additionally or alternatively be placed on one or both ears and / or along the neck and larynx of the subject 106 . each electrode 100 may be adapted to measure both sporadic or continuous high - level electrical nerve stimulation and continuous , low - level electrical nerve stimulation of the muscles in the face 107 . in some embodiments , each electrode 100 may be directly affixed to the face 107 of the subject 106 using a suitable adhesive . in other embodiments , the system 100 may include a flexible or stretchable mask 116 , which conforms to the features on the face 107 . the electrodes 110 may be provided on a contact surface ( not illustrated ) of the mask 116 with the skin on the face 107 . adhesive ( not illustrated ) may be provided on the contact surface of the mask 116 to facilitate adhesion of the mask 116 to the skin on the face 107 and maintain electrically - conductive contact between the electrodes 110 and the skin on the face 107 . in some embodiments , the electrodes 110 may be surgically implanted in the skin at the desired locations on the face 107 . the system 100 may further include a computer 101 which in some embodiments may be connected to the electrodes 110 through electrode wiring 111 . the electrode wiring 111 may be wrapped in a wiring bundle 112 . in other embodiments , the electrodes 110 may interface with the computer 110 through wireless transmissions 130 ( fig3 ), according to the knowledge of those skilled in the art . the computer 101 may be conventional and may include a computer disk drive 102 with a computer keyboard 103 and a computer monitor 104 having a display 105 connected to the computer disk drive 102 . in applications in which the electrodes 110 function as facial movement sensors that measure movement of the musculature ( not illustrated ) in the face 107 of the subject 106 , the computer 101 may function as a facial movement measuring and indicating device which receives electrical signals from the electrodes 110 in contact with the face 107 . accordingly , as illustrated in fig2 , the computer 101 with supporting software may be programmed to display a facial image 120 on the display 105 of the computer monitor 104 . the computer 101 may additionally be programmed to convert the electrical output signals from the electrodes 110 into facial movement indications 121 and present the facial movement indications 121 on the facial image 120 in the areas of the facial image 120 which correspond to areas of muscle movement in the face 107 of the subject 106 in real time as sensed by the electrodes 110 . the strength of the electrical output signals that the computer 101 receives from the electrodes 110 may be proportional to the level or intensity of electrical nerve stimulation and therefore , the level or intensity of contraction of the musculature in the face 107 of the subject 106 . accordingly , the facial movement indications 121 may be adapted to visually differentiate the intensity of muscle movement in each area from the intensity of muscle movement in the other areas in the face 107 of the subject 106 . as illustrated in fig2 , in some applications each facial movement indication 121 may be represented by one or multiple circles . facial movement indications 121 having a single circle may indicate muscular contraction of relatively low - level intensity in the corresponding area or areas on the face 107 , whereas facial movement indications 121 having multiple concentric circles of increasing number may indicate muscular contraction of correspondingly increasing intensity in the corresponding area or areas on the face 107 . the information that is provided by the facial movement indications 121 may be used to formulate diagnoses and / or treatment of the subject 106 or may be used for other purposes . in some embodiments , the facial movement sensors of the apparatus 100 may be accelerometers instead of the electrodes 110 . accordingly , the accelerometers may be attached to or secured into contact with the skin on the face 107 of the subject 106 or alternatively , surgically implanted in the face 107 in the same manner as was heretofore described with respect to the electrodes 110 . the accelerometers sense movement of the muscles in the face 107 of the subject 106 and convert the movement of the muscles into electrical output signals that are transmitted to the computer 101 through the electrode wiring 111 . the computer 101 may convert the electrical output signals into the facial movement indications 121 , which may be presented on the facial image 120 displayed on the display 105 of the computer monitor 104 . in some applications , the apparatus 100 may electrically stimulate movement of muscles in the face 107 of the subject 106 for any of a variety of purposes . for example , the apparatus 100 may be used in therapeutic applications to enable or train the subject 106 to make facial movements or to assume facial expressions that accurately reflect the person &# 39 ; s underlying thoughts and emotions , for example . in some therapeutic applications , the apparatus 100 may be used to train the subject 106 in changing facial expressions to accurately reflect the person &# 39 ; s changing thoughts and emotions , for example . in some therapeutic applications , the apparatus 100 may be used to provide a low level stimulus , which causes sensory stimulation for regulation of emotions without causing firing of the muscles . in some therapeutic applications , the apparatus 100 may be used for clinical treatment of headaches , depression , anxiety and the like . in some applications , the apparatus 100 may be used to train a person in accurately mimicking or portraying facial expressions in response to staged situations as in the training of an actor , for example . accordingly , in these applications the electrodes 110 may be placed on the face 107 of the subject 106 as was heretofore described with respect to the muscle movement measurement functions of the apparatus 100 . the computer 101 with supporting software may function as an electrical input device which may be programmed to transmit electrical impulses to the electrodes 110 through the electrode wiring 111 in such a pattern and with such an intensity as to electrically stimulate and contract the musculature in the face 107 and induce the desired facial movements or expressions in the face 107 of the subject 106 . in some applications , the computer 101 may be programmed to effect changing facial expressions in the face 107 of the subject 106 by changing the pattern and intensity of the electrical impulses that are transmitted to the electrodes 110 . referring next to fig3 of the drawings , an alternative illustrative embodiment of the facial movement measurement and stimulation apparatus is generally indicated by reference numeral 138 . the apparatus 138 may be adapted to transfer voluntary or involuntary facial movements or expressions from a first subject 126 to a second subject 128 in any of a variety of applications . for example , in some applications the apparatus 138 may transfer voluntary facial movements or expressions from the first subject 126 , who may be an acting trainer , to the second subject 128 , who may be an actor - in - training . in such applications , the first subject 126 may use the apparatus 138 to train the second subject 128 to accurately mimic or portray facial expressions in response to various staged situations such as those which may occur during dramatic productions , for example . in some applications , the apparatus 138 may be used to facilitate the sharing of emotions between the first subject 126 and the second subject 128 via facial expressions . the apparatus 138 may include a first set of electrodes 110 for placement on or surgical implantation in the face 107 of the first subject 126 and a second set of electrodes 114 for placement on or surgical implantation in the same corresponding areas on the face 107 of the second subject 128 , either with or without the mask 116 as was heretofore described with respect to fig1 . the first set of electrodes 110 may function as facial movement sensors which sense movement of the various muscles in the face 107 of the first subject 126 via typically voluntary nerve - induced electrical stimulation of the facial muscles . in some embodiments , the facial movement sensors may be a set of accelerometers which are applied instead of the first set of electrodes 110 to the face 107 of the first subject 126 and which sense movement of the facial muscles . the second set of electrodes 114 may electrically stimulate movement of the various muscles in the face 107 of the second subject 128 according to the intensities and locations of the muscle movements in the face 107 of the first subject 126 . therefore , the computer 101 with supporting software may function as a stimulus transfer device which transfers the muscle movements in the face 107 of the first subject 126 , received via the first set of electrodes 110 , to the muscles in the face 107 of the second subject 128 via the second set of electrodes 114 . in some embodiments , the first set of electrodes 110 and the second set of electrodes 114 may interface with the computer 101 via electrode wiring 111 , as was heretofore described with respect to the apparatus 100 in fig1 . in other embodiments , the first set of electrodes 110 and the second set of electrodes 114 may interface with the computer 101 via wireless transmissions 130 , as illustrated in fig3 , according to the knowledge of those skilled in the art . the computer 101 with supporting software is adapted to receive electrical signals that correspond to typically voluntary , nerve - induced electrical stimulation of the musculature in the face 107 of the first subject 126 through the first set of electrodes 110 . the computer 101 may be programmed to determine the locations and intensities of the electrical signals from the electrodes 110 on the various areas on the face 107 of the first subject 126 and transfer electrical impulses which correspond to the electrical signals to the second set of electrodes 114 which are applied to the corresponding areas on the face 107 of the second subject 128 . the locations and intensities of the electrical impulses that are transmitted to the second set of electrodes 114 correspond to the locations and intensities of the electrical signals which were received from the first set of electrodes 110 . therefore , the electrical impulses which the second set of electrodes 114 applies to the muscles in the face 107 of the second subject 128 cause contraction of the respective facial muscles to effect the corresponding facial movements or expressions in the second subject 128 that were made by the first subject 126 as the first set of electrodes 110 transmitted the electrical signals to the computer 101 . in some embodiments , the locations and intensities of the muscle movements in the face 107 of the first subject 126 may be indicated on the display 105 of the computer 101 such as in the form of the facial movement indications 121 , as was heretofore described with respect to fig2 . referring next to fig4 of the drawings , in an alternative application of the apparatus 100 , which was heretofore described with respect to fig1 and 2 , the electrodes 110 may be applied to the face 107 of a subject 106 as the subject 106 lies on a bed or other support 135 . oculography glasses 132 may be placed on the head of the subject 106 to record eye position and movements of the subject 106 such as in the analysis of various stages of sleep in the subject 106 , for example . the stages of sleep can include both non - rem ( rapid eye movements ) and rem sleep periods . criteria for rem sleep include not only rapid eye movements , but also low muscle tone and a rapid , low voltage eeg . these features are easily discernible in a polysomnogram , the sleep study typically done for patients with suspected sleep disorders . accordingly , in use of the apparatus 100 , such as during sleep studies conducted on the subject 106 , the computer 101 ( fig1 ) may function as a facial movement measuring and indicating device which receives from the electrodes 110 electrical signals that correspond to nerve - induced stimulation of the muscles in the face 107 of the subject 106 either through the electrode wiring 111 , as shown , or via wireless transmissions 130 as was heretofore described with respect to fig3 . as was heretofore described with respect to fig2 , the computer 101 may be programmed to display a facial image 120 on the display 105 of the computer monitor 104 and present facial movement indications 121 on the areas of the facial image 120 which correspond to areas of muscle movement in the face 107 of the subject 106 in real time as sensed by the electrodes 110 , as was heretofore described with respect to fig1 . the information that is revealed by the facial movement indications 121 on the facial image 120 and by the data received from the oculography glasses 132 may be used for diagnostic , therapeutic and / or other purposes . additionally or alternatively , the computer 101 may be programmed to electrically stimulate the muscles in the face 107 of the subject 106 via the electrodes 110 for diagnostic , therapeutic and / or other purposes , as was heretofore described . referring next to fig5 of the drawings , an alternative illustrative embodiment of the facial movement measurement and stimulation apparatus is generally indicated by reference numeral 140 . the apparatus 140 may include a video game console 141 which may be adapted to receive one of various types of video game cartridges 142 for the playing of video games on a display 144 connected to the video game console 141 . a joystick 143 may be connected to the video game console 142 to facilitate the movement of video game characters ( not illustrated ) on the display 144 as the video game is played . electrodes 110 may interface with the video game console 141 via electrode wiring 111 , as illustrated in fig5 , or alternatively , via wireless transmissions 130 ( fig3 ). the electrodes 110 are adapted for placement at various areas on the face 107 of a subject 106 either with or without the mask 116 . in some applications , the electrodes 110 may function as facial movement sensors which are adapted to sense facial movements or expressions of the subject 106 by measuring typically voluntary , nerve - induced electrical stimulation of the various muscles in the face 107 of the subject 106 . the electrodes 110 may transmit electrical signals that correspond to the locations and intensities of the typically voluntary nerve - induced electrical stimulation of the facial muscles of the subject 106 to the video game console 141 . the video game console 141 may be adapted to utilize the electrical signals from the electrodes 110 as audio components and / or as visual components of a video game on the display 144 as the video game is played by the subject 106 or by another . the facial movements or expressions of the subject 106 may be used to control one or more aspects or characters of the video game . in some applications , the video game console 141 may be adapted to transfer electrical impulses to the electrodes 110 to effect various facial movements in the face 107 of the subject 106 via electrical stimulation of the facial muscles . the facial movements which are induced in the face 107 of the subject 106 via the electrical impulses may correspond to facial or other movements which are made by a character presented on the display 144 as a video game is being played . referring next to fig6 of the drawings , a flow diagram of an illustrative embodiment of a facial movement measurement method is generally indicated by reference numeral 600 . in block 602 , facial movement sensors are provided . in some applications , the facial movement sensors may be electrodes . in some applications , the facial movement sensors may be accelerometers . in block 604 , a facial movement measuring and indicating device is provided . in block 606 , the facial movement sensors are connected to the facial movement measuring and indicating device . in block 608 , the facial movement sensors are placed on or surgically implanted in the face of a subject . in block 610 , outputs of the facial movement sensors in the form of electrical signals are measured . in block 612 , the outputs of the facial movement sensors may be indicated on a facial image in the form of facial movement indications provided on a display . in block 614 , the outputs of the facial movement sensors may be used for diagnostic , therapeutic and / or other purposes . referring next to fig7 of the drawings , a flow diagram of an illustrative embodiment of a facial movement stimulation method is generally indicated by reference numeral 700 . in block 702 , electrodes are provided . in block 704 , an electrical input device is provided . in block 706 , the electrodes are connected to the electrical input device . in block 708 , the electrodes are placed on or surgically implanted in the face of a subject . in block 710 , electrical impulses are provided to the electrodes by transmitting an electrical current from the electrical input device to the electrodes . in block 712 , the response of the facial muscles of the subject to the electrical impulses may be used for diagnostic , therapeutic and / or other purposes . referring next to fig8 of the drawings , a flow diagram of an illustrative embodiment of a facial movement stimulation method in which facial movements or expressions are transferred from a first subject to a second subject is generally indicated by reference numeral 800 . in block 802 , facial movement sensors are provided . in some applications , the facial movement sensors may be electrodes . in some applications , the facial movement sensors may be accelerometers . in block 804 , electrodes are provided . in block 806 , a stimulus transfer device is provided . in block 808 , the facial movement sensors and the electrodes are connected to the stimulus transfer device . in block 810 , the facial movement sensors are placed on or surgically implanted in the face of a first subject . in block 812 , the electrodes are placed on or surgically implanted in the face of a second subject . in block 814 , the output of the facial movement sensors , which may be in the form of electrical signals , is transferred to the stimulus transfer device . in block 816 , the output of the facial movement sensors may be measured . in block 818 , the output of the facial movement sensors may be transferred from the stimulus transfer device to the electrodes in the form of electrical impulses to effect the same facial movements or expressions in the second subject , as were made by the first subject . referring next to fig9 of the drawings , a flow diagram of an illustrative embodiment of a therapeutic facial movement stimulation method is generally indicated by reference numeral 900 . in block 902 , electrodes are provided . in block 904 , an electrical stimulus device is provided . in block 906 , the electrodes are connected to the electrical stimulus device . in block 908 , the electrodes are placed on or surgically implanted in the face of a subject . in block 910 , a therapy program is selected . in block 912 , the electrical stimulus device is operated according to the selected therapy program to induce facial movements or expressions in the subject for therapeutic purposes . in some applications , the selected therapy program may be preprogrammed into a computer which may then automatically cycle through the electrical stimuli induced in the face of the subject to implement the therapy . referring next to fig1 , a flow diagram of an illustrative embodiment of a facial movement measurement method in which facial movements of a subject are utilised in a video game is generally indicated by reference numeral 1000 . in block 1002 , facial movement sensors are provided . in some applications , the facial movement sensors may be electrodes . in some applications , the facial movement sensors may be accelerometers . in block 1004 , a video game console connected to a display is provided . in block 1006 , the facial movement sensors are connected to the video game console . in block 1008 , the facial movement sensors are placed on or surgically implanted in the face of a subject . in block 1010 , the output of the facial movement sensors may be measured . in block 1012 , the output of the facial movement sensors may be utilized as an audio and / or visual component of a video game that is played using the video game console . referring next to fig1 , a flow diagram of an illustrative embodiment of the facial movement stimulation method in which electrical stimuli from a video game are transferred to a subject to effect facial movements in the subject is generally indicated by reference numeral 1100 . in block 1102 , electrodes are provided . in block 1104 , a video game console connected to a display is provided . in block 1106 , the electrodes are connected to the video game console . in block 1108 , the electrodes are placed on or surgically implanted in the face of a subject . in block 1110 , electrical impulses are transferred from the video game console to the electrodes to induce facial movements or expressions in the subject . the facial movements or expressions which are induced in the face of the subject may correspond to facial or other movements or expressions which are made by a character presented on the display as a video game is being played using the video game console . in some applications , the facial movements or expressions of the subject may be used to control one or more aspects of the video game . it will be appreciated by those skilled in the art that the apparatus and method in the various embodiments described herein above have numerous potential applications beyond those which are expressly described herein . for example , the apparatus and method may be used to study the contagiousness of emotions or the effect which changing facial expressions have on emotions in human subjects . in some applications , the apparatus and method may be used in mood intervention scenarios in which facial expressions that are indicative of positive emotions are transferred from one subject to another subject . the apparatus and method may be used as a polygraph in which facial twitches and movements may indicate whether a subject is lying in response to questioning . in some embodiments , the apparatus may be constructed with non - magnetic parts for use in conjunction with an mri or other medical device . since many modifications , variations , and changes in detail can be made to the described preferred embodiments of the invention , it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense . thus , the scope of the invention should be determined by the appended claims and their legal equivalence

an illustrative embodiment of a facial movement measurement and stimulation apparatus includes at least one facial movement sensor adapted to sense facial movement in a subject and a device interfacing with the facial movement sensor or sensors and adapted to receive at least one signal from the facial movement sensor or sensors and indicate facial movement of the subject . a facial movement measurement and stimulation method is also disclosed .

fig1 to 15 e show a shopping caddy and organizer system 50 in accordance with the invention , including a shopping caddy 100 and a shopping bag 200 . caddy 100 holds the bags upright , for example , in the trunk of a car or on the floor of a van . although this preferred embodiment caddy 100 is not fixed in the vehicle , shopping bag 200 will generally be restrained from sliding around or tipping when it is constrained through caddy 100 as compared with such a bag placed separately in a car . while the caddy system is particularly adapted for holding shopping articles , it may have many other uses such as shipping and storage of other articles . as explained below in more detail , this preferred caddy 100 is advantageous because it collapses in the end - to - end direction , thereby allowing the collapsed caddy 100 to have a smaller length and width footprint than it would if collapsed in a side - to - side direction or top - to - bottom direction , which other configurations would typically result in the bottom panel being non - foldable . also , end panels 110 , 114 can be rotated inwardly toward intermediate divider panels 112 to lie flat against the bottom panel 120 of the caddy . this feature can be used to provide a longer and more rigid base for the caddy when one or both endmost compartments are not filled with and supported by shopping bags . this is especially important because bottom panel 120 is pliable to allow for the end - to - end caddy collapsing action mentioned earlier in this paragraph . as shown in fig1 , caddy 100 includes first end panel 110 , two intermediate divider panels 112 , center divider panels 115 , second end panel 114 , a first side panel 116 , a second side panel 118 , and a bottom panel 120 . the panels 110 , 112 , 114 , 115 , 116 , 118 , and 120 define four rectangular compartments 102 , 104 , 106 , 108 . it is contemplated herein that by designing caddies with more or fewer intermediate divider panels 112 , different numbers of compartments may be obtained . in addition , the compartments could be square shaped as well . while the compartments are shown as each being the same size as the others , that is not a requirement of the invention . side panels 116 , 118 and bottom panel 120 are preferably made of pliable nylon fabric . end panels 110 , 114 and intermediate divider panels 112 and center divider panel 115 are formed as somewhat rigid boards ( preferably made of plastic , rubber or hardboard - like condensed cardboard , or the like ) encased in a suitable pliable sheet such as nylon . the “ somewhat ” rigid boards are preferably more flexible and elastic than a cardboard box or the wire mesh of a typical shopping cart , but much more rigid than cloth . the desired balance of rigidity and flexibility would be something like that provided by the sole of a light duty shoe . this intermediate degree of rigidity provides good support for bags in caddy 100 , while allowing plenty of give to prevent breakage of the panels . as used herein , the word “ rigid ” will be used to generically denote the preferable intermediate degree of rigidity described above , as well as higher degrees of rigidity . the nylon casing of the rigid boards of panels 110 , 112 , 114 , and 115 allows the panels to be sewn to the nylon side and bottom panels 116 , 118 , 120 and provides the caddy with an attractive , uniform color and texture . of course , materials other than nylon could be employed for the fabric casings . it is not essential to the invention that there be any fabric casing , but it is part of the preferred embodiment . as seen in fig1 , caddy 100 further includes a strap 122 with first a hook and loop fastening means such as that sold under the trademark velcro ® end 126 and end 124 can be secured together , for example . a portion of strap 122 is sewn to bottom panel 120 to hold it in place . the strap is long enough to hold caddy 100 in a collapsed and stacked state ( see fig1 ). because of the end - to - end collapsing action of the caddy , the stack held by strap 122 also has a small footprint . due to the careful dimensioning of the caddy in the stacked state it is nearly flush along its edges . this makes for a compact , attractive stack which is easy to carry during shopping excursions . because caddy system 50 forms such a nice stack , strap 122 is a very useful adjunct of the preferred caddy system 50 , but it is not an essential element of the invention . because the ends 124 , 126 are formed with complementary velcro portions , they are detachably attachable so that the length of the loop circumscribed by strap 122 can be varied depending on the height of the stack , which in turn depends upon whether the user chooses to secure bags , for example , in addition to the stack . of course , other adjustable attachably detachable structures could be used , such as buttons , snaps , magnets , tieable cords , and so on . at least some conventional caddies are made to be mounted to a car trunk . in these conventional caddies , the mounted caddy prevents tipping or translation of the caddy and its bags . in a preferred embodiment , no means are provided to mount caddy 100 to a floor or surface , so the manner in which unmounted caddy 100 prevents motion and tipping of the grocery bags will be described in some detail . however , as seen in fig9 and 10 , caddy 100 alternatively has non - skid feet 121 , which aid in keeping the device fixed and upright , especially in a moving vehicle . however , in other embodiments of the invention , it is contemplated that the caddy is mounted or secured to a vehicle . for example , the caddy could be mounted to the floor of the trunk , or it could be integrated with the rear portion of the back seat of the vehicle . first , with respect to tipping , when a bag is used without the caddy , its weight is distributed over a fairly small width w ( see fig1 ). further , the center of gravity of a loaded bag is likely to not be close to the bottom of the bag . when forces tend to rotate the bag about its bottom edge , tending to thereby tilt up the base of the bag about one of its bottom edges , the countervailing weight of the bag will act only along a fairly short moment arm w and will only produce a limited moment to resist this tipping . on the other hand , when a bag is constrained by caddy 100 in compartment 104 or 106 , for example , to act as a unit , the weight of the bag acts along longer moment arm 2w so that the weight of the bag produces a much greater moment to resist the tipping forces . similarly , if all four compartments 102 , 104 , 106 , 108 are filled with bags , the unit has a base which is 4w long . this long effective base is very resistant to tipping due to its length . second , with respect to sliding or translation of the bags , the constraint provided by caddy 100 effectively prevents such translation of either the bags or the caddy itself . this is because the combined weight of bags result in greater static frictional forces that must be overcome before caddy 100 will move along the surface upon which it rests . it is also noted that some limited degree of translation of the caddy , for example , within the trunk of a moving car , will generally not cause damage to or tumbling of the groceries . while the preferred caddy does not have mounting structures , it is noted that caddy 100 could be modified to include mounting structures . as stated above , in a preferred embodiment herein , caddy 100 has anti - skid pads 121 ( fig1 and 12 ) on bottom 120 to further prevent movement during transport . as mentioned above , caddy 100 collapses in the end - to - end direction . this is shown in detail in fig9 , 11 , and 12 . fig8 shows caddy 100 in a fully open position with panels 110 , 112 , 114 , and 115 being spaced apart to form compartments 102 , 104 , 106 , 108 . fig9 shows caddy 100 in a partially closed position with first end panel 110 moved in direction c toward the opposite second end panel 114 . pliable fabric side panels 116 , 118 fold inwardly to allow this collapsing motion . fig1 shows a further partially collapsed position , with first end panel 110 and each of intermediate divider panels 112 and center divider panel 115 moved in direction c toward close proximity with each other and with second end panel 114 . fig1 shows the caddy in the collapsed position with panels 110 , 112 , 114 , and 115 being in such close proximity that they actually come into contact with each other to form a very compact stack . alternatively , the panels may be brought into close proximity without quite touching each other . this end - to - end collapsing brings out one of the powerful advantages of the present invention , which is the balance between sturdiness , support and collapsibility of caddy 100 . more specifically , side panels 116 , 118 and bottom panel 120 are large in size . however , these large panels are made of pliable material such as nylon fabric so that they fold up and do not significantly increase the size of the caddy in the collapsed position . materials other than nylon could be used , as could heavier materials such as canvas . on the other hand , rigid , parallel panels 110 , 112 , 114 , and 115 provide good support for bags and allow the caddy to hold its shape when open and empty . therefore , the end - to - end collapsing feature of caddy 100 allows several somewhat conflicting design objectives to be simultaneously accommodated . as shown in fig3 and 14 , another feature of caddy 100 is the folding down action of end panels 110 and 114 . first end panel 110 can be rotated in direction r 1 down and inward relative to intermediate divider panels 112 . as shown in fig3 and 14 , first end panel 110 has been rotated all the way down into a position lying along bottom panel 120 , so that first end panel 110 is substantially perpendicular to intermediate divider panels 112 . second end panel 114 can also be rotated in direction r 2 down and inward relative to intermediate divider panels 112 . in the preferred caddy 100 , the end panels can be rotated because they are sewn to pliable bottom panel 120 along their axis of rotation , and because pliable side panels 116 , 118 collapse and fold to allow the rotational motion . it is noted that such rotational motion could be provided for in other ways , such as by a hinge and other hardware , which would allow rotational movement between the end panels and the side and bottom panels of caddy 100 . first end panel can be snugly folded all the way down because height h 2 ( fig1 ) of first end panel 110 is approximately equal to width w of compartment 102 . by approximately matching these dimensions , first panel 110 can be held in the folded down orientation by holding a portion of the bottom panel in tension between the seam joining intermediate divider panel 112 to bottom panel 120 and the seam joining first end panel 110 to bottom panel 120 . this tension detachably engages first end panel 110 in the folded down position so that it does not pop back up , for example , under the influence of small mechanical shocks . when the first compartment 102 is not holding a bag , first end panel 110 is preferably rotated all the way down to lie flat against bottom panel 120 in order to keep the effective width of the base of the caddy in its longer condition and thereby to help prevent tipping in the counter - r 1 direction ( see fig1 ). similarly , second end panel 114 can be folded down to maintain the effective width of the base longer and thereby prevent tipping in the counter - r 2 direction . in this way , tipping can be minimized even when caddy 100 holds only one or two bags . although end panels 110 , 114 of preferred caddy 100 can be folded to lie down against bottom panel 120 , the end panels could be alternatively dimensioned relative to the width of the compartments 102 , 108 so that they can be only partially rotated downward before physical interference with divider panels 112 blocks further rotation . in this alternative embodiment , the end panels would act as sort of a flying buttress , both supporting intermediate divider panels in the upright position while also helping to prevent tipping of the entire caddy by increasing the effective length of the base . fig5 shows an alternate arrangement of the embodiment of the invention shown in fig4 . as shown in place in fig4 , end panel 114 , in conjunction with the portion of bottom panel 120 that it covers , can be folded upward relative to intermediate panel 112 . side panels 116 and 118 are tucked inward during the folding up process so that they are placed neatly between end panel 114 and intermediate panel 112 . then using velcro strap 107 , the end panel is secured in close relation to intermediate panel 112 . for the other end , end panel 110 is positioned similarly . this arrangement then produces and open box configuration with a flat bottom portion and double - thickness ends . handles 101 are used for transporting the open box . the embodiment of fig5 is particularly useful for larger items that would not otherwise fit within one compartment and also which are relatively heavy and require lifting with handles for convenience . fig6 shows an alternate arrangement of the embodiment of the invention according to fig5 . in this arrangement , as compared to the arrangement of fig5 , center divider panels 115 have been raised to the upright position , thereby forming two compartments . these dividers can be secured together with straps 107 . fig7 shows an alternate position of the present invention , suitable for placement on a car seat , or between seats in a van , for example . this configuration is generally referred to herein as the “ w ” shape , because from the side , it forms the shape of the letter “ w .” the w shape is achieved by first folding end panels 110 and 114 inward relative to divider panels 112 . as described above , end panels 110 and 114 will be inclined to be substantially perpendicular to divider panels 112 . next , divider panels 112 are also folded down to be inclined substantially perpendicular to center divider panel 115 . the first divider panel and second divider panel are movable between a first angular orientation substantially parallel to the center divider panel and a second angular orientation inclined substantially perpendicular to the center divider panel . folding down the divider panels causes the end panels to rotate upward , with handle 101 moving to the top of the device . divider panels 112 are held in the downward position primarily by an interference fit with the side panels and the center divider panel . in addition , hook and loop engagement means 103 and 105 ensure that the divider panels stay in position . also as shown in fig7 , a water bottle , for example , may be placed in mesh pocket 128 , and will be retained within the perimeter of the device . this is particularly advantageous for securing the bottle . in case the bottle becomes unrestrained by the mesh , it will still be held within the confines of the device . in addition , various other personal items , such as a pen or a file folder may be placed between center divider panels 115 . center divider panel 115 is preferably composed of two substantially rigid panel members , arranged parallel and hinged at the bottom of the device . as shown in fig4 , hook and loop fastening means 113 secures the center divider panels in the upright position . however , by disengaging this fastening means , the center divider panels can be rotated downward in the s 1 and s 2 directions ( fig3 ) to the bottom of the device to be substantially parallel thereto . tabs 107 located on a top edge of the center divider panels aid in the s 1 and s 2 rotations . further hoop and loop fastening means 105 on panel 112 and 103 on bottom panel 120 engage with each other , thereby securing panels 112 to the bottom . this feature is particularly advantageous in holding the w configuration shown in fig7 . this thereby forms an enlarged compartment , suitable for larger items , such as container 300 ( fig4 ). in further embodiments of the invention , another container , such as a cooler bag , may be provided and sized for engagement in the enlarged compartment formed by folding down the center divider panels . alternatively , other containers having other sizes and shapes may be provided to be retained in any of the compartments of the organizer . as shown in fig4 , cooler bag 300 is approximately square in shape and is sized to engage snugly within the enlarged center compartment . handles 304 allow for convenient placement and removal of the cooler bag from the enlarged compartment . although not shown in the drawing , it is also contemplated herein that the cooler bag may have a zippered or otherwise closeable cover , may be substantially waterproof and may be constructed of material that reduces the transmission of heat or cold , thereby keeping items therein either cold or hot , depending on the particular application . cooler bag 300 may also have velcro patches 302 on one or more exterior surfaces thereof , suitably arranged for engagement with complementary velcro patches on the divider panels . in additional embodiments of the invention , the device includes a first end panel having a first side edge , a second side edge and a bottom edge , a second end panel having a first side edge , a second side edge and a bottom edge , a center divider panel having two substantially parallel divider members , each having a first side edge , a second side edge and a bottom edge , and a pliable base . a pliable base is also provided . it will be appreciated that in this embodiment , the first and second divider panels 112 found in previous embodiments , are not present . also , any type of fasteners , such as clips , clamps , staples , or the like , could be used in place of the hook and loop fasteners shown and described . an additional preferred embodiment of the disclosed device herein is depicted in figure fig1 a in the form of a cooler caddy 400 having a cooler compartment 402 positioned in between a first end compartment 408 and a second end compartment 410 . the end compartments are positioned on opposite ends of the cooler caddy 400 . the cooler compartment 402 provides great utility for storing items 407 which are sensitive to temperature and may exhibit symptoms of leaking if overheated , sweating and developing exterior condensation in humid conditions and the like . further , the cooler compartment 402 provides an excellent means to negate temperature extremes which can develop in car such as a parked car in the summer or winter months . as can be surmised by those skilled in the art , since the cooler compartment 402 is insulated , it may also serve as a compartment to maintain the heat of stored items 407 such as for instance , a pizza . however , when employed to hold items 407 to maintain heat , the lining of the cooler department must be formed of fabric adapted to endure the anticipated temperatures . the cooler compartment has a lid portion 404 adapted for engagement around portions of its perimeter with the cooler compartment 402 using a means for closing such as a zipper 406 or hook and loop fabric or other closing means suitable to the task . while shown with a fabric hinge along one edge of the lid portion 404 perimeter , which is the preferred mode of this embodiment since it maintains the lid portion 404 in permanent proximity to the cooler compartment 402 , a non - hinged version could also be employed . under the lid portion 404 the cooler compartment 402 is defined by a plurality of cooler sides 416 and the cooler bottom 417 . the means for closure , in this case the zipper 406 would be employed to engage the loose perimeter edges of the lid portion 404 to a respective aligned cooler side 416 . the interior lining of the cooler compartment 402 in the preferred mode , employs insulation materials and any suitable moisture barriers that might be desirable to protect the contents 407 stored in the cooler compartment 402 . such linings should also be substantially leak proof to maintain melted ice , water , or condensation , inside the cooler compartment 402 during use . a few materials suitable for the lining include one or a combination of pvc or eva plastics , and / or closed cell insulation which would have the additional benefit of an insulating factor . the lining may also be of a , or include , a thermal reflective material such as silver heat - sealed vinyl fabric which is adapted for the anticipated temperature of the cooler compartment 402 bet it cool or hot . while reinforced vinyl fabric may serve well as the lining , additional resistance from tearing and abrasion may be desirable in which case canvas , nylon , polyester , or other fabrics which are tear and abrasion resistant may be employed with the lining to increase the cooler compartment resistance to those potential hazards . as with other embodiments of the device herein , the ability of the cooler caddy 400 to collapse is particularly useful to the user since it allows the device to be expanded for use , or collapsed for storage , or when the entire device is not employed for storage . further , collapsing the first and second end compartments 408 and 410 , aids in insulating the cooler compartment 402 and forms very strong folded support sidewalls with the bottom handles 524 on the upper side of the device for extra support of potentially heavy loads inside the cooler compartment 402 . the formed support sidewalls , having the bottom handles 524 attached , are effectively three layers thick with the exterior sides 401 and 403 , the interior sides 416 , and part of the bottom 416 rotated to a vertical position . they thus insulate better and provide better support to the user of the load when carrying the device . the collapsible nature of the cooler caddy 400 is depicted in the series of fig1 a - 15c . in fig1 a the cooler caddy 400 is fully extended or in open configuration . as shown in fig1 b a partial collapse is provided by collapsing first and second end compartments 408 and 410 . this partial collapse still provides lateral support to the cooler sides 416 during use to keep it from tipping or sliding such as in a moving car , but renders the device smaller . additional stability would be available by stacking something heavy on top of the flattened end panels 401 and 403 . the fully collapsed configuration of the cooler caddy 400 is very similar to that as shown in fig1 , and a strap 411 is provided as a means to maintain the cooler caddy in that collapsed position through engagement of the distal ends of the strap 411 . in the fully deployed mode of the cooler caddy 400 shown in fig1 a , there is seen a first end compartment 408 and a second end compartment 410 both on opposite sides of the cooler compartment 402 of the cooler caddy 400 . both the first , and second compartments have an area for transport of cargo defined by the depicted plurality of panels . the first compartment 408 is defined by the adjoined surfaces of the first end panel 403 , the two side panels 413 , the bottom panel 412 and one sidewall defined by a cooler side 416 . the second end compartment 410 has a cargo area defined by the second end panel 401 , the bottom panel 412 , two end panels 413 , and the opposite side of the cooler shown as cooler side 418 . in fig1 b there is depicted the result of folding the first end 403 and second end 401 downward to a position adjacent to the bottom panels 412 of the respective two compartments . rotation of the two ends is provided by a fabric hinge formed along their respective engagements to the bottom panel 412 and form a respective axis of rotation of each of the first end 403 and second end 401 toward the bottom panel 412 . during this rotation , the pliable side panels 413 will fold and collapse to a position contacting the bottom panel 412 and in frictional engagement with the cooler side 416 . during a counter rotation to the vertical position of the end panels , the side panels 413 provide a means to limit the rotation away from the bottom panel 412 and thereby form the two storage compartments . as noted earlier , in the collapsed or folded position of both end compartments , additional support is provided to the cooler compartment 402 when carrying a heavy load therein . the placement of the bottom handles 524 , to be deployed above the top surface of the cooler lid 404 , gives the user both the increased support , and handles to hold onto when carrying the device . the end panels 401 and 403 of the cooler caddy 400 are formed to be substantially rigid . this can be accomplished by placing the fabric or material around a rigid interior member during manufacture . the result being that both end panels , when folded to the collapsed position shown in of 15 b , provide a rigid strut extending from either cooler side 416 . this allows for placing weight on top of the folded end panels 401 and 403 which will maintain the caddy 400 in place better since the projecting portion from the sides is rigid and won &# 39 ; t bend or flex as it would with plain fabric . as shown in fig1 c , the rigid end panels 401 and 403 also provide a means for a rigid support to the sides 416 of the cooler compartment 402 and means for a rigid communication between the lower handles 524 and the engagement at the bottom of the cooler sides 416 on both sides of the cooler compartment 402 . the resulting rigid sidewalls positioned adjacent to the cooler sides 416 in the collapsed position , will help to maintain the cooler compartment 402 in a fully elevated or enlarged position holding up the lid 404 from two side edges , and , in addition , it will aid by providing a means for protecting the contents of the cooler compartment 402 from side impacts . as noted earlier , a strap 411 is affixed to the cooler caddy 400 as a means to maintain it in a collapsed position . the strap 411 is affixed to a securing point 415 one outer surface of either the first end panel 403 or the second end panel 401 . the strap 411 has a length sufficient to encircle the fully collapsed cooler caddy 400 and secure and maintain that collapsed position . securement is provided by opposite distal ends of the strap 411 having means for engagement to each other in the form of a fastener . in the current preferred mode , hook and loop fabric works especially well , however any fastener that those skilled in the art would employ , such as snaps , buttons , hooks , eyelets , or buckles , are anticipated . as shown in 15 c , in the semi - collapsed mode of the cooler caddy 400 , the panel ends 401 and 403 are substantially vertical and positioned adjacent to opposed cooler sides 416 . in this position , the cooler caddy 400 is well supported by the aforementioned rigid nature of the folded panel ends , and easy to carry with the bottom handles 524 having rotated to the top of the device . total deployment to the collapsed position wherein the strap 411 is employed to maintain the device in a small form for storage or transport , is accomplished by compressing the first end panel 403 toward the second end panel 401 wherein the exterior cooler sides 416 being fabric and supple will tend to bend inward therebetween . once the first panel end 403 and second panel end 402 are in close proximity with the deformed cooler sides 416 and bottom 512 compressed therebetween , the strap 411 would be cinched around the cooler caddy 400 preferably through the top handles 524 to provide resistance to the strap sliding off . finally , an optional component that may be employed for additional utility and is preferred if the cooler caddy 400 is being employed for food transport and delivery such as a restaurant delivery , or transport to the beach for a picnic , there is provided a planar support surface 424 which is adapted for securement to a car seat with one or a plurality of straps 422 having fastening means on the distal ends of the straps engageable to mating fastening means on the support surface 424 a canvas or vinyl material works well for the support surface 424 . the support surface has a top surface which is adapted for removable engagement to the bottom surface 512 of the cooler caddy 400 or the bottom surface of the other embodiments herein . a first fastening means adapted to engage the fasteners 525 on the bottom panel 512 when the cooler caddy 400 is placed thereon , will hold the cooler caddy 400 in position during transport . if hook and loop fabric is employed as the mating fasteners , a simple lifting of the handles 409 or 524 will disengaged the bottom panel 512 from the support surface 420 . however during transport , the caddy 400 will remain engaged which is especially important during high speed cornering or fast stops . further a thermal element 425 may be provided in a pocket or other means of engagement to the support surface 420 and positioned for a registered engagement underneath the cooler compartment 402 when the cooler caddy 400 is engaged to the top surface 424 . such thermal elements 425 are readily available and plug into the cigarette lighter of conventional vehicles and will radiate heat on one side and cold on the opposite side . consequently if heat is wanted for communication to the cooler compartment , the thermal element 425 or the entire support surface 424 with a bottom side similar to the top surface 424 can be flipped over to change to heating mode . alternatively , if the caddy 400 is only hauling heated food or contents , then a resistive thermal element may be employed to impart heat to the caddy 400 . the multi - positionable caddy and organizer system device , shown in the drawings and described in detail herein , consists of arrangements of elements of particular construction , and configuration for illustrating preferred embodiments of structure and method of operation of the present invention . it is to be understood , however , that elements of different construction and configuration and different steps and process procedures and other arrangements thereof , other than those illustrated and described , may be employed for providing the apparatus herein and still be within the scope of this invention . as such , while the present invention has been described herein with reference to particular embodiments thereof , a wide latitude of modifications , various changes and substitutions are intended in the foregoing disclosure , and it will be appreciated that in some instance some features of the invention could be employed without a corresponding use of other features without departing from the scope of the invention as set forth in the following claims . all such changes , alternations and modifications as would occur to those skilled in the art are considered to be within the scope of this invention as broadly defined in the appended claims .

a caddy device for carrying and organizing articles being transported in a vehicle . the caddy is user - configurable to one or multiple individual compartments for optimizing their dimensions for carrying , holding and organizing articles such as filled shopping bags or food and drinks . employing multiple dividers the device may be deployed to numerous different positions to adjust the compartment size . an optional cooler bag for transport of cold items is also engagable within the compartments .

the following description is of the best mode presently contemplated for carrying out the invention . this description is not to be taken in a limiting sense , but is made merely for the purpose of describing the general principles of the invention . the scope of the invention should be determined with reference to the claims . in fig1 an implantable medical device , a three chamber biventricular pacemaker and cardioverter / defibrillator 10 that is connected to pacing / sensing leads placed in a heart 12 is illustrated . implantable medical device 10 incorporates a monitoring device . the implantable medical device 10 is electrically coupled to heart 12 by way of leads 14 , 16 and 30 . lead 14 is a right atrial electrode lead that has a pair of right atrial electrodes 22 and 24 that are in contact with the right atrium 26 of the heart 12 . lead 16 is a right ventricular electrode lead that has a pair of ventricular stimulation and sensing electrodes 18 and 20 that are in contact with the right ventricle 28 of heart 12 . further , a ventricular defibrillation shock coil 38 and an atrial defibrillation shock coil 40 are arranged on lead 16 . electrodes 22 and 18 are tip electrodes at the very distal end of leads 14 and 16 , respectively . electrode 22 is a right atrial tip electrode ra tip and electrode 18 is a right ventricular tip electrode rv tip . electrodes 24 and 20 are ring electrodes in close proximity but electrically isolated from the respective tip electrodes 22 and 18 . electrode 24 forms a right atrial ring electrode ra ring and electrode 20 forms a right ventricular ring electrode rv ring . ventricular defibrillation shock coil 38 and atrial defibrillation shock coil 40 are coil electrodes providing a relatively large surface area when compared to the electrodes 18 , 22 , 20 and 24 . lead 30 is a left ventricular electrode lead passing through the coronary sinus of heart 12 and having a left ventricular ring electrode lv ring 32 , and a left ventricular tip electrode lv tip 34 . further , a left ventricular defibrillation shock coil 36 is arranged on lead 30 . implantable medical device 10 has a case 42 made from electrically conductive material such as titanium that can serve as a large surface electrode herein called “ can ”. the plurality of electrodes 18 , 20 , 22 , 24 , 32 , 34 , 36 , 38 and 40 connected to implantable medical device 10 together with case 42 allow for a number of different electrode configurations for measuring intrathoracic and intracardiac impedance . a subset of configurations possible with the device in fig1 , are the preferred configurations illustrated conceptually in fig3 . fig2 illustrates a simplified block diagram of an implantable medical device , for example , the one shown as item 10 in fig1 . while fig1 shows a three chamber biventricular pacemaker and cardioverter / defibrillator , in fig2 no means for connecting atrial electrodes or shock electrodes and means for driving these electrodes are shown . however , such means may be provided as is known in the art . during operation of the implantable medical device leads 16 and 30 ( of fig1 ) are connected to respective output / input terminals rv ring , rv tip , lv ring and lv tip , items 20 , 18 , 32 , and 34 , respectively , of implantable medical device 10 as indicated in fig1 . for pacing the right and the left ventricle they carry stimulating pulses to the tip electrodes 18 and 34 from a right ventricular stimulation pulse generator rv stim 50 and a left ventricular stimulation pulse generator lv stim 52 , respectively . further , electrical signals from the right ventricle are carried from the electrode pair 18 and 20 , through the lead 16 , to the input terminal of right ventricular sensing stage rv sens 50 ; and electrical signals from the left ventricle are carried from the electrode pair 32 and 34 , through the lead 30 , to the input terminal of a left ventricular sensing stage lv sens 52 . controlling the implantable medical device 10 is a control unit ctrl 54 that is connected to stimulation pulse generators / sensing stages rv stim / rv sens 50 and lv stim / lv sens 52 . control unit ctrl 54 receives the output signals from the right ventricular sensing stage rv sens 50 and from the left ventricular sensing stage lv sens 52 . the output signals of sensing stages rv sens 50 and lv sens 52 are generated each time an r wave representing an intrinsic ventricular event in the respective ventricle is sensed within the heart 12 . thus , control unit is capable of detecting excitations of the myocardium indicating a ventricular contraction and to act as a heart rate detector for determination of a heart rate . control unit ctrl 54 also generates trigger signals that are sent to the right ventricular stimulation pulse generator rv stim 50 and the left ventricular stimulation pulse generator lv stim 52 , respectively . control unit ctrl 54 comprises circuitry for timing ventricular stimulation pulses ( atrial stimulation pulses are also possible but not shown in fig2 ) according to an adequate stimulation rate that can be adapted to a patient &# 39 ; s hemodynamic need as pointed out below . still referring to fig2 , the implantable medical device 10 includes a memory circuit mem 56 that is coupled to the control unit ctrl 54 over a suitable data / address bus . this memory circuit mem 56 allows certain control parameters , used by the control unit ctrl 54 in controlling the operation of the implantable medical device 10 , to be programmable , stored and modified , as required , in order to customize the implantable medical device &# 39 ; s operation to suit the needs of a particular patient . such data includes basic timing intervals used during operation of the implantable medical device 10 for triggering of ventricular or atrial stimulation pulses . further , data sensed during the operation of the implantable medical device may be stored in the memory mem 56 for later retrieval and analysis . for impedance measurement , an impedance measurement unit 70 is provided . impedance measurement unit 70 comprises a constant current source 72 and a voltage measurement unit 74 that are respectively connected or can be connected to electrodes for intracorporeal placement as shown in fig1 . in order to allow for a plurality of impedance measurement electrode configurations , preferably some means of switching is provided between the constant current source 72 and the electrode terminals of the implantable medical device 10 . in fig2 switches sw 1 and sw 2 are shown . as an alternative to constant current source 72 a constant voltage source can be provided . then , the measuring unit will be adapted to measure a current strength of a current fed through a body by said constant voltage source . both , constant current source 72 and measuring unit 74 , are connected to an impedance value determination unit 76 that is adapted to determine an impedance value for each measuring current pulse delivered by the constant current source 72 . further , an impedance evaluation unit 78 is provided , that is connected to said impedance determination unit 76 and that is adapted to control said impedance determination unit and to evaluate a sequence of consecutive impedance values determined by said impedance measurement unit 70 . impedance evaluation unit 78 is also connected to memory 56 for storing of impedance data . impedance measurement unit 70 and impedance evaluation unit can be controlled by control unit ctrl 54 . the impedance measurement unit 70 is adapted to determine at least transthoracic impedance values and preferably in addition intracardiac impedance values for same period of time , wherein the intracardiac impedance values are preferably sampled with a higher sampling rate than the transthoracic impedance values . a telemetry circuit tel 58 is further included in the implantable medical device 10 . this telemetry circuit tel 58 is connected to the control unit ctrl 54 and memory mem 56 by way of a suitable command / data bus . telemetry circuit tel 58 allows for wireless data exchange between the implantable medical device 10 and some remote programming or analyzing device , which can be part of a centralized service center serving multiple implantable medical devices . implantable medical device 10 usually comprises an activity sensor act 60 that is used for rate adaptation and can be of further use for evaluation of impedance values and therefore is connected to the impedance evaluation unit 78 via control unit ctrl 54 . in particular , an output signal by activity sensor 60 is used by impedance evaluation 78 to derive and recognize periods of physical activity and periods of rest . this information is used for further processing and trending of the information derived from the impedance signal . monitoring the heart failure status is accomplished by the impedance evaluation unit 78 by trending analysis of multiple physiological parameters of the patient , including at least the diurnal pattern of the respiration rate , which is measured by means of transthoracic impedance of the implantable cardiac device . in one typical embodiment , early detection of heart failure decompensation is made when the implantable cardiac device detects an increase of the night respiration rate of the patient , and / or decrease of the daytime respiration rate of the patient , and / or decrease of the circadian variability of the respiration rate of the patient . alternatively , heart failure monitoring is achieved by trending analysis of multiple physiological parameters , including but not limited to , the respiration rate , the heart rate , and the heart rate variability . according to this invention , the implantable cardiac device continuously measures the transthoracic impedance signal to derive the patient &# 39 ; s respiration rate . as is well known in the art , there are different means to measure the transthoracic impedance signal by choosing various electrode configurations for current injection and voltage measurement . typically , the impedance vectors pass through the lung in order to detect the respiration activity . fig3 shows two representative tripolar configurations for such impedance measurement . further configurations and preferred details for impedance measurement are disclosed in us2008 / 0300504 incorporated herein by reference . in the left panel of fig3 , the current is injected between the right ventricular ring and can , and the voltage is measured between the right ventricular tip and can . in the right panel of fig3 , the current is injected between the left ventricular ring and can , and the voltage is measured between the left ventricular tip and can . impedance value determination unit 76 calculates the transthoracic impedance as the ratio between the measured voltage and the injected current . in a preferred embodiment , the impedance signal is measured with sampling frequency of at least 8 hz . impedance evaluation unit 78 further processes the impedance signal to remove a high frequency cardiac component , e . g ., by using a low - pass filter with corner frequency of 2 . 5 hz , to thus obtain the low frequency respiratory component . impedance evaluation unit 78 further determines the peak - to - peak interval of the resulting respiration component of the transthoracic impedance signal , or the respiration cycle length . its inverse , or the number of respiration cycles within a predefined time interval ( e . g ., one minute ), is the respiration rate . in an alternative embodiment the inflection at the end of expiration to begin inspiration is identified to determine the respiration cycle length . fig4 illustrates the circadian patterns of the respiration rate measured in a chronic animal study . in this study , 10 mature yucatan minipigs were chronically instrumented with a biventricular pacemaker and a left ventricular pressure - measuring device . for each animal , after a recovery and stabilization period following device implantation , heart failure was inducted by using high rate right ventricular pacing at 240 ppm over 2 - 4 weeks . hourly left ventricular pressure measurements and weekly echo data were used to monitor the development of heart failure . hourly recording of right ventricular and left ventricular tripolar impedance ( during intrinsic rhythm ) was performed over the course of the study , including 2 - 4 weeks after cessation of high rate pacing ( recovery period ). respiratory measurements of respiration rate , tidal amplitude , and minute ventilation were extracted hourly from the tripolar impedance measurements . still refer to fig4 . in all panels , the x - axis is the hour of the day , and the y - axis is the respiration rate ( unit : cycles / minute ) measured by the implantable cardiac device . the plotted respiration rate data are averaged over 10 subjects . the left panels show the respiration rate derived from the right ventricular tripolar impedance data obtained using the configuration shown in the left panel of fig3 , and the right panels show the respiration rate derived from the left ventricular impedance data obtained using the configuration shown in the right panel of fig3 . the top panels show the 24 - hour respiration rate during the baseline period ( bl ) ( before heart failure induction ). the respiration rate shows clear circadian variation that increases during the daytime whereas it decreases during the night time . the middle panels show the 24 - hour respiration rate during the period with confirmed heart failure ( hf ) status . clearly , the circadian variation of the respiration rate is dramatically reduced , evidenced by decreased respiration rate in the daytime and elevated respiration rate in the night time . the bottom panels show the 24 - hour respiration rate during the recovery period ( rec ) ( after stopping high rate pacing ). evidently , the circadian pattern of the respiration rate also recovered to some extent , although not to the baseline level ( prior to heart failure induction ). it is believed by the inventors that the patient &# 39 ; s respiration rate contains important diagnostic information on heart failure status , which is independent from other physiological parameters such as heart rate and heart rate variability . normal function of the physiological system requires balance of the autonomic nervous system ( ans ). however , in heart failure patients the sympathetic tone is increased whereas the parasympathetic tone is suppressed . consequently , this results in increase of resting respiration rate , increase in resting heart rate , and decrease of the hear rate variability . according to this invention , the night respiration rate is a reasonable measure of the resting respiration rate , thus elevation of the night respiration rate is a strong indicator of worsening heart failure . the nighttime respiration is less subject to the interference of a conscious subject and environmental stimuli , and thus reflects more autonomic driven respiration . it is also believed by the inventors that the daytime respiration rate also contains prognostic information on patient &# 39 ; s heart failure status , because reduced daytime respiration rate likely reflects decreased daytime activity level , which is associated with worsening heart failure . consequently , the damped circadian variation of the respiration rate ( reduced difference between daytime and night time respiration rates ) is also a strong indicator of worsening heart failure . in a preferred embodiment , a pacemaker , implantable cardioverter / defibrillator ( icd ), or cardiac resynchronization therapy ( crt ) device with configurable impedance circuits is used to measure the tripolar intrathoracic impedance signal as illustrated in fig3 . methods for monitoring heart failure status by processing a transthoracic impedance signal are illustrated hereinafter . these methods can be carried out by the impedance evaluation unit 78 or by other means including a remote service center . then , from the transthoracic impedance signal , the cardiac component is separated from the respiration component . in a predefined time interval e . g . hourly , the respiration cycle length and / or the respiration rate is measured from the respiration component . measured values ( time interval , respiration cycle length and / or respiration rate ) are stored in memory 56 for further processing . the processing ( to be carried out by the impedance evaluation unit 78 ) comprises : calculation of overall statistics of the measured respiration rate , e . g . moving average within the past x - hours . calculation of separate day and night statistics of the measured respiration rate with user - programmable daytime and night time settings , e . g . daytime between 10 am and 5 pm , and night time between 1 am and 5 am . data may be transmitted routinely ( daily ) and as necessary ( alert ) via telemetry unit 58 to one or all of a remote server , data base and expert system using well known data transmission technologies for further processing e . g . for heart failure assessment . change from a baseline state of heart function to a worsening state , will be characterized by an increase of the night respiration rate , and / or decrease of the day - time respiration rate , and / or decrease of the circadian variability of the respiration rate of the patient . alert for worsening heart failure is generated when the increase or decrease of the above parameters crosses a predefined threshold value or percentage as compared to the baseline . alternatively , a composite score ( cs ) is constructed from multiple physiological parameters . for example , define cs = a * rrr + b / drr + c * rhr + d / hrv , where cs is the composite score , a , b , c , and d are predefined non - positive coefficients ( weighting factors ), rrr is the resting ( night ) respiration rate , drr is the difference between day and night respiration rates ( or alternatively , an index of 24 - hour respiration rate variability ), rhr is the resting ( night ) heart rate , and heart rate variability ( hrv ) is an index of 24 - hour heart rate variability as known in the art . worsening heart failure is indicated by increase of rrr , increase of rhr , decrease of drr , and decrease of heart rate variability ( hrv ). thus , early detection of heart failure decompensation is made when cs is increased above a predefined threshold . it should be understood that other definitions of cs can also be made based on the same concept .

the invention refers to a monitoring device for monitoring and analyzing physiological signals . the monitoring device comprises a transthoracic impedance measurement unit and an evaluation unit connected to the transthoracic impedance measurement unit . the transthoracic impedance measurement unit is adapted to conduct a transthoracic impedance measurement and to generate a transthoracic impedance signal representing a measured transthoracic impedance at consecutive points in time . the evaluation unit being configured to process the transthoracic impedance signal received from the transthoracic impedance measurement unit and to thus generate a respiration signal and to generate therefrom an evaluation signal reflecting at least a diurnal pattern of the respiration rate .

before the present disclosure is described in greater detail , it is to be understood that this disclosure is not limited to particular embodiments described , and as such may , of course , vary . it is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only , and is not intended to be limiting , since the scope of the present disclosure will be limited only by the appended claims . where a range of values is provided , it is understood that each intervening value , to the tenth of the unit of the lower limit unless the context clearly dictates otherwise , between the upper and lower limit of that range and any other stated or intervening value in that stated range , is encompassed within the disclosure . the upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the disclosure , subject to any specifically excluded limit in the stated range . where the stated range includes one or both of the limits , ranges excluding either or both of those included limits are also included in the disclosure . unless defined otherwise , all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs . although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure , the preferred methods and materials are now described . all publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited . the citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure . further , the dates of publication provided could be different from the actual publication dates that may need to be independently confirmed . as will be apparent to those of skill in the art upon reading this disclosure , each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure . any recited method can be carried out in the order of events recited or in any other order that is logically possible . embodiments of the present disclosure will employ , unless otherwise indicated , techniques of chemistry , botany , biology , and the like , which are within the skill of the art . the following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to perform the methods and use the probes disclosed and claimed herein . efforts have been made to ensure accuracy with respect to numbers ( e . g ., amounts , temperature , etc . ), but some errors and deviations should be accounted for . unless indicated otherwise , parts are parts by weight , temperature is in ° c ., and pressure is at or near atmospheric . standard temperature and pressure are defined as 20 ° c . and 1 atmosphere . before the embodiments of the present disclosure are described in detail , it is to be understood that , unless otherwise indicated , the present disclosure is not limited to particular materials , reagents , reaction materials , manufacturing processes , or the like , as such can vary . it is also to be understood that the terminology used herein is for purposes of describing particular embodiments only , and is not intended to be limiting . it is also possible in the present disclosure that steps can be executed in different sequence where this is logically possible . it must be noted that , as used in the specification and the appended claims , the singular forms “ a ,” “ an ,” and “ the ” include plural referents unless the context clearly dictates otherwise . thus , for example , reference to “ a compound ” includes a plurality of compounds . in this specification and in the claims that follow , reference will be made to a number of terms that shall be defined to have the following meanings unless a contrary intention is apparent . si is used herein to mean silicon dioxide , which is also commonly known as “ silica .” ng stands for “ nanogel ”, which is the gel - like substance formed by the interconnection of nanoparticles , for example , the interconnection of multifunctional silica based nanoparticles . np stands for “ nanoparticle ”, which can have a particle size ( e . g ., diameter for spherical or substantially spherical nanoparticles ) of about 10 to 500 nm , about 10 to 250 nm , about 10 to 100 , or about 10 nm to 50 nm . the diameter can be varied from a few nanometers to hundreds of nanometers by appropriately adjusting synthesis parameters , such as amounts of silane precursor , amounts of hydrolyzing agents , polarity of reaction medium , and the like . hcusing stands for hybrid cu - loaded silica nanogel , where the sing matrix is loaded with a second silane compound to achieve uniform or substantially uniform plant surface coverage . kocide ® 3000 pesticide / bactericide ; kocide is a registered trademark of e . i . du pont de nemours and company . “ uniform plant surface coverage ” refers to a uniform and complete ( e . g ., about 100 %) wet surface due to spray application of embodiments of the present disclosure . in other words , spray application causes embodiments of the present disclosure to spread throughout the plant surface . “ substantial uniform plant surface coverage ” refers to about 70 %, about 80 %, about 90 %, or more uniform plant surface coverage . “ substantially covering ” refers to covering about 70 %, about 80 %, about 90 %, or more , of the leaves and branches of a plant . “ plant ” refers to trees , plants , shrubs , flowers , and the like as well as portions of the plant such as twigs , leaves , stems , and the like . in a particular embodiment , the term plant includes a fruit tree such as a citrus tree ( e . g ., orange tree , lemon tree , lime tree , and the like ). the terms “ alk ” or “ alkyl ” refer to straight or branched chain hydrocarbon groups having 1 to 12 carbon atoms , preferably 1 to 8 carbon atoms , such as methyl , ethyl , n - propyl , i - propyl , n - butyl , i - butyl , t - butyl , pentyl , hexyl , heptyl , n - octyl , dodecyl , octadecyl , amyl , 2 - ethylhexyl , and the like . alkyl can include alkyl , dialkyl , trialkyl , and the like . as used herein , “ treat ”, “ treatment ”, “ treating ”, and the like refer to acting upon a disease or condition with a multifunctional silica based nanoparticle or gel of the present disclosure to affect the disease or condition by improving or altering it . in addition , “ treatment ” includes completely or partially preventing ( e . g ., about 70 % or more , about 80 % or more , about 90 % or more , about 95 % or more , or about 99 % or more ) a plant form acquiring a disease or condition . the phrase “ prevent ” can be used instead of treatment for this meaning . “ treatment ,” as used herein , covers one or more treatments of a disease in a plant , and includes : ( a ) reducing the risk of occurrence of the disease in a plant predisposed to the disease but not yet diagnosed as infected with the disease ( b ) impeding the development of the disease , and / or ( c ) relieving the disease , e . g ., causing regression of the disease and / or relieving one or more disease symptoms . the term “ antibacterial ” refers to a compound or composition that destroys bacteria , suppresses or prevents bacteria growth , and / or suppresses , prevents or eliminates the ability of bacteria to reproduce . the term “ antifungal ” refers to a compound or composition that destroys fungus , suppresses or prevents fungus growth , and / or suppresses , prevents or eliminates the ability of the fungus to reproduce . embodiments of the present disclosure include multifunctional silica based nanoparticles , methods of making multifunctional silica based nanoparticles , multifunctional silica based nanoparticle gels , methods of making multifunctional silica based nanoparticle gels , methods of using methods of making multifunctional silica based nanoparticle and methods of making multifunctional silica based nanoparticle gels , methods of treating plants , and the like . embodiments of the present disclosure provide for a composition that can be used for multiple purposes . embodiments of the present disclosure are advantageous in that they can slowly release one or more agents that can be used to prevent or substantially prevent and / or treat or substantially treat a disease or condition in a plant , act as an antibacterial and / or antifungal , and / or act as a repellent to certain types of insects . another advantage of an embodiment of the present disclosure is that the agent ( s ) can be controllably released over a long period of time ( e . g ., from the day of application until a few weeks or months ( e . g ., about 6 or 8 months )). embodiments of the present disclosure and features and advantages of these embodiments will be discussed in further detail herein . embodiments of the multifunctional silica based nanoparticle can include a first component and a second component . in addition , embodiments of the present disclosure can include a multifunctional silica based nanoparticle gel that includes multifunctional silica based nanoparticles . the multifunctional silica based nanoparticle and / or multifunctional silica based nanoparticle gel can be included in a composition to be administered ( e . g ., spraying ) to a plant . the multifunctional silica based nanoparticle gel includes multifunctional silica based nanoparticles inter - connected in an amorphous silica material . the nanoparticles can be inter - connected covalently ( e . g ., through — si — o — si — bonds ), physically associated via van der waal forces , and / or through ionic interactions ( e . g ., positively charged copper ions and negatively charged silica nanoparticles ). the first and second components can be within the amorphous material as well as in the multifunctional silica based nanoparticle . the first component can function as an antibacterial and / or antifungal , specifically , treating , substantially treating , preventing or substantially preventing , plant diseases such as citrus greening ( hlb ) and citrus canker diseases . the first component ( e . g ., cu ) can be released from the multifunctional silica based nanoparticle or gel so that it can act as an antibacterial and / or antifungal for a period of time ( e . g ., from application to days to months ). the second component functions as a repellant for insects that can harm plants and / or carry bacteria , diseases , fungi , and the like , that can harm plants ( e . g ., fruit tree ). the second component ( e . g ., a sulfur compound ) of the multifunctional silica based nanoparticle or gel can act as an asian citrus psyllid ( acp ) repellant for a period of time ( e . g ., from application to days to months ). embodiments of the present disclosure have multifunctional purposes to combat diseases in plants such as trees , bushes , and the like , for example , simultaneously treating , substantially treating , preventing and / or substantially preventing citrus greening and citrus canker diseases . in an embodiment , the release rate of the first and / or second component can be controlled so that characteristics of one or both can be effective for time frames of days to weeks or to months . in other words , the first component and / or second component can be released from the multifunctional silica based nanoparticle or gel starting from the day of application and continuing release to about a week , about a month , about two months , about three months , about four months , about five months , about six months , about seven month , or about eight months . the multifunctional silica based nanoparticle includes a core and shell . the core includes silica loaded with a first type of first component ( e . g ., cu ions ). the silica shell that can support a second type of first component ( e . g ., copper oxide ), while also including the first component ( e . g ., cu ions ). although not intending to be bound by theory , in an embodiment the second component can interact with the first component ( e . g ., cu ions ) via a charge - transfer type of interaction , where interaction between the first component and the second component can occur in the nanoparticle and / or in the amorphous silica material . in an embodiment , the first component can include a copper component , a zinc component , a titanium component , a cerium component , a magnesium component , a zirconium component , polyethyleneimine ( pei ), a carbon component ( e . g ., mixed carbon or soot ), fullerene , carbon nanotubes , and a combination thereof . specifically , the first component can include a copper ion , metallic copper ( cu ), copper salt , copper complex , a zinc ion , metallic zinc ( zn ), zinc oxide , zinc salt , a silver ion , metallic silver ( ag ), silver salt , silver complex , a titanium ion , titanium dioxide ( tio 2 ), a cerium ion , cerium oxides , a magnesium ion , magnesium oxide , a zirconium ion , zirconium oxide , and a combination thereof . in an embodiment , the copper component can include a copper ion , metallic copper , copper oxide , copper oxychloride , copper sulfate , copper hydroxide , and a combination thereof . the copper component can include copper ions that are electrostatically bound to the silica nanoparticle core or amorphous silica matrix , copper covalently bound to the hydrated surface of the nanoparticle or amorphous silica matrix , and / or copper oxides and / or hydroxides bound to the surface of the nanoparticle or amorphous silica matrix . in an embodiment , the multifunctional silica based nanoparticle and / or gel includes the copper component in two or in all three of these states . in an embodiment , the copper component can be in a soluble ( amorphous ) and an insoluble ( crystalline ) form . by controlling the soluble and insoluble ratio , the release rate of the copper component can be controlled as a function of time . as a result , the release rate of the copper component can be controlled so that antibacterial and / or antifungal characteristics can be effective for time frames of days to weeks or to months . in other words , the copper component can be released from the multifunctional silica based nanoparticle or gel staring from the day of application and continuing release to about a week , about a month , about two months , about three months , about four months , about five months , about six months , about seven month , or about eight months . the ratio of the soluble to insoluble copper component can be adjusted to control the release rate . in an embodiment , the ratio of the soluble copper to the insoluble copper ( e . g ., chelated cu ) x ( crystalline cu ) 1 - x ) can be out 0 : 1 to 1 : 0 , and can be modified in increments of about 0 . 01 to produce the ratio that releases the cu for the desired period of time . parameters that can be used to adjust the ratio include : solvent polarity and protic nature ( i . e ., hydrogen bonding capability ), cu precursor ( e . g ., cu sulfate ) concentration , temperature , concentration of silane precursor ( such as tetraethylorthosilicate , teos ), and the like . in an embodiment , the second component can include a sulfur compound . the sulfur compound does not react or reacts very little ( e . g ., at such a low percentage or at such a slow rate that the first and second components can still function in a manner and for a time frame described herein ) with the first component . the sulfur compound can include alkyl sulfides , alkyl disulfides , alkyl trisulfides , alkyl tetrasulfides , analogues of each , and a combination thereof , where alkyl can include alkyl , dialkyl , and trialkyl . in particular , the sulfur compound can include compounds dimethyl disulfide ( dmds ), dimethyl sulfide , diethyl disulfide , diethyl trisulfide , diethyl tetrasulfide , and a combination thereof . the release rate of the second component can be controlled to release starting from the day of application to about a week , about a month , about two months , about three months , about four months , about five months , about six months , about seven month , or about eight months . in an embodiment , the sulfur compound is dmds . it should be noted that the sulfur compound can be used as a acp repellant and is attractive strategy to control the hlb . it should be noted that dmds is toxic to insects because it disrupts cytochrome oxidase system of the mitochondria and is considered a strong repellent to acp . dmds can interact with the first component ( e . g ., cu ion ) in a charge - transfer type of interaction . thus , by controlling the amount of first component that the dmds can interact with , the amount of the first component can be used to control the amount of dmds present in the multifunctional silica based nanoparticle or gel . although not intending to be bound by theory , sulfur ( electronegative element , polarizable ) in dmds is weakly bound to copper ions ( type of ion - dipole interaction ). once cu is released from the product , dmds will mostly release as there is no other strong interaction between dmds and silica nanoparticle / nanogel matrix other than van der waals force . in an embodiment , the amorphous silica gel has no ordered ( e . g ., defined ) structure ( opposite to crystalline structure ) so an “ amorphous gel ” refers to gel material having amorphous structural composition . in an embodiment , the number of multifunctional silica based nanoparticle in a gram of multifunctional silica based nanoparticle gel can be difficult to accurately determine . however , the following provides some guidance . let &# 39 ; s assume amorphous silica gel ( completely dehydrated ) including about 10 nm size ( diameter ) inter - connected particles as our test material . one could roughly estimate number of particles per gram of material in the following way : mass ( m ) of a single particle = density of the particle ( d )× volume of the particle ( v ) if we plug in these numbers , v = 5 . 23 × 10 − 19 cm 3 the multifunctional nanoparticle / nanogel product contains two active components , dmds and first component ( e . g ., cu ) and a second component ( e . g ., dmds ). experimentally , we can load about 33 to 45 wt % of cu in silica nanoparticle material ( measured by icp - aas analysis ; icp stands for inductively coupled plasma - atomic absorption spectroscopy ). for example , cu loading is about 33 % in cu loaded silica nanogel material synthesized in acidic ethanol - water mixture containing ethanol ( 95 %) up to 45 . 5 % of total volume . cu loading is about 45 % in cu loaded silica nanoparticle material synthesized only in acidic water . roughly one cu can hold at least one dmds molecule . these estimates can be applied to the first component and the second component . an embodiment of the multifunctional silica based nanoparticle and gel are described in pct patent application us 2009 / 006496 entitled “ silica - based antibacterial and antifungal nanoformulation ”, which is incorporated herein by reference . in addition , methods of making an embodiment of the multifunctional silica based nanoparticle and gel are described in the aforementioned pct patent application . in general , the precursor material to make the multifunctional silica based nanoparticles and gel can be made by mixing a silane compound ( e . g ., alkyl silane , tetraethoxysilane , tetramethoxysilane , sodium silicate , or a silane precursor that can produce silicic acid or silicic acid like intermediates and a combination of these silane compounds ) with a first component precursor compound in an acid medium ( e . g ., acidic water ) that may contain an alcohol such as ethanol . after mixing for a period of time ( e . g ., about 30 minutes to a few hours ), a mixture including silica nanoparticles loaded with the first component ( also referred to as a “ loaded silica nanoparticle ”) is formed . after the loaded silica nanoparticle are formed , the medium can be brought to a ph of about 7 and held for a time period ( e . g ., a few hours to a day ) to form a precursor material that includes a loaded silica nanoparticle gel , where the nanoparticles are inter - connected . this process can be performed using a single reaction vessel or can use multiple reaction vessels . once the loaded silica nanoparticle is made , the multifunctional silica based nanoparticles and gel can be formed . the loaded silica nanoparticle can be disposed in a reaction vessel in an aqueous reaction medium ( e . g ., acidic water ) or can be dried and mixed as a powder . the second component ( e . g ., dmds ) is also added to the reaction vessel that includes the aqueous reaction mixture or the dry precursor material . the ratio of the amount of precursor material and the second component ( dry ) can be about 1 to 1 . this mixture is mixed for a period of time ( e . g ., from minutes to hours ) to form the multifunctional silica based nanoparticles and gel . the multifunctional silica based nanoparticles and gel can be separated ( e . g ., centrifuge ) from the aqueous solution and dried ( e . g ., air dried ). the mixture does not require any additional purification , although further purification and processing can be performed . this process can be performed using a single reaction vessel or can use multiple reaction vessels and can be performed at ambient temperature and pressure . in a particular embodiment , the second component is dmds and can be added under mechanical stirring after cu loaded silica nanoformulation is prepared . however , dmds can be added anytime during the nanoformulation preparation process . in an embodiment , about 100 micrograms of dmds is added to about 45 g equivalent of cu . in another embodiment of the present disclosure the multifunctional silica based nanoparticles gel can be formed using a second silane compound , where the addition of the second silane compound improves the uniformity of the plant surface coverage . during the step when the silane compound is added , the second silane compound can also be added . the second silane compound can include compounds such as alkyl silanes . the second silane compound can be about 0 . 01 to 30 % or about 10 to 30 % weight of the silane compound . the resulting silane mixture can include the first component and / or the second component , such as those described above . the nanoparticle is the same or similar to the nanoparticle described above and herein . it should be noted that an objective in this embodiment is to tailor nanoparticle / nanogel surface hydrophilicity or hydrophobicity to further improve adherence property of nanoformulations . for example citrus leaves are waxy ( hydrophobic ). to improve adherence of nanoformulation to waxy surface via hydrophobic - hydrophobic interaction , silica nanoparticle / nanogel material can be further modified with a hydrophobic silane reagent such methyl - or propyl - or butyl silane . as mentioned above , embodiments of the present disclosure are effective for the treatment of diseases affecting plants such as citrus plants and trees . in addition , embodiments of the present disclosure can be effective as a protective barrier against phloem - feeding acps as it uniformly covers the plant surface ( e . g ., leaf surface ). in particular , embodiments of the present disclosure can be used to combat citrus canker and greening diseases ( hlb ). the design of the multifunctional silica based nanoparticle or gel facilitate uniform plant surface coverage or substantially uniform plant surface coverage . in an embodiment , the multifunctional silica based nanoparticle or gel that is applied to plants can have a superior adherence property in various types of exposure to atmospheric conditions such as rain , wind , snow , and sunlight , such that it is not substantially removed over the time frame of the release of the first and / or second components . in an embodiment , the multifunctional silica based nanoparticle or gel has a reduced phytotoxic effect on plants and reduced environmental stress due to minimal cu content . embodiments of the present disclosure can applied on the time frames consistent with the release of the first and second components , and these time frames can include from the first day of application to about a week , about a month , about two months , about three months , about four months , about five months , about six months , about seven month , or about eight months . a specific embodiment of the multifunctional silica based nanoparticle or gel can include a multifunctional dimethyl disulfide ( dmds ) and copper co - loaded silica based nanoparticle or nanogel ( dmds - cusinp / ng ), which can be used to combat citrus canker and greening diseases is disclosed . when the composition is applied to citrus plants , it is effective for simultaneously controlling citrus canker and citrus greening diseases in a single application during one citrus growing season . now having described the embodiments of the present disclosure , in general , the examples describe some additional embodiments of the present disclosure . while embodiments of the present disclosure are described in connection with examples and the corresponding text and figures , there is no intent to limit embodiments of the present disclosure to these descriptions . on the contrary , the intent is to cover all alternatives , modifications , and equivalents included within the spirit and scope of embodiments of the present disclosure . laboratory - based experimental data confirmed the following : ( i ) much improved antibacterial properties of cusing material in comparison to controls , kocide ® 3000 ( a dupont product ; cu hydroxide material ) and cu sulfate , ( ii ) exceptionally strong adherence property to the citrus leaf surface in comparison to controls and ( iii ) improved surface coverage , uniform throughout , upon spray application . based on materials characterization data ( high resolution transmission electron microscopy and selected area electron diffraction patterns ), it is confirmed that cu is present in silica nanogel ( sing ) matrix in two different forms and in two different oxidation states , crystalline cu oxide ( cu + 1 state ) and amorphous cu complex ( cu + 2 state ). the cusing is thus a unique , nanotechnology - enabled engineered nanomaterial . the disc diffusion assay confirmed that the cusing material has the ability to diffuse out from the application location . this diffusion property will have strong impact in protecting rapidly expanding young fruit and leaf surfaces . in the present disclosure , dmds and cu co - loaded silica nanogel ( dmds - cusing ) based materials and related formulations are prepared . multidisciplinary research is used to develop and study dmds loaded materials , conduct a number of laboratory based bioassays to test the efficacy and perform field study to evaluate the efficacy in controlling hlb and citrus canker diseases . the loading of dmds in cusing has been studied in solution state ( as synthesized cusing liquid formulation ) and characterized by the gas chromatography - mass spectrometry ( gc - ms ). in solution state , loading of dmds into cusing material was carried out by directly adding dmds into the aqueous reaction mixture that contains cusing material . stirring was continued to ensure uniform mixing of dmds with the cusing material . the reaction medium composition greatly facilitated direct loading of dmds into cusing material . after 24 hrs , dmds - cusing material was centrifuged and air - dried for more than seven days . we were able to smell strong sulphur odor . fig1 a is gc - ms spectra of dmds used as a control under conditions wherein the silica nanogel ( sing ) does not contain copper . fig1 b is a gc - ms spectra of dmds - cusing material . a dmds odor from the dmds - cusing powder is discernable even after seven days . for gc - ms sample preparation , spectroscopy grade chloroform was added to the powder and dmds . gc - ms data of dmds ( control ) and chloroform extract of dmds - cusing are shown in fig1 a and fig1 b , respectively . characteristic molecular peak for dmds at 93 ( m / z ) along with other peaks for its fragmented structure is shown in fig2 where the gc - ms spectra of dmds - sing material products were found in both cases , confirming the presence of dmds in dmds - cusing sample . similar experiment was also carried out with sing ( instead of cusing ). after 3 days , we were not able to detect characteristic dmds odor from dmds - sing material and gc - ms study showed no noticeable dmds characteristic peaks as shown in fig2 . these results suggest that cu 2 + ions play a critical role with dmds loading and retention . loading of dmds in dry state using lyophilized cusing powder was carried out by adding dmds ( 100 μl neat ) directly to cusing ( 150 mg of vacuum dried powder ) sample in a 20 ml glass vial . for a quick comparison purposes , we took 100 μl neat dmds in another 20 ml glass vial ( control ). both vials were kept side - by - side inside a laboratory fume hood to allow dmds to evaporate at the same rate . after 3 days , we were able to smell strong dmds odor from the dmds - treated cusing sample only . subsequently , chloroform is added to both vials and results are shown in fig3 a and 3 b . gc - ms spectra of dmds added to dry cusing lyophilized powder is shown in fig3 a . in fig3 b a control extract of dmds is taken and performed gc - ms . as expected , characteristic dmds peaks were obtained from dmds - cusing sample ( fig3 a ) and no such peaks from the control ( fig3 b ). the above preliminary experiments thus confirmed that cusing material is able to load , retain and slowly release dmds . a synthesis method for preparation of a silica matrix with embedded metallic particles is reported in u . s . pat . no . 6 , 548 , 264 to tan et al ., u . s . pat . no . 6 , 924 , 116 to tan et al ., and u . s . pat . no . 7 , 332 , 351 to tan et al ., which are incorporated herein by reference . the synthesis of cusing is disclosed in international patent application no . pct / us2009 / 006496 filed dec . 10 , 2009 and is incorporated herein by reference . the following material characterization techniques were used to characterize the dmds - cusing material of the present disclosure . first a gc - ms study will qualitatively confirm loading of dmds in cusing and sing materials . second quartz crystal microbalance ( qcm ) based sensing study will confirm loading and release of dmds in real - time . considering practical application of dmds - cusing material in the field , it is desirable to perform quantitative study to monitor dmds loading / release processes in real - time . therefore qcm based sensing technology will be adapted for quantitative measurements of dmds loading / release and determine kinetics . the sensitivity of qcm technique is reported at the parts per billion level by j . w . gardner et al , “ a brief - history of electronic noses .” sensors and actuators b - chemical 1994 , 18 , ( 1 - 3 ), 211 - 220 . the characterization of dmds - cusing clarifies the nature of interaction of dmds with the cusing material . our goal is to investigate the physico - chemical environment around dmds and the role of cu in dmds adsorption . briefly , the experimental setup includes using a sample of cusing material that is spray - coated onto qcm sensor followed by exposure to dmds in a closed chamber . it is expected that with time the resonating frequency of the qcm will continue to decrease as more and more dmds is loaded into the cusing material . once equilibrium is reached , no further frequency drop will take place . the sensor is removed from the chamber and monitoring of the dmds release process with time is observed . we expect to observe increase in frequency as more and more dmds is released . similar experiments will be performed for the sing material , as a control . dmds loading into sing matrix is driven by hydrogen bonding between the silica surface / pores containing silanol (— si — oh ) group ( proton donor ) and dmds sulfur atom ( proton acceptor ), according to r . w . glass , et al , in “ surface studies of adsorption of sulfur - containing gases at 423 degree k on porous adsorbents . 1 . adsorption of hydrogen sulfide , methanethiol , ethanethiol , and dimethyl sulfide on silica gels .” journal of physical chemistry 1973 , 77 , ( 21 ), 2571 - 2576 . unlike sing , the physico - chemical environment of dmds in cusing is expected to be somewhat different due to presence of cu ( ii ) ions . preliminary results suggest that characteristic odor dmds does not change over time which indicates that dmds is non - reactive to cu ( ii ) ions . however , the dmds electron - rich sulfur atom has the ability to weakly interact with electron - deficient cu ( ii ) ion . this could further facilitate adsorption of dmds into cusing . thorough ft - ir studies are performed to understand the nature of intermolecular interactions that exist between dmds and sing . in addition , thermogravimetric analysis ( tga ), calorimetry and qcm sensing studies to obtain dmds loading / release characteristics ( isotherms ) against cusing and sing materials will be used to determine the role of cu ii ions in dmds loading . a comparative isotherm data analysis along with ft - ir analysis will reveal the effect of cu in dmds loading / release process . the manipulation of the molecular environment around dmds at the nanoscale level was conducted to improve dmds loading efficiency into cusing and sing materials . first hybrid silica nanogel ( hsing ) and cu loaded hsing ( cuhsing ) materials were synthesized . a combination of two inexpensive silica precursors were used during the hsing synthesis consisting of a silane based ester and an alkyl based ( e . g . methyl or propyl ) silane . the rationale of introducing small alkyl chain polymers into the silica matrix is that it will improve interaction with dmds via intermolecular hydrophobic - hydrophobic interaction . a series of experiments were performed by varying the ratio of these two silica precursors to optimize loading of both cu and dmds into hsing material . both the dmds - hsing and dmds - hcusing materials are systematically characterized . dmds loading efficiency to hsing and hcusing materials will be evaluated and results will be compared with dmds - cusing material . for bioassays and field trials , only one dmds - cusing material that has maximum loading of cu and dmds will be selected , the two active components responsible for preventing canker and hlb diseases , respectively . characterization : cu loading efficiency will be quantitatively determined by the atomic absorption spectroscopy ( aas ) whereas dmds loading / release kinetics will be determined by the qcm study . in addition , several material characterization techniques such as tem / hrtem ( size and morphology ), saed ( crystallinity ), xps ( identification of cu oxidation states ), xrd ( bulk crystallinity ), sem - edax ( elemental analysis for estimating cu to si ratio ), bet ( surface area / porosity measurements ) and ftir ( studying interaction of dmds as well as cu with silica matrix ) will be used for systematic characterization of hsing and cuhsing materials . further improvement of dmds loading into hsing and hcusing is expected due to additional hydrophobic - hydrophobic intermolecular interactions between the methyl groups of dmds and alkyl groups of silane precursor . laboratory bioassays for efficacy evaluation of dmds loaded materials include , disc diffusion assays against x . alfalfae and olfactometer bioassays against acps and the disc diffusion assay . to test anti - bacterial activity of the dmds - cusing and dmds - hcusing materials , a known ‘ disc diffusion assay ’ method is used . briefly , appropriate dilution of overnight grown x . alfalfae culture ( 200 μl of about 106 cfu / ml based on dilution of the 0 . 5 mc farland standard ) will be spread on nutrient agar plates ( 90 mm ) to achieve a confluent lawn of growth . comparative analysis of growth inhibition by different concentrations of the test materials ( dmds - cusing and dmds - hcusing ) using dmds - sing and dmds - hsing as negative controls , and cu sulfate and kocide ® 3000 as positive controls will be performed to find out the difference in minimum inhibitory concentration ranges under the test conditions . the same volume containing different concentrations of each formulation will be applied per disc to avoid any variation of unequal diffusion perimeter on the agar plate . the level of anti - bacterial ability will be determined by measuring the zone of inhibition after 24 hrs of incubation at 30 ° c . the minimum inhibitory concentration ( mic ) of all the above mentioned compounds , including dmds - cusing and dmds - hcusing , will also be determined by spreading appropriate dilution of x . alfalfae culture on nutrient agar plates containing log 2 ( two fold ) serial dilutions of the test compound ( s ) to correlate the results of the zone of inhibition in the disc diffusion test and to refine the concentration of dmds - cusing and dmds - hcusing necessary for effective killing of the pathogens . all the test plates will be incubated for longer periods beyond 24 hours to detect any delayed growth of the test organism by the formation of isolated colonies in the zone of inhibition or on the dilution series agar plates at the mic level . this will tentatively indicate the difference in stability between the dmds - cusing ( or dmds - hcusing ) and kocide ® 3000 or cu sulfate under the test conditions , which will be an indirect evaluation of the difference in cu release kinetics of the dmds - cusing ( or dmds - hcusing ) and the kocide ® 3000 . we will also generate dose - response plots wherever appropriate . briefly , dosage of the cu compound will be varied and the relative response or percentages of disease control to those dosages will be determined . statistical analysis : we will test the significance of anti - bacterial activity by different statistical analyses such as annova discussed in design and analysis of experiments by hinkelmann , k . ; kempthorne , o ., wiley : 2008 ; vol . i and ii ( second ed .). diameter of inhibition zone with all the respective anti - bacterial materials at different concentrations and incubation times will be measured to use in the statistical analysis , assessing the suitability of cusing and h — cusing as a better anti - bacterial material with respect to the controls . the benefits of applying nanotechnology in citrus research are enormously high . silica nanogel matrix provides a unique environment for co - hosting cu and dmds , making dmds - cusing nanomaterial multifunctional for combating both citrus canker and greening diseases . recent studies suggest that silica nanogel is able to slowly spread out from the point of application in moist environment . the impact would be tremendously high as this cusing will form a uniform film - like coating on the surface over time . we identify two major advantages of silica nanogel film ; ( i ) ability to protect rapidly growing young fruit and leaf surfaces and ( ii ) ability to serve as protective barrier for phloem - feeding acps . the dmds - cusing technology will offer the following benefits : ( a ) a two - in - one formulation for combating both citrus canker and greening , ( b ) superior cu bioavailability and longevity , ( c ) sustained release of dmds for protecting invasion of acp ( primary defense mechanism ), ( d ) robust coating of dmds - cusing onto leaf surface ( secondary defense mechanism against acp ), ( e ) simple one - pot bulk synthesis technique , ( f ) inexpensive ingredients ( raw material cost ˜$ 3 . 00 per acre ) and ( g ) multiple applications are not required . due to nanoscale engineering , the cusing of the present disclosure has the following advantages over the existing cu based compounds : uniform coverage of plant surface because of ultra - small particle size , better adherence property due to gel - like nanostructure , sustained ( long - term ) cu release profile , better control on cu release rate ( adjustable “ soluble ” to “ insoluble ” cu ratio ), more antibacterial / antifungal activity with less amount of cu content , reduced phytotoxic effect because of adjustable “ soluble ” to “ insoluble ” cu ratio and environment - safe due to less cu content , no harmful by - product formation , water - based synthesis , utilization of excess cusing as plant nutrient and minimal possibility of having elevated local cu concentration that could cause environmental toxicity . the synthesis protocol has the following advantages : ( i ) simplicity , ( ii ) water - based , ( ii ) scalable to field applications , ( iii ) single - pot synthesis method , requiring no purification steps and ( v ) concentrated cusing material could be easily diluted for field application . a non - technical person can do this task by adding an appropriate amount of water , thus reducing shipping costs . the method also uses inexpensive raw chemicals and is easily produced in a cost - effective manner . it should be noted that ratios , concentrations , amounts , and other numerical data may be expressed herein in a range format . it is to be understood that such a range format is used for convenience and brevity , and thus , should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range , but also to include all the individual numerical values or sub - ranges encompassed within that range as if each numerical value and sub - range is explicitly recited . to illustrate , a concentration range of “ about 0 . 1 % to about 5 %” should be interpreted to include not only the explicitly recited concentration of about 0 . 1 wt % to about 5 wt %, but also include individual concentrations ( e . g ., 1 %, 2 %, 3 %, and 4 %) and the sub - ranges ( e . g ., 0 . 5 %, 1 . 1 %, 2 . 2 %, 3 . 3 %, and 4 . 4 %) within the indicated range . in an embodiment , the term “ about ” can include traditional rounding according to significant figures of the numerical value . in addition , the phrase “ about ‘ x ’ to ‘ y ’” includes “ about ‘ x ’ to about ‘ y ’”. it should be emphasized that the above - described embodiments of the present disclosure are merely possible examples of implementations , and are set forth only for a clear understanding of the principles of the disclosure . many variations and modifications may be made to the above - described embodiments of the disclosure without departing substantially from the spirit and principles of the disclosure . all such modifications and variations are intended to be included herein within the scope of this disclosure .

briefly described , embodiments of this disclosure , among others , include compositions , gels , methods for synthesizing multifunctional silica based nanoparticle gel , method of treating , preventing , or both treating and preventing , a disease in a plant species , method for simultaneously treating citrus plants for citrus canker and preventing the invasion of an asian citrus psyllid vector that carries the pathogen and spreads the citrus greening disease in citrus plants , and the like .

the present invention provides a method and apparatus to close a subject &# 39 ; s eyes when the subject is sleeping or resting his eyes . in one embodiment , the apparatus of the present invention comprises a support member that covers over the nose and eye sockets , extending about half way across the eyelid over each eye , and covers from the lower forehead to below the lower edge of the eye sockets . adjustable elastic bands that encircle the subject &# 39 ; s head are attached to hold it in place . in one embodiment , this support member is made from a lightweight , rigid material on the outside , which is shaped to conform to the nose and forehead . in one embodiment , the support member rests on the bones around the central edges of the eye sockets : on the forehead at the top about at the central ends of the eyebrows , and at the bottom near the nose below the eye socket . in one embodiment , the support member has an inner layer of foam to prevent discomfort where it rests on the face . the support member also has soft protrusions near the edges over the eyelids . when the apparatus is put in place and the elastic bands are put around the head , these protrusions contact the eyelids with a gentle inward pressure and pull the eyelids closed . similar protrusions to occlude the nasolacrimal sacs can also be incorporated into the apparatus to make it even more effective . in one embodiment , the protrusions are made of soft medical foam or elastomer , or can be jel - filled sacs . these protrusions may be part of the inner foam layer , small pieces that are held in place with adhesive or pieces held in pockets in the support member . the present invention fills a need for an effective , comfortable apparatus to hold a subject &# 39 ; s eyes closed when sleeping or resting , thereby preventing evaporation of tear fluids and keeping the eye moist . the present invention applies gentle pressure obliquely to the side of the eyeball , primarily on the tissues of the eyelids and between the eye and nose . other methods of holding eyelids closed either use pads to apply greater pressure over a wide part of the eyelids and eyeball , which distorts the eyeball and causes visual problems , or use medical tape to hold the eyelids shut , which causes irritation and discomfort and pulls out eyelashes . in one embodiment , the present invention can also provide clamps or protrusions to occlude the nasolacrimal drainage system , which will further improve retention of fluids in the subject &# 39 ; s eyes . in one embodiment , the apparatus of the present invention comprises a support member ( 1 ) covers over the nose and eye sockets , extending about half way across the eyelid over each eye , and covers from the lower forehead to below the lower edge of the eye sockets . in one embodiment , adjustable , elastic bands ( 2 ) that encircle the subject &# 39 ; s head are attached to hold the support member in place . the outer surface of this support member is made from a lightweight , rigid material , including but not limited to polyvinylchloride , polyethylene , polypropylene or some other suitable thermoplastic material . it is shaped to conform to the places where it contacts the subject &# 39 ; s face . in one embodiment , the inner surface of the support member has soft material ( 3 ), such as medical grade foam , attached to provide comfort where it rests on the face . in one embodiment , the support member has four support points over the bones around the eye sockets : two on the forehead about at the inner ends of the eyebrows above the inner corners of the eye sockets ; and two on either side of the nose below the inner corners of the eye sockets . in one embodiment , there are also two protrusions ( 4 ) on the inner surface near the edges of the support member , which are over the innermost ⅛ to ¼ inch of the upper eyelids . when the apparatus is put in place and elastic bands are put around the head , these protrusions pull the eyelids inward ( toward the nose ) and downward ( toward the mouth ) with gentle pressure , which pulls the eyelids closed . slightly larger or separate protrusions can be used to also occlude the nasolacrimal sacs on the sides of the nose to make the apparatus even more effective at retaining tear fluids in the eye . in one embodiment , the protrusions are made of soft medical foam , elastomer or gel - filled sacs . they may be molded as part of the inner foam layer , small pieces of medical foam or elastomer that are held in place with adhesive or pieces held in a pocket in the support member . the size of the protrusions depends on the design of the apparatus and the contours of the subject &# 39 ; s face . in particular , the length of the protrusion must exceed the distance from the edge of the support member to the inner end of the subject &# 39 ; s eyelid and must be long enough to draw the eyelids closed . in one embodiment , a generally satisfactory shape and size is an oblique paraboloid with a base diameter and height of about ⅜ths of an inch , which is canted about 20 to 40 degrees toward the nose and downward . the softness must be about that of a fingertip and soft enough to allow the protrusion to deform as it bends toward the nose , as shown in section y - y in fig2 and 4 , where the direction that the eyelids are pulled is shown with small arrows . one of ordinary skill in the art would readily choose various materials to construct the apparatus of the present invention ; for example , one may choose from those discussed in paragraphs 0053 - 0057 in the davison wo publication , among others . one skilled in the art would readily design variations from the apparatus of the foregoing paragraphs . for example , the support member can be made to flex around the bridge of the nose as it is put in place and secured by the elastic straps . this would cause the protrusions to pivot toward the nose as they move in toward the face . as a result , its movement relative to the eyeball would be more nearly tangential , the pulling action would be enhanced and pressure on the eyeball would be minimized . the shape of the support member may differ from that in fig1 and 2 , as long as it performs the essential functions : holding the device in place ; and positioning the protrusions to properly pull the eyelids closed . for example , one variation is to shape the support member like an asterisk , with six arms crossing at the bridge of the nose : four go to the four support points discussed earlier and two go out sidewise to hold the protrusions over the eyes ( see fig3 - 4 ). in another embodiment , the present invention can be further modified to employ an “ x ” shaped support member , with no edges extending over the eyes . a bar would clip to the support member above the bridge of the nose and would extend outward over the inner end of the eyes . this bar , in turn , would have replaceable protrusions attached to the ends over the eyelids . the bar and protrusions could be selected from a selection of sizes to fit each individual &# 39 ; s measurements . in another embodiment , the support member is in two parts connected across the nose by a flexible ( rubber ) strap or hinged connector instead of the single - piece support member ( see fig5 ). elastic straps extend backward around the head to hold the device in place . pieces of foam on the inner surface of the support members hold the device in the proper position across the bridge of the nose , and the outermost edges of the foam press on the inner ends of the eyelids to close them . in practice , the apparatus of this invention must be “ customized ” to be best suited to the subject . the support member would be selected from a variety of different sizes prepared to fit a variety of subjects with different sizes and shapes of facial features . the design can also differ from that described in the figures , as long as it employs the method of this invention . in one embodiment , a second set of pressure protrusions that contact the lower eyelid can be added , although just pulling the upper eyelid inwardly usually closes the eye effectively . in another embodiment , the present apparatus can be made in the form of sleep goggles , with a rigid shield over the eye socket to protect the eye from contact with bedding . conventional sleep goggles can be converted to function as the apparatus claimed in this application by affixing suitable protrusions to the rigid lens of the goggle , e . g . as with adhesive . the apparatus of the present invention can be made to close only a single eye by putting pressure protrusions over only one eye . one skilled in the art can devise many ways to apply the method of this application to close the eyelids of subjects . fig6 illustrates designs that are modifications to existing “ moisture chamber ” sleep goggles like those described in the davison 922 patent . such “ moisture chamber ” sleep goggles are held over the eyes by an elastic band around the head . they have a strip of foam around the edge of each goggle where they rest on the bones around the eye socket . this foam supports the goggle on the face and forms an airtight chamber over each eye . the foam does not touch the eyelid . in fig6 , goggles have foam around the edges to support them comfortably on the face , but the inner ends of the goggles ( the sides touching an subject &# 39 ; s face ) are modified to apply pressure on the inner ends of the eyelids to close the eyelids and hold them shut . in one embodiment , the foam at the inner ends of the goggles is enlarged and shaped so that it presses on the eyelids to close them when the goggles are put on ( see fig6 a , 17 ). in another embodiment , fig6 b and 6c show means for adjusting the size and / or shape of the contacting element that presses on the eyelids ; that is , they can be extended to close the eyelids after the device is in place or can be adjusted to make the device more comfortable . for example , fig6 b shows an air - filled bubble or sac ( 18 ) is used to press on the eyelids to close them . in the example shown , the bubble is inflated by injecting air through a flap valve ( 20 ) similar to those used to inflate athletic balls . a hypodermic style pump or other type can be used . in one embodiment , fluids other than air can also be used . in fig6 c , fluid - filled bubbles or foam protrusions are used . they are extended or adjusted by “ squeezing ” them mechanically in one direction to make them expand in another direction . the screw ( 21 ) shown in fig6 c can be turned in to make the underlying bubble or foam press against the eyelid , or out , to relieve the pressure on the eyelid . sliding mechanisms that force the bubble or foam posteriorly can be used to accomplish the same purpose as the screw . in one embodiment , non - adjustable contacting elements , like those in fig6 a , can be made protrusive by fashioning them from “ memory foam ”, which the user can compress just before putting the goggles on . the foam will then expand and press the user &# 39 ; s eyelids shut as it returns to its original shape . in one embodiment , the present invention provides an apparatus for pulling one or both eyelids over the eyes of a subject , comprising ( 1 ) a support member for positioning the apparatus on the subject &# 39 ; s face , said support member comprises ( i ) an outer layer of rigid material to provide structural strength , ( ii ) an inner layer of soft material that contacts the subject &# 39 ; s face , and ( iii ) means to properly pull the eyelids closed ; and ( 2 ) a means for securing the support member on the subject &# 39 ; s face . for example , an elastic band can be connected to the support member , wherein said elastic band can be extended around the subject &# 39 ; s head . in one embodiment , said means for pulling the eyelids closed comprises one or more of first pressure protrusions extending from the inner layer of the support member , wherein when the support member is secured on the subject &# 39 ; s face , the protrusions will contact the inner portion of the subject &# 39 ; s upper eyelid ( s ) and apply gentle pressure obliquely to pull the eyelid ( s ) towards the nose , thereby pulling the eyelid ( s ) over the eye ( s ) and holding the eye ( s ) closed . in one embodiment , the pressure protrusions contact the inner ⅛ to ¼ of the length of each upper eyelid . in another embodiment , the pressure protrusion is fashioned from a soft pliable material . in one embodiment , the soft pliable material is water resistant . in one embodiment , the support member rests on the bones at the inner ends of the subject &# 39 ; s eye sockets above and below each eye and partially covers the subject &# 39 ; s eyes and nose . in one embodiment , the support member comprises two support points on the forehead at about the inner ends of the eyebrows above the inner corners of the eye sockets , and two support points on either side of the nose below the inner corners of the eye sockets . in one embodiment , the support member is fashioned in a shape comprising six arms that cross over the bridge of the subject &# 39 ; s nose , the ends of two of said arms comprises means to pull the eyelids closed . in one embodiment , the apparatus comprises two sections of support members that are connected across the nose by a flexible strap or hinged connector . in one embodiment , the apparatus comprises ( i ) a support member fashioned in the shape of an “ x ” with no edges extending over the eyes , and ( ii ) a bar connected to the support member , wherein said bar crosses over the bridge of the nose and extends outward over the inner end of the eyes , and each end of said bar comprises the means to pull the eyelids closed . in one embodiment , the apparatus further comprises one or more of second pressure protrusions , wherein when the support member is secured on the subject &# 39 ; s face , the second pressure protrusions will contact the inner portion of the subject &# 39 ; s lower eyelid . the present invention also provides a method of closing one or both eyes of a subject , comprising the step of securing the apparatus described herein over the face of said subject . in one embodiment , the subject is a person with nocturnal lagophthalmos . the present invention also provides an apparatus for pulling one or both eyelids over the eyes of a subject , said apparatus comprises a pair of goggles and means to pull the eyelids over the eyes , wherein said means for pulling the eyelids is located on the side of the google that touches the subject &# 39 ; s face , wherein when said goggle is secured on the subject &# 39 ; s face , said means to pull the eyelids will contact the inner portion of the subject &# 39 ; s upper eyelid ( s ) and apply gentle pressure obliquely to pull the eyelid ( s ) towards the nose , thereby pulling the eyelid ( s ) over the eye ( s ) and holding the eye ( s ) closed . in one embodiment , the means to pull the eyelids comprises air - filled or fluid - filled sac . in one embodiment , there is also provided a method of using such apparatus to close one or both eyes of a subject , comprising the step of securing the apparatus described herein over the face of said subject . in one embodiment , the subject is a person with nocturnal lagophthalmos . throughout this application , various references or publications are cited . disclosures of these references or publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains . it will be understood that the foregoing description is of preferred exemplary embodiments of the invention , and that the invention is not limited to the specific forms shown . other modifications may be made in the design and arrangement of the elements described herein without departing from the scope of the invention as expressed in the appended claims .

this invention provides a method and apparatus for closing the eyelids of persons suffering from nocturnal lagophthalmos , so as to keep their eyes moist and to protect their eyes from contacting the bedding while they sleep . the method is to apply gentle pressure on the inner ends of the eyelids with soft fingerlike protrusions affixed to a support that spans the nose and is held in place by adjustable , elastic headbands . this pressure pulls the eyelids towards the nose , which forces the eyelids to close and stay closed , thereby preventing loss of tear fluids by evaporation . in one embodiment , pressure can also be applied to the nasolacrinal drainage system to prevent tear fluids from draining out of the eye into the nasal cavity .

as shown in fig1 and 3 , a base member 10 , preferably of steel or other sturdy material , supports a vertical pedestal 12 and is connected thereto by fasteners 14 . a mixing chamber 16 comprising a front half shell 18 and a rear half shell 20 ( see fig2 ), whose concave sides face one another , is secured by set screws 22 in channel 24 of the pedestal . both the pedestal and the mixing chamber may be comprised of acrylic plastic , or other suitable material , for handling breath specimens . in a preferred embodiment of the invention , an acrylic plastic chamber approximately eleven inches in diameter is used . the channel 24 of pedestal 12 grips flange members 30 and 32 of half shells 18 and 20 compressing them to form a fluid tight seal sandwiching gasket 34 . a globe 40 suitably sized to fit within mixing chamber 16 is removably mounted in mixing chamber 16 by springs 42 affixed about the inner wall 44 of rear half shell 20 . in a preferred embodiment of the invention , excellent results are achieved using a substantially spherical globe approximately eight inches in diameter and formed of plastic , or other suitable material . the glove is equipped with pins 46 , which may be integrally formed with the globe or adhesively attached thereto , and are adapted to fit compatibly with springs 42 to suspend the globe within the mixing chamber . as shown in fig2 the globe need not be centered within the mixing chamber 16 , but may be positioned such that its center is slightly to the rear of the center of the mixing chamber . an inlet port member 50 is provided in front half shell 18 , and a substantially axially aligned outlet port member 52 is provided in rear half shell 20 . these port members may be fabricated of any convenient material , such as plexiglass or other material , which can be readily secured to the half shells . in the preferred embodiment of the invention employing the aforementioned mixing chamber and globe , port members approximately 13 / 16 in inside diameter with walls 3 / 16 inch thick have been found to have sufficient structural characteristics to provide excellent results . fig2 also depicts a source 60 of a breath specimen ( which may be a patient or other person whose breath is to be analyzed ). the specimen is introduced through the opening 62 , through inlet port member 50 , and front half shell 18 , and exits from the mixing chamber through opening 64 , through outlet port member 52 , and rear half shell 20 , from which it passes to a breath specimen analyzer 66 , after being thoroughly mixed in mixing chamber dead space 70 . the dead space 70 surrounds all , or substantially all , of the globe 40 providing a relatively symmetrical cross section about the globe , as shown in fig3 . for the particularly preferred design of the mixing device described above , the dead space 70 constitutes approximately 5 . 3 liters for a globe approximately eleven inches in diameter within a chamber of approximately eleven inches in diameter . such device has been found to produce very low back pressures when in use , and tests at fixed flow rates have produced the following results : ______________________________________ back pressureliters per minute mm h . sub . 2 o______________________________________ 0 0100 0 . 48200 1 . 6300 3 . 5400 5 . 9500 8 . 3600 12 . 6______________________________________ while these data were obtained using a generally round shell , even better results with lower back pressures may be obtained using elongated configurations . fig4 shows an alternative globe 80 , which may be used interchangeably with globe 40 , to increase the residence time or volume of breath handled in a given specimen . the globe 80 is hollow and has an opening 82 which in an eight inch globe is preferably approximately three and a half inches in diameter . by using the open hollow globe , the capacity of the mixing chamber may be effectively approximately doubled to about ten liters for the above - described chamber . thus , in using the invention herein , globes of various sizes may be used . in general , the units which have a smaller mixing chamber dead space 70 provide excellent mixing for high respiratory rates and moderate volumes . they offer extremely low back pressures and are excellent for pediatrics where small volume flows are expected . on the other hand , by using a globe of the same diameter but which is hollow and open as in fig4 the mixing device provides excellent mixing for higher volume use , such as for analyzing breath specimens from individuals undergoing vigorous excerise , with only a slightly increased back pressure . the mixing chamber of the invention thus provided for a variable dead space with excellent mixing over a very wide range of flow rates and extremely low back pressures . also , a key and novel feature of the invention is that it is extremely easy to disassemble for cleaning or changing globes . thus , to disassemble the mixing chamber , one merely loosens the set screws 22 and lifts the two half shells 18 and 20 out of the channel 24 of pedestal 12 . the half shells are then separated , and their interior surfaces can be washed or sterilized , as desired , while the surfaces of the globe can also be cleansed . the same or different globe can then be pressed into position inside the spaced springs 42 , which snap into position over the pins 46 , thus , instantly suspending the globe within the mixing chamber . the two half shells are then reassembled about the gasket 34 and repositioned within channel 24 and secured in place by set screws 22 . as far as is known , there is no other device capable of such rapid and simple disassembly for cleaning , inspection or change of mixing space volume . the invention in its broadest embodiments comprehends a device in which a specimen is introduced into one side and forced to expand about a suspended mixing means and is then collected at the opposite side and withdrawn therefrom . while generally spherical or slightly oblong shells have been described , it will be appreciated that other variations are possible within the scope of alternative embodiments of the invention . many other uses and variations of the invention will be apparent to those skilled in the art , and while specific embodiments of this invention have been described , these are intended for illustrative purposes only . it is intended that the scope of the invention be limited only by the attached claims .

a mixing chamber designed for ready disassembly is described in which a generally spherical - shaped outer container encloses an inner sphere . entry and exit openings are provided on opposite sides of the outer sphere , so that breath specimens pass through the chamber between the outer surface of the inner sphere and the inner surface of the outer sphere and undergo thorough mixing with low back pressure over a wide flow range . the interior volume can be increased by using a hollow inner sphere with an opening through the wall thereof to permit the inner sphere to fill with breath specimen also .

referring to fig1 , an instant win gaming ticket 10 is illustrated . the ticket 10 has a win table 20 , betting number columns 30 a , 30 b , a wager column 40 a , 40 b , player &# 39 ; s result columns 50 a , 50 b , and dealer / house result columns 60 a , 60 b . the win table 20 indicates the possible prizes or prize amounts if a given set of conditions are fulfilled by the results of the games on the ticket 10 . the betting number columns 30 a , 30 b serve as reference points by which the player can track the games being played . the wager columns 40 a , 40 b indicate the amounts being wagered for each game and , concomitantly , the distinct or specific possible prize identifiable with each game . the player &# 39 ; s result columns 50 a , 50 b indicate the game result for the player . this result is to be compared to the entry in the dealer / house result columns 60 a , 60 b to determine if the player has won a particular game . it should be noted that similar instant win gaming tickets are generally pre - printed with the results covered . players purchase or otherwise obtain the tickets not knowing the results and sequentially uncover the results to determine if their gaming ticket has won a prize or not . initially , columns 50 a , 50 b , 60 a , 60 b are covered prior to a player purchasing or obtaining the ticket . these columns may be uncovered in any sequence but preferably sequentially to effectively play the games . the ticket is divided into three areas — one area for the first set of games ( columns 30 a , 40 a , 50 a , 60 a ), a second area for a second set of games ( columns 30 b , 40 b , 50 b , 60 b ), and a third area for the win table 20 . as can be seen in fig1 , each row in a particular area denotes a single game . for the ticket illustrated in fig1 , the single game type to be played is a simulation of the well - known game of roulette . the object is for the player result ( as shown in columns 50 a , 50 b ) to match the wheel result ( as shown in columns 60 a , 60 b ). it can be seen from the ticket in fig1 that the player has not won for bet / game a — the player result is red 10 while the wheel result is black 23 . it can also be seen that the player has a similar losing result for bets / games b , c , and d . however , for bet / game e , the player result is the same as the wheel result . this therefore means that the player has won this particular game . similarly , for bets / games f and g , the player &# 39 ; s results match the wheel results . as such , the player has won 3 games in a row or 3 consecutive games have been won . because of these consecutive wins , the player thus wins more than what he would have won had he only won three non - consecutive games . the player &# 39 ; s distinct prize identifiable with a specific game is dependent on the wager . since game e had a wager of $ 5 + d prize , and since the prize for game d is zero ( due to the player losing game d ), then the wager for game e is $ 5 . assuming that the ticket pays double the wager for every game won , then the prize for winning game e is using the same logic and process , the prize for winning game g is $ 70 . it should be noted that since the player did not win game h , the player &# 39 ; s “ streak ” ends . the same rationale for awarding prizes apply to the game tickets illustrated in fig2 and 3 but applied to different types of games . as can be seen in fig2 , instead of playing a roulette type of game , the well - known card game of blackjack is played . instead of trying to match the dealer &# 39 ; s total in columns 70 a , 70 b , the player &# 39 ; s total in columns 80 a , 80 b must be greater than the dealer &# 39 ; s total . again , the prize per game / row ( the rows being denoted by a letter indicator in columns 90 a , 90 b ) is determined by the wager column 100 a , 100 b . the win table 110 will show the amount the player can win for consecutive wins . as is accepted in most card games , an ace ( represented by a letter a ) is given a value of 11 and a “ face ” card ( a king , queen , or jack as represented by the letters k , q , and j respectively ) is given a value of 10 . as can be seen , the player only wins in hand f for the game ticket in fig2 . it should be noted that the player &# 39 ; s total columns 80 a , 80 b and the dealer &# 39 ; s columns 70 a 70 b are covered prior to the player &# 39 ; s playing the game ticket . referring to fig3 , instead of a card game or another game of chance , the results of a football season or a series of football games is simulated on the game ticket . the idea behind this type of a game ticket is that the player will wager on the outcome of a sporting event . for this game ticket , the sport is american football with the teams of the national football league being represented on the ticket . each row ( denoted by a letter in columns 120 a , 120 b ) denotes a single football game . wager columns ( columns 130 a , 130 b ) denotes the wager on the game while team columns 140 a , 140 b note the teams playing the particular game for that particular row . the player &# 39 ; s bet columns ( columns 150 a , 150 b ) denote the preselected teams that the player is “ betting ” to win . this column may or may not be covered prior to the playing of the game or purchase of the ticket . the game result columns 160 a , 160 b , on the other hand , are covered prior to the purchase of the game ticket . as can be seen , the game result columns 160 a , 160 b notes who won the particular football game . similar to the roulette game ticket in fig1 , the object of the game for the fig3 ticket is for the player &# 39 ; s bet to match the game result . thus , if for a particular row , a player &# 39 ; s preselected bet entry matches the entry for a game result , then the player has won the game . for the ticket in fig3 , it can be seen that the player has won games a , c , d , e , f , g , and h . the player has thus had a streak of 6 consecutive wins of games c to h . using the same rationale as for the tickets illustrated in fig1 and 2 , the longer a player &# 39 ; s streak of consecutive wins , the larger is the ultimate wager per game and therefore , the larger the possible prize amount . this would be denoted in a win table 170 . in many instant win gaming tickets , the prize amount for winning a single game is double the amount wagered . thus , if the amount wagered is $ 5 as in game a of the ticket in fig3 , winning that game results in a payout of $ 10 for the player . for the same ticket , the progressive nature of the wagering , with each wager dependent on the result of the immediately preceding game , results in an increasingly larger prize amount as the number of consecutive games won increases . four consecutive games won results in cumulative winnings of $ 260 with the prize amount for the fourth game being $ 150 . the amount wagered on the fourth hand was therefore $ 75 . the given total does not include the $ 10 won in game a . to simplify matters , the individual amount won for the nth consecutive game won can be represented as in equation 1 : w = amount won on the nth consecutive game won n = number of games won consecutively y = multiplier applied to wager if a game is won x = fixed starting wager per game for the game ticket in fig1 , 2 , and 3 , x = 5 and y = 2 if the wager is doubled for every win . if a player wins three times his wager if he wins a game , then y = 3 . using the same logic as above , the amount wagered on the nth game can be represented as in equation 2 after ( n − 1 ) consecutive games won : the variables in equation 2 are as defined for equation 1 . the cumulative prize amount won after n consecutive games won can be represented as in equation 3 : using the above formulas , a sample win table ( table 1 ) can be as follows using y = 2 and x = 5 : as can be seen , the increase in the prize amounts between consecutively won games is geometric in pattern with the variable y denoting how fast or how slow the increase is in the winnings . clearly , the higher the value for y , the larger the cumulative prize amounts . the increase in prize amounts between two consecutive prize amounts is a multiple of a previous increase . the prize amount for 4 consecutive games won is $ 150 while the prize amount for 3 consecutive games won is $ 70 . the increase between these two prize amounts is $ 80 — a multiple of the prize amount increase ($ 40 ) between prize amounts for two games won ($ 30 ) and three games won ($ 70 ). this fixed multiplier between increases prize amounts is due to the geometric progression between the increases . while the game tickets in fig1 , 2 , and 3 , all use a single type of game for the individual games , this need not be the case for every gaming ticket . referring to fig4 , an alternative type of gaming ticket is illustrated which also uses a progressive type method of awarding prizes . for this gaming ticket , the object is to simulate games that may be played in a casino . as such , four types of games , blackjack , roulette , keno , and poker are represented . for keno , the object is to match all five numbers that the dealer / house is given while conventional poker need not be explained here . from fig4 , the wager columns 180 a , 180 b denote the wagers for each game with wagers increasing for consecutive wins . however , the wagers increase only for consecutive games won of the same type . as such , consecutive poker games won increase the player &# 39 ; s prize but consecutive dissimilar games won , such as blackjack and roulette , do not increase the player &# 39 ; s prize . the amount a player may win still depends on whether a previous game was won or not but a caveat exists in that the previous game has to be of the same type as the game currently being played . another alternative configuration for a gaming ticket is that illustrated in fig5 . the gaming ticket configuration in fig5 simulates a slot machine . column 190 documents the wagers for every slot game on the ticket while column 200 documents the gaming index letter . columns 210 a , 210 b , 210 c , 210 d indicate the player &# 39 ; s simulated slot machine results . the prize amount allocation for this game may be different from that of the gaming tickets illustrated in the previous figures . for the previous gaming tickets , each game was either completely won or lost . for slots , it is possible to have a partial win and be accorded a proportionate prize . the wining combinations for the slot machine may be documented in a win table 220 , an example of which is reproduced in table 2 : based on the above sample , win table and the ticket in fig5 , the player wins double his wager for game a and does not win anything for game b . for game c , the player wins triple his wager and , again , does not win for game d . for game e , the player wins one - and - a half times his wager . his total winnings for the ticket are therefore as follows : the above calculations assume that the player does not lose any of his previous winnings if he loses any games . other , more complex win tables may be used and other , more complex formulas for penalizing the player for losing games may be used . it should be noted that other games and configurations , such as other card games like pai gow , poker , high - low , and others , and numbers games may be used for the games in the gaming tickets . also , other sporting events , such as basketball games , soccer games , and hockey games may be simulated in place of the football events illustrated and explained above . furthermore , numbers games , some of which may be similar to keno , and other wagering games such as slots , can also be used for the gaming tickets . the above invention should provide increased enjoyment to instant wins game ticket players . as further inducement to purchase and play these games , one possible caveat to the wagering on the ticket is that players do not lose any prizes they win regardless of any wagers they make in subsequent games . as an example , using the game tickets in fig1 , 2 , and 3 , if a player wins games a , b , and c and , and because of the progressive nature of the wagering , the wager for game d is the amount won for game c , if the player loses game d , he does not lose his winnings for game c . the only drawback for the player is that his wager for game e is not very large since his winnings for game d is zero . an alternative to the above scheme is to have a feature in the gaming ticket such that a player loses some or all of his previous winnings if he loses a game . thus , the player must , before playing a game , decide whether to continue playing or to redeem any winnings he may already have . a person understanding this invention may now conceive of alternative structures and embodiments or variations of the above all of which are intended to fall within the scope of the invention as defined in the claims that follow .

methods and apparatus for playing an instant win gaming ticket . an instant win gaming ticket has multiple instant win games which can be played by the player . the amount won per game is dependent on the results of at least one previous game on the same ticket . the player plays the games on a single ticket and the amount the player wins for each game depends on whether previously played games on the same ticket were won or lost .

for the purposes of promoting an understanding of the principles of the invention , reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same . it will nevertheless be understood that no limitation of the scope of the invention is thereby intended , such alterations and further modifications in the illustrated device , and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates . referring now to the drawings in detail , and particularly fig1 and 2 , a stationary wall 11 , in the building has a doorway 12 therein which includes the door jamb at the left and right side 13 and 14 and the header 16 . a door header 17 is affixed in the doorway at the bottom of the doorway header 16 . a front hanger bar 18 is mounted to the header in a manner to be more fully described hereinafter . strands 19 hang from the bar 18 and support a plurality of beads 21 which are strung on the strands and supported by a knot at the bottom of the strand and engaging the lowermost one of the beads . referring now to fig3 the specific nature of the beads 21 can be better seen . they are preferably made of polystyrene foam and are relatively large in size ( approximately 2 inch diameter and approximately 4 inch overall length ), but very light in weight . being of this material and in this size , they have significant ability to provide sound and temperature insulation . each of them is provided with a stepped center bore , the upper portion 22 being of smaller diameter than the lower portion 23 . the step 24 is above the center of gravity of the bead . although these beads do not actually look like beads , they are referred to in this manner for ease of description . because the material is polystyrene , and therefore very soft and susceptible to wear , a small bead or bushing 26 is provided at the top of the upper bore 22 and slidably receives the strand 19 through it . a large bead or knob 27 is provided under the step 24 and retained by the knot 28 in the strand to thereby support the beads on the strand . in the illustrated embodiment , each of the beads has a flat at 29 , around the aperture at the top and a flat at 31 , around the aperture at the bottom . this promotes some stability of the beads in contact with each other and provides some bearing surface which is particularly desirable for the beads near the bottom of the strand as they must support all of the beads above them . but , there is also provided a conical surface 32 immediately outboard of the flat at both the top and bottom of each of the beads . this provides some relief space 33 between the beads to enable them to tilt with respect to each other when pushed aside by a person when passing through the doorway . accordingly , the frusto - conical surfaces at the opposite ends of the beads , have the combined effect of providing good and adequate bearing area between one bead and the next contiguous bead , and also accommodating whatever tilting of the beads is necessary to enable passage through the door , and then contribute to stabilizing of the beads in columns when the person has passed through the doorway . referring now to fig3 and 5 , an example of a possible mounting of the bar 18 to the header member 17 is shown . in this example , arm 34 is pivotally mounted to a shoulder bolt 36 secured in the member 17 by a nut 37 . being a shoulder bolt and having a shoulder at 38 abutting the lower face of header bar member 17 , the arm 34 can rest on the head 39 of the bolt so that it can pivot freely about the axis 41 of the bolt . a washer such as 42 may be provided between the bar 17 and bolt head 39 , if desired to promote stability . the nut 37 is received in a recess 43 in the top of the bar 17 . exactly the same type of construction and mounting can be provided for the bar 34a near the right - end of the hanger bar 18 . the hanger bar is mounted to both of these arms 34 and 34a in the same way . more specifically , a pivot pin 44 received through the arm 34 and through the washer 46 , bar 18 , and washer 47 is secured by means of a cotter pin 48 . this permits the arm to pivot relative to the bar 18 . it is done for both of the arms 34 and 34a . a second and rear hanger bar 51 is mounted behind and parallel to bar 18 . it is mounted to the pivot arms 34 and 34a in exactly the same way as described above with reference to hanger bar 18 . likewise , a back row of bead hanging strings or strands are provided on bar 51 just as the front row of strands is hung on bar 18 . the columns of beads strung on the back row of the strands is done the same as the columns of beads on the front row of strands as described above . in order to shift the rows from the closed or occluding position of fig1 and 4 , to the open position of fig5 two pulled cords are used . for the front hanger bar , the cord 53 is stapled to the top of the bar 18 at 54 , and passed through a screw eye 55 which is screwed into the header bar 17 . pendants or knobs 56 can be provided at the bottom of each of the two cords 53 , one for the front bar and one for the rear bar . accordingly , the curtain can be opened from the closed position of fig1 to the open position of fig2 by pulling the rear cord 53 , and closed again by pulling the front cord 53 . it was mentioned just above that the cords are fastened to the bars 18 and 51 by staples . this is also a convenient way to secure the hanger strands 19 as by staple 20 ( fig3 ). fig6 and 7 shown an alternate construction for opening and closing the screen . in this example , the doorway header 16 and jambs 13 and 14 are shown with the same reference numerals . however , in contrast to the header bar 17 for the embodiment of fig1 - 5 a different type of header bar 61 is used . this one has a somewhat serpentine groove 62 in the top face thereof . it has a carrier cord or rope 63 laid in it . the rope can be any suitably strong , flexible , and durable material . pull cords 64 and 66 are secured to the carrier rope at 67 and 68 , respectively . the bead hanger strands are secured to the rope at 69 , 71 , 72 , 73 , 74 and 76 . a slot through the bottom of the bar is provided at six locations 77 , 78 , 79 , 81 , 82 and 83 . there are pull cord groove extensions 84 and 86 at the right - hand ends of the serpentine carrier port groove 62 . holes 87 and 88 , at the ends of these extension grooves extend through the bottom of the bar 61 and receive the pull cords 66 and 64 through them , respectively . the beads are shown in the screen closed position in fig7 and in the dotted lines of fig6 . the alternate position ( not shown in fig7 ) is shown by the phantom lines in fig6 . to achieve that , the cord 66 is pulled downward , pulling the carrier rope in the serpentine groove to move the hanger strands in the through slots from one end of each slot to the other . to again close the screen , the cord 64 is pulled to return the strands to their initial positions . fig8 and 9 show two alternate shapes of beads in two rows . these can be mounted in either the manner shown in fig1 through 5 , or that shown in fig6 and 7 , and operated in the same way . the cross section of the beads in fig8 is hexagonal , while that in fig9 is triangular . in either case , the opening and shutting can be achieved by pull cords in the same way as described above . referring to fig1 and 11 , there is shown an arrangement whereby the clearance space between the upper and lower ends of touching beads can be closed for an additional measure of insulation and / or screening . foam rubber washers 91 with conical faces 92 and 93 merging at aperture 94 can be provided in the clearance space , the washer being of the type shown in fig1 . the use of this arrangement will make the curtain a bit stiffer when a person passes through it , but it will readily return to the original condition , encouraged to do so not only by the gravity influence as with the previously described embodiments , but also the resilience of the washers tending to align the beads between which it is sandwiched . it should be recognized from the foregoing description , that the bars and arms can be made of wood , metal or plastic . similarly , the pivoting parts can be made of appropriate materials , metal or plastic being more likely than wood . also , it may be recognized that variations of the cross sections of the pieces as mentioned above with reference to fig8 and 9 , will provide surface textures of the overall door that are different from the cylinders of fig1 - 5 . squares would provide still another apparent surface texture . also , the beads themselves can have different surface textures , from smooth to flocked , for example . the colors may vary if , and as desired , to achieve different decorative effects . thus , the present invention provides a very versatile partitioning apparatus which is adjustable from a completely closed appearance to a moderate screening appearance but , in all instances , penetrable by a person walking through the doorway , when desired . at other times , and when in the closed condition , the apparatus provides an excellent sound and thermal insulating function . while the invention has been illustrated and described in detail in the drawings and foregoing description , the same is to be considered as illustrative and not restrictive in character , it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected .

a screen is made of hanging strands of beads of relatively large size and light weight . the beads are arranged to provide sound and thermal insulation to the extent desired between the spaces in a building on opposite sides of the screen . two types of strand mountings are disclosed , with mechanism suitable to shift the strands laterally to increase or decrease the amount of occlusion provided between the spaces by the screen .

the present invention provides certain substituted oxaspirodiaminocyclohexane compoundswhich are useful as diuretic , antiinflammatory , and cerebrovascular agents . the compounds are ## str1 ## wherein n is an integer of from one to six ; either of x or y is oxygen and the other is -- ch 2 --; r 1 is selected from ## str2 ## where r 4 and r 5 are independently hydrogen , fluorine , chlorine , bromine , nitro , trifluoromethyl , alkyl of from one to six carbon atoms , alkoxy of from one to six carbon atoms , or aryl ; 3 , 4 , 5 - trimethylphenoxy ; ## str3 ## where r 6 is hydrogen , fluorine , chlorine , alkyl of from one to six carbon atoms , or aryl ; z is -- ch 2 --, -- o --, -- s --, or -- nr 7 -- where r 7 is hydrogen , alkanoyl of from one to six carbon atoms , or alkyl of from one to six carbon atoms ; ## str4 ## where r 8 and r 9 are independently hydrogen , fluorine , bromine , alkyl of from one to six carbon atoms , or alkoxy of from one to four carbon atoms ; or ## str5 ## where r 8 and r 9 are as defined above ; r 2 is methyl and r 3 is hydrogen , alkyl of from one to six carbon atoms , ## str6 ## where r 10 is alkyl of from one to four carbon atoms ; or where r 2 and r 3 when taken together with the nitrogen atom to which they are attached , form a pyrrolidinyl , piperidinyl , or hexahydro - 1h - azepinyl ring ; and the pharmaceutically acceptable acid addition salts thereof . the compounds of the present invention constitute a class of derivatives of certain substituted oxaspirodiaminocyclohexane compounds of formula i above in which one nitrogen atom is an amine nitrogen substituted with methyl and a second substituent selected from the group r 3 as defined above , or when taken together with the nitrogen atom to which they are attached , r 2 and r 3 form a pyrrolidinyl , piperidinyl , or hexahydro - 1h - azepinyl ring , and the other nitrogen atom is a n - methyl amide nitrogen further substituted with the group r 1 as defined above . compounds of the present invention contain one or more asymmetric carbon atoms and therefore exist in various stereoisomeric forms . additionally , the compounds of this invention are capable of existing in different geometric isomeric forms . for example , the oxgen atom of the 5 - membered spiro - ring may be positioned on the same side of the average plane of the cyclohexane ring as the amide nitrogen , or on the side opposite . the present invention contemplates all geometric and stereoisomeric forms of the compounds of formula i above . the individual stereosiomers are obtained , if desired , from mixture of the different forms by known methods of resolution such as the formation of diastereomers , followed by recrystallization . compounds of the instant invention include solvates , hydrates , and salts of formula i above . preferred compounds of the present invention are those of formula i above wherein r 1 is ## str7 ## where r 4 and r 5 are independently hydrogen , fluorine , chlorine , bromine , nitro , trifluoromethyl , alkyl of from one to six carbon atoms , alkoxy of from one to six carbon atoms , or aryl . by the term &# 34 ; aryl &# 34 ; is meant phenyl ; phenyl substituted with fluorine , chlorine , alkoxy of from one to four carbon atoms , nitro , or trifluoromethyl ; 2 - or 3 - thienyl ; and 2 - or 3 - thienyl substituted with alkyl of from one to four carbon atoms or alkoxy of from one to four carbon atoms . preferred compounds of the present invention are those of formula i above where r - is ## str8 ## wherein r 6 is as defined above . the most preferred compounds are substituted inden - 1 - yl compounds of formula i above . other preferred compounds of the present invention are those of formula i wherein r is ## str9 ## wherein r 6 is as defined above . the most preferred compounds are substituted benzofuran - 4 - yl compounds of formula i . yet other preferred compounds of the present invention are those of - formula i wherein r 1 is ## str10 ## wherein r 6 is as defined above . the most preferred compounds are substituted benzo [ b ] thiophen - 4 - yl compounds of formula i . yet other preferred compounds of the present invention are those of formula i wherein r 1 is ## str11 ## wherein r 6 and r 7 are as defined above . the most preferred compounds are indol - 4 - yl compounds of formula i . yet other preferred compounds of the present invention are those of formula i wherein r 1 is ## str12 ## wherein r 8 and r 9 are independently hydrogen , flourine , chlorine , bromine , alkyl of from one to four carbon atoms or alkoxy of from one to four carbon atoms . preferred substituents for r 2 and r 3 are those where r 2 is methyl and r 3 is lower alkyl , most preferably methyl , or where r 2 and r 3 taken together with the nitrogen atom to which they are attached form a pyrrolidinyl ring . preferred compounds of the present invention include but are not limited it : more preferred compounds of the present invention include but are not limited to : the compounds of formula i of the present invention have a very high kappa opioid affinity , selectivity and potency . for example , (-)-( 5α , 7α , 8β )- n - methyl - n -[ 7 -( 1 - pyrrolidinyl )- 1 - oxaspiro [ 4 . 5 ] dec - 8yl ]- 4 - benzo [ b ] furanacetamide gives a ki of 0 . 73 nm with a μ / kappa ratio of 798 . the mpeso in the rat paw pressure test for analgesia is 0 . 030 ( iv ) this is considerably better than any selective kappa opioid compound known to the inventors . the compounds of the present invention possess significant analgesic activity , as disclosed in u . s . pat . no . 4 , 737 , 493 , with the potential for minimum dependence liability due to their selective kappa opioid receptor properties . in addition to acting as analgesics , selective kappa opioid agonists also cause opioid receptor - mediated sedation , diuresis , and corticosteroid elevations . accordingly , the compounds of the present invention are also useful diuretics , antiinflammatories , and psychotherapeutic agents . the compounds of the formula i of the present invention also have application in congestive heart failure , advanced hepatic cirrhosis , nephrotic syndrome , chronic renal failure , trauma associated with surgery , emotional and physical stress , endocrine disorders , syndrome of inappropriate antidiuretic hormone secretion , and therapy with certain pharmacologic drug agents such as certain sulfonyl ureas , clofibrate , certain tricyclics such as carbamazipine , amitriptyline , thiothixene , flubenzaine , and thioridazine , certain antineoplastic agents , certain analgesics , and certain natriuretic diuretics . the compounds of formula i of the present invention also have neuroprotective indications . as such , they are useful in the treatment of stroke and the treatment of cerebral ischemia ( p . f . vonvoightlander in brain research 435 : 174 - 180 ( 1987 ) and a . h . tang , et al in brain research 403 : 52 - 57 ( 1987 ).) the effectiveness of the aforementioned compounds as neuroprotective agents is determined by a pharmacological test procedure as described and illustrated below . the surgical procedure is a modification of that originally proposed by a . tamura , et al , j . cerb . blood flow metab ., 1 : 53 - 60 ( 1981 ). it is similar to the methods described by d . duverger , et al , j . cereb . blood flow metab . 8 : 449 - 461 ( 1988 ), and by s . brint , et al , j . cereb . blood flow metab . 8 : 474 - 485 ( 1988 ). male f - 344 rats weighing 300 - 350 g were anesthetized in 2 % halothane in room air . the right femoral vein was cannulated and the tubing led subcutaneously to an exit behind the neck to allow intravenous ( iv ) drug injection . the left common carotid was permanently occluded with a 6 - 0 silk ligature . the left middle cerebral artery ( mca ) was exposed through a 2 - mm burr hole drilled 1 - 2 mm rostral to the fusion of the zygomatic arch with the squamosal bone . the dura was cut , the mca lifted off the surface of the brain , electrocauterized , and cut . the wound margins were sutured shut and the anesthesia stopped . the compound ,(-)-( 5α , 7α , 8β )- n - methyl - n -[ 7 - 1 - pyrrolidinyl )- 1 - oxaspiro [ 4 . 5 ] dec - 8 - yl ]- 4benzo [ b ] furanacetamide , ( 0 . 5 mg / kg ) and vehicle ( 0 . 9 % saline ) were administered iv 30 minutes and 24 hours after occlusion to groups of 12 animals each . forty - eight hours following occlusion rats were anesthetized with ketamine ( 150 mg / kg , ip ), decapitated , the brains rapidly removed , and placed on ice . with the aid of a brain mold ( activational systems ), the brain was sliced into four 2 - mm sections : one section anterior to the mca and three sections posterior to the mca . the sections were then placed for 30 minutes in a 2 % solution of 2 , 3 , 5 - triphenyltetrazolium chloride ( ttc ) in saline . the brains were stored in 10 % neutral buffered saline for analysis . the brains were coded and the analysis was performed blind . the area of infarction in each section was outlined with the aid of a morphometric analysis program ( bioquant iv , r & amp ; m biometrics ). the ttc stain is converted into a red marker in live mitochondria , while the infarcted area remains white . the total volume of infarction was calculated from the areas of the four sections assuming two truncated cones . the mean area for each section and the mean total volume were calculated ; vehicle and drug treatment were compared using the student &# 39 ; s t - test . the means ± standard deviation , % change , and statistical data are presented in table i . table i______________________________________ infarct size ( mm . sup . 2 )* compound ** de - section saline ( 0 . 5 mg / kg ) crease t - value probability______________________________________anterior 8 . 9 6 . 5 - 26 . 4 1 . 42 0 . 168 ± 5 . 4 ± 1 . 9anterior 12 . 3 7 . 8 - 36 . 8 2 . 76 0 . 011medial ± 4 . 9 ± 2 . 8posterior 10 . 8 4 . 0 - 62 . 7 2 . 35 0 . 028medial ± 8 . 5 ± 5 . 2posterior 9 . 3 1 . 8 - 80 . 9 2 . 7 0 . 012 ± 8 . 7 ± 4 . 1total 63 . 1 30 . 1 - 52 . 3 2 . 68 0 . 013volume ± 38 . 5 ± 18 . 4______________________________________ * mm . sup . 3 for total volume ** compound is (-)( 5α , 7α , 8β ) n - methyl - n -[ 71 - pyrrolidinyl )- 1 - oxaspiro [ 4 . 5dec8 - yl4 - benzo [ b ] furanacetamide in summary , the compound produced a significant decrease in the infarct area in three of the four brain sections and in the total volume . the data support the beneficial activity in the treatment of focal brain ischemia . the compound , (-)-( 5α , 7α , 8β )- n - methyl - n -[ 7 - 1 - pyrrolidinyl )- 1 - oxaspiro [ 4 . 5 ] dec - 8 - yl ]- 4 - benzo [ b ] furanacetamide , was tested in carrageenan footpad edema test . rats were injected iv with the compound , dissolved in saline , and administered at a final vehicle volume of 0 . 15 ml / kg . fifteen minutes later the rats were injected in one rear footpad with 0 . 05 ml of a 1 % solution of carrageenan . five hours later swelling was measured in the injected hindpaw by mercury plethysmography . indomethacin , a standard cyclooxygenase inhibitor , was administered orally as a control . the results are summarized in table ii below . table ii__________________________________________________________________________ dose delta edemacompound * route ( mg / kg ) n ( x ± sem ) % i p value__________________________________________________________________________vehicle iv 10 77 ± 4 . 7test compound iv 0 . 01 10 55 ± 4 . 9 29 & gt ; 0 . 01 iv 0 . 03 10 50 ± 3 . 2 36 & gt ; 0 . 001 iv 0 . 1 10 49 ± 2 . 5 37 & gt ; 0 . 001 iv 0 . 3 9 29 ± 3 . 9 63 & gt ; 0 . 001 iv 1 . 0 9 19 ± 3 . 7 75 & gt ; 0 . 001indomethacin po 5 . 0 10 40 ± 2 . 5 48 & gt ; 0 . 001__________________________________________________________________________ * as can be seen in the above table , the test compound is a potent inhibitor of the acute inflammatory response in rats the diuretic effect of compounds of the instant invention is demonstrated below in table iii . it is well established that kappa opiate agonists produce water diuresis in rats as in d . c . horwell , drugs of the future , 13 1068 ( 1988 ). one highly selective kappa agonist is (±)-( 5α , 7α , 8β )- n - methyl - n [ 7 -( 1 - pyrrolidinyl )- 1 - oxaspiro [ 4 . 5 ] dec - 8 - yl ]- 4benzo [ b ] furanacetamide , which is a mixture of two enantiomers . in vitro receptor binding studies demonstrate that the (-) enantiomer of the compound possesses very high affinity and selectivity for the kappa receptor and that the (+) enantiomer has much lower affinity . following subcutaneous administration a compound of the instant invention (-)-( 5α , 7α , 8β )- n - methyl - n [ 7 - 1 - pyrrolidinyl )- 1 - oxaspiro [ 4 . 5 ] dec - 8 - yl ]- 4 - benzo [ b ] furanacetamide , (-) enantiomer , produced a dose - related increase in the volume of urine produced over the six - hour test period ( table iii ). the maximum volume of urine produced by the highest dose tested was comparable to the maximum effect produced by (±)-( 5α , 7α , 8β )- n - methyl - n -[ 7 -( 1 - pyrrolidinyl )- 1oxaspiro [- 4 . 5 ] dec - 8 - yl ]- 4 - benzo [ b ] furanacetamide : 15 . 5 ± 1 . 2 ml for the (-) isomer (-), (-)-( 5α , 7α , 8β )- n - methyl - n -[ 7 - 1 - pyrrolidinyl )- 1 - oxaspiro [ 4 . 5 ] dec - 8 - yl ]- 4 - benzofuranacetamide compared to 14 . 9 ± 0 . 7 ml for the racemate (±), (±)-( 5α , 7α , 8β )- n - methyl - n -[ 7 -( 1 - pyrrolidinyl )- 1 - oxaspiro [ 4 . 5 ] dec - 8 - yl ]- 4 - benzo [ b ]- furanacetamide . as was expected from the in vitro receptor binding assays which suggested that the (+) enantiomer has negligible affinity for the kappa receptor , this compound was found to have no effect on urine output , as is shown in figure iiib . these results together confirm that the kappa opiate receptor activity of the compound (±)-( 5α , 7α , 8β )- n - methyl - n -[ 7 -( 1 - pyrrolidinyl )- 1oxaspiro [ 4 . 5 ] dec - 8 - yl ]- 4 - benzo [ b ] furanacetamide resides entirely in the (-) enantiomer with the (+) enantiomer having no activity in the rat diuresis test , a reliable and sensitive test for detecting kappa opiate agonist activity in vivo . a comparison of the effects of ( a ) (-) enantiomer and ( b ) (+) enantiomer on urine output in the normally hydrated rat . both compounds were dissolved in saline and administered subcutaneously in a dose volume of 1 ml / kg . vehicle - treated controls received saline only . the data shown represent mean values (± sem ) for groups of six animals per dose level . for the therapeutic uses described above , the usual mammalian dosage range for a 70 - kg human subject is from 0 . 01 to 10 mg per day or 0 . 001 mg to 1 . 0 mg per kg of weight per day ; optionally in divided portions . determination of the proper dosage for a particular situation is within the skill of the art . pharmaceutical compositions of the compound of the present invention or its salts are produced by formulating the active compound in dosage unit form with a pharmaceutical carrier . some examples of dosage unit forms are tablets , capsules , pills , powders , aqueous and nonaqueous oral solutions , and suspensions and parenteral solutions packaged in containers containing either one or some larger number of dosage units and capable of being subdivided into individual doses . some examples of suitable pharmaceutical carriers , including pharmaceutical diluents , are gelatin capsules ; sugars such as lactose and sucrose ; starches such as corn starch and potato starch ; cellulose derivatives such as sodium carboxymethyl cellulose , ethyl cellulose , methyl cellulose , and cellulose acetate phthalate ; gelatin ; talc ; stearic acid ; magnesium stearate ; vegetable oils such as peanut oil , cottonseed oil , sesame oil , olive oil , corn oil , and oil of theobroma ; propylene glycol ; glycerin ; sorbitol ; polyethylene glycol ; water ; agar ; alginic acid ; isotonic saline ; and phosphate buffer solutions ; as well as other compatible substances normally used in pharmaceutical formulations . the compositions of the invention can also contain other components such as coloring agents , flavoring agents , and / or preservatives . these materials , if present , are usually used in relatively small amounts . the compositions can , if desired , also contain other therapeutic agents . the percentage of the active ingredient in the foregoing compositions can be varied within wide limits , but for practical purposes it is preferably present in a concentration of at least 10 % in a solid composition and at least 2 % in a primarily liquid composition . the most satisfactory compositions are those in which a much higher proportion of the active ingredient is present . routes of administration of the subject compound or its salts are oral , parenteral , transdermal , or intranasal . for example , a useful intravenous dose is between 0 . 001 and 10 mg / kg . a preferred intravenous dose is 0 . 01 to 1 mg / kg . a still further preferred dose is 0 . 01 to 0 . 55 mg / kg . a useful oral dose is 0 . 01 to 30 mg / kg . the following examples of formulations are provided to enable one skilled in the art to practice the invention . these examples are not intended to limit the scope of the invention in any way but rather to be illustrative thereof . compound i is a compound of formula i as described hereinbefore . the hydrochloride salt of compound i is dissolved in water and passed through a 0 . 2 - micron filter . aliquots of the filtered solution are added to ampoules or vials , sealed , and sterilized . ______________________________________compound i 12 . 5 gpurified water usp 200 mlcherry syrup qu 1000 ml______________________________________ compound i is dissolved in the water and to this solution the syrup is added with mild stirring . ______________________________________compound i 250 glactose usp , anhydrous q . s . or 250 gsterotex powder hm 5 g______________________________________ combine compound i and the lactose in a tumble , blend for two minutes , blend for one minute with the intensifier bar , and then tumble blend again for one minute . a portion of the blend is then mixed with the sterotex powder , passed through a # 30 screen and added back to the remainder of the blend . the mixed ingredients are then blended for one minute , blended with the intensifier bar for thirty seconds , and tumble - blended for an additional minute . the appropriately sized capsules are filled with 141 mg , 352 . 5 mg , or 705 mg of the blend , respectively , for the 50 - mg , 125 - mg , and 250 - mg containing capsules . ______________________________________compound i 125 gcorn starch nf 200 gcellulose , microcrystalline 46 gsterotex powder hm 4 gpurified water q . s . or 300 ml______________________________________ combine the corn starch , the cellulose , and compound i together in a planetary mixer and mix for two minutes . add the water to this combination and mix for one minute . the resulting mix is spread on trays and dried in a hot air oven at 50 ° c . until a moisture level of 1 to 2 percent is obtained . the dried mix is then milled with a fitzmill through a # rh2b screen , and added back to the milled mixture and the total blended for five minutes by drum rolling . compressed tablets of 0 . 150 mg , 3 . 75 mg , and 7 . 50 mg , respectively , of the total mix are formed with appropriate sized punches the 0 . 50 mg , 1 . 25 mg , or 5 . 00 mg containing tablets .

methods for using substituted phenoxy -, 1 -, and 2 - naphthalenyloxy -, indenyl -, indolyl -, benzo - furanyl -, and benzothienylcarboxamides of 7 , 8 -- 1 - oxaspirodecanes as cerebrovascular , diuretic , and antiinflammatory agents are disclosed . pharmaceutical compositions employing the compounds are also disclosed .

with reference now to the figures wherein like numbers refer to the same item or area throughout the figures . fig1 is an isometric view of a preferred embodiment . shaft 1a can be of a conventional short , medium or elongated shaft and made from any of the conventional materials . grip 1 can also be conventional and will be located conventionally upward at the top of shaft 1a . shaft 1a will be firmly secured at the bottom end to the top surface 3 of the putter head 2 . the shaft is located about 3 / 16 to 1 / 2 inch off center ( heel 6 to toe 11 ) toward the heel 6 . the head 2 will weigh about eleven ( 11 ) ounces with a short shaft , about 12 to 13 ounces with a medium shaft and about 15 to 16 ounces with an elongated shaft . the head 2 can be made of any one of or a combination of several materials weighing different pounds per cubic foot . the pilot model putters used for testing the performance of the present invention were made of brass . a wooden pattern was first carved into the putter head shape design . most patterns used for making rough sand castings are made from mahogany . then a mold is made using the wooden pattern , the wooden pattern is removed and molten metal is poured into the void in the mold thereby taking the shape of the removed wooden pattern . after cooling , the mold is knocked away revealing a rough metal casting of a putter head in the shape of the wooden pattern . to remove the pattern from the mold the pattern must be slanted on all sides to allow the pattern to be slid or pulled out of the mold . the slanted sides are called a draft and is usually one to three degrees of slant . if the sides are straight removing the pattern from the mold would pull the packed sand loose along the sides and thereby destroy the mold each and every time . the head is then sanded into its final configuration . this is only one of the ways a putter head can be fabricated . the present invention was fabricated using this method . the heads 2 of the test models of the present invention were about 4 to 4 1 / 2 inches long ( heel 6 to toe 11 ), about 7 / 8 to 7 / 8 inches face 5 height with top surface varying from about 13 / 16 to one inch from face 5 to backside 12 . the best known shape of head 2 forms a right triangle as viewed from heel 6 toward toe 11 , especially when head 2 composed of only one material throughout . for reference purposes said face is lying substantially in a vertical plane , ( less the positive loft of face 5 .) face 5 being the vertical leg , the top surface 3 being horizontal and being at right angle to said face 5 . loft is at least one ( 1 ) degree . the loft of the test models of the present invention were two ( 2 ) degrees . two ( 2 ) degrees of loft creates sufficient lift to clear the turf grass during the golf ball &# 39 ; s flight to first bounce . the backside 12 completes the right triangle by forming the diagonal side of the right triangle . the backside 12 is slanted backwards at the top . the top of the triangle connects to the rearmost portion of the top surface 3 and the bottom end connects to the sole 8 of face 5 . the diagonal angle of backside 12 is from 35 to 70 degrees from the vertical plane of face 5 when right triangular shape being employed . the right triangular shape as viewed from heel 6 toward toe 11 as heretofore described creates a perfect shape for distributing increasingly heavier weight simultaneously in two directions at right angles to each other , i . e . increasingly heavier weight forwardly toward face 5 and increasingly heavier weight upwardly toward top surface 3 of head 2 , said right triangular shape specifically selected as a means for distributing weight when only a single material is involved . this assists in moving the cp of the putter head as far as practicable into the apex of the right angle formed by face 5 and top surface 3 . the unique distribution as described also results in an unusual amount of weight being distributed all across the top area of head 2 immediately adjacent to top surface 3 . it is believed that the unique weight distribution characteristics of the right triangular shape contributes significantly to the ability of the putter to create airborne overspin . the diagonal angle of backside 12 may be of various shapes : bulged , concave , or otherwise and will sometimes effect the shape of the backside of top surface 3 . attention is invited to alignment mark 4 and its location just forward of shaft 1a toward toe 11 . earlier it was mentioned that shaft 1a was located a little off center ( heel 6 to 11 ) toward heel 6 ( repeat 3 / 16 to 1 / 2 inch ). the shaft being moved enough to make room for alignment mark 4 . this shaft movement will also move the center of percussion ( cp ) of the putter head 2 toward the heel 6 but not as far as the shaft 1a was moved . three general areas ; heel area 7 , toe area 10 and area 9 will be covered after brief remarks to assure a complete understanding . in this invention the center of percussion ( cp ) is being moved into a position that is primarily responsible for overcoming backspin and in this discussion assuring that sidespin is no longer built - in by an alignment mark 4 being misaligned with the cp of putter head 2 . the cp is the point at which if a moving body encounters an immovable obstacle , the motion would be arrested without producing any strain on the axis . for this putter application , it can be more simply stated : the cp inside the putter head when striking through the center of gravity ( cg ) of the golf ball will result in zero or no twist of the putter head 2 around shaft 1a . the cp in this case is commonly referred to as the &# 34 ; sweet spot .&# 34 ; looking at this from the golf ball side of the physical reaction , the ball will not twist or sidespin when similarly hit in line with the alignment mark , provided of course the alignment mark 4 is positioned directly over the cp in the head 2 . referring now back to areas 7 , 10 and 9 . area 9 depicts where weight is removed generally along the bottom of backside area 12 . the cross sectional view of a -- a in fig1 is shown in fig2 with area 9 shown in fig1 and 2 . it can be seen that area 9 fig1 has more material ( weight ) removed from the heel area 7 and less material ( weight ) removed from the toe area 10 . this naturally results in more toe area 10 weight and less heel area 7 weight . zero to one and one half ( 11 / 2 ) times more weight being contained in toe area 10 compared to heel area 7 . this will move the cp back a little toward the toe 11 whereby the alignment mark 4 can be located directly over the cp of the head and be located on the toe side of shaft 1a . this assures the alignment mark 4 can be easily seen and aligned with the center of the ball . a percussion test must be made against the face , as often as necessary to ascertain at what exact location on face 5 results in no twisting of the heel 6 or toe 11 around said shaft . the alignment mark 4 will be located exactly directly over that location which is the cp of the putter head 2 . the ball will not sidespin or twist except when the individual hits the ball off center of the alignment mark 4 . all these little movements and changes to shaft 1a , weight toward toe and alignment mark location creates another built - in accuracy advantage . when the alignment mark 4 is positioned directly over the cp the unequal extra weight toward the toe 11 is neutralized , that is to say , the weight is now equally divided on either side of the alignment mark 4 thus creating equal heel and toe weighting . better accuracy with less sidespin can be expected even when the ball is hit off center of alignment mark 4 . wider sole 8a is securely fastened to backside 12 approximately centered between heel 6 and toe 11 . the bottom portion of wider sole 8a being in line with the bottom of narrow sole 8 providing a wider sole to stabilize the putter at address . wider sole 8a being as light in weight as lightest weight material of head 2 . wider sole 8a is limited to no more than two ( 2 ) inches long when measured from the toe 11 end toward heel 6 end . wider sole 8a is narrower than the width of top surface 3 and not being visible by putter operator . for later reference notice in fig2 how area 9 previously described is located below the centerline of head 2 between top surface 3 and sole 8 . the reason is forthcoming during description of fig3 through 6 . fig3 and 4 depicts locations of a rectangular cross sectional area 13 . fig5 and 6 depicts a rectangular cross sectional area 14 . area 13 is narrower across the top surface 3 and area 14 is narrower across face 5 . note that these rectangles are located into the apex of the right angle formed by face 5 and top surface 3 . the dimensional characteristics of these rectangles are established by one half ( 1 / 2 ) the height of face 5 and one half of depth of top surface 3 . the two opposite sides of the rectangle are naturally the same size as described for the other two sides . the different sizes of the rectangle is determined by the angle of backside 12 ( repeat 35 to 70 degrees ). rectangle 13 will be narrower along top surface 3 when backside 12 is less than 45 degrees to the vertical plane of face 5 . rectangle 14 will be narrower along face 5 when backside 12 is greater than 45 degrees to the vertical plane of face 5 . only when backside 12 is substantially 45 degrees will the rectangular area become a square area . hereinafter this area will be referred to as the rectangular cross sectional area . this rectangular cross sectional area 13 and 14 will be 100 % filled with material from heel 6 to toe 11 . weight of this material will be at least equal to the weight per cubic foot of material used in the remainder of head 2 . the rectangular cross sectional area will contain at least forty ( 40 ) percent of the total weight of the entire head . exception is made for the hole needed to secure shaft 1a into top surface 3 . referring back to fig1 and fig2 it can now be noted that area 9 being located below the centerline of head 2 between top surface 3 and sole 8 is indeed located below and not interfering with the rectangular cross sectional areas 13 and 14 as just described and defined . material missing ( by design prior to fabrication ) in area 9 from backside 10 between heel 6 and toe 11 establishes the differential and extent of heel / toe weighing of heel 6 and toe 11 . generally material missing in area 9 from backside 10 will be adjacent to but not interfering with rectangular cross sectional area 13 and 14 . method and manner used for location of missing material in area 9 will effect thickness and general configuration of wider sole 8a from top to bottom . length and width of wider sole 8a remaining as described above . fig3 through 6 depicts area 15 in four illustrative shapes ( dotted lines ) to provide a wider sole 8 across the bottom of head 2 . this keeping said putter from leaning backward at the grip end when golf operator is preparing to putt with only one hand . additional views of the wider sole are shown in fig1 and fig1 as wider sole 8a . material 18 used for this purpose will be at least as low in weight per cubic foot compared to the weight contained in other areas of head 2 . said added weight creates no negative effect on the 40 % requirement for the rectangular cross sectional area . also depicted are four illustrative shapes for backside 12 . said backside 12 being of various shape will occasionally effect the shape of the backside of top surface 3 . the rectangular cross sectional area just described is established for the purpose of moving the cp upward and forward into the apex of the right angle formed by face 5 and top surface 3 . this is believed to contribute to the elimination of backspin normally expected from positive loft and replacing same with airborne overspin . fig7 through 10 depicts four simple cross sectional views as viewed from heel 6 to toe 11 . these views depict 4 illustrative ways that dissimilar materials may be employed to provide improved management of weight distribution . present invention will be made from at least one material . area 16 has the highest weight per cubic foot , area 18 has the lowest and area 17 falls between the weight per cubic foot of area 16 and 18 . fig7 and 9 are self explanatory except that fig9 distributes weight increasingly upwardly only . fig1 depicts a complete head made from material with low weight per cubic foot being used to accommodate heavier weights being placed in drilled holes . holes could be clear through from heel 6 to toe 11 . other methods of creating and filling voids may be used . these illustrations should not be construed as limiting the number of materials . fig1 shows a typical airborne overspin putter head with face 5 in contact with the curved circumference of a conventional golf ball 19 . 22cp represents the relative position of the center of percussion ( cp ) of the putter head . additional locational data for cp 22cp is shown in fig1 . 23cg represents the center of gravity ( cg ) for the golf ball . the 2 degrees of positive loft causes the face 5 to contact the curve of the ball less than ( 0 . 03125 ) 1 / 32 inch below the center of gravity ( cg ) 23cg of the ball , actually , 0 . 0292 inch below . fig1 also shows the area 20 supporting the shaft 1a , area 14 covered in fig5 and 6 , area 9 covered in fig1 and 2 , and the golf green turf 21 . comment : fig1 and the 0 . 0292 dimension covering where face 5 contacts ball 19 below the ball &# 39 ; s cg is shown and mentioned to mentally register a relationship between the contact point and the amount of weight in head 2 that is above the cg of the ball at impact . fig1 ( a ), 12 ( b ), 12 ( c ) and 12 ( d ) show four views of the relative location of the center of percussion 22cp and the wider sole 8a . 24vcl is relative position of vertical centerline and 25hcl , is relative position of horizontal centerline . the center of percussion 22cp is shown in its relative location in all 4 views . based on video studies one ( 1 ) degree of loft is borderline . two ( 2 ) degrees , however , provides adequate height of flight to overcome golf green turf grasses , especially with the shorter cut , faster greens of today . it &# 39 ; s believed to be somewhat like adding extra weight to the toe of a fairway or driving wood and placing it forward close to the face . this will cause the ball to sidespin counter - clockwise causing the ball to draw or hook ( right handed club ). this will happen even when the ball is struck on the center of the clubface ( heel to toe ). in the case for the present invention the extra weight is upward and forward and believed to work in the same way . anyway , the amazing thing about all this inventive effort is not so much the accomplishment of overspin but the tremendous improvement in accuracy . tests prove at least two to four times more accurate . what i know for sure is that i kept adding more and more weight upward toward the top surface and forward toward the face until airborne overspin was achieved . regarding actual use of the present invention , it is required that the person putting keep the shaft 1a in the vertical position . if the putter shaft 1a is hooded ( slanting grip end toward target ) the two ( 2 ) degrees of loft can be reduced or eliminated . this would cause reduced loft , reduced height of flight and reduced overspin , negative loft could also result in pinching the ball against the turf causing overspin of another kind . after playing many games of golf i find this to be a simple task but it &# 39 ; s importance should not be underestimated . a . the rectangular cross sectional area may be invaded by means creating voids , thereby causing less weight and mass , at least one void providing a hole for shaft 1a and other voids such as holes from heel 6 to toe 11 being used to reduce percentage of weight below the cg of the golf ball at impact , whereas weight remaining in this area creates no negative effect on airborne overspin , and the forty ( 40 ) percent of the total weight limit is maintained . this alternative alters only the 100 % fill requirement . b . a difference can exist between the ratio of increasingly heavier weight upwardly toward top surface 3 when compared to the weight ratio of the increasing heavier weight being located forwardly toward face 5 . the ratio of increasingly heavier weight upwardly will be at least equal to the ratio of the increasingly heavier weight forward . this will serve to summarize the foregoing description and briefly indicate how the objects of the invention covered in the &# 34 ; background of the invention &# 34 ; have been met . a . backspin normally expected from positive loft was eliminated by severely changing the cp of the putter head upwardly and forwardly into the apex of the right angle formed by face 5 and top surface 3 of head 2 . b . backspin was replaced with airborne overspin of the ball which will occur immediately upon impact with the ball . the ball will overspin all the way to the first bounce . c . the alignment mark is located directly over the cp of the putter head . it is easily seen and can be easily positioned on the center of the ball . discounting human error of alignment , the ball will not sidespin or twist upon impact . d . the object of greater ball accuracy was decisively achieved and test proven using a mechanical putting machine on well manicured golf greens . two commercial putters tested using 24 foot putts had a directional dispersion of 251 / 2 inches . a betting man would say &# 34 ; that chances are five ( 5 ) to one ( 1 ) against hitting the hole .&# 34 ; using the same putting machine , the same balls on the same green and with the same clubhead speed the airborne overspin putter ( with no sidespin ) had a directional dispersion of six ( 6 ) inches . the betting man would say &# 34 ; two to one for hitting the hole .&# 34 ; as is known the hole is 41 / 4 inches to diameter . i personally only claim two ( 2 ) to four ( 4 ) times more accuracy simply because not all putters will have as much loft and added weight across the sole area as the commercial putters used for the tests . e . the object of reducing to an absolute minimum the amount of practice required to be a good putter is realized . with the airborne overspin ( no sidespin ) putters no practice is required to overcome built - in inaccuracies such as backspin and sidespin . practice will be required only for the purposes of getting clubhead squared , hitting the ball in the direction desired , and hitting the ball with enough energy to reach and enter the golf hole . f . and the final and most important object is assured by the above objectives being met . &# 34 ; any individual , beginner , high handicapper , amateur or professional can be expected to putt more accurately with the present invention .&# 34 ; the foregoing description of the preferred embodiment of the invention has been presented for the purposes of illustration and description . it is not intended to be exhaustive or to limit the invention to the precise form disclosed . many modifications and variations are possible in light of the above teaching . it is intended that the scope of the invention be limited not by this detailed description but by the claims appended hereto .

weight is moved essentially in three different directions within the putter head causing the center of percussion to be uniquely relocated to create overspin and no sidespin . other related changes to head shape , face loft , shaft location and positioning of alignment mark cooperate with the above to significantly improve accuracy . the basic shape of the putter head is much revised but looks conventional since the changes are hidden under the top surface as seen by the person positioned to putt . the backspin normally expected from positive loft is eliminated and replaced with the more accurate airborne overspin . sidespin is also eliminated , resulting in a truly straight forward turning ball that , compared to commercial putters , lifts less , covers less distance to first bounce , and gently touches down already turning in the direction hit . the ball is much quicker to settle down to a fully rolling condition against the turf . present invention tests prove it to be at least 2 to 4 times more accurate . present putter meets the united states golf association rules of golf .

unless otherwise indicated like numerals identify like features in the disclosed embodiments . in this application , ′ and ″ are not to be understood to be designations for feet or inches or any other unit of measurement . fig1 a and 1b illustrate a perspective view of a first embodiment of a suitcase 10 in an apparatus according to the present invention . suitcase 10 includes a container section 12 . container section 12 is integrated with a top panel 14 which may be hingedly coupled to container section 12 so that it may be selectively moved to allow access to an interior storage space of container 12 . in a typical configuration , container section 12 may have a cubical configuration with two opposing and generally parallel long panels 12 ′ and two opposing and generally parallel short panels 12 ″ each being directly or indirectly attached to a common base panel 16 to define the storage space of container section 12 . the storage space so defined receives transportable , travel - related items such as clothing and other personal items . top panel 14 is connected ( e . g ., via a living hinge or the like ) to one of the panels 12 ′, 12 ″. in the embodiment illustrated , top panel 14 is connected to a long panel 12 ′, although it could also be connected to a short panel 12 ″ without deviating from the scope of the present invention . a top panel 14 so connected can be selectively rotated about its hinged connection to allow access to the storage space of container section 12 . furthermore , top panel 14 can be coupled to panels 12 ′, 12 ″ to enclose the storage space of container section 12 . a handle 18 or the like may be coupled to an exterior surface of one or more of panels 12 ′, 12 ″. according to one aspect of the present invention , two support arrangements 20 , 22 are integrated with container section 12 . in the first embodiment of the present invention , each support arrangement 20 , 22 includes a frame section 24 , which is a relatively rigid body ( e . g . a steel or aluminum tube ), and a foldable or rollable sheet 26 of fabric , plastic , or the like compliant material that is detachably attachable to frame section 24 . in the first embodiment , the sheet 26 may be rolled around a spring loaded roller 28 , which may be an elongated , cylindrical rod , tube or the like body . a suitable spring loaded roller 28 may be a roller that is used for spring loaded shades , which are well known . the spring loading of roller 28 allows roller 28 to rotate under the force of a loaded spring so that , upon detachment from frame 24 , sheet 26 is rolled up by roller 28 . note that the spring is loaded when sheet 26 is drawn out to be attached to a frame 24 much like a roller mechanism of a spring loaded shade . in the first embodiment , roller mechanism 28 resides adjacent the storage space of container section 12 . a cover 29 or the like may be used to separate a roller 28 from the items inside the storage space of container section 12 as illustrated by fig1 d . in the first embodiment , each sheet 26 is accessible and retractable through a slot 30 defined between an edge of base panel 16 and an edge of a short panel 12 ″ as illustrated by fig1 d . it should be noted that the free edge of each sheet 16 may include an integrated bar portion 17 . bar portion 17 includes a plurality of spaced through holes 19 therein . each hole 19 can be used to couple a sheet 16 to a portion of a frame 24 using a hook or the like fastener whereby sheet 16 can be readily attached to or detached from a frame section 24 . according to another aspect of the present invention , each frame section 24 includes two side legs 24 ′ and an elongated connector 24 ″ that is connected at each end thereof to an end of a respective side leg 24 ′. each frame 24 may be a single piece of elongated material ( e . g . a tube or a rod ) which is bent to have two legs 24 ′ and a connector section 24 ″. alternatively , a frame 24 may be made with two elongated bodies serving as legs 24 ′ which are connected at respective ends thereof to ends of another elongated body serving as a connector 24 ″. a sheet 16 in the first embodiment may be coupled to a connector 24 ″ by hooks or other appropriate means as described above . optionally , at least one of the connector 24 ″ may include a handle section 34 . each side leg 24 ′ is longitudinally aligned and receivable inside the interior space of a longitudinally extending , elongated support 32 , which may be a tube or the like body . according to one aspect of the present invention , two parallel supports 32 are provided positioned opposite one another , each extending along a bottom edge of a long panel 12 ′. each support 32 is open at both opposing ends thereof . each leg 24 ′ is receivable inside a support 32 from an open end of the support 32 whereby legs 24 ′ can be inserted into and retracted from supports 32 in a telescopic manner . furthermore , according to another aspect of the present invention , a stabilizer 36 may be pivotably attached ( e . g ., with a pivot pin 38 or the like ) at one end thereof to at least one connector 24 ″, but preferably both connectors 24 ″ as illustrated by fig1 b . stabilizer 36 may be a rigid body ( e . g ., a tube or the like body ). stabilizer 36 may be pivotably moved into a position so that it may be axially aligned generally transverse to the direction of the longitudinal axis of a leg 24 ′. fig1 c illustrates a stabilizer 36 in a stored state . as illustrated , a recess 36 ′ or the like feature may be provided to receive the stabilizer therein for storage . fig1 c ′ illustrates a stabilizer 36 in a partially deployed state . referring to fig1 e , cover 29 includes two integrated brackets 47 , 49 to support the mechanism that supports roller 28 . referring to fig1 f , one bracket 47 includes an elongated slot 51 formed in the body thereof . another bracket 49 includes a concave recess 53 formed in the body thereof as illustrated by fig1 g . referring to fig1 h , roller 28 is coupled by a spring 55 to a supporting rod 57 . supporting rod 57 is disposed inside roller 28 and includes a first end 59 ( see fig1 i ) which is cylindrical in shape and received in recess 53 , and another end 61 ( see fig1 i ) which is flat and receivable in slot 51 . fig1 e illustrates this arrangement . sheet 26 is rolled around roller 28 and coupled at a terminal edge thereof to the body of roller 28 . when sheet 26 is withdrawn it causes roller 28 to rotate about its longitudinal axis . since supporting rod 57 is fixed to brackets 47 , 49 , it does not rotate with roller 28 . consequently , the rotation of roller 28 stores energy in spring 55 , which is coupled to roller 28 and supporting rod 57 . the energy so stored can rotate roller 28 automatically , which would in turn allow sheet 26 to be automatically rolled around roller 28 . this mechanism has been employed for the automatic withdrawal of shades . fig1 j shows the interior space of container section 12 without roller mechanisms . fig1 k shows the interior of container section 12 with the roller mechanism installed therein , and one frame withdrawn . note that each cover 29 may include two integrated portions 63 the purpose of which is to extend over side legs 24 ′. as will be appreciated each cover 29 will separate the roller mechanisms from the storage space of container section 12 in order to prevent items stored therein from interfering with the operation of the roller mechanism . referring to fig1 l , in another embodiment of the present invention , a slot 30 for feeding a sheet 26 from the interior of container section 12 to the exterior thereof is defined in base panel 16 instead of between a side panel 12 ″ and base panel 16 as shown in fig1 d . in this embodiment , recesses 65 are defined in the exterior of container section 12 . recesses 65 are defined deep enough to at least partially receive connector sections 24 ″ to achieve a more compact arrangement when side legs 24 ′ are stored in supports 32 . fig1 o - 1t illustrate different views of the embodiment illustrated by fig1 l . thus , fig1 o shows the embodiment with both support arrangements 20 , 22 in an extended state . fig1 p illustrates the support arrangements in a stored state . fig1 q shows a side plan view of the embodiment of fig1 l with one frame 24 thereof in an extended state . fig1 r illustrates a perspective view of the embodiment of fig1 l with a frame 24 thereof in an extended state and ready for use as a handle . fig1 s illustrates a back plan view while fig1 t illustrates a perspective of the apparatus with the support arrangements 20 , 22 in an extended state . note that fig1 t discloses two spaced stabilizers 36 integrated with each support arrangement 20 , 22 . according to another aspect of the present invention , flexible reinforcing ribs 67 may be integrated with sheet 26 to improve the mechanical integrity thereof . fig1 m and 1n further illustrate the arrangement described above . referring to fig1 d ′, bar portion 17 may be replaced with an elongated latch 17 ′. elongated latch 17 ′ includes a hook - shaped profile ( cross - section ). hook - shaped latch 17 ′ is receivable in an elongated slot 19 ′ having a cross - section with a shape complementary to the shape of the cross - section of latch 17 ′. slot 19 ′ may be defined in connector 24 ″ portion of each frame as illustrated by fig1 d ″. when a latch 17 ′ is received in a slot 19 ′, sheet 26 that is attached to latch 17 ′ is coupled to a frame 24 . to disassemble sheet 26 , latch 17 ′ is withdrawn from slot 19 ′. in addition to what has been shown and described , other mechanisms such as hooks or the like may also be used to couple a sheet 26 to an associated frame 24 . to use a suitcase 10 according to the present invention , a user can pull out one or both frames 24 from supports 32 , pull out a sheet 26 associated with a frame 24 and attach the same to its associated frame 24 by attachment to a connector section 24 ″ thereof . then , suitcase 10 is positioned so that top panel 14 makes contact with the floor or the like external support surface . consequently , base panel 16 of container section 12 is positioned between two support sections 20 , 22 , and therefore , can support most of the weight of an individual . note that a suitcase 10 according to the first embodiment , can be converted into a bed without having to open top panel 14 . moreover , advantageously , if base panel 16 is made of a flexible , compliant material , such as fabric , the soft items ( e . g ., clothing etc .) can serve as a soft support ( e . g ., a cushion ). thus , in an arrangement according to the present invention , most of the weight of the user can be supported by container section 12 and the contents thereof , which may allow for construction of frames 24 and sheets 26 with lighter weight materials . an apparatus according to the present invention advantageously embodies the following features . these features are present in every embodiment disclosed herein . support arrangements 20 , 22 can be deployed and stored without having any part thereof interfering ( i . e . crossing or passing through ) the storage space of container section 12 . thus , a user can conveniently make use of the support mechanisms of the present invention without the need to remove the items contained in the storage space of container section 12 . moreover , when deployed ( i . e . extended state ) at least one support arrangement 20 , 22 ( and preferably both support arrangements 20 , 22 ) will include a region on a support surface thereof ( i . e . a portion on a sheet 26 ) that intercepts a horizontal plane coinciding and coplanar with a region of the exterior surface of base panel 16 ( or top panel 14 ). consequently , the mid section of a person can be supported by a region coinciding and coplanar with the exterior surface of base panel 16 ( or top panel 14 if support arrangements 20 , 22 are located at a side nearest to top panel 14 ) while the upper section of the person can be supported by the region on a support surface that intercepts a horizontal plane coinciding and coplanar with the exterior surface of base panel 16 , whereby the body of the person lying down is not forced into an arched position . rather , the body of the person lying down will find a support position for its mid section on a horizontal plane that coincides and is coplanar with a region on the exterior surface of base panel 16 and another support position for its upper section on a surface of sheet 26 . the distance between these two support positions can be determined statistically for a commercial embodiment of the present invention . preferably , this distance will not be less than two feet . note that the same support configuration can be provided to support the mid section and the lower section of a person lying down , whereby the body of a person lying down can be supported by three support points on a horizontal plane that coincides and is coplanar with a region on base panel 16 , is intercepted by a support surface of a sheet 26 in one support arrangement 20 , 22 , and intercepted by a support surface of a sheet 26 of the other support arrangement 20 , 22 . the appropriate distances between the support points can be determined statistically . as is apparent from the figures , the support arrangements are wider than the width of side panels 12 ′, 12 ″ to provide adequate surface area to support the width of a human body lying down . this width ( i . e . the distance between legs 24 ′ in each frame ) can also be calculated statistically . preferably , the width is not less than eighteen inches . in one embodiment of the present invention , each side legs 24 ′ of one frame 24 is hollow , open at one end , and capable of receiving in the interior thereof a side leg 24 ′ of the other frame 24 . fig2 a and 2b illustrate one of the two side legs 24 ′ of frame 24 . the other of the two side legs 24 ′ would be arranged in the same manner . as illustrated , one side leg 24 ′ ( side leg 24 ′ illustrated on the left ) is a hollow tube which receives in the interior thereof another side leg 24 ′ ( side leg 24 ′ on the right ). thus , one side leg 24 ′ is receivable into and retractable from the interior of another side leg 24 ′. note that , both side legs 24 ′ are received in the interior of support 32 in a telescopic manner . thus , the interior of support 32 is wide enough for both side legs 24 ′. note that while in this embodiment one leg 24 ′ is received inside another leg 24 ′, such a configuration is not necessary . each pair of legs 24 ′ can be telescopically received inside a respective common support 32 and arranged side by side or one under the other . referring now to fig2 c - 2f , in one embodiment , a side leg 24 ′ can be stopped from being further withdrawn by a catch mechanism . the catch mechanism includes a spring - loaded catch 40 , which may be a spring - loaded ball or the like , residing at a location near the free end of at least one side leg 24 ′. a corresponding opening 42 can be provided in support 32 . opening 42 and catch 40 are positioned to register with one another when a side leg 24 ′ is withdrawn from support 32 far enough for the two features to coincide . thus , catch 40 is received inside opening 42 whereby it abuts the interior wall of opening 42 to restrict leg 24 ′ from being further withdrawn . to insert leg 24 ′ into the interior of support 32 , catch 40 may be manually pressed down so that it no longer restricts the ability of leg 24 ′ to be inserted into support 32 . referring now to fig2 g - 2i , a release mechanism may be provided to release catch 40 so that legs 24 ′ may be inserted into supports 32 . the release mechanism includes a button 31 , which may be generally t - shaped , a first elongated transmission arm 33 and a second elongated transmission arm 35 each coupled to button 31 , and a first elongated release arm 37 and second elongated release arm 39 each coupled to a respective elongated transmission arm 33 , 35 . t - shaped button 31 includes a narrow portion 31 ″ coupled to the middle of a wide portion 31 ′ to realize a t shape . wide portion 31 ′ is longitudinally aligned with the longitudinal axis of connector 24 ″, and includes two terminal ends each connected by a pivot pin 41 to an end of an elongated transmission arm 33 , 35 . each transmission arm 33 , 35 is coupled by another pivot pin 41 at an opposite end thereof to an end of a respective release arm 37 , 39 , whereby the motion of each transmission arm 33 , 35 can cause the motion of release arm 37 , 39 . the release mechanism is configured to allow a user to cause the release arms 37 , 39 to move along an axis parallel to the longitudinal axis of a side leg 24 ′. specifically , each transmission arm 33 , 35 is pivotably coupled by a pivot pin 41 to connector 24 ″ of frame 24 such that the motion of button 31 toward the interior of frame 24 causes release arms 39 to be directed in the opposite direction ( see arrows ). to realize this motion , each transmission arm 33 , is coupled to connector 24 ″ by a pivot pin 41 . note that only narrow portion 31 ″ of button 31 may be accessible to a user , and the remaining parts may be disposed inside of connecter 24 ″ and side legs 24 ′ of frame 24 . referring to fig2 g , each release arm 37 , 39 includes an actuator 43 at an end thereof that is cooperatively coupled with the spring loaded catch 40 so that when release arm 39 is moved upon moving button 30 , catch 40 can be withdrawn from opening 42 , thus allowing side legs 24 ′ to be inserted into support 32 . note that a stop 45 may be provided inside each support 32 to abut catch 40 and prevent legs 24 ′ from being withdrawn completely from supports 32 in the event of misuse by the operator . note that although only on arm 39 is illustrated , the other arm 37 will function in the same manner . thus , a button 30 can cause the simultaneous operation of two arms 37 , 39 . referring to fig2 j actuator 43 may be an enlarged body in which spring - loaded catch 40 resides . thus , when release arm 39 is moved catch 40 is selectively moved to register with or deregister from opening 42 . alternatively , a cradle 43 ′ may be defined in arm 39 ( or 37 ) which is moved under ball catch 40 in order to effect release of catch 40 from opening 42 . note that optionally a spring 70 or the like body may be coupled to the end of arm 39 ( and 37 ) and abutted against a surface for additional mechanical force . also , a stop 45 may be provided in the interior of leg 24 ′ to prevent the catch from falling out . referring to fig3 a , in another embodiment of the present invention , supports 32 can be attached to the exterior surface of base panel 16 of container section 12 instead of being disposed adjacent the interior surface of base panel 16 , thus providing further space for storage of items . fig3 a further shows wheels 44 disposed on one of the short panels 12 ″. according to one aspect of the present invention , the provision of wheels 44 allows for the use of a connector 24 ″ as a handle for pulling the suitcase . fig3 b illustrates a side plan view of the embodiment of fig3 a , with frames 24 in an extracted position . fig3 c illustrates a side plan view of the embodiment of fig3 a with legs 24 ′ of frame 24 retracted inside support 32 . fig3 d illustrates a side plan view of the embodiment of fig3 a with a stabilizer 36 . referring to fig4 a and 4b , in which like numerals identify like features , support arrangements 20 , 22 may be rigid flat bodies that are coupled to short panels 12 ″ of container section 12 by hinges 46 or the like devices . in this embodiment , the exterior section of top panel 14 ( see fig4 b ) may be used as part of the bed when supports 20 , 22 are extended out to provide support points for a person lying down in the manner described above . note that , in this embodiment , support arrangements 20 , 22 may be received over the storage space of container section 12 below top panel 14 when not in use , but do not interfere with the storage space when extended for use as can be easily appreciated by an ordinary user . further , note that each support in this embodiment , may include a stabilizer 36 , one of which is illustrated . as in the other embodiments , if top panel 14 is made of a soft material ( e . g ., fabric ), soft items ( e . g ., clothes ) inside container 12 may provide the necessary support when the suitcase is converted into a bed . fig5 a - 5e illustrate a plurality of views of a variation of the embodiment of fig4 a and 4b . in this variation , supports 20 , 22 are not positioned under top panel 14 when stored . rather , support arrangements 20 , 22 fold over the exterior surface of top panel 14 ( or alternatively exterior surface of base panel 16 ) and are secured in place by straps 48 that are long enough to wrap around the suitcase . support 20 , 22 may be hingedly connected ( e . g . using living hinges ) to short panels 12 ′ of container section 12 . support arrangements 20 , 22 in this variation may also include stabilizers . fig6 a illustrates a side plan view of a variation of an embodiment in which support arrangements 20 , 22 are folded over top panel 14 . in this variation , one support arrangement 20 is stored directly over top panel 14 , and under the other support arrangement 22 . both support arrangements may be coupled to exterior surfaces of short panels 12 ″ by hinges 46 . note that to fit snuggly between support 22 and top panel 14 , support 22 is provided with a spacer section 23 . spacer section 23 abuts top panel 14 to provide a space between the bottom surface of support 22 and top panel 14 to accommodate support 20 . fig6 b shows a side plan view of the suitcase illustrated by fig6 a , in which support arrangements 20 , 22 are deployed . fig6 c shows a top plan view of the suitcase of fig6 b . fig6 d illustrates schematically how support arrangements 20 , 22 are deployed ( the arrows illustrating rotation of supports 20 , 22 about the axes of hinges 46 ). fig7 a illustrates a support arrangement 20 , which includes an exterior closed frame 21 and a lattice 25 disposed inside and coupled to the interior of closed frame 21 . the provision of a lattice 25 can provide enough mechanical support for the user , while further reducing the weight of support arrangement 20 . a support arrangement 22 can be provided with the same features to further reduce the weight as illustrated by fig7 b . fig7 c illustrates that support arrangements 20 , 22 as shown in fig7 a and 7d can be folded over top panel 14 in the same manner as the embodiments of fig5 , and 6 a - 6 d . referring to fig8 a - 8d , a suitcase according to another embodiment may include support arrangements 20 , 22 , that are flat and relatively rigid , and slide out from the interior of container section 12 through slots 30 defined between side walls 12 ″ and base panel 16 . support arrangements 20 , 22 may be provided with handle sections 20 ′, 22 ′ to facilitate the manipulation thereof . fig9 a illustrates a perspective view of an apparatus according to another embodiment of the present invention . in this embodiment , top panel 14 does not include a surface that coincides with the exterior , top surface of suitcase 10 . rather , in this embodiment top panel 14 is hidden inside a cover section 100 . cover section 100 cooperates to enclose hidden top panel 14 , and support arrangements 20 , 22 in a space above the storage space of container section 12 . fig9 b illustrates the embodiment of fig9 a with a cover section 100 thereof open . as illustrated , hidden top panel 100 is received inside cover section 100 . fig9 b further illustrates support arrangements 20 , 22 in a stored state . note that in this embodiment support arrangements 20 , 22 overlap one another . when cover section 100 is closed , hidden top panel 14 also overlaps support arrangements 20 , 22 . fig9 c illustrates the embodiment of fig9 a with support arrangements 20 , 22 in an extended state . support arrangements 20 , 22 may be rigid flat bodies which are rotatably coupled to respective sides of container section 12 ( e . g . interior edges of short sides 12 ″). a hinge or the like feature may be used to rotatably couple each support arrangement 20 , 22 to a side of container section 12 . referring to fig9 d , once support arrangements 20 , 22 are deployed and are in an extended state , hidden top panel 14 is moved to a position over the storage space of container section 12 and between support arrangements 20 , 22 to provide a platform that can serve as a bed or the like for a person in a lying position . note that a living hinge 102 can couple hidden top panel 14 to the interior surface of cover section 100 . thus , hidden top panel 14 can also be rotatably moved into and out of cover section 102 . further note that in this embodiment , two spaced stabilizers 36 can be integrated with each support arrangement 20 , 22 . each stabilizer 36 in this embodiment may be rotatably coupled ( by a pivot pin or the like ) to the support arrangement 20 , 22 and rotated into a recess for storage . fig9 e illustrates that optionally a covering like a curtain 106 can be integrated into cover section 100 and deployed for the user &# 39 ; s privacy when needed . in this figure a headrest 108 that is integrated with one of the support arrangements 20 is also shown . fig9 e ( open with extended support arrangements 20 , 22 ) and 9 g ( closed position ) are further views of the embodiment . as can be appreciated by a skilled person , an apparatus according to the present invention advantageously embodies the following features . these features are present in every embodiment disclosed herein . support arrangements 20 , 22 can be deployed and stored without having any part thereof interfering ( i . e . crossing or passing through ) the storage space of container section 12 . thus , a user can conveniently make use of the support mechanisms of the present invention without the need to remove the items contained in the storage space of container section 12 . moreover , when deployed ( i . e . extended state ) at least one support arrangement 20 , 22 ( and preferably both support arrangements 20 , 22 ) will include a region on a support surface thereof ( e . g . a portion on a sheet 26 or a portion on the rigid bodies serving as support arrangements 20 , 22 ) that intercepts a horizontal plane coinciding and coplanar with a region of the exterior surface of base panel 16 or top panel 14 . consequently , the mid section of a person can be supported by a region coinciding and coplanar with the exterior surface of a base panel 16 or top panel 14 while the upper section of the person can be supported by the region on a support surface that intercepts a horizontal plane coinciding and coplanar with the exterior surface of base panel 16 or top panel 14 , whereby the body of the person lying down is not forced into an arched position . rather , the body of the person lying down will find a support position for its mid section on a horizontal plane that coincides and is coplanar with a region on the exterior surface of base panel 16 or top panel and another support position for its upper section on a surface of a support arrangement 20 , 22 . the distance between these two support positions can be determined statistically for a commercial embodiment of the present invention . preferably , this distance will not be less than two feet . note that the same support configuration can be provided to support the mid section and the lower section of a person lying down , whereby the body of a person lying down can be supported by three support points on a horizontal plane that coincides and is coplanar with a region on base panel 16 or top panel 14 , is intercepted by a support surface in one support arrangement 20 , 22 , and intercepted by a support surface of the other support arrangement 20 , 22 . the appropriate distances between the support points can be determined statistically . as is apparent from the figures , the support arrangements are wider than the width of side panels 12 ′, 12 ″ to provide adequate surface area to support the width of a human body lying down on his / her back . this width should be taken in a direction transverse to the direction of extension of support arrangements and can also be calculated statistically . preferably , the width is not less than eighteen inches . although the present invention has been described in relation to particular embodiments thereof , many other variations and modifications and other uses will become apparent to those skilled in the art . it is preferred , therefore , that the present invention be limited not by the specific disclosure herein , but only by the appended claims .

an apparatus that includes a suitcase and integrated support arrangements that are transformable from an extended state to provide support for a person to lie down and a stored state for ease of transport .

a device 100 for deploying a detachable sealing element 160 ( shown in fig2 ) in a puncture wound is shown in fig1 , herein referred to as a closure device 100 . examples of such a sealing element or plug 160 are described in u . s . application ser . no . 10 / 687 , 848 , filed oct . 17 , 2003 , ser . no . 10 / 850 , 795 filed may 21 , 2004 , and ser . no . 11 / 038 , 995 , filed jan . 19 , 2005 , each of which applications are hereby incorporated by reference . sealing element 160 occludes blood flow from a puncture . in a preferred embodiment , the sealing element 160 will be fabricated from a material which expands upon contact with blood such as a felt made from polyglycolic acid and / or polylactic acid polymers or copolymers or other materials such as collagens . the sealing element 160 may also have one or more hemostasis , antibiotic or other therapeutic agents added to it . alternatively , in other preferred embodiments , the sealing element 160 will be made in such a manner that it will expand spontaneously or upon removal of a restraining force . in still other embodiments , the sealing element 160 can be expandable mechanically , hydraulically or pneumatically . in all such embodiments , it is preferred that the sealing element 160 be fabricated from a bioabsorbable material . the closure device 100 for deploying the sealing element 160 includes a tubular elongate member 1 , herein referred to as the “ housing ,” which houses various components that will be described below . the device 100 also comprises a wire actuator 2 which is external and distal to the housing 1 and is slidably mounted and configured to actuate an indicator wire 6 , as described below . extending through the distal end of the housing 1 is a deployment tube 7 configured to be received by an introducer sheath 300 known in the art . the deployment tube 7 is slightly longer than the introducer sheath 300 . the deployment tube 7 receives an indicator wire 6 ( shown in fig2 a and 2 b ) and a pusher 80 , which operates as a backing member supporting a detachable sealing element 160 at a distal section of the deployment tube 7 . the pusher 80 preferably includes a channel through which the indicator wire 6 may be received within the tube 7 . the channel is preferably located on or near the edge or the periphery of the backing portion of the pusher 80 , i . e ., near the internal surface of the deployment tube 7 . optionally , an indicator wire tube or other lumen ( not shown ) may be provided within the interior of the deployment tube 7 . the indicator wire tube is preferably attached to the housing 1 at its proximal end , and extends through the deployment tube 7 . the indicator wire 6 then extends through the indicator wire tube or other lumen and exits the indicator wire tube at or near the distal end of the deployment tube 7 . ( additional details of the structure and operation of the pusher 80 are described in ser . no . 10 / 850 , 795 , filed may 21 , 2004 , which is incorporated by reference ) the deployment tube 7 includes an inlet port 22 in the distal section of the tube 7 , configured to take in blood when exposed to a vessel , and the housing 1 includes an outlet port 23 communicatively coupled to the inlet port 22 for allowing the blood to exit outside of the puncture wound . also extending out of the housing is a trigger 8 that preferably includes a rotary link 14 configured to deploy the detachable sealing element 160 . before operation of the closure device 100 , the rotary link 14 is locked , i . e ., the operator is prevented from actuating the rotary link 14 despite pressing the trigger 8 , as described below . turning to fig2 ( a - d ) , deployment of a detachable sealing element 160 within a puncture wound 400 using the closure device 100 is illustrated . an introducer sheath 300 is already deployed within the tract 410 of the wound 400 with its distal end 310 exposed within the lumen 420 of a blood vessel defined by a vessel wall 430 . the deployment tube 7 of the closure device 100 is inserted into the introducer sheath 300 . upon substantially complete insertion , the device 100 is engaged with the introducer sheath 300 , and the distal section of the deployment tube 7 extends out of the distal end of the sheath 300 . when the inlet port 22 is exposed to the lumen 420 of the vessel 430 , blood will enter the inlet port 22 and travel out of the outlet port 23 extending out of the housing 1 . the blood exiting the outlet port 23 will be visible to the operator ( not shown ) of the device 100 , notifying the operator that the distal end of the deployment tube 7 is within the lumen 420 of the vessel 430 and outside of the tract 410 of the puncture wound 400 . also upon substantially complete insertion , the wire actuator 2 of the device 100 is actuated by the proximal end of the sheath 300 , causing the wire actuator 2 to be pushed toward the housing 1 . the wire actuator 2 is mechanically coupled to the indicator wire 6 and configured to actuate the indicator wire 6 in the distal direction . thus , as the wire actuator 2 is pushed towards the housing 1 , the wire actuator 2 causes the indicator wire 6 to extend out of the distal end of the deployment tube 7 . when the indicator wire 6 exits the tube 7 , the distal section of the wire 6 forms into a loop 5 located adjacent the distal tip of the tube 7 . the loop 5 of the wire 6 will come into contact with the vessel wall 430 near the edge 415 of the tract 410 when the device 100 and the sheath 300 are withdrawn , as shown in fig2 b . turning to fig2 b , after the device 100 is inserted and engaged into the sheath 300 as described above , the operator withdraws or pulls back the device 100 and sheath 300 within the tract 410 . when the distal section of the deployment tube 7 exits the lumen 420 and enters the tract 410 , the inlet port 22 is no longer exposed to the blood within the lumen 420 and thus , the blood flow out of the outlet port 23 ceases . this notifies the operator that the distal section of the deployment tube 7 has exited the lumen 420 and entered the tract 410 of the puncture wound 400 . the indicator wire &# 39 ; s 6 resistance that is caused by the loop 5 engaging the vessel wall 430 will unlock the rotary link 14 , as described below , and optionally toggle the indicator window 13 to a state that indicates that the loop 5 has engaged the vessel wall 430 near the edge 415 of the tract 410 , which places the distal end of the deployment tube 7 at a desirable location within the tract 410 and substantially adjacent to the edge 415 . in the embodiment shown in fig2 b , the indicator window 13 toggles from a striped pattern , fig2 a , to a solid pattern , as described below . the operator is then enabled to actuate the unlocked rotary link 14 to deploy the sealing element 160 by pressing the trigger 8 . turning to fig2 c and 2d , the rotary link 14 actuates and withdraws both the wire 6 and the tube 7 while the sealing element 160 remains substantially in place by the pusher 80 , thereby deploying the sealing element 160 . the device 100 then disengages from the sealing element 160 , thus sealing or plugging the puncture wound 400 . preferably , in one motion , the rotary link 14 is configured to withdraw the indicator wire 6 into the tube 7 before the tube 7 is withdrawn . thus , the wire 6 is withdrawn before the sealing element 160 deployed , preventing the wire 6 from interfering with the deployment of the sealing element 160 , such as damaging or dislodging the sealing element 160 . turning to fig3 , a rack and pinion system for actuating the tube 7 and the wire 6 within the housing 1 of the device 100 is shown . the device 100 is shown not engaged to a introducer sheath 300 , and thus the wire actuator 2 is in its original state away from the housing 1 . the wire actuator 2 is coupled to a first rack 4 that is configured to engage a first gear 3 when the wire actuator 2 is actuated in the proximal direction as described above . the first gear 3 is attached to a second gear 16 , which causes a second rack 50 to move in the distal direction . the second rack 50 is engaged with the indicator wire 6 , causing the indicator wire 6 to extend out of the tube 7 when wire actuator 2 is actuated by engaging with the introducer sheath 300 as described above . the wire actuator 2 proximally withdraws the first rack 4 , which rotates the second gear 16 via the first gear 3 , which then advances distally the second rack 50 , thus advancing distally the indicator wire 6 , causing the indicator wire to extend out of the deployment tube 7 . the first and second gears 3 and 16 share an axis that is secured by a bottom plate 101 . the bottom plate 101 is actuated by a trigger that includes a rotary link 14 . when the trigger 8 is pressed to deploy the plug 160 , the rotary link 14 , which includes an arcuate gear section 15 that engages and actuates the bottom plate 101 in the proximal direction , is actuated . a tube collar 115 , which is engaged to the deployment tube 7 , is anchored at a distal portion of the bottom plate 101 . when the bottom plate 101 is withdrawn proximally , the collar tube 115 is withdrawn as well , which in turn withdraws proximally the deployment tube 7 , which deploys the plug 160 . proximally withdrawing the bottom plate 101 causes the first gear 3 to rotate along the first rack 4 , which is locked in place by the wire actuator 2 engaged with the introducer sheath 300 . proximal to the wire actuator 2 is a post 116 that extends from the housing 1 . when the distal portion of the closure device 100 is inserted into the lumen of the introducer sheath 300 , a proximal portion of the introducer sheath 300 that defines a lip ( not shown ) engages the post 116 , which connects and locks the closure device 100 to the introducer sheath 300 . thus , the second rack 50 is proximally withdrawn by the second gear 16 , which causes the indicator wire 6 to retract substantially simultaneously with the deployment tube 7 . the figures show that the first gear 3 has a smaller diameter than the second gear 16 . first and second gears 3 and 16 each provide a mechanical advantage to the control of the indicator wire 6 and deployment tube 7 respectively . preferably , the mechanical advantage regarding the indicator wire 6 is 4 : 1 and the mechanical advantage regarding the deployment tube 7 is 2 : 1 . other mechanical advantage relationships may be used e . g ., 3 : 1 for the indicator wire 6 and 1 . 5 : 1 for the tube 7 . it is preferred that the mechanical advantage for the indicator wire 6 be twice that for the tube 7 . thus , when trigger 8 is depressed , the bottom plate 101 and tube collar 115 will withdraw the tube 7 more slowly than the indicator wire 6 is withdrawn into the device 100 and the indicator wire 6 will be retracted into the deployment tube 7 before the sealing element 160 is deployed and / or disengaged from the tube 7 and the device 100 . as described above , this advantageously prevents the indicator wire 6 from interfering with the deployment of the sealing element 160 . one of ordinary skill in the art will appreciate that though a rack and pinion system is described and shown in fig3 , any suitable type of actuating system may be configured to retract the indicator wire 6 before a sealing element 160 is deployed and / or disengaged from the device 100 in accordance with a preferred embodiment of the present invention . for example , a hydraulic , electronic , and / or a pulley system may be used instead of or in addition to the rack and pinion system to retract the indicator wire 6 into the deployment tube 7 before the sealing element 160 is deployed and / or disengaged from the device 100 . the housing 1 can also include an indicator assembly 200 coupled to a stationary top plate 150 of the device 100 . the indicator assembly 200 can indicate to the operator , via an indicator panel 13 in the top plate 150 , whether the distal end of the deployment tube 7 is in the desired location , e . g ., near the edge 415 of the tract 410 of the puncture wound . in addition to , or in the alternative , the indicator assembly 200 may further lock the trigger 8 until the deployment tube 7 is in the desired location . in fig4 a and 4b , an implementation of the indicator assembly 200 of the device 100 is shown . the indicator assembly 200 comprises an indicator 20 , indicator spring 19 and lockout plate 17 . as can be seen from fig4 a , a slidable lockout plate 17 engages groove 18 in rotary link 14 , thereby preventing substantial movement of rotary link 14 . the indicator spring 19 applies a proximal force on the lockout plate 17 to maintain the lockout plate &# 39 ; s 17 position even after the indicator wire 6 is deployed from the tube 7 . turning to fig4 b , the indicator wire 6 is fixedly attached to the lockout plate 17 , which is coupled to a block 9 via the indicator spring 19 . the block 9 is in a secured position , fixed to the housing 1 and / or the tube 7 . because the indicator wire 6 is connected to the tube 7 and / or housing 1 via a spring 19 and slidable lockout plate 17 , the indicator wire 6 is capable of axial movement independent of the housing 1 and / or tube 7 . during operation , after the indicator wire 6 has been deployed through the puncture wound 400 with the formed loop 5 exposed to the lumen 420 of a vessel defined by a vessel wall 430 , the operator is then ready to withdraw the device 100 and sheath 300 to deploy the sealing element 160 within the tract 410 of the puncture wound 400 . even if blood stops flowing out of the outlet port 23 , that only indicates that the inlet port 22 is within the tract 410 , not necessarily that the sealing element 160 is desirably near the edge 415 of the tract 410 . however , the indicator wire 6 may provide such an indication . when the loop 5 of the wire 6 approaches the edge 415 of the tract 410 , the loop 5 will engage the vessel wall 430 near the edge 415 as the device 100 is withdrawn by the operator . when the loop 5 engages the vessel wall 430 , it will cause a force to be applied on the wire 6 toward the distal direction , or direction opposite that of the device 100 as its being withdrawn . this force will overcome the force of the spring 19 securing the lockout plate 17 , proximally withdraw the lockout plate 17 in the distal direction , and cause the lockout plate 17 to disengage from the groove 18 of the rotary link 14 , thereby unlocking the trigger 8 . when the trigger 8 is unlocked , because the loop 5 has caught the edge 415 , the distal end of the tube 7 is substantially adjacent to the edge 415 of the tract 410 , which is a desirable location for the deployment of the sealing element 160 . the operator is then enabled to deploy the sealing element 160 . even though a spring loaded system is described above for locking and unlocking the trigger 8 , one of ordinary skill in the art would appreciate that any locking mechanism may be employed in accordance with an embodiment of the present invention , such as a hydraulic and / or electronic system . in addition to locking and unlocking the trigger 8 , the indicator assembly 200 may also provide a visual and / or audio notification to the operator that the distal end of the tube 7 is in a desirable position . as will be explained in more detail with regard to fig4 a , 4 b , 5 a , 5 b , and 6 , indicator 20 can be seen through indicator panel 13 , which defines two windows 21 , on the top plate 150 and indicates to the user when the appropriate time to depress trigger 8 with rotary link 14 has been reached . fig5 a and 5b show a top view looking down through the windows 21 , indicator 20 is provided with opaque portions 22 . the windows 21 preferably have a shape consistent with the shape of markings 22 on the indicator 20 . thus , prior to the indicator wire 6 being axially displaced opposite of the housing 1 and / or tube 7 , some or all of the windows 21 are clear , but when the indicator wire 6 is axially displaced opposite of the housing 1 and / or tube 7 as described above , markings 22 on the indicator 20 come into correspondence with the windows 21 of the indicator panel 13 as shown in fig5 b . when this registration occurs , trigger 8 may be depressed . fig6 essentially shows the same thing as fig5 a and 5b , but from a perspective view . one of ordinary skill in the art would appreciate that though windows 21 are described , the indicator panel 21 may also utilize other mechanisms , such as electronic circuitry , light emitted diodes ( led ), and / or other visual and / or audio mechanisms known in the art . for example , the device 100 may be configured such that when the indicator wire 6 engages the vessel wall 430 near the edge 415 of the tract 410 , a circuit ( not shown ) is triggered within the housing 1 that causes a light to be emitted and / or an audio alarm to be invoked . in the foregoing specification , the invention has been described with reference to specific embodiments thereof . it will , however , be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention . for example , the reader is to understand that the specific ordering and combination of process actions described herein is merely illustrative , and the invention can be performed using different or additional process actions , or a different combination or ordering of process actions . as a further example , each feature of one embodiment can be mixed and matched with other features shown in other embodiments . additionally and obviously , features may be added or subtracted as desired . accordingly , the invention is not to be restricted except in light of the attached claims and their equivalents .

the present invention is directed to a device which is capable of both locating a punctured blood vessel wall and sealing the puncture in the vessel and to the method of using the device as well . in one embodiment , the device includes an elongate deployment member having a sealing element releasably disposed within a distal end thereof , said deployment member being coupled to a first actuator configured to retract said deployment member relative to said sealing element , and an elongated indicator member having a proximal end and a distal end , said indicator member extending through a lumen in said deployment member such that the distal end of said indicator member extends distally of the distal end of the deployment member , and said indicator member being coupled to a second actuator configured to retract said indicator member relative to said deployment member .

the principle of treating osahs according to the present invention lies in that : supported by a hard palate 6 , a support 2 inserted into a muscular layer of a soft palate is used to lift the collapsed soft palate 7 , thereby achieving the objective of treating osahs . see fig1 to fig1 - 3 . since the support 2 inserted into the muscular layer of the soft palate needs to swing along with the soft palate during swallowing , a high requirement is imposed on the fatigue resistance of the support 2 . how to improve the fatigue resistance of the soft palate support 2 becomes a key to the improvement of the service life of the soft palate support 2 . in view of how to improve the fatigue resistance of the soft palate support 2 , a technical solution of improving the fatigue life of the soft palate support is disclosed in the present invention , that is , a layered structure of supporting plates that is formed by stacking thin - walled plates is used as the support 2 , which not only improves the adaptability of the support but also significantly improves the fatigue fracture resistance of the support while ensuring the supporting force . when a single - layer titanium - nickel shape memory alloy sheet having a thickness of 0 . 6 mm after heat treatment is used as the soft palate support , the fatigue life is about 3 × 10 6 cycles , and calculated based on one swallow per minute , the fatigue life is about 5 years . when the thickness decreases to 0 . 1 mm , and a 0 . 1 mm single - layer titanium - nickel shape memory alloy sheet after the same heat treatment process is used as the soft palate support , the fatigue life is about 5 × 10 7 cycles , and calculated based on one swallow per minute , the fatigue life is about 95 years . when a ti - based amorphous metal material , also referred to as ti - based metallic glass , having a thickness of 0 . 1 mm is used , the fatigue life is greater than 1 × 10 8 cycles , and the fatigue life is about 190 years . it can be seen that , the layered soft palate support formed by stacking thin - walled plates surely can meet clinical requirements . a layered soft palate support in a descending configuration of the present invention referring to fig1 , this embodiment shows a layered soft palate support in a descending configuration of the present invention . for ease of description , it is defined that supporting plates 21 close to teeth are front supporting plates 21 , supporting plates 21 close to a posterior pharyngeal wall are rear supporting plates 21 , and supporting plates 21 of the same length are supporting plates 21 of an equal - length layer . in this embodiment , the support 2 includes a total of five equal - length layers of supporting plates 21 , namely , p 1 , p 2 , p 3 , p 4 and p 5 layers , where the p 1 layer and the p 2 layer are each formed by two layers of supporting plates 21 . each of the thin - walled supporting plates 21 of the p 1 layer and the p 2 layer has a thickness of 0 . 1 mm , and each of the thin - walled supporting plates 21 of the p 3 layer , the p 4 layer and the p 5 layer has a thickness of 0 . 2 mm . in this way , the support 2 has an overall thickness δ 1 of 1 mm at a near end , that is , close to the hard palate connecting end 1 ; and the support 2 has a thickness δ 2 of 0 . 2 mm at a distal end . the support 2 has a length l 2 of 30 mm . a frontmost supporting plate 21 is the longest , a rearmost supporting plate 21 is the shortest , the lengths of the supporting plates 21 gradually decrease from front to back , and the layers of the supporting plates 21 have lengths satisfying p 1 & gt ; p 2 & gt ; p 3 & gt ; p 4 & gt ; p 5 , and are arranged in a descending order of length and sequentially stacked to form the layered soft palate support 2 . the geometrical shape and dimension of the layered soft palate support 3 of the present invention vary with different specific conditions of patients . see fig1 - 1 and fig1 - 4 . generally , the hard palate connecting end 1 has a length l 1 of 5 to 30 mm , and the support 2 has a length l 2 of 15 mm to 60 mm ; a lifting angle β of the support 2 , that is , an angle between a plane of the hard palate and a most distal end of the support 2 , is 30 ° to 80 °; a bending radius r 1 of the near end of the support 2 , that is , close to the hard palate connecting end 1 , is 10 mm to 100 mm ; a bending radius r 2 of the distal end of the support 2 , that is , away from the hard palate connecting end 1 , is 20 mm to 120 mm ; a sweepback angle γ of a warped end 211 at the distal end of the support 2 , that is , an angle γ between a plane of the supporting plate 21 at the distal end of the support 2 and a plane of the warped end 211 , is 0 ° to 75 °, and preferably 20 ° to 50 °; the near end of the support 2 has a thickness δ 1 of 0 . 5 mm to 1 . 8 mm , and the distal end has a thickness δ 2 of 0 . 1 mm to 0 . 8 mm . the supporting plate 21 is a thin - walled plate made of a medical - purpose elastic material and having a curvature matching the shape of the soft palate , and the thin - walled plate has a thickness of 0 . 01 mm to 1 . 5 mm , and preferably 0 . 01 mm to 0 . 8 mm . the medical - purpose elastic material of the supporting plate 21 is selected from a group consisting of amorphous alloy also referred to as metallic glass , titanium - zirconium - niobium alloy , titanium - nickel shape memory alloy , titanium and titanium alloy , medical grade stainless steel , medical grade elastic non - metallic materials , and other medical materials . the most commonly used material is titanium - nickel shape memory alloy or amorphous alloy also referred to as metallic glass . the two materials both have excellent elasticity and excellent fatigue resistance , and metallic glass has superior fatigue resistance . the used amorphous alloy is mainly selected from a group consisting of ti - based amorphous metal materials , zr - based amorphous metal materials , nb - based amorphous metal materials , fe - based amorphous metal materials and the like . the ti - based amorphous metal material is a more preferable material for the soft palate support 2 , and its fatigue life is greater than 1 × 10 8 cycles . in addition , the supporting plate 21 is configured with through holes 22 . the through holes 22 can facilitate growth and coverage of tissues , to effectively fix the supporting plate 21 into the muscular layer of the soft palate . see fig1 - 1 . generally , the hard palate connecting end 1 may be configured with a fixing rivet 26 for riveting the supporting plates 21 , so as to facilitate clinical mounting and fixing . see fig9 and fig9 - 1 . in clinical use , a small incision is made at a junction of the soft palate 7 and the hard palate 6 , and the support 2 is inserted into a muscular layer at a middle portion of the soft palate 7 ; and a medical bone nail 5 is passed through a through hole 111 on the hard palate connecting end 1 to fix the hard palate connecting end 1 to the hard palate 6 . during clinical implantation , the support 2 is inserted into the soft palate by a length equal to ⅕ to ⅘ , and most preferably , ⅔ to ¾ , of a total length of the soft palate . since the layered structure of supporting plates that is formed by stacking thin - walled plates is used as the support 2 , not only the adaptability of the support is improved but also the fatigue fracture resistance of the support is significantly improved while ensuring the supporting force , and the fatigue life is greater than 1 × 10 8 cycles . provided that the same material and process are adopted , the smaller the thickness of the supporting plates 21 forming the support 2 is , the longer the fatigue life is . a layered soft palate support in an ascending configuration of the present invention referring to fig2 , this embodiment is different from the above embodiment in that the stacking manner of the supporting plates 21 forming the support 2 is changed , and the lengths of the supporting plates 21 gradually increases from front to back , that is , p 1 & lt ; p 2 & lt ; p 3 & lt ; p 4 & lt ; p 5 , form a configuration in an ascending order of length . another difference lies in that the supporting plates 21 have the same thickness . in addition , the supporting plates 21 forming the support 2 may be stacked in various manners . fig3 shows a layered soft palate support in a symmetric configuration . in this embodiment , the length of the p 1 layer is equal to the length of the p 5 layer , the length of the p 2 layer is equal to the length of the p 4 layer , the p 3 layer is the longest , and a symmetric configuration centered about the p 3 layer is formed . fig4 shows a layered soft palate support in a sandwiched descending configuration . in this embodiment , the length of the p 1 layer is equal to the length of the p 5 layer , the intermediate three layers have lengths satisfying p 2 & gt ; p 3 & gt ; p 4 , and a descending configuration is formed . fig5 shows a layered soft palate support in a sandwiched symmetric configuration . in this embodiment , the length of the p 1 layer is equal to the length of the p 5 layer , the intermediate three layers , the length of the p 2 layer is equal to the length of the p 4 layer , and a symmetric configuration centered about the p 3 layer is formed . fig6 shows a layered soft palate support in a sandwiched ascending configuration . in this embodiment , the length of the p 1 layer is equal to the length of the p 5 layer , the intermediate three layers have lengths satisfying p 2 & lt ; p 3 & lt ; p 4 , and an ascending configuration is formed . among the numerous configurations , the soft palate supports of the descending configuration and the sandwiched symmetric configuration are preferred . in addition , in these embodiments , five equal - length layers are adopted , which is for ease of description . for actual product manufacturing , the layered structure forming the support 2 may also be one equal - length layer , two equal - length layers , three equal - length layers , four equal - length layers , or the like . each of the equal - length layers may be formed by stacking one or more thin - walled supporting plates 21 . fig7 shows a layered soft palate support with one equal - length layer of the present invention . in this embodiment , five thin - walled supporting plates 21 of the same length are stacked to form the support 2 , where each of the thin - walled supporting plates 21 has a thickness of about 0 . 12 mm . fig8 shows a layered soft palate support with two equal - length layers of the present invention . in this embodiment , the p 1 layer is formed by three thin - walled supporting plates 21 of the same length , the p 2 layer is formed by four thin - walled supporting plates 21 of the same length , and the p 1 layer and the p 2 layer are stacked to form the support 2 , where each of the thin - walled supporting plates 21 has a thickness of about 0 . 08 mm . a u - shaped layered soft palate support in a sandwiched descending configuration of the present invention referring to fig9 and fig9 - 1 , in this embodiment , the frontmost supporting plate 21 of the p 1 layer and the rearmost supporting plate 21 of the p 5 layer are formed by bending a single thin - walled metal plate into a u - shape , the supporting plates 21 of the intermediate p 2 , p 3 and p 4 layers are sequentially arranged in a descending order of length . the advantage of such a design lies in that swinging of the supporting plate 21 is limited between the frontmost p 1 layer and the rearmost p 5 layer , so that the supporting force of the support 2 can be increased without compromising the adaptability . a layered soft palate support with a blunt edge being a coil spring of the present invention referring to fig1 , in this embodiment , the support 2 includes a blunt edge 23 . the blunt edge 23 is a single wire - wound coil spring . the coil spring passes through the through holes 22 at an edge of the supporting plate 21 , to connect the supporting plates 21 of the layers , which on one hand prevents excessive separation of the supporting plates 21 of the layers during swinging of the support 2 , and on the other hand provides a function of blunting the edge of the support 2 , thereby facilitating fixation and growth of tissues . the blunt edge 23 being the coil spring is movably wound in the through holes 22 at the edge of the supporting plate 21 , so that a gap between the supporting plates 21 of the layers is maintained in a reasonable range , where the gap is generally smaller than 0 . 6 mm . the coil spring may be wound in different manners . fig1 shows a segmented winding manner , where multiple segments of metal wires are used to connect the supporting plates 21 of the layers at different positions . when the blunt edge 23 adopts the coil spring structure , the blunt edge 23 of the coil spring structure may be made of a medical grade metal wire selected from a group consisting of medical grade stainless steel wires , medical titanium metal wires , medical grade titanium - nickel shape memory alloy , medical grade amorphous alloy wires and wires of other metal materials , or may be made of various high - strength medical polymer material threads or films . a layered soft palate support with a blunt edge being flanges of a concave - convex position - limiting engagement structure referring to fig1 to fig1 - 6 , in this embodiment , the blunt edge 23 on the support 2 is tiny flanges 232 of a concave - convex position - limiting engagement structure . the tiny flanges 232 of a concave - convex position - limiting engagement structure are discontinuously distributed , and fixed to the edge of the support 2 to connect the supporting plates 21 of the layers . a layered soft palate support including a position - limiting mechanism of the present invention referring to fig1 to fig1 - 2 , in this embodiment , the support 2 includes a position - limiting mechanism 24 . the provision of the position - limiting mechanism 24 is to prevent excessive separation of the supporting plates 21 of the layers during swinging of the support 2 , that is , to control the gap between the supporting plates 21 of the layers . the simplest and most effective method is adopting a rivet - type limiting structure , that is , fixing the supporting plates 21 of the layers by using a rivet . see fig1 - 1 . the objective of controlling the gap between the supporting plates 21 of the layers may also be achieved through a concave - convex position - limiting engagement structure . a protruding lock screw 242 is embedded in a recessed lock nut 241 to form a concave - convex engagement limiting mechanism 24 , which can control the gap between the supporting plates 21 of the layers . see fig1 - 2 . a layered soft palate support including a u - shaped slot type limiting structure of the present invention referring to fig1 to fig1 - 4 , in this embodiment , the support 2 is configured with a position - limiting mechanism 24 . the limiting mechanism 24 is formed by a limiting groove 244 and a limiting plate 243 . the limiting plate 243 is part of an edge of one of the supporting plates 21 , and is bent to form a rectangular or u - shaped slot opening serving as the limiting groove 244 . a removable layered soft palate support including an adjustment washer of the present invention referring to fig1 to fig1 - 1 , this embodiment shows a removable layered soft palate support including an adjustment washer of the present invention . the hard palate connecting end 1 is removably assembled to the support 2 . by removing the bone nail 5 , the support 2 can be detached from the hard palate connecting end 1 ; and by tightening the bone nail 5 , the support 2 can be fixed to the hard palate connecting end 1 , and then fixed to the hard palate 6 together with the hard palate connecting end 1 . in this embodiment , an adjustment washer 252 is further configured . by appropriately loosening the bone nail 5 at the distal end , the height of the adjustment washer 252 is increased , the lifting angle β of the support 2 is increased , and the lifting degree of the soft palate 7 is increased ; by appropriately tightening the bone nail 5 at the distal end , the height of the adjustment washer 252 is reduced , the lifting angle β of the support 2 is reduced , and the lifting degree of the soft palate 7 is reduced . in this way , the lifting degree of the soft palate 7 by the support 2 can be adjusted within a certain range , thereby facilitating clinical mounting . a removable layered soft palate support including a wedge - shaped adjustment mechanism of the present invention referring to fig1 to fig1 - 1 , this embodiment shows a removable layered soft palate support including a wedge - shaped adjustment mechanism of the present invention . the hard palate connecting end 1 is removably assembled to the support 2 . by removing the bone nail 5 , the support 2 can be detached from the hard palate connecting end 1 ; and by tightening the bone nail 5 , the support 2 can be fixed to the hard palate connecting end 1 , and then fixed to the hard palate 6 together with the hard palate connecting end 1 . in this embodiment , a wedge - shaped adjustment mechanism 251 is further configured . by appropriately loosening the bone nail 5 at the distal end , the wedge - shaped adjustment mechanism 251 is pushed toward the near end , the lifting angle β of the support 2 is increased , and the lifting degree of the soft palate 7 is increased ; by appropriately tightening the bone nail 5 at the distal end , the wedge - shaped adjustment mechanism 251 is pushed toward the distal end , the lifting angle β of the support 2 is reduced , and the lifting degree of the soft palate 7 is reduced . in this way , the lifting degree of the soft palate 7 by the support 2 can be adjusted within a certain range , thereby facilitating clinical mounting . in addition , the adjustment mechanism 25 may be designed in various ways , and is merely described by way of example herein . a removable layered soft palate support including a wedge - shaped adjustment mechanism of the present invention referring to fig1 to fig1 - 3 , this embodiment shows a soft palate support of the present invention capable of being implanted in stages . the hard palate connecting end 1 may be fixed to the hard palate 6 through a bone nail 5 , and the support 2 is removably assembled to the hard palate connecting end 1 through a screw 8 . in a clinical surgery , the support may be implanted in two stages . first stage surgery : under local anesthesia or general anesthesia , first a small incision is made at a proper portion of the hard palate 6 , and then the hard palate connecting end 1 of the layered soft palate support is implanted , the bone nail 5 is passed through the through hole 111 on the hard palate connecting end 1 to fix the hard palate connecting end 1 to the hard palate 6 , and the incision is sutured . see fig1 - 2 . second stage surgery : one month to three months later after the first stage surgery is finished , the hard palate connecting end 1 has been firmly fixed to the hard palate 6 . at this time , a second stage surgery is performed . under local anesthesia or general anesthesia , a small incision is made at the junction of the soft palate 7 and the hard palate 6 , and then one end of the support 2 is inserted into the muscular layer at the middle portion of the soft palate 7 , where the support 2 is inserted into the soft palate by a length equal to ⅕ to ⅘ of the total length of the soft palate ; and then , the other end of the support 2 is fixed to the hard palate connecting end 1 by using the screw 8 , and the incision is sutured . see fig1 - 3 . it should be noted that , the structures disclosed and described in the present invention may be replaced by other structure with the same effect , and the embodiments described in the present invention are not intended to limit the present invention . though the preferred embodiments of the present invention have been introduced and described in the specification , persons skilled in the art should know that these embodiments are merely described by way of example , and persons skilled in the art may make various changes , improvements , and replacements without departing from the present invention . therefore , the protection scope of the present invention should be defined in accordance with the spirit and scope of the appended claims of the present invention .

the present invention relates to a layered soft palate support and an implantation method for treating sleep apnea / hypopnea syndrome or snoring . the layered soft palate support is a layered structure formed by two or more supporting plates . the layered soft palate support has a hard palate connecting end and a soft palate insertion end , where the soft palate insertion end is configured for insertion into a soft palate , and the hard palate connecting end is configured to be fixed to a hard palate . at least two of the two or more supporting plates have distinct lengths with respect to a longitudinal axis .

the various embodiments will be described in detail with reference to the accompanying drawings . wherever possible , the same reference numbers will be used throughout the drawings to refer to the same or like parts . as used herein , the terms “ about ” or “ approximately ” for any numerical values or ranges indicates a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein . also , as used herein , the terms “ patient ”, “ host ” and “ subject ” refer to any human or animal subject and are not intended to limit the systems or methods to human use , although use of the subject invention in a human patient represents a preferred embodiment . phased array ultrasound imaging catheters are used for performing intracardiac echocardiography . examples of phased array ultrasound imaging catheters and methods of using such devices in cardiac diagnosis are disclosed in u . s . patent application publication nos . 2004 / 0127798 to dala - krishna , et al ., 2005 / 0228290 to borovsky , et al ., and 2005 / 0245822 to dala - krishna , et al ., each of which is incorporated herein by reference in their entirety . referring to fig1 , an intracardiac echo catheter 10 with a phased array ultrasound transducer positioned near its tip 14 is advanced under fluoroscopic control into the right ventricle 2 of the heart 1 . this is illustrated as step 100 in the flowchart of fig1 . as illustrated in fig1 , the transducer can positioned in the right ventricular 2 inflow tract in mid cavity in order to obtain a long axis view 15 of the left ventricle 3 ( step 105 in fig1 ). this allows imaging and evaluation of the left ventricular free wall 5 apex 8 , base 8 and the septum 6 . procedures for positioning the phased array ultrasound transducer within the heart for imaging the left and right ventricles are described in u . s . patent application ser . no . ______ , entitled “ method for evaluating regional ventricular function and incoordinate ventricular contraction ” filed contemporaneous herewith and which is hereby incorporated by reference in its entirety . positioning of the intracardiac echo catheter 13 within the right ventricle may be accomplished before or after an implantable cardiac resynchronization stimulator device has been positioned in the patient with stimulator electrodes attached to the left and right ventricle walls . typically , the intracardiac echo catheter 13 is used during the stimulator electrode attachment procedure since the imaging data can aid the practitioner in properly positioning the electrodes . with the catheter phased array transducer 14 properly positioned within the heart , an ultrasound system , such as the viewmate ® intracardiac ultrasound catheter system manufactured by ep medsystems , inc . of west berlin , n . j ., is connected to the catheter , an example of which is illustrated in fig2 and 3 . the ultrasound system generates the electrical pulses which cause the transducer elements to emit ultrasound pulses . the ultrasound system also receives and processes the resulting echoes detected by the transducers . an ultrasound system includes a data cable 50 connected between the catheter 13 and an electrical isolation box 51 . the data cable 50 may be connected to a handle ( not shown ) on the catheter 13 or may be an extension of the catheter itself . a data cable typically includes a number of coaxial cables , one for each phased array transducer element . the electrical isolation box 51 electrically isolates the catheter , thereby protecting the patient from stray currents that may be induced in the system or cabling 52 by radio frequency emissions and from fault currents that may result from an electrical short within the system equipment . an example of a suitable electrical isolation box 51 is described in u . s . patent application ser . no . 10 / 997 , 898 , published as u . s . publication no . 2005 - 0124898 to borovsky et al ., and ser . no . 10 / 998 , 039 , published as u . s . publication no . 2005 - 0124899 to byrd et al ., the entire contents of both of which are incorporated herein by reference in their entirety . connected to the electrical isolation box 51 , maybe another data cable 52 which conducts electrical information to a system processor 53 . coupled to the system processor 53 will typically be a monitor 54 for presenting a display 55 of the ultrasound data , and a keyboard 56 and pointing device 57 and / or other human interface device for accepting user commands and data inputs . when the catheter is positioned within a patient &# 39 ; s heart , the ultrasound system generates electrical pulses which cause the ultrasound transducers in the phased array transducer 14 to emit ultrasound pulses . by a controlling the phase lag of the pulses emitted by each transducer element within the phased array , a combined sound wave is generated with a preferential direction of propagation . echoes from structures within the heart are received by the transducer elements and transformed into electrical pulses by the transducer . the electrical pulses are carried via the cables 50 , 52 to the processor 53 . the processor 53 analyzes the electrical pulses to calculate the distance and direction from which echoes were received based upon the time of arrival of the echoes received on each transducer element . in this manner , ultrasound energy can be directed in particular directions , such as scanned through a field of regard 15 , and the resulting echoes interpreted to determine the direction and distance from the phased array that each echo represents . scanning the ultrasound energy through a field of regard 15 generates a two - dimensional ( 2d ) image of the heart , examples of which are shown in fig4 and 5 . after a 2d scan is obtained , the catheter phased array transducer is rotated and another 2d image obtained , so that most of the endocardial surface of the ventricle ( left or right ) can be imaged . the b - mode ultrasound imaging technique is employed in this process . b - mode ultrasound imaging displays an image representative of the relative echo strength received at the transducer . a 2 - d image can be formed by processing and displaying the pulse - echo data acquired for each individual scan line across the angle of regard 15 of the phased array transducer . this process yields a two - dimensional b - mode image of the endocardial surface of the ventricle , examples of which is illustrated in fig4 and 5 . such images are obtained and recorded during approximately 10 or more cardiac cycles . since the scan rate of a phased array ultrasound transducer is much faster than the cardiac cycle , each scan presents a 2 - d image at a particular time or phase in the cycle . thus , individual scans , or a plurality of scans obtained at a particular phase or relative time within the cardiac cycle over a number of beats combined into an average image , can be used to provide a “ freeze frame ” image of the heart at particular instants within the cardiac cycle . methods for combining and averaging multiple scans at a particular phase or relative time within the cardiac cycle ( time gating ) are described in u . s . application ser . no . 11 / 002 , 661 published as u . s . patent publication no . 2005 / 0080336 to byrd , et al ., the entire contents of which are incorporated herein by reference in their entirety . the freeze frame capability of b - mode images is used to obtain recordings particularly at the onset of qrs complex , which is near the end of diastole , and at the beginning of the t wave which is near the end of systole . fig4 illustrates b - mode image of the left ventricle at diastole , and fig5 illustrates a b - mode image of the left ventricle at systole . sensing the qrs complex and t wave measurements obtained by electrocardiogram ( ecg ) sensors provides a signal that can be used to select a particular single image , or collect a number of images for averaging at the points of diastole and systole . the ecg sensors may be placed intracardiac via an electrode catheter or on the chest . automated edge - seeking algorithms or manual delineation of the endocardial signals is performed on the obtained images throughout the entire ventricle . edge - seeking algorithms locate the edges of structure ( e . g ., ventricle walls ) by noting a steep change in brightness ( indicating echo intensity ) from pixel to pixel . alternatively , the cardiologist may define the edge of the endocardial surface 5 ′, 7 ′ in the image by manually tracing the edge using an interactive cursor ( such as a trackball , light pen , mouse , or the like ) as may be provided by the ultrasound imaging system . by identifying the edges of structure within an ultrasound image , an accurate outline of ventricle walls can be obtained and other image data ignored . the result of this analysis is a set of images and dimensional measurements defining the position of the ventricle walls at the particular instants within the cardiac cycle at which the “ freeze frame ” images were obtained . the dimensional measurements defining the interior surface 5 ′ or 7 ′ of the endocardium can be stored in memory of the ultrasound system and analyzed using geometric algorithms to determine the volume of the ventricle . edge detection algorithms applied in the ultrasound system to the ultrasound echo image data to identify the endocardial surface of the left ventricular wall 5 can generate an image of the ventricle structures such as illustrated in fig4 and 5 . by identifying the ventricular wall 5 structure , the system is able to detect and measure wall motion ( step 110 in fig1 ). a b - mode image , illustrated in fig4 , of the left ventricle from the phased array ultrasound transducer is used to measure global ejection fraction of the heart ( step 115 ) using methods such as described herein and in co - pending u . s . patent application ser . no . ______ already incorporated by reference . an m - mode image of the left ventricle from the phased array ultrasound transducer is used to measure the length and area of the left ventricle . then these measurement results are used to estimate the left ventricular ejection fraction ( step 120 ) using the following estimation methods . for the left ventricle 3 , an image of most of if not the entire endocardium can be obtained , preferably from the base of the aortic valve to the left ventricular apex and across back to the base of the aortic valve . an illustration of such an ultrasound image at diastole is provided in fig4 . the aortic valve plane is imaged and defined using edge - seeking algorithms to complete the delineation of the cavity enclosing the blood flow . in particular , these images are obtained for the end - diastolic and end - systolic portions of the cardiac cycle , fig4 , 5 , thereby measuring the dimensions and contours of the ventricle walls at the instances of maximum ( fig4 ) and minimum volume ( fig5 ). having obtained dimensional measurements of the left ventricle 3 from the ultrasound images at or near diastole and systole , the ultrasound system processor can calculate the volume in the ventricle at both instances and , from the ratio of these two volumes , calculate the ejection ratio of the left ventricle 3 . while fig4 and 5 and the foregoing description address the left ventricle 3 , similar images are obtained for the right ventricle 2 , except that the image extends from the base of the tricuspid value 9 to the right ventricular apex 93 and across back to the base of the tricuspid value 9 . from the images of the right ventricle 2 , similar calculations of ventricle volume are obtained at points in the cardiac cycle of maximum and minimum volume to calculate the ejection fraction of the right ventricle 2 . ventricle ejection fraction can be estimated based on linear dimensional measurements of the ventricle without calculating the volume of the ventricle . in this embodiment , the long axis 80 of the left ventricle 3 is defined from the mid point 81 of the aortic valve plane 82 to the left ventricular apex 83 , as illustrated in fig6 . similarly , the long axis 90 of the right ventricle 2 is defined from the mid plane 91 of the tricuspid of the pulmonic valve plane 92 to the right ventricular apex 93 . the long axis 80 , 90 from the midpoint of the valvular plane to the apex is then subtended and bisected . the perpendicular axis 84 , 94 at the midpoint 85 , 95 of the long axis 80 , 90 is used for subtending the short axis at a perpendicular . additional radians 86 , 96 are then subtended at an acute angle , such as 30 or 45 degree angles , from the central point 85 , 95 of the ventricle as defined by the intersection of the two axes . these radial axes are superimposed along with the short and long axes on the end - systolic and end - diastolic frames of the ventricle b - mode image , as illustrated in fig8 for the left ventricle . the area in each segment as defined by the radial axes is then planimetered and automatically computed . the area in each sector of the ventricle or the fractional shortening along the radian in the sector can be used as a measure of regional ventricular function and ejection fraction . the difference in area between the measured area in the end - diastolic image and the measured area in the end - systolic image characterizes the regional ejection fraction for the region of the heart subtended by each such pair of corresponding sectors . this change in area of a region may be used to estimate the regional ejection fraction for the measured segment . this estimate is based upon the assumption that the length of the long axis 80 , 90 does not change significantly during contraction , so that the change in volume is proportional to the change in area of a transverse cross section . in this manner , the regional ejection fraction for each of the segments can be easily calculated by the ultrasound system processor to provide ejection fractions for multiple regions of the ventricle . the definition of axes and radians is further illustrated in fig8 which shows a stylized ventricle which may be either the left ventricle 3 or right ventricle 2 . referring to fig8 , an embodiment method defines a long axis 90 to extend from the midplane of the tricuspid 9 of the pulmonic valve plane to the right ventricular apex 93 . for the left ventricular cavity 3 , the method defines the long axis 80 to extend from the mid point 91 of the aortic valve plane 91 to the left ventricular apex 83 . the long axis 80 , 90 from the midpoint 81 , 91 of the valvular plane 82 , 92 to the apex 83 , 93 contains a midpoint 85 , 95 , which bisects the long axis 80 , 90 . a transverse line or plane 84 , 94 is defined at the midpoint perpendicular to the long axis 80 , 90 . radials 86 , 96 are then defined in the plane of the cross - sectional image at an acute angle to the transverse axis 84 , 94 and crossing the midpoint 81 , 91 . the ultrasound system processor may construct further radials 87 extending from the midpoint 85 , 95 of the long axis 80 , 90 at a plurality of angles ( e . g ., multiples of 30 or 45 degrees ) with respect to the long axis 80 , 90 . each radial 87 terminates where it intersects the endocardial wall 5 ′ or 7 ′ in the ultrasound image . each half of the long axis 80 , 90 also forms a radial . the embodiment method may approximate the area of each sector or region in an image of the ventricular cavity 2 or 3 being examined as the sum of the areas of multiple , small , disjoint , abutting triangles which effectively subdivide and cover the sector or region . for example , each triangle may have the long axis bisection point 85 , 95 as one vertex , and two sides defined by radials 87 from the bisecting midpoint 85 , 95 terminating at the edge of the endocardial wall 5 ′ or 7 ′. as an alternative or addition to the area method of estimating ejection fraction , the change in length of each of the radials 84 , 86 , 87 can provide information characterizing the instantaneous ejection fraction by monitoring the endocardial wall motion in the direction along each radial . these radials 84 , 86 , 87 relate to specific anatomic regions of the imaged heart ventricle . the values and relative timing of the regional ejection fractions , which correspond to the various radials 84 , 86 , 87 , can be used to assess the effect of alternative interventions as described herein . calculation of regional ejection fractions can also be accomplished at various predefined points in the systolic cycle , such as , for example , at or near early (˜ 33 %), mid (˜ 50 %), late (˜ 67 %) and end (˜ 100 %) points of the systolic period of ventricular contraction . this can be accomplished by subtracting the area of each segment at the predefined point in the cycle from the area of the segment measured at diastole . overall global ejection fraction can be estimated by summing all of the regional ejection fractions obtained according to the above methods . the global ejection fraction can be measured at different predefined points in the systolic cycle , such as at or near early (˜ 33 %), mid (˜ 50 %), late (˜ 67 %) and end (˜ 100 %) points of the systolic period of ventricular contraction . this calculation permits evaluation of ventricular ejection fraction at different points in the cardiac cycle . by calculating the ventricular ejection fraction at different points in the cardiac cycle , detection and evaluation of ventricular dysynchronous contraction is possible . the foregoing measurements and estimations of regional and global ventricle ejection fraction can be performed in sinus rhythm or atrial fibrillation prior to applying resynchronization stimulation in order to document the baseline state of an individual patient . once a baseline state of the patient &# 39 ; s heart function has been obtained according to the methods described above , the practitioner can use spectral doppler ultrasound to measure the aortic flow velocity , the time duration of the aortic ejection , and its maximum velocity ( step 125 ). methods for measuring aortic flow velocity , the time duration of the aortic ejection and maximum velocity are obtained by measuring the doppler shift of the ultrasound echoes as is well known in the cardiac ultrasound imaging practice . other measurements , such as an estimate of the volume of blood ejected , can be used instead of or in addition to these measurements . spectral doppler ultrasound measurements are also obtained in sinus rhythm or atrial fibrillation prior to applying resynchronization stimulation in order to document the baseline state in an individual patient . b - mode and m - mode measurements of left ventricular ejection fraction , maximum aortic flow velocity , overall aortic flow with an area computation and an aortic ejection time provide the practitioner with information useful for setting the current timing configuration of the patient &# 39 ; s cardiac resynchronization stimulator device . the resynchronization stimulator device configuration parameters include at least the atrioventricular interval and the interventricular delay timing . using the atrioventricular interval and the interventricular delay timing settings obtained from the patient &# 39 ; s baseline measurements , the practitioner initially programs the implantable resynchronization stimulator device and initiates stimulator operation . with stimulator operation initiated , the above measurement steps , beginning with the application of the endocardial surface edge detection , are repeated . the measurement steps provide measurements of ventricle dimensions which are used to estimate ventricle ejection fraction which is indicative of the heart &# 39 ; s function with the initial resynchronization stimulator device settings . in particular , measurements and estimations indicative of the heart &# 39 ; s function include one or more of the left ventricular ejection fraction , maximum aortic flow velocity , overall aortic flow with an area computation and an aortic ejection time . the practitioner then adjusts the programmed atrioventricular interval parameter values to a new setting or settings ( step 135 ) and the measurements are repeated . the measurement steps provide measurements of the heart &# 39 ; s left ventricular ejection fraction , maximum aortic flow velocity , overall aortic flow with an area computation and an aortic ejection time with the new resynchronization stimulator device settings . when each set of measurements is obtained , the practitioner again adjusts the programmed atrioventricular interval parameter values to new settings ( repeating step 135 ) and repeats the measurement steps to obtain ventricular ejection fraction , maximum aortic flow velocity , overall aortic flow with an area computation and aortic ejection time values . by incrementally adjusting settings and repeating this process , the measures of ventricle function can be acquired at across a range of atrioventricular interval parameter settings . in performing this sequence , the practitioner adjust the atrioventricular intervals in increments of between about 5 and about 10 milliseconds to cover the range of settings . the range of atrioventricular interval settings may be between about 100 milliseconds and about 250 milliseconds . as the above steps are repeated , but before a new atrioventricular interval parameter is set , the system or practitioner notes which device configuration produces the maximum aortic flow and the best left ventricular ejection fraction so far ( step 130 ), as well as noting the measurements produced thereby . when the optimal heart efficiency measurements over the full range of atrioventricular intervals have been obtained , or when it is clear that no better measurements will been obtained , the adjust - measure - repeat cycle is ended ( step 140 ), and the atrioventricular interval which produced the optimal measurements ( the optimal atrioventricular interval ) is stored in memory along with the final optimal left ventricular ejection fraction , maximum aortic flow velocity , overall aortic flow with an area computation and an aortic ejection time measurements ( memorized by step 130 ). after determining the optimal atrioventricular interval , interventricular conduction delay is then optimized as follows . with the atrioventricular interval setting of the implantable cardiac resynchronization stimulator device fixed at the optimal atrioventricular interval , the flow and ejection fraction measurements described above are repeated with the stimulator device settings adjusted for each set of measurements to an interventricular delay in a sequence of interventricular delays ranging preferably from about 0 to about 120 milliseconds in increments of about 5 to about 10 milliseconds ( step 175 ). additionally , measurements are taken with the interventricular delay set so the left ventricle precedes the right ventricle and / or so the right ventricle precedes the left ventricle . at each delay value in the range , the specific delay is associated with the flow and ejection measurement values , such as noted by the practitioner or stored in memory as a linked data set . as the flow and ejection measurements are taken at each interval setting of the interventricular delay ( note that steps 150 through 165 repeat the measurements taken in steps 110 through 125 ), the optimal flow and ejection measurements so far and the associated delay parameter are retained ( step 170 ). when the measurements over the full range of intervals have been obtained , or when it is clear that no better measurements will be obtained , the adjust - measure - repeat cycle is ended ( step 180 ) and the interventricular delay which produced the optimal measurements ( the optimal interventricular delay ) is retained along with the final optimal measurements ( as memorized in step 170 ). the final retained atrioventricular and interventricular delay parameters are set in the resynchronization stimulator device , and a set of measurements are conducted to determine the percent increase in aortic flow and the percent improvement in the left ventricular ejection fraction achieved compared to the baseline measurements ( step 190 ). finally , b - mode ultrasound images are analyzed for evidence of actual resynchronization of the left and right ventricles under stimulation by the device ( step 195 ). this resynchronization is measured by comparing the timing delay of movements within the septum on the posterior wall . in pilot studies , improvement in left ventricle ejection fraction of greater than 10 % was observed following use of this method , with virtually each patient showing improvement . such outcomes represent substantial improvement in therapeutic results over current experience where 30 - 40 % of patients fail to show improvement with cardiac resynchronization devices . it should be noted that there are other embodiments or improvements that would be obvious to those familiar with the field of this invention . for example , the order of the two parametric optimizations ( atrioventricular and interventricular parameters ) may be reversed . also , the optimizations can be iterated and interleaved , which will allow detecting interdependencies ( such as false maximums ) between atrioventricular and interventricular delay values and refining both atrioventricular and interventricular delay values together . also , steps of the method may be performed in a different order than illustrated in fig1 , such as reversing steps 120 and 125 . while the present invention has been disclosed with reference to certain preferred embodiments , numerous modifications , alterations , and changes to the described embodiments are possible without departing from the sphere and scope of the present invention , as defined in the appended claims . accordingly , it is intended that the present invention not be limited to the described embodiments , but that it have the full scope defined by the language of the following claims , and equivalents thereof .

a method for reversing ventricular dyssynchrony uses intracardiac echocardiographic measured parameters to systematically determine an optimal , individualized configuration for a cardiac resynchronization stimulator device . this method is particularly relevant for patients with congestive heart failure . the algorithm evaluates improvement in aortic flow and in left ventricular ejection fraction as atrioventricular and interventricular delay parameters of the patient &# 39 ; s resynchronization stimulator device are varied .

referring to fig1 there is shown a towing vessel 10 at the surface 11 of the ocean 12 towing a mid - water trawl 13 of the of the trawl system 9 of the invention . the trawl 13 is positioned between the surface 11 and the ocean bottom 14 . the trawl 13 can be connected to the towing vessel 10 in many different configurations and the one chosen includes a main towing line 18 connected through door 19 , towing bridles 20 and mini bridles 21 , 22 . a series of weights 23 is attached to minibridle 22 . likewise , the shape and pattern of the trawl 13 can vary as is well known in the art . as shown , the trawl 13 shown includes wings 25 for better herding open at mouth 26 . the wings 25 are seen to define a mesh size that is larger than that used to form mid - portion jacket 27 , intermediate portion jacket 28 or codend 29 . [ 0108 ] fig2 illustrates the trawl 13 of fig1 in more detail . as shown , the wing 25 includes a series of mesh cells 30 of rectangular cross section that is part of a panel 31 offset from axis of symmetry 32 of the trawl 13 . the trawl 13 includes meshes 33 of a selected size determined by the length between adjacent knots or equivalent couplers 34 . the mesh cells 30 are of a general rectangular cross section that is repeated through the longitudinal and lateral scope of the trawl 13 . as shown in fig3 the mesh cells 30 each have a longitudinal axis of symmetry 30 a parallel to the axis of symmetry 32 of the trawl 13 and are formed of a series of threads 35 comprising first and second product strands 36 , 37 . as explained in more detail below , the product strands 36 , 37 of each mesh cell 30 are twisted about a common axis of symmetry 38 either in one of two lay directions : clockwise or counterclockwise as viewed axially along longitudinal axis of symmetry 38 and in a receding direction established at the mouth 26 of the trawl 13 ( fig1 ). [ 0111 ] fig4 , 6 and 8 shows how a given segment of thread 35 is formed . as show , a single strand 40 that is the product of a conventional manufacturing process as well as has termini 41 , is formed in a loop 42 after which the termini 41 are permanently attached together to form a spliced region 42 a . thereafter , ends 43 of the loop 42 are attached between a fixed post 45 and a reel 46 located on a table 44 . the reel 46 has a handle 47 capable of providing rotation to a spindle 48 attached to one end 43 of the loop 42 . result : when the handle 47 is rotated in a counterclockwise direction as indicated by arrow 49 a , the loop 42 becomes twisted to form a counterclockwise lay segment 50 of thread 35 , wherein segment 50 has a length l 1 measured between the ends 43 and is composed of the first and second strands 36 , 37 previously mentioned wound in a counterclockwise lay direction ( fig8 ). thereafter , the method is repeated except that the handle 47 is rotated in a clockwise direction ( fig7 ) wherein a new segment 51 ( fig9 ) is provided having a length l 1 measured between ends 52 , 53 and of course is composed of the strands 36 ′, 37 ′ twisted in a clockwise direction , i . e . in a direction opposite to that of the segment 50 composed of strands 36 , 37 . note that the pitch po of the segments 50 and 51 are the same and is in a range of 3 d to 70 d where d is the diameter of the strands 36 , 37 , 36 ′, 37 ′. note that the methods depicted in fig5 - 9 produces segments 50 , 51 . each segment 50 or 51 , after twisting has occurred , has turns which contain residual torque . such torque can be balanced by conventional thermal setting techniques , however . but a better method has been discovered in which the large loops 42 ( as depicted in fig5 - 9 ) are eliminated prior to the twisting process to permit the formation of torque - free segments . as shown in fig9 a , two ( say first and second ) strands 40 ′ are placed side - by - side of each other across a long table 44 ′. each of strands 40 ′ have separate near and far termini 41 ′ and 41 ″. each near and far termini 41 ′, 41 ″ comprises first and second terminus positioned side - by - side , i . e ., so they are parallel to each other . then the parallel positioned near termini 41 ′ at the near ends of the first and the second strands 40 ′ and 40 ″ are formed into mini loops 56 . these mini loops 56 attach to the respective opposed t - arms 48 a of the spindle 48 as shown in fig9 b . the opposed parallel far termini 41 ″ of the same first and second strands 40 ′ and 40 ″ are each then attached to a series of in - line conventional barrel swivels 57 a ( such as used in removing torque in fishing lines and purchasable at any sporting goods store ) and thence through a second residual strand 57 b to a separate fixed post 45 ′ attached at the far end of the table 44 ′. then with rotation of the spindle 48 in a first direction , the first and second strands 40 ′ and 40 ″ twisted together , while the residual strands 57 b attached thereto , are not so wound because of the action of the barrel swivels 57 a . after the mini loops 56 at the near termini 41 ′ of the first and second strands 40 ′ and 40 ″ ( at the spindle 48 ) are removed from contact with the t - arms 48 a as are the far termini 41 ″ from the barrel swivels 57 followed by the formation of mini loops similar in shape to the mini loops 56 for the near temini 41 ′, the result is segment 59 a having a length l 1 and a pitch po in the range precisely (?) set forth above , as shown in fig9 c . that is , a segment 59 a twisted in a left - handed or counterclockwise lay direction is formed wherein the resulting turns have no or substantially minimum residual torque . hence thermal setting is unneeded . thereafter , the method is repeated but rotation of the spindle 48 being in an opposite direction as shown , producing segment 59 b of fig9 d having a length li and a pitch po where po has a range of values as previously set forth . further iteration of the method produces further pairs of segments 59 c and 59 d which can then be assembled together in a x - pattern as shown in fig9 e . [ 0117 ] fig9 e shows a x - pattern layout of pairs of segments 59 a - 59 d produced by the method of fig9 a and 9 b . as shown , a pair of left - handed or counterclockwise segments 59 a , 59 c ( each constructed as depicted in fig9 c and positioned parallel to each other ) is located in the aforementioned x - pattern along with a pair of right - handed or clockwise segments 59 b , 59 d ( each constructed as depicted in fig9 d and positioned parallel to each other ). the segments 59 a - 59 d are offset from a central axis 32 ′ associated with the axis of symmetry of the trawl to be manufactured and terminate in mini loops 56 . the result is the formation of a mesh cell 58 of a quadratic design in accordance with the invention which consists of four mesh bars or sides associated with sub - segments 59 a ′, 59 b ′, 59 c ′ and 59 d ′. note that the two mesh bars or sides of the cell 58 associated with sub - segments 59 b ′, 59 d ′ are of a right - handed or clockwise lay and positioned parallel to each other while the two mesh bars or sides of the cell 58 associated with sub - segments 59 a ′ and 59 c ′ are of a left - handed or counterclockwise lay and are positioned parallel to each other . assuring a normalizing receding direction in the manner of arrow a ′, note that the sub - segments 59 a ′ and 59 b ′ diverge from a common intersection point b ′ and leading and trailing edges are established for each of the sub - segments 59 a ′ and 59 b ′ wherein the leading edge for the sub - segment 59 a ′ when normalized to the receding direction arrow a ′ relative to the central axis 32 ′, reside at a right side of the sub - segment 59 a ′ as viewed in the receding direction arrow a ′ and wherein the leading edge of the subsegment 59 b ′ when normalized to the receding direction arrow a ′, reside along a left side of the sub - segment 59 b ′ as viewed in the receding direction as indicated by arrow a ′. similarly , for the sub - segments 59 c ′ and 59 d ′ converging toward common intersection point b ″, leading and trailing edges are established for each of the sub - segments 59 c ′ and 59 d ′ wherein the leading edge for the sub - segment 59 c ′ when normalized to the receding direction arrow a ′ relative to the central axis 32 ′, reside at a right side of the sub - segment 59 b ′ as viewed in the receding direction arrow a ′ and wherein the leading edge of the subsegment 59 d ′ when normalized to the receding direction arrow a ′, reside along a left side of the sub - segment 59 d ′ as viewed in the receding direction as indicated by arrow a ′. further characteristics of the mesh cell 58 is discussed by inference in fig1 , below . [ 0120 ] fig1 shows the layout of a series of the segments 50 , 51 to form the mesh cells 30 of the invention . as shown , the clockwise lay directed segment 51 and counterclockwise lay direction segment 50 are lain in a x - pattern relative to each other when viewed in plan so that their mid - points 55 are coincident with and make intersection with each other and with the axis of symmetry 30 a of the cell 30 to be formed . that is , the segment 50 is positioned such that its end 43 a is offset a distance d 1 above the axis of symmetry 30 a , while end 43 b is offset a distance d 1 below the axis of symmetry 30 a . and the segment 51 is positioned such that its end 52 is offset a distance d 1 below the axis of symmetry 30 a and its other end 53 is positioned above the axis of symmetry 30 a . thereafter , a second pair of segments 50 ′, 51 ′ are likewise lain in x - pattern relative to each other wherein their mid - points 55 ′ are coincident with and make intersection with each other and with the axis of symmetry 30 a . that is , the end 53 ′ of clockwise twisted segment 51 ′ overlays end 43 a of counterclockwise segment 50 and is thus , offset a distance d 1 above the axis of symmetry 30 a . similarly , end 52 ′ of the segment 51 ′ is offset a distance d 1 below the axis of symmetry 30 a . in similar fashion , end 43 b ′ of counterclockwise twisted segment 50 ′ overlays end 52 of clockwise twisted segment 51 , and thus , is offset a distance d 1 below the axis of symmetry 30 a . similarly , the end 43 a ′ of counterclockwise twisted segment 50 ′ is positioned a distance d 1 above the axis of symmetry 30 a . as a result , note that resulting mesh cell 30 is rectangularly shaped and begins with a counterclockwise twisted mesh bar 60 and clockwise twisted mesh bar 61 and ends with a clockwise twisted mesh bar 62 and counterclockwise twisted mesh bar 63 . note that additional mesh cells can be formed at the exterior of the mesh cell 30 in both longitudinal and transverse directions relative to the axis of symmetry 30 a by a continuation of the method of the invention . in more detail , counterclockwise mesh bar 60 starts at intersection 55 ′, diverges transversely outward relative to the axis of symmetry 30 a and terminates at the intersection of pair ends 43 b ′, 52 , a distance d 1 below the axis of symmetry 30 a . while , mating clockwise twisted mesh bar 61 starts at intersection 55 ′, diverges transversely outward relative to the axis of symmetry 30 a and terminates at the intersection of pair ends 43 a , 53 ′ a distance d 1 above the axis of symmetry 30 a . clockwise mesh bar 62 starts at the intersection of pair ends 43 b ′, 52 a distance d 1 below the axis of symmetry 30 a , diverges transversely inwardly relative to the axis of symmetry 30 a and terminates at the intersection 55 . while , mating counterclockwise twisted mesh bar 63 starts at the intersection of ends 43 a , 53 ′, diverges transversely inward relative to the axis of symmetry 30 a and terminates at the intersection 55 coincident with the axis of symmetry 30 a . thereafter , the mesh bars 60 , 61 , 62 , 63 can be permanently attached together at intersections 55 ′, 55 and at pair ends 43 a , 53 ′ and 43 b ′, 52 via couplers not shown that are conventional in the art , such as bindings , seams , braids , metallic bands or the like , or the ends 43 a , 53 ′ and 43 b ′, 52 may be joined to one another . note that for the mesh cell 30 , a longitudinal working plane p 1 is seen to bisect the mesh bars 60 - 63 and defines a rectangular ( including square ) cross section . note that half of the mesh cell 30 means one - half of the cell 30 as bisected by a transverse working plane p 2 normal to the longitudinal working plane p 1 , such working plane p 2 passing through centroid c , such centroid being positioned coincident with the axis of symmetry 30 a of the cell 30 . for the quadratic mesh cell 30 , as shown , the transverse working plane p 2 passes through paired ends 43 b ′, 52 and 53 ′, 43 a . such working plane p 2 forms the base from which each half of the mesh cell 30 extends . each of the halves of the mesh cell 30 are positioned back - to - back normalized to the transverse working plane p 2 . note that in viewing half of the mesh cell 30 , one half faces forward toward the front of the trawl 13 ( fig1 ) and such half includes the pair of mesh bars 60 , 61 that have been twisted in opposite directions when viewed axially and in a direction receding from intersection 55 ′. that is , the mesh bar 60 begins at intersection 55 ′ coincident with the axis of symmetry 30 a and is twisted in a counterclockwise direction ; and the mesh bar 61 also begins at intersection 55 ′ and is twisted in a clockwise direction . similarly , the remaining half of mesh cell 30 faces backward toward the aft of the trawl 13 ( fig1 ) and includes the pair of mesh bars 62 , 63 that have been twisted in opposite directions when viewed axially and in a direction receding from the intersection of paired ends 43 a , 53 ′ and 43 b ′, 52 and terminating at intersection 55 coincident with the axis of symmetry 30 a . that is , the mesh bar 62 begins at the ends 43 b ′, 52 coincident with the transverse working plane p 2 and is twisted in a clockwise direction ; and the mesh bar 63 begins at the ends 43 a , 53 ′ also coincident with the transverse working plane p 2 and is twisted in a counterclockwise direction . now having described the method of forming the mesh cell 30 and the nature of the twist directions of the mesh bars 60 - 63 , it is now believed to be important to show how the twist directions affect operations . in this regard , one - half mesh cell of the invention as depicted in fig1 has been tested in a flume tank by locating the mesh bars 60 , 61 between three posts positioned in 3 - spot triangular orientation . that is , one post was located slightly forward of the intersection 55 ′ and two remaining posts were positioned adjacent to the ends 53 ′, 43 a and 43 b ′, 52 . a 1 - kilogram weight was positioned at the intersection 55 ′ and its normalized positioned noted . the half of mesh cell 30 was then subjected to vertically distributed water flow at a velocity of 2 meters per second and pictures taken to show the change in position of the weight . the results of the test are shown below . [ 0135 ] fig1 shows the engineering reasons for providing lift in the operations of the mesh cell 30 of the invention . as shown , the mesh 30 is seen to be bisected by longitudinal working plane p 1 previously mentioned wherein the plane p 1 passes through the common longitudinal axis of symmetry 30 a of the mesh bars 60 , 61 , 62 and 63 . at the intersection of plane p 1 with the forward surface 69 of the mesh bar 60 note that water particles that have a relative velocity vector v in the direction of water flow arrow 71 . since the direction of twist of the mesh bar 60 is counterclockwise , likewise the direction of grooves 70 of mesh bar 60 at the upper surface 72 is parallel of the larger of the component of the relative velocity vector v . similarly the direction of twist of the grooves 73 of mesh bar 61 ( being clockwise ) is also parallel of the larger of the component of the relative velocity vector v as the grooves 73 initially make contact with water flow arrow 71 at surface 74 of the mesh bar 61 . note in this regard that angle alpha denotes angle of attack of the mesh cell 30 , i . e ., the vertical angle between the direction of water flow arrow 71 and the axis of symmetry 30 a of the mesh cell 30 , and the angle alpha zero measures the transverse angle between the mesh bar 60 and the direction of water flow arrow 71 . when angle alpha zero is between 10 to 70 degrees , the water particles splitting at the intersection of plane p 1 with the surfaces 69 , 74 of the mesh bars 60 , 61 for flow about the mesh bars 60 , 61 , have large components of force that maximize hydrodynamic forces acting normal to the longitudinal working plane p 1 . that is , due to position , orientation , and direction of grooves 70 , 73 relative to the direction of water flow force vector v , the moving water passing over and under the mesh bars 60 , 61 acquires both a forward and circular velocity wherein the direction of the circular velocity is dependent upon lay direction of twist of the mesh bars 60 , 61 and angle alpha zero , the angle of attack of the mesh bar 60 . moreover , with the twist lay direction of mesh bars 60 , 61 as shown , the magnitude of the circular velocity component that passes over the upper surfaces of the mesh bars 60 , 61 is larger than that which passes under the undersurfaces of such mesh bars . the result is akin to the production of lift above the wing of an airplane in which decreased pressure zones are provided at the upper surfaces of the mesh bars 60 , 61 resulting in creation of lift force vector f having a upwardly directed direction that is slightly angled inward toward the axis of symmetry 30 a of the mesh cell 30 due to the pressure differential at the adjacent surfaces thereof . resolution of the lift force f provides for a component fn normal to the longitudinal working plane p 1 and tangential component ft and − ft that are each inwardly directed towards the axis of symmetry of the mesh cell 30 . note that the normal forces fn of the mesh bars 60 , 61 are thus additive while the tangent forces ft and − ft are equal and opposite . result : if the mesh cell 30 is united with like cells to form a truncated conical trawl 13 as depicted in fig1 , such normal forces fn are additive as a function of radial angle t centered at axis symmetry 32 to substantially increase the interior volume of the trawl 13 ( see fig1 ) relative to longitudinal axis of symmetry 32 . likewise , since there is cancellation of all tangential components ( ft , − ft ), drag of the trawl 13 is also substantially reduced . moreover , it is also apparent that the direction of the resultant forces acting on the trawl 13 , say acting on bottom panel 77 of fig1 during operations , could be inverted from that depicted in fig1 whereby the normal forces fny for the bottom panel 77 have a direction that points inwardly of the trawl 13 ′ toward the axis of symmetry 32 ′ causing outer surface 77 a to become convexed relative to the axis of symmetry 32 ′. note that the shape of the bottom panel of the trawl 13 could also be changed as depicted in fig1 whereby outer surface 77 a ′ of the bottom panel 77 ′ defines a longitudinal plane p 6 parallel to the axis of symmetry 32 ″ of the trawl 13 ″. such a construction occurs by forming the bottom panel 77 ′ of mesh cells constructed in accordance with the prior art , i . e ., the cells are formed of strands of the same twist . [ 0139 ] fig1 shows an additional method of formation of the segments 50 , 51 of fig1 . as shown the segments 50 , 51 are divided into separate subsegments 50 a , 50 b and 51 a , 51 b formed in a x - pattern about a central point 80 . each subsegment is formed of a two strands 81 , 82 having loops 83 at exterior and interior end segments 84 , 85 . the loops 83 having openings 86 large enough to permit passage of selected subsegments through such openings 86 at the intersection of the interior end segment 85 of the subsegments to form handing knot 87 , see fig1 a , at the central point 80 . thereafter , the subsegments are twisted about central axes 88 a , 88 b to provide the orientation depicted in fig1 . that is , the subsegments 50 a , 50 b are twisted to form a counterclockwise lay direction as viewed from exterior end segment 84 a of subsegment 50 a . likewise , the subsegments 51 a , 51 b are twisted to form a clockwise lay direction as viewed from exterior end segment 84 b of subsegment 51 a . [ 0140 ] fig1 shows another method of formation of the segments 50 , 51 of fig1 . as shown the segments 50 , 51 are divided into separate subsegments 50 a ′, 50 b ′ and 51 a ′, 51 b ′ formed in a x - pattern about a central point 90 . each subsegment is formed of a two strands 91 , 92 having interior ends 93 that fit through radial openings 94 in a collar 95 . after attachment say via overhand knot 96 , each subsegment is twisted as previously indicated above . [ 0141 ] fig1 shows yet another method of formation of the segments 50 , 51 of fig1 . as shown the segments 50 , 51 are divided into separate subsegments 50 a ″, 50 b ″ and 51 a ″, 51 b ″ formed in a x - pattern about a braided or woven intersection segment 97 . each subsegment is formed of a two strands 98 , 99 that attach together via intersection segment 97 . as shown , all strands 98 , 99 are independent of each other . thereafter , each subsegment is twisted as previously indicated above . [ 0142 ] fig1 shows still another method of formation of the segments 50 , 51 of fig1 . as shown the segments 50 , 51 are divided into separate subsegments 50 a ′″, 50 b ′″ and 51 a ′″, 51 b ′″ wherein subsegment 50 a ′″ is integrally united with subsegment 51 a ′″ and subsegment 50 b ′″ is integrally united with subsegment 51 b ′″ in a x - pattern about separate braided or woven intersection segments 101 . each subsegment is formed of a two strands 102 , 103 which are twisted as previously indicated above . [ 0143 ] fig1 shows yet still another method of formation of the segments 50 , 51 of fig1 . as shown the segments 50 , 51 are divided into separate subsegments 50 a ″″, 50 b ″″ and 51 a ″″, 51 b ″″ wherein subsegment 50 a ″″ is integrally united with subsegment 51 b ″″ and subsegment 50 b ″″ is integrally united with subsegment 51 a ″″ in a x - pattern about separate braided or intersection segments 104 . each subsegment is formed of two strands 105 , 106 which are twisted as previously indicated above . [ 0144 ] fig2 shows still yet another method of formation of the segments 50 , 51 of fig1 . as shown the segments 50 , 51 are divided into separate subsegments 50 a ′″″, 50 b ′″″ and 51 a ′″″, 51 b ′″″ wherein subsegment 50 a ′″″ is integrally united with subsegment 51 a ′″″ and subsegment 50 b ′″″ is integrally united with subsegment 51 b ′″″ in a x - pattern about twine or metallic connector 107 . each subsegment is formed of a two strands 108 , 109 which are twisted as previously indicated above . [ 0145 ] fig2 shows still yet another method of formation of the segments 50 , 51 of fig1 . as shown the segments 50 , 51 are divided into separate subsegments 50 a ″″″, 50 b ″″″ and 51 a ″″″, 51 b ″″″ wherein subsegment 50 a ″″″ is integrally united with subsegment 51 a ″″″ and subsegment 50 b ″″″ is integrally united with subsegment 51 b ″″″ in a x - pattern intertwined as shown to form knot 110 . each subsegment is formed of two strands 111 , 112 which are twisted as previously indicated above . [ 0146 ] fig2 shows still yet another method of formation of the segments 50 , 51 of fig1 . as shown the segments 50 , 51 are divided into separate subsegments 50 a ′″″″, 50 b ′″″″ and 51 a ′″″″, 51 b ′″″″ formed in a x - pattern about braided or woven intersection segments 113 formed by opening up strands 114 , 115 of subsegments 50 a ′″″″, 50 b ′″″″ and passing subsegments 51 a ′″″″, 51 b ′″″″ therethrough , then opening up strands 114 , 115 of subsegments 51 a ′″″″, 51 b ′″″″ and passing subsegments 50 a ′″″″ and 50 b ′″″″, therethrough . thereafter , each subsegment is twisted as previously indicated above . note that the load bearing capability of subsegments 51 a ′″″″ and 51 b ′″″″ are maximal . [ 0147 ] fig2 shows still yet another method of formation of the segments 50 , 51 of fig1 . as shown the segments 116 , 117 are integrally formed in a x - pattern about a seamed intersection segment 118 . the segments 116 , 117 are each formed of separate strands 119 , 120 . thereafter the segments 116 , 117 are twisted as previously indicated above . note in fig2 that each strand 119 , 120 can themselves be composed of substrands 119 a , 119 b , 119 c and 120 a , 120 b , 120 c . these sub - strands 119 a - 120 c are provided a twist direction that matches that of segment 116 or 117 into which the former is incorporated . for example , since the segment 117 of fig2 is provided with a clockwise direction . hence the sub - stands 119 a - 119 c and sub - stands 120 a - 120 c are also provided with a clockwise direction . result : there is an increase in the magnitude of hydrodynamic forces generated in operations . that is , an incremental circular vector v 5 is created in addition to usual vector force v 6 created by water passage through grooves 121 between the sub - strands 119 a - 120 c . [ 0148 ] fig2 a - 24 c illustrate variations in the construction of the strands 119 , 120 of segment 117 of fig2 . in fig2 a , the strands 119 ′, 120 ′ are twisted in a right - handed or clockwise direction about axis of symmetry 117 a as previously mentioned , but more particularly , each strand 119 ′ or 120 ′ is formed by a conventional braided formation technique in which synthetic or natural fibers or filaments are braided together about the axis of symmetry 117 a . in fig2 b , a combination of braided and conventional twisted strands 119 ″ and 120 ″ is illustrated . that is , note that strand 119 ″ is of a conventional twisted line or rope product formed of conventional synthetic or natural fibers or filaments twisted about axis of symmetry 117 b , as shown in fig2 . while strand 120 ″ is formed of a braided construction as hereinbefore described with reference to fig2 a . in fig2 c , the strands 119 ′″ and 120 ′″ ( akin in twist direction to that of segment 116 of fig2 ) have multiplied to form separate strand pairs 116 ′, 116 ″ nested together about axis of symmetry 117 c in which the dominated twist direction for all elements is counterclockwise or left - handed . that is , note that segment 116 ′ that comprises strands 119 ′″ and 120 ″″ twisted together in a left - handed direction , while pair 116 ″ that comprises strands 119 ″″ and 120 ′″ also twisted together in a similar left - handed or counterclockwise direction . yet the pair segments 116 ′, 116 ″ also twist about each other in a left - handed or counterclockwise direction relative to the axis of symmetry 117 c . [ 0149 ] fig2 shows still yet another method of formation of the segments 50 , 51 of fig1 . as shown the segments 122 , 123 are integrally formed in a x - pattern about a seamed intersection segment 124 . the segments 122 , 123 are each formed of a single strand 125 of material of rectangular cross section . thereafter , each subsegment is twisted as previously indicated above . [ 0150 ] fig2 shows yet another method of formation of the segments 50 , 51 of fig1 . as shown , the segments 126 , 127 are formed in x - pattern about a seamed region 128 . the segments 126 , 127 are each formed of three strands 129 , 130 , 131 twisted as previously indicated . fig2 - 30 show alternate shapes for the mesh cell of the invention . as show in fig2 , a series of mesh cells 135 are depicted , each of which being of a triangular cross section that includes side mesh bars 136 , 137 and base mesh bar 138 . the side mesh bars 136 , 137 meet each other at apex knot 139 and meet the base mesh bar 138 at corner knots 140 . the side mesh bars 136 , 137 include first and second strands 141 , 142 which are twisted in opposite directions , i . e ., the strands 141 , 142 which comprise mesh bar 136 are twisted in a clockwise direction while such strands which comprise mesh bar 137 ( when viewed from apex knot 139 ) are twisted in a counterclockwise direction . and the base mesh bar 138 which includes the strands 141 , 142 twisted in a clockwise direction when view axially from initiation of contact with the velocity vector v 8 representing relative water flow during operations . repeating the shape of the series of mesh cells 135 places the apex knots 139 in a common transverse plane p 8 . while the corner knots 140 are longitudinally spaced a common longitudinal distance d 4 that repeats along the series of mesh cells 135 . note that the pitch po of the strands 141 , 142 are common and are in a range of 10d to 70d . result : hydrodynamic forces are created in which normalized components of mesh bars 136 , 137 , 138 are additive in a direction of arrow 143 out of the plane of fig2 toward the viewer . but in fig2 , the base mesh bar 138 ′ is composed of a rope of clockwise orientation of fibers in which the pitch p 7 is less than po of the mesh bars 136 ′, 137 ′. results are identical but since the longitudinal forces are born by the base mesh bars 138 ′ of greater load carry capability , the diameter of the mesh bars 136 ′, 137 ′ can be reduced with subsequent reduction in drag . as shown in fig2 , the triangularly shaped mesh bars 143 , 144 are composed of a single strand 146 of material of rectangular cross section in which mesh bar 143 is twisted clockwise and mesh bar 144 is twisted counterclockwise . base mesh bar 145 is also composed of a single strand 146 of material of rectangular cross section is twisted in a clockwise direction as viewed from the initialization of the mesh bars 143 , 144 , 145 with water flow vector v 9 in operations . as shown in fig3 , a hexagonal mesh cell 150 is depicted , and is composed mesh bars 151 , 152 , 153 , 154 , 155 , and 156 . the mesh bars 151 - 156 are appropriately attached at braided intersections 157 a - 157 f . the mesh bar 151 includes first and second strands 158 , 159 which are twisted in a counterclockwise direction when viewed from braided intersection 157 a . the mesh bar 152 also includes first and second strands 158 , 159 which are twisted in a clockwise direction when viewed from braided intersection 157 a . mesh bars 153 , 154 also includes first and second strands 158 , 159 which are twisted in a clockwise direction when viewed braided intersection 157 b or 157 c . mesh bar 155 also includes first and second strands 158 , 159 which are twisted in a counterclockwise direction when viewed from braided intersection 157 d . and mesh bar 156 also includes first and second strands 158 , 159 which are twisted in a clockwise direction when viewed from braided intersection 157 e . note that the pitch po of the strands 158 , 159 are common and are in a range of 10d to 70d . result : hydrodynamic forces are created in which normalized components of mesh bars 151 - 156 are additive in a direction of arrow 160 out of the plane of fig3 toward the viewer . [ 0158 ] fig3 and 32 show variations in trawl designs using the mesh cell of the invention . as shown in fig3 , a modified trawl 161 is depicted in accordance with the invention . in this aspect the mesh cells 162 of the invention are created in the fashion previously described so that subsequent operations generates increased volume of the trawl 161 . however , such operations are unaffected by the fact that the trawl 161 is overlaid with netting 163 of a conventional twist , i . e ., of a common direction . in this embodiment , the trawl 162 acts as frame to accommodate the netting 163 while the mesh cells 162 provide for increased volumetric performance as previously mentioned . as shown in fig3 , a further modified trawl 165 is illustrated in accordance with the invention . trawl 165 comprises the following : ( i ) mesh cells 166 formed in accordance with invention , ( ii ) headrope 167 bisected at midpoint 168 to define a left - hand lay sub - headrope 167 a and a right - hand lay sub - headrope 167 b , and ( iii ) footrope 169 comprising right hand lay sub - footrope 169 a and left - hand lay sub - footrope 169 b extending from bottom segments 170 . in subsequent operations , as previously discussed , the twist directions of the headrope 167 provides for generation of upwardly , vertical force vectors 171 . during similar operating conditions , the footrope 169 provides for generation of downwardly , vertical directed force vectors 172 . result : a substantial increase in the size of opening 173 measured between the headrope 167 and the footrope 169 . [ 0161 ] fig3 a and 32 b show variations in the headrope 167 or footrope 169 in which the cell construction depicted in fig3 is changed . in more specific reference to fig3 a , a detail of sub - headrope 167 a ′ comprises an axis of symmetry 175 , a first cylindrical strand 176 having internal axis of symmetry coincident with the axis of symmetry 175 and a second strand 178 . the first strand 176 is hence in an unwound state while the second strand 178 is seen to wind about the first strand 176 to define a series of turns 180 in tangential contact with outer surface 181 thereof . ratio of the diameters of the strands 176 , 178 : preferably 1 : 1 but can be larger say 2 : 1 to about 4 : 1 . direction of twist of second strand 178 : the same as before , i . e ., in a left - handed or counterclockwise lay . note that any transverse cross section of the first strand 176 is circular and the outer surface 181 thereof is equi - spaced from both the internal axis thereof and the axis of symmetry 175 of the sub - headrope 167 a ′. note that the mate of the sub - headrope 167 a ′ would have a similar construction as the latter but with opposite winding as that shown . in fig3 b , a detail of sub - footrope 169 a ″ comprises an axis of symmetry 183 , a first cylindrical strand 184 having internal axis of symmetry coincident with the axis of symmetry 183 and a second strand 186 . the first strand 184 is hence in an unwound state while the second strand 186 is seen to wind about the first strand 184 to define a series of turns 187 in tangential contact with outer surface 188 thereof . ratio range of the diameters of the strands 184 , 186 : preferably about 1 : 1 but can be larger say from 2 : 1 to 4 : 1 . direction of twist : the same as before , i . e ., in a right - handed or clockwise lay . note that any transverse cross section of the first strand 184 is circular and the outer surface 188 thereof is equi - spaced from both the internal axis 185 thereof and the axis of symmetry 183 of the sub - footrope 169 a ′. note that the mate of the sub - footrope 169 a ′ would have a similar construction to the latter but with opposite winding as that shown . [ 0164 ] fig3 shows an alternative mesh cell 200 . the mesh cell 200 comprises four mesh bars — viz ., mesh bars 201 , 202 , 203 and 204 . each mesh bar 201 - 204 has an angulated axis of symmetry 205 and includes a first strand 210 and a second strand 211 . as explained in more detail below , the first strand 210 can be created using a conventional manufacturing process ( or otherwise as previously explained ) and includes an outer surface 212 . such outer surface 212 defines a common diameter d . the outer surface 212 is seen not to undulate relative to the axis of symmetry 205 of each mesh bar 201 - 204 but instead remain parallel thereto throughout the length of the latter , beginning from upstream point 206 . that is , the axis of symmetry 209 of the first strand 210 remains coincident with the axis of symmetry 205 over the entire length of each mesh bar 201 - 204 and is not twisted about such axis of symmetry 205 . however , this is not the case with regard to the second strand 211 . it is seen to be twisted about such axis of symmetry 205 of each mesh bar 201 - 204 in helical fashion and to form a series of turns 195 in contact with the outer surface 212 of the first strand 210 . the direction of the turns 195 in contact with the outer surface 212 of the first strand 210 is in either one of two directions thereabout — clockwise or counterclockwise as viewed along the axis of symmetry 205 in a receding direction established at the upstream end 206 of each mesh bar 201 - 204 . in more detail with regard to mesh bar 201 , the second strand 211 is constructed to define a clockwise lay direction . as to mesh bar 202 , the second strand 211 defines a counterclockwise lay direction . with respect to mesh bar 203 ( opposite to mesh bar 201 ), the second strand 211 is created to provide a clockwise lay direction . finally , with regard to mesh bar 204 ( opposite to mesh bar 202 ), the second strand 211 defines a counterclockwise direction . [ 0167 ] fig3 shows an enlarged view of the outer surface 212 of the first strand 210 of the mesh bar 201 in contact with turns 195 of the second strand 211 . note that the first strand 210 may be constructed of one ( or more ) twisted thread or threads 215 defining a lay direction ( normalized relative to the upstream end 206 ), that is opposite to the lay serpentining direction of the second strand 210 about the first strand 210 . in that way , a series of openings 196 are provided adjacent to intersections 197 between the turns 195 and the outer surface 212 of the first strand 210 that aid in creating macro - lift vectors during operations apart from the lift mechanism ( s ) previously described . since the direction of twist of the threads 215 making up the first strand 210 is based upon the lay serpentining direction of second strand 211 about such first strand 210 as each mesh bar 201 - 204 is constructed , note in fig3 that the lay direction of second strand 211 associated with the mesh bar 201 is clockwise . hence , the twist direction of threads 215 comprising the first strand 210 for such mesh bar 201 is counterclockwise . a similar construction scheme is used for the remaining mesh bars 202 - 204 wherein the lay direction of the threads 215 associated with the first product strand 210 is clockwise , counterclockwise , and clockwise , respectively , for the mesh bars 202 , 203 and 204 . [ 0169 ] fig3 shows yet another alternative mesh cell 220 comprising four mesh bars — viz ., mesh bars 221 , 222 , 223 and 224 . each mesh bar 221 - 224 has an angulated axis of symmetry 225 and is composed a first strand 230 as hereinbefore described . however , instead of a single strand , note that the invention embodied within the mesh cell 220 includes a like oriented pair of second and third strands 231 , 232 that serpentine about the first strand 230 . as previously explained , the first strand 230 has an outer surface 226 defining a common diameter do , such outer surface 226 remaining parallel to the axis of symmetry 225 beginning at upstream point 227 . that is to say , note that the internal axis of symmetry 229 of the first strand 230 remains coincident with the axis of symmetry 225 of mesh bar 221 - 224 over the entire length of the latter and is not twisted about such axis of symmetry 225 . however , the pair of second and third product strands 231 , 232 is twisted about such axis of symmetry 225 of each mesh bar 221 - 224 in uniform fashion to form turns 219 in contact with the outer surface 226 of the first strand 230 in either one of two directions — clockwise or counterclockwise as viewed along the axis of symmetry 225 in a receding direction established at the upstream end 227 of each mesh bar 221 - 224 . in more detail with regard to mesh bar 221 , the pair of second and third strands 231 , 232 is constructed to each provide a clockwise lay direction . as to mesh bar 222 , the pair of second and third strands 231 , 232 defines a counterclockwise lay direction . with respect to mesh bar 223 ( opposite to mesh bar 221 ), the pair of second and third strands 231 , 232 is created a clockwise lay direction . finally , with regard to mesh bar 224 ( opposite to mesh bar 222 ), the pair of second and third strands 231 , 232 defines a counterclockwise direction . [ 0171 ] fig3 shows an enlarged view of the outer surface 226 of the first strand 230 of the mesh bar 223 . note that the first strand 230 is similar in construction to that previously described and includes one or more twisted threads 235 defining a lay direction that is opposite to the direction of the pair of second and third strands 231 , 232 . that is , since the lay direction of the pair of second and third strands 231 , 232 of the mesh bar 223 is clockwise , the twist direction of threads 235 comprising the first strand 230 is counterclockwise . a similar construction scheme is used for the remaining mesh bars 221 , 222 and 224 wherein the lay direction of the threads 235 associated with the mesh bars 221 , 222 , and 224 , is counterclockwise , clockwise , and clockwise , respectively . [ 0172 ] fig3 shows still yet another alternative mesh cell 240 comprising four mesh bars — viz ., mesh bars 241 , 242 , 243 and 244 . each mesh bar 241 - 244 has an angulated axis of symmetry 245 and is composed of a first strand 250 of diameter d 1 and a second strand 251 of diameter d 2 where d 2 = ½ d 1 . as previously explained , the first strand 250 has an outer surface 252 defining the aforementioned diameter d 1 , such outer surface 252 remaining parallel to the axis of symmetry 245 beginning from upstream point 246 . that is , the axis of symmetry 249 of the first strand 250 remains coincident with the axis of symmetry 245 over the entire length of mesh bar 241 - 244 and is not twisted about such axis of symmetry 245 . however , the second strand 251 is twisted about such axis of symmetry 245 of each mesh bar 241 - 244 in contact with the outer surface 252 of the first strand 250 in either one of two directions — clockwise or counterclockwise as viewed along the axis of symmetry 245 in a receding direction established at the upstream end 246 of each mesh bar 241 - 244 . in more detail with regard to mesh bar 241 , the second strand 251 is constructed in a clockwise lay direction . as to mesh bar 242 , the second strand 251 defines a counterclockwise lay direction . with respect to mesh bar 243 ( opposite to mesh bar 241 ), the second strand 251 is created a clockwise lay direction . finally , with regard to mesh bar 244 ( opposite to mesh bar 242 ), the second strand 251 defines a counterclockwise direction . [ 0174 ] fig3 shows an enlarged view of the outer surface 252 of the first strand 250 of the mesh bar 243 in contact with the second strand 251 . note that the first strand 250 is constructed of braided construction while the second strand 251 is constructed of one ( or more ) twisted thread or threads 255 defining a lay direction that can be the same as or can be opposite to its lay serpentining direction about the first strand 250 . in either circumstance , a series of openings 256 are provided adjacent to intersections 257 and the outer surface 252 of the first strand 250 that aid in creating macro - lift vectors during operations as previously mentioned , such vectors being separate and apart from the main lift mechanism ( s ) previously described . [ 0176 ] fig3 shows another embodiment of the invention . a towing vessel 260 is shown the surface 261 of a body of water 262 towing a mid - water trawl 263 of the trawl system 264 positioned between surface 161 and the bottom 265 . the trawl system 264 includes the trawl 263 connected to the vessel 260 via main tow lines 268 , doors 269 , towing bridles 270 , mini bridles 270 a , and frontropes 271 that include breastlines 271 a , headropes 271 b ( see fig4 ), minibridles , etc . a series of weights 272 attach to the bridles 270 . the trawl 263 is made up four panels ( tow side panels , a top panel and a bottom panel ), and includes wings 274 for a better herding at open mouth 275 . the wings 274 are seen to define a mesh size that is larger than that used to form mid - portion jacket 276 , intermediate jacket 277 or codend 278 . as shown in fig4 , the wing 274 a includes a series of mesh cells 280 of rectangular cross section that are offset from the central axis of symmetry 281 of the trawl 263 . [ 0177 ] fig4 and 41 show the mesh cells 280 in more detail . as shown in fig4 , the mesh cells 280 each have a longitudinal axis of symmetry 282 that is offset from the central axis of symmetry 281 of the trawl 263 . since the shape of the trawl 263 varies along the axis of symmetry 281 from almost cylindrically shaped at the wing 274 a to a more frustoconical shape over the remainder , the position of the axes of symmetry 282 of individual cells 280 vary with respect to the axis of symmetry 281 , from parallel and coextensive , non - parallel and non - intersecting and / or to non - parallel and intersecting . but note that axes of symmetry 282 of the cells 280 are always offset therefrom . in fig4 , each cell 280 is formed of a plurality of straps 284 formed into a x - pattern using a series of connections 285 to maintain such orientation . each strap 284 is twisted , such direction being normalized to the receding direction of use , as indicated by arrow 286 , such twisting occurring about its own axis of symmetry 286 in either one of two lay directions : left - handed or clockwise or right - handed or counterclockwise as viewed relative to the central axis 281 of the trawl 263 ( see fig4 ). as a result , leading and trailing edges 287 are formed . as shown in fig4 a , 42 b and 42 c , the cross section of each strap 284 is seen to be basically rectangular . in fig4 a , the twisted strap 284 includes rounded short sides 284 a and parallel long sides 284 b with the leading and trailing edges occurring at the short sides 284 b alternating between the former and the latter based on the pitch , as explained below . in fig4 b , instead of the cross section being of a solid geometrical rectangle , strap 284 ′ includes a side wall 290 defining a cavity 291 into which three strands 292 reside — in side - by side fashion . that is , outer surfaces 293 of the three strands 292 have tangential contact with each other as well as inner surface 290 a of the oval side wall 290 . in fig4 c , strap 284 ″ includes side wall 295 defining a cavity 296 into which two strands 297 reside — in side - by side fashion . that is , outer surfaces 297 a of the two strands 297 have tangential contact with each other as well as inner surface 295 a of the oval side wall 295 . [ 0181 ] fig4 d shows an alternate connection 285 ′ in which the long sides 284 b ′ of adjacent x - ed straps 284 are attached together in a butting relationship . a series of seams 298 provide for such attachment as shown in fig4 e . the seams 298 are parallel to short sides 284 a ′. note that the right - handiness or left - handiness twist of the straps 284 of fig4 is determined using the concept of a figure of man 298 as shown in fig4 as a normalizing icon positioned as described below . note that the figure 298 has feet 299 rotatable affixed to the central axis 281 of the trawl 263 . as the trawl 263 and figure 298 are moved through the water , the figure 298 faces downstream so that his back first encounters the resistance provided by the water to the moving trawl 263 . hence , the figure 298 always looks in the direction of the arrow 286 with reference to the cell 280 of fig4 , in a receding direction relative to such movement . the right - handed ( clockwise ) or left - handed ( counterclockwise ) twist of the straps 284 is hence based of the particular position of the right arm 300 versus left arm 301 as so positioned . since the figure 298 can rotate relative to the central axis 281 , the twist direction of each strap 284 can be easily determined irrespective of the fact that the particular strap 284 is positioned above , below or offset to the side from the central axis 281 . as shown , the mesh cell 280 ′ is formed of a plurality of straps 303 formed into a x - pattern using a series of connections 299 to effect such orientation . each strap 303 is untwisted and can be of a quasi - rectangular in cross section as shown in fig4 . note that each such strap 303 in cross section includes long sides 304 and short sides 305 . the short sides 305 form either the leading or trailing edges of the straps 303 . in order have the capability of a hydrofoil , the exterior far long side 304 a ( exterior relative to the central axis 281 of the trawl ) is preferably cambered relatively more than the near long side 304 b . as a result , lift vector 307 is provided . in addition , the short sides 305 can be rounded at corners 305 a . the ratio of width w to thickness t of the strap 303 is as set forth supra . [ 0185 ] fig4 shows an alternate strap design . as shown , the straps 303 ′ are untwisted and have a x - pattern layout as previously described wherein the particularly straps 303 ′ form the four mesh sides and use a series of connections 306 to maintain such orientation . each strap 303 ′ is of a quasi - rectangular in cross section as shown in fig4 . note that each such strap 303 ′ includes long sides 308 and short sides 309 . the short sides 309 form either the leading or trailing edges of the straps 303 ′. in order have the capability of a hydrofoil , the exterior far long side 308 a ( exterior relative to the central axis 281 of the trawl ) is preferably cambered relative to uncambered near long side 308 b , via placement of a series of shape - altering support sleeves 310 therealong , see fig4 . as a result , lift vector 311 of fig4 is provided . in addition , the short sides 309 can be rounded at corners 309 a . the ratio of width w to thickness t of the strap 293 ′ is preferably as previously stated , greater that 1 . 1 . 1 and preferably in a range of 2 : 1 to 10 : 1 but can be as large as 1 . 1 : 1 to 50 : 1 . [ 0186 ] fig4 shows the support sleeve 310 in more detail . each sleeve 310 is preferably of plastic ( but metals can be substituted ) and includes a cavity 312 having common cambered long side surfaces 312 a and short side surfaces 312 b built to accept each strap 303 ′ even though the latter is of a rectangular cross section , and reform the cross section of the latter to match the cross sectional shape of the cavity 312 . as a result , the lift vector 311 is provided in a direction away from the central axis of the trawl . leading and trailing edges 313 thereof are as depicted . [ 0188 ] fig4 shows one of the connections 306 in more detail . as shown , the connection 306 has its long sides 308 of adjacent x - ed straps 303 ′ are attached together after each of the long sides 308 a ′, 308 b ′ have been folded into two plies . a series of seams 315 provide for such attachment . the seams 315 are parallel to short sides 309 a ′, 309 b ′. attributes are provided by the quasi - rectangular cross sectional straps 303 , 303 ′ that , in operations , relate primarily to reducing the noise and drag of the trawl system 264 of fig3 whether such straps 303 , 303 ′ are used in fig3 in the construction of the trawl 263 , main tow lines 268 , towing bridles 270 and / or frontropes 271 that include breastlines , footropes , headropes , minibridles , etc ., as explained below . suffice it to say , experiments have shown a rather large reduction in noise using the cell design of the present invention when compared to conventional cell designs . with reference to fig5 , graph 320 shows the relationship between generated noise in db versus time for two separate , independent cell bar designs — curve 321 for a conventional uni - twisted cell bars presently used in construction of the trawls and the like , and curve 322 associated with bi - directional twisted strands construction in accordance with the teachings of the invention . note over the time interval 6 - 10 , there is a 20 db improvement in the cell construction in accordance with the invention . as shown , the straps 330 include clock - wise lay segments 331 and counterclockwise segments 332 lain in an x - pattern so that midpoints 333 are coincident with and make intersection with each other at connections 334 . each segment 331 is positioned so that its end 331 a ( that aids in defining the resulting cell 334 ) is offset a distance d 1 above axis of symmetry 335 while end 331 b is offset a distance d 1 below the axis of symmetry 335 . the segments 332 are positioned ( relative to the cell 334 ) so that an end 332 a is offset a distance d 1 below axis of symmetry 335 while end 332 b is offset a distance d 1 above the axis of symmetry 335 . thereafter additional pairs of segments ( akin to the segments 331 , 332 ) are similar constructed and positioned along the lines previously described , supra . [ 0194 ] fig5 a and 52 b show alternate details of a connection 334 ′ in which the long sides 338 a of adjacent x - ed straps 330 are attached together . a series of seams 339 provide for such attachment . the seams 339 are parallel to short sides 338 b . [ 0195 ] fig5 , 54 , 55 and 56 show the cell design of the invention used in the construction a tow line assembly 348 . in detail , the fig5 shows starboard tow line 349 and fig5 shows a port tow line 350 . both are offset from central axis 351 , see fig5 and 56 midway between them . in fig5 , note that the starboard tow line 349 comprises first and second product strands 352 , 353 and is twisted about axis of symmetry 354 in a right - hand or clockwise direction normalized to vessel 355 . in [ 0196 ] fig5 the port tow line 350 is shown to included first and second product strands 357 , 358 twisted about its axis of symmetry 359 in a left - hand or counterclockwise direction normalized to vessel 355 . result of the action of fig5 - 56 : force vectors are generated which spread the towlines 349 , 350 relative to the central axis 351 midway between them and increase the volume of the trawl 360 . [ 0198 ] fig5 , 58 , 59 and 60 are similar depictions in regard to tow line assembly 348 ′ to those shown in fig5 - 56 except for the most part , twisted straps 365 , 366 are substituted for the strand pairs 352 , 353 , and 357 , 358 , respectively used in the tow line assembly 348 . in detail , the fig5 shows starboard strap tow line 349 ′ and fig5 shows a port tow line 350 ′. both are offset from an central axis 351 ′ midway between them . twist directions are also similar . in more detail , the starboard strap 365 related to the starboard tow line 349 ′, is twisted in a right - handed or clockwise direction normalized to the vessel 355 ′ and wherein strap 366 associated with the port tow line 350 ′, is twisted in a left - handed or counterclockwise direction , as viewed . results of fig5 - 60 : force vectors are generated which spread the towlines 349 ′, 350 ′ relative to the central axis 351 ′ and increase the volume of the trawl 360 ′. still further , fig5 - 56 also illustrate the cell design of the invention , say when used in the constructing and using bridle assemblies generally indicated at 370 , 370 ′ offset from the central axis 351 of the trawl 360 which causes spreading of the trawl and an increase in volume . [ 0201 ] fig5 shows the starboard bridle assembly at 370 . it includes a lower starboard bridle 372 composed of a pair of strands 373 , 374 twisted about axis of symmetry 375 in a right - handed or clockwise direction offset from central axis 351 . connection with the starboard tow line 349 is at connector 376 . a weight 371 along the bridle 372 positions the same correctly . on the other hand , upper starboard bridle 377 comprises a pair of strands 378 , 379 , twisted about axis of symmetry 380 in a left - handed or counterclockwise direction and also connects to the starboard tow line 349 at the connector 376 . in fig5 showing the port bridle assembly 370 ′, note that the same includes lower port bridle 381 composed of a pair of strands 383 , 384 twisted about axis of symmetry 385 in a left - handed or counterclockwise direction . connection with the port tow line 350 is at connector 386 . a weight 371 ′ along the bridle 381 correctly positions the same . on the other hand , upper port bridle 388 comprising a pair of strands 389 , 390 , is twisted about its axis of symmetry 391 in a right - handed or clockwise direction . it also connects to the port tow line 350 via the connector 386 . result : force vectors are generated at mouth 393 of the trawl 360 resulting in an increase in its volume relative of central axis 351 . with further regard to bridle construction , note that fig5 and 58 are similar depictions to those shown in fig5 and 54 except that pairs of starboard and port straps , viz ., starboard strap pair 395 , 396 and port strap pair 397 , 398 , respectively are substituted for the stranded pairs of starboard and port bridles viz ., for starboard strand pairs 373 , 374 and 378 , 379 , and for port strand pairs 383 , 384 and 389 and 390 also respectively . twist directions remain the same . in more detail , the lower starboard strap 395 associated with the starboard towline 349 ′ via connector 400 , is twisted in a right - handed or clockwise direction normalized to the vessel 355 ′ and wherein upper starboard strap 396 associated with the starboard tow line 349 ′, is twisted in a left - handed or counterclockwise direction , as viewed . and in fig5 , the lower port strap 397 associated with the port tow line 350 ′ via connector 401 , is twisted in a left - handed or counterclockwise direction normalized to the vessel 355 ′ and wherein upper port strap 398 also associated with the port tow line 350 ′, is twisted in a right - handed or clockwise direction , as viewed . results of fig5 and 58 with regard to bridle construction : force vectors are generated which spread the trawl 360 ′ and increase its volume relative to its central axis of symmetry 351 ′ ( fig5 and 60 ). still further , fig5 , 54 and fig5 , 58 also illustrate the cell design of the invention , say when used in the constructing and using a frontrope assembly such as breast line assemblies generally indicated at 405 , 405 ′ offset from the central axis 351 , 351 ′ of the trawl 360 , 360 ′, respectively ( fig5 , 56 , 59 , 60 ) which result in spreading of the trawl and an increase in volume . [ 0206 ] fig5 and 57 show the starboard breast line assembly 405 . it includes a lower starboard breast line 406 ( fig5 and 57 ) composed of a pair of strands 407 , 408 and twisted about axis of symmetry 409 in a left - handed or counterclockwise direction offset from the central axis 351 , 351 ′. connection with the lower starboard stranded bridle 372 ( fig5 ) or with the lower starboard strapped bridle 395 ( fig5 ) is at connection 410 . on the other hand , upper starboard breast line 411 ( fig5 and 57 ) comprises a pair of strands 412 , 413 , twisted about axis of symmetry 414 in a right - handed or clockwise direction and also connects to the upper stranded starboard bridle 377 ( fig5 ) or with the upper strapped starboard bridle 396 ( fig5 ) at the connection 415 . in fig5 and 58 show the port breast line assembly 405 ′ which has a similar construction as starboard breast line assembly 405 , such port breast line assembly 405 ′ being best shown in fig5 and including a lower port breast line 415 composed of a pair of strands 416 , 417 and twisted about axis of symmetry 418 in a right - handed or clockwise direction offset from the central axis 369 , 351 , 351 ′. connection with lower strapped port bridle 397 ( fig5 ) is at connection 419 or with the lower stranded port bridle 381 ( fig5 ) at a similar connection 419 . on the other hand , upper port breast line 420 comprises a pair of strands 421 , 422 , twisted about axis of symmetry 423 in a left - handed or counterclockwise direction and also connects to the upper strapped port bridle 398 ( fig5 ) at the connector 425 or with the upper stranded port bridle 388 ( fig5 ) at a similar positioned connection 425 . results of fig5 , 54 and fig5 , 58 with regard to breast line construction : force vectors are generated which spread the trawl 360 , 360 ′ and increase its volume relative to its central axis of symmetry 351 , 351 ′. still further , fig5 and 59 also illustrate the cell design of the invention in another aspect , say when used in the constructing and using a frontrope assembly such as a headrope assemblies generally indicated at 430 , 430 ′ offset from the central axis 351 , 351 ′ which result in spreading of the trawl and an increase in volume . [ 0210 ] fig5 shows headrope assembly 430 in more detail . it includes a starboard headrope subassembly 431 and a port headrope subassembly 432 each composed of a pair of strands : subassembly 431 including strands 433 , 434 and subassembly 432 comprising strands 435 , 436 . the subassemblies 431 , 432 meet at connection 437 in a vertical plane through the central axis 351 . in detail , the strands 433 , 434 are twisted about axis of symmetry 438 in a left - handed or counterclockwise direction . on the other hand , the strands 435 , 436 are twisted about axis of symmetry 439 in a right - handed or clockwise direction . connection of the subassemblies 431 , 432 with the upper starboard bridle 377 and upper port bridle 388 is at connector 440 or equivalent . [ 0211 ] fig5 shows headrope assembly 430 ′ which includes a starboard subassembly 441 and a port headrope subassembly 442 . the former is composed of a single strap 443 twisted about axis of symmetry 444 in a left - handed or counterclockwise direction , while the port headrope subassembly 442 comprises a single strap 445 twisted about axis of symmetry 446 in a right - handed or clockwise direction . connection of the strap 443 with strap 445 is at connection 447 in a vertical plane through the central axis 351 ′. but the strap 443 connects with the upper starboard strapped bridle 377 ′ at connection point 448 , while the strap 445 connects with the upper port strapped bridle 388 ′ at connector 449 or equivalent . results of fig5 and 59 with regard to footrope construction : force vectors are generated which spread the trawl 360 , 360 ′ and increase its volume relative to its central axis of symmetry 351 , 351 ′, respectively . still further , fig5 and 60 also illustrate the cell design of the invention in another aspect , say when used in the constructing and using a frontrope assembly such as footrope assemblies generally indicated at 450 , 450 ′ offset from the central axis 351 , 351 ′ which result in spreading of the trawl and an increase in volume . [ 0214 ] fig5 shows footrope assembly 450 in more detail . it includes a starboard footrope subassembly 451 and a port footrope subassembly 452 each composed of a pair of strands : subassembly 451 including strands 453 , 454 and subassembly 452 comprising strands 455 , 456 . the subassemblies 451 , 452 meet at connection 457 in a vertical plane through the central axis 351 . in detail , the strands 453 , 454 are twisted about axis of symmetry 458 in a right - handed or clockwise direction . on the other hand , the strands 455 , 456 are twisted about axis of symmetry 459 in a left - handed or counterclockwise direction . connection of the subassemblies 451 , 452 with the upper starboard bridle 377 and upper port bridle 388 is at connector 460 or equivalent . [ 0215 ] fig6 shows headrope assembly 450 ′ which includes a starboard subassembly 461 and a port headrope subassembly 462 . the former is composed of a single strap 463 twisted about axis of symmetry 464 in a right - handed or clockwise direction , while the port headrope subassembly 462 comprises a single strap 465 twisted about axis of symmetry 466 in a left - handed or counterclockwise direction . connection of the strap 463 with strap 465 is at connection 467 in a vertical plane through the central axis 351 ′. but the strap 463 connects with the upper starboard strapped bridle at connection point 468 , while the strap 465 connects with the upper port strapped bridle 388 ′ at like connector 468 or equivalent . results of fig5 and 60 with regard to footrope construction : force vectors are generated which spread the trawl 360 , 360 ′ and increase its volume relative to its central axis of symmetry . in order to use the cell constructed in accordance with the invention , note that use in the field is particularized as to where the cell is used within the trawl system of the invention , viz ., with a towline , a trawl , or frontrope in the shape of a breastlines , bridles , headrope or footrope . ( i ) from a vessel positioned at the surface of a body of water , deploying first and second cell bars of a trawl system below the surface of the body of water wherein a central axis offset from the first and second cell bar means is established and the first and second cell bar means have at least one interconnecting connection therebetween , ( ii ) establishing positional and directional integrity between the shaped hydrofoil means associated with the first and second cell bars relative to the central axis , and ( ii ) propelling the shaped hydrofoil means of the first and second cell bars whereby leading and trailing edges are established therefor along with separate pressure differentials that provide lift vectors relative to the central axis to increase cell performance wherein said leading edge for the first cell bar when normalized to a receding direction relative to the central axis , always resides at a right side of the first cell bar as viewed in the receding direction and wherein the leading edge of the second cell bar when normalized to the same receding direction , reside along a left side thereof as viewed . then with particular usage in association with a tow line , the steps ( i )-( iii ) are modified as follows : step ( i ) is further characterized by the first and second cell bars being associated with a tow line selected from one of a port and starboard tow line and the at least one interconnecting connection therebetween is established at the vessel itself ; step ( ii ) includes positioning first and second strands comprising the hydrofoil means of the first cell bar so that at least one strand thereof is positioned along a first axis of symmetry offset from the central axis wherein at least one of which is of a left - hand , loosely wound lay relative to a receding direction established relative to the central axis and positioning third and fourth strands comprising the said shaped hydrofoil means of said second cell bar along a second axis of symmetry so that at least one of which is of a right - hand , loosely wound lay relative to the receding direction and the central axis ; and step ( iii ) includes the substep of increasing spread between the port and starboard tow lines relative to the central axis to gain increased cell performance . instead of strands , straps can be substituted as previously discussed . further , with particular usage in association with a trawl , the steps ( i )-( iii ) are modified as follows : step ( i ) is further characterized by the central axis being longitudinally symmetrical of the trawl and the at least one interconnecting connection being established below the surface of the body of water ; step ( ii ) includes positioning first and second strands comprising the hydrofoil means of the first cell bar so that at least one strand thereof is positioned along a first axis of symmetry offset from the central axis wherein at least one of which is of a left - hand , loosely wound lay relative to a receding direction established relative to the central axis , as well as positioning third and fourth strands comprising the shaped hydrofoil means of said second cell bar along a second axis of symmetry so that at least one of which is of a right - hand , loosely wound lay relative to the receding direction and the central axis ; and in which step ( iii ) includes the substep of increasing volume of the trawl relative the central axis by the creation of the lift vectors to gain increased cell performance . instead of strands , straps can be substituted as previously discussed . still further , with particular usage in association with a frontrope , the steps ( i )-( iii ) are modified as follows : step ( i ) is further characterized by the central axis being longitudinally symmetrical of a trawl to which the frontrope attaches and the at least one interconnecting connection therebetween being established below the surface of the body of water ; in which step ( ii ) includes positioning first and second strands comprising the hydrofoil means of the first cell bar so that at least one strand thereof is positioned along a first axis of symmetry offset from the central axis wherein at least one of which is of a left - hand , loosely wound lay relative to a receding direction established relative to the central axis , as well as positioning third and fourth strands comprising the shaped hydrofoil means of said second cell bar along a second axis of symmetry so that at least one of which is of a right - hand , loosely wound lay relative to the receding direction and the central axis ; and in which step ( iii ) includes the substep of increasing volume of the trawl relative the central axis by the creation of the lift vectors due to the frontrope to gain increased cell performance . instead of strands , straps can be substituted as previously discussed . yet still further , with particular usage in association with one of a pair of port and starboard bridles , the steps ( i )-( iii ) are modified as follows : step ( i ) is further characterized by the central axis being longitudinally symmetrical of a trawl to which the bridles attach and the at least one interconnecting connection therebetween being established below the surface of the body of water ; in which step ( ii ) includes positioning first and second strands comprising the hydrofoil means of the first cell bar so that at least one strand thereof is positioned along a first axis of symmetry offset from the central axis wherein at least one of which is of a left - hand , loosely wound lay relative to a receding direction established relative to the central axis , as well as positioning third and fourth strands comprising the shaped hydrofoil means of the second cell bar along a second axis of symmetry so that at least one of which is of a right - hand , loosely wound lay relative to the receding direction and the central axis ; and in which step ( iii ) includes the substep of increasing volume of the trawl relative the central axis by the creation of the lift vectors due to the selected pair of bridles to gain increased cell performance . instead of strands , straps can be substituted as previously discussed . still further , with particular usage in association with a headrope , the steps ( i )-( iii ) are modified as follows : step ( i ) is further characterized by the central axis being longitudinally symmetrical of a trawl to which the headrope attaches and the at least one interconnecting connection therebetween being established below the surface of the body of water ; in which step ( ii ) includes positioning first and second strands comprising the hydrofoil means of the first cell bar means so that at least one strand thereof is positioned along a first axis of symmetry offset from the central axis wherein at least one of which is of a left - hand , loosely wound lay relative to a receding direction established relative to the central axis , as well as positioning third and fourth strands comprising the shaped hydrofoil means of said second cell bar means along a second axis of symmetry so that at least one of which is of a right - hand , loosely wound lay relative to the receding direction and the central axis ; and in which step ( iii ) includes the substep of increasing volume of the trawl relative the central axis by the creation of the lift vectors due to the headrope to gain increased cell performance . instead of strands , straps can be substituted as previously discussed . yet still further , with particular usage in association with a footrope , the steps ( i )-( iii ) are modified as follows : step ( i ) is further characterized by the central axis being longitudinally symmetrical of a trawl to which the footrope attaches and the at least one interconnecting connection therebetween being established below the surface of the body of water ; in which step ( ii ) includes positioning first and second strands comprising the hydrofoil means of the first cell bar means so that at least one strand thereof is positioned along a first axis of symmetry offset from the central axis wherein at least one of which is of a left - hand , loosely wound lay relative to a receding direction established relative to the central axis , as well as positioning third and fourth strands comprising the shaped hydrofoil means of said second cell bar means along a second axis of symmetry so that at least one of which is of a right - hand , loosely wound lay relative to the receding direction and the central axis ; and in which step ( iii ) includes the substep of increasing volume of the trawl relative the central axis by the creation of the lift vectors due to the footrope to gain increased cell performance . instead of strands , straps can be substituted as previously discussed . from the foregoing , it will be appreciated that one skilled in the art can make various modifications and changes to the embodiments and methods within the spirit and scope of the claimed invention as set forth below . for example , in retrofitting trawls with the mesh cell of the invention , it should be appreciated that the tensile strength of the mesh cell construction of the invention , should be at least equal in strength to that of the cells undergoing replacement . that means that if the mesh cell of the invention is a composed of two product strands each manufactured in accordance with conventional manufacturing processes having a tensile strength s , the 2 × s must be at least equal to the tensile strength of the single strand that is being replaced . in addition , the lengths of bridles and minibridles used to tow upon the upper mouth edge and lower mouth edge of the trawl , should be lengthened in order to maintain the proper angle of attack of the trawl during operations , i . e ., as there is an incremental change in volume of the trawl , the bridles and minibridles must be increased to maintain the proper angle of attack . yet further , referring to fig1 it is seen that intermediate portion 28 of trawl 13 is made up of smaller size mesh which may continue to decrease in size toward the aft of the trawl 13 . result : high drag components . it has been discovered that drag can be significantly reduced using mesh cells comprising rather loosely ( not tightly ) wound strands in a common direction . the pitch of the turns in the aforementioned range 3d to 70d but preferably are within a pitch range that results in a series of cambered sections parallel ( or closely parallel ) to the axis of symmetry of the trawl 13 being formed . result : vibration and drag are substantially reduced . experiments show a reduction in drag in a range of 30 to 50 %. further advantages : such mesh cells can be constructed by conventional mesh making machines . additionally , to manufacture the cells , a process similar to one associated with processing two - stand netting , can be used , with modification as indicated below . e . g ., a hook for handling the pair of strands for knotting , is modified to after pick up , but before knotting , the paired strands can be spun a certain number of revolutions to provide the desired pitch of the mesh bar . the direction of rotation is controlled so that the direction of twist normalized to the hook , is opposite . there is also an equal distance along the mesh bars measured from the knot . hence the pitch of each mesh bar will be essentially equal and the direction of twist is opposite . further , machine produced mesh cells can be modified to produce seines that have the following field capabilities . the mesh cells of the invention are reproduced in full or intermediate sections or areas throughout the seine . such a construction in whole or in part , permits the creation of composite forces say , during pursing of the seine , causes diametrically opposite sections of the seine to dive , lift and / or otherwise expand relative to remaining sections or areas . result : the volume of the seine is surprisingly increased during such pursing operations in the field , and the occurrence of excess billowing of the seine during such operations , is significantly reduced . the pitch of the bridle lines and the forward sections of the frontropes may be longer than the pitch of the middle sections of the frontropes and those cells making up meshes aft of the forward sections of the frontropes .

a mesh cell construction which is systemized wherein opposite mesh bars of the rectangularly shaped mesh cell have a common lay direction when viewed in an axially receding direction that is opposite to that associated with the remaining opposite mesh bars of such mesh cell . in another aspect , when incorporated in a trawl , such cell construction of the invention provides for improved shaping and performance of the trawl wherein the mesh cells of different geometrical locations positioned relative to and about the longitudinal axis of the trawl can be controlled such that resulting trawl panels wings act analogous to a series of mini - wings capable of acting in concert in operation . such concerted action provides , when the trawl is in motion , outwardly directed force vectors which significantly increase the trawl volume and hence mouth volume while simultaneously decreasing drag .

“ cosmetics ,” as used herein , include without limitation , application stick , mascara , eyebrow coloring , eyeliner , eye shadow or other eye lid cosmetics , facial or body powder , sun tanning lotions and creams and sprays , sunscreens and blocks , nail polish , mousse , sprays , styling gels , nail conditioner , whether in the form of creams , lotions , gels , ointments , emulsions , colloids , solutions , suspensions , compacts , solids , pencils , brushes , spray - on formulations , brush - on formulations and the like . “ personal care products ” include , without limitation , bath and shower gels , shampoos , conditioners , cream rinses , hair dyes and coloring products , leave - on conditioners , sun tanning lotions and creams and sprays , sunscreens and sunblocks , lip balms , skin conditioners , hair sprays , soaps , body scrubs , exfoliants , astringents , depilatories and permanent or temporary waving solutions , antidandruff formulations , antisweat and antiperspirant compositions , shaving , preshaving and after shaving products , moisturizers , deodorants , cold creams , cleansers , skin gels , rinses , whether in solid , powder , liquid , cream , gel , ointment , lotion , emulsions , colloids , solutions , suspensions , or other form . pharmaceutical preparations in accordance with the present invention include , without limitation , carriers for dermatological purposes , including topical and transdermal application of pharmaceutically active ingredients . these can be in the form of gels , patches , creams , sprays , ointments , lotions , emulsions , colloids , solutions , suspensions , powders and the like . as used herein the term “ hair ” is meant to encompass all mammalian hair . while in humans the hair whose growth is to be regulated is typically located upon the head , scalp , eyebrows , eyelids , eyelashes , mustaches , beards , chest , arms , legs , and the pubic area , the inventive method and compositions described herein may be applied to hair located anywhere on the body . as used herein , the terms “ hair growth ,” “ regulating hair growth ,” “ hair growth regulation ,” and “ regulating the growth of hair ,” are meant to include : stimulating hair growth ; stimulating hair thickening ; preventing , reducing , arresting and / or retarding the loss of hair ; preventing , reducing , arresting and / or retarding the thinning of hair ; increasing the rate of hair growth ; inducing the formation of a greater number of hair strands ; increasing the diameter of the hair strand ; lengthening the hair strand ; changing the hair follicle from vellus follicle to terminal follicle ; inducing the formation of vellus follicles . the methods and compositions of the instant invention may comprise any agent which stimulates hair growth and / or prevents hair loss , or thinning , including but are not limited to polypeptides , beta - turn mimetics , polysaccharides , phospholipids , hormones , prostaglandins , steroids , aromatic compounds , heterocyclic compounds , benzodiazepines , oligomeric n - substituted glycines , oligocarbamates , polypeptides , saccharides , fatty acids , steroids , purines , pyrimidines , derivatives , small molecules , sina , sirna , dsrna , dsdna , anti - sensedna , nucleic acids , antibodies , polyclonal antibodies , monoclonal antibodies , structural analogs , synthetic molecules , other natural molecules , small molecules , and combinations thereof , which may be employed to achieve the therapeutic effect on stimulation of hair growth and / or prevention of loss of hair in the types of tissues discussed above , e . g ., the eyelid , eyebrow , scalp , and skin . non - limiting examples of hair growth stimulant , and / or hair growth stimulating agent and / or hair density increasing agent and / or hair loss prevention agents include prostaglandins or prostaglandin analogues which may be employed to achieve the therapeutic effect on stimulation of hair growth in the types of tissues discussed above , e . g ., the eyelid , eyebrow , scalp , and skin . non - limiting examples of prostaglandins are those of the a , f and e types . to minimize side effects , such as irritation and redness of the skin , it may be advantageous to use prostaglandin derivatives or analogues which have been found to exert fewer side effects , such as phenyl - and other ring - substituted prostaglandin derivatives . on the other hand , increased hyperemia experienced with other substituents may be more beneficial in causing increased vasodilation , resulting in hair growth . prostaglandin derivatives that exhibit high pharmacological activity and no or only very small side effects , such as 13 , 14 - dihydro - 15 - dehydro - 17 - phenyl - 18 , 19 , 20 - trinor - pgf2α and its carboxylic acid esters . further non - limiting examples of suitable prostaglandins agonists or antagonists include latanoprost and those described in wo 98 / 33497 , johnstone , published aug . 6 , 1998 , wo 95 / 11003 , stjernschantz , published apr . 27 , 1995 , jp 97 - 100091 , and ueno , jp 96 - 134242 , nakamura . examples of pharmaceutical hair growth stimulating agent and / or hair growth stimulating agent and / or hair density increasing agent and / or hair loss prevention agents include , but are not limited to prostaglandin a2 , prostaglandin f2α , prostacyclin , prostaglandin e1 , prostaglandin e2 , 7 - thiaprostaglandin e1 , 16 , 17 , 18 , 19 , 20 - pentanol - 15 - cyclohexyl - 7 - thiaprostaglandin e1 , 16 , 17 , 18 , 19 , 20 - pentanol - 15 - cyclopentyl - 7 - thiaprostaglandin e1 , 16 , 16 - dimethyl - 7 - thiaprostaglandin e1 , 17 , 20 - dimethyl - 7 - thiaprostaglandin e1 , 16 , 17 , 18 , 19 , 20 - pentanol - 15 - cyclohexyl - δ2 - 7 - thiaprostaglandin e1 , 16 , 16 - dimethyl - δ2 - prostaglandin e1 , 7 - fluoroprostacyclin , 5 - fluoroprostacyclin , 16 , 17 , 18 , 19 , 20 - pentanol - 15 - cycrohexylprostacyclin or 16 , 17 , 18 , 19 , 20 - pentanol - 15 - cycropentylprostacyclin . other examples of prostaglandins and prostaglandin analogues which may be used in the instant invention include , but are not limited to , arbaprostil , carboprost , enprostil , bimatoprost , bemeprost , latanaoprost , limaprost , misoprostol , minoxidil , omoprostil , prostacyclin , prostaglandin e1 , prostaglandin e2 , prostaglandin f2α , rioprostil , rosaprostol , sulprostone , travaprost , trimoprostil , and viprostol . other examples of hair growth stimulating and / or hair loss prevention agents include , but are not limited to 15 - hydroxyprostaglandin dehydrogenase ( 15 - pgdh ) inhibitors , including but not limited to pyrazolecarboxamide compounds , tetrazole compounds , and 2 - alkylideneaminooxyacetamide compounds ( see u . s . patent application publication nos . 20060026775 , 2004 / 0052760 , and 2004 / 0235831 ). prostaglandins and derivatives thereof are described in wo 98 / 33497 , wo 95 / 11003 , jp 97 - 100 091 and jp 96 - 134 242 , prostaglandin receptor agonists or antagonists , the non - prostanoic prostaglandin analogues as described in ep 1 175 891 , ep 1 175 890 , wo 01 / 74307 , wo 1 / 74313 , wo 01 / 74314 , wo 01 / 74315 or wo 01 / 72268 , and mixtures thereof . the methods and compositions of the instant invention may comprise any agent which prevent darkening or change of the skin , hair , and / or eyes in response to the application of the hair growth stimulating agent and / or hair loss prevention agent . the methods and compositions of the instant invention may comprise any agent which will neutralize any darkening or change of the skin , hair , and / or eyes in response to the application of the hair growth stimulating agent and / or hair loss prevention agent . lightening or bleaching of hair and / or skin is discussed in the publication perfumes , cosmetics and soaps , vol . iii modern cosmetics , chapter 7 , by w . a . poucher , revised by george m . howard , eighth edition ( 1976 ) ( j . wiley and sons , new york ); and the publication harry &# 39 ; s cosmeticology , vol i by r . g . harry , sixth edition ( 1973 ) ( leonard hill books , london ). examples of hair and / or skin lightening and / or neutralization agents or bleaching agents include but are not limited to hydroquinone , hydroquinone monobenzyl ether , and hydroquinone monoethyl ether , which act as substitute substrate for the melanization enzyme tyrosinase and may be included in certain peels to enhance the skin lightening ability of the peel . the addition of citric acid and malic acid in peels containing hydroquinone or its derivatives serve to act as antioxidants to help stabilize the hydroquinone in the peel and to enhance the penetration and the efficacy of the hair and / or skin lightening and / or neutralization agent . examples of hair and / or skin lightening and / or neutralization agents or bleaching agents also include but are not limited to perborate or persulfate salts , citric acid , hydroquinone , kojic acid ascorbic acid , and combinations thereof . where the composition is to be in contact with human keratinous tissue , the composition may include additional components which are suitable for application to keratinous tissue , that is , when incorporated into the composition are suitable for use in contact with human keratinous tissue without undue toxicity , incompatibility , instability , allergic response , and the like within the scope of sound medical judgment . the ctfa cosmetic ingredient handbook , second edition ( 1992 ) describes a wide variety of non - limiting cosmetic and pharmaceutical ingredients commonly used in the skin care industry , which are suitable for use in the compositions of the present invention . examples of these ingredient classes include : abrasives , absorbents , aesthetic components such as fragrances , pigments , colorings / colorants , essential oils , skin sensates , astringents , etc . ( e . g ., clove oil , menthol , camphor , eucalyptus oil , eugenol , menthyl lactate , witch hazel distillate ), anti - acne agents , anti - caking agents , antifoaming agents , antimicrobial agents ( e . g ., iodopropyl butylcarbamate ), antioxidants , binders , biological additives , buffering agents , bulking agents , chelating agents , chemical additives , colorants , cosmetic astringents , cosmetic biocides , denaturants , drug astringents , external analgesics , film formers or materials , e . g ., polymers , for aiding the film - forming properties and substantivity of the composition ( e . g ., copolymer of eicosene and vinyl pyrrolidone ), opacifying agents , ph adjusters , propellants , reducing agents , sequestrants , skin bleaching and lightening agents ( e . g ., hydroquinone , kojic acid , ascorbic acid , magnesium ascorbyl phosphate , ascorbyl glucosamine ), skin - conditioning agents ( e . g ., humectants , including miscellaneous and occlusive ), skin soothing and / or healing agents ( e . g ., panthenol and derivatives ( e . g ., ethyl panthenol ), aloe vera , pantothenic acid and its derivatives , allantoin , bisabolol , and dipotassium glycyrrhizinate ), skin treating agents , thickeners , and vitamins and derivatives thereof , and combinations thereof . while the exact composition of the hair and / or skin lightening and / or neutralization agents or bleaching agents will vary depending upon the specific end use , an essential component of the system is the oxidizing or bleaching agent . useful oxidizing agents for compositions of this invention include but are not limited to hydrogen peroxide , urea peroxide , melamine peroxide , sodium perborate , sodium percarbonate and sodium persulfate . the quantity of oxidizing agent used will vary according to the particular agent employed and the specific end use of the composition . generally , the oxidizing agent will be present in the range from about 0 . 5 % to about 20 % by weight based upon the total weight of the lightening or bleaching system . when hydrogen peroxide is employed as the oxidizing agent , a non - limiting example of the range is from about 2 % to about 4 % by weight , based upon the total weight of the composition . the hair and / or skin lightening and / or neutralization agents or bleaching agents of the subject composition is an aqueous based composition with the terminology being used in its usual generic sense as inclusive of any water - containing compositions embodied in the invention . thus , this includes true solutions or mixtures of materials dissolved or dispersed in the aqueous medium . the amount of water present in this component can vary over a wide range depending in a large measure on the quantity of the other ingredients . various organic solvents may also be present in the composition for the purpose of solubilizing any of the components which may be insufficiently soluble in water . generally , the solvent selected is such as to be miscible with water and innocuous to the skin . suitable solvents include , for example , ethanol , isopropanol , glycerine , ethylene glycol , propylene glycol , ethylene glycol monoethyl ether , diethylene glycol , diethylene glycol monoethyl ether , etc . various thickening agents may also be incorporated in the composition component of the subject composition . useful thickening agents including sodium alginate , gum arabic , cellulose derivatives , such as methyl cellulose , hydroxyethyl cellulose , etc . likewise , inorganic thickening agents such as bentonite , talc and kaolin may be useful . the composition may have an antioxidant incorporated in it , and useful antioxidants for this purpose include sodium sulphite , thioglycollic acid , sodium hydrosulfite , and ascorbic acid . sequestering agents may also be present in the bleaching system . useful sequestering agents include ethylenediamine tetraacetic acid and its various sodium salts , tetrasodium pyrophosphate and the like . surfactants , additionally , may be present in the bleaching system and useful surfactants include the anionic , non - ionic and cationic type . also , the bleaching system may contain dyes , perfumes , and conditioners as are conventionally employed in the art . the term “ topical ” as employed herein relates to the use of a compound , derivative or analogue as described herein , incorporated in a suitable pharmaceutical carrier , and applied at the site of thinning hair for exertion of local action . accordingly , such topical compositions including those forms in which the compound is applied externally by direct contact with the skin surface to be treated . conventional forms for this purpose include ointments , liniments , creams , shampoos , lotions , pastes , jellies , sprays , aerosols , soaps , and the like , and may be applied in patches or impregnated dressings depending on the part of the body to be treated . the term “ ointment ” embraces formulations ( including creams ) having oleaginous , absorption , water - soluble and emulsion - type bases , e . g ., petrolatum , lanolin , polyethylene glycols , as well as mixtures of these . for topical use on the skin , eyelids , eyebrows , the active hair growth stimulating agents as well as their derivatives and analogues , including esters and salts , can be formulated in aqueous solutions , creams , ointments or oils exhibiting physiologically acceptable osmolarity by addition of pharmacologically acceptable buffers and salts . such formulations may or may not , depending on the dispenser , contain preservatives such as benzalkonium chloride , chlorhexidine , chlorobutanol , parahydroxybenzoic acids and phenylmercuric salts such as nitrate , chloride , acetate , and borate , or antioxidants , as well as additives like edta , sorbitol , boric acid etc . as additives . furthermore , particularly aqueous solutions may contain viscosity increasing agents such as polysaccharides , e . g ., methylcellulose , mucopolysaccharides , e . g ., hyaluronic acid and chondroitin sulfate , or polyalcohol , e . g ., polyvinylalcohol . various slow releasing gels and matrices may also be employed as well as soluble and insoluble ocular inserts , for instance , based on substances forming in - situ gels . depending on the actual formulation and the hair growth stimulating agents to be used , various amounts of the drug and different dose regimens may be employed . typically , the daily amount of the hair growth stimulating and / or hair loss prevention agent may be about 0 . 1 ng to about 100 mg , or about 1 ng to about 100 μg , but may be out of that range . for topical use , the hair growth stimulating and / or hair loss prevention agent can be advantageously formulated using ointments , creams , liniments or patches as a carrier of the active ingredient . also , these formulations may or may not contain preservatives , depending on the dispenser and nature of use . such preservatives include those mentioned above , and methyl -, propyl -, or butyl - parahydroxybenzoic acid , betain , chlorhexidine , benzalkonium chloride , and the like . various matrices for slow release delivery may also be used . typically , the dose to be applied is in the range of about 0 . 1 ng to about 100 mg per day , or about 1 ng to about 10 mg per day , or about 10 ng to about 1 mg per day depending on the hair growth stimulating agent and the formulation . to achieve the daily amount of medication depending on the formulation , the hair growth stimulating and / or hair loss prevention agent may be administered once or several times daily , with or without antioxidants . the composition or regime for application can be provided in the form of a hair care lotion , at various times , including but not limited to for example for daily or twice - weekly application , of a shampoo or of a hair conditioner , in particular for twice - weekly or weekly application , of a liquid or solid soap for cleaning , for daily application , of a product for shaping the hairstyle ( lacquer , hairsetting product , styling gel ), of a treatment mask , of a cream or of a foaming gel for cleaning the hair . it can also be provided in the form of a hair dye or mascara to be applied with a brush or comb . furthermore , for application to the eyelashes or body hairs , the composition and regime to which the invention relates can be provided in the form of a pigmented or nonpigmented mascara , applied with a brush pencil or other applicator device to the eyelashes or alternatively to the beard or moustache hairs , or scalp . according to a specific embodiment , the composition and regime according to the invention is provided in the form of a hair cream or lotion , shampoo , hair conditioner , hair mascara , or other hair coloring device , or of a mascara eyeliner , or pencil . non - limiting examples of topical products can include , without limitation , application stick , mascara , eyebrow coloring products , eye shadow or other eye lid coloring products , eyeliner , make - up removal products , antiaging products , facial or body powder , nail polish , mousse , sprays , styling gels , nail conditioner , bath and shower gels , shampoos , conditioners , cream rinses , hair dyes and coloring products , hair conditioners , sun tanning lotions and creams and sprays , sunscreens and sunblocks , skin conditioners , cold creams , moisturizers , hair sprays , soaps , body scrubs , exfoliants , astringents , depilatories and permanent waving solutions , antidandruff formulations , antisweat and antiperspirant compositions , shaving , preshaving and after shaving products , moisturizers , deodorants , cold creams , cleansers , skin gels , and rinses . furthermore , the topical product can be applied topically through the use of a patch or other delivery device . delivery devices can include , but are not limited to , those that can be heated or cooled , as well as those that utilize iontophoresis or ultrasound . for instance , the topical product can be applied , for example , by applying a composition in the form of a skin lotion , clear lotion , milky lotion , cream , gel , foam , ointment , paste , emulsion , spray , conditioner , tonic , cosmetic , application stick , pencil , foundation , nail polish , after - shave , or the like which is intended to be left on the skin or other keratinous tissue ( i . e ., a “ leave - on ” composition ). after applying the composition to the keratinous tissue ( e . g ., skin ), it in one embodiment , it is left on for a period of at least about 15 minutes , or at least about 30 minutes , or at least about 1 hour , or for at least several hours , e . g ., up to about 12 hours . in one embodiment , the topical product is left on overnight . in another embodiment , the topical product is left on all day . any part of the external portion of the face , hair , and / or nails can be treated , ( e . g ., face , lips , under - eye area , eyelids , scalp , neck , torso , arms , legs , chest , hands , legs , feet , fingernails , toenails , scalp hair , eyelashes , eyebrows , etc .) any suitable method can be used to apply the topical product , including but not limited to for example using the palms of the hands and / or fingers or a device or implement ( e . g ., a cotton ball , swab , pad , applicator pen , spray applicator , eyebrow brush , eyebrow brush pencil , pencil , mascara brush , etc .) another approach to ensure a continuous exposure of the keratinous tissue to at least a minimum level of the topical product is to apply the compound by use of a patch applied , e . g ., to the face . the patch can be occlusive , semi - occlusive or non - occlusive , and can be adhesive or non - adhesive . the topical product can be contained within the patch or be applied to the skin prior to application of the patch . the patch can also include additional actives such as chemical initiators for exothermic reactions such as those described in pct application wo 9701313 , and in u . s . pat . nos . 5 , 821 , 250 , 5 , 981 , 547 , and 5 , 972 , 957 to wu , et al . the patch can be left on the for any suitable period of time . for example , a period of at least about 5 minutes , or at least about 15 minutes , or at least about 30 minutes , or at least about 1 hour , or at night as a form of night therapy , or in another embodiment all day . the topical product can comprise any suitable desired materials . for instance , such materials can be selected from the group consisting of sugar amines ( e . g ., n - acetylglucosamine ), vitamin b3 compounds , sodium dehydroacetate , dehydroacetic acid and its salts , phytosterols , soy derivaties ( e . g ., equol and other isoflavones ), niacinamide , phytantriol , farnesol , bisabolol , salicylic acid compounds , hexamidines , dialkanoyl hydroxyproline compounds , flavonoids , n - acyl amino acid compounds , retinoids ( e . g ., retinyl propionate ), water - soluble vitamins , ascorbates ( e . g ., vitamin c , ascorbic acid , ascorbyl glucoside , ascorbyl palmitate , magnesium ascorbyl phosphate , sodium ascorbyl phosphate ), particulate materials , sunscreen actives , anti - cellulite agents , butylated hydroxytoluene , butylated hydroxyanisole , their derivatives , and combinations thereof . other examples include cationic polymers , conditioning agents ( hydrocarbon oils , fatty esters , silicones ), anti - dandruff agents , suspending agents , viscosity modifiers , dyes , nonvolatile solvents or diluents ( water soluble and insoluble ), pearlescent aids , foam boosters , surfactants , nonionic cosurfactants , pediculocides , ph adjusting agents , perfumes , preservatives , chelants , chelating agents , proteins , uv absorbers , pigments , other amino acids , and other vitamins . for instance , topical products for use herein may comprise one or more vitamins and / or amino acids such as : water soluble vitamins such as vitamin b1 , b2 , b6 , b12 , c , pantothenic acid , pantothenyl ethyl ether , panthenol , biotin , and their derivatives , water soluble amino acids such as asparagine , alanine , indole , glutamic acid and their salts , water insoluble vitamins such as vitamin a , d , e , and their derivatives , water insoluble amino acids such as tyrosine , tryptamine , and their salts . topical products may also contain one or more pigment materials such as inorganic , nitroso , monoazo , disazo , carotenoid , triphenyl methane , triaryl methane , xanthene , quinoline , oxazine , azine , anthraquinone , indigoid , thionindigoid , quinacridone , phthalocianine , botanical , natural colors , including : water soluble components such as those having c . i . names . the topical products may also contain antimicrobial agents which are useful as cosmetic biocides and antidandruff agents including : water soluble components such as piroctone olamine , water insoluble components such as 3 , 4 , 4 ′- trichlorocarbanilide ( trichlosan ), triclocarban and zinc pyrithione . in addition to the hair growth stimulating and / or hair loss prevention agent , and hair and / or skin lightening and / or neutralization agent , the compositions of the invention may include various other and additional ingredients , which may be active , functional , conventionally used in cosmetic , personal care or topical / transdermal pharmaceutical products or otherwise . of course , a decision to include an additional ingredient and the choice of specific additional ingredients depends on the specific application and product formulation . also , the line of demarcation between an “ active ” ingredient and an “ inactive ingredient ” is artificial and dependent on the specific application and product type . a substance that is an “ active ” ingredient in one application or product may be a “ functional ” ingredient in another , and vice versa . a particular ingredient might provide substantivity in one formulation , facilitate transdermal application in another , and merely provide proper viscosity in a third . which of these is functional and which is active is subject to debate . but , regardless of the outcome , the material in question would qualify as an additional ingredient in accordance with the present invention . thus , the compositions of the invention may include one or more additional ingredients , which provide some benefit to the object of the composition . such additional ingredients may include one or more substances such as , without limitations , cleaning agents , hair conditioning agents , skin conditioning agents , hair styling agents , antidandruff agents , hair growth promoters , perfumes , sunscreen and / or sunblock compounds , pigments , moisturizers , film formers , hair colors , make - up agents , detergents , pharmaceuticals , thickening agents , emulsifiers , humectants , emollients , antiseptic agents , deodorant actives , dermatologically acceptable carriers , surfactants , hair straightening agents , hair coloring agents , hair bleaching agents , and combinations thereof . the compositions of the present invention generally contain at least one additional ingredient . the compositions of the present invention may contain a plurality of additional ingredients as well . where the composition is to be in contact with human keratinous tissue , the additional ingredients should be suitable for application to keratinous tissue , that is , when incorporated into the composition they are suitable for use in contact with human keratinous tissue ( hair , nails , skin , lips ) without undue toxicity , incompatibility , instability , allergic response , and the like within the scope of sound medical judgment . the ctfa cosmetic ingredient handbook , ninth edition ( 2002 ) describes a wide variety of nonlimiting cosmetic and pharmaceutical ingredients commonly used in the skin care industry , which are suitable for use as additional ingredients in the compositions of the present invention . non - limiting examples of these additional ingredient classes include : abrasives , absorbents , aesthetic components such as fragrances , pigments , colorings / colorants , essential oils , skin sensates , astringents , etc . ( e . g ., clove oil , menthol , camphor , eucalyptus oil , eugenol , menthyl lactate , witch hazel distillate ), anti - acne agents , anti - caking agents , antifoaming agents , antimicrobial agents ( e . g ., iodopropyl butylcarbamate ), antioxidants , binders , biological additives , buffering agents , bulking agents , chelating agents , chemical additives , colorants , cosmetic astringents , cosmetic biocides , denaturants , drug astringents , external analgesics , film formers or materials , e . g ., polymers , for aiding the film - forming properties and substantivity of the composition ( e . g ., copolymer of eicosene and vinyl pyrrolidone ), opacifying agents , ph adjusters , propellants , reducing agents , sequestrants , skin bleaching and lightening agents ( e . g ., hydroquinone , kojic acid , ascorbic acid , magnesium ascorbyl phosphate , ascorbyl glucosamine ), skin - conditioning agents ( e . g ., humectants , including miscellaneous and occlusive ), skin soothing and / or healing agents ( e . g ., panthenol and derivatives ( e . g ., ethyl panthenol ), aloe vera , pantothenic acid and its derivatives , allantoin , bisabolol , and dipotassium glycyrrhizinate ), skin treating agents , thickeners , vitamins and derivatives thereof , hair straightening agents , hair coloring agents , hair bleaching agents , and combinations thereof . in any embodiment of the present invention , however , the additional ingredients useful herein can be categorized by the benefit they provide or by their postulated mode of action . however , it is to be understood that the additional ingredients useful herein can in some instances provide more than one benefit or operate via more than one mode of action . therefore , classifications herein are made for the sake of convenience and are not intended to limit the additional ingredients to that particular application or applications listed . the compositions of the invention may be used in various cosmetic and / or personal care products , for example , skin care , hair care , nail care , facial and body care and sunscreen compositions , such as lotions , gels , sprays , and the like , hand cleaners , bath compositions , suntan oils , anti - perspirant compositions , perfumes and colognes , cold creams , hair sunscreen compositions , pre - shaves , deodorants , topical pharmaceutical ointments , skin moisturizers , facial cleansers , cleansing creams , skin gels , shampoos , hair conditioners , detergents , household cleaning products , make - up products , lipstick products , mascara , hair coloring products , hair straightening agents , hair coloring agents , hair bleaching agents , and combinations thereof . therefore , in addition to any of the above cited skin care or hair care peptides and other actives , the cosmetic compositions described in the present invention may often include as an additional ingredient a dermatologically acceptable carrier . the form of the composition and the final product may be any of the following : liquids , gels , creams , water - in - oil and oil - in - water , and silicone emulsions , foams , and solids ; they may be clear or opaque ; and may be formulated as both aqueous and non - aqueous preparations , including but not limited to topical preparations . to realize the invention in any of these physical forms , further substances , agents and compounds are useful although not always necessary such as conditioning agents , structuring agents and thickening agents . these compounds sometimes also have the role of adjuvant and sometimes the role of additional ingredient . the nature of the dermatologically acceptable carrier , the nature of the final product , and the methods of preparing those need not be described here in detail ; many examples can be found in the available literatures , such as pct application no . wo 00 / 62743 filed by larry r . robinson et al . on apr . 19 , 2000 , published on oct . 26 , 2000 , or , more generally , in milady &# 39 ; s standard textbook of cosmetology 2000 , ( delmar learning ) or in formulation technology : emulsions , suspensions , solid forms by hans mollet , arnold grubenmann and helen payne , published by john wiley & amp ; sons ( jan . 23 , 2001 ), or in chemistry and technology of the cosmetics and toiletries industry by clifford williams schmitt , kluwer academic publishers , dordrecht july 1996 , all hereby incorporated . fiedler &# 39 ; s encyclopedia of excipients , fifth edition , edition cantor verlag aulendorf , 2002 is also a useful guide for the formulator skilled in the art of developing cosmetic carriers . all ingredients listed therein may in one way or another be combined to form a dermatologically acceptable carrier and / or used as an additional ingredient for the cosmetic compositions of the invention . in most instances , the additional ingredients will include a dermatologically acceptable carrier either alone or in combination with still other additional ingredients . the amounts of additional ingredients may range from about 99 . 5 % to about 99 . 99999 %, or from about 99 . 9 % to about 99 . 9999 %, or from about 99 . 99 % to about 99 . 999 %, of the composition , but may be outside these ranges . in short , it is the balance of the composition . if carriers ( either singularly , such as water , or complex cosolvents ) are used , they may make up the entire balance of the compositions . the carrier can be in a wide variety of forms . for example , emulsion carriers , including , but not limited to , oil - in - water , water - in - oil , water - in - oil - in - water , and oil - in - water - in - silicone emulsions , are useful herein . non - limiting examples of carriers include carriers which contain an emulsion such as oil - in - water emulsions , water - in - oil emulsions , and water - in - silicone emulsions . as will be understood by the skilled artisan , a given component will distribute primarily into either the water or oil / silicone phase , depending on the water solubility / dispersibility of the component in the composition . emulsions according to the present invention generally contain a solution as described above and a lipid or oil . lipids and oils may be derived from animals , plants , or petroleum and may be natural or synthetic ( i . e ., man - made ). emulsions may also contain a humectant , such as glycerin . emulsions may further contain from about 0 . 01 % to about 10 %, or from about 0 . 1 % to about 5 %, of an emulsifier , based on the weight of the carrier . emulsifiers may be nonionic , anionic or cationic . suitable emulsifiers are disclosed in , for example , u . s . pat . no . 3 , 755 , 560 , issued aug . 28 , 1973 , dickert et al . ; u . s . pat . no . 4 , 421 , 769 , issued dec . 20 , 1983 , dixon et al . ; and mccutcheon &# 39 ; s detergents and emulsifiers , north american edition , pages 317 - 324 ( 1986 ). the emulsion may also contain an anti - foaming agent to minimize foaming upon application to the keratinous tissue . anti - foaming agents include but are not limited to high molecular weight silicones and other materials well known in the art for such use . lotions and creams according to the present invention generally contain a solution carrier system and one or more emollients . lotions and creams may for example contain from about 1 % to about 50 %, or from about 1 % to about 20 %, of emollient ; from about 50 % to about 90 %, or from about 60 % to about 80 % of water ; and the tetrapeptide and tripeptide mixture and the optional additional skin care active ( or actives ) in the above described amounts . creams are generally thicker than lotions due to higher levels of emollients or higher levels of thickeners . ointments of the present invention may contain a simple carrier base of animal or vegetable oils or semi - solid hydrocarbons ( oleaginous ); absorption ointment bases which absorb water to form emulsions ; or water soluble carriers , e . g ., a water soluble solution carrier . ointments may further contain a thickening agent , such as described in sagarin , cosmetics , science and technology , 2nd edition , vol . 1 , pp . 72 - 73 ( 1972 ), incorporated herein by reference , and / or an emollient . for example , an ointment may contain from about 2 % to about 10 % of an emollient ; from about 0 . 1 % to about 2 % of a thickening agent ; and the tetrapeptide and tripeptide mixture and the optional additional skin care active ( or actives ) in the above described amounts . typically , the composition may be applied repeatedly for a sustained period of time topically on the part of the body to be treated , for example , the eyelids , eyebrows , skin or scalp . the dosage regimen will generally involve regular , such as daily , administration for a period of treatment of at least one month , or at least three months , or at least six months . alternatively , the composition may be applied intermittently , or in a pulsed manner . accordingly , an alternative embodiment of the invention is to apply the composition on an intermittent or pulsed dosage schedule . for example , the composition of the invention may be used for two or more days , stopped , then restarted again at a time from between 2 weeks to 3 months later , and at even more long - spaced intervals in the case of the scalp . for topical use on the eyelids or eyebrows , the composition can be formulated in aqueous solutions , creams , ointments or oils exhibiting physiologically acceptable osmolarity by addition of pharmacologically acceptable buffers and salts . such formulations may or may not , depending on the dispenser , contain preservatives such as benzalkonium chloride , chlorhexidine , chlorobutanol , parahydroxybenzoic acids and phenylmercuric salts such as nitrate , chloride , acetate , and borate , or antioxidants , as well as additives like edta , sorbitol , boric acid etc . as additives . furthermore , particularly aqueous solutions may contain viscosity increasing agents such as polysaccharides , e . g ., methylcellulose , mucopolysaccharides , e . g ., hyaluronic acid and chondroitin sulfate , or polyalcohol , e . g ., polyvinylalcohol . various slow releasing gels and matrices may also be employed as well as soluble and insoluble ocular inserts , for instance , based on substances forming in - situ gels . depending on the actual formulation and hair growth stimulant , and / or hair growth stimulating agent and / or hair density increasing agent and / or hair loss prevention agent to be used , various amounts of the drug and different dose regimens may be employed . typically , the daily amount of hair growth stimulant , and / or hair growth stimulating agent and / or hair density increasing agent and / or hair loss prevention agent for treatment may be about 0 . 1 ng to about 100 mg , or about 1 ng to about 100 μg . for topical use on the skin and the scalp , the composition can be advantageously formulated using ointments , creams , liniments or patches as a carrier of the active ingredient . also , these formulations may or may not contain preservatives , depending on the dispenser and nature of use . such preservatives include those mentioned above , and methyl -, propyl -, or butyl - parahydroxybenzoic acid , betain , chlorhexidine , benzalkonium chloride , and the like . various matrices for slow release delivery may also be used . typically , the dose to be applied is in the range of about 0 . 1 ng to about 100 mg per day , or about 1 ng to about 10 mg per day , or about 10 ng to about 1 mg per day depending on the hair growth stimulant , and / or hair growth stimulating agent and / or hair density increasing agent and / or hair loss prevention agent and the formulation . to achieve the daily amount of medication depending on the formulation , the hair growth stimulant , and / or hair growth stimulating agent and / or hair density increasing agent and / or hair loss prevention agent may be administered once or several times daily with or without antioxidants . the invention will be illustrated in more detail with reference to the following examples , but it should be understood that the present invention is not deemed to be limited thereto . 2 syntran 5170 , containing 41 % by weight waterinsoluble polymer solids , available from interpolymer corp . 1 vinex , available from air products and chemicals , incorporated via a 16 . 22 w / w % stock solution in deionized water . 5 syntran 5170 , containing 41 % by weight waterinsoluble polymer solids , available from interpolymer corp . 2 dow corning 3225c , supplied as a solution of dimethicone copolyol in cyclomethicone available from dow corning 5 vinex , available from air products and chemicals , incorporated via a 20 . 0 w / w % stock solution in deionized water . this lotion is applied to the scalp one or two times daily at the rate of 1 ml per application , the scalp being lightly massaged to bring about the penetration of the active principle . the hair is subsequently dried in the open air . this lotion makes it possible to reduce hair loss and to promote hair regrowth . the mascara is applied to the eyelashes like a conventional mascara with a mascara brush . while the invention has been described in detail and with reference to specific examples thereof , it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof .

this invention relates to compositions and processes for stimulating the growth of mammalian hair comprising the topical application of compositions comprising a hair growth stimulating and / or hair loss prevention agent , and a hair and / or skin lightening and / or neutralization agent , in association with a topical pharmaceutical carrier . unlike other products , the composition of the invention can be used with dyed / treated hair so as to not affect the color of the hair .

refer now to fig1 to 3 showing a preferred embodiment of the injection site apparatus 10 . the flexible tube 11 of an i . v . delivery set is shown passing through tube housing 12 . tube housing 12 is provided with a recess channel 13 having a circular portion 14 and a converging tapered insert guide 15 . the circular portion 14 embraces more than 180 degrees of the circumference of the flexible tube 11 . the flexible tube 11 and its tube housing 12 must provide a sterile environment . accordingly , the injection site apparatus 10 may be sterilized after being placed on the flexible tube 11 employing prior art sterilizatation means or processes . further , the flexible tube 11 may be snapped into the tube housing 12 with an antiseptic solvent type cement therebetween which provides self sterilization . tube housing 12 is preferably made of a non - toxic grade of a semi - rigid plastic such as the polystyrenes , the polycarbonates and / or acrylics . a piercable hypodermic closure receiver 16 is formed as a recess in the end of tube housing 12 . a piercable closure 17 of the well known resilient type is mounted in the piercable closure receiver 16 and held in place therein by secondary needle guide 18 which also forms a sealing ring for compressing the piercable closure 17 in the receiver 16 . preferably , piercable closure 17 and receiver 16 are cylindrical in shape and the sealing ring 18 is formed as an annular ring . primary needle guide 19 is formed in the tube housing 12 intermediate the piercable closure receiver 16 and the recess channel 13 . recess channel 13 comprises an outlet portion 21 which is axially aligned with the primary needle guide 19 and the secondary needle guide 18 . the inlet portion 22 of recess channel 13 is formed at an angle with outlet portion 21 so as to cause the flexible tube 11 to be bent and to expose a side wall surface to the small diameter end of primary needle guide 19 . it will be understood that when a hypodermic needle is inserted through the secondary needle guide 18 it is guided through the center of the piercable closure 17 and into the large diameter end of the primary needle guide 19 . then it is aligned as it passes through the small diameter end of the primary needle guide 19 directly into alignment with the inside diameter of the flexible tube 11 in the outlet portion 21 of recess channel 13 . when the hypodermic needle is inserted through the side wall of flexible tube 11 , there is no air introduced into the inside of the flexible tube 11 of the i . v . delivery set . when the hypodermic needle is removed from the flexible tube 11 of the i . v . delivery set , the flexible tube 11 closes at the puncture site so as to prevent leakage of fluid therefrom or air therein . the piercable closure 17 prevents any liquid that may seep out of the puncture hole in the flexible tube 11 from escaping from the tube housing 12 and also both seals and holds any air that was already in the primary needle guide 19 from being pulled into or pumped into the flexible tube 11 . refer now to fig4 and 5 showing a modified embodiment structure of the preferred embodiment . recess channel 13 of tube housing 12 &# 39 ; is provided with an outlet portion 21 and an inlet portion 22 . also formed in tube housing 12 &# 39 ; is a primary needle guide 23 which connects to the outlet portion 21 . an extended cylindrical portion 24 of housing 12 &# 39 ; forms a piercable hypodermic needle closure receiver for piercable closure 25 . portion 24 is provided with a sealing flange 26 and an aperture or recess 27 in the body or cylindrical portion 24 . the secondary needle guide 28 is formed in the extended cylindrical portion 24 of housing 12 &# 39 ;. it will be understood that the primary needle guide 23 is longer than the primary needle guide 19 and the secondary needle guide 28 is further removed from the outlet of the primary needle guide 23 so that a hypodermic needle is more accurately axially aligned with the center of the flexible tube 11 . further , the extended cylindrical portion 24 may be manufactured as a separate hat - shaped element and bonded onto a flange on tube housing 12 &# 39 ;. the piercable closure 25 is shown as a molded hat - shaped part , but may be made in the form of a flat disk from flat sheet stock instead of making a molded part . the advantage of a flat disk shape piercable closure is that it is cheaper and the amount of resistance to a hypodermic needle may be more easily controlled . refer now to fig6 showing an end view of another modified embodiment structure . tube housing 29 has a recess channel 31 therein comprising a circular portion 32 and a converging tapered guide portion 33 . lock portion 34 of recess channel 31 is adapted to receive tube retainer 35 therein . tube retainer 35 comprises a circular tube engaging portion 37 and a tube locking portion comprising tapered keys 38 . tube retainer 35 may be provided with a connector portion 39 which may be molded as a separate element . the diameter of the circular portion of the tube housings 12 and 29 are made slightly smaller than the outside diameter of the flexible tubes 11 so that there is a slight compressive force applied by the tube housings . when tube retainer 35 is snapped into the lock portion 34 , it is adapted to apply a slight compressive force similar to that being applied by the tube housings 12 . by applying a continuous compressive force to the outside diameter of flexible tube 11 , there is provided a pressure seal between the flexible tube 11 and the circular recess portion 32 of tube housing 29 . fig7 shows another modified embodiment in which the preferred embodiment needle guides are integral with closed recess channel 41 . channel 41 is cylindrical in shape and comprises a cylindrical outlet portion 42 and a cylindrical inlet portion 43 . the intermediate ends 44 of flexible tube 11 are adhesively bonded into cylindrical recess ends 45 and 46 of tube housing 40 . preferably the cylindrical portions 42 and 43 of the closed recess channel are approximately the same diameter as the inside diameter of the flexible tube 11 . it will be understood that a hypodermic needle will be guided by the primary needle guide 19 and secondary needle guide 18 through the center of piercable closure 17 so as to enter the center of axially aligned outlet portion 42 of the recess channel 41 without engaging the side walls . the needle guide 18 is preferably provided with symmetrical tapers . piercable closure receiver 16 is preferably tapered , thus , needle guide 18 may be machine assembled and ultrasonically welded in place without having to be oriented . fig8 shows a modified enlarged partial section in elevation of the novel needle guides 18 and 19 . primary needle guide 19 &# 39 ; is preferably shaped as a converging cone having its reduced diameter outlet 47 terminating directly in engagement with the side wall of flexible tube 11 . when the hypodermic needle 48 passes through the side wall of the flexible tube 11 it causes bulging of the tube against the hypodermic needle 48 . in similar manner when the hypodermic needle 48 is inserted through the piercable closure 17 &# 39 ;, it causes bulging of the resilient piercable closure at the large diameter inlet 49 of the primary needle guide 19 &# 39 ; and seals against the sides of needle 48 . secondary needle guide 18 &# 39 ; is provided with a reduced diameter outlet 50 which has a larger diameter than the reduced diameter outlet 47 of the primary needle guide 19 &# 39 ;. preferably the large diameter inlet 49 of the primary needle guide 19 &# 39 ; is larger than the reduced diameter outlet 50 of secondary needle guide 18 &# 39 ;. housing 51 is shown having a cylindrical extension 52 . a piercable closure receiver 53 is mounted on extension 52 and adapted to hold in compression piercable closure 17 &# 39 ;. while the piercable closure 17 &# 39 ; is shown with a bulge induced by the hypodermic needle 48 , it will be understood that the compressive force of receiver 53 causes piercable closure 17 &# 39 ; to extend outward into opening 50 , thus , permitting piercable closure 17 &# 39 ; to be easily wiped sterile prior to inserting hypodermic needle 48 . the injection sites shown in fig1 and 8 are adapted to permit the novel needle guides 19 , 23 and 19 &# 39 ; and piercable closures 17 , 25 , and 17 &# 39 ; to be leak tested prior to use . when an opening is provided in the flexible tube 11 at the needle guide opening 47 , leak testing of flexible tube 11 also tests the seal of the piercable closure as well as the outside wall of flexible tube 11 against its housing . the opening in flexible tube 11 may be made prior to being inserted into its housing , at the time of insertion into its housing or by a needle inserted through the piercable closure after assembly of tube 11 into its housing and mounting of the piercable closure thereon . it will be noted by examination of the enlarged fig8 that the hypodermic needle 48 may be removed from flexible tube 11 and there is no requirement that the puncture in the side wall of flexible tube 11 be completely sealed . no air has been introduced into the inside diameter of flexible tube 11 by virtue of a hypodermic needle 48 being inserted there through , and the small amount of air which is entrapped in primary needle guide 19 &# 39 ; cannot be pumped or forced out by the flow of the fluid inside of tube 11 . the air in primary needle guide 19 &# 39 ; is trapped in a manner which prevents it from entering tube 11 even though fluid from tube 11 may enter primary needle guide 19 &# 39 ;.

an injection site apparatus is adapted to be attached to a continuous unbroken portion of a flexible tube of an intravenous delivery set . the apparatus is provided with a recessed channel for supporting and bending a portion of the flexible tube . the apparatus is provided with a piercable closure and a needle guide which are axially aligned with a portion of the recessed channel . the piercable closure and needle guide align a hypodermic needle in axial alignment with the center of said flexible tube to prevent interference therewith .

the present invention relates to linear or cyclic peptides of the general formula : d is ser , thr , asn , glu , arg , ile , leu or absent , all of the mentioned amino acids may be in the configuration of l - or d - isomers , and candidates for h might be esterified or amidated . the peptide comprises at least 4 amino acids . the tetra -, penta -, hexa -, hepta -, octa - and nonapeptides are all of the peptides chosen within the sequence : by deleting one at a time from either the carboxyl or amino terminal . quite often it may be an advantage to have the amino terminal amino acid as a d - stereoisomer , to protect the molecule from degradation from aminopeptidases , and the carboxy terminal amino acid may also quite often be an amino acid amide to protect the molecule from degradation from carboxypeptidases . compounds 5 , 6 and 7 include the analogues with d - thr as the amino terminal residue and / or an amide derivative at the carboxy terminal . furthermore , it should be understood that one or more of the amino acids in the peptides may be substituted n - alkyl amino acids instead of primary amino acids , e . g . substituted by methyl or ethyl . the hydroxyl group side chains of one or more of the amino acids ( ser , thr , tyr ) may be derivatized into an ether or ester group . any alkyl ester or ether may be formed , for example phenylester , benzylether or thiophenol ethylester . the presently preferred ethers are methyl , ethyl and propylethers , and presently preferred esters are methyl , ethyl and propylester . the linear peptides described in this invention may be prepared by any process , such as conventional solid phase peptide synthetic techniques , see solid phase peptide synthesis , 2nd ed ., j . m . stewart , j . d . young , pierce chemical company , 1984 , isbn : 0 - 935940 - 03 - 0 . another possibility is solution phase techniques . the cyclic peptides may be prepared by known techniques , such as , for example , described in y . hamada , tetrahedron letters , vol . 26 , p . 5155 , 1985 . the cyclic peptides may be established in the form of an - s - s - bridge between two cys - residues and / or reacting the carboxy terminal amino acid residue with the amino terminal residue and / or reacting the amino terminal residue with for example the gamma carboxyl group of glu , when glu is at position d . the invention also relates to pharmaceutical compositions and compositions of matter comprising the peptides for treating or preventing any disease or condition caused by herpes viruses , especially herpes simplex virus - 1 ( hsv - 1 ), herpes simplex virus - 2 ( hsv - 2 ), varizella zoster virus ( vzv ), human cytomegalovirus ( hcv ) or epstein - barr virus ( ebv ). the peptides can be used for the manufacture of a medicament for treatment of or preventing any disease or condition caused by herpes viruses , especially herpes simplex virus - 1 ( hsv - 1 ), herpes simplex virus - 2 ( hsv - 2 ), varizella zoster virus ( vzv ), human cytomegalovirus ( hcv ) or epstein - barr virus ( ebv ). the peptides and the compositions according to the invention may be administered orally , buccally , parenterally , topically , rectally or by inhalation spray . in particular , the peptides according to the invention may be formulated for topical use , for inhalation by spray , for injection or for infusion and may be presented in unit dose form in ampoules or in multidose containers with an added preservative . the compositions may take such forms as suspensions , solutions , or emulsions in oily or aqueous vehicles , and may contain formulatory agents such as suspending , stabilizing and / or dispersing agents . alternatively , the active ingredient may be in powder form for constitution with a suitable vehicle , e . g . sterile , pyrogen - free water , before use . the pharmaceutical compositions according to the invention may also contain other active ingredients such as anti - microbial agents , or preservatives . the compositions are administered in therapeutically or immunogenically effective doses , i . e . 0 . 05 - 10000 mg of peptide per day , preferred 0 . 5 - 1000 mg of peptide per day , in particular 5 - 100 mg per day . very large doses may be used as the peptide according to the invention is non - toxic . however , normally this is not required . the dose daily administered of course depends on the disease or condition to be treated or prevented and on the mode of administering . the invention further provides a method for treatment of any illness caused by herpes simplex virus - 1 ( hsv - 1 ), herpes simplex virus - 2 ( hsv - 2 ), varizella zoster virus ( vzv ), human cytomehalovirus ( hcv ) or epstein - barr virus ( ebv ), wherein a peptide or a composition is administered in an effective amount for treatment of the illness caused by the virus . all usual excipients and carriers can be used in the composition of the invention . it will of course also be possible to use the peptides of this invention for diagnoses of herpes viruses . a 38 - year - old caucasian male with a two - day history of painful lesions of the lower lip , clinically consistent with hsv - 1 infection , was examined . the patient had experienced similar lesions during the past 18 years , primarily during the winter months . he would usually experience 3 - 5 outbreaks each winter lasting 10 - 14 days before complete resolution . one year ago , he applied aciclovir topical to the lesions and on that occasion , resolution occured in 6 - 8 days . on this occasion , he denied recent use of any topical or systemic therapy . on examination , he appeared as a well man , afibrile and vital signs within normal limits . there were two immature vesicles , one mature vesicle , two vesicles that had already ulcerated and a small patch of skin that was erythematous and painful to palpation , indicating a site of future vesicle formation . in addition , there were two three mm diameter ulcers on the buccal surface of the lower lip . no significant adenopathy was palpable at any site . the patient was given ( d - ala 1 )- peptide - t amide , 10 mg / ml in pyrogen - free distilled water to be applied to the lesions as a thin film three times daily . within 36 hours , the early lesions as well as the vesicular lesions had virtually resolved and the ulcerative lesions were healing well . essentially , complete resolution was achieved within 3 days and within 6 days the ulcerated lesions had cleared . no drug was applied to the lesions of the buccal mucosa , however they had also resolved within 4 days . the patient did not report any systemic or local effects other than those noted above . a 42 - year - old caucasian female with a one - day history of a painful lesion just under the right nostril , consistent clinically with hsv - 1 infection , was examined . the patient had experienced lesions caused by hsv - 1 regularly during the last three years , normally in connection with a cold . normal frequency of outbreaks would be 6 - 7 times per year , lasting approximately 12 - 14 days before a complete resolution . the outbreaks would normally be centered around the nostrils and on the lips and would , untreated , develop into open and painful suppurating ulcers with a diameter close to 8 mm . when the lesions are treated with a 5 % aciclovir ointment , topically , resolution is normally achieved within 6 - 7 days . very early treatment of the lesions with aciclovir has not been able to stop the vesicles developing into painful ulcers although the ulcers tend to decrease in size . on this occasion , she denied any recent use of any topical or systemic therapy . there was one mature painful vesicle situated just under the right nostril . the patient was given ( d - ala 1 )- peptide - t amide , 10 mg / ml in pyrogen - free distilled water to be applied three times per day . immediately after the first treatment , the patient experienced a relief of pain and after two days , resolution had occured without the vesicles developing into open ulcers . the same patient as described in example 2 was , four weeks later , treated for a new attack of hsv - 1 . four mature one - day old painful vesicles had developed . they were treated with ( d - ala 1 )- peptide - t amide , 2 mg / ml in pyrogen - free distilled water . the drug was applied in a thin film twice a day for two days and the outcome was a repeating of the first treatment described in example two . the vesicles were resolved without developing into ulcers . however , the vesicles were appearing again one day after the treatment had stopped and the same solution of the drug was applied for the next two days , twice a day , with complete resolution of the vesicles . no outburst was observed within the next month . a 29 - year - old caucasian male with a 2 - day history of ulcerated lesions in the left nostril , consistent clinically with hsv - 1 infection , was examined . the patient had experienced lesions caused by hsv - 1 regularly during the last 10 years with a frequency of 3 - 5 times per year . untreated , the lesions would normally have healed within 12 - 15 days . the outbreaks would normally be centered just inside the nostrils and under the nose . the patient has never experienced any effect from the use of aciclovir . the ulcer was treated with ( d - ala 1 )- peptide - t amide , 10 mg / ml in water , four times in 36 hours . within 48 hours , the ulcers had become dry and then disappeared . no medications were used concomitantly and the patient did not experience any systemic or local effects other than those noted above . a 23 - year - old caucasian female with a thirteen - day history of painful lesions of the upper lip , consistent clinically with hsv - 1 infection , was examined . the patient had experienced outbreaks from hsv - 1 from the age of two . five years ago the patient started to use aciclovir topically on a regular basis , but switched to take aciclovir orally 11 / 2 years ago . normally the outbreaks would be on the lips , but occasionally the outbreaks would also appear on the neck and on the buccal mucosa . without any form of medication , complete resolution would happen within 2 - 3 weeks and complete resolution by using aciclovir orally would happen within 1 - 2 weeks . on this occation , the patient had started treatment of a hsv - 1 outbreak on the left side of the upper lip by aciclovir tablets ( 200 mg per tablet , 3 - 5 tablets per day ), just as the first outbreak appeared 11 days ago and before mature vesicles had appeared . the treatment continued for five days until ulceration had occured . five days later , another outbreak started approximately 0 . 5 cm away from the first outbreak , which was still ulcerated . no treatment by any medication was started this time and within the next three days , several small vesicles were developing into one large vesicle followed by ulceration that easily cracked causing pain . the patient was given ( d - ala 1 )- peptide - t amide ,. 10 mg / ml in pyrogen - free destined water , to be applied to the lesion two times daily as a thin film . an immediate decrease in the size of the vesicle and the ulcer was observed , and within seven days complete resolution had occured . compared to the aciclovir treatment , the following differences were observed : the ulcer was thinner and did not tend to crack and bleed as easily as usually and the pain related to the outbreak from the time of ulceration was heavily reduced compared with treatment using aciclovir . the patient did not observe any systemic or local effects other than those noted above . __________________________________________________________________________sequence listing ( 1 ) general information :( iii ) number of sequences : 7 ( 2 ) information for seq id no : 1 :( i ) sequence characteristics :( a ) length : 8 amino acids ( b ) type : amino acid ( c ) strandedness :( d ) topology : linear ( ii ) molecule type : peptide ( xi ) sequence description : seq id no : 1 : alaserthrthrthrasntyrthr15 ( 2 ) information for seq id no : 2 :( i ) sequence characteristics :( a ) length : 8 amino acids ( b ) type : amino acid ( c ) strandedness :( d ) topology : linear ( ii ) molecule type : peptide ( xi ) sequence description : seq id no : 2 : alaserthrthrthrasntyrthr15 ( 2 ) information for seq id no : 3 :( i ) sequence characteristics :( a ) length : 8 amino acids ( b ) type : amino acid ( c ) strandedness :( d ) topology : linear ( ii ) molecule type : peptide ( xi ) sequence description : seq id no : 3 : alaserthrthrthrasntyrthr15 ( 2 ) information for seq id no : 4 :( i ) sequence characteristics :( a ) length : 8 amino acids ( b ) type : amino acid ( c ) strandedness :( d ) topology : linear ( ii ) molecule type : peptide ( xi ) sequence description : seq id no : 4 : alaalaserserserasntyrmet15 ( 2 ) information for seq id no : 5 :( i ) sequence characteristics :( a ) length : 5 amino acids ( b ) type : amino acid ( c ) strandedness :( d ) topology : linear ( ii ) molecule type : peptide ( xi ) sequence description : seq id no : 5 : thraspasntyrthr15 ( 2 ) information for seq id no : 6 :( i ) sequence characteristics :( a ) length : 5 amino acids ( b ) type : amino acid ( c ) strandedness :( d ) topology : linear ( ii ) molecule type : peptide ( xi ) sequence description : seq id no : 6 : thrthrsertyrthr15 ( 2 ) information for seq id no : 7 :( i ) sequence characteristics :( a ) length : 5 amino acids ( b ) type : amino acid ( c ) strandedness :( d ) topology : linear ( ii ) molecule type : peptide ( xi ) sequence description : seq id no : 7 : thrthrasntyrthr15__________________________________________________________________________

peptides of the general formula : i - a - b - c - d - e - f - g - h - ii are disclosed as being active against herpes virus infections in animals and human beings , wherein a is ala , gly , val or absent ; b is ala , gly , val , ser or absent ; c is ser , thr or absent ; d is ser , thr , ans , glu , arg , ile , leu or absent ; e is ser , thr , asp or absent ; f is thr , ser , asn , gln , lys , trp or absent ; g is tyr or absent ; h is thr , gly , met , met , cys , thr or gly ; i is cys or absent , and ii is cys , an amide group , substituted amide group , an ester group or absent , wherein the peptides comprise at least 4 amino acids and physiologically acceptable salts thereof .

referring now to fig1 we see a typical illustration of the subject invention in use by an exerciser 12 . the pulse monitoring system consists of the sensor assembly 14 and the electronic package assembly 18 connected by a thin , flexible , stress relieved cable 20 disposed between the sensor and electronic assembly . the entire system weighing only a few ounces , is powered by small batteries and is generally worn by the subject or attached to the exercise equipment . in normal use , pulse rate is automatically indicated without prior settings or adjustments . as shown , the sensor assembly 14 is attached to the ear 16 of the exerciser and the electronic package assembly 18 is attached to his belt . the method of attaching sensor assembly 14 to the ear is shown in detail in fig2 . near the end of wire 20 there is a clip 22 which attaches to an earpiece 24 of a pair of glasses worn by the exerciser . the attachment could just as well be made on a head band , hat or some other article of clothing or equipment worn by the exerciser . the loop in wire 20 between the sensor assembly and the clip 22 serves to isolate the sensor assembly 114 from physical stresses imposed by the total weight of wire 20 which if unrelieved would tend to change the physical relationship between the ear and the sensor . this change could degrade the signals leading to incorrect pulse rate values . sensor assembly 14 is shown attached to the upper area of ear 16 . while the unit will work equally well attached to the lobe or to other appendages such as the septum of the nose or the web between the thumb and forefinger of the hand , this position has the advantage of convenience , good signal level , and rigidity of tissue . all of these factors tend to optimize the sensor performance . in normal operation with sensor assembly 14 attached to the exerciser &# 39 ; s or subject &# 39 ; s ear and with the unit turned &# 34 ; on &# 34 ;, the emitter / detector light path is modulated by the ebb and flow of blood through the ear . the signal is conducted to the electronic package assembly 18 through wire 20 where it is amplified , filtered , converted to digital counts and shown on a display . audio signal setting for high and low pulse rates can be made to warn the exerciser when the limits have been exceeded . the physical design of sensor assembly 14 is shown in detail in fig3 and 5 . the electrical circuit is shown in fig6 . referring now to fig3 a side view of the sensor assembly is shown . a light shield plate 40 and a sensor plate 50 comprise the two main parts of the sensor assembly . both plates contain contain emitters 44a and 44b in housings 46a and 46b respectively whereas only the sensor plate 50 contains the detector 52 in housing 46c . in the present instance the detector 52 may be a photodetector for sensing light reflected or transmitted by the emitters . the two plates are pivoted about bolt 32 . as shown in fig4 tension to hold the two sensor plates 40 and 50 normally closed is maintained by a tab 34 on the end of spring 36 which is disposed around and along the length of bolt 32 . the spring is locked in place by nut 37 . the effect of the physical configuration and the spring is to bring the emitters and detector in close proximity to one another with enough clamping action provided by the spring so as to prevent the sensor assembly from moving when applied to the user &# 39 ; s ear , for example . the pressure applying relation , however , is not so great to materially change normal flow of blood . the light shield prevents extraneous ambient light from entering into the detector 52 . the details of light shield plate 40 are shown in fig4 and is characterized by a relatively large plate which , as shown in fig1 and 2 fits on the outer side of the subject &# 39 ; s ear . roughly centered within the light shield plate 40 is a small housing 46a containing the infrared emitting diode ( ired ) 44a which physically fits up against the outer side of ear 16 . the housings 46a , 46b and 46c as illustrated in fig3 have confronting curved or arcuate faces so that the skin conforms to the housings providing good contact at the point of interest ; namely , the desired area of the skin for monitoring blood flow . the housing 46a containing the ired 44a along with leads 20a and 20b is attached to the light shield plate 40 with the leads fitted into a channel - like slot 48 of the arm of the light shield plate . turning now to fig5 we see the details of sensor plate 50 . this comprises a basically rectangular piece rotatably attached to clamp 30 so as to fit onto the inside of ear 16 . at the upper end , two arcuate faced housings , disposed side by side are attached . one housing 46b contains a second ired 44b and the other housing 46c contains a small infrared detector 52 . leads 20c , 20b and 20e are fitted into a channel - like slot of the arm of the sensor plate 50 . as shown in fig6 the two ired emitters are electrically connected in series but physically they are not located directly opposite one another . rather they are offset slightly from one another with the outer one 44a aimed at detector 52 and directed at approximately the centerline between itself and detector 52 . the net effect is to provide as large a signal variation as possible by both reflecting and transmitting a maximum amount of light during diastolic and a minimum amount of light during systolic conditions . by so doing , the overall sensitivity of the system is greatly increased and erratic behavior noted in prior art devices is essentially eliminated . to keep the sensor assembly moment of inertia around the point of contact with ear and the mass as low as possible , all pieces are customarily fabricated from aluminum or other lightweight materials which minimizes motion artifacts caused by mass inertia considerations . because the sensor electrical components are low voltage , low power units , light gauge wire can be used throughout . to preclude or minimize external light sources from entering the detector 52 , all passive parts are customarily painted black to absorb light rays . the total system , which as previously described consists of the sensor assembly 14 , the electronics package assembly 18 , and the interconnecting cable 20 , and its operation can best be understood by considering the functions defined in block diagram 7 . in normal operation , the subject &# 39 ; s pulse rate is sensed by the ebb and flow of blood modulating the emitters / detector light path . the resulting modulated signal is processed and operated on to provide -- analog , digital , and audio outputs of the subject &# 39 ; s pulse rate . while the processing circuits taken individually may be a somewhat conventional approach to signal processing , the total design synthesizes these circuits into a system which provides a novel approach for obtaining a pulse rate signal which is highly tolerant of external noise sources . common to all circuits is power supply 70 shown in fig7 and 8 . the power source is generally provided by a pair of 1 . 2 volt aa size , rechargeable nickel cadmium batteries . the power supply output consists of four dc voltages ; 9 . 5 v , + 9 v , 5 . 5 v and 4 . 5 v ; required by the various integrated circuits . to extend battery life , low power bifet operational amplifiers and cmos integrated circuits are used wherever possible . nickel cadmium batteries are also rechargeable and power supply 70 includes jack j1 to which a commercial aa battery charging system may be connected . the use of this system is facilitated by single pole double throw switch s1 which in the &# 34 ; off &# 34 ; position sets up the circuit for battery charging . from block diagram of fig7 the sensor assembly 14 emitters 44a and 44b are power strobed by modulator 102 . the pulse train thus provided is in turn modulated by the relatively low frequency pulse rate of the subject . this composite signal is detected by detector 104 and then into low pass amplifier / inverter 106 . this serves the function of stripping the subject &# 39 ; s relatively low frequency low level pulse signal from the much higher frequency waveform . automatic gain control 108 is provided to eliminate manual manipulation by the subject . the final signal processing converts the pulse signal to a constant amplitude square wave by comparator 112 . this is then converted into an analog dc voltage by frequency to voltage converter 114 which is scaled so that the output correlates with the pulse rate . this can be displayed on a conventional o - 1 ma meter 116 . both the signal and an auxiliary signal from the frequency to voltage comparator 114 can be used to drive a digital display of pulse rate , a high / low limit alarm 300 as shown on fig7 or a light blinking at the exerciser &# 39 ; s pulse rate . having now described the sensor assembly details and the overall system , the following sets forth the details of the circuitry more specifically . both the pair of ireds 44 and detector 52 operate from a common + 9 volt dc supply which in the preferred embodiment is supplied from a battery power source ( shown in fig8 ). this voltage is brought in on conductor 20c which feeds into inner side ired . this voltage is then fed via conductor 20b to series connected outer ired . the 9 v current is switched on and off by a signal at a frequency of 200 hz coming in on conductor 20a from modulator 102 , shown in fig7 and 9 . the function of this will be discussed herein below . the + 9 volts is further supplied to sensor 52 by an internal jumper 20d , as shown in fig5 . the sensor output , as stated hereinabove , is an oscillating dc voltage in which the low frequency heart beat pulse rate oscillation is impressed onto the much higher frequency oscillatory output generated by ireds 44 switching on and off . the net effect is in much the same manner as a carrier wave is modulated in a radio circuit . this modulated output is carried by conductor 20e to analog logic circuit 100 shown in block form in fig7 and schematically in fig9 . turning now to fig7 we see a block diagram of the circuitry including analog , logic , digital output and audio alarm portions of module 18 . this should be read in conjunction with fig9 and 10 which are detailed circuit diagrams . common to all subsystems is power supply 70 shown in fig7 and 8 . in the preferred embodiment this comprises a pair of 1 . 2 volt aa nickel cadmium batteries b1 , working in conjunction with power controller ic1 and operational amplifier ic2 to provide the + 4 . 5 , + 5 . 5 , + 9 and + 9 . 5 vdc outputs required by the various integrated circuits used . to extend battery life , low power bifet operational amplifiers and cmos integrated circuits should be used wherever possible . nickel cadmium batteries are also rechargeable and power supply 70 includes a jack , j1 , to which a commercial aa battery charging system may be connected . the use of this system is facilitated by single pole double throw switch s1 which in the &# 34 ; off &# 34 ; position sets up the circuit for battery charging . looking again at fig7 and 9 , we see that analog logic subsystem 100 comprises the basic signal processing circuitry common to all embodiments of the invention . as shown , it comprises an astable oscillator / modulator 102 which drives infrared emitting diodes 44a and 44b at a frequency of 200 hz in the manner described hereinabove . the output is an asymmetric square wave having an output pulse width of about 50 microseconds . the output of modulator 102 is also used to gate the p - channel field effect transistor ( fet ) q3 in detector 104 . diode d3 is biased so that modulator 102 output is fed to the gate of fet q3 only when the ireds are not being pulsed . this turns fet q3 off when no signal is produced in sensor 14 and on when the signal is produced . as a result , the charge on capacitor c13 develops a voltage equal to the peak of the square wave signal coming from photodetector 52 . this voltage varies in an inverse proportion to the blood density in the ear . superimposed on this varying voltage is a sawtooth waveform of a magnitude greater than the varying voltage itself ; the sawtooth being at the frequency of modulator 102 and caused by leakage through fet q3 when in the off state . the combination pulse signal and sawtooth are fed into low pass amplifier / invertor 106 . this serves the function of stripping the relatively low frequency pulse signal from the much higher frequency sawtooth . to eliminate all extraneous sources of noise , the upper cutoff frequency of amplifier 106 is set at 0 . 3 - 0 . 4 hz which is adequate to pass the exerciser pulse oscillations but very little else . the input to automatic gain contol ( agc ) amplifier 108 cuts off frequencies below 0 . 5 hz which limits dc level shifts caused by motion artifacts . the limited signal from amplifier 106 is then fed into amplifier 108 which has a high cut off frequency of about 1 . 7 hz . the combination of all the low and high cut off frequencies eliminates motion artifacts , noise and the ired modulation frequency superimposed on the pulse waveform . since the blood pulse signal is also affected by these cut off frequencies , the agc amplifier 108 working in conjunction with agc driver 110 restores that signal to a needed operational level . agc amplifier 108 is also an important factor in generating relatively constant amplitude signals arising from different users . the final signal processing converts the demodulated exerciser pulse rate oscillation from a sine wave to a constant amplitude square wave by comparator 112 . this is then converted into an analog dc voltage by frequency to voltage convertor 114 , the output from which can easily be scaled so that it correlates with pulse rate . this voltage can be displayed on a conventional 0 - 1 ma meter , 116 , to produce a simplified low cost system . the square wave output portion of frequency to voltage convertor 114 is used for timing purposes . after processing by differential circuit 118 to convert the square wave to a dual spike , the negative signal is used as a trigger for pulsed led driver 120 . the negative trigger signal is used so that when the output of driver 120 is fed into a conventional light emitting diode d5 , the diode flashes in sync with the exerciser &# 39 ; s pulse . diode d5 is usually positioned so that the exerciser can easily observe it blinking on and off in response to the intermittent output of driver 120 . the output of the frequency to voltage converter 114 is also fed into rate smoother 122 . this limits the digital output display 204 and audio alarm 200 from following the unimportant , beat - to - beat heart rate changes . these unimportant changes are automatically eliminated from meter 116 due to its internal damping . turning now to fig7 and 10 we see the details of the digital output and audio alarm subsystem of the subject invention . of the two , the digital output 200 is the simpler . although there are numerous circuit designs for digitizing an analog voltage , recent development now permit this to be done quite simply . in the preferred embodiment the analog voltage output of rate smoother 122 is fed directly into a single chip 31 / 2 digit analog to digital convertor 202 . the output of this unit , which in the preferred embodiment is an intersil icl 7106 , is a 24 bit signal with the correct power and impedance levels to drive a signed 31 / 2 digit , seven bar liquid crystal display ( lcd ) 204 . since the output of convertor 114 is scaled , the readout is directly in pulse beats per minute . while led or other types of readout devices can be used quite easily as the circuit may require , lcd units are particularly preferred because of their distinct superiority in terms of low power consumption on extended use . turning again to fig7 and 10 we now consider audio alarm 300 . this serves the function of allowing the user to set maximum and minimum pulse beat rates as a warning of over - exercise and of inadequate exercise levels . these settings are made in rate limit setter 302 which comprises a pair of variable resistance circuits 304 and 306 through which 9 vdc is dropped to 4 . 5 vdc . the center tap of potentiometer r38 sets a high level compared in high comparator 308 to the output from rate smoother 122 . when this pulse rate exceeds the high set rate ( between 75 and 200 beats per minute ) fed into it , comparator 308 goes from low to high and turns off normally on analog switch 312 . when this happens , the input to limit alarm audio oscillator 326 is no longer grounded and it oscillates so that a steady audio alarm is emitted by speaker 324 . a similar activity takes place with the low pulse rate signal . this is set by potentiometer r41 to provide a signal equal to a pulse beat rate in the range of 40 to 150 beats per minute . this too is compared with the output of rate smoother 122 in low comparator 314 . here , however , the low rate analog switch 316 is reversed so that when comparator 314 is low , the analog switch is off allowing oscillator 326 to drive speaker 324 . in order to identify the low alarm from the high alarm audio signal , analog switch 322 is added to pulse analog switch 316 in sync with the heart beat . this results in a pulsed audio alarm which is synchronized with heart rate . when the low rate limit is exceeded , comparator 314 goes high and analog switch 316 is switched to the on position turning off oscillator 326 . when the low level comparator 314 is high , analog switch 322 can no longer pulse the low rate analog switch 316 . as a result , when the level of the low rate potentiometer r41 is set lower than the high rate potentiometer r38 , a pulsed audio tone will be heard if the user &# 39 ; s heart rate is below the low rate set , no sound will be heard when the user &# 39 ; s heart rate is between the low rate set and the high rate set , and a continuous tone will be heard when the user &# 39 ; s rate exceeds the set high rate . finally , both rate comparators 308 and 314 have built in hysteresis so that when the user rate just exceeds the set level , the alarm is not switched on and off due to slight fluctuations in the rate or reference voltage . it was noted above that the high and low pulse beat limits were user setable . this is done in connection with limit set 318 which comprises single pole double throw switches 52 and 53 . in the normal position these provide a direct path from smoother 122 to digital convertor 302 as shown in fig1 . however , when 52 is switched , it shuts off the smoother 122 output voltage and shunts the high pulse beat set signal from the center tap of potentiometer r38 into digital convertor 302 for display . switch 53 performs the same function with the low pulse beat set signal from potentiometer r41 . these adjustments are readily made by making the center tap of the two potentiometers readily accessible from the outside casing of module 18 . the circuit diagram and present invention described herein may be described in other specific forms without departing from the spirit or essential attributes thereof , and accordingly , reference should be made to the appended claims rather than to the foregoing specification as indicating the scope of the invention .

an improved pulse rate monitoring system for detecting and displaying the heart beat of a subject while exercising or performing other activities . the subject invention comprises a pair of infrared emitters adapted to be positioned on either side of a thin appendage of the body , such as the septum of the nose or the upper part of an ear . the emitter light paths are modulated by changes in the superficial blood volume in these areas , causing corresponding changes in the output of these emitters as sensed by an infrared detector . the emitters are power strobed to provide a pulsed sensor output which is processed by electronic means to provide both analog and digital displays for use by the exerciser . the unit further comprises a visual pulse output which blinks on and off at a rate corresponding to the exerciser &# 39 ; s heartbeat . the unit further comprises means for setting high and low levels which when exceeded will provide an audio output to warn the exerciser in time to take corrective measures in his exercise regime .

in the following description , for purposes of explanation and not limitation , specific details are set forth in order to provide a thorough understanding of the present invention . however , it will be apparent to one skilled in the art that the present invention may be practiced in other embodiments that depart from these specific details . in other instances , detailed descriptions of well - known exercise methods and devices are omitted so as to not obscure the description of the present invention with unnecessary detail . fig1 - 3 illustrate an apparatus 10 constructed in accordance with the present invention . the apparatus is supported by a fixed frame 12 which comprises a main longitudinal member 14 . frame member 14 abuts forward transverse support member 16 and rests on rear transverse support member 18 . upright frame member 20 is secured to rear end 15 of frame member 14 . fixed frame 12 supports a movable subframe 22 comprising a generally l - shaped member 24 . the subframe includes a seat 26 and a back rest 28 to support a user while performing exercises with apparatus 10 . it should be observed that , since both seat 26 and back rest 28 are secured to subframemember 24 , the relative positions of the support cushions remain fixed while performing exercises , unlike certain prior art devices such as the gravity edge ™ referred to above . seat 26 is secured to subframe member 24 so that it can be adjusted vertically to accommodate users of varying sizes . to provide adjustability , seat frame 30 includes a downwardly extending member 32 which telescopes within tube member 34 secured to subframe member 24 . the seat is secured at a desired elevation with a pop pin ( not shown ) as is common practice for exercise equipment . seat frame 30 supports seat cushion 36 and knee cushion 38 . the latter is provided mainly for support when performing a leg extension or leg curl exercise as more fully described below . when performing other exercises , the user &# 39 ; s knees will generally straddle knee cushion 38 as shown in fig1 . subframe 22 includes a foot support platform 40 suspended from member 24 bymembers 42 and 44 . cross members 46 provide lateral support for platform 40 . stops 47 on the underside of forward cross member 46 rest against transverse frame member 16 when subframe 22 is in its rest position ( illustrated in fig2 ). stops 47 are adjustable in height so that the rest position of subframe 22 may be adjusted vertically . the utility of this adjustment will be explained below . subframe 22 is coupled to fixed frame 12 by upper pivot arms 50a , 50b and lower pivot arms 52a , 52b . upper pivot arms 50a , 50b are coupled to upright frame member 20 at pivot 53 and to subframe member 22 at pivot 54 . in like fashion , lower pivot arms 52a , 52b are coupled to upright member 20at pivot 55 and to subframe member 42 at pivot 56 . subframe 22 is thus coupled to fixed frame 12 by a four - bar linkage so that it remains relatively level as it is lifted from the rest position . the seating position actually reclines somewhat as the subframe is elevated owing to the fact that upper pivot arms 50a , 50b are shorter than lower pivot arms 52a , 52b . lever arm 60 , which is shown in greater detail in fig4 is pivotally coupled to fixed frame 12 at pivot 62 , the latter being supported by bracket 64 . carriage 66 is slidably disposed on lever arm 60 and carries rollers 68a , 68b . these rollers bear against the underside of lower pivot arms 52a , 52b , respectively . the position of carriage 66 along the length of lever arm 60 is selectable by the user with pop pin 70 . this pin , whichis spring biased in a downward direction , engages a selected one of a plurality of holes 69 in the upper surface of lever arm 60 . as will be better appreciated from the discussion that follows , the position of carriage 66 along the length of lever arm 60 determines the amount of exercise resistance experienced by the user when performing the exercises that are available with apparatus 10 and also varies the height to which subframe 22 is lifted by the exercise stroke . as mentioned above , stops 47allow the rest position of subframe 22 to be adjusted vertically . this permits pivot arms 52a , 52b to be aligned parallel with lever arm 60 . in turn , this permits carriage 66 to be smoothly positioned anywhere along the lever arm . although lever arm 60 is a preferred means for transmittingthe load of subframe 22 to the cable and pulley system of the apparatus , itshould be noted that the load could be transferred directly to one or more of the pivot arms . for example , a cable attachment could be made to a sleeve or carriage that is slidably positionable on the pivot arms . the principal structural members of apparatus 10 are preferably constructedof square and rectangular section steel tubing as is common practice for exercise equipment . the individual members are joined by welding or by mechanical fasteners as appropriate in each case . apparatus 10 incorporates a plurality of operable members coupled to subframe 22 for performing exercises . one such operable member is press arm 72 which is pivotally coupled to subframe member 74 at pivot 76 . pressarm 72 is provided with both horizontal grips 78 and vertical grips 80 . when not in use , press arm 72 rests against stop member 71 which projects from subframe member 24 . a second operable member is lat bar 82 which is suspended on cable 84 at a lat pull down station above the user &# 39 ; s head . when not in use , lat bar 82 is retained on brackets 86a and 86b which extend forwardly from subframe member 74 . a third operable member is leg extension arm 88 , which is pivotally suspended from subframe member 44 at pivot 90 . it is important to note that all of these operable members are mounted on the moving subframe structure and thus remain in a fixed relationship to seat 26 and back rest 28 . this is in contrast to most prior art body weight resistance machines that have their operable membersmounted on a stationary frame . each of the above - mentioned operable members is coupled through the cable and pulley system of apparatus 10 so that as the user exercises , subframe 22 is lifted , thereby providing exercise resistance . to illustrate this , consider first a leg extension exercise using exercise arm 88 . as the userapplies forward pressure against ankle cushion 92 , lower cable 94 , which iscoupled to arm 88 , is placed in tension . cable 94 passes under pulley 96 , which is rotatably mounted on subframe member 44 , and then under pulley 98which is rotatably mounted on lever arm 60 . cable 94 then passes over lowerpulley 102 of floating pulley assembly 100 and downwardly under pulley 104 mounted on lever arm 60 adjacent to pulley 98 . cable 94 continues upwardlyand is secured between upper pivot arms 50a , 50b at location 106 . as exercise arm 88 is moved forwardly , lever arm 60 is drawn upwardly by the action of cable 94 on pulleys 98 and 104 . this , in turn , causes lower pivot arms 52a , 52b to be lifted by rollers 68a , 68b , respectively . the lifting force is thus communicated to subframe 22 causing it to be elevated in a nearly linear vertical path as shown by the dashed arrow in fig2 . in a similar fashion , operation of press arm 72 causes subframe 22 to be lifted from its rest position . upper cable 84 , one end of which is coupledto lat bar 82 , is routed over pulley 108 on bracket member 86 and then around pulleys 110 , 112 , 114 and 116 which are alternately mounted on press arm 72 and subframe member 24 . cable 84 then passes around pulley 101 of floating pulley assembly 100 and upwardly over pulley 118 on subframe member 24 . cable 84 terminates with cable stop 120 which is retained against subframe member 24 when cable 84 is in tension . as the user moves press arm 72 forwardly to the position shown in fig3 floating pulley assembly 100 is drawn upwardly causing lever arm 60 to be pulled upwardly by cable 94 . subframe 22 is thus lifted in the same mannerdescribed above in connection with operation of the leg extension exercise . it will be observed that use of lat bar 82 pulls downwardly on cable 84 andcauses the same result , but without the force multiplying effect experienced with press arm 72 as a result of the serpentine path of cable 84 through pulleys 110 - 116 . as already mentioned , lower cable 94 is attached between upper pivot arms 50a , 50b at location 106 . this attachment is preferably adjustable to accommodate variations in the lengths of cables 84 and 94 and also to periodically compensate for cable stretch . with this adjustment , which need not have a great range of travel , the cables can be placed in a taut condition while subframe 22 is in its rest position . this removes any slopin the operation of the various operable members . it will be recognized that adjustment of the cable length at attachment 106 will influence the position of lever arm 60 , and thus further adjustment of stops 47 may be necessary to maintain a parallel relationship between lever arm 60 and lower pivot arms 52a , 52b . as mentioned above , cable 84 terminates with cable stop 120 at pulley 118 , which is slightly above and behind the user &# 39 ; s head . a loop 122 is secured to this end of cable 84 to permit the attachment of an auxiliary exercise bar or strap ( not shown ). additional exercises , such as an abdominal crunch or overhead tricep , can thus be performed from this exercise station . cable 94 also terminates with a cable stop 124 at pulley 126 on leg extension arm 88 . loop 128 is provided at the end of cable 94 to provide a low pulling point for additional exercises . for example , arm curls and upright row exercises may be performed while standing on platform 40 with an auxiliary exercise bar coupled to an extension chain or cable attached to loop 128 . it should be noted that a number of exercises may also be performed using this low pulling point while standing on the floor adjacent to apparatus 10 . in this regard , the weightof subframe 22 alone is more than adequate for performing a number of exercises , such as side leg raises . while the combined weight of subframe 22 and the user seated thereon is generally adequate for providing the maximum desired exercise resistance , additional resistance may be desired by certain users . in this situation , auxiliary weights may be added to subframe 22 on support bars 130 . such auxiliary weights may comprise disc - shaped weight plates of the type that are widely used for barbells and dumbbells . in an alternative embodiment of the present invention , press arm 72 may be replaced with press arm 172 as shown in fig5 - 7 . press arm 172 is configured to be used as a conventional press arm , but may also be used toperform a pectoral fly exercise . upper press arm members 178 and 180 are pivotally coupled to frame member 200 at pivot 173 . for use as a conventional press arm , individual arm members 174 and 176 are locked withrespect to cross member 181 by pins 182 and 184 , respectively . to perform the pectoral fly exercise , pins 182 and 184 are retracted so that arms 174and 176 are free to rotate about pivots 186 and 188 , respectively . in addition , pin 210 is inserted through press arm stop member 212 and into bar 214 , which is attached to cross member 181 . this locks the upper pressarm assembly in position so that it cannot rotate about pivot 173 . a plurality of holes for pin 210 are preferably provided in bar 214 so that arms 174 , 176 may be optimally positioned with respect to the seat for performing the pectoral fly exercise . opposite ends of cable 190 are secured to sectors 192 and 194 , which are attached to arms 174 and 176 , respectively . cable 190 is reeved around pulleys 196 and 198 mounted on subframe arm 202 and around floating pulley204 . pulley 204 is the upper member of floating pulley assembly 206 which communicates with the remainder of the apparatus in the same manner as discussed above . in yet a different configuration , the press arm may combine the features ofboth press arms 72 and 172 . in this regard , a press arm with pulleys 110 and 114 and the cable rigging as shown in fig1 - 3 may be provided with folding pec fly arms similar to arms 174 and 176 of fig5 - 7 . in this arrangement , lower cable 94 of apparatus 10 may be conveniently extended from attachment point 106 ( this fitting being omitted ) to a pulley or &# 34 ; y &# 34 ; fitting at which it would be coupled to cable 190 . the exercise resistancefor press exercises would thus be communicated through upper cable 84 with the force multiplying effect of pulleys 110 - 116 , whereas exercise resistance for the pec fly exercise would be communicated through lower cable 94 and cable 190 . this arrangement obviates the need for pin 210 since operation of the pec fly arms against the relatively lower amount ofresistance communicated by cables 94 and 190 would not tend to displace thepress arm assembly about the press action pivot ( 76 in fig1 - 3 or 173 in fig5 - 7 ). referring now to fig8 a further alternative embodiment of the present invention is illustrated . in this embodiment , apparatus 250 employs a single pivot arrangement in contrast to the four - bar linkage employed in the previously described embodiment . subframe 254 of apparatus 250 pivots with respect to fixed frame 252 only at pivot point 256 , thus following anarcuate path as indicated by the dashed arrow . the construction of apparatus 250 is somewhat more economical than that of apparatus 10 ; however , it will be recognized that greater declination of the seating angle is experienced with apparatus 250 as subframe 254 is elevated from its rest position . except for the pivot arrangement , apparatus 250 is otherwise functionally identical to apparatus 10 . it will be recognized that the above described invention may be embodied inother specific forms without departing from the spirit or essential characteristics of the disclosure . thus , it is understood that the invention is not to be limited by the foregoing illustrative details , but rather is to be defined by the appended claims .

a multi - station exercise machine has a movable subframe on which a user sits while performing various exercises . the subframe is pivotally attached to a stationery frame and is supported by a lever arm that is also pivotally attached to the stationery frame . the pivot arms coupling the subframe to the stationery frame bear against a carriage that is movable located on the lever arm . a cable and pulley system couples the lever arm to the various operable members of the apparatus so that a selectable ratio of the weight of the subframe , including the user , is communicated as exercise resistance . the amount of weight that is coupled to the operable members is selected by positioning the carriage along the lever arm . this adjustment also varies the height to which the subframe is lifted by the exercise stroke and hence the effort that must be exerted by the user .

a preferred embodiment of the present invention relates to protective headgear for athletes . more particularly , a preferred embodiment of the present invention relates to a protective head guard for soccer players . however , although discussed with reference to headgear for soccer players , one skilled in the art will recognize that the present invention is applicable for participants in athletics generally . fig1 - 6 illustrate a preferred embodiment of the soccer headgear 10 of the present invention . in one preferred embodiment of the soccer headgear 10 , the headgear 10 comprises a helmet 15 comprising several components that are integral with each other . the components include , but are not limited to , a circumferential band 20 , ear flaps 30 a and 30 b , a chin strap 40 and crossing members 50 a and 50 b . a header pad 24 can be detachably affixed to the headgear 10 or integral with the circumferential band 20 . the components of one preferred embodiment of the present invention are preferably unitarily molded from a suitable resilient material , capable of absorbing energy . preferably , the resilient material is polystyrene or polyurethane foam . however , one skilled in the art will recognize that other suitable materials such as synthetic rubber foam can be used to advantage and still remain within the purview of the invention . a suitable outer surface coating covers the entire outer surface of the resilient material . in a preferred embodiment , the coating is a tough , pliable , tear resistant plastic material that can be formed during heating and molding of resilient foam to produce a fused coating . however , one skilled in the art will recognize that the surface coatings can be applied by laminating , dipping , brushing or spraying and still remain within the purview of the invention . further , one skilled in the art will recognize that , alternatively , the soccer headgear 10 can be manufactured from harder , more rigid materials , plastics for example . the chassis of the soccer headgear 10 of one preferred embodiment of the present invention is a circumferential band 20 . the circumferential band 20 forms a continuous protective band around the forehead , temples , and the back of the head . the circumferential band 20 defines a plurality of ventilation holes 22 located along its circumference . the ventilation holes 22 provide adequate ventilation to ensure comfort to the wearer of the soccer headgear 10 . it should be noted that one skilled in the art would recognize that any number of ventilation holes 22 could be utilized and is remain within the purview of the invention . further , one skilled in the art will recognize that it is not necessary to have any ventilation holes 22 . also located along the circumferential band 20 of a preferred embodiment of the present invention is a header pad 24 . the header pad 24 is a strip of suitable resilient material that provides additional protection for the forehead region of the head to guard against the injurious consequences resulting from continuous impact with the soccer ball . the header pad 24 is comprised of a material whose outer surface frictionally contacts the soccer ball to dissipate the rotational force of the ball and facilitate control of the ball by the player . in one preferred embodiment of the present invention , the header pad 24 is affixed to the circumferential band 20 of the soccer headgear 10 by an adhesive . however , one skilled in the art will recognize that the header pad 24 can be affixed to the soccer headgear 20 by any number of means such as velcro stripping , taping , etc . in an alternative embodiment , the header pad 24 is integral with the chassis . in another preferred embodiment , the header pad 24 can be manufactured integrally with the headgear 10 either internally within the band 20 of the headgear in the region of the forehead or externally on the outside portion of the band 20 , away from the player &# 39 ; s head . alternatively , as illustrated in fig8 a , an internal armor plate or skeleton 70 is used to help disperse sudden high energy impact loads that may occur by bumping heads , balls or accidental kicks to the head . the internal skeleton 70 can comprise individual plates within the circumferential band 20 and other parts of the headgear 10 or one continuous skeleton 70 throughout the internal structure of the headgear 10 . preferably , a set of ear flaps 30 a and 30 b extend down from the circumferential band 20 . the ear flaps 30 a and 30 b have openings 32 a and 32 b which generally outline the ears for hearing purposes . the ear flaps 30 a and 30 b also provide additional protection to the player along the side of the head . the ear flaps 30 a and 30 b absorb much of the force resulting from a ball striking the ear region of the player which reduces the risks involved with a direct strike to the ear . in a preferred embodiment of the present invention , a chin strap 40 for securing the soccer headgear to the wearer &# 39 ; s head is affixed to one of the ear flaps 30 a or 30 b . the chin strap 40 is comprised of a band 42 and securing means 44 . in a preferred embodiment of the present invention , the band 42 is formed from a stretchable material that provides sufficient resistance to secure the soccer headgear 10 to the wearer &# 39 ; s head under normal conditions , and is able to stretch to absorb forces pulling the soccer headgear 10 away from the head . without suitable stretchability , such forces could result in the band 42 restricting the wearer &# 39 ; s breathing or cutting into the wearer &# 39 ; s neck or chin . in a preferred embodiment , the band 42 is permanently affixed to one of the ear flaps 30 a or 30 b . for purposes of illustration , in fig1 the band 42 is permanently affixed to ear flap 30 b . however , one skilled in the art will recognize that the particular ear flap 30 a or 30 b to which the band 42 is permanently affixed is of no significance . in use , the band 42 is secured to the opposite ear flap 30 b by the securing means 44 . the securing means 44 comprises a velcro fastener affixed to a mating piece of velcro affixed to the ear flap 30 b . it should be noted that although the securing means 44 in the preferred embodiment of the present invention comprises a velcro fastener . in alternative embodiments , any number of suitable fasteners such as buckles or clasps may be utilized and remain within the purview of the invention . in a further alternative embodiment , both ends of the band 42 can be permanently affixed to the ear flaps 30 a and 30 b . in still a further embodiment , depending upon its intended use , it is not necessary that the soccer headgear of the present invention have a chin strap 40 . as best illustrated in fig5 a top view of a preferred embodiment of the present invention , crossing members 50 a and 50 b form the top of the soccer headgear . the crossing members 50 a and 50 b provide protection for the upper portions of the head . in a preferred embodiment of the present invention , the crossing members 50 a and 50 b define a series of ventilation holes 22 . as discussed with reference to the circumferential band 20 , one skilled in the art will recognize that the crossing members 50 a and 50 b can have any number of ventilation holes 22 and remain within the purview of the invention . further , one skilled in the art will recognize that it is not necessary to have any ventilation holes 22 . the ventilation holes 22 are only intended to provide additional comfort to the wearer . in the further interest of comfort , the crossing members 50 a and 50 b further define ventilation openings 52 . these ventilation openings 52 facilitate ventilation and cooling of the wearer &# 39 ; s head by placing the wearer &# 39 ; s head in substantial communication with the outside air . the large ventilation openings 52 are used to particular advantage when the soccer headgear 10 is being worn by smaller children . when the soccer headgear 10 is worn by small children , the major concerns are safety and comfort ( to encourage the headgear &# 39 ; s use ) rather than providing a uniform surface to accurately direct the ball . an alternate preferred embodiment of the soccer headgear 10 of the present invention is shown in fig7 a and 7b . in this alternate embodiment , the header pad 24 is integral with the circumferential band 20 . the integral header pad 24 has a series of ventilation holes 22 to provide ventilation to the athlete &# 39 ; s forehead . further , in the alternate embodiment shown in fig7 a and 7b , the crossing members 50 a and 50 b intersect in an upper pad 50 c which provides increased protection of the top of the head and provides a smoother surface to control balls striking the top of the head . yet another alternate preferred embodiment of the soccer headgear 10 of the present invention is shown in fig8 . in this alternate embodiment , the header pad 24 is integral with the circumferential band 20 , but less protruding than other embodiments . having the header pad 24 integral results in a smoother surface by eliminating protruding edges of the header pad 24 . the integral header pad 24 results in a smoother surface from which to head the ball and eliminates the risk of misdirected balls as a result of striking an edge of the header pad 24 . the integral pad 24 can be more advantageous for the higher skilled players . in the alternate embodiment shown in fig8 the helmet 15 is devoid of the ventilation openings 52 . the uppermost surface 54 of the soccer headgear 10 is completely closed forming a smooth surface to accurately direct the headed ball . in this alternate embodiment , ventilation is provided by the ventilation holes 22 located along the circumferential band 20 . yet still another alternate preferred embodiment of the soccer headgear 10 of the present invention is shown in fig9 . this alternate embodiment includes a protective mask 60 . the protective mask 60 is particularly advantageous for athletes such as soccer goalkeepers who have a increased risk of contact by the ball or other players directly to the face . in this alternate embodiment , the protective mask 60 is detachably affixed to the soccer headgear 10 . however , in an alternate embodiment , the protective mask 60 can be integrally attached . further , one skilled in the art will recognize that the configuration of the protective mask 60 can vary depending upon the intended use . although described in terms of the preferred embodiments shown in the figures , those skilled in the art who have the benefit of this disclosure will recognize that changes can be made to the individual component parts thereof which do not change the manner in which those components function to achieve their intended result . for instance , the ventilation holes 22 located along the circumferential band 20 need not be circular openings . other embodiments of the ventilation holes 22 can be utilized to achieve the desired function . it is only necessary that the ventilation holes 22 be capable of facilitating the influx of air to the wearer of the helmet . all such changes are intended to fall within the scope of the following non - limiting claims .

protective headgear for protecting the head of an athlete comprising a circumferential band , two subtending ear flaps integrally molded to the circumferential band , an upper portion ; and a header pad affixed to the circumferential band . alternatively the protective headgear for a soccer player can comprise a helmet defining ventilation holes and a header pad affixed to a frontal area of the helmet . the helmet comprises a circumferential band , two integral ear flaps ; an upper portion ; and a header pad is affixed to the circumferential band . the protective headgear can further comprise an internal skeletal to help disperse sudden high energy impacts .

fig1 shows a chair 10 designed in accordance with the principles of the present invention and having a substantially flat bottom 11 , substantially straight vertical side surfaces 12 and 13 and a substantially straight vertical rear surface 14 . the seat portion 15 inclines upwardly toward the straight vertical front surface 16 forming a gentle convex curved portion 17 therebetween . the seat portion 15 conversely slopes downwardly toward the seat - back portion 18 and forms a gentle concave curved portion 19 therebetween . the top portion of the chair has a curved convex contour 19a merging with the rear surface 14 of the chair . as can be seen , the fabric completely covers the sides 11 and 12 , the seat 15 , seat - back 18 , top 19a , rear surface 14 and front surface 16 . from a consideration of fig2 it can be seen that the bottom - most portions of the fabric side pieces ( to be more fully described ) are drawn across the uprights ( to be more fully described ) and tautly joined to one another by the lacing arrangement 20 . the basic structure of the assembled chair frame can best be understood from fig4 and 7 showing a pair of uprights 21 and 22 . since uprights 21 and 22 can be seen to be substantially identical to one another from the viewpoint of both design and function , only one such upright will be described in detail herein , for purposes of simplicity . upright 21 can be seen to have curved surfaces 21a and 21b which generally conform to the seat and seat - back ; 21c and 21d which conform to the front and rear surface of the fully assembled chair ; and 21e which serves as the bottom or support for the chair frame which is adapted to be positioned upon a floor or other supporting surface . the surfaces 21a and 21b are also beveled . the upright member 21 is formed of a relatively inexpensive , rigid cellular plastic foam material , such as , for example , foamed polystyrene , polyurethane foam , polyethylene foam and polyvinylchloride ( pvc ) foam , which are well known to be quite light in weight and inexpensive while yielding adequate supporting strength . a cardboard element 23 shown in dotted fashion in fig4 is comprised of a substantially stiff paper or cardboard sheet has a contour which generally conforms to the contour of upright 21 may be imbedded into the upright and thereby serves to provide added structural strength for the upright for a purpose to be more fully described . it has been found , however , that the dimensions of the border portion of the upright gives sufficient structural strength to avoid the need for sheet 23 . the outer surface of upright 21 ( see surface 22f of upright 22 in fig4 ) is substantially flat and smooth , while the opposite or interior surface is provided with an indentation or shallow cutaway portion 21g which serves to reduce the amount of plastic material required while maintaining the overall thickness around the marginal or border region 21h . the thicker marginal or border region 21h is provided with a plurality of openings o 1 - o 5 each being adapted to receive one end of a hollow cylindrical paper tube t 1 - t 5 , respectively , as can best be seen in fig4 . there is in place of the cardboard sheet 23 , a plurality of discs 23 - 1 through 23 - 5 inserted into each opening to prevent the tubes from piercing the plastic upright . considering both fig4 and 3 , the tubes t 1 - t 5 , which are formed of a suitable cardboard are , hollow tubular members and are initially force - fitted , for example , into the openings o 1 - o 5 in upright 21 . although the cylindrical tubes can be seen to be of different diameters , tubes of the identical diameter may be utilized if necessary . since the tubes t 1 , t 3 and t 4 support the major load imposed upon the chair when someone is seated thereon , these tubes are of the greatest diameter and , in fact , tubes t 1 , t 4 are larger in diameter than the tube t 3 , tubes t 2 and t 5 being the tubes having smallest diameters . one distinct advantage of this arrangement resides in the fact that for packaging , transportation and storage purposes , tube t 5 may be inserted and telescoped into tube t 4 ; t 2 may be inserted into tube t 3 and these two tubes may , in turn , be inserted into the interior of tube t 1 so that , in actuality , the total space occupied by the tubes constitutes no more than the space that would be occupied by tubes t 1 and t 4 . as a practical matter , and if desired , tube t 1 may be designed to be one of the largest diameter , tube t 4 may be of the next largest diameter and slightly smaller than tube t 1 ; tube t 3 may be of slightly smaller diameter than t 4 , and so forth so that all of the tubes may be received by tube t 1 thus requiring only the amount of space necessary for a single tube , i . e ., tube t 1 thereby significantly reducing the amount of space occupied by the individual components when packaged . after assembly of each of the ends of the tubes t 1 - t 5 into the appropriate openings o 1 - o 5 of upright 21 , the upright 22 is then aligned so that its openings ( not shown for purposes of simplicity ) are axially aligned with the openings o 1 - o 5 in upright 21 and then the upright 22 is moved or pressed toward upright 21 in the direction of arrows a 1 - a 1 so that the opposite ends of tubes t 1 - t 5 are force - fittingly received within the openings provided in upright 22 , thereby forming a fully assembled chair frame . the tubes are preferably force - fitted into the openings to a depth so that their free ends ( for example , the free end t 1a of tube t 1 ) abut against the cardboard insert ( for example , the cardboard discs 33 ) inserted in the openings of upright 22 . since each of the tubes t are preferably of equal length , the uprights 21 and 22 are maintained in spaced parallel fashion . after having once assembled the chair frame , the single one - piece cover 23 ( see fig5 ) which may be formed of a suitable fabric or plastic , is pulled over the frame in the direction shown by arrows a1 . as can clearly be seen , the fabric cover is preferably formed of a pair of side panels 24a and 24b having perimeters which substantially generally conform to the perimeters of the uprights against which they ultimately rest . the center or main panel 25 is sewn to the uprights substantially along the front side , top side and back side perimeters so as to form the front side 25a , seat 25b , back 25c , top 25d and rear surface 25e portions of the completed chair assembly . preferably , the sections 25b , 25c and 25d , which form the region upon which a person sits , may be reenforced with an additional fabric panel of a suitable material sewn to the central panel 25 along the interior side of the cover to provide additional structural supporting strength for the seat . the side panels 24a and 24b are each provided with downwardly depending portions 24c and 24d which are pulled down and around the bottom surfaces of uprights 21 and 22 as can best be seen in fig6 so as to form a pair of cooperating flaps . each of the flaps has its free edge bent over and back again upon the flap and is then sewn to the body of the flap as represented by the stitch marks s1 and s2 whereby a pair of hollow sleeves are formed by this construction . the innermost facing edges of these sleeves are slitted such as , for example , at 24d - 1 , 24d - 2 , 24d - 3 and 24d - 4 so as to form slits or openings at spaced intervals along the sleeve . an elongated metallic rod 27 and 27 &# 39 ; is inserted into each of the aforementioned sleeves . each rod is provided with a plurality of bends so as to form a plurality of substantially u - shaped portions 27 - 1 , 27 - 2 , 27 - 3 and 27 - 4 ( as well as 27 &# 39 ;- 1 - 27 &# 39 ;- 4 ), which bends are in substantially exact alignment with slits 24 d - 1 through 24d - 4 respectively when the rod 27 is inserted within its associated sleeve ( by aligning the rod and slipping it into the sleeve in the direction shown by arrow a2 ). as a result , each of the u - shaped portions 27 - 1 through 27 - 4 ( and 27 &# 39 ;- 1 through 27 &# 39 ;- 4 ) extend through the associated slit so as to form eyelets . an elongated tape 28 is laced or otherwise threaded through these eyelets in a manner shown best in fig2 and a tightening assembly 29 , shown best in the inset portion of fig2 receives the free ends 28a and 28b of the tape so as to permit the lacing structure to be tightened to the extent necessary in order to maintain the fabric covering sufficiently taut about the chair frame assembly . it should of course be understood that the chair frame cover 25 should initially be tightly drawn about the frame before tightening the tape 28 . in this manner , the seat and back portions 25b and 25c are &# 34 ; slung &# 34 ; between the uprights and are actually suspended above the upper ends of tubes t 1 , t 3 and t 4 so as to make no contact whatsoever with these tubes when someone is seated on the chair and thereby render the seat comfortable to the user . since fabric is known to &# 34 ; give &# 34 ; after certain periods of use , this possibility may be fully compensated for by loosening the laced tape 28 , pulling the covering so as to draw the sleeves more closely toward one another to compensate for the loosening or the give experienced by the fabric , and then retightening and refastening the lacing in the same manner in which it was originally secured . this structure assures that the fabric ( or plastic ) covering remains in position and with sufficient tautness , as well as assuring that the lightweight frame assembly remains in the assembled condition . thus , it can be seen that the only fastening means per se is the laced tape 28 , all other conventional types of fastening means being totally eliminated . the force - fitting arrangement between the tubes t and the uprights 21 and 22 need not be overly tight since the combination of the fabric cover , which is preferably made so as to initially provide a tight fit , and the laced tape serves to provide the necessary holding strength for maintaining the chair in the fully assembled condition . the chair , when fully assembled , in addition to providing more than adequate structural and supporting strength , provides a chair which is quite aesthetically appealing in appearance and which is extremely light in weight and is quite inexpensive from the viewpoint of cost of raw materials , the cost of packaging , shipment and storage , as well as enabling the purchaser to eliminate the need for factory assembly due to the fact that the simplicity of design enables the purchaser to assemble the chair in a fast , simple and straightforward manner . in one typical example , the unique design of the chair is such as to permit it to be packaged within a carton whose length and width are respectively equal to the height and width of the chair ; whose width is equal to double the width of one upright ( i . e ., the width of two uprights standing side - by - side ), there being more than adequate room in the remaining hollow interior region of the carton defined by the carton side and top walls and the surfaces 21a and 21b ( and 22a and 22b ) of the uprights 21 and 22 for insertion and storage of the fabric cover ( which may be neatly folded into a small compact package ); the paper tubes t 1 - t 5 ; the elongated tape 28 and the small clamping member 29 ; and the tube eyelet - defining rods 27 and 27 &# 39 ;, as well as a single instruction sheet . a chair , fully assembled , and conforming to the embodiment recited hereinabove and having a height of 261 / 2 inches , a width of 26 inches and a depth of 29 inches weighs of the order of 8 lbs . in the fully assembled state within a carton and including the carton , the chair weighs approximately 9 lbs . the package is quite compact , having an overall dimension of 8 × 26 × 30 inches . it can thus be seen that the package is extremely light in weight , is capable of taking a reasonable amount of punishment in the storage , transportation and other handling thereof , has a frame assembly formed of extremely inexpensive components and yet is quite structurally strong , is light in weight and yields a rather aesthetically pleasing appearance . although there has been described a preferred embodiment of this novel invention , many variations and modifications will now be apparent to those skilled in the art . therefore , this invention is to be limited , not by the specific disclosure herein , but only by the appended claims .

a chair adapted to be packaged , transported and sold in knocked - down fashion and constructed of extremely lightweight and inexpensive components while providing a chair of more than adequate structural strength for normal usage . a pair of uprights are formed from an extremely lightweight relatively soft plastic material such as foamed polystyrene preferably having imbedded therein either cardboard discs or a flat cardboard sheet generally conforming to the outline of each upright for yielding added structural strength ; the uprights each being provided with coaligned openings for receiving paper tubes to collectively define an assembled chair frame . the discs or the sheet define the base of each opening . a one - piece fabric cover is stretched over the frame and is tied along the bottom serving as a means for securing the frame pieces in the assembled state , as well as maintaining the fabric spanning the seat and back portions of the chair sufficiently taut to assure comfortable seating thereupon .

some embodiments of the present invention are described with reference to fig3 to 14 . in particular , fig3 and 4 show a cervical plate 300 and bone graft 302 . cervical plate 300 has a viewing window 304 , screw holes 306 , and an attachment mechanism 400 ( shown in phantom in fig3 ). as best seen in fig4 , cervical plate 300 has attachment mechanism 400 attaching the bone graft 302 to the cervical plate 300 . while cervical plate 300 could be made of numerous biocompatible materials , it is believed cervical plate 300 should be made of bio absorbable material . bio absorbable or resorbable devises are generally known in the art , see for example , u . s . pat . no . 6 , 241 , 771 , titled r esorbable i nterbody s pinal f usion d evices , issued to gresser et al ., on jun . 5 , 2001 , incorporated herein by reference . generally , the devices explained and contained herein may be constructed out or any number of biocompatible materials , including titanium , shaped memory allows , milled bone , resorbable material , peek , or the like . attachment mechanism 400 can be any of a number of different attachment mechanisms . for example , as shown in fig4 , attachment mechanism 400 comprises a pin or stud attached to the cervical plate inserted into a hole or detent in the bone graft 302 . alternatively , attachment mechanism 400 could be a spike inserted into bone graft 302 without bone graft 302 having a corresponding hole or detent to receive the spike , similar to a thumb tack . alternatively , attachment mechanism 400 could comprise a pin or stud attached to the bone graft 302 inserted into a hole or detent in cervical plate 300 . also , attachment mechanism 400 could be any style snap lock or friction fitting , such as the cavity formed in fig5 between protrusions 504 , explained in more detail below . it would be possible to provide barbs and / or lips on attachment mechanism 400 to facilitate the connection . moreover , while two attachment mechanisms 400 are shown , more or less attachment mechanisms could be used . further , attachment mechanism 400 could be an adhesive layer between the cervical plate 300 and bone graft 302 . still further , attachment mechanism 400 could be a screw device so that bone graft 302 and cervical plate 300 are attached using a screw mechanism . finally , the cervical plates 300 could be made as a single integral unit with the bone graft 302 , although that would be difficult due to the numerous sizes and shapes of bone grafts and plates necessary to perform the surgery . fig5 shows cervical plate 500 attached to a bone graft 502 by prongs 504 on bone graft 502 . as shown , prongs 504 attached to the bone graft grasp cervical plate 500 forming a frictional engagement . alternatively , but not shown , cervical plate 500 could have prongs that grasp bone graft 502 . as one of ordinary skill in the art would recognize on reading this disclosure , the number of ways the bone grafts could be attached to the cervical plate is numerous . to the extent alternative attachment means are not expressly identify above , this description should not be limited to the embodiments identified and described above . rather , the specific embodiments identified are for illustrative purposes . fig6 is a flowchart 600 illustrating a method of using the present invention . in particular , the surgeon fits a bone graft into the intervertebral space , step 602 . then , with the bone graft in place and the adjacent discs holing the bone graft in place , the surgeon sizes a cervical plate , step 604 . once the cervical plate and bone graft are sized , the surgeon removes the plate and graft from the patient , and attaches the bone graft to the cervical plate , step 606 . next , the combination bone graft and plate device is placed in the intervertebral space such that the adjacent discs hold the bone graft and plate in place , step 608 . the cervical plate is then anchored to the adjacent vertebral bodies , step 610 . because surgeon attached the cervical plate to the bone graft , and the adjacent vertebrae hold the bone graft in place , the cervical plate remains fixed in place while the surgeon anchors the plate to the vertebrae . as one of ordinary skill in the art would recognize on reading the above disclosure , the same general device and procedure is used when inserting multiple bone grafts . for example , if fusing four vertebrae , a surgeon would need to place three bone grafts . conventionally , the three bone grafts are sized and placed in the intervertebral space and a cervical plate is sized for the three grafts . using the present invention , the three bone grafts could all be removed and attached to the cervical plate and then refitted into the patient . however , it is believed attaching multiple bone grafts to the cervical plate would make it difficult to fit the device into the patient . it is believed to be more efficient to insert bone grafts and size the bone grafts and cervical plate , then remove one of the bone grafts while leaving other bone grafts in the spine . the removed bone graft would be attached to the plate . the one bone graft with the cervical plate attached is refitted into the patient and screws can be used to anchor the entire device with the one bone graft providing the stability for the cervical plate . as mentioned above , inserting the bone graft and cervical plate includes using a retracting device to hold the adjacent discs apart , inserting the bone grafts and sizing the cervical plate , removing cervical plate and the retracting device , allowing the adjacent discs to squeeze the bone graft , then replacing and anchoring the cervical plate . a difficulty arises using the present invention because the retracting devices need to be removed prior to placing and anchoring the cervical plate . thus , when the bone graft is removed and attached to the cervical plate , the retracting devices need to be removed prior to replacing the combined bone graft and cervical plate . however , on removing the retracting devices , the adjacent discs move together making it difficult to insert the bone graft between the adjacent discs . fig7 shows an impactor 700 capable of opening the space between the discs to ease the insertion of the bone graft attached to the cervical plate . impactor 700 has a handle 702 , a cervical plate holder 704 , and prongs 706 forming cavity 708 . impactor 702 could have various numbers of prongs , but it is believed two prongs work well . cervical plate holder 704 is designed to hold the cervical plate such that the prongs 706 extend downward beyond the cervical plate and bone graft attachment . prongs 706 could be spaced to form cavity 708 such that placing the cervical plate in the cavity 708 would form a friction fitting releasably coupling the cervical plate to the impactor 700 . the prongs 706 would act as a wedge to separate the adjacent discs allowing placement of the bone graft in the intervertebral space . once the bone graft is placed , the impactor 700 would be completely removed from the patient . thus , the cervical plate and impactor would be releasably coupled prior to insertion . fig8 shows a top side elevation view of the impactor 700 holding a cervical plate 802 . cervical plate 802 is shown without a viewing window , but one could be used if desired . fig9 is a flowchart 900 illustrating using the impactor 700 with the cervical plate 802 . for convenience , flowchart 900 is described for insertion of a single bone graft . one of skill in the art will recognize on reading the disclosure , however , that the device and procedure would be usable with insertion of multiple bone grafts . initially , the surgeon fits a bone graft into the intervertebral space , step 902 . then , with the bone graft in place and the adjacent discs holing the bone graft in place , the surgeon sizes a cervical plate , step 904 . once the cervical plate and bone graft are sized , the surgeon removes the plate and graft from the patient , and attaches the bone graft and the cervical plate , step 906 . next , the impactor is releasably attached to the cervical plate , step 908 . the impactor with the cervical plate and bone graft is used to separate the adjacent vertebrae , step 910 . with the impactor holding the adjacent vertebrae apart , the bone graft is inserted in the intervertebral space such that the cervical plate is placed to be anchored to the adjacent vertebrae , step 912 . the impactor is removed allowing the adjacent vertebrae to hold the bone graft and cervical plate in place , step 914 . finally , the cervical plate is anchored to the vertebrae , step 916 . once surgically placed and anchored , cervical plate bone screws have a tendency to become loose , which is commonly referred to as backing out . many devices have been devised to inhibit bone screws from backing out ; however , none are particularly satisfactory . referring now to fig1 a and 10b , a cervical plate 1000 with a back out prevention device 1002 in accordance with one embodiment of the present invention is shown . while the respective vertebrae have not been specifically shown in fig1 a and 10b , cervical plate 1000 has been surgically implanted , and bone screws 1004 have been threaded into vertebral bodies through screw holes 1006 in plate 1000 . a surface 1008 of plate 1000 contains at least one channel 1010 or groove . two grooves 1010 are shown , but channel 1010 could be a single channel extending the length of the plate as well . back out prevention device 1002 comprises a cover 1012 and locking extension 1014 ( best seen in fig1 b ). cover 1012 is sufficiently large to allow at least one perimeter edge 1016 of cover 1012 to extend over a head 1018 of screw 1004 . when installed , edge 1016 is substantially aligned with head 1018 and prevents backing out of screw 1004 . locking extension 1014 comprises one or more elastic prongs 1020 , for example biocompatible plastic or spring metal . prongs 1020 fit into channel 1010 to hold back out prevention device 1002 in place . to facilitate placement of prongs 1020 into channel 1010 , cover 1012 may have at least one access port 1022 through which a tool ( not specifically shown ) can be inserted . the tool would flex prong 1020 such that prong 1020 easily fits into channel 1010 . when the tool is removed , prong 1020 would tend to return to its original position and apply a frictional force to seat back out prevention device . similarly , the tool could compress prongs 1020 to allow removal of backout prevention device 1002 as desired . as shown by fig1 b , one embodiment of back out prevention device 1002 comprises cover 1012 with multiple prongs 1020 forming an inverted v shape . while the inverted v shape is shown for convenience , prongs 1020 may be independent of each other and baised as explained below . prongs 1020 have a distal end 1024 with a locking edge 1026 . in this case , locking edge 1026 comprises a shoulder or protrusion . as shown in fig1 b , locking edge 1026 could have a wedge shape to facilitate insertion of prongs 1020 into channel 1010 . in this case , use of the tool and access port 1022 may be unnecessary . correspondingly , channel 1010 includes an engaging edge 1028 . prongs 1020 should be biased to force locking edge 1026 and engaging edge 1028 . in this case , prongs 1020 are biased to diverge , but in other arrangements they may be biased to converge . in this case , engaging edge 1028 comprises a lip or undercut . of course , locking edge 1026 could comprise a hollow and engaging edge 1028 could comprise a corresponding protrusion , etc . similarly , surface 1008 could have a raised extension with protrusions and cover 1012 could have a channel with a lip or shoulder . the channel of cover 1012 would be aligned with raised extensions on surface 1008 forming a fitting , such as a snap lock or a frictional engagement . while shown as a square or rectangular shape , cover 1012 can be formed of many shapes and / or configurations . for example , cover 1012 could be elliptical , circular , some other polygon , linear , an arc or curve , convex or concave , irregular , a zig - zag , a letter shape , or the like . further , as shown head 1018 resides above plate 1000 and cover plate 1012 resides above head 1018 ; however , one of skill in the art would recognize on reading the disclosure , that head 1018 and cover plate 1012 could be countersunk such that the head 1018 and cover plate 1012 reside substantially in the same plane as plate 1000 . referring now to fig1 , another cervical plate 1100 with two back out prevention devices 1102 d and 1102 u is shown . prevention device 1102 d is shown deployed and prevention device 1102 u is shown undeployed . plate 1100 would be surgically implanted and bone screws 1104 threaded into the vertebral body through screw holes 1106 . prevention devices 1102 comprise a plurality of bars 1108 having a deployed state ( shown by prevention device 1102 d ) and an undeployed state ( shown by prevention device 1102 u ). in the deployed state , prevention device 1102 d has a peripheral edge 1110 on bars 1108 that extend over a head 1112 of screws 1104 . in the undeployed state , prevention device 1102 u has bars 1108 relatively closer to each other where peripheral edge 1110 does not extend over head 1112 , which makes screws 1104 freely movable . when deployed , a locking device 1114 , such as a pin , stud , screw , clip , cam , or the like is inserted or rotated between bars 1108 to lock prevention device 1102 d in the deployed state . for example , after bars 1108 are deployed , a screw could be inserted to maintain the separation . alternatively , a cam could be rotated to maintain separation . locking device 1114 would be removed to undeploy the prevention device . while prevention device 1102 is shown sized similar to a single screw head , prevention device 102 could have bars 1108 that extend the length of the cervical plate so only one prevention device is necessary for multiple sets of screws . fig1 shows a top plan view of another back out prevention device 1200 consistent with the present invention . unlike prevention devices 1000 and 1100 , which generally prevent screws from backing out by engaging a screw head , prevention device 1200 engages , for example , a thread of a screw or a notch located , for example , in the screw head . back out prevention device 1200 includes a bushing 1202 and at least one locking pin 1204 , in which three pins 1204 are shown in this case . bushing 1202 forms a ring or thread through which a screw ( not specifically shown ) can be threaded . a spring 1206 or other elastic device pushes locking pin 1204 radially inward such that pins 1204 provide sufficient force on at least one thread or notch of the bone screws ( not specifically shown in fig1 ). spring 1206 should not be construed as a conventional helical spring , but could be a number of elastic devices including , for example , elastic plastics , air loaded dampers , magnetics , shaped memory alloys , or the like . thus , spring or spring loaded should be used generically to mean a device with elastic movement ability . basically , spring 1206 needs to provide sufficient outward force to seat pin 1204 against a thread , notch , or surface of the screw or screw head , but be sufficiently resilient to allow the screw to be threaded into bone . ( notice , spring 1206 and pin 1204 could be combined into a single unit using ). spring 1206 could be flush between the pin 1204 and bushing or , as shown , spring 1206 could reside in a channel 1208 in bushing 1202 . fig1 and 14 show cross - sectional views of screw back out prevention device 1300 and 1400 , respectively . fig1 shows a portion of a cervical plate 1302 about a screw hole 1304 . residing in screw hole 1304 would be a bushing 1306 that contains a notch 1308 , groove , or channel . a screw would be threaded into vertebral bodies ( not specifically shown in fig1 ) through screw hole 1304 such that screw head 1310 resides as shown . screw head 1310 has a notch 1312 , groove , or channel , corresponding to notch 1308 . residing in notch 1308 and notch 1312 is a self - bonding material 1314 , such as high molecular weight polyethylene , nylons , and biopolymers and other self - bonding material commonly used in the aeronautical and automotive industries . instead of self - bonding material 1314 , material 1314 could be replaced with heat fusible material , pressure sensitive material , radiation curing , or other adhesives that require activation to adhere . self - bonding material 1314 provides back out prevention because when the screw is threaded into the vertebral bodies bonding material 1314 in notch 1308 engages bonding material 1314 in notch 1312 and bonds . thus , screw head 1310 is held in place . although shown in a notch , material 1314 could be layered , such as by a coating or spray , on bushing 1306 and screw head 1310 . similarly , fig1 shows a portion of a cervical plate 1402 about a screw hole 1404 . residing in screw hole 1404 is a screw head 1406 . screw hole 1404 as sidewalls 1408 . residing on sidewalls 1408 exists at least one strip of self - bonding material 1410 . while the materials identified above for material 1314 could be used , in this particular example , self - bonding material 1410 is a spray on type of material . screw head 1406 has exterior sidewalls 1412 . residing on sidewalls 1412 exists at least one strip of self - bonding material 1410 corresponding to the strip of self - bonding material 1410 on sidewalls 1408 . again , instead of a spray or coating , material 1410 could reside in a notch on sidewall 1408 and sidewall 1412 . alternatively to a self - bonding material , other materials may be used . for example material 1410 ( or 1314 ) may be a type of heat fusion plastic . to use heat fusion , once the screw is threaded and the materials align , a heat activation signal would be applied to fuse the materials . other bonding materials , such as epoxies , acrylics ( such cyanoacrylates and anaerobics ), silicones , pastes , tapes , and glues , and the like could be used for bonding material 1410 ( or 1314 ), but would inhibit threading of the screw as well as be useful as a screw back out prevention device . while the invention has been particularly shown and described with reference to some embodiment thereof , it will be understood by those skilled in the art that various other changes in the form and details may be made without departing from the spirit and scope of the invention .

screw back out prevention devices to inhibit screws from reverse threading or backing out are provided . the devices include first bonding materials on either a bushing in a bore of a plate or directly on the bore and second bonding materials on the screw head . the bonding materials for a bond that inhibits back out or reverse threading of the screw .

embodiments of the invention will be described in detail with reference to the drawings . the present invention is not limited to the embodiments described herein . the construction of an exemplary x - ray imaging apparatus is shown schematically in fig1 . as shown in fig1 , this apparatus includes an x - ray irradiation device 200 and an x - ray detecting device 400 . the x - ray irradiation device 200 is made up of a column 210 suspended from a ceiling and an x - ray irradiator 220 attached to a lower end of the column 210 . the x - ray irradiator 220 can change its direction , thereby making it possible to change the x - ray irradiating direction . the column 210 which supports the x - ray irradiator 220 is capable of expansion and contraction in its longitudinal direction and is movable horizontally along the ceiling . the x - ray irradiation device 200 is an example of the x - ray irradiation device defined in the present invention . in the x - ray detecting device 400 , a carriage 420 is attached vertically movably to a column 410 which is erected upright on a floor , an arm 430 is attached to the carriage 420 horizontally , and a detector housing 440 is attached to a tip end portion of the arm 430 . the x - ray detecting device 400 is a so - called wall stand type x - ray detecting device . the x - ray detecting device 400 is an example of the best mode for carrying out the invention . with the construction of the x - ray detecting device 400 , there is shown an example of the best mode for carrying out the invention with respect to the x - ray detecting device . the detector housing 440 is a flat structure in the shape of a rectangular parallelepiped and incorporates an x - ray detecting panel . the detector housing 440 has an x - ray incidence surface whose inclination is adjustable so as to provide a horizontal or vertical state or any other desired angle in accordance with an incidence direction of x - ray . the detector housing 440 is an example of the detector housing defined in the present invention . an x - ray detection signal is inputted to an operator console 600 from the detector housing 440 . on the basis of the input signal from the detector housing 440 , the operator console 600 reconstruct a radioscopic image of the subject and displays it on a display 610 . the operator console 600 controls both x - ray irradiation device 200 and x - ray detecting device 400 . for the x - ray irradiation device 200 , the operator console 600 controls horizontal and vertical positions and x - ray irradiating direction of the x - ray irradiator 220 and further controls x - ray intensity and irradiation timing . for the x - ray detecting device 400 , the operator console 600 controls the height of the detector housing 440 so as to match the x - ray irradiator 220 , and adjusts the angle of the detector housing 440 , thereby controlling the direction of the x - ray incidence surface in conformity with the x - ray incidence direction . a mechanism for controlling the direction of the x - ray incidence surface of the detector housing 440 in accordance with a control signal provided from the operator console 600 is provided in the interior of the arm 430 . the following description is now provided about an angle adjusting mechanism for controlling the direction of the x - ray incidence surface . fig2 shows an appearance of the arm 430 which incorporates the angle adjusting mechanism . as shown in fig2 , the arm 430 has a horizontal shaft 432 in an upper position of its tip and the detector housing 440 is attached to the horizontal shaft 432 pivotably through a bracket 442 . the bracket 442 is provided on a back side , namely , the side opposite to the x - ray incidence surface located on the surface side , of the detector housing 440 . with the bracket 442 , a predetermined distance from the horizontal shaft 432 up to the back surface of the detector housing 440 is ensured . with this distance as a radius the detector housing 440 pivots and causes the angle of the x - ray incidence surface to change from 90 ° ( horizontal ) to − 20 ° via 0 ° ( vertical ). the angle of the x - ray incidence surface will also be referred to hereinafter as the angle of the detector housing . the angle adjustment of the detector housing 440 is performed by an angle adjusting mechanism 500 disposed within the arm 430 . the angle adjusting mechanism 500 is constructed so as to also permit manual adjustment of the angle of the detector housing 440 . fig3 , 4 and 5 show a constructional example of the angle adjusting mechanism 500 . fig3 , 4 and 5 are vies of the angle adjusting mechanism 500 as seen sideways , from the front side , and from an obliquely downward position , respectively . fig6 is an enlarged view of a part of the angle adjusting mechanism 500 . the angle of the detector housing 440 is set at 90 ° ( horizontal ). as shown in fig4 and 5 , the bracket 442 is an inverted u - shaped member . the horizontal portion of the bracket 442 is fixed to the back surface of the detector housing 440 and tip ends of the vertical portions on both sides are connected to upper positions of the tip end of the arm 430 through horizontal shafts 432 a and 432 b , respectively . the horizontal shaft 432 and the bracket 442 are an example of the support mechanism defined in the present invention . the angle adjusting mechanism 500 has a shaft 510 . one end of the shaft 510 is connected through a pin 512 to a tip end of a support rod 444 suspending from the back surface of the detector housing . the support rod 444 is positioned ahead of the horizontal shafts 432 a and 432 b . the pin 512 is parallel to the horizontal shaft 432 . the shaft 510 is an example of the shaft defined in the present invention . an opposite end of the shaft 510 is connected to a shaft support 520 through a pin 514 . the shaft support 520 underlies the horizontal shafts 432 a and 432 b . the pin 514 is parallel to the pin 512 . the shaft support 520 is an example of the shaft support defined in the present invention . the shaft support 520 is fixed onto a slider 532 . the slider 532 is engaged with and movable along a rail 534 . the rail 534 is fixed to the interior of the arm 430 . the slider 532 and the rail 534 constitute a linear guide . the portion comprised of the slider 532 and the rail 534 is an example of the restriction mechanism defined in the present invention . a tip end of a drive shaft 550 of a drive mechanism 540 is connected to the shaft support 520 . as shown in fig6 , the tip end of the drive shaft 550 is put in contact from above with the shaft support 520 through an adaptor 554 which is connected to the drive shaft through a pin 552 . the pin 552 is parallel to the pin 514 . the shaft support 520 includes a horizontal surface with which a lower surface of the adaptor 554 is put in contact and a vertical surface with which a front end of the adaptor 554 is put in contact . an opposite end side of the drive shaft 550 is positioned within a cylinder 560 . in the interior of the cylinder 560 the power of a motor 570 acts on the drive shaft 550 . the motor 570 is integral with the cylinder 560 . with the power of the motor 570 , the drive shaft 550 reciprocates rectilinearly in its longitudinal direction . a base portion of the cylinder 560 is connected to a stud 564 through a pin 562 . the pin 562 is parallel to the pin 552 . the stud 564 is fixed to the interior of the arm 430 . the drive mechanism 540 is supported at both ends thereof by both stud 564 and shaft support 520 . the drive mechanism 540 is pivotable about the pin 562 . consequently , a force based on a turning moment induced by the own weight of the drive mechanism 540 acts downwards on the contact portion between the adaptor 554 at the tip end of the drive shaft 550 and the shaft support 520 . in the drive mechanism 540 , as a result of reciprocating motion of the drive shaft 550 caused by forward and reverse rotations of the motor 570 , a lower end of the shaft 510 pinned to the shaft support 520 is allowed to reciprocate along the rail 534 and the detector housing 440 pinned to an upper end of the shaft 510 is allowed to pivot about the horizontal shaft 432 , thereby adjusting the angle of the x - ray incidence surface . the drive mechanism 540 is an example of the drive mechanism defined in the present invention . the motor 570 is an example of the motor defined in the present invention . the drive shaft 550 is an example of the drive shaft defined in the present invention . the portion comprised of the pin 562 and the stud 564 is an example of the second support mechanism defined in the present invention . the angle adjusting mechanism 500 includes a brake shaft 580 . one end of the brake shaft 580 is pinned to a tip end of a support rod 446 suspended from the back surface of the detector housing 440 . the support rod 446 is positioned ahead of the horizontal shafts 432 a and 432 b . the pin is parallel to the horizontal shaft 432 . an opposite end side of the brake shaft 580 extends through a brake 590 which underlies the horizontal shaft 432 . the brake 590 inhibits the passing of the brake shaft 580 where required . a lower end portion of the brake 590 is fixed to the interior of the arm 430 through a hinge . a shaft of the hinge is parallel to the horizontal shaft 432 . as the brake 590 there is used , for example , an electromagnetic brake . the brake 590 turns off and on in interlock with operation and non - operation , respectively , of the motor 570 . that is , during rotation of the motor 570 , the brake 590 does not obstruct the passing of the brake shaft 580 , while when the motor 570 is stopped , the brake 590 inhibits the passing of the brake shaft 580 . therefore , while the drive mechanism 540 adjusts the angle of the detector housing 440 , the brake 590 does not operate , and when the angle adjustment is over , the brake 590 turns on and maintains the angle of the detector housing 440 . the portion comprised of the brake shaft 580 and the brake 590 is an example of the brake mechanism defined in the present invention . the brake shaft 580 is an example of the second shaft defined in the present invention . the brake 590 is an example of the brake defined in the present invention . a lift mechanism 700 is annexed to the drive mechanism 540 . the lift mechanism 700 is for lifting the drive mechanism 540 to pull a drive end of the drive mechanism apart from the object to be driven . the lifting operation is performed by applying force from below to induce an upward pivoting motion of the drive mechanism 540 about the pin 562 . the lifting of the drive mechanism 540 is done when adjusting the angle of the detector housing 440 manually . since the drive end moves apart from the object to be driven as a result of the lifting operation , it becomes easy to effect the manual adjustment of the angle . when the lifting operation is stopped , the drive mechanism 540 pivots downward and the drive end and the object to be driven again assume their contacted state . thus , by operating the lift mechanism 700 manually , it is possible to switch from one to the other between contact and non - contact states of the drive end and the object to be driven . the lift mechanism 700 is an example of the switching mechanism defined in the present invention . it is necessary that the manual adjustment of the angle of the detector housing 440 be performed with the brake 590 off . a brake operating switch 448 is disposed on the back surface of the detector housing 440 . the switch 448 is an example of the brake operating means defined in the present invention . fig7 shows the structure of the lift mechanism 700 . as shown in fig7 , the lift mechanism 700 comprises a shaft bar 702 , as well as a vertical arm 704 and a lateral arm 706 both secured to the shaft bar 702 . the shaft bar 702 is disposed under the drive mechanism 540 and in parallel with the horizontal shaft 432 and is attached to the arm 430 through a bearing ( not shown ). the vertical arm 704 is provided on one end of the shaft bar 702 at a position outside the arm 430 , while the lateral arm 706 is provided so as to face forward at an intermediate position of the shaft bar 702 and just under the drive mechanism 540 . the combination of the horizontal shaft bar 702 with the vertical arm 704 and the lateral arm 706 both provided on the shaft bar is an example of the lever defined in the present invention . the vertical arm 704 is a handle for manual operation . by turning the vertical arm 704 to the left , the drive mechanism 504 can be lifted with the lateral arm 706 . as a result of the lifting operation the adaptor 554 disposed at the tip end of the drive shaft 550 is pulled apart from the shaft support 520 . in this state , if the brake 590 is turned off by the switch 448 , the maintenance of the angle of the detector housing 440 is released , so that it becomes possible to manually adjust the direction of the detector housing 440 , as shown in fig8 , 9 and 10 . then , if the brake 590 is actuated by the switch 448 in a desired state of inclination , the angle of the detector housing 440 is maintained .

an x - ray detecting device comprises a support mechanism for supporting a detector housing pivotably about a horizontal shaft parallel to an x - ray incidence surface , a shaft connected at one end to the detector housing and having an opposite end adapted to perform a rectilinear motion to induce a pivotal motion of the detector housing , a drive mechanism having a drive end connected to the opposite end of the shaft , the drive mechanism inducing the rectilinear motion of the opposite end of the shaft in a mutually connected state of the drive end and the opposite end of the shaft , a switching mechanism for between connection and non - connection of the opposite end of the drive shaft and the drive end , a brake mechanism for inhibiting the pivotal motion of the detector housing , and brake operating means for switching between operation and non - operation of the brake mechanism .

the exemplary embodiments of the fluid conduit connector apparatus and methods of operation disclosed are discussed in terms of prophylaxis compression apparatus and vascular therapy including a prophylaxis compression apparatus for application to a limb of a body and more particularly in terms of a compression apparatus having removable portions . it is envisioned that the present disclosure , however , finds application with a wide variety of pneumatic systems having removable fluid conduits , such as , for example , medical and industrial applications requiring timed sequences of compressed air in a plurality of air tubes . in the discussion that follows , the term “ proximal ” refers to a portion of a structure that is closer to a torso of a subject and the term “ distal ” refers to a portion that is further from the torso . as used herein the term “ subject ” refers to a patient undergoing vascular therapy using the prophylaxis sequential compression apparatus . according to the present disclosure , the term “ practitioner ” refers to an individual administering the prophylaxis sequential compression apparatus and may include support personnel . the following discussion includes a description of the fluid conduit connector apparatus , followed by a description of an exemplary method of operating the fluid conduit connector apparatus in accordance with the principals of the present disclosure . reference will now be made in detail to the exemplary embodiments and disclosure , which are illustrated with the accompanying figures . turning now to the figures , wherein like components are designated by like reference numerals throughout the several views . referring initially to fig1 and 2 , there is illustrated a fluid conduit connector apparatus 10 , constructed in accordance with the principals of the present disclosure . the fluid conduit connector apparatus 10 includes a connector having a first connector 12 and second connector 14 . first connector 12 is configured for removable engagement with a second connector 14 . the first connector 12 includes a first plurality of fluid ports 16 extending proximally therefrom and adapted for receiving a first plurality of fluid conduits 18 . fluid conduits 18 are connected to a compression apparatus , including for example , a compression sleeve ( not shown ) adapted for disposal and treatment about a limb of a subject ( not shown ). the second connector 14 includes a second plurality of fluid ports 20 extending distally therefrom and adapted for receiving a second plurality of fluid conduits 22 . fluid conduits 22 fluidly communicate with a pressurized fluid source ( not shown ) that is adapted to inflate the compression sleeve via the advantageous configuration of fluid conduit connector apparatus 10 , as described in accordance with the principles of the present disclosure . it is envisioned that conduits 18 , 22 may include various tubing such as , for example , non - webbed tubing , etc . the fluid ports 16 , 20 of connectors 12 , 14 respectively , each define an inner fluid orifice or passageway that facilitate fluid communication between connectors 12 , 14 . in turn , connectors 12 , 14 facilitate fluid communication between the pressurized fluid source and the compression sleeve . although the fluid conduit connector apparatus 10 is illustrated as having a set of three fluid ports in each connector for connecting sets of three fluid conduits , it is contemplated that each connector can have any number of fluid ports without departing from the scope of the present disclosure . the first connector 12 includes a sleeve 24 defining a cavity 26 having a distal opening . the cavity 26 houses distal portions of the first plurality of fluid ports 16 which extend distally within the cavity 26 . the second connector 14 includes a plurality of fluid couplings 28 extending proximally therefrom . the plurality of fluid couplings 28 is formed by proximal portions of the second plurality of fluid ports 20 for alignment with the distal portions of the first plurality of fluid ports 16 . a locking arm 30 extends proximally from the body portion 32 of the second connector 14 . a slot 34 in the sleeve 24 of first connector 12 includes a window 36 adapted for removably accepting the locking arm 30 to retain the first connector 12 to the second connector 14 . at least one of the first plurality of ports is a coupling port 38 adapted for receiving a coupling fitting 40 . the coupling fitting 40 is permanently attached to the distal end of a corresponding one of the first plurality of fluid conduits 18 . a locking tab extending radially from the coupling fitting 40 is configured for engaging a detent cavity 44 in the first connector 12 , for example in the sleeve 24 as shown in fig1 . a streamlined outer surface 25 prevents the connectors from snagging on patient clothing or bedding . referring now to fig3 - 7 , the various components of the fluid conduit connector apparatus will be described in further detail . a gasket 46 conforms to the space between the plurality of couplings 28 and the distal portion of the first plurality of fluid ports 16 within the cavity 26 when the first 12 is engaged with the second connector 14 . the gasket 46 provides sealing for pressurized fluid communication between corresponding fluid conduits by providing a sealed fluid channel including the first plurality of fluid ports and second plurality of fluid ports . it is envisioned that the gasket 46 can be efficiently and inexpensively manufactured using a variety of common materials or fabrication methods , for example by injection molding an elastomeric material or dye cutting a cork or paper based gasket material . it is envisioned that the gasket 46 can be configured for retention to one or the other of the first connector 12 and second connector 14 . in the illustrative embodiment , the gasket includes a proximal lip 48 configured to engage the distal portion of each of the first plurality of fluid ports to provide fluid sealing between the first connector 12 and the second connector 14 . the gasket includes a retention portion extending therefrom . the sleeve 24 includes a gasket retention groove adapted to accept the retention portion and thereby retain the gasket to the sleeve 24 when the second connector 14 is removed therefrom . the slot 34 at least partially bifurcates the sleeve 24 to allow spreading of the sleeve 24 under stress when the locking arm 30 is pressed into the slot 34 at its distal end as the first connector 12 is mated to the second connector 14 . when an engagement portion 48 of the locking arm 30 reaches the window portion 36 of the slot 34 the sleeve returns to its relaxed shape to releasably retain the second connector 14 by its locking arms 30 . the locking arm 48 is formed with a leading surface 39 inclined at an angle ( i . e ., first angle ) and a trailing surface 41 inclined at a second angle . in the illustrative embodiment , the leading surface 39 is inclined at a shallower angle than the trailing 41 surface so that the force to connect the first connector 12 to the second connector 14 is lighter than the force to disconnect the first connector 12 from the second connector 14 . predetermined connection / disconnection forces can thereby be achieved by proper selection of the first and second angle when designing a particular locking arm 48 . although the illustrative embodiment described herein refers to a particular locking arm and slot configuration , it is envisioned that virtually any type of removable retention method may be used to removably retain the first connector to the second connector without departing from the scope of the present disclosure . for example , an interference fit may be provided between the first connector 12 and second connector 14 or may be provided by a properly configured deformable gasket 46 . alternatively , a snap or detent arrangement known in the art may be used to retain the first connector 12 to the second connector 14 . for example , as shown in fig8 a , 8b and 8 c , first connector 12 includes a locking arm 234 that is configured for mating engagement with corresponding slot 230 formed in second connector 14 , similar to the arm and slot structure described . an alignment rib 59 ( fig1 ) extends radially from at least one of the plurality of couplings 28 along its longitudinal axis . a corresponding alignment slot ( not shown ) is provided in the inner surface of the sleeve 24 extending to the distal end thereof for accepting the alignment rib 59 . it is contemplated that virtually any type of alignment rib / slot configuration commonly used in the art of for alignment of mating connectors can be used without departing from the scope of the present disclosure . the coupling fitting 40 includes a proximal cylinder 52 and a distal cylinder 54 aligned along a longitudinal axis 56 . the proximal cylinder 52 includes a proximal opening 58 and an inside diameter 60 defining an inner surface 62 configured for a press fit corresponding to the outside diameter of one of the first plurality of fluid conduits 18 . in the illustrative embodiment , the corresponding fluid conduit is an air tube which is press fit into the proximal cylinder 52 through its proximal opening 58 . in an illustrative embodiment , the fluid conduit is substantially permanently attached to the proximal cylinder 52 by friction . in alternative embodiments a variety of suitable adhesives may be applied to the inner surface 62 of the proximal cylinder 52 to permanently attach the fluid conduit and provide a fluid tight seal therebetween . for example , it is envisioned that a silicon adhesive , rubber cement , a material specific adhesive compound , an o - ring , a gasket or the like can be used according to methods well known in the art to attach the fluid conduit to the coupling fitting . the distal cylinder 54 comprises an inner surface defined by an inside contour 64 revolved about the longitudinal axis 56 and an outer surface 66 defined by an outside diameter . in the illustrative embodiment , the inside contour 64 includes a sealing portion 68 , a flexing portion 70 and an annular lip portion 72 . the sealing portion 68 has an inside diameter adapted for a tight fit against the outside surface of the coupling port 38 to provide at least partial fluid sealing therebetween . the annular lip portion 72 defines an annular ring that compresses against the outside surface of coupling port 38 and provides fluid sealing therebetween . the flexing portion 70 is defined by a reduced wall thickness which allows the distal cylinder 54 to deflect inwardly to facilitate engagement of the locking tab 42 to the detent cavity 44 . although the illustrative embodiment is described with respect to a particular retention and sealing configuration between the coupling fitting 40 and coupling port 38 , it is envisioned that virtually any type of coupling fitting retention and sealing method known in the art can be used between the coupling fitting 40 and the external surface of the coupling port 38 without departing from the scope of the present disclosure . for example , it is envisioned that a threaded collar , a cantilever snap arm or the like can be used for attachment of the coupling fitting 40 to the coupling port 38 or to the first connector 12 . in another example referring to fig9 and 10 , the sleeve 24 or interior surface of the first connector 12 can include a detent cavity 44 extending at least partially into the interior surface and adapted for accepting the locking tab 42 of the coupling fitting 40 . a detent 57 of tab 42 is inserted into sleeve 24 to become disposed in cavity 44 . detent 57 is rotated through cavity 44 , via manipulation of fitting 40 and retained in position by bump formed in the wall of cavity 44 . in an alternate embodiment , the detent cavity shown in fig1 includes a longitudinal track portion 55 ( shown in phantom ) adapted for guiding the locking tab 42 ( fig9 ) during engagement and disengagement and an annular portion 57 adapted for retaining the locking tab 42 ( fig9 ) when the coupling fitting 40 is rotated about its longitudinal axis 56 . along its length , the detent cavity 44 can have varying depth or width into the interior surface . the varying depth of the detent cavity 44 provides a predetermined engagement / disengagement force / displacement profile between the locking tab 42 and the detent cavity . in one embodiment , the locking tab has an outer portion with an enlarged manual engagement surface 43 to assist manipulation of the locking tab 42 . in an illustrative embodiment of the invention , the coupling fitting includes an engagement portion 74 adapted for opening a valve 76 disposed within the coupling port 38 . the engagement portion 74 extends distally from a transverse wall 78 within the coupling fitting 40 to displace a plunger 80 in the valve 76 . in the illustrative embodiment , the transverse wall 78 is disposed within the coupling fitting 40 about between the proximal cylinder 52 and the distal cylinder 54 and orthogonal to the longitudinal axis 56 . at least one fluid passageway extends through the transverse wall . although the illustrative embodiment is described in terms of a distally extending engagement portion , it is envisioned that virtually any type of valve engagement structure can be used to displace a valve plunger 80 within the scope of the present disclosure . for example , a flat surface of the transverse wall 78 or a rib extending from the inner surface of the distal cylinder 54 , can be aligned with a complementary structure within a valve 76 to displace a valve plunger 80 when the coupling fitting 40 is engaged with the coupling port 38 . the illustrative embodiment includes a valve 76 is disposed within the coupling port 38 . the valve 76 includes a plunger 80 movable along the longitudinal axis of the coupling port 38 and biased proximally by a spring 82 . the spring 82 is supported by the gasket 46 which is held in place in cavity 26 by protrusion 51 on the gasket 46 . adhesive may alternatively be used to maintain gasket 46 in position . the gasket 46 includes a spring seat formed along the longitudinal axis of any gasket passageway to be aligned with a coupling port . ( fig4 - 5 ) the spring seat in the illustrative embodiment includes a central stub 84 supported by radial spars 86 within the gasket opening . the valve can be easily assembled by installing the spring 82 over the distal end of the plunger 80 to form a plunger and spring sub - assembly . the plunger 80 includes a step 88 to engage the proximal end of the spring 82 . the plunger and spring sub - assembly can then be installed into the coupling port 38 from its proximal end . the gasket 46 can then be installed into the cavity 26 . alternatively , the plunger and spring sub - assembly can be installed to the gasket 46 by fitting the spring 82 to the spring seat before installing the gasket 46 spring 82 and plunger 80 together to the first connector 12 . fig7 and 8 provide two illustrative embodiments of a plunger 80 according to the present disclosure . although the present disclosure illustrates the use of a coil spring 82 to bias the plunger 80 , it is contemplated that virtually any type of plunger and spring arrangement known in the art can be used to provide biasing of the plunger 80 within the scope of the present disclosure . for example , it is envisioned that spring force could be applied to the plunger 80 by forming a plastic cantilever spring arm that could be formed within the first connector 12 . alternatively a structure similar to the spring seat could be formed of elastomeric material as part of the gasket 46 to provide a biasing force to the plunger 80 without departing from the scope of the present disclosure . when the coupling fitting 40 is engaged with the coupling port 38 , the engagement portion 74 of the coupling fitting forces the plunger 80 to move distally against the force of the spring 82 which is thereby compressed . an open fluid connection is thereby provided from the fluid conduit connected to the coupling fitting 40 , through the coupling port 38 to the corresponding one of the second plurality of fluid conduits 22 , i . e ., the corresponding air tube . for example , a portion of the compression sleeve that fluidly communicates with the pressurized fluid source via coupling port 38 may be removed from the remainder of the compression sleeve . the remaining portion of the compression sleeve continues to provide treatment to the limb of the subject . upon removal of the selected portion , the coupling fitting 40 is disconnected and not engaged to the coupling port 38 . spring 82 forces the plunger 80 to its proximal limit of travel where the plunger 80 engages a proximal stop such that valve 76 is in a closed position . the plunger 80 is configured to cooperate with an internal structure in the coupling port 38 to define a reduced fluid orifice when the plunger 80 is displaced to its proximal limit . the reduced fluid orifice is designed to provide pneumatic characteristics approximating the pneumatic characteristics of a detached device . in an illustrative embodiment , ( fig6 - 7 ), a cap 90 having a fluid passageway 92 therethrough is disposed in the proximal opening of the coupling port 38 . the cap 90 provides a stop defining a proximal limit of plunger travel and is configured to cooperate with the plunger 80 of valve 76 , such that valve 76 reduces the dimension of the fluid orifice of coupling port 38 . for example , as shown in fig6 a and 6b , coupling fitting 40 is connected to the coupling port 38 to force plunger 80 distally and open the fluid connection ( fig6 a ), described above , for inflating a removable portion of an inflatable compression sleeve ( not shown ). to provide such an open connection , a valve seat 282 of plunger 80 is disposed via spring 82 ( not shown in fig6 a and 6b for clarity ), out of engagement with a conical seat 284 of cap 90 . this configuration allows air to flow around the conical seat 284 and through conduit 22 ( not shown ), and out to the inflatable removable portion of the compression sleeve , as shown by arrows a . for removal of the removable portion of the compression sleeve , coupling fitting 40 is removed from coupling port 38 . spring 82 forces valve seat 282 into engagement with a counter bore edge of conical seat 284 . thus , this configuration advantageously reduces the dimension of the fluid orifice of coupling port 38 such that air only flows through cavities defined by semi - circular slots 286 of valve seat 282 and the bore edge of conical seat 284 . slots 286 are formed on the sides of valve seat 282 . the cavities defined by slots 286 and conical seat 284 facilitate fluid flow that approximates the pneumatic behavior of the removable portion of the compression sleeve when coupling fitting 40 is connected to coupling port 38 during an open fluid connection . the cavities defined by slots 286 and conical seat 284 may have various configurations and dimensions including geometries such as , for example , elliptical , polygonal , etc . this configuration advantageously approximates the pneumatic characteristics of a detached device . it is contemplated that the fluid orifice of coupling port 38 may be variously configured such that corresponding engagement with plunger 80 reduces the orifice dimension to approximate fluid flow through coupling port 38 that would otherwise occur with valve 76 in the open position . it is further contemplated that plunger 80 may includes openings to approximate fluid flow . it is envisioned that valve 76 is operable to reduce the dimension of the fluid orifice of coupling port 38 over a range of closed positions , including partial fluid flow , leakage , etc . to approximate fluid in the port or alternatively , the orifice may completely close to prevent fluid flow through the corresponding port . in a completely closed configuration , pump speed or other settings may be adjusted . in a particular embodiment , the present disclosure provides an air tubing connector for use with a compression apparatus having removable portions , see , for example , the compression sleeve described in u . s . patent application ser . no . ______ , filed on feb . 23 , 2004 and entitled compression apparatus . three separate air tube are connected to an ankle portion , a calf portion and a knee portion of the apparatus . each portion is supplied with a timed sequence of compressed air through its respective air tube . the proximal end of each of the three air tubes is connected to the first plurality of fluid ports 16 in a first connector 12 according to the present disclosure . a mating set of three air tubes extends from a timed pressure source and is connected to the second plurality of fluid ports 18 in a second connector 14 according to the present disclosure . in the illustrative embodiment , the distal end of the thigh tube is connected to the first connector 12 via a coupling fitting 40 and port 38 as described hereinbefore . when a patient no longer requires the thigh portion of the prophylaxis compression apparatus , the thigh portion can be removed and the tubing attached thereto can be disconnected from the first connector at the coupling port 38 . operation of the valve 76 in the coupling port 38 provides a reduced fluid orifice that restricts airflow therethrough to approximate the pneumatic characteristics of the thigh portion and its corresponding air tube . thus , sensors in the timed pressure source will not detect a change in fluid pressure or flow rate when the thigh portion is removed . this allows the timed pressure source to continue supplying uninterrupted timed air pressure to the ankle and calf portions of the prophylaxis compression apparatus . referring to fig1 and 12 , certain embodiments are provided wherein the first plurality of fluid conduits 18 is a set of webbed tubing 98 having increased webbing volume 100 between at least one pair of adjacent conduits . at least one interference rib 94 is formed between at least one pair of adjacent fluid ports in the first plurality of fluid ports . the increased webbing volume 100 is aligned with the interference rib 94 if the set of webbed tubing 98 is improperly oriented with the first connector 12 . the interference rib 94 thereby prevents attachment of improperly oriented fluid conduits to the first connector 12 . similarly , the second plurality of fluid conduits 22 can include an increased webbing volume configured to interfere with an interference rib between adjacent ports in the second connector 14 to prevent attachment of improperly oriented fluid conduits to the second connector 14 . referring to fig1 , one embodiment includes a first connector 12 having an interference key 96 in the cavity 26 to prevent the first connector 12 from mating with legacy connector components . the second connector 14 includes a clearance space for the interference key 96 . fig1 schematically depicts the function of an interference key 96 to prevent connection of certain embodiments of a first connector 12 to certain embodiments of a second connector 13 . for example , key slot 98 in second connector 13 b provides clearance for interference key 96 in first connector 12 b to facilitate mating one to the other . second connector 13 b can also be mated to certain first connectors such as 12 a which do not include an interference key . second connector 13 a does not include a key slot and therefore can not be mated with first connector 12 b . in at least one embodiment , second connector 13 a is a legacy connector . in the illustrative embodiment , the interference key 96 in a non - compatible connector such as first connector 12 b is used to prevent connection of the non - compatible connector to the legacy connector . it will be understood that various modifications may be made to the embodiments disclosed herein . for example , the connector of the present disclosure may be used with various single and plural bladder compression sleeve devices including , for example , the compression sleeve described in u . s . patent application ser . no . ______ , filed on feb . 23 , 2004 and entitled compression apparatus , the entire contents of which is hereby incorporated by reference herein . therefore , the above description should not be construed as limiting , but merely as exemplification of the various embodiments . those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto .

a fluid conduit connector apparatus that the approximates pneumatic characteristics of a removed pneumatic system component when a fluid conduit is removed from a pneumatic system . the fluid conduit connector apparatus includes a port portion having a valve disposed therein . the valve closes to provide a reduced fluid orifice when a fluid conduit is removed from the port . the reduced fluid orifice is configured to provides pneumatic characteristics of the device being disconnected to facilitate uninterrupted operation of a timed pressure source having pneumatic sensing capability .

fig1 - 6 illustrate the details of the shoe insert construction of the present invention . fig7 is a schematic perspective view illustrating one of the steps in the sequence of the method of the invention . with regard to the construction of the insert , as illustrated in fig1 - 7 , the insert comprises a base layer 12 , a support layer 13 , a foam layer 11 , and a fabric layer 14 . the layers 11 , 12 , and 14 are relatively resilient and conform in shape to the desired shoe size . the support layer 13 is rigid and as noted in fig1 is principally at the heel area of the shoe insert . the foam layer 11 as well as the support layer 13 is preferably constructed of a polyurethane foam material . the support layer 13 is of a denser foam thus making the support layer more rigid . the layer 11 preferably has a density of 5 lbs . per cubic ft . and it is preferred that this density be in the range of 4 - 6 lbs . per cubic ft . the layer 11 has a preferred thickness of 1 / 8 &# 34 ;+ or - 5 % and is preferably in a range of thickness of 3 / 32 &# 34 ;- 5 / 32 &# 34 ;. the material used for layer 11 as well as layer 13 may be made by crestfoam company . the layer 12 preferably also has a density in a range of 4 - 6 lbs . per cubic ft . the base layer 12 is preferably of cross - linked polyethylene . the thickness of the base layer 12 is preferably on the order of 5 / 16 &# 34 ;+ or - 10 %. the thickness of the base layer 12 may actually extend through a range of 1 / 4 &# 34 ; to 7 / 16 &# 34 ; in thickness . the material of the base layer 12 may be made by dynamet nobel company . with regard to the support layer 13 , which is formed primarily at the heel area of the insert , this is also made of a polyurethane foam . however , this is made by being compressed so that the final density is on the order of 22 - 23 lbs . per cubic ft . the fabric layer 14 may be constructed of , for example , cotton , polyester , or a polypropylene knit . reference may now be made to fig7 which shows one of the steps in the method of construction of the shoe insert of this invention . the shoe insert is formed by first joining the foam layer 11 with the fabric layer 14 . the layers 11 and 14 are laminated together by a flame lamination technique which employs an open flame which is directed to the foam layer 11 . the open flame generates sufficient heat on the surface to cause melting of the flat sheet layer 11 . once melted , the fabric layer 14 is joined therewith and the two sandwiched together layers are preferably run between chilled rollers and sufficient pressure is applied between the rollers so that the layers 11 and 14 are joined together . at this point in the process , these layers are still maintained in a flat sheet form . the integrated layers 11 and 14 are then next joined also by flame lamination to the base layer 12 . this step in the method of manufacture may also be carried out by the use of an open flame directed to either layer 11 or layer 12 to cause melting thereof . the previously integrated layers 11 and 14 are then joined to layer 12 and the laminated layers are then run betweeen chilled rollers . at this stage of the process , the layers are still in flat sheet form . the layers thus laminated to this point are then ready for molding . this requires a neating of the laminated layers to a molding temperature of approximately 250 ° f . for a period of about 225 seconds . this heats the previously laminated layers sufficiently to permit them to be inserted into the mold . reference may now be made to fig7 which shows the mold in the schematic manner as comprised of mold pieces 20 and 21 . the mold may be made of aluminum . fig7 also shows the tri - laminate 22 which is comprised of layers 11 , 12 , and 14 . the tri - laminate 22 is shown as still in flat sheet form in fig7 and disposed adjacent the pre - formed support layer or cup 13 . reference is made hereinafter to the manner in which the compressed foam cup 13 is formed . the pre - formed heel layer or cup 13 is placed in the mold comprised of mold pieces 20 and 21 and an adhesive is applied to the inside of the layer 13 . the tri - laminate 22 is appropriately positioned and the mold is closed . the adhesive is preferably a chlorinated rubber base adhesive which is heat and pressure reactivatable . one adhesive that is used is made by jetco . thus , during this molding step , it is seen that the adhesive is activated at substantially the same time that the shaping of the tri - laminate 22 along with the heel layer 13 occurs . this shaping is accomplished of course , by means of the mold press . the molding occurs under a pressure , preferably of 85 lbs . psi . the mold is illustrated in fig7 in a schematic fashion and is preferably a water cooled mold . the mold may be cooled by passage of water therethrough so as to maintain the temperature at approximately 40 ° f . the mold is maintained in its press - mold state for approximately 50 - 65 seconds . thus , the material inserted into the mold which includes the tri - laminate 22 and the layer 13 , essentially is inserted into the mold in a hot condition , recalling that at least the tri - laminate 22 is heated to proper molding temperatures , and is then brought to a colder temperature by virtue of the cooling of the mold . also , at the same time that this molding occurs , the adhesive is activated by virtue of contact with the preheated tri - laminate 22 along with the activation of the adhesive by means of the pressure applied during the molding operation . thus , the molding step schematically illustrated in fig7 causes the simultaneous shaping of the insert . it also causes the affixing of the cup or heel layer 13 to the previously formed tri - laminate 22 . now , with regard to the technique for forming the cup or heel 13 , it is noted that previously it has been indicated that this member is constructed of a polyurethane foam that has been compressed to a density on the order of 22 - 23 lbs . per cubic ft . in its compressed state , the layer 13 may have a thickness of 1 / 16 &# 34 ;- 1 / 8 &# 34 ;. however , initially , before being compressed , the polyurethane has a thickness of 1 . 5 &# 34 ; and is constructed of a urethane product that has characteristics of being clickable and reticulated . the urethane is preferably clickable so that when it is cut with , for example , a scissors , there will not be a pinching on the ends . the reticulated form of the urethane means that the cell membranes have been removed electrically or chemically . ideally , the reticulation is on the order of 80 - 90 pores / inch , although , a preferred range is 50 - 90 pores / inch of reticulated foam . in this regard , the higher the cell or pore count , the more cosmetically acceptable is the material because the cells are smaller and thus have a more pleasing aesthetic appearance . the 1 . 5 &# 34 ; thick urethane is compressed by means of a steel or brass tool . the compressing tool preferably has a high heat conductivity and in this regard , brass is preferred . the tool is heated , preferably to a temperature of 450 ° f . and this causes the foam to be uniformly softened whereby it is caused to be compressed by the tool . once compressed , it is set into this compressed state and it maintains the compressed state . the tool is similar in form to a mold and operates at say , 86 psi . for 90 seconds . the heat , as mentioned previously , is preferably at 450 ° f . it is preferred that this temperature be maintained during the compressing phase and that the heat not be allowed to drop substantially from that temperature . once the cup layer 13 has been preformed , then it is employed in the mold illustrated in fig7 with the adhesive being coated inside of the cavitated heel layer 13 . having now described one form of the present invention , it should now be apparent to those skilled in the art that numerous other embodiments and modifications thereof are contemplated as falling within the scope of this invention .

a shoe insert for use with a shoe or sneaker to reduce impact to the foot and to absorb shock and attenuate shock to the foot . the insert is comprised of a base layer of a relatively resilient material , a foam layer disposed over the base layer , a fabric disposed over the foam layer and means integrally forming the base layer , foam layer and fabric into a sheet tri - laminate . a support layer is disposed only at the heel area and is constructed of a rigid material of higher density than that of the tri - laminate . means are provided for attaching and forming the tri - laminate with the support layer .

referring now to fig1 the eye 12 comprises a cornea 14 shown to the left or front of the eye and an annular iris 16 shown in the middle of the eye . the iris 16 divides the eye 12 into an anterior chamber 18 at the front and a posterior chamber ( not shown ) in back of the iris . for purpose of orientation , the directions “ anterior ” and “ posterior ” are as commonly known , i . e ., forward and rearward , respectively . the iris 16 also defines the aperture or pupil 22 , which is a variable opening in the middle of the iris . the posterior face of the cornea 14 and the anterior face of the iris 16 meet at the peripheral ciliary band defining an iridio - corneal angle 24 . behind the iris 16 is the ciliary process 26 , which controls the movements of the natural crystalline lens 30 of the eye 12 via a plurality of fibrous zonules 32 . in the human eye , an optical axis oa is generally aligned along the centers of the cornea 14 , the natural lens 30 and the retina ( not shown ) of the eye 12 . with reference to fig1 a , the cornea 14 comprises five layers , including , from the outermost to the innermost , posterior layer , an outer layer 34 of epithelial cells , bowman &# 39 ; s membrane 36 , the stroma 38 , descemet &# 39 ; s membrane 40 , and the endothelium 42 . fig2 a - 2b illustrate an exemplary intraocular lens 60 that can be positioned in the anterior chamber 18 of the eye 12 and implanted in the posterior aspect of the cornea 14 , as described below with respect to fig4 a - 4b . the intraocular lens 60 includes a generally circular optic 62 defining an optical axis 63 at its center , a first fixation member 64 projecting generally in one direction from the optic , and a second fixation member 66 projecting generally in the opposite direction relative to the first fixation member . the fixation members 64 , 66 are sometimes known as haptics or loops . the optical axis 63 is an imaginary line that passes through the optical centers of both faces of the intraocular lens 60 . as seen in fig2 b , the optic 62 includes a typically convex anterior face 68 a , and a typically concave posterior face 68 b . the fixation members 64 , 66 are coplanar or angled forwardly away from the optic 62 , in the anterior direction . an angle θ is shown to indicate the degree of forward angle of each of the fixation members 64 , 66 . the angle θ is desirably between about 10 or about 15 and about 65 degrees . the intraocular lens 60 may be made from a variety of materials , and the optic 62 may be the same as or a different material than the fixation members 64 , 66 . for example , the optic 62 and / or fixation members 64 , 66 may be made from hydrophobic or hydrophilic acrylic polymeric materials , silicone polymeric materials , collagen , collagen - containing composites , polymethyl methacrylate ( pmma ) and the like and mixtures thereof . desirably , the fixation members 64 , 66 are relatively stiffer with respect to the deformable , e . g ., foldable , optic 62 . with reference again to fig3 a , the first fixation member 64 includes an elongate , curved strut 70 that attaches to the optic 62 and terminates in a single , enlarged foot 72 . using a clock - face nomenclature , with the optical axis 63 at the center , the curved strut 70 commences at a reinforced region 74 at about the 10 : 00 position on the outer edge of the optic 62 . the strut 70 extends in a clockwise direction a small distance 76 away from and conforming to the upper edge of the optic 62 until a u - bend 78 at approximately the 2 : 00 position . the strut 70 then reverses in a counter - clockwise direction to a 90 degree bend 80 at the 12 : 00 position , the strut extending directly radially outward therefrom to the enlarged foot 72 . the second fixation member 66 includes an elongate , curved strut 82 attached the optic 62 that diverges to a pair of outer struts 84 a , 84 b . the curved strut 82 commences at a reinforced region 86 at about the 4 : 00 position on the outer edge of the optic 62 and extends in a clockwise direction a small distance 88 away from and conforming to the lower edge of the optic 62 until a three - way junction portion 90 at approximately the 6 : 00 position . the two outer struts 84 a , 84 b diverge outward by an included angle of about 90 degrees and terminate in feet 92 a , 92 b , each of which is angled with respect to the outer strut so that the feet point away from one another . in a particularly preferred embodiment , the two outer struts 84 a , 84 b have a thickness , and the feet 92 a , 92 b also have a thickness that is approximately the same as the struts . the advantage of such a configuration will be described below in reference to a method of implantation . the combination of the enlarged foot 72 of the first fixation member 64 and the bifurcated feet 92 a , 92 b on the second fixation member 66 results in a three - point fixation of the intraocular lens 60 within the eye . more specifically , and with reference again to fig2 the enlarged foot 72 , and bifurcated feet 92 a , 92 b are implanted in the cornea 14 from the inside or posterior aspect of the cornea , and support the optic 62 along the optical axis 63 . there are a number of ways to implant fixation members of intraocular lenses into the cornea 14 . perhaps the easiest way is to create incisions from the posterior face of the cornea 14 . another solution is to create elongated tunnels within the cornea from the outside . subsequently , the intraocular lens is inserted into the anterior chamber and the fixation members are positioned within the tunnels . in this manner , the fixation members are not directly adjacent to an incision leading to the outer face of the cornea , and thus they remain securely implanted in the eye . another consideration is the particular positioning of the fixation members within the corneal layers . it has been found that the middle stroma layer 38 , as seen in fig1 and 2 , is most suited for receiving the fixation members because of its relative thickness with respect to the other layers , and because it relatively tougher and less susceptible to wear from the inserted fixation members . one example of an implantation procedure of the present invention is shown schematically in fig3 a - 3 b , and 4 a - 4 b . with reference to fig3 the outer circle represents the cornea 14 , as viewed from the front . in a first step , a so - called phaco incision 100 is created from the outside or anterior aspect 102 of the cornea 14 through to the inside or posterior aspect 104 . the plan view of the incision 100 is seen in fig3 with a schematic sectional view shown in fig3 a through the cornea 14 ( note that the various layers of the cornea are not illustrated for clarity ). as viewed from the front view of fig3 the incision 100 has a circumferential width w about the optical axis oa , a generally radial length l , and a depth through the corneal layers . as seen in fig3 a , the incision 100 desirably includes three sub - incisions : an entrance sub - incision 106 from the anterior aspect 102 into the stroma ( not shown ), a tunnel sub - incision 108 extending within the stroma , and an exit sub - incision 110 opening to the posterior aspect 104 . as illustrated , the entrance sub - incision 106 is generally perpendicular with respect to the anterior aspect 102 , the exit sub - incision 110 is generally perpendicular with respect to the posterior aspect 104 , and the tunnel sub - incision 108 extends within the stroma and generally perpendicular to both of the other sub - incisions . in practice , due to the minute distance involved , these sub - incisions will not likely assume such idealized configurations , but will be formed in this stepped configuration nonetheless . in an exemplary embodiment , the entrance sub - incision 106 has a circumferential width w of approximately or about 3 mm and extends through the corneal layers a depth of approximately 0 . 25 mm . the tunnel sub - incision 108 also has a width w of about 3 mm , and a radial length l of about 2 mm . finally , the exit sub - incision 110 has the same circumferential width as the tunnel sub - incision 108 , and extends through the corneal layers a depth of approximately 0 . 25 mm . the average depth of the cornea 14 is about 0 . 5 mm , so the tunnel sub - incision 108 desirably lies in a plane of the cornea 14 that is midway between the anterior and posterior aspects 102 , 104 , and within the stroma . in one embodiment , the tunnel sub - incision 108 is widened at a pair of pockets 112 a , 112 b . these pockets 112 a , 112 b may take a variety of forms , and are illustrated as rounded incisions . the pockets 112 a , 112 b extend in the stroma layer in the same plane as the rest of the tunnel sub - incision 108 . a secondary incision 120 is formed in the cornea 14 at a location that is approximately diametrically opposite from the phaco incision 100 . the secondary incision 120 has a width w , a length l , and a depth , as seen in the section view of fig3 b . the incision 120 may be formed from the outside or anterior aspect 102 of the eye , or from the inside or posterior aspect 104 using an instrument passed through the phaco incision 100 . therefore , an exit sub - incision 122 is shown in dashed line extending generally perpendicular from the anterior aspect 102 . a tunnel sub - incision 124 extends generally perpendicularly through the stroma layer from the exit sub - incision 122 , and leads to an entrance sub - incision 126 opening generally perpendicularly to the posterior aspect 104 . the tunnel sub - incision 124 extends generally radially , such that the exit sub - incision 122 is located radially outward from the entrance sub - incision 126 . as before , these sub - incisions are shown as idealized , and likely will not have such sharp and well - defined intersections . in an exemplary embodiment , the width w of the secondary incision 120 is about 1 mm , while the length l is about two mm . the depth of the stepped sub - incisions are as described above with respect to the phaco incision 100 , with the tunnel sub - incision 124 being generally located in the stroma and in a plane that is midway between the anterior aspect 102 and posterior aspect 104 . the phaco incision 100 is sized to permit introduction of the intraocular lens 60 of the present invention to the anterior chamber . specifically , the incision 100 is sized to permit the intraocular lens 60 to pass therethrough in a folded configuration . a method of implanting the intraocular lens 60 into an eye 12 will now be described with respect to fig4 a - 4b . various techniques instruments are known for incising the cornea 14 , and for a introducing and manipulating intraocular lenses within the anterior chamber 18 ( fig1 ) of the eye . for example , various diamond keratomes or blades may be used to form the incisions 100 , 120 , and a conventional bartell type intraocular lens folding system used to introduce the intraocular lens 60 through the phaco incision 100 . manipulation of the intraocular lens 60 , and in particular the fixation members 64 , 66 may be accomplished using forceps or other such fine grabbing tools . description of these various implements will not be included herein , as they are well - known by those of skill in the art . the first step in implantation comprises the formation of the phaco incision 100 from the outside or anterior aspect of the eye . as described above , the incision 100 is desirably stepped as indicated in fig3 a , with a relatively large tunnel sub - incision 108 being formed parallel to the corneal layers , and within the stroma . subsequently , the secondary incision 120 is formed , either from the outside or anterior aspect of the eye , or from the inside or posterior aspect . in the latter instance , a suitable keratome may be inserted through the phaco incision 100 to form just the entrance sub - incision 126 and tunnel sub - incision 124 , as indicated in fig3 b . alternatively , the secondary incision 120 may be formed from the outside , with the three sub - incisions 122 , 124 , and 126 being formed in sequence . the intraocular lens 60 can then be introduced to the anterior chamber 18 through the phaco incision 100 . after unfolding , the intraocular lens 60 is desirably in an orientation as seen in fig4 a , or is manipulated into that orientation , with the first fixation members 64 extending generally toward the secondary incision 120 , and the second fixation members 66 extending generally toward the phaco incision 100 . the first fixation members 64 is then inserted into the secondary incision 120 by passage of the enlarged foot 72 through the entrance sub - incision 126 and into the tunnel sub - incision 124 ( see fig3 b ). this relative arrangement seen in fig4 a . the radial length 1 of the tunnel sub - incision 126 is approximately the same as the length of the radial portion of the strut 70 between the 90 ° bend 80 and the enlarged foot 72 . in this manner , the 90 ° bend 80 is positioned within the anterior chamber 18 , closely adjacent to the entrance sub - incision 126 . because of the flexibility of the fixation members 64 , 66 , the intraocular lens 60 can be manipulated to implant the second fixation member 66 into the phaco incision 100 . in a preferred embodiment , the spacing between the feet 92 a , 92 b is slightly larger than the width w of the incision 100 . therefore , the diverging outer struts 84 a , 84 b are first bent inward toward one another so that the feet 92 a , 92 b can pass through the exit sub - incision 110 . after proper positioning of the second fixation member 66 , with the three - way junction portion 90 remaining within the anterior chamber 18 just adjacent the exit sub - incision 110 , the diverging outer struts 84 a , 84 b are released such that the feet 92 a , 92 b spring outward to the sides of the tunnel sub - incision 108 . as mentioned above , the optional pockets 112 a , 112 b may be provided to receive the feet 92 a , 92 b . alternatively , the feet 92 a , 92 b may contact the sides of the tunnel sub - incision 108 , such that the resilient bias of the struts 84 a , 84 b holds the fixation member 66 in place . furthermore , because the feet 92 a , 92 b are not enlarged as are prior art acrylic lens fixation members for use in the iridio / corneal angle , they may become embedded in the stroma layer on the sides of the tunnel - incision 108 . this anchoring effect helps prevent movement of the intraocular lens 60 within the cornea 14 . in any event , the intraocular lens 60 is positioned as seen in fig4 a , with the optic 62 in the desirable centered position . fig4 b shows the exemplary intraocular lens 60 of the present invention positioned in the anterior chamber 18 of the eye 12 , and desirably centered along the optical axis oa for focusing light at or near the retina ( not shown ). desirably , the optical axis 63 of the intraocular lens 60 coincides with the optical axis oa of the natural eye . as mentioned above , the fixation members 64 , 66 extend directly radially outward or outward and forward from the typically circular optic 62 and are implanted in the cornea 14 from the inside , or posterior aspect of the cornea . the ends of the fixation members 64 , 66 reside within the stroma 38 , and in particular within the tunnel sub - incisions as described above . the optic 62 is thus positioned and suspended by the fixation members 64 , 66 so as not to touch the cornea , which might result in harmful endothelial cell loss . in one embodiment , as shown , the struts 84 a , 84 b are divergent to an extent that they provide good balance for the intraocular lens 60 when implanted in the cornea . that is , the struts 84 a , 84 b and feet 92 a , 92 b are desirably centered about a vertical plane intersecting the optical axis oa , and thus support approximately the same amount of weight of the lens . therefore , in combination with the implantation of the first fixation member 64 , the second fixation member 66 helps prevent movement of the lens in the anterior chamber . while this invention has been described with respect to various specific examples and embodiments , it is to be understood that the invention is not limited thereto and that it can be variously practiced within the scope of the following claims . for example , although only two fixation members are shown , there may be three or more . alternatively , only one of the disclosed fixation members may be used in combination with one or more other types of fixation member .

an intraocular lens configured to be implanted in the cornea from the posterior aspect . the lens has an optic and a pair fixation members extending outward therefrom . one of the fixation members includes a single enlarged foot , while the other fixation member has two bifurcated feet . the fixation members are sized and shaped to fix within tunnels formed in the cornea . a method of the invention includes forming tunnels in the stroma layer of the cornea , and positioning the fixation members in the tunnels . the tunnels may be formed from outside or inside the cornea . the method may include inserting the folded intraocular lens into the anterior chamber , permitting the lens to unfold , inserting the fixation member with the enlarged foot in one of the tunnels , and bending the two bifurcated feet of the other fixation member together so as to fit within the other tunnel .

fig1 - 16 depict a universal pull cart attachment device suitable for attaching a conventional pull cart to a motorized golf cart , according to one embodiment . as shown in fig1 , the attachment device 10 includes a base member 20 and an extension member 30 . the base member 20 of the illustrated embodiment is configured to mount to a motorized golf cart via a plurality of mounting holes and corresponding hardware . the base member 20 can be pre - installed on a motorized cart or attached as an add - on feature . in an alternate embodiment , the universal pull cart attachment 10 is formed integrally with the motorized golf cart . for example , the base member 20 of the pull cart attachment may be molded into a golf cart frame . the extension member 30 is coupled to the base member 20 such that the extension member 30 can be selectively extended to facilitate design variations in motorized golf carts . the extension member 30 can extend from a right side of the motorized cart or from a left side , or both . the extension member 30 allows selective placement of the device such that a golfer may access one or both sides of a pull cart when attached thereto . in a preferred embodiment , two extension members 30 are provided for attachment of two pull carts . in the illustrated embodiment , the base member 20 is steel square tubing and the extension member 30 is steel u channel , although numerous structural shapes ( e . g ., round stock ) and materials are contemplated ( e . g ., stainless steel , composite materials ). the base member 20 includes an aperture proximate at least one end thereof to receive a fastener 24 for coupling to one of a series of spaced apertures 32 in the extension member 30 . in an alternate embodiment , the base member 20 and extension member 30 are integral . the extension member 30 includes a cylindrical mounting stem ( not shown ) that defines a first axis of rotation a . the mounting stem is sized for insertion into a first retention member 40 . the first retention member 40 includes a hook 42 and a cylindrical sleeve 44 for mating with the mounting stem of the extension member 30 to allow rotational movement about the first axis of rotation a . the rotational movement of the first retention member 40 may be limited by stops . in the illustrated embodiment , an internal dowel ( not shown ) engages slots in the mounting stem of the extension member 30 to limit rotational travel . other features for limiting rotational movement are well known in the art . the hook 42 is sized and shaped to retain a handle of varying sizes as commonly found on conventional pull carts . in an alternate embodiment , the hook 42 is selectively adjustable to provide selective engagement with the handle of a pull cart . in one embodiment , a cushioning material may be placed on an under surface of the hook 42 to provide protection against chafing , absorption of vibration , and / or adaptation to various handle configurations . a second retention member 50 having a cylindrical stem 52 and support surface 54 is coupled to the first retention member 40 via a cylindrical insert 60 and extension spring 70 . the cylindrical insert 60 is press - fit or otherwise fastened to the cylindrical stem 52 of the second retention member 50 and sized to slidably engage the sleeve 44 of the first retention member 40 . the insert 60 may include a groove in the face thereof to engage a surface feature of the sleeve 44 so as to prevent relative rotational movement between the sleeve 44 and the insert 60 . the first and second retention members 40 , 50 are able to at least partially rotate about the first axis of rotation a to enable a pull cart attached thereto to turn in combination with the motorized cart . the second retention member 50 translates along the first axis of rotation a from an engaged position to a disengaged position and is biased towards the engaged position by the extension spring 70 that is retained in the first retention member 40 and secured to the second retention member 50 . the bias force of the extension spring 70 is selected such that a user can easily displace the second retention member 50 to the disengaged position by hand . extension features 56 , 58 at opposing ends of the second retention member 50 provide levers for displacement of the second retention member 50 to the disengaged position . in the engaged position , the hook 42 of the first retention member 40 cooperates with the support surface 54 of the second retention member 50 to retain the handle of a pull cart while simultaneously allowing the handle of the pull cart to rotate , such that the pull cart is able to pitch up and down . edges of the support surface 54 may be contoured to reduce chafing or abrasion of the pull cart handle . when a handle of a pull cart is engaged , the wheels of the pull cart remain in contact with the ground . because the wheels remain in contact with the ground , it is preferable to use the universal pull cart attachment device with pull carts having larger diameter wheels that are better adapted for traveling at higher speeds . fig1 a and 11b depict a universal pull cart attachment device suitable for attaching a conventional pull cart to a motorized golf cart , according to another embodiment . similar to the device described above , the attachment device 10 includes an extension member 30 for attaching to a base member ( not shown ), which is configured to mount to a motorized golf cart via a plurality of mounting holes and corresponding hardware . the illustrated extension member 30 includes a series of spaced apertures 32 for coupling to the base member in such a manner that the extension member 30 can be selectively extended to facilitate design variations in motorized golf carts . in this manner , the extension member 30 may allow for selective placement of the attachment device 10 such that a golfer may access one or both sides of a pull cart when attached thereto . the extension member 30 further includes a cylindrical mounting stem 36 that defines a first axis of rotation a and that is sized for insertion into a first retention member 40 . the first retention member 40 includes a hook 42 and a cylindrical sleeve 44 for mating with the mounting stem 36 of the extension member 30 to allow rotational movement about the first axis of rotation a . the rotational movement of the first retention member 40 about axis a may be limited by stops . in the illustrated embodiment , a dowel 34 is coupled to the first retention member 40 , for example , by welding , such that the dowel 34 comes into contact with sidewalls of the extension member 30 during operation . other features for limiting rotational movement are well known in the art . in accordance with the illustrated embodiment , the first retention member 40 includes a threaded insert ( not shown ) fixedly attached within cylindrical sleeve 44 for coupling the first retention member 40 to the extension member 30 . in particular , a threaded rod 38 of extension member 30 mates with the threaded insert of the first retention member 40 to couple the components together while allowing for rotational movement therebetween . as can be appreciated from fig1 a and 11b , dowel 34 is coupled to the first retention member 40 after having attached the first retention member 40 to the extension member 30 . a second retention member 50 having a cylindrical body 62 and support surface 54 is coupled to the assembly of the first retention member 40 and extension member 30 via an extension spring 70 , such that the second retention member 50 may be displaced vertically from the first retention member 40 along axis a against a bias force of the spring 70 . the extension spring 70 may be attached at one end to a nut 68 that is sized to engage threaded rod 38 of the extension member 30 and may be attached at the other end via a retaining rod 64 that is welded or otherwise coupled to the second retention member 50 . the cylindrical body 62 of the second retention member 50 slidably engages the cylindrical sleeve 44 of the first retention member 40 to maintain these components about a common rotation axis a . an additional alignment feature may also be included to keep the first and second retention members 40 , 50 aligned with respect to each other throughout rotational movement . for example , a fastener received in a threaded hole formed on the cylindrical sleeve 44 of the first retention member 40 may engage a vertical slot ( not shown ) formed in cylindrical body 62 of the second retention member 50 . alternatively , a stud or other projecting feature located on the cylindrical sleeve 44 may similarly engage a vertical slot formed in the cylindrical body 62 . in this manner , the first and second retention members 40 , 50 are able to at least partially rotate together about the first axis of rotation a to enable a pull cart attached thereto to turn in combination with the motorized cart . as described above , the second retention member 50 may be displaced vertically from the first retention member 40 along axis a against a bias force of the spring 70 . more particularly , the second retention member 50 translates along the first axis of rotation a from an engaged position to a disengaged position , the second retention member being biased towards the engaged position by the extension spring 70 . the bias force of the extension spring 70 is selected such that a user can easily displace the second retention member 50 to the disengaged position by hand . extension features 56 , 58 at opposing ends of the second retention member 50 provide levers for displacement of the second retention member 50 to the disengaged position . in the engaged position , the hook 42 of the first retention member 40 cooperates with the support surface 54 of the second retention member 50 to retain the handle of a pull cart while simultaneously allowing the handle of the pull cart to rotate , such that the pull cart is able to pitch up and down . edges of the support surface 54 may be contoured to reduce chafing or abrasion of the pull cart handle . a universal pull cart attachment device , such as , for example , the embodiment shown in fig1 - 4 or the embodiment shown in fig1 a and 11b , is used to provide a novel method for coupling a conventional pull cart to a motorized golf cart . the method includes the steps of displacing a retention member of the universal pull cart attachment device from a first engaged position to a second disengaged position , inserting a handle of a pull cart beneath a hook of the universal pull cart attachment device , and releasing the retention member such that the handle of the pull cart is retained in the attachment device while allowing wheels of the pull cart to remain in contact with a ground surface . employing such a method allows a user to attach a wide variety of pull carts to a motorized golf cart without customizing the pull cart for attachment thereto . nor is a user required to lift the pull cart . wheels of the pull cart remain in contact with the ground , thus facilitating quick withdraw of the pull cart from the motorized golf cart . fig5 - 8 illustrate examples of a method of playing golf using a universal pull cart attachment device that allows for quick disconnection so players are never separated from their clubs and similarly allows for quick reconnection so players can quickly traverse a golf course via a motorized cart on long fairways or between holes . for the purposes of clarity and ease of comprehension , the method of play using a universal pull cart attachment device , such as , for example , the embodiment shown in fig1 - 4 , will be explained with reference to a foursome of golfers a , b , c , and d and their respective carts , cart 1 and cart 2 . each of cart 1 and cart 2 is outfitted with a universal pull cart attachment device on both the left and right side . each golfer &# 39 ; s clubs are retained in a respective pull cart that is initially attached to each universal pull cart attachment device . in any given hole , each of golfer a , b , c , and d will take a tee shot and then one of three scenarios will happen : ( 1 ) each golfer will stay with his respective cart and they will proceed to their respective shot location without disengaging the pull carts from the attachment device , as illustrated in fig5 ; ( 2 ) each golfer will stay with his respective cart and proceed to one shot location and then one golfer will disconnect his pull cart while the other golfer , using the motorized cart , moves on to his shot location , as illustrated in fig6 ; or ( 3 ) one golfer in cart 1 and one golfer in cart 2 will switch carts before leaving the tee box and each pair of golfers will proceed in their motorized cart to their ball location , as illustrated in fig7 . subsequent shots feature the same scenarios above in various combinations . for example , fig8 illustrates one possible outcome of a par five hole using the method of play described herein . the method of play allows each golfer the freedom to continue moving forward towards the green at all times while eliminating the need to traverse laterally or across the course , or to return to one &# 39 ; s cart to retrieve a club . unnecessary travel is eliminated resulting in faster game play and increased revenues . fig1 and 11 illustrate potential revenue gains associated with the system of playing golf illustrated in fig5 - 8 . it has been calculated that using a universal pull cart attachment in accordance with the method of playing golf described above will substantially reduce playing time . for example , playing time for a foursome on a eighteen hole course may be reduced by ninety minutes or more . such a reduction in play time can equate to an increase in the number of golfers that can play during a given day in upwards of 10 foursome a day . as shown in fig1 , based on a $ 40 greensfee , an additional 10 foursomes a day can generate $ 160 , 000 in revenue over the span of 100 days . as can be appreciated , the universal attachment device not only generates increased revenue for golf course associations and owners , but enhances a player &# 39 ; s golf experience by eliminating unnecessary travel . moreover , aspects and features of the various embodiments described above can be combined to provide further embodiments . in addition , u . s . patent application ser . no . 12 / 430 , 781 , filed apr . 27 , 2009 , and u . s . provisional application no . 61 / 125 , 799 , filed apr . 28 , 2008 , are incorporated herein by reference for all purposes and aspects of the invention can be modified , if necessary , to employ features , systems , and concepts disclosed in these applications to provide yet further embodiments . these and other changes can be made to the embodiments in light of the above - detailed description . in general , in the following claims , the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims , but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled .

this disclosure generally relates to a universal pull cart attachment device and method to enhance golf play . in some cases , a universal pull cart attachment device having a displaceable member is coupled to a motorized golf cart to allow users to displace the member to interchangeably receive a handle of a conventional golf bag pull cart . a method of playing golf using such a universal pull cart attachment device is also provided .

fig1 is a representation of an outsole ( 110 ) and an insole ( 120 ). the outsole ( 110 ) has a front end ( 130 ) and a rear end ( 140 ); a left side ( 150 ) and a right side ( 160 ). the outsole ( 110 ) also has an inner wall ( 170 ), a perimeter wall ( 175 ), an inner bottom ( 180 ), and an outer bottom ( not shown ). the outsole ( 110 ) can be composed of a polymer block copolymer , or other durable material . examples of such material include sbs rubber , plastic , and foam to name a few . such materials used in the outsole ( 110 ) provide durability , traction , support , and some cushion to the user of the sandal . in some embodiments , the material chosen for the outsole ( 110 ) can be chosen to withstand significant contact with rough ground surfaces such as concrete , dirt , grass , carpet , stone , wood , and asphalt . the outsole ( 110 ) is generally formed such that the insole ( 120 ) is able to rest in the space formed by the combination of the inner wall ( 170 ) and inner bottom ( 180 )— protected further by the perimeter wall ( 175 ) and outer bottom ( not shown ). this insole receiving area ( 170 / 180 ) can provide a protective environment into which a comfortable insole ( 120 ) may be manufactured directly or into which a comfortable insole ( 120 ) may be placed once it has been manufactured separately . the insole ( 120 ) has a front end ( 185 ) and a rear end ( 190 ) and may be composed , for example , of a solid polymer gel , a viscoelastic polymer gel , a semi - liquid “ squishy ” polymer gel , or some combination of the above . the primary purpose of using a polymer gel material for the insole ( 120 ) is to provide comfort and relief to tired and sore feet . in some embodiments , the material used for the insole ( 120 ) is thick enough to provide outstanding comfort , yet thin enough to provide a high level of support . throughout the remainder of this application , the insole will be referred to as a single layer of polymer gel or gel - like material ( 120 ); however , a multiple layer insole ( 190 ) could also be used . as shown in fig2 , a solid or viscoelastic polymer gel / other solid material used to form the insole may be completely or partially exposed to the air ( 210 ) or contained in / covered with a cloth , rubber , nylon , plastic , vinyl , foam , or other type of material covering ( 220 ) to provide the insole with desired characteristics such as added comfort , traction , durability , protection , design , and / or styling . referring to fig3 , a semi - liquid or “ squishy ” polymer gel ( 310 ) can be contained in some kind of container or pouch ( 320 ) to keep the material enveloped within the insole while the sandal is in use . this container ( 320 ) would preferably be composed of a plastic , rubber , or some other material capable of housing a liquid or semi - liquid substance without being prone to excessive damage which would allow the liquid to escape . for example , the material can be durable enough to hold the liquid without being ruptured or damaged by various amounts of pressure caused by the foot or other stress factors that could affect the semi - liquid or “ squishy ” polymer gel container ( 320 ). also , as illustrated in fig3 , the container holding the semi - liquid or “ squishy ” polymer gel ( 320 ) could be completely exposed to the air ( 320 ) or contained in / covered with cloth , rubber , nylon , plastic vinyl , foam , or some other type of material covering ( 330 ). one purpose of the cover ( 330 ) is to provide desired characteristics such as added comfort , traction , durability , protection , design , and / or styling — similar to the application described for a solid or viscoelastic polymer gel application ( see fig2 ). referring to fig4 , a semi - liquid or “ squishy ” gel ( 410 ) may be enclosed in a one - piece pouch ( 420 ) or in a pouch with several internal gates or boundaries ( 430 ). said gates could be formed vertically , horizontally , or in any number of directions or combination of directions . these gates or boundaries can be strategically placed within the pouch ( 420 / 430 ) to prevent excess amounts of gel from moving to any one area of the insole when pressure is applied to the pouch ( 420 / 430 ) under the weight of the user . for example , the gates can be placed so as to form several square inch enclosures , each of which would be filled with gel ( 440 ). in some embodiments , the gel can be free to move within its own square inch area , but not beyond . thus , regardless of the amount of pressure being applied to the insole , the gel would maintain a relatively even distribution throughout the greater insole . as in other application , this conglomerate of pouches formed by the internal gates could be completely or partially exposed to the air ( 440 ) or contained in / covered with cloth , rubber , nylon , plastic , vinyl , foam , or some other type of material covering ( 450 ) to provide desired characteristics such as added comfort , traction , durability , protection , design , and / or styling . fig5 provides a top plan illustration of an additional application in which the insole ( 520 / 530 ) could be produced using several separate gel pouches ( 510 ) placed side - by - side within the entire gel insole receiving area of the outsole ( 520 ) rather than being produced in a one - piece pouch that is separated by internal gates as shown in fig4 . this conglomerate of individual polymer gel packets could be packaged individually ( 540 ) and placed within the gel receiving area of the outsole ( 520 ), or packaged in a larger container or pouch ( 550 ) which would be placed in the gel receiving area of the outsole ( 520 ) for additional security , durability , and / or stability . as in applications described in fig2 , and 4 , this conglomerate of pouches could be completely or partially exposed to the air ( 210 ) or contained in / covered with cloth , rubber , nylon , plastic , foam , or some other type of material covering ( 220 ) to provide desired characteristics such as added comfort , traction , durability , protection , design , and / or styling . the insole ( 530 ) is not restricted to one specific type of polymer gel . just as different parts of the foot have different sensitivities , a combination of solid or viscoelastic gel and semi - liquid or “ squishy ” polymer gel can be used in the insole ( 530 ). one purpose of using different materials for different areas of the foot is to provide additional comfort and support to specific areas of the foot prone to soreness , fatigue , or excessive irritation from blisters or other foot issues cased by cleats . if several different types of gel are used , the “ squishy ” portion of the gel insole ( 530 ) can be contained in a special cloth , nylon , plastic , or rubber package as previously explained and shown in fig4 ( 410 / 420 ). the package can then be integrated into the solid gel insole ( 530 ) base . the semi - liquid gel can be strategically placed in areas of the insole ( 530 ) that house portions of the foot requiring special attention . fig6 shows one such area of the foot which , in some embodiments , can potentially require special attention — the arch ( 610 ). in this instance , the base of the insole can be comprised of a solid or viscoelastic polymer gel ( 620 ). a special semi - liquid or “ squishy ” polymer gel pocket can be assigned to the area of the insole that touches the arch of the foot ( 610 ). fig7 illustrates another potential area of sensitivity in the foot that could need special attention — the heel ( 710 ). in this instance , the base of the insole can be comprised of a solid or viscoelastic polymer gel ( 720 ). a special semi - liquid or “ squishy ” polymer gel pocket can be assigned to the area of the insole that touches the heel of the foot ( 710 ). likewise , the ball of the foot is an area that often causes athletes and other active people pain . as shown in fig8 , in this embodiment , the base of the insole can be comprised of a solid or viscoelastic polymer gel ( 820 ). a special semi - liquid or “ squishy ” polymer gel pocket can be assigned to the area of the insole that touches the ball of the foot ( 810 ). in addition to limiting the “ squishy ” polymer gel to one area of sensitivity as discussed in the previous three paragraphs , any combination of these three areas of sensitivity could be supplied with the semi - liquid or “ squishy ” gel . fig9 gives one example . in this embodiment , the base of the insole could be comprised of a solid or viscoelastic polymer gel ( 910 ). the area of the insole that touches the arch ( 910 ) and the ball ( 930 ) of the foot can contain the semi - liquid or “ squishy ” polymer gel material . similarly , as shown in fig1 , a semi - liquid or “ squishy ” polymer gel can be applied to the arch of the foot ( 1010 ) and the heel of the foot ( 1020 ), both of which would benefit from the semi - liquid or “ squishy ” gel pockets . the rest of the insole can be comprised of a solid or viscoelastic polymer gel ( 1030 ). fig1 shows that the heel of the foot ( 1110 ) and the ball of the foot ( 1120 ) constitute another possible combination area for the semi - liquid or “ squishy ” gel pocket application . the remaining part of the insole can be comprised of the solid or viscoelastic polymer gel material ( 1130 ). as illustrated schematically in fig1 , an insole covering all three of the previously mentioned areas of the foot ; the arch ( 1210 ), the heel ( 1220 ), and the ball of the foot ( 1230 ), can be formed using the semi - liquid or “ squishy ” polymer gel material in one single application . the rest of the insole can be formed using a solid or viscoelastic polymer gel ( 1240 ). referring now to fig1 , a solid or viscoelastic polymer gel can be used for the base of the insole ( 1310 ) and the semi - liquid or “ squishy ” polymer gel can be applied in small pockets throughout the insole in a uniform manner ( 1320 ) to create additional comfort or other desired characteristics . these semi - liquid gel pockets can also be spread through the insole strategically or randomly to provide added comfort and to enhance the sandal &# 39 ; s appearance and marketability through specific design cues ( 1330 ). for example , the gel pockets can be made to look like shapes , objects , letters , numbers , or any variety of possible pictures of symbols ( 1340 ). as illustrated in fig1 , in addition to an insole comprised completely of a polymer gel substance ( 1410 ), an insole comprised of a polymer gel , integrated or combined with another material such as cloth , rubber , plastic , or foam could also apply ( 1420 ). one purpose of a partially gel / partially rubber , cloth , foam , plastic , or other material insole ( 1420 ) is to add comfort , structure , stability , traction , durability , protection , support , and / or unique design to the sandal . similar to the solid gel base insole application previously discussed , several applications can be used with a base comprised of rubber , plastic , foam , or some other non - polymer gel material for the insole . for example , fig1 shows how a polymer gel , solid or “ squishy ” ( 1520 / 30 / 40 ), can be strategically placed in or on areas of the rubber , plastic , foam , or other material base insole ( 1510 ) in such a way as to provide additional padding , massage , comfort , and relief from stress to the foot . as seen in fig1 , one such area of the insole where gel can be applied within the rubber , plastic , foam , or other material base ( 1510 ) is area of the insole where the arch of the foot would rest ( 1520 ). another possible area of the insole where the gel could be applied within the rubber , plastic , foam , or other material base insole ( 1510 ) is the part of the foot where the heel would rest ( 1530 ). yet another area within the rubber , plastic , foam , or other material base insole ( 1510 ) where a solid or “ squishy ” polymer gel could be applied is the area of the insole where the ball of the foot would rest ( 1540 ). as discussed earlier in this application , any combination of these three areas of the foot : the arch ( 1520 ), the heel ( 1530 ), and the ball ( 1540 ), can be used as areas where the gel would rest within the larger base insole made of such materials as plastic , rubber , foam , or some other materials ( 1510 )— similar to the options show with the semisolid or solid viscoelastic polymer gel base in fig7 - 13 . for example , the area of the insole where the heel ( 1530 ) and the ball of the foot ( 1540 ) rest could contain a solid or semi - liquid “ squishy ” polymer gel with the rest of the insole being composed of plastic , rubber , foam , or some other material ( 1510 ). likewise , the area of the insole where the arch ( 1520 ) and the heel ( 1530 ) rest can contain solid or “ squishy ” polymer gel with the rest of the insole being composed of plastic , rubber , foam , or some other material ( 1510 ). the area of the insole where the arch ( 1520 ) and the ball of the foot ( 1540 ) will rest can contain solid or “ squishy ” polymer gel with the rest of the insole being composed of the foot , the arch ( 1520 ), the heel ( 1530 ), and the ball ( 1540 ) can contain the solid or “ squishy ” polymer gel — placed within the larger base of the insole made of a plastic , rubber , foam , or some other durable material ( 1510 ). one purpose of the gel in these embodiments would be to provide additional comfort and support to specific areas of the foot prone to soreness , fatigues , or excessive irritation from blisters or other foot issues caused by cleats . fig1 illustrates another embodiment using an sbs rubber , plastic , foam , or some other material base ( 1610 ) combined with a solid or “ squishy ” polymer gel ( 1620 ). in this embodiment , the gel ( 1620 ) can be provided throughout the larger insole made of plastic , rubber , foam , or some other durable material ( 1610 ) in a uniform manner to create additional comfort or to enhance the sandal &# 39 ; s appearance through specific design cues ( 1620 ). fig1 also shows that these gel pockets can be distributed strategically or randomly throughout the insole with the primary purpose of providing comfort and relaxation to specific pressure points located in the foot ( 1630 ). a strategic or random distribution of gel pockets within the sbs rubber , plastic , foam , or other material base insole ( 1610 / 20 / 30 ) can also be made with the dual purpose of providing desired design and styling as well as outstanding comfort . continuing with fig1 , many possible insole designs can achieve a strategically or randomly distributed gel applications . for example , the gel pockets can be scattered throughout the sbs rubber , plastic , foam , or other material base , and made to look like objects , shapes , letters , numbers , or any of a variety of possible pictures , or symbols ( 1640 ). once the material and design of the insole have been determined , at least four recommended manufacturing techniques can be used . other manufacturing techniques known to those of skilled in this field could also be used . shown in fig1 , one of these methods involves the gel insole ( 1710 ) manufactured as a separate ( to the outsole ( 1720 )) piece and subsequently placed in the insole receiving area ( 1730 / 1740 ) created by the inner side wall ( 1730 ) and inner bottom ( 1740 ) of the outsole ( 1720 ). this independent ( from the outsole ( 1720 )) insole ( 1710 ) can then be sewn to the perimeter wall ( 1750 ) and / or bottom ( not shown ) of the outsole ( 1720 ) or attached to the inner side wall ( 1730 ) and / or inner bottom ( 1740 ) of the outsole ( 17200 ) with an adhesive substance such as glue . this method of manufacturing can be carried out by a single entity or split into two or more entities . fig1 shows another manufacturing technique that can be applied to the sandal , protective material ( 1820 ) into which the insole ( 1810 ) can be placed . once combined , this newly created insole ( 1830 ) could then be sewn to the perimeter wall ( 1840 ) and / or bottom ( not shown ) of the outsole ( 1850 ) or attached to the inner side wall ( 1860 ) and / or inner bottom ( 1870 ) with an adhesive substance such as glue . fig1 shows that if a semi - liquid or “ squishy ” polymer gel ( 1910 ) is chosen for a portion ( or all ) of the insole ( 1930 ), the area formed by the inner side wall ( 1940 ) and inner bottom ( 1950 ) of the outsole ( 1920 ) can act as a receptacle for this gel , thus forming an insole ( 1930 ) integrated into the outsole ( 1920 ). in this instance , the gel ( 1920 ) can be placed directly into the outsole receiving area ( 1940 / 1950 ) and then be covered by a plastic , rubber , vinyl , or some other suitable , durable material or combination of materials ( 1960 ). this covering ( 1960 ) can protect the gel and prevent it from seeping out of the gel receiving area ( 1940 / 1950 ) of the outsole ( 1920 ). as mentioned earlier in this application , a semi - liquid or “ squishy ” gel insole ( 1930 ) solution would likely include gates or boundaries so the gel would not move significantly to any one area when pressure from the foot or body is applied to the insole ( see fig4 and 5 ). as shown in fig2 , the polymer gel insole ( 2010 ) can be simply manufactured as one piece within the sbs rubber , plastic , vinyl , or other material base outsole ( 2020 ). this solution would probably work best with a partial gel - based insole ( 2010 ) rather than with a completely gel base insole ( 2010 )— especially if a “ squishy ” polymer gel is being used for a portion of the insole ( 2010 ). also , a solid or viscoelastic gel insole ( 2010 ) would likely be easier than a semi - liquid or “ squishy ” gel insole ( 2010 ) to manufacture as part of the complete combined sole of the sandal . fig2 illustrates an embodiment of a sandal ( 2110 ) according to the invention . the sandal ( 2110 ) is comprised of an outsole ( 2120 ), an insole ( 2130 ), and an upper ( 2140 ). the upper ( 2140 ) is preferably attached to the perimeter wall ( 2150 ) of the outsole ( 2120 ) on both sides . the upper ( 2140 ) can be sewn , glued , or otherwise attached to the inner side wall ( 2160 ) and / or perimeter wall ( 2150 ) of the outsole ( 2120 ). the upper ( 2140 ) can be constructed of one or more pieces depending on the desired functionality of the sandal . a one - piece upper ( 2140 ) can provide more stability and security to the foot . a two - piece ( or more ) upper ( 2140 ) can provide a tighter , more customized fit to the individual foot . the upper ( 2140 ) can be comprised of any material deemed sturdy enough to support the foot during use . the upper ( 2140 ), combined with the insole ( 2130 ), provides a receiving area for the foot . the upper ( 2140 ), combined with the insole ( 2130 ), provides a receiving area for the foot . the upper ( 2140 ) is intended to help keep the foot in place while the sandal is in use .

disclosed is footwear , such as a sandal , having an outsole , an insole , and an upper . the upper is attached to the outsole and / or the insole and is meant to hold the foot in place when the sandal is worn . the outsole includes a bottom surface and a sidewall extending upwardly from the bottom surface to provide an area of insertion for the insole . the insole is comprised either partially or fully of a gel or gel - like substance and is placed within the gel insole receiving area of the outsole . the gel insole can be manufactured within the gel insole receiving area or manufactured separately and placed within the gel insole receiving area .

in the following detailed description , a bed - monitoring device comprising an optical fibre fixed within an overlocked bag according to the invention will be further clarified . the intention of this description is only to further explain the general principles of the present invention , therefore nothing in this description may be interpreted as being a restriction of the field of application of the present invention or of the patent rights demanded for in the claims . thus in a first aspect the present invention provides a bed - monitoring system having an optical fibre ( 8 ) fixed within an overlocked bag ( 1 ) consisting of a top layer ( 4 ) and a base ( 5 ), and characterized in that the optical fibre is interlocked at the base of said overlocked bag and comprises break points , hereinafter also referred to as pressure points at discrete locations . as further explained herein below , the locations comprising said pressure points define measuring zones along said optical fiber . as already explained hereinbefore , the optical fibre enables detection of bodily activity by measuring a polarization variation of light propagating through said optical fibre . again with reference to the cited prior art , fixation of the optical fibre at the base of the overlocked bag is known to reduce eventual noise in the optical signal caused by independent movement of the optical fibre vis - à - vis the bed occupant . within the context of the present invention , it has however been found that an absolute immobilization of the optical fiber with respect to substrate support material is not a requisite , and far from optimal when applied in adjustable beds . a fixation with still limited mobility of the optical fibre with respect to the substrate support material ( i . e . the base of the overlocked bag ), in a number of discrete zones with break points alongside the optical fibre , results in an optimal integration of such an optical measurement system in a sleeping environment , in particular when applied in adjustable beds . in other words , using support members comprising break points at regular intervals , interlocked ( bound ) to the base of the overlocked bag and surrounding the optical fiber , the latter is guided through the sleeping environment like a belt in a pair of trousers . the optical fiber in itself is not fixed to the substrate support material , it is only restricted in its mobility through the support members defining measuring zones alongside the optical fiber . where this freedom of movement of the optical fiber allows adaptability of the bed monitoring devices to changes in shape and / or orientation of the sleeping environment ; e . g . when the bed is put in upward ( sitting position ), without affecting its performance , the absence of adhesives in positioning the fiber to the sleeping environment has further advantages in the daily application of such bed monitoring device . assembly can be achieved using standard confection methods , e . g . all elements can be stitched and sewn together . consequently the integration of the bed monitoring device as described herein does not change the intrinsic characteristics , such as for example moisture vapour permeability , mechanical strength , machine wash - ability , texture perception upon touch and flame resistance of the fabrics used . in addition , in case of damage to the optical fiber , it can easily be replaced by pulling a new fiber into the overlocked bag . the break points as used herein generally refer to spacer or pressure points created by means of hard , rigid materials in - between the optical fiber and the top and / or base fabric of the overlocked bag . as such , pressure exerted by the user on these hard , rigid materials will create a kink or at least a deformation of the optical fiber at said points , thus disturbing the light propagating through said cable . such pressure points can for example be realized by means of hard , rigid materials ( 9 ) such as but not limited to small blocks , slabs , strips , bands , threads or plates positioned between the optical fibre and the top and / or base fabric of the overlocked bag . in principle any material can be used to realize said pressure points provided a minimal spacer width is maintained when compressed by the user of the bed - monitoring system . in a particular embodiment of the present invention the pressure points are created by means of rigid plastic blocks , such as for example made from polyethylene described in european patent ep1527428 fixed to the optical fibre or support members ( such as slabs , strips , bands or plates ) fixed to the base fabric of the overlocked bag . in one embodiment of the present invention , the pressure points are selected from the group consisting of thin , hard , rigid materials such as for example in the shape of blocks , strips , bands , threads or plates fixed to the support members at the side facing the optical fiber . in particular the pressure points are made of thin , hard , rigid u - shaped strips ( 49 ), fixed to the support member with the legs facing the optical fiber ( see fig8 ). in general the pressure points have a thickness of about 1 to 2 mm , a width of about 5 to 20 mm and a length of about 2 . 0 to about 6 . 0 cm ; in particular a thickness of about 1 to 2 mm , a width of about 1 . 0 cm and a length from about 2 . 5 to about 5 . 5 cm . the break or pressure points are present at discrete locations alongside the length of the optical fibre and in particular spaced from one another from about 5 mm to about 10 cm . as already mentioned hereinbefore , the pressure points are fixed at regular intervals to support members surrounding the optical fibre , such as shown in fig4 . in this embodiment the support members surrounding the optical fiber and comprising the pressure points at regular intervals , will define the measuring zones . alongside said measuring zone the pressure point are spaced from one another from about 2 . 0 cm to about 10 cm ; in particular spaced from one another at about every 2 . 5 , 3 . 0 , 3 . 5 , 4 . 5 , 5 . 0 , 5 . 5 , or 6 . 0 cm . as will be apparent to the artisan skilled in the field of optical pressure sensors , the reliability and reproducibility of the signals will be dependent on a proper transfer of the bodily displacements to the optical fiber within the overlocked bag . it has been observed by the present inventors that an optimal integration and transfer is realized when discrete measuring zones are realized alongside the optical fiber using support members fixed to a substrate support material and surrounding said optical fiber , wherein said support members are further characterized in comprising pressure points at regular intervals . in an object of the present invention and as exemplified in the different embodiments shown in the accompanying figures , said substrate support material is the base of an overlock bag , in particular an overlocked bag consisting of a high weight fabric top layer ( 4 ) and an elastic back layer , in particular a light weight elastic back layer , provides optimal results . it is thus an object of the present invention to provide a bed - monitoring device comprising an optical fiber fixed within an overlocked bag consisting of a top layer ( 4 ) and a base ( 5 ), wherein the optical fiber is interlocked at the base of said overlocked bag using one or more support members ( 10 ) defining measuring zones along said optical fiber and characterized in that said support members surround said optical fiber and comprise pressure points at regular intervals . in its application in adjustable beds , the support material surrounding the optical fibre and restricting its mobility with respect to the substrate support , should be made of a flexible , pliant material capable of accommodating changes in shape or orientation of the bed mattress . as already mentioned herein before , using such support members , the optical fiber retains a degree of freedom in its movement with respect to the substrate support and can accordingly adjust its position in response to changes in shape or orientation of the substrate support without creating undesired kinks or even breaks in the optical fiber , that would be detrimental to the working of the optical bed - monitoring system . thus in a particular embodiment of the present invention , the support members comprising the pressure points are made of flexible , pliant bands , slabs or strips . more in particular made from a woven or non - woven fabric ; even more in particular a pliant woven or non - woven fabric . in an even further embodiment of the present invention the support members surrounding the optical fiber and defining the measuring zones , form a sleeve or tube that slidable fits around said fiber . the sleeve are fixed ( stitched ) to the substrate support material ( base fabric of the overlocked bag ) and vary in width from about 2 . 0 cm to about 6 . 0 cm ; in particular from about 3 . 5 cm to about 5 . 0 cm . the fabrics as used herein , are meant to include any of the standard fabrics used in the manufacture of mattress covers , mattress ticking and the like , including a woven , knitted or non - woven fabric ; in particular a woven or knitted fabric , such as for example but not limited to a single knit including terry velour , double knit including double jersey knit , warp knit , and woven fabrics . in addition , and in particular the top layer of the overlocked bag may consist of a spacer knitwear or spacer fabric comprises standard filler materials such as for example textured polyester , hollow polyesters fibres , nylon yarns , foam materials or the like . in other words , any woven , or knitted fabric from the collection of fabrics suitable in the manufacture of mattress covers , mattress ticking and the like can be incorporated in the overlocked bag according to the present invention . the support members are typically made from a woven or non - woven fabric of at least 100 g / m2 , optionally comprising a further filler material . in a further embodiment of the present invention the bed - monitoring device according to the present invention is further characterized in that the top layer ( 4 ) of the overlocked bag consists of a fabric with a high weight , in particular a knitted fabric with a high weight , including spacer knitwear , spacer fabric or foam materials . in a more particular embodiment , the knitted fabric of the top layer has a weight of at least 150 g / m2 ; in particular of at least 250 g / m2 ; more in particular ranging from about 150 g / m2 to about 600 g / m2 ; even more in particular ranging from about 250 g / m2 to about 400 g / m2 . in an even further embodiment the bed - monitoring device according to the present invention is further characterized in that the base ( 5 ) of the overlocked bag consists of a fabric with a low weight ; in particular an elastic fabric with a low weight ; more in particular a knitted fabric with a low weight in a more particular embodiment , the fabric of the base has a weight of up to about 200 g / m2 ; in particular up to about 150 g / m2 . in principle any low - weight elastic fabric can be used as back layer ( base ) of the overlocked bag , including woven , non - woven and knitted fabrics , by employing elastic yarns for a part or the entire portion of the fabric . typical examples of elastic yarns used in the manufacture of the back layer include but are not limited to elastane ( lycra / spandex ), rubbers , polyether - ester elastomers , elastoesters and the like . in a particular embodiment of the present invention the fabrics used in the manufacture of the overlocked bag or either both knitted fabrics or both woven fabrics ; in a more particular embodiment both fabrics are knitted fabrics with a high weight top layer as described herein and a low weight back layer as described herein . within the context of the present invention the ‘ overlocked bag ’ generally refers to a two - sheet material having a top layer ( 4 ) and a base ( 5 ) wherein the edges of said base material , in particular only the edges of said base material , are connected to the edges of the top material , thus creating a closed bag . in one embodiment the based layer is stitch to the top layer ; alternatively the base and the top layer of the overlocked bag are removably attached to one another , such as for example by means of a zipper . the bed - monitoring device as defined herein , is useful in monitoring bodily activity of a person using a sleeping environment such as a bed , bedding , a pad , a futon and the like . dependent on the localization of the optical fibre within said sleeping environment , and its associated measuring zones , different bodily activities may be assessed . for example , when solely allocated in the circumference of the sleeping environment , the bed - monitoring device allows detecting of a person entering or leaving the bed . when allocated at the chest region of sleeping environment , the bed - monitoring device enables for example detection of breathing and heartbeat motion . evidently , in an even further embodiment of the present invention , more than one optical fibre may be present within the bed - monitoring device to allow combined determination of for example bed occupancy and breathing . again , and as already described hereinbefore , in certain of said instances , the bed - monitoring device according to present invention comprises a spacer knitwear or spacer fabric as top layer of the overlocked bag , in a particular embodiment said spacer knitwear or spacer fabric is limited in width and length to the region wherein the optical fibre is allocated , and does not extend throughout the whole width and length of the bed - monitoring device . this constrained presence of the spacer knitwear or spacer fabric is particularly useful when the optical fibre is allocated at the circumference of the sleeping environment , more in particular at the long sides of the perimeter of the mattress . in said embodiment the spacer fabric is limited in width and length to the region wherein the optical fibre is allocated , and does not extend throughout the whole width and length of the bed - monitoring device . given its adaptability to the sleeping environment , the bed - monitoring device as described herein can for example be positioned on top or underneath of the mattress to detect presence , absence , step in / out or even falling out of a person using the sleeping environment . in an exemplary embodiment the bed monitoring device comprising the optical fiber consists of an overlocked bag having a top layer and a base , wherein the optical fiber is interlocked at the base of said overlocked bag using one or more support members ( 10 ) defining measuring zones along said optical fiber and characterized in that said support members surround said optical fiber and comprise pressure points at regular intervals , and further characterized in that the top layer consists of a knitted fabric with a high weight ( in particular at least 150 g / m2 , preferably a multi - layered fabric ) and in that the base consists of a low weight knitted fabric ( in particular with a weight up to about 200 g / m2 ). in other words in an embodiment of the present invention , the bed monitoring devices consists of a multi - layered overlocked bag comprising the optical fiber at its base and characterized in that the optical fiber is surrounded by support members comprising pressure points at regular intervals , thus defining measuring zones alongside said optical fiber , wherein said support members are bound to the base material . dependent on the localization of the optical fibre within said multi - layered overlocked bag and its position within the sleeping environment different bodily activities may be assessed . in one embodiment the multi - layered overlocked bag comprises one optical fibre wherein said fibre is located within any one of the chest region , shoulder region , lower back region , hip region , upper leg region , circumference of the sleeping environment ( e . g . mattress ) or combinations thereof . in another embodiment of the present invention the bed - monitoring device as described herein is part of a mattress cover . in an even further embodiment , the overlocked bag comprising the optical fibre constitutes the top panel ( 2 ) and / or the bottom panel ( 3 ) of said mattress cover and may be removably attached ( for example by means of a zipper ) to rest of said mattress cover . in said embodiment the fabric characteristics of the mattress cover may further influence the transfer of the bodily displacements to the optical fiber , and accordingly have an impact on the reproducibility and reliability of the measurements . it has been observed by the present inventors , that in said embodiment the best results are obtained when the panel comprising the optical fiber is composed of a multi - layered fabric comprising a high weight filler of at least 150 g / m2 as top layer and a low weight back layer as base . in one embodiment of the mattress cover the top panel ( 2 ) consists of the overlocked bag as described herein and a bottom panel ( 3 ) wherein ; — said overlocked bag is composed of a multi - layered fabric comprising a high weight filler of at least 150 g / m2 as top layer and a low weight back layer ; and wherein said bottom panel is composed of a multi - layered fabric comprising a high weight filler of at least 150 g / m2 . in another embodiment of the mattress cover the bottom panel ( 3 ) consists of the overlocked bag as described herein and a top panel ( 2 ) wherein ; — said overlocked bag is composed of a multi - layered fabric comprising a high weight filler of at least 150 g / m2 as top layer and a low weight back layer ; and wherein said top panel is composed of a multi - layered fabric comprising a high weight filler of at least 150 g / m2 . thus in an even further embodiment the present invention provides a mattress cover consists of a top panel and a bottom panel wherein both the top panel ( 2 ) and the bottom panel ( 3 ) consist of the overlocked bag as described herein . in particular a mattress cover wherein the top panel or the bottom panel consists of an overlocked bag comprising an optical fibre and composed of a multi - layered fabric comprising a high weight filler of at least 150 g / m2 as top layer and a low weight back layer ; and wherein said other panel is composed of a multi - layered fabric comprising a high weight filler of at least 150 g / m2 . in one embodiment the optical fibre within said bed monitoring device or mattress cover comprising said bed monitoring device , is located within the chest region of mattress . in another embodiment the optical fibre is located within the hip region of mattress , in a further embodiment the optical fibre is located within the shoulder region , in another embodiment the optical fiber is located within the lower back region , in another embodiment the optical fiber is located within the upper leg region , and in an even further embodiment the optical fibre is located in the circumference of the mattress and in particular at the long sides of the perimeter of the mattress . evidently in an even further embodiment , the mattress cover or overlocked bag may comprise one or more optical fibres wherein said fibres are located within the chest region , shoulder region , lower back region , hip region , upper leg region , circumference of the sleeping environment ( e . g . mattress ) or combinations thereof . in one embodiment the mattress cover or overlocked bag comprises one optical fibre wherein said fibre is located within any one of the chest region , shoulder region , lower back region , hip region , upper leg region , circumference of the sleeping environment ( e . g . mattress ) or combinations thereof . in a particular embodiment of the bed monitoring device or of the mattress cover comprising said bed monitoring device , the optical fiber is located within the lower back , hip and upper leg region of the mattress or sleeping environment . as further shown in the accompanying figures , when allocated in the circumference of the sleeping environment ( see fig5 ) this configuration is particularly useful in determining a person entering or leaving the bed , and is accordingly useful in medical service , geriatric care , mental health care services , etc . . . . , where continuous surveillance of patients that for different reasons cannot be permitted to leave the bed is required . the system alarms the nurse / care staff from the moment the patient wants to leave his bed . thus before a possible fall so that accidents can be avoided . in said embodiments , wherein the measuring zones of the optical fibre are located at the circumference of the mattress or sleeping environment , the break points alongside the length of the optical fibre are realized by means of thin , hard , rigid materials ( 9 ) fixed to support members ( 10 ) at either side of , and thus surrounding the optical fibre , interlocked at the base fabric of the overlocked bag , and spaced from one another from about 2 cm to about 10 cm , in particular spaced from one another at about every 2 . 5 , 3 . 0 , 3 . 5 , 4 . 5 , 5 . 0 , 5 . 5 , 6 . 0 cm . in said embodiments , wherein the measuring zones of the optical fibre are located within the chest region , shoulder region , lower back region , hip region , upper leg region of the mattress or sleeping environment , the break points alongside the length of the optical fibre are realized by means of thin , hard , rigid materials ( 9 ) fixed to support members ( 10 ) at either side of the optical fibre , interlocked at the base fabric of the overlocked bag , and spaced from one another from about 5 mm to about 1 cm , in particular spaced from one another at about every 2 , 3 , 4 , 5 , 6 , 7 , 8 or 9 cm . in said embodiments wherein the optical fibre is located within the chest region , shoulder region , lower back region , hip region , upper leg region , the measuring zones of the optical fibre are arranged in a plurality of stripes of wavy lines across the width of the mattress cover . in particular the measuring zones of the optical fibre are arranged in at least 3 , in particular up to 6 stripes , more in particular up to 10 stripes of wavy lines across the width of the mattress cover . in said embodiments the fibre is interlocked to the base of the overlocked bag , by means of support members ( 10 ) surrounding the optical fiber and comprising pressure points at regular intervals , in particular spaced from one another at about every 2 , 3 , 4 , 5 , 6 , 7 , 8 or 9 cm . as already mentioned hereinbefore , dependent on the localization of the optical fibre within said sleeping environment different bodily activities may be assessed . for example , when solely allocated in the circumference of the sleeping environment , the bed - monitoring device allows detecting of a person entering or leaving the bed . when allocated at shoulder , lower back , chest , hip region , upper leg region , or combinations thereof , the bed - monitoring device enables for example detection of breathing , heartbeat motion , presence or absence of a person using the sleeping environment . accordingly , the present invention further provides the use of the bed - monitoring device as described herein for one or more of the following applications ; detecting of a person entering or leaving the bed , breathing , heartbeat motion , presence or absence of a person using the sleeping environment . in detecting the presence or absence of a person using the sleeping environment the bed - monitoring device is either positioned on top or underneath of the mattress , futon or the like ; in particular underneath of the mattress , futon or the like . thus in one embodiment the present invention provides a mattress cover for detecting of a person entering or leaving the bed ; said mattress cover ( 100 ) comprising a top panel ( 2 ) and a bottom panel ( 3 ), wherein the top panel consists of an overlocked bag as described herein , and characterized in that the optical fibre is allocated at the circumference of the sleeping environment , more in particular with the measuring zones at the long sides of the perimeter of a mattress ; even more in particular with the measuring zones below the hip zone at the long sides of the perimeter of the mattress . with reference to fig5 , as an exemplary embodiment of the integration of the optical fiber in a bed - monitoring device according to the invention , further to the measuring zones that are allocated below the hip zone and at the long sides of the perimeter of the mattress , further guiding means ( 11 ) for the optical fiber may be present in the bed - monitoring device ( s ) of the present invention . in the present example they guide the optical fiber throughout the circumference of the sleeping environment , in particular in the circumference of the mattress . thus in an embodiment of the present invention , the bed monitoring device ( s ) and mattress covers as described herein may further comprise guiding means ( 11 ) for the optical fiber . again and similar to the support members defining the measuring zones , these guiding means will not result in an absolute immobilization of the optical fiber but still allow a limited mobility of the optical fibre with respect to the substrate support material . in other words , these guiding means will consist of sleeves , tubes , rings or combinations thereof fixed to the substrate support material , and capable of slidably accommodating the optical fiber . typically these guiding means are made from the same materials as the support members comprising the pressure points , i . e . they are made of a flexible , pliant material capable of accommodating changes in shape or orientation of the bed mattress . thus in a particular embodiment of the present invention , the guiding means are made of bands , slabs or strips . more in particular made from a woven or non - woven fabric ; even more in particular a pliant woven or non - woven fabric . in an even further embodiment of the present invention the guiding means ( 11 ) form a sleeve or tube that slidable fits around said fiber . the sleeve are fixed ( stitched ( 16 ) to the substrate support material ( base fabric of the overlocked bag ) and vary in width from about 2 . 0 cm to about 6 . 0 cm ; in particular from about 3 . 5 cm to about 5 . 0 cm . where the support members comprising the pressure points define measuring zones along the optical fiber , the guiding means , given the absence of the pressure points , define ‘ non ’- measuring zones along the optical fibre . combining such measuring and non - measuring zones along the optical fiber and throughout the sleeping environment allows tailoring the sensitivity of the bed monitoring device ( s ) to the requisite needs . in the embodiment shown in fig5 , the absence of measuring zones in the head , shoulder and hip area greatly reduced false signals in monitoring a person entering or leaving the bed . for example the free loop of the optical fiber between the guiding means in the head to shoulder region and the measuring zone below the hip region , gives the optical fiber sufficient freedom of movement to accommodate bending of the bed in upward ( sitting ) position without disturbing the measuring . to protect these free loops of optical fiber from getting damaged , they may be put into a protector cable ( 15 ). since in the bed - monitoring devices as described herein the optical fiber is not fixed to the substrate support material it may inadvertently be removed . it can slide out of the guiding means and the support members surrounding it . consequently , in a particular embodiment the bed - monitoring device is further characterized in that it comprises at least one anchoring mean ( 12 , 13 ) to hold and prevent the optical fiber from sliding out of the bed - monitoring device . in a particular embodiment said anchoring means is / are present at the entrance and / or exit of the optical fiber with the overlocked bag . it is an anchor in that it will prevent the optical fiber from being removed , but still gives it a certain space trough the presence of an anchor rode . as such , the anchor part ( 13 ) is fixed to the overlocked bag and the anchor rode ( 12 ) to the optical fiber , such as for example using a heat shrink ( 16 ). a further exemplary embodiment of the bed - monitoring device according to the present invention , and particularly useful in assessing presence and / or absence of a person , is provided in fig6 . in said instance the measuring zones , consisting of the support members ( 10 ) comprising the pressure points , are solely present at the lower back , hip and upper leg zone of the sleeping environment . further guiding members ( 11 ) are present in - between each of said measuring zones and at the top and side - member of the substrate support material . again , said guiding members include long sleeve like guiding means ( 11 a ) in the upper perimeter of the sleeping environment and one ore more short ring - like sleeves ( 11 b ) in - between the measuring zones . as such it provides a mattress cover for detecting assessing presence and / or absence of a person ; said mattress cover comprising a top panel and a bottom panel , wherein the top panel consists of an overlocked bag as described herein , and characterized in that the optical fibre is allocated at the lower back , hip and upper leg zone of the sleeping environment , more in particular with the measuring zones at the lower back , hip and upper leg zone of the sleeping environment .

the invention relates generally to bed monitoring device for monitoring bodily activity of a person and in particular vital signs such as respiration , cardiac activity and body &# 39 ; s physical movement , including the presence , absence , step out or even falling out of a person using a sleeping environment such as a bed ; mattress ; top - mattress , bedding such as mattress covers , and pillow covers ; a pad ; a futon and the like . based on the monitoring of bodily activity , the bed - monitoring device further allows determining sleep comfort and sleeping position of the user . it accordingly provides a valuable r & amp ; d tool to manufacturers of sleeping articles like beds , mattresses , top - mattresses , futons and the like ; but also in counselling consumers when buying sleeping articles under professional guidance . the bed monitoring device of the present invention is characterized in comprising an optical fiber fixed to or mixed into a flat body positioned within said sleeping environment . this optical fiber enables detection of bodily activity by measuring a polarization variation of light propagating through said optical fiber . further integration of this device with other monitoring systems such as home automation and alarm systems is also possible . further integration of this device with other monitoring systems such as home automation , bed automation and control systems , and alarm systems is also possible .

specific embodiments of the invention will now be described in detail with reference to the accompanying figures . in the following detailed description of embodiments of the invention , specific details are set forth in order to provide a more thorough understanding of the invention . however , it will be apparent to one of ordinary skill in the art that the invention may be practiced without these specific details in lieu of substitutes . in other instances , well - known features have not been described in detail to avoid unnecessarily duplication and complication . the present invention provides an escape apparatus , enabling an individual in time of crisis to escape an impending disaster while trapped at a dangerously elevated height . such an individual can don the invention suit and take suit accessories , initiate the inflation of and throw themselves into free fall , thus escaping the impending disaster by descending to the ground at a rate which can be decelerated without harm to the jumper . the present invention uses at least five mechanisms to slow descent , and decelerate jumper ; lighter than air gas for buoyancy , small parasail to slow descent , bursting gas sub - compartments for deceleration of impact , advantageous use of inflatable advantage on ground for added padding , and rotational landing dynamics to translate vertical descent kinetic energy to inertial rotational kinetic energy for impact time dilation . the detailed description is described in the figures and in the paragraphs following . fig1 is an front view drawing of a parasail jump suit in accordance with an embodiment of the present invention . indicated elements of an inflatable parasail jump suit combination are the inflatable parasail 101 , parasail attachment 103 point , strings or tube - like conduits 105 for coupling parasail to suit arm attachment 107 anchors , outer suit 111 , suit inner lining 113 , suit hood 115 , and suit footing 109 . these elements comprise parts of an embodiment which takes advantage of deceleration mechanisms for a individual in atmospheric free fall . the parasail 101 provides descent support to the suit in suspension , slowing but not necessarily totally supplying all of the lift for slowing descent . the inflatable suit filled with lighter than air gas is expandable , made of material capable of some expansion or designed for sufficient volume to supply some buoyancy to the jumper , but not necessarily all of the buoyancy needed for reversing descent . the inner 113 and outer suit 111 need not be of the same material , as they have slightly different functions and weight , strength , density , stretch expandability etc will be factors in their design . whereby a user wearing suit can safely jump from a minimum height and be protected fig2 is an side view drawing of a parasail jump suit in accordance with an embodiment of the present invention . the elements comprising the parasail and suit combination are shown as the parasail leading edge 201 , parasail trailing edge 217 , string or coupler attachment 203 points , string or conduit couplers 205 , inner 211 and outer suits 213 walls , footer 209 , inflatable hood 215 , and bulge geometry 207 . the inflatable bulge geometry 207 provides not only the capacity for a large volume of gas , but also for the cushion upon deceleration , dispersion of energy in rotation upon impact , buffer for structure impingement during descent , in the eventuality of large building densities and proximity of structures interfering with descent trajectory . in the case of collision with structures during descent , the bulge cushion character of the suit acts as a bounce buffer to reflect the trajectory away from and towards a path to further descend to ground or lower and safer elevation . here an inflatable parasail does not collapse , but changes direction to recover and maintain lift as soon as air flow is resumed and maintaining its shape by inflation thereby instantaneously becoming the wing in an altered direction friction from a mid - air collision is used advantageously impart momentum to the structure , to further slow descent and provide yet another mechanism slowing descent . the parasail may have more then one compartment , to make up more buoyancy from gas , better foil aerodynamics for sail foil shaping , or more cushion upon impact , providing inflation speed characteristics and impact mitigation similar to a auto airbag . fig3 is an isometric drawing of a parasail jump suit in accordance with an embodiment of the present invention . the suit outside 301 can be most any light but inflatable material and coupled to an inside 303 lining , conformably pressured against the user . the outer 301 side is not drawn to scale , and may be much larger than illustrated in the figures . the material of the outer 301 suit and inner lining 303 may be different , but both will be as low weight as allowable and air tight coupled together . the outer 301 suit may need undergo some expansion or stretch , while the inner 303 lining will not necessarily stretch very much . these materials are know to those skilled in the art . the outer 301 suit will sustain more tensile forces , from landing impact and internal gas pressure stresses . the geometry of the outer suit as illustrated is bulgy 319 and circular in the forward direction , for the reason that collisions will need more deceleration time and hence more cushion effect . the somewhat thinner sides 307 allow for steering , grasping and all around balancing of the suit before and during the jump . a pocket opening in the suit side 307 is provided for the hand control 309 mechanism for arm length use of hands . the hand controler may be a simple bar or a sophisticated electronic mechanism for automatic steering , opening , and landing sequence manipulation . the parasail attachment lines 305 will attach to the hand control 309 . the inner 303 lining will integrate a harness belt 315 with attachments 317 to the outer 301 suit at reinforced attachment supports 315 . the feet 313 will have separate leg extensions 311 for ambling to a ledge or building side . the suit head 321 will be contoured to round out the suit 301 for protection in rotation and bouncing upon landing impact . not shown is an inflator device , which can be external or internal to the suit . fig4 is an isometric view of a parasail jump suit footing in accordance with an embodiment of the present invention . cells 401 of gas sub compartments are layered 403 in a fashion shown as shoe soles . these cells 401 , plurality of adjacent one - way pressurized gas or vapor sub - volume compartments capable of gas energy absorption upon compression can have one - way gas valves or membranes that allow compressed gas to enter quickly but not leave quickly . releasing the pressurized gas would dissipate energy from collision . these layered cells are securely coupled to the suit footing 405 and can be inside or outside of the suit 407 , depending in the gas pressurization device and location . the object of the cell 401 sub compartment are much like those in plastic packing material , which deform and absorb energy which is released thru rupturing . in doing so , multiple layers 403 of these cells will decelerate the jumper and mitigate the impact force over a larger time interval and spatial area . a gas inflator device , not shown , can be stored near the footing as well , providing addition energy absorption from crumpling on impact . the cells 401 and layers 403 can be of most any light and gas internally pressurizable material , capable of deformation from external pressure and rupture at a design pressure . only three layers 403 are shown but more can be added . the top layer will have a plate structure which integrates the ruptures of the group of cells and distributes the pressure over time of rupturing and area above all the cells . fig5 is an illustration of suit &# 39 ; s trajectory while in use from a height with proximate dwellings according to an embodiment of the present invention . a jumper 503 is shown to have availed himself of a jumper parasail suit 503 and stepped off a building 500 which is presumably disallowed other forms of escape . the parasail 501 is inflated immediately and the coupling 507 attaching the parasail 501 to the suit 503 can be inflated from a common inflator device , pressurizing with a lighter than air gas such as helium or hydrogen or mixture , forcing the gas thru the attachment tubs 507 . alternatively , separate compressed gas inflators can reside in the parasail and in the suit . the attachment strings 507 or tubes 507 are foreshortened on one side or the other , forcing the descent trajectory 505 to spiral downward . this is so that collisions with nearby structures are avoided . in the event that a mid trajectory collision is incurred , the suite 503 and inflated parasail 501 will bounce off and continue in a reflected direction , in a somewhat changed trajectory but continuing to slow descent . upon reaching the bottom 509 , the jumper will have vertical and circular component terminal velocities . the vertical terminal velocity will be damped on impact 509 but continue to dissipate the fall energy by transfer into rotational inertial energy which will be eventually damp out from deformable collisions and motion will come to a halt 511 . fig6 is an illustration of a final approach of a jumper in accordance with an embodiment of the present invention . as the jumper approache the landing 601 , the parasail will need to move forward 603 as it will provide additional cushion upon impact . the timing of the touchdown 605 and the parasail position must be synchronized in such a fashion as to find the parasail directly in front of 605 and approaching below the jumper . thus as jumpers footing absorbs some energy , the forward motion component will act to put the vertical component into rotational energy , wherein the inflated suit with the inflated parasail act as cushions in damping and dispersing energy in compression and rotation until the motion is completely damped and the jumper comes to a halt . fig7 is an illustration of a landing maneuver of a user of a parasail jump suit in accordance with an embodiment of the present invention . upon final approach 701 703 the jumper will maneuver the parasail to cushion the impact 705 . the impact with ground will be an elastic and deformable , but will impart a spring force 707 pushing the jumper into a rotational dynamic , from the compressed inflatable cushioning spring affect and the terminal velocity components applying overturning moments to the jumper . the jumper will continue to bounce 709 and roll 711 entangled with the inflated parasail 713 until collisions have been damped out 715 . therefore , while the invention has been described with respect to a limited number of embodiments , those skilled in the art , having benefit of this invention , will appreciate that other embodiments can be devised which do not depart from the scope of the invention as disclosed herein . accordingly , the scope of the invention should be limited only by the attached claims . other aspects of the invention will be apparent from the following description and the appended claims .

the present invention is a fast inflating parasail jump suit combining an inflatable parasail , an inflatable jump suit with outside and inside coupled at edges to provide an inflatable pressurized gas volume , at least one inflator device for storing and swiftly releasing pressurized gas into the parasail and suit upon activation , a suit harness coupling outside of suit to inside liner to body center of mass , and attachments coupling to parasail providing sail support to suit in suspension .

referring to fig1 and 2 , there is illustrated an example of the present invention providing a portable barbeque and rotisserie rack 10 . the portable rotisserie 10 comprises a frame 12 having a center open portion 14 for receiving a source of heat . in the illustrated embodiment , the frame 12 includes a rectangular base 16 . base 16 has upwardly extending columns 18 at each corner of the base 16 . the columns 18 have open ends 20 for receiving another portion of the frame 12 as disclosed hereinafter . the frame 12 further includes a pair of u - shaped brackets 22 , wherein each bracket includes a pair of leg portions 24 and a center crossover portion 26 . the center crossover portion 26 has a center groove 25 formed therein for purposed discussed hereinafter . the leg portions 24 of the bracket 22 are configured for sliding within the open end 20 of columns 18 on the base 16 . each bracket 22 may include a locking means , which locks the bracket 22 into the base 16 . as shown in fig2 the locking means includes a spring loaded ball 27 extending from an aperture 29 located adjacent to the exposed ends of the leg portions 24 . the spring loaded ball 27 is recessed into aperture 29 as the leg portion 24 is inserted into column 18 . column 18 may also include an aperture 31 sized and orientated to receive the spring loaded ball 27 . once the spring loaded ball 27 encounters aperture 31 in the column 18 , the spring 27 a biases the ball 27 through aperture 31 to lock the bracket 22 to the base 16 . as shown in fig2 the spring loaded ball 27 is located on only one leg portion 24 of each bracket 22 . further , in fig2 apertures 31 are located in only two columns 18 . it is evident that the spring loaded balls 27 and apertures 31 may be located in all of the leg portions 24 and columns 18 respectively . to remove the bracket 22 from the base 16 , the spring loaded ball 27 is manually depressed into aperture 31 while the bracket 22 is lifted away from the base 16 . although the embodiment shown in fig1 and 2 shows cylindrically shaped frame members which form the base 12 , bracket 22 , and cradle 30 , other configurations of the frame members are possible . the base 16 of the frame 12 provides a stable support on the ground or other horizontal surface , such as a stationary grille typically located at an outdoor campground . the u - shaped bracket 22 provides an elevated support for the rotisserie cradle 30 . the portable rotisserie further includes end plates 32 that are slidably connectible to the u - shaped brackets 22 . a pair of end plates 32 are shown in fig1 and 2 . it is possible to use the portable barbeque without the end plates 32 or with only one end plate 32 connected to one u - shaped bracket 22 . however , it is preferred to install an end plate 32 on each u - shaped bracket 22 to provide added strength and stability to the brackets 22 . the end plates 32 are configured to slidably mount onto one of the u - shaped brackets 22 . the end plate 32 has integral side portions 34 that curve toward the inner surface 44 of the end plate 32 . the integral curved side portions 34 are spaced from each other to accommodate the distance between the pair of leg portions 24 of the u - shaped bracket 22 . the end plate 32 also has an integral shoulder portion 36 curved toward the inner surface 44 of the end plate 32 for hanging on the center crossover portion of the bracket 22 . each end plate 32 is cut and shaped from a single piece of sheet metal . the curved shoulder portion 36 acts as a stop for the end plate 32 to prevent the end plate 32 from sliding to the base 16 of the rotisserie . there are a pair of shoulder portions on each end plate with a center groove portion 35 disposed therebetween . beneath the integral curved side portions 34 , notches 37 are cut from the sides of the end plates 32 to accommodate space for the columns 18 when the end plates 32 are assembled onto the frame 12 . the end plate 32 further includes latching means for installing rotisserie accessories such as a motor 40 to the portable barbeque and rotisserie 10 . the latching means 38 as shown in the figures includes a pair of parallel punched out tracks 38 on the end plates 32 which corresponds with rails 39 located on the rotisserie accessory 40 . the rails 39 slidably mate into the tracks 38 . the tracks 38 are exposed to the exterior surface 42 of the end plate 32 . the embodiment shown in the figures of the latching means 38 or the rotisserie accessory 40 is only one configuration to be considered . other considerations could include an extending horizontal ledge on the exterior surface 42 of the end plate 32 for receiving an extension from the rotisserie accessory 40 . other known hanging means or latching means are also contemplated . for the rotisserie cradle , any grille basket , or cradle may be used with this portable barbeque that is sized for positioning between the u - shaped brackets 22 . it is preferred that the cradle 30 will have a pair of longitudinally extending and circumferentially spaced rods 50 fixedly secured to side plates 52 . a pair of adjacent rods 50 are circumferentially spaced from each other at sufficient distance to define a longitudinal opening 54 for the passage of food into the interior of the cradle 30 . extending from the exterior face of the side plates 52 are spindles 56 . the spindles 56 may be secured to the appropriate plate 52 by means of a washer and a nut 58 , or by similar means . it is preferred that one of the spindles 56 has a handle 60 attached at its exposed end , and the other spindle 56 will have an exposed end 62 configured for connecting to a corresponding portion of the rotisserie accessory 40 . the spindle 56 may be configured to have a recessed portion 66 at a location such that each recessed portion 66 on each spindle 56 can be positioned within the center groove 25 of the crossover portion of the bracket 22 and also within the grooved portion 35 of end plates 32 . this configuration helps to prevent the rotisserie cradle 30 from falling off the frame 12 . as shown in fig2 the portable barbeque and rotisserie , according to the present invention , can be easily disassembled into a smaller package for transporting to a picnic or camping location . upon assembly , the leg portions 24 of the u - shaped bracket 22 are snapped within the apertures 20 of the base 16 . the end plates 32 are slidably connected over the u - shaped bracket 22 . if a rotisserie accessory 40 is required , the latching means 39 on the accessory 40 can be positioned within the corresponding latching means 38 on the exterior face 42 of the end of plates 32 . there are no screws or bolts required to connect the portable barbeque and rotisserie . therefore , no tools are required for assembly . after assembly , the rotisserie cradle 30 can be filled with the food product for cooking and then placed upon the u - shaped brackets 22 . the frame 12 can be placed over any campfire , grille , or other generally horizontal surface having a heat source to cook the food . while the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment , it is to be understood that the invention is not to be limited to the disclosed embodiments but , on the contrary , is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims , which scope is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures as is permitted under the law .

a portable barbeque and rotisserie rack is composed of components that can be easily assembled and disassembled into a small package for transporting from one location to another and adaptable for positioning over various types of sources of heat . the components include a frame having a base for placement over a source of heat and two end portions slidably and releasably connectible to the base . a pair of end walls are slidably connectible to the end portions . the frame is configured to hold a rotisserie cradle at an elevated position over the source of heat .

for example , a folate - b12 composition comprises at least 3 forms of folate in combination with a vitamin b12 component . the 3 forms of folate required are selected from the group comprising : a . at least one of folic acid ( aka pteroylmonoglutamic acid ), a pharmaceutically acceptable salt thereof , a pharmaceutically acceptable ester thereof , and mixtures thereof ; b . at least one of a folinic acid ( aka formyltetrahydrofolate , aka formylthf ) comprising at least a 5 - formyl - tetrahydrofolic acid ( preferable a diasterioisomerically enriched ( 6s ) form of 5 - formyl - tetrahydofolic acid , most preferably a diasteriomerically pure ( 6s ) form of 5 - formyl - tetrahydofolic acid ), a pharmaceutically acceptable salt thereof , a pharmaceutically acceptable ester thereof , and mixtures thereof ; and c . at least one of a 5 - methyl - tetrahydrofolic acid ( aka 1 - methylfolate , aka methf , aka mthf ) ( preferably comprising at least a diastereoisomerically enriched 1 - methyl - folate most preferably a diasteriomerically pure 1 - methyl - folate ( aka 1 - 5 - methyl tetrahydrofolic acid )), a pharmaceutically acceptable salt thereof , a pharmaceutically acceptable ester thereof , and mixtures thereof . when used in the present invention , “ diasteriomerically pure ” is intended to mean at least the referenced material is 98 % of the intended isomer , preferably at least 98 . 5 %, more preferably at least 99 %, still more preferably at least 99 . 5 %, even more preferably at least 99 . 9 % of the intended isomer . in a preferred embodiment of the invention at least one of said three forms of folate is present as a sugar amine conjugate ( such as , without limitation , but preferably , glucosaminyl or galactosaminyl conjugated form thereof , more preferably a d - glucosaminyl or d - galactosaminyl conjugated form thereof ). when desired , additional forms of folate may also be present , such as , without limitation , dihydrofolic acid , 5 , 10 - methylene - tetrahydrofolic acid , and / or a tetrahydrofolic acid ( other than the foregoing ). the present invention contains three different forms of folate , 1 - methylfolate , folinic acid , and folic acid , to increase folate availability as a means to enhance homocysteine degradation . l - methylfolate is the metabolically active form of folate , readily available to participate in homocysteine remethylation reactions . it , unlike folic acid , does not require reduction by mthfr - dependent process , and is therefore particularly indicated in the presence of a mthfr polymorphism , such as c677t . folinic acid , also known as 5 - formyltetrahydro - folate or leucovorin , is a derivative of tetrahydrofolic acid . widely accepted as a folate rescue strategy to counter methotrexate toxicity in cancer treatment , its reduced folate properties lend itself to folate supplementation , particularly in the presence of dihydrofolate reductase inhibitors , such as pyrimethamine and methotrexate . it is also indicated for patients with certain genotypes of the dihydrofolate reductase enzyme that disturbs the reduction of dihydrofolate to tetrahydrofolate . folic acid administration has been shown to lower homocysteine in various populations ( without the mthfr polymorphism ). the vitamin b12 component is at least in the form of one or both of adenosylcobalamin or methylcobalamin , or pharmaceutically acceptable salts , esters , amides , or other metabolically useful prodrugs thereof , preferably in the form of adenosylcobalamin or methylcobalamin . in a preferred embodiment both an adenosylcobalamin ( or a pharmaceutically acceptable salt , ester , amide , or other metabolically useful prodrug thereof and a methylcobalamin ( or a pharmaceutically acceptable salt , ester , amide , or other metabolically useful prodrug thereof ) are present . methylcobalamin has the structure i below while adenosylcobalamin has the structure ii below they each differ from cyano cobalamin in the replacement of the cn group ( bound to the co atom ) of cyanocobalamin with methyl ( methylcobalamine ) or adenosyl ( adenosylcobalamin ), the methyl group and the adenosyl group being bound directly to the co atom . in general , the various required folates are present in independent amounts of up to 4 mg each , although they need not be present in equal amount preferably independently up to 3 mg of each , with a preferable minimum of at least 0 . 4 mcg . in some specific dosage forms preferred dosages include those where the three required forms of folate are present in equal weights . other preferred dosage forms contain independently from 0 . 4 mcg up to 800 mcg of each of the three required forms . in other preferred dosage forms , each of the required three forms of folate is present independently in an amount of at least 2 mg and preferably ( but not necessarily ) each of these three forms is present in equal weights , in still other preferred dosage forms , each of the three required folate forms is independently present in a range in which the minimum and maximum ( with the maximum being greater than the minimum ) are selected from 0 . 4 mcg , 0 . 8 mcg , 1 mcg , 2 mcg , 5 mcg , 10 mcg , 20 mcg , 25 mcg , 50 mcg , 100 mcg , 200 mcg , 400 mcg , 800 mcg , 1000 mcg , 1200 mcg , 1600 mcg , 2000 mcg , 2400 mcg , 2800 mcg , 3200 mcg , 3600 mcg , and 4000 mcg . in particular embodiments , each of the 3 required folates is independently present in an amount selected from 0 . 4 mcg , 0 . 8 mcg , 1 mcg , 2 mcg , 5 mcg , 10 mcg , 20 mcg , 25 mcg , 50 mcg , 100 mcg , 200 mcg , 400 mcg , 800 mcg , 1 . 000 mcg , 1200 mcg , 1600 mcg , 2000 mcg , 2400 mcg , 2800 mcg , 3200 mcg , 3600 mcg , and 4000 mcg , although dosage amounts intermediary between any of these specific amounts are also suitable where desired . it should be noted that the above amounts are calculated based on the uncomplexed , non - salt , non - ester folate form . regardless of the form of the particular compounds , a highly preferred dosage form provides 3 . 83 mg 1 - methylfolate , 2 . 4 mg 1 - leucovorin , and 2 . 5 mg of folic acid . the b12 component , whether adenosylcobolamin or methylcobolamin , are present in amounts which together are at least 10 mcg per dosage form up to 2000 mcg per dosage form , preferably at least 20 mcg . when a salt or ester or amide of these is used , the amount is an amount which provides the stated amount of the non - salt , non - ester , non - amide form . a highly preferred dosage form contains both the adenosylcobalamin and the methylcobalamin ( whether in their free form or as a salt or ester or amide of either or each ). preferred dosage amounts of the cobalamin component are a total within a range selected from ranges having a minimum and maximum ( with the maximum being greater than the selected minimum ) selected from 10 mcg , 20 mcg , 30 mcg , 40 mcg , 50 mcg , 62 . 5 mcg , 75 mcg , 100 mcg , 125 mcg , 250 mcg , 375 mcg , 500 mcg , 625 mcg , 750 mcg , 875 mcg , 1000 mcg , 1200 mcg , 1250 mcg , 1500 mcg , 1600 mcg , 1750 mcg , 1800 mcg , and 2000 mcg , and highly preferred embodiments have a total of the cobalamin content selected from 10 mcg , 20 mcg , 30 mcg , 40 mcg , 50 mcg , 62 . 5 mcg , 75 mcg , 100 mcg , 125 mcg , 250 mcg , 375 mcg , 500 mcg , 625 mcg , 750 mcg , 875 mcg , 1000 mcg , 1200 mcg , 1250 mcg , 1500 mcg , 1600 mcg , 1750 mcg , 1800 mcg , and 2000 mcg , each being calculated based on the non - salt , non - ester , non - amide forms thereof , with dosages intermediary to those stated being equally suitable . highly preferred dosage forms contain a total of 500 mcg and contain both an adenosylcobalamin and a methyl cobalamin . in a most highly preferred form , the dosage form contains 250 mcg of adenosylcobalamin and 250 mcg of methylcobalamin . vitamin b6 ( as pyridoxyl - 5 - phosphate ), when present , is present in an amount to deliver from 0 . 125 mg of pyridoxine up to 0 . 375 mg of pyridoxine , most preferably 0 . 25 mg of pyridoxine per dosage form with intermediary amounts between those specifically stated being suitable as well . in addition to the foregoing active agents , the invention formulation can be prepared with a wide range of pharmaceutically acceptable excipients and carriers known in the art , such as binders , disintegrants , dispersants , flow agents , suspending agents , solvents , carrier fluids , flavorings , colorings , buffers , processing aids , etc . the compositions of the present invention are generally administered once daily , but if desired , a particular daily dose can be administered in fractional doses multiple times a day . in this example , the following formulation is prepared . amounts are given in mg / dosage unit . where desired , dosage forms having fractional amounts for administration multiple times per day may also be prepared using proportional amounts of the ingredients . the b12 component , whether adenosylcobalamin or methylcobalamin are present in amounts which together are at least 10 mcg per dosage form up to 2000 mcg per dosage form , preferably at least 20 mcg . when a salt or ester or amide of these is used , the amount is an amount which provides the 1 - methylfolate glucosamine 1 - leucovorin calcium folic acid adenosylcobalamin methylcobalamine in this example , the following formulation is prepared . amounts are given in mg / dosage unit . where desired , dosage forms having fractional amounts for administration multiple times per day may also be prepared using proportional amounts of the ingredients . the formulations of examples 1 and 2 are administered to a patient experiencing depression generally once per day . where the alternate fractional dosage form is used , the dosage form is administered in the appropriate multiple of times per day . the formulations of examples 1 and 2 are administered to a patient in need of increasing or improving mental alertness generally once per day . where the alternate fractional dosage form is used , the dosage form is administered in the appropriate multiple of times per day . in one example , examples 1 - 4 also comprise : a phospholipid from one of the omega - 3 fatty acids , such as dha , epa or ara / aa . for example , the phospholipid may be conjugated to a phospholipid moiety selected from phosphatidylserine ( ps ), phosphatidylethanolamines ( pe ) or phosphatidylcholines ( pc ), such as from eggs , with pc being preferred , the amount of phospholipid being in an amount greater than 1 mg and not more than 200 mg of a conjugated phospholipid . the folate composition of claim 1 , wherein the types of folate consist of between 0 . 1 mg and 1 mg of folic acid , between 0 . 9 mg and 3 . 9 mg of a folinic acid , and between 1 mg and 14 mg of the 5 - methyl - tetrahydrofolic acid . the folic acid may be of a pteroylmonoglutamic acid . the folinic acid may be of a pure 6s isomer , 6s - 5 - levoformylfolic acid . the 5 - methyl - tetrahydrofolic may be of a 6s - 5 - levomefolic acid . each of these may be found in the usp or merck manual for provitamin b6 ( synthetic — folic acid ; natural vitamer — folinic ; or vitamin b12 - coenzyme form of vitamin b9 — 5 - methyl - tetrahydrofolic acid ).

a multiple folate composition comprising the following three different forms of folate : a folic acid ; a folinic acid ; and a 5 - methyl - tetrahydrofolicacid and other non - folate ingredients . the composition is useful as a nutritional supplement or medication in the treatment of a folate deficiency and sequella thereof and / or in conditions responsive to administration of a metabolically useful folate . the compositions are particularly of use in patients who have impaired or reduced ability to convert folic acid to its metabolically active forms and in the treatment of depression , particularly in pregnant women or women who may become pregnant .

an apparatus made in accordance with the present invention is amenable for use in yoga exercises or physical therapy , with or without additional components for supporting or isolating the muscles to be stretched . fig1 illustrates one preferred embodiment of a stretching apparatus that is employed by a user 20 for controlled , gradual stretching of the hamstring muscle . the apparatus may be operated while the user 20 is reclined , on his back , with one “ rested ” leg 22 extending horizontally on a flat surface 28 . the other “ stretched ” leg 24 is rotated at the hip and extends vertically upwardly , with the knee held straight . the back of the stretched leg 24 is adjacent to the surface of a stationary , rigid member 26 . in one embodiment , the member 26 may be an existing doorjamb , which is the vertical component of a door frame . in such an embodiment , the components of the stretching apparatus include an expandable member 30 that will hereafter be referred to as an expander 30 . the expander 30 is located adjacent to the vertical member 26 between that member and the back of the user &# 39 ; s stretched leg 24 . the expander 30 may abut or be removably attached to the stationary surface of the vertical member . the expander 30 is cushioned and / or contoured to comfortably receive the stretched leg , preferably in the vicinity of the user &# 39 ; s achilles tendon . in this regard , the expander 30 may have a boot - like configuration as shown in fig2 and discussed more below . the expander 30 is controlled for providing incremental or gradual expansion from a contracted position to an expanded position for correspondingly gradual stretching of the user &# 39 ; s hamstring muscle . as one aspect of this invention , the user may maintain the reclined position while remotely controlling the expander 30 . in the contracted position of the expander 30 , the user &# 39 ; s stretched leg 24 is generally vertical , thus making an angle “ a ” of about 90 degrees with the horizontal surface 28 . the contracted position of the expander 30 appears in fig1 as cross - hatching of the back portion of the expander 30 that is between the leg 24 and the vertical member 26 . movement of the expander 30 toward the expanded position ( shown in dashed lines in fig1 ) increases the angle between the stretched leg 24 and the surface 28 by angle “ b ” from vertical . the act of gradually moving the user &# 39 ; s leg 24 through the angle “ b ” effectively stretches the hamstring muscle of that leg . as noted , the expansion of the expander 30 is controlled by the user in a manner that permits the user to maintain an otherwise relaxed , reclined position . to this end , a remote control 32 is positionable near the hand 34 of the user . the expansion of the expander 30 may be provided by a pneumatic system , and the control 32 may comprise a hand pump or other valving that communicates with the expander 30 via line 36 for directing pressurized air into the expander 30 to expand it . the control 32 may also include a release valve for slowly returning the expander to the contracted state upon completion of the desired stretching time . a conventional sphygmomanometer bulb will suffice as the pump and release valve . it is also contemplated that the control can be electronically automated with a simple controller for activating an air pump and associated valves for inflating and deflating the expander 30 in accord with built - in or user - defined programming . fig2 illustrates in greater detail a preferred embodiment of the expander 30 . in this embodiment , the expander 30 has a boot - like configuration that includes a base 42 , a back 44 , and two opposing sidewalls 46 , 48 . the expander 30 may be formed of , for example , sewn synthetic material , such as nylon , that forms the outer casing for internal cushioning and an expandable air bladder 50 . the base 42 of the expander 30 extends across the sole of the user &# 39 ; s foot 25 . the back 44 of the expander 30 extends from the rearward end of the base and along the back of the user &# 39 ; s leg 24 generally adjacent to the achilles tendon . the sidewalls 46 , 48 are attached to or integrally formed with the base 42 and back 44 and extend therefrom in a generally parallel relationship across the sides of the user &# 39 ; s foot 25 , ankle , and lower leg . between the sidewalls 46 , 48 at the forward edge of the expander 30 ( that is , the leftmost side in fig2 ) there is an open space to permit the user to insert the foot 25 into the expander . preferably , the sidewalls 46 , 48 carry one or more straps 52 with associated hook and loop fastening to secure the sidewalls together with the foot inserted into the expander 30 . the base 42 and sidewalls 46 , 48 may be filled with cushioning ( shown cross - hatched in fig2 ), such as foam , to provide a snug , comfortable fit when the expander is worn . the back 44 houses the expandable air bladder 50 to which the pneumatic line 36 is coupled . as described above , the apparatus is controlled by the user to direct pressurized air through the line 36 for controlled expansion of the bladder 50 and consequent stretching of the hamstring muscle . in a preferred embodiment , the bladder 50 and back 44 are configured so that the portion of the back 44 that is placed in contact with the vertical member 26 remains relatively flat or planar , and the expansion of the bladder 50 is thus primarily directed toward the user &# 39 ; s leg 24 . moreover , the bladder 50 is shaped so that in expanding away from the stationary surface the bladder enlarges by a progressively greater amount in the direction toward its outermost ( upper ) part ( note the broken line 30 in fig1 ), so that the portion of the leg that contacts the back 44 of the expander 30 is supported in a generally straight line . fig3 shows an alternative embodiment of the invention whereby the vertical member 126 is integrated with the apparatus . in one approach , the vertical member 126 is in a stationary vertical position and carries the expander 30 ( fig1 and 2 ). branching from the vertical member is a brace 38 that is configured to provide contact with the knee of user &# 39 ; s rested leg 22 , so that leg 22 does not bend upwardly ( as it otherwise tends to do ) while the other leg 24 is being stretched . as another approach to the integrated vertical member embodiment ( fig3 ), the vertical member 126 is constructed to rotate about a pivot point 40 to provide the user - controlled increase in angle “ b ” mentioned above . any suitable pneumatic , hydraulic or mechanical system would be employed for moving the member 126 . this type of movable member could be used without , or in combination with , an expander 30 . fig4 a and 4b illustrate another preferred embodiment of the present invention . these figures show a side view of this embodiment , which includes a rigid , thin back plate 144 . the back plate 144 comprises two layers : a rigid plastic layer 146 , such as acrylonitrile butadiene styrene ( abs ) to which is bonded an outer layer 148 , such as polyester felt . the outer layer 148 bears against a stationary surface 150 , such as the surface of a doorjamb , and permits slight vertical sliding movement of the apparatus along the doorjamb without marring that surface . it is noteworthy here that the back plate 144 may be constructed in a variety of other configurations . for example , the back plate could be mounted to a vertical pole or other structure in a fitness club and adjustable in height to enable use of the apparatus by users of various heights ( that is , leg lengths ). it will be appreciated that the presently described embodiment , featuring abutting contact with a doorjamb , for example , provides a readily portable and compact apparatus that may be used in various locations around the user &# 39 ; s house , hotel room , etc . a generally u - shaped linkage 152 ( see especially , fig5 a ) is pivotally mounted to the back plate 144 . that linkage includes a pair of arms 154 , one arm extending from each of the opposing ends of a connector part 156 of the linkage that extends across the inner surface 158 of the back plate 144 . the connector part 156 is secured by spaced - apart sleeves 157 that are fastened to the back plate 144 to make a hinge - like , pivoting connection of the linkage 152 so that the arms 154 are able to swing about the long axis of the connector part 156 toward and away from the back plate 144 . the free end of each arm 154 of the linkage is pivotally attached as at 159 to opposite sides of a boot member 160 . the linkage arms 154 are rigid , preferably metal , and serve to stabilize the position of the boot member 160 relative to the back plate 144 . the linkage 152 also controls or guides the movement of the boot member as it moves away from and toward the plate . the boot member 160 may be a molded plastic member , or cut from a flat sheet of plastic ( such as polyethylene ) and bent and joined to define a base 162 and sidewalls 164 , 166 into which fits the foot 125 of a user . one of the sidewalls 164 , 166 carries a strap 168 with associated hook and loop fastening . the free end of the strap is threaded through an aperture in the other sidewall so that the strap may be folded back on itself to secure the sidewalls together and hold the user &# 39 ; s foot within the boot member 160 . the boot member 160 may be formed solely of somewhat rigid plastic or , preferably , lined with foam cushioning to enhance the comfort of the boot member . an expandable bladder 170 is connected to the boot member 160 and to the inner surface 158 of the back plate 144 . the bladder 170 is formed or two air - impermeable plastic sheets that are heat - welded together at their peripheral edges . preferably , the heat - welded edge of the bladder is made wide enough to define a flange 173 ( fig5 b ) to which are riveted the male portions 172 of conventional snap fasteners . the male portions 172 on the bladder flange engage corresponding female portions 174 of snap fasteners that are carried on the both the back 176 of the boot member 160 and on the inner surface 158 of the back plate . in this embodiment , two spaced - apart snap fasteners are thus provided for attaching part of the bladder flange 173 to the boot member , and two fasteners are so used to attach another part of the bladder flange to the back plate 144 . it will be appreciated that there may be a variety of alternative ways to attach the bladder between the boot member and back plate . for example , the bladder flange may be stapled or bonded to those respective components . a pneumatic line 178 couples to the bladder for conducting air to and from the bladder as discussed above in connection with the earlier - described embodiment . it is noteworthy that the bladder 170 is somewhat trapezoidal in shape ( see fig4 b ) when fully inflated . in this regard , the bladder 170 is connected along a length of the back 176 of boot member , generally adjacent to the user &# 39 ; s achilles tendon , and configured to expand between the boot member 160 and the stationary surface 150 by a varying amount along the length of the boot member in the direction toward the heel 180 of the user . this configuration of the bladder , in conjunction with the pivotal connection with the linkage 152 , causes rotation of the boot member as the boot member moves away from the stationary surface so that the stretched leg can be held straight as it rotates about the hip . fig6 is an isometric view showing a portion of another alternative embodiment that employs a linkage 182 that is essentially a modification of the linkage 152 described above . the bladder and other components have been omitted for illustration purposes . the modified linkage provides the same stability and guidance as mentioned above , but also provides a relatively greater travel distance for the boot member 184 away from the back plate 186 , thereby to provide a greater amount of muscular stretching . the linkage of fig6 includes two pivotally attached parts : a plate - mounted part 188 , and a boot - mounted part 190 . the plate - mounted part 188 is generally u - shaped and includes a pair of arms 192 , one arm extending from each of the opposing ends of a connector part 194 of the linkage that extends across the inner surface 258 of the back plate 186 . the connector part 194 is secured to the surface 258 by spaced - apart sleeves 196 that are fastened to the back plate 186 to make a hinge - like , pivoting connection of the plate - mounted linkage part 188 so that the arms 192 are free to swing about the long axis of the connector part 194 toward and away from the back plate 186 . the free end of each arm 192 is pivotally joined to the u - shaped , boot - mounted part 190 of the linkage at the location 204 where the connector part 200 of that linkage joins the arms 202 . the free ends of those boot - mounted linkage arms 202 are each pivotally attached as at 206 to opposite sides of the boot member 184 . as mentioned , this two - bar linkage 188 , although able to collapse so that the boot member 184 can move adjacent to the back plate 186 , also permits a relatively large travel distance for the boot member away from the back plate . while the present invention has been described in terms of preferred embodiments , it will be appreciated by one of ordinary skill in the art that modifications may be made without departing from the teachings and spirit of the foregoing . for example , the expander may be sized to extend nearly the entire length of the user &# 39 ; s leg , between the ankle and upper thigh to enhance the comfort or support of the apparatus during its use . moreover , it is contemplated that the stationary surface against which the back plate is placed may be horizontal rather than vertical . also , the air bladder could be replaced with a foam - and / or compression - spring - filled interior that is compressed before use and controlled so that the natural resilience of the foam and / or spring expands the bladder and displaces the boot member from the back plate . a fluid - driven , lightweight telescoping member might also be used alone or with a bladder to expand the distance between the boot member and the back plate .

the present invention concerns a stretching apparatus that is useful to apply controlled , gradual muscular stretching , and is particularly useful for controlled stretching of the hamstring muscle .

referring now the figures , fig1 illustrates one embodiment of the present invention showing the movable handrail 6 , as a complete system , as it would be installed on a typical wall , such as the long wall alongside a bathtub . the main assembly of the movable handrail 6 , comprises three major components , namely , the lower wall mounting member 1 , the pivot rail assembly , 10 , and the pivot collar assembly 20 . these three major components are combined in place , secured on a wall surface to achieve the working main assembly . fig1 shows the pivot rail assembly 10 , located in its rotational position for storing the pivot rail assembly 10 alongside the wall . this position is advantageous both for storing the pivot rail assembly 10 , out of the way along the wall , as well as , for actual use of the pivot rail assembly 10 in this position , to benefit from the higher gripping levels of the pivot rail assembly 10 . by comparison , fig2 shows the pivot rail assembly 10 , in one of the available locked rotational positions whereby the pivot rail assembly 10 , is situated at approximately 90 degrees outward from the wall . the pivot rail assembly 10 , as described in the preferred embodiment , is also able to pivot and lock at additional angular positions , including 45 , 135 and 180 degrees to the wall . additional in - between locking angular positions could be achieved by modification to the preferred embodiment by those skilled in the art . the mechanism for locking is described later in this text . the illustrated embodiment in fig2 shows the vertical member 11 , of the pivot rail assembly 10 , supported above the left side of the lower wall mounting member 1 . alternatively , it should be noted that the ambidextrous design of the lower wall mounting member 1 , is such that it will permit the system to have the vertical member 11 , of the pivot rail assembly 10 , supported above the right side of the lower wall mounting member 1 , by inverting the lower wall mounting member 1 , as is described further on in this text . turning now to better describe the major sub assemblies , fig3 shows the lower wall mounting member 1 , which comprises two wall mount members 3 , fastened onto ends of lateral member 2 , such that lateral member 2 is held essentially parallel to a wall when installed . wall mount members 3 , have apertures 7 , through which fasteners ( not shown ) may be installed to secure the lower wall mounting member 1 , to a wall . lower pivot 4 is secured within a mating notch in the outer surface of lateral member 2 by permanent means such as welding , adhesive , or fasteners . it is located such that its central vertical axis intersects with the central horizontal axes of the lateral member 2 , wall mount member 3 . the elements of wall mount member 1 , may be constructed of a strong corrosion resistant material such as high strength reinforced plastic , or more favourably , steel with a corrosion resistant finish , or an aluminum alloy , or most favourably , stainless steel , which is both strong , and corrosion resistant through it &# 39 ; s entire depth , even in moving mating areas where a protective surface finish may wear off over time continuing with major assemblies , fig4 shows the pivot rail assembly 10 , which comprises tubular member construction of arm member 12 which is permanently fastened onto vertical member 11 by permanent means such as welding , adhesive or fasteners ( not shown ). the arm member 12 provides strength due to it &# 39 ; s closed loop design , however alternative embodiments such as a wider “ d ” shape , “ b ” shape or other profiles could be attached to the vertical member 11 . the cross section of the u - rail could favourably be circular , oval , or oblong . a lower end 14 , is located coaxially within the bottom end of the vertical member 11 , and secured by means such as welding , adhesive or fasteners ( not shown ). an axial projection 15 is held in place coaxially to the lower end 14 central axis to the bottom end of the lower end 14 , by means of a screw 16 . the top end of the vertical member 11 is sealed by means of the top cap 13 , which forms a liquid and vapour tight seal which is important in a bathtub and shower environment . top cap 13 may be fabricated from a lightweight corrosion resistant material such as plastic . the elements of pivot rail assembly 10 , may be constructed of a strong corrosion resistant material such as high strength reinforced plastic , or more favourably , steel with a corrosion resistant finish , or an aluminum alloy , or most favourably , stainless steel , which is both strong , and corrosion resistant , even in moving mating areas where a protective surface finish may wear off over time the final major assembly , shown in fig5 , is the pivot collar assembly 20 . it comprises annular upper pivot 23 , which is held by and attached to spacer 22 which is attached to wall mount member 21 by permanent means such as welding or fasteners ( not shown ). wall mount member 3 has apertures 7 to permit screws to mount the pivot collar assembly 20 to a wall . the pivot collar assembly 20 is most favourably fabricated from a corrosion resistant material such as plastic or stainless steel . in the case of stainless steel , the inner bore 25 of annular upper pivot 23 may be lined with a guide sleeve 24 to provide a more resilient surface to interface with the outside surface of the vertical member 11 ( not shown ) of the pivot rail assembly 10 ( not shown ) fig6 better illustrates the makeup of the pivot collar assembly 20 , by means of a section view “ a - a ”. vertical member 11 is held coaxially within the bore of annular upper pivot 23 . guide sleeve 24 may be held by a press fit , or within a groove 26 within the bore of annular upper pivot 23 . there is advantageously a small amount of diametrical clearance between the outside diameter of vertical member 11 , and the inside diameter of guide sleeve 24 to permit to permit free rotational pivoting , as well as free up and down axial motion of vertical member 11 within the pivot collar assembly 20 . advantageously , the inner bore 25 surface is tapered somewhat outward in each direction from the middle of the inner bore 25 . this permits the pivot collar assembly 20 to accommodate some degree of angular error of installation , yet still maintain free motion of vertical member 11 . moving now to the method of pivot and locking , fig7 is a partial perspective view of the lower end 14 of the pivot rail assembly 10 . the lower end 14 is shown situated in the bottom of vertical member 11 , and secured with permanent means such as welding . the lower end 14 , has a plurality of grooves 17 , which are spaced at equal angles about the bottom shoulder face 18 of the lower end 14 . a tapered stem 30 further protrudes from the bottom shoulder face 18 of the lower end 14 . the bottom surface 31 of the lower end 14 has a centrally located aperture ( not shown ) that is threaded to receive screw 16 . axial projection 15 has a first diameter member 32 , and distal second diameter member 33 , that provides shoulder 34 . the axial projection 15 has an aperture ( not shown ) coaxially located through its entire length , to permit the clearance passage of the screw 16 . moving now to fig8 , this shows a partial perspective view of the lower pivot 4 on the lower wall mounting member 1 . fig8 shows a plurality of teeth 8 , located on the top surface and the bottom surface of the lower pivot 4 arranged in a circular pattern in with equal angles between them . the presence of a plurality of teeth 8 , located on the top and bottom surface of the lower pivot 4 , permits the lower wall mounting member 1 to be used with the lower pivot 4 located on the left or the right side as most advantageous for the particular need of the user . fig9 shows a partial perspective section view “ c - c ” of the lower wall mounting member 1 , with the section cut through the middle of the lower pivot 4 . from this view we can see the second diameter 42 , the first diameter 9 , and resulting shoulders 41 a , and 41 b . fig1 shows a partial perspective section view “ b - b ” of the locking interface between the bottom end of the pivot rail assembly 10 and the lower pivot 4 . referring to fig7 , 9 and 10 , the pivot rail assembly 10 is installed into the lower pivot 4 by first removing the screw 16 , of the axial projection 15 , and setting the tapered stem 30 , of the lower end 14 , into the top second diameter 42 of the lower pivot 4 . the first diameter member 32 of the axial projection 15 is then inserted up through the bottom of the lower pivot 4 , and held in place against the bottom surface 31 of the tapered stem 30 of the lower end 14 by screw 16 engaging into threaded hole ( not shown ) of lower end 14 . the first diameter divides the wider second diameter into a top wider second diameter 42 and a bottom wider second diameter 42 ′. the bottom end of the pivot rail assembly 10 , is held coaxially within the lower pivot 4 , by the tapered stem 30 , centering itself within the second diameter 42 of the lower pivot 4 , as well as the first diameter 32 of the axial projection 15 centering itself within the first diameter 9 of the lower pivot 4 . this arrangement allows the pivot rail assembly 10 to rotate coaxially about the lower pivot 4 , and move a limited amount of up and down axial motion within the lower pivot 4 . when the pivot rail assembly 10 is allowed to move down , the plurality of teeth 8 of the lower pivot 4 , will fit up inside of the plurality of grooves 17 of the lower end 14 . this will prevent the pivot rail assembly 10 from pivoting , thereby locking the rotational position of the pivot rail assembly 10 relative to the lower pivot 4 on the lower wall mounting member 1 . at this point the user may apply a lateral load or downward load to the pivot rail assembly 10 , without it moving . the load force is taken by the plurality of teeth 8 of the lower pivot 4 , and the pivot rail assembly 10 , is also restrained at its top by the pivot collar assembly 20 which prevents lateral movement , yet permits axial movement when the user wishes to lift the pivot rail assembly 10 , to unlock it . in order to unlock the pivot rail assembly 10 , to permit free rotation , the user must lift the pivot rail assembly 10 upward , thereby lifting the lower end 14 such that the plurality of teeth 8 of the lower pivot 4 are no longer in the plurality of grooves 17 of the lower end 14 . at this point the pivot rail assembly 10 may be freely rotated coaxially about the lower pivot 4 , and guided at the top by the pivot collar assembly 20 . the pivot rail assembly 10 , is prevented to lifting right out of the lower pivot 4 , by the shoulder 34 of the axial projection 15 hitting against the shoulder 41 of the lower pivot 4 . although the invention has been described relating to a preferred embodiment , it should be understood that various modifications , additions , and alterations may be made to the invention by one skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims .

a wall mounted pivoting and locking support rail assembly providing improved support to assist elderly and physically challenged persons with safely using a bathtub or shower area . the present invention mounts to the wall in a similar way to a conventional grab bar , however , it adds an additional rail handle with the ability to pivot outward from the wall , and lock in one of several angular positions to extend support outward from the wall , and more to the centre of a shower or tub . this outward support is invaluable to assist with elderly and disabled persons to safely enter , use , and exit from the bathtub without dangerous reaching .

the quantity of the aforementioned enzyme to be used can vary considerably , but it will usually be between about 0 . 5 and about 20 units per gram / milliliter of the dentifrice . by one unit of enzyme is meant that quantity of enzyme which will oxidize 1 micromol of substrate per minute at 30 ° c . and ph 6 under standard conditions . it has proved to be advantageous to add to the glucose oxidase containing dentifrice one or more carbohydrases which can supply glucose as substrate for the glucose oxidase applied . the carbohydrase can be , for example , α - amylase , glucoamylase or amylglucosidase , cellulase , dextranase , invertase and α - and β - glucosidase . these carbohydrases are measured according to conventional methods and their activites are indicated in units in accordance with the recommendations of the international union of biochemistry ( report of the commission on enzymes of the iub , pergamon press , oxford , 1961 ). the amount by weight of additional enzymes may range from about 1 to about 8 times the amount of glucose oxidase present . preferably , amyloglucosidase is applied as a carbohydrase . a dentifrice prepared in accordance with the present invention includes as its essential active ingredient an amount , based upon the dentifrice , of glucose oxidase which forms hydrogen peroxide by oxidative decomposition of its substrate glucose , effective , when applied to a dental surface , to product an approximately neutral range of ph at said dental surface , together with a pharmaceutically acceptable carrier . the approximately neutral ph range will be between about 6 and about 8 . the amount of glucose oxidase can be varied considerably so as to allow for the time needed for the enzyme to dissolve in the saliva , particularly if the dentifrice is in the form of tablets or chewing gum . preferably , the effective amount of glucose - oxidase will be between about 0 . 5 and about 20 units per gram / milliliter of the dentifrice , said unit being defined as set forth previously . the dentifrice of the invention is applied to a dental surface for the purpose of cleaning the surface and suppressing the formation of dental plaque thereon , employing a quantity of dentifrice sufficient to provide the effective quantity of enzyme referred to above , or the unit dosage range of 0 . 5 to 20 units previously described . the following tests relate to glucose oxidase , amylglucosidase , and a combination of these components . in order to show the surprising effect of the enzymes according to the invention the ph - value was measured at the surface of the tooth in the plaque . the micro - antimony electrode used for this purpose has been described in the literature by f . clarence thompson , et al . in the journal of dental research , 33 , 849 ( 1954 ). the measurements were performed on the buccal surfaces of the first and second molar , at least one hour after the last consumption of food . thus , there were 4 measuring points in total person , always in the sequence : m 1 sd - m 2 sd - m 1 ss - m 2 ss . the tests were performed on groups of 15 - 30 children ( boys and girls ) of from 12 to 14 years . the children were divided into 3 groups : the results of the ph measurements are given in the following table : table i______________________________________ percentage of children with ph 6 . 8 5 . 6 - 6 . 8 5 . 6______________________________________controls1st day 23 53 242nd day 19 58 2330 u amyloglucosidaseper 10 ml1st day 33 39 282nd day 28 47 256 u glucoseoxidaseper 10 ml1st day 25 55 202nd day 31 6030 u amyloglucosidase + 6 u glucoseoxidase per 10 ml1st day 21 59 202nd day 60 40 0______________________________________ on the first day the subjects tested rinsed their mouths for 4 minutes with 10 ml of a 70 % saccharose solution , after which the ph was measured . after these measurements they rinsed with 10 ml of mouth wash in which the enzymes had been dissolved , which , of course , was not done by the controls . the tests were performed so that there was an interval of at least 1 hour between the last rinse and the next meal . on the second day the process was repeated with 10 ml of a 70 % saccharose solution , after which the ph was measured . the next day the useful effect of the rinse with enzyme on the ph could be clearly demonstrated by measuring the ph at the surface of the tooth after the rinse with saccharose . in order to avoid mechanical offset of the plaque both the saccharose and the enzymes were applied in a liquid form . from the above table it appears that the hydrolase enzyme amyloglucosidase , by itself , has no appreciable influence on the percentage of children in the danzer zone below ph 5 . 6 , and that glucoseoxidase , and to an even high degree glucose - oxidase in combination with amyloglucosidase , reduces this percentage considerably ( 23 % to 9 %) or even to zero . another striking factor was that the structure of the plaque had become less firm by the treatment with the enzyme mixture so that the plaque came off easily in many cases . in the foregoing test using a mouth wash , a reduction of dental surface ph was observed using an oxidoreductase system . in order to ascertain whether a similar improvement could be obtained employing a toothpaste , comparative tests were performed , as between two toothpastes according to the present invention , namely a and b , a commercial peroxide - containing toothpaste c , and a &# 34 ; blank &# 34 ; toothpaste d containing neither a peroxide nor a peroxide - yielding substrate . toothpaste a contained glucose oxidase and toothpaste b contained glucose oxidase and amyloglucosidase . toothpaste a , b and d had the following identical composition , except for ingredient x : ______________________________________ingredient % by weight______________________________________levilite . sup . x 23 . 0methylcellulose 1 . 3glycerol 10 . 0sorbitol ( 70 % solution ) 10 . 0sodium benzoate 0 . 1ethyl - p - hydroxybenzoate 0 . 1propyl - p - hydroxybenzoate 0 . 1sodium saccharin 0 . 15flavor 0 . 5ingredient x -- distilled water to 100 % ______________________________________ in toothpaste a , ingredient x is 1 . 2 units of glucose oxidase . in toothpaste b , ingredient x is 1 . 2 units of glucose oxidase and 15 units amyloglucosidase . in toothpaste d , ingredient x is absent . ______________________________________ingredient % by weight______________________________________calcium carbonate 36glycerol 30chloroform 3 . 5sodium lauryl sulfate 1 . 0natural tragacanth gum 1 . 0flavor ( peppermint ) 1 . 0peroxide 0 . 5distilled water to 100 % ______________________________________ the measurements on the test subjects were performed by the same team consisting of a dental surgeon , a dental assistant , and an administrative assistant . neither of the first two knew which toothpaste the subject group was using . immediately after the first measurement of the dental surface ph , a toffee type of sweet consisting mainly of saccharose was eaten , and exactly 12 minutes later the dental surface ph was measured again . the shifts in ph following the use of the various toothpastes , before and after the use of the sugar , are shown in the following table : table ii______________________________________toothpaste start ph ph - shift______________________________________a 6 . 28 + 0 . 47 ( before sugar ) 5 . 92 + 0 . 32 ( after sugar ) b 6 . 28 + 0 . 48 5 . 80 + 0 . 55c 6 . 36 - 0 . 08 6 . 07 + 0 . 10d 6 . 51 + 0 . 20 6 . 46 - 0 . 40______________________________________ from the above table it appears that the toothpastes a and b of the present invention gave a significant rise in ph , whereas the commercial peroxide - containing toothpaste c did not give any statistically significant effect and the blank toothpaste d gave a decrease of the dental surface ph . the only ingredient influencing the ph in the above toothpastes was the calcium carbonate present in toothpaste c . this alkaline component tends to raise the ph , thus masking the unfavorable low dental surface ph actually produced by this toothpaste , which would have been even lower , and hence still more unfavorable , had this polishing agent been replaced by a neutral polishing agent , such as levilite . but even without taking this factor into account , the differences between the ph shifts caused by the toothpastes according to the invention and the commercial peroxide - containing toothpaste are substantial . the dentifrices according to the invention can be prepared in various forms , e . g . in the form of toothpaste , mouth wash , tablets , chewing gum or other conventional forms . besides the enzyme products according to the invention and a substrate , if any , for the oxidase applied these dentifrices contain the conventional ingredients . thus , for example , these are incorporated in toothpaste abrasive and / or polishing materials such as calcium carbonate , dicalcium phosphate , calcium phosphate , calcium sulphate , or silicon compounds , thickeners such as carboxymethylcellulose , tragacanth or guar , water , flavorings , and / or natural or synthetic sweetening agents . further , fluoro compounds can be added such as sodium - or potassium - monofluoro phosphate or sodium fluoride , and / or thiocyanates . the dentifrice compositions of the invention are illustrated further by the following examples , to which it is , of course , not limited : ______________________________________toothpasteingredient % by weight______________________________________precipitated silica ( e . g . neosyl ) about 23paraffin 15p - amino benzoic acid ( pab ) esters 0 . 2methylcellulose 1 . 8aromatic substances 2glucoseoxidase ( 2 . 0 u / g ) amyloglucosidase ( 15 u / g ) distilled water up to 100______________________________________ ______________________________________toothpasteingredient % by weight______________________________________calcium carbonate 50tricalcium phosphate 5sorbitol ( 70 % solution ) 10glycerol 20tragacanth 2aromatic substances 0 . 8glucoseoxidase ( 0 . 5 ( u / g ) dextranase ( 4 u / g ) p - amino benzoic acidpab - esters 0 . 9distilled water up to 100______________________________________ ______________________________________toothpasteingredient % by weight______________________________________aluminum - hydroxide 40na - fluoride 0 . 1sorbitol ( 70 % solution ) 25glycerol 5aromatic substances 1 . 2na - alginate 1p - amino benzoic acid ( pab )- esters 0 . 1saccharine 0 . 25glucoseoxidase ( 5 u / g ) water to to 100______________________________________ ______________________________________tooth powderingredient % by weight______________________________________aromatic substances 2na - cyclamate 0 . 5detergent 1glucoseoxidase ( 1 . 0 u / g ) invertase ( 2 . 5 u / g ) calcium phosphate up to 100______________________________________ ______________________________________mouth washingredient % by weight______________________________________methylcellulose ( low viscous ) 1aromatic substances 1p - amino benzoic acid ( pab )- esters 0 . 15disodium phosphate 0 aq . 1 . 5citric acid 1 aq . 1 . 0glucoseoxidase ( 3 u / ml ) amyloglucosidase ( 5 u / ml ) distilled water up to 100______________________________________ ______________________________________toothpasteingredient % by weight______________________________________aluminum hydroxide 35precipitated silica 5glycero 25carraghenate 2na - fluoride 0 . 1detergents 2aromatic substances 1k - thiocyanate 0 . 02glucose oxidase ( 2 . 4 u / g ) water up to 100______________________________________ ______________________________________chewing tabletingredient % by weight______________________________________carbowax 6000 2aromatic substances ( micro - capsules ) 0 . 5coloring matter 0 . 1glucoseoxidase ( 10 u / g ) na - fluoride 0 . 1mannitol up to 100______________________________________ ______________________________________chewing gumingredient % by weight______________________________________gum basis 14sorbitol ( 70 % solution ) 25aromatic substances 0 . 5glucoseoxidase ( 20 u / g ) invertase ( 100 u / g ) sorbitol up to 100______________________________________ ______________________________________lozenge tabletingredient % by weight______________________________________calcium gluconate 57mannitol 40aromatic substances 1cmc - na 2glucoseoxidase 20 u / gamyloglucosidase 20 u / g______________________________________

a novel enzymatic dentifrice comprises as its essential active ingredient an amount of glucose oxidane enzyme which forms hydrogen peroxide by oxidative decomposition of a glucose substrate provided by glucose present in saliva and tooth plaque so as to cause a substantial shift toward neutral values in the ph at the surface of teeth , when said ph is below the neutral range .

the following is a detailed description of the preferred embodiments of the invention , reference being made to the drawings in which the same reference numerals identify the same elements of structure in each of the several figures . fig1 a schematically shows a radiography system in accordance with the present invention wherein a radiographic image is recorded on a storage phosphor screen . the storage phosphor screen is disposed within a cassette 100 . a cassette code / information is associated with cassette 100 . means are provided on cassette 100 for identifying the cassette or the cassette code . for example , the code can be directly stored in an id member 120 affixed to or disposed within cassette 100 . id member 120 can be a bar code or a radio frequency tag or the like . id member 120 would store the particular information which would be employed by the system , as will be more particularly described below . alternatively , the code can be obtained indirectly using id member 120 . that is , the id member 120 can be a pointer / marker to a database 130 ( such as stored on a workstation 140 ), wherein id member 120 is associated with the code . for example , id member 120 might indicate refer to “ code x ” in a database , wherein “ code x ” would comprise particular information . workstation 140 can be a preview station or computer or the like . workstation 140 can be networked by means of network 160 to one or more modalities 180 . a computed radiography reader / scanner 200 is provided for reading the exposed storage phosphor screen disposed within cassette 10 . a processor 210 is provided for conducting image processing on the image read by reader 200 . both reader 200 and processor 210 can be in communication with network 160 . a printer 220 , such as laser printer , can also be provided to generate a hardcopy of an image processed by processor 210 . an archive 230 may be in communication with network 160 for storing data . workstation 140 is provided with a device 240 for reading the information disposed in id member 120 . alternatively , for example if id member 120 is a radio frequency tag , device 240 can be a read / write device for reading the information and writing new / different information to the id member . device 240 can also be provided with reader 200 . while fig1 a shows the element being networked , it is noted that the elements can be directly connected or routed to combinations of other destinations , such as the printer and archives . fig1 b generally illustrates the method of the present invention using the system shown in fig1 a . more particularly , fig1 b shows a diagrammatic illustration of the use of the coded cassette and the subsequent scanner interaction in accordance with the present invention . using the cr cassette system of the present invention , a user selects / chooses a cassette based on the type of image that is to be acquired ( shown at block 5 ). the selected cassette includes a special scannable code associating the reading / scanning procedure with the cassette type ( shown at block 10 ). as indicated above , the code can be disposed in id member 120 or obtained by database 130 . the image is acquired using proper computed radiography techniques ( shown at block 30 ) using modality 180 . referring now to block 40 , once the image is acquired ( i . e ., the storage phosphor screen is exposed ), device 240 can be used to scan id member 120 and determine the code associated with selected cassette . the code includes information about the image and / or cassette relevant to the reading / scanning of the exposed screen by reader 200 . for example , a grid can be disposed within cassette 100 , attached to cassette 100 , otherwise associated with cassette 100 , or absent from cassette 100 . for example , the cassette code can include information about the type of grid and / or the scanning characteristics which should be employed since a particular type of grid was used ( or absent from ) the cassette . for example , information which would affect a change in the pixel matrix size . the code can also include information about further image processing of the scanned image . that is , any image processing that might be applied to the image by processor 210 once the image is read / scanned by reader 200 . other information that can be included in the cassette code includes information regarding : laser spot size ( for example , 100 or 60 micron ) laser spot shape ( for example , round or elliptical , and the like ) laser power ( for example , 3 , 7 , 15 , 30 , 60 mw ) variable sampling clock for frequency ( e . g ., can be set by the pmt board , frequency examples are 300 khz and 600 khz ) enable and disable collector profile correction for calibration enable / disable recalibration ( for example , reload electronic gain setting without recalibration , e . g ., 1 ×, 5 ×, or 10 ×) variable pmt gain ( for example , 900 , 800 , 700 , 600 , and 500 volts ) ability to enable / disable fast scan filter ability to change the dc level of the electronics signal ability to turn on / off the laser for scanning variable or differing galvo speed variable slow scan sampling pitch variable pixel size ( for example , 100 , and 50 micron ) variable pixel matrix size exposure level patient size body part and / or projection grid ( use or not use ) grid characteristics ( for example , resolution , orientation , focus range , thickness , lead content , ratio , and the like ) screen characteristics ( for example , phosphor type , thickness , age , flexibility , backing , and the like ) portable vs . ambulatory cassette type ( for example , light - weight , regular , and the like ) using the cassette code , reader 200 can read the image in accordance with the code ( block 50 , step a ). the cassette code might indicate that the image requires particular pre - processing ( block 50 , step b ). at block 60 , the architecture passes the data along to the designated cr image processing software ( processor 210 ). the x - ray imaging modality 18 used to acquire the image ( referenced in at block 30 ) is typically either a cr or a dr imaging device . example placements of id member 120 are shown in fig2 a and 2b . cassette 100 includes a cassette housing 12 having a frame 14 . disposed within cassette housing 12 is a phosphor material / screen 16 used to capture the latent image . as indicated above , depending on the id member employed , id member 120 can be disposed on or within cassette 100 . candidate locations of id member 120 are indicated by elements 20 - 28 shown in fig2 a and 2b . it is noted that more than one id member can be employed with a cassette . one method for programming cassette codes of id member 120 is described with reference to fig3 a . cassette 100 with a programmable and scannable id member 120 is first scanned by device 240 . a user interface disposed on workstation 140 allows a one time set - up , periodic or as needed configuration of one , several or all cr cassettes . possible options that can be provided without requiring configuration are shown by groups a through d in fig3 b . in fig4 there is shown three example embodiments of the present invention . referring to blocks 5 and 10 of fig1 and 4 , a cassette is chosen . example cassette types include a general - purpose cassette , a cassette with an imbedded grid , and a cassette with a high - resolution screen . different handling is required for each cassette type , however this handling is not governed by exam information such as body part and projection . rather , it is governed by the qualities of the cassette type . the selection of the cassette may depend on the image being acquired . for example , if a technologist is performing an upright chest exam , the technologist may choose a general - purpose cassette to perform this exam . using the selected cassette , the image is acquired ( block 30 shown in fig1 and 4 ). at block 40 , device 240 is used to scan id member 120 to acquire ( either directly , or indirectly through database 130 ), the associated cassette code . the code provides information about the scanning / handling ( block 45 ) and / or pre - processing protocols ( block 50 ) for reader 200 or processor 210 . once the image is read , image processing can be conducted by processor 210 ( block 65 ). the output image can then be transmitted , displayed a display ( block 70 ), printed using printer 220 , or archived to archive 230 . an example is now provided wherein a technologist desires to perform an upright chest exam . for such an exam , the technologist may choose a general - purpose cassette . the proper positioning and technique are provided ( block 30 ) and the cassette is taken to device 240 for the id member to be accessed . first , the id member is scanned and the associated code is determined ( either directly or indirectly ). based on the code ( block 45 ), a scanning protocol for reader 200 will be chosen and used to scan the latent image 50 disposed within the storage phosphor . in this example , outlined as example 1 for cassette 1 ( block 51 ), the protocol includes scanning at 100 - micron pixel resolution . also , since there is no grid in the cassette , and either a stationary grid , reciprocating grid or no grid may be used during the exam , grid detection and suppression software would be useful , and is thus part of the protocol for example 1 ( block 51 ). a second example is now described with reference to a portable chest exam . in this example , the technologist may choose cassette type 2 , which is a cassette with a ( preferably lightweight , possibly imbedded ) grid . this cassette may be used for a portable exam ( chest , abdomen , pelvis , and the like ) where a grid is expected to improve image contrast and otherwise not attached to the x - ray system in the form of a stationary or reciprocating grid . the code associated with the selected cassette ( obtained by scanning id member 240 disposed on the cassette ) would indicate ( at block 52 ) that a scanning protocol would include a switch to a gain calibration allowing for the exploitation of lower code value deviations in a lower exposure acquisition , a 100 - micron scan and grid suppression , as the specs of the grid in the cassette are known . a third example is now provided wherein the acquisition is a mammographic acquisition . the technologist would choose cassette 3 for this exam , which includes a high - resolution screen . this cassette could be used for an exam requiring high resolution such as fingers , wrists , ankles , mammograms , and the like . these exams also tend to require less overall exposure as the body part is small , and in the interest of dose reduction for exams where lower energy beams are required ( all of the aforementioned , especially mammography ) a switch to a gain calibration which allows for higher deviations between the lower code values in a lower exposure acquisition could be part of this protocol as well ( block 53 ). the code associated with this selected cassette ( by means of the id member ) also indicates the scanning resolution , and in the case of a high - resolution screen , a 50 - micron scan would be indicated and performed . fig5 a and 5b show three examples of calibration which can be used with cassette types 2 and 3 of fig4 . in a cr reader , a photo multiplier board 54 supplies a high voltage 55 to a photo multiplier tube ( pmt ), then amplifies 56 the signal it receives from the pmt and attenuates 57 the signal depending on calibration . the signal then passes through a multi - pole filter 58 before it is sampled by an analog and digital converter 59 . the multi - pole filter is made up of combinations of high pass and low pass circuits to discriminate signals based on frequency . the pmt gain can be adjusted by varying the pmt voltage and the electronic gain can be adjusted by the attenuator . for a calibration of 1 × gain , it attenuates the signal only 1 ×. for a very low exposure , the signal to noise ratio is low . the image quality is relatively poor in such instances . when the cr is calibrated at a 5 × or 10 × gain , the pmt gain and / or the electronic gain increases the signal 5 × or 10 × above the noise floor . in such cases , when the cr cassette is exposed at very low exposure , the image quality is increased visually and the signal to noise ratio is higher . thus , the cassette code can include information regarding the adjustment of the gain . all further handling of the device or the image data is known to those skilled in the art and so has been previously described in available literature . a computer program product may include one or more storage medium , for example ; magnetic storage media such as magnetic disk ( such as a floppy disk ) or magnetic tape ; optical storage media such as optical disk , optical tape , or machine readable bar code ; solid - state electronic storage devices such as random access memory ( ram ), or read - only memory ( rom ); or any other physical device or media employed to store a computer program having instructions for controlling one or more computers to practice the method according to the present invention . all documents , patents , journal articles and other materials cited in the present application are hereby incorporated by reference . the invention has been described in detail with particular reference to a presently preferred embodiment , but it will be understood that variations and modifications can be effected within the spirit and scope of the invention . the presently disclosed embodiments are therefore considered in all respects to be illustrative and not restrictive . the scope of the invention is indicated by the appended claims , and all changes that come within the meaning and range of equivalents thereof are intended to be embraced therein .

a method for scanning and processing computed radiography x - ray images in order to maximize the usage of cassette options . the storage phosphor radiography imaging method of the invention employs a cassette comprising a storage phosphor screen adapted to be exposed to x - rays to store a latent x - ray image in the screen and read using a reader . the method includes the steps of : associating cassette information with the cassette using an identification member affixed to the cassette or storage phosphor screen , the cassette information comprising information relating to characteristics of the cassette relevant to the reading of the screen by the reader ; prior to reading the exposed storage phosphor screen to generate a digital image signal , scanning the identification member to obtain the cassette information ; and reading the exposed storage phosphor screen in accordance with the cassette information to generate the digital image signal .

while the present invention is susceptible of embodiment in various forms , there is shown in the drawings and will hereinafter be described a presently preferred , albeit not limiting , embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated . referring to fig1 - 6 , an illustrative embodiment of the spinal implant , preferably an interbody spinal implant device , in accordance with the present invention is shown . the spinal implant 10 is preferably suited for placement between adjacent human vertebral bodies . the implant 10 may be used in various spinal procedures , including but not limited to anterior lumbar fusion ( alif ), posterior lumbar fusion ( plif ), or transforaminal lumbar fusion ( tlif ), or extreme lateral interbody fusion ( xlif ) or direct lateral interbody fusion ( dlif ). the spinal implant 10 contains a body 12 having a top surface 14 , a bottom surface 16 , opposing lateral sides 18 and 20 , and opposing anterior 22 and posterior 24 portions . each of the top surface 14 and the bottom surface 16 may contain ridges or teeth ( not shown ) to aid in implant stability . the device 10 is preferably made of a durable material , such as stainless steel , stainless steel alloy , titanium , aluminum , an alloy , carbon fiber composite , or other durable materials such as but not limited to polymeric , ceramic , and composite materials . for example , certain embodiments of the present invention may be comprised of a biocompatible , polymeric matrix reinforced with bioactive fillers , fibers , or both . certain embodiments of the present invention may be comprised of a high - performance engineering thermoplastic such as polyetherether - ketone ( peek ) or other polymers such as polyvinyl chloride ( pvc ), polyethylene , polyesters of various sorts , polycarbonate , teflon coated metal or ultra high molecular weight polyethylene ( uhmwpe ). certain embodiments of the present invention may be comprised of urethane dimethacrylate ( dudma )/ tri - ethylene glycol dimethacrylate ( tedgma ) blended resin and a plurality of fillers and fibers including bioactive fillers and e - glass fibers . durable materials may also consist of any number of pure metals , metal alloys , or both . titanium and its alloys are generally used due to their strength and biocompatibility . the body 12 of the spinal implant 10 contains one or more magnets 26 imbedded into the implant . the magnets 26 may be arranged to be an integral part of the outer surface of the top surface 14 , the bottom surface 16 , the opposing lateral sides 18 and 20 , and the opposing anterior 22 and posterior 24 portions , or combinations thereof . as illustrated in fig1 and 2 , magnets 26 are located at opposing ends of the anterior ( fig1 ) and posterior portion 24 ( fig2 ). fig4 illustrates an alternative embodiment of the spinal implant 10 which contains a pair of magnets 26 located at one end of the anterior portion 22 and a pair of magnets along the opposing ends of the anterior portion 22 . referring to fig5 , individual magnets 26 are replaced by a magnetic bar 28 . magnets 26 or magnetic bars 28 may be permanent magnets , temporary magnets , or electromagnets , and can be made from any material that produces a magnetic field and is insertable into a human which does not result in a biological or an immune reaction or that does not pose safety risks to the individual . as an illustrative example , the magnets may be rare - earth magnets made from alloys of rare earth materials , such as neodymium magnets . such magnets may be encased by materials such as polyetherether - ketone ( peek ), parylene coatings , or ceramic coatings . other forms of the magnet may be used ; for example , a magnetic powder or nano - magnetic particles can be applied to one or more portions of the main body 14 or be incorporated within the material that comprises the body 12 . fig6 illustrates an alternative embodiment of the spinal implant 10 . in this embodiment , the magnet 26 or magnetic bar 28 ( not illustrated ) is integrally formed with the material that makes up the body 12 . while the embodiments shown in fig1 - 6 illustrate the placement of the magnetic materials , either the magnets 26 or the magnetic bar 28 , shown being placed along the anterior portion 22 or the posterior portion 24 , or within the main body 12 , such magnetic material can be placed anywhere along or within the top surface 14 , the bottom surface 16 , the opposing lateral sides 18 and 20 , or combinations thereof . regardless of the positioning within or on the body 12 , the magnets 26 or magnetic bar 28 provide a self - aligning function when two or more spinal implants 10 are aligned or placed at a proper distance so that the two or more spinal implants 10 are magnetically affected or drawn towards each other . referring to fig1 , a top view of a vertebra 30 with an inserted first spinal implant 10 a is illustrated . as shown , the vertebral disc has been removed to expose the vertebral endplate 32 . the spinal chord , not illustrated , runs through the spinal canal 34 . a single spinal implant 10 is shown inserted in between opposing endplates , not shown , and resting on endplate 32 . use of implants having magnets overcomes some of the problems associated with implanting multiple implants . for example , when an individual undergoes removal of the disc , it is a common procedure for the surgeon to prepare the endplate for insertion therein . part of the preparation includes scraping of the endplate to provide a smooth surface for the implant to rest upon . however , the surface of the endplate is not always uniform , even with surgical preparation intervention . this presents a problem or insertion of multiple implants where the first implant is tightly secured between adjacent endplates but a remote portion of the endplate or an adjacent second endplate does not provide such a tight fit for the second implant because of the non - uniform nature of the endplate surface . the second implant is subject to floating , in which the second implant may move from its original implant site , risking sliding into the spinal canal or nerve roots , subjecting the patient to increased risk of serious damage . in bone fusion surgeries not using the spinal implant 10 in accordance with the present invention , inserting a second implant and aligning with a first spinal implant requires manipulation ; there is no guarantee that correct alignment can be accomplished . however , using an implant in accordance with the present invention , self - alignment and self - centering can be accomplished . referring to fig1 , as the second spinal implant 10 b is inserted in between adjacent vertebrae , the surgeon is required to manipulate the spinal implant 10 b until it is in close proximity to be affected by the magnetic fields 36 of the magnets 26 of spinal implant 10 a , see fig1 . once in close proximity , the magnetic field 36 of the second spinal implant 10 b is drawn to the magnetic field 36 of the first spinal implant 10 a . accordingly , the magnets 26 cause the second spinal implant 10 b to self align and self center with the first spinal implant 10 a , see fig1 . in order to achieve the self - aligning and self - centering function , it is critical that the polarity of the magnets 26 on the spinal implant 10 a are arranged so as to respond to the magnetic field produced by the magnets 26 of the spinal implant 10 b . the two spinal implants 10 a and 10 b are aligned along their anterior 22 and posterior 24 sides , but could be arranged so that opposing sides 18 and 20 , or the top surface 14 and bottom surfaces 16 align . this capability allows the spinal implants 10 a and 10 b to be arranged in different orientations , such as vertical alignment across the endplates arranged side to side or end to end , see fig1 , as opposed to horizontally aligned across the endplates . in any orientation , the spinal implants 10 a and 10 b self - align . while not illustrated , additional spinal implants may be inserted . referring back to fig7 - 9 , alternative embodiments of the spinal implants 10 are shown . the size and shape of the spinal implant 10 can be varied depending on the type of surgical procedure undertake , the size and shape of the individual &# 39 ; s vertebrae , the type of procedure used ( for example plif or tlif ), or vertebral separation and / or support . the spinal implant 10 may also contain additional features that aid in implantation . for example , fig7 illustrates a spinal implant 10 in which one of the opposing ends 18 contains a curved surface 38 , forming an angled or ramped surface area 40 . fig8 illustrates a spinal implant 10 in which opposing sides 18 and 20 are curved . referring to fig9 , the main body 12 is shown having a half - moon or crescent shape . each of the embodiments shown in fig7 - 9 , as well as those illustrated in fig1 - 6 may contain cancellous autograft bone , allograft bone , demineralized bone matrix ( dbm ), porous synthetic bone graft substitutes , bone morphogenic proteins ( bmp ), or combinations thereof , inserted within a hollow portion of the spinal implant 10 . additionally , the spinal implant 10 may contain one or more vertical apertures 42 and one or more traverse apertures 44 sized and shaped to maximize access to bone graft material provided within the implant 10 . an additional opening ( not illustrated ) may be utilized to facilitate manipulation of the implant 10 by a surgical tool . one of the unique features of the spinal implant 10 in accordance with the present invention is that a plurality of implants can be arranged to provide a predetermined shape , height , or combinations thereof , prior to or at the time of performing a surgical procedure . as such , the spinal implant 10 can be either laterally or vertically stacked to achieve such purposes . referring to fig1 a - 15c , spinal implants are shown arranged and secured to each other to form a predetermined shape . by laterally stacking each of the spinal implants , the user can form variable geometrical shapes which are dependent on the anatomical structure of the patient . such variable geometrically shaped formation provides an advantage in situations where the anatomical structures are not ideal or are diseased causing irregularly shaped features . moreover , because the spinal implants 10 are self - aligning or can be secured to adjacent spinal implants based on magnetic principles , the geometrical shapes can be formed at the time of the surgical implant procedure and inserted into the graft site . the ability to form a desired shape provides the surgeon the ability to customize the implant shape to fit the contours of the vertebrae . alternatively , the spinal implants 10 can be pre - assembled to a pre - determined shape prior to a surgical procedure . given the ability to secure to adjacent implants , any number of geometrical shapes can be formed . for example , fig1 a and 15b illustrate spinal implants 10 c and 10 d having an end 18 which has tapering or inclined surface 37 . securing each implant so that the tapered ends 37 face outwardly provides a generally trapezoidal shape , see fig1 a and 15b . alternative shapes , such as the square shaped configuration of spinal implants 10 a , 10 b , 10 e and 10 f shown in fig1 c , may be formed . such functioning allows for a modular spinal implant system that can be pre - packaged and shipped to a user . such pre - packaging could include individual spinal implant units that have been sterilized , thereby allowing the user the ability to assemble each implant to a desired height , configuration , or combinations thereof on field . as described previously , the shapes can be formed in vitro during the surgical procedure , or can be assembled ex vivo , and shipped in a pre - packaged configuration having a desire shape and inserted into the anatomical landscape . in addition to lateral stacking , the spinal implants 10 can be vertically stacked , see fig1 a or 16b . as seen in fig1 a , two spinal implants 10 a and 10 b are illustrated in a vertically stacked position in which spinal implant 10 b rests on top of spinal implant 10 a . fig1 b illustrates a plurality of spinal implants , 10 a , 10 b , 10 e , and 10 f in a vertically stacked arrangement . in this configuration , each adjacent spinal implant not only secures to the spinal implant above and below , but also is maintained in a correct spatial alignment so that none of the spinal implants overhang or are misaligned with the other spinal implants . this arrangement ensures that the stacked spinal implants form a flush , single unit comprising of multiple , independent implants . by providing for such functionality , the user can stack one or more sized implant to achieve a larger size . for example , standard sized implant devices can range from 2 mm , 4 mm , 6 mm , 8 mm , 10 mm , or 20 mm in size . typically , spinal implant companies provide surgeons with a plurality of differently sized implants for each procedure . having to package and ship a large number of spinal implants , each having different sizes , is costly . moreover , the surgeon may not actually utilize all of the implant sizes . however , such costs can be avoided as the spinal implants in accordance with the present invention can be vertically stacked to form a secondary , larger sized implant . for example , instead of packaging and shipping a 10 mm , 12 mm , or 20 mm sized spinal implant , a 6 mm and a 4 mm sized implant can be vertically stacked to form a size 10 spinal implant . fig1 d illustrates two spinal implants 10 g and 10 h which when stacked together form a “ larger ” implant . as illustrated , spinal implant 10 g is a 2 mm implant ; spinal implant 10 h is an 8 mm implant . when stacked together , the combination of the two form a 10 mm structure . in a typical surgical setting , the surgeon is usually forced to obtain numerous spinal implants varying in size . having a plurality of smaller sized implants which can be vertically stacked together not only reduces the inventory and shipping costs , but the surgeon will also be capable of creating a specific spinal implant height onsite during the surgical procedure . additionally , the surgeon can utilize a combination of laterally stacked spinal implants , 10 a and 10 b with a plurality of vertically stacked implants 10 e and 10 f , see fig1 c . this arrangement allows the surgeon the ability to build up certain areas of an implant site relative to other areas . this may be important for implant sites that contain depressions or erosion within the bone . referring to fig1 a , an illustrative example of spinal implant holder and insertion device 46 a spinal implant holder and insertion device 46 is constructed and arranged to provide a tool to assist the surgeon during insertion of the insert the spinal implant 10 , whether inserted as an individual units or as a pre - assembled structure . the spinal implant holder and insertion device 46 may contain a proximal end 48 , a distal end 50 , and a main body 52 therebetween . the distal end 50 contains a pair of prongs 54 and 56 . the prongs 54 and 56 are arranged in a generally parallel manner and spaced apart to form a spinal implant holding area 58 . the spinal implant holding area 58 is sized and shaped to receive and hold at least one spinal implant 10 . preferably , the spinal implant holder and insertion device 46 is designed to allow for at least one of the prongs 54 or 56 , to separate from the other to allow for insertion or removal from the spinal implant holding area 58 . alternatively , both prong 54 and 56 can be adapted to move and separate from each other . the proximal end 48 may contain an actuating button 53 adapted to provide separation and / or closure of prongs 54 and 56 . spinal implants 10 may contain grooves or channels 60 sized and shaped to receive at least a portion of prongs 54 and 56 , thereby securing the spinal implant within the spinal implant holding area 58 . fig1 illustrates a plurality of spinal implants arranged in a kit 62 . the kit 62 includes a housing structure constructed and arranged to hold a plurality of variable sized spinal implants 10 g - 10 m . as an illustrative example , the kit 36 may contain two size 2 mm spinal implants 10 g , 10 h , two size 4 mm spinal implants 101 , 10 j , two size 6 mm spinal implants 10 k , 10 l , and one size 8 mm spinal implant 10 m . using this kit , the surgeon has a plurality of spinal implants from which to form vertically stack units , easily building the spinal implants to 10 g - 10 m a desired height . while a kit may be employed , each individual spinal implant 10 may be pre - sterilized and pre - packaged individually . although the present invention has been described in the spinal surgical setting , the implant devices can be adapted to be used in other surgical settings , such as orthopedic implants for orthopedic surgeries . all patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains . all patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference . it is to be understood that while a certain form of the invention is illustrated , it is not to be limited to the specific form or arrangement herein described and shown . it will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings / figures included herein . one skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned , as well as those inherent therein . the embodiments , methods , procedures and techniques described herein are presently representative of the preferred embodiments , are intended to be exemplary and are not intended as limitations on the scope . changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims . although the invention has been described in connection with specific preferred embodiments , it should be understood that the invention as claimed should not be unduly limited to such specific embodiments . indeed , various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims .

the present invention provides for an improved spinal implant which is useful in bone fixation surgeries . the spinal implant as described herein provides a surgeon with a device that can easily and safely be inserted into the space previously occupied by the spinal disc . the spinal implant contains one or more magnets positioned on or within the device to self - align with one or more additional spinal implants inserted therein for the purpose of preventing misalignment of a plurality of implant devices during surgical procedures and preventing implant expulsion .

the best mode for carrying out the invention is presented in terms of its preferred embodiment , herein depicted within fig1 through 5 . however , the invention is not limited to the described embodiment and a person skilled in the art will appreciate that many other embodiments of the invention are possible without deviating from the basic concept of the invention , and that any such work around will also fall under scope of this invention . it is envisioned that other styles and configurations of the present invention can be easily incorporated into the teachings of the present invention , and only one particular configuration shall be shown and described for purposes of clarity and disclosure and not by way of limitation of scope . the terms “ a ” and “ an ” herein do not denote a limitation of quantity , but rather denote the presence of at least one of the referenced items . the present invention describes a configurable and portable system for cleaning and / or collecting dirt , soil , dust , grime , and the like in hard - to - reach areas , specifically under furniture or other objects . the broom with interchangeable accessories and carrying case therefor ( herein described as the “ system ”) 10 comprises a main handle assembly 20 , a broom head assembly 30 with a replaceable bristle portion 35 , a dustpan assembly 50 , and a carrying case 70 . the system 10 comprises an ergonomically designed handle portion 20 that may be selectively altered to become an integrated and collapsible broom . the system 10 is envisioned to be introduced in a plurality of sizes to accommodate proper cleaning of various areas as well as reaching hard - to - reach areas . the system 10 is envisioned to be fabricated of sturdy plastic and metal materials utilizing standard industrial fabrication processes . referring now to fig1 and 2 , a perspective view and an exploded view of the system 10 , according to the preferred embodiment of the present invention , are disclosed . the system 10 comprises cleaning components which include a main handle assembly 20 , an extending member 25 , a broom head assembly 30 , and a dustpan assembly 50 . the main handle assembly 20 provides a gripping means to operate the system 10 . the main handle assembly 20 is linear in shape and made using metal or plastic tubular materials with a hollow center thereby allowing the system 10 to be lightweight as well as sturdy . the main handle assembly 20 comprises an appropriate diameter and thickness for optimum stability and strength capabilities . the main handle assembly 20 comprises a first gripping device 22 and a second gripping device 23 located at upper and lower portions , respectively . the gripping devices 22 , 23 comprise cylindrical lengths of dense urethane foam rubber and provide an ergonomic gripping means during use using two ( 2 ) hands . said gripping devices 22 , 23 radially envelop portions of the main handle assembly 20 . the main handle assembly 20 is envisioned to further comprise a spring - loaded and protruding first locking button 24 along a lower edge , thereby providing a telescoping and locking attachment means thereto an extending member portion 25 in a similar manner as that of awning or tent posts , thereby being joined together to form a substantially single unit . the extending member 25 comprises an “ s ”- shaped length of tubing which may be adjustably lengthened or shortened for a plurality of respective cleaning job functions . the extending member 25 is made using similar materials as the main handle assembly 20 ; however , said extending member 25 provides an upper diameter sized specifically to fit slidingly and telescopingly over the aforementioned main handle assembly 20 . thereat said telescoping and overlapping portion , the extending member 25 further comprises a plurality of equally - spaced extending member apertures 27 arranged in a vertical linear fashion providing selectable engagement therewith the first locking button portion 24 of said main handle assembly 20 , thereby forming a substantial connection therebetween which may be extended for a longer length or retracted for a shorter length acting to adjust an overall vertical length of the system 10 . the main handle assembly 20 and extending member 25 are envisioned to be locked into an extended orientation , a retracted orientation , or a plurality of intermediate positions therebetween via the extending member apertures 27 . the main handle assembly 20 and extending member 25 may be selectively detached by depressing the spring - loaded button 24 inwardly thereby releasing said portions 20 , 25 therefrom one another . the extending member 25 further comprises a second locking button 28 along a lower opening portion providing similar construction as the aforementioned first locking button 24 , thereby providing a similar telescoping engagement means thereto a tube receiver aperture portion 36 of the broom head assembly 30 ( see fig3 ). the “ s ” shape nature of the extending member 25 comprises a low - profile shape providing easy access thereunder furniture and other obstacles . it is envisioned that a lower end portion of the extending member 25 extends upwardly a short distance and subsequently curves and extends at an angle of approximately thirty degrees )( 30 ° from a horizontal plane . the main handle assembly 20 , extending member 25 , and broom head assembly 30 are designed to provide engaging diameters such that each respective section is slightly larger than the previous to enable each section to be slidably received therewithin one another to provide convenient disassembly as well as a means to vary an overall height of the system 10 . it is further understood that the main handle assembly 20 and extending member 25 may also be utilized individually being affixed thereto the broom head assembly 30 , thereby providing additional configurations of the system 10 for a variety of cleaning tasks . finally , said attachment and engagement of the main handle assembly 20 , extending member 25 , and broom head assembly 30 provides compact disassembly of the system 10 to be stored therein a carrying case 70 ( see fig5 ). the main handle assembly 20 , extending member 25 , and broom head assembly 30 are illustrated here utilizing a preferred attachment means using spring - loaded buttons 24 , 28 and corresponding apertures 27 , 36 ; however , it is understood that various other tubular attachment means may be utilized which provide equal benefit to a user such as threaded , snapping grooves , various locking clips , quick - disconnect pins , other fasteners , or the like . the system 10 is to be introduced in a plurality of sizes to accommodate various household , commercial , indoor , and outdoor cleaning applications . furthermore , the system 10 is envisioned being introduced having a variety of external decorative colors and patterns . referring now to fig3 , a close - up view of the system 10 depicting a broom head assembly portion 30 , according to the preferred embodiment of the present invention , is disclosed . the broom head assembly 30 is removably attached thereto the lower - most extremity of the extending member 25 , if so configured ( see fig1 ). the broom head assembly 30 extends perpendicularly in both directions therewith a longitudinal axis of the extending member 25 . the broom head assembly 30 comprises a one - piece molded member further comprising a broom head body 31 , a handle 32 , and a stationary tube receiver 34 . the stationary tube receiver 34 provides a removably securing means thereto the extending member 25 as previously described such to permit normal sweeping . the handle portion 32 may be utilized to grasp said broom head assembly 30 to be utilized as a whisk broom while attachably removed therefrom the extending member 25 . the handle 32 comprises an ergonomic horizontally extending appendage therefrom the stationary tube receiver 34 having a plurality of finger indentations 33 sized and positioned to removably receive fingers of a user . the broom head assembly 30 further comprises a plurality of bristles 35 being collectively removably attached thereto said broom head assembly 30 . the broom head assembly 30 comprises a broom head body 31 comprising a horizontally extending cylinder shape further comprising an included cylindrical female receiver feature 38 along an entire lower surface providing a firm interference fit therewith a corresponding cylinder - shaped binding portion 37 . the receiver 38 and binder 37 provide a removably attachable clamping means providing convenient removal thereof a plurality of bristles 35 affixed thereto said binder 37 when worn and / or in need of replacement . the binder 37 comprises a length correspondingly matching that of the broom head body 31 and is envisioned to be made of similar materials as said broom head assembly 30 . the binding 37 and bristles 35 are envisioned being securely affixed thereto one another using conventional broom assembly techniques utilizing a plurality of bored holes designed to receive tufts or bundles of bristles 35 being secured thereinto using common adhesives ; however , various other fastening means may be provided such as staples , other fasteners , or the like . the bristles 35 are envisioned to comprise a plurality of natural and / or synthetic strands and may be tufted in a variety of sizes and / or configurations , including a cylindrical shape , a rectangular shape , an oval shape , or various other regular or irregular shapes . the bristles 35 are to flare outwardly therefrom leading and / or trailing edges of the binder 37 thereby permitting the user to extend the bristles 35 in tight spaces ; for example , between a piece of furniture , along a wall , or the like . referring now to fig4 , a side view of a dustpan assembly portion 50 of the system 10 , according to the preferred embodiment of the present invention , is disclosed . the system 10 comprises a dustpan assembly 50 being removably attachable thereto the extending member 25 . the dustpan assembly 50 provides an accessory thereto the system 10 , when it is so desired , for collection of dirt , soil , debris , and other undesirables thereupon a surface . the dustpan assembly 50 is substantially rectangular with three ( 3 ) upwardly extending dustpan walls 54 acting as mechanical barriers thereby providing accessibility thereto a floor portion 52 through a frontward - facing open portion 55 . the front opening 55 is envisioned to be tapered downwardly to permit easy collection of dirt , debris , and / or other undesirables . the dustpan assembly 50 is envisioned being made using plastic or other equivalent materials . the floor portion 52 is further envisioned to comprise standard features found on common dustpans such as ridges to provide as a gripping means thereto included dirt , a seal along a forward edge to seal against an underlying surface , and the like . the dustpan assembly 50 further comprises a pivoting tube receiver 56 thereat an intermediate position along an external surface of the rear dustpan wall 54 , thereby enabling angular adjustment of said dustpan assembly 50 with regards to the attached extending member 25 ( see fig2 ). the dustpan assembly 50 provides an attachment means therewith the extending member 25 via engagement of the second locking button portion 28 and a tube receiver aperture portion 36 of the pivoting tube receiver 56 located along an upper edge . engagement of said second locking button 28 and aperture 36 functions in a similar manner as that of the previously described attachment of the broom head assembly 30 . the rotating function of the pivoting tube receiver 56 is accomplished via an integrally - molded slot feature 58 and a protruding tab feature 59 being integrally molded thereinto the rear dustpan wall 54 . said slot 58 and tab features 59 are in mechanical communication therewith one another via a rotary connection comprising a tightening wing nut 61 , thereby forming an angular adjustable axle mechanism providing infinitely selectable and lockable positions therebetween a horizontal orientation and a vertical orientation as shown here . referring now to fig5 , a perspective view of the system 10 disassembled and stored accordingly therein a carrying case 70 , according to the preferred embodiment of the present invention , is disclosed . the carrying case 70 comprises a plastic folding “ clamshell ” design of a triangular shape providing protection thereto cleaning portions of the system 10 as well as providing a portable transportation means . the carrying case 70 comprises an overall inner cavity 72 sizable so as to accommodate and protect the cleaning portions of the system 10 as well as provide a pair of internal open - topped storage pockets 74 to facilitate in static placement of the broom head 20 and dustpan 50 assemblies . it is understood that main assemblies 20 , 25 , 30 , 50 are to be disassembled and disposed therewithin the carrying case 70 for storage and / or transportation . the interior pockets 74 provide generally rectangular enclosures particularly sized so as to snuggly contain said broom head assembly 30 and dustpan assemblies 50 . said pockets 74 are envisioned being made using rigid or semi - rigid extruded plastic sheets being affixed thereto a lower portion of the inner cavity 72 of the carrying case 70 using common plastic welding processes . the carrying case 70 further comprises a plurality of securing straps 76 . the straps 76 comprise standard lengths of elastic strapping or hook - and - loop fastener material providing an entrapping and securing means thereto the main handle assembly 20 and extending member 25 thereto an inner wall portion of the carrying case 70 . the straps 76 are envisioned being affixed thereto said carrying case 70 using a common fastening means such as double - face adhesives , rivets , or the like . the carrying case 70 further comprises a plurality of integrally - molded features including a pair of opposing “ u ”- shaped handles 75 , a pair of molded hinging snap fasteners 78 with corresponding snap features 80 , and a pair of case hinges 82 along an adjacent mirrored vertical edge portion . said molded features 75 , 78 , 80 , 82 provide a latching and carrying means thereto the carrying case 70 . whenever it is so desired , half portions of the “ clamshell ” design of the carrying case 70 may then be pivoted thereabout the molded - in case hinges 82 , closed thereagainst abutting outer perimeter edges thereof , and subsequently secured theretogether in a folded form via the hinging snap fasteners 78 . the snap fasteners 78 are extended and forced over corresponding molded protruding snap features 80 along an edge region of an opposing half portion of the carrying case 70 . said snap fasteners 78 and snap features 80 are envisioned to be similar thereto like devices used on plastic fishing tackle boxes , plastic tool kits , and the like ; however , it is understood that other common latching devices may be provided to secure the carrying case 70 such as hook - and - loop fasteners , button snaps , and the like , while providing equal benefit . it is envisioned that other styles and configurations of the present invention can be easily incorporated into the teachings of the present invention , and only one particular configuration shall be shown and described for purposes of clarity and disclosure and not by way of limitation of scope . the preferred embodiment of the present invention can be utilized by the common user in a simple and effortless manner with little or no training . the present invention describes a means by which a cleaning system 10 may be utilized in a plurality of fashions with the accommodation of easy transportation thereof . after initial purchase or acquisition of the system 10 , it would be configured as indicated in fig2 and 5 . the method of utilizing the system may be achieved by performing the following steps : opening the carrying case 70 by unlatching the snap fasteners 78 therefrom the snap features 80 ; unfolding half portions of the carrying case 70 , thereby exposing the interior cavity 72 ; unfastening the straps 76 therefrom the individual portions of the system 10 ; inserting a lower portion of the main handle assembly 20 thereinto the extending member 25 ; adjusting a length of the extending member 25 to be shortened and lengthened as desired for operation or storage using the first locking button 24 and the extending member apertures 27 , as desired ; removably attaching the broom head assembly 30 , if desired or ; attaching the dustpan assembly 50 thereto the extending member 25 ; using the system 10 in the assembled form , to sweep a desired surface by ; grasping the gripping devices 22 , 23 and motioning in a sweeping motion contacting the desired floor surface ; manipulating the bristles 35 of the broom head assembly 30 thereby moving debris , dirt , soil , and / or other undesirable substances in a desired direction ; utilizing the broom head assembly 30 being removed therefrom the extending member 25 , as a whisk broom using the handle portion 32 ; using the dustpan assembly 50 either in a stand - alone state or alternately affixed thereto the main handle assembly 20 or the extending member 25 ; adjusting a relative operating angle of said dustpan assembly 50 if desired , using the wing nut 61 ; gathering said debris and dirt by utilizing the dustpan assembly 50 ; replacing the binding 37 and affixed bristles 35 in such an event as when said bristles 35 become worn and require replacement by manually removing the binding portion 37 therefrom the receiver portion 38 thereupon the broom head assembly 30 ; installing new bristle 35 and binding 37 portions by inserting the binding 37 thereinto the receiver portion 38 ; disassembling the cleaning portions of the system 10 after use ; placing the broom head assembly 30 and dustpan assembly 50 portions of the system 10 within the carrying case 70 using the pockets 74 ; securing the main handle assembly 20 and extending member 25 portions therewithin the carrying case 70 using the strap portions 76 ; folding and fastening the two ( 2 ) halves of the carrying case 70 using the snap fasteners 78 ; transporting the system 10 using the carrying case handle 75 . the system 10 is envisioned to be easily transportable in a compact state stored within a carrying case 70 . the carrying case 70 also provides a means to protect the cleaning mechanisms therewithin via straps 76 . once desired for utilization , the system 10 may then be fully assembled with minimal time and effort . the dustpan assembly 50 is designed with a front open portion 55 being tapered thereby allowing the easy collection of debris , soil , dirt , and / or other undesirables . the dustpan assembly 50 may then be attached thereto the extending member 25 or the main handle assembly 20 disposed substantially in a perpendicular or parallel arrangement therewith the extending member 25 or the main handle assembly 20 using adjustable characteristics of the pivoting tube receiver 56 . the foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description . they are not intended to be exhaustive or to limit the invention and method of use to the precise forms disclosed . obviously many modifications and variations are possible in light of the above teaching . the embodiment was chosen and described in order to best explain the principles of the invention and its practical application , and to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated . it is understood that various omissions or substitutions of equivalents are contemplated as circumstance may suggest or render expedient , but is intended to cover the application or implementation without departing from the spirit or scope of the claims of the present invention .

a cleaning system stored within its own storage case having an integrated and collapsible handle , a dustpan , and a broom head specifically designed to sweep under furniture and other obstacles is herein disclosed . when in a broom configuration , a curved handle portion and the bristled broom head allows cleaning beneath objects . the handle can be removed from the broom portion and attached to the dustpan to remove dirt and debris . the broom head , with its own separate angled handle , may also be utilized as a whisk broom to collect the dirt and refuse into the dustpan . all components are stored in a self - contained carrying case . the storage case also has internal fasteners to secure the components of the apparatus securely therewithin .

referring now to fig1 , an exemplary support catheter 10 comprises a catheter body 12 including a proximal region or portion 14 and a distal region or portion 16 . the proximal region 14 may have a variety of configurations , as shown in fig2 a - 2c , but it will always comprise a single open lumen which is free from walls or barriers which define isolated lumens or compartments therein . the distal region 16 , as illustrated in fig3 , will have a cross section which is less than that of the proximal region and will usually comprise a regular or circular inner wall which is free from structure . one or more radiopaque marker bands 39 ( such as platinum , gold , tungsten , and the like ) may be located at or near the distal end of the proximal portion 14 of the catheter body 12 . the marker band ( s ) 39 allows the user to fluoroscopically image the location to which the guidewire or working device must be retracted to in order to clear the distal lumen in order to advance a different guidewire or working device . one or more radiopaque marker bands 40 ( such as platinum , gold , tungsten , and the like ) may also be placed at or near the distal end of the distal portion or region 16 of the catheter body 12 to allow the user to fluoroscopically image the distal end of the catheter to assist positioning the distal end at the target region in the body lumen . the support catheter 10 will typically have a proximal hub 20 which includes one or more luer or other connectors ( described in more detail with reference to fig4 and 5 , below ) for introducing two or more working devices , such as guidewires , therapeutic catheters , imaging catheters , and the like , into the common lumen of proximal region 14 . a distal end of the proximal hub 20 may be attached to a proximal end of the proximal region with adhesive or by insert molding . exemplary working devices 26 and 28 are illustrated in fig2 a - 2c , with a third exemplary working device 30 shown in fig2 c . the working devices 26 , 28 , and 30 , may , as described previously , be any elongate body or element which is desired to be introduced to a target location within the vasculature or other body lumen . typically , for vascular applications , the working devices will be guidewires , imaging catheters , therapeutic catheters , and in the exemplary embodiments illustrated below , a drilling wire for crossing a total chronic occlusion . after entering through the hub 20 , the working devices 26 and 28 will be received within the lumen of the proximal region 14 . the lumen of the proximal region 14 may be free from structure , as shown in fig2 a , which will be adequate for many devices which have little propensity to tangle or constrict one another . in many instances , however , it will be desirable to provide structure on the inner luminal wall of the proximal region 14 to align the working devices 26 and 28 and to inhibit the risk of tangling and interference . for example , as shown in fig2 b , axial ridges 34 and 36 may be formed along the inner luminal wall , typically opposed at 180 . degree ., in order to partially confine the working devices 26 and 28 within upper and lower regions of the lumen . it would also be possible to provide a third axial ridge 38 or more , as illustrated in fig2 c . since only one working device at a time will be introduced into the distal region , it will usually be unnecessary to provide any surface features or other elements along the inner rim of the walls of the distal region . the hub 20 and the proximal end of proximal portion 14 may be configured to facilitate the transition of multiple working devices into the single open lumen , often being tapered . the hub 20 may also have one , two , or more separate luer or other connectors for simultaneously receiving the multiple working devices . as illustrated in fig4 , the hub 20 includes only a single luer connector 22 which can receive two or more working devices . the proximal end of the proximal region 14 of the catheter body has a taper or counter sink 21 in the inner diameter . the taper 21 allows the multiple working devices to self - align between the ridges ( when present ). referring now to fig5 , an alternative hub 23 hub includes two ports 25 ( such as luer connectors ) for separately introducing working devices , such as guidewires , therapeutic catheters , imaging catheters , and the like , into the common lumen of proximal region 14 . alternatively , one port 25 may be used for introducing two or more working devices and the second port 25 may be used for flushing the catheter lumen with saline or injecting contrast into the lumen without having to remove the working devices . a taper or counter sink 27 is provided to assist in alignment as described above . referring now to fig6 a - 6h , a method utilizing the support catheter 10 of the present invention for introducing a conventional guidewire and drilling wire to cross a total chronic occlusion in the vasculature will be described . as shown in fig6 a , a conventional guidewire gw is introduced through the lumen of a blood vessel bv to a proximal side of a chronic total occlusion cto . the support catheter 10 is then introduced over the guidewire so that the distal region 16 approaches the proximal side of the chronic total occlusion cto , as shown in fig6 b . the proximal portion of the guidewire gw will pass through the single lumen of the proximal region 14 of the support catheter and externally through the hub 20 ( fig1 ). after the support catheter 10 has been properly positioned proximate the chronic total occlusion cto , as shown in fig6 c , a cutting guidewire cw may be introduced through the other hub 20 ( fig1 ) and advanced through the single lumen of the proximal portion 14 . after the cutting wire cw is positioned just proximally of the distal region 16 , as shown in fig6 c , the guidewire may be withdrawn proximally and stowed in the lumen of the proximal portion 14 , as shown in fig6 d , while the cutting wire cw is advanced distally through the distal portion 16 to engage a proximal surface of the chronic total occlusion cto . the cutting wire may then be activated , as shown in the co - pending applications previously incorporated herein by reference , and advanced through the chronic total occlusion cto , as shown in fig6 e , until the cutting wire fully penetrates the occlusion , as shown in fig6 f . after the passage p has been formed in the chronic total occlusion cto , the support catheter 10 may be advanced distal to the chronic total occlusion cto , and the cutting wire cw may be withdrawn as shown in fig6 g . the guidewire gw can then be advanced from the proximal portion 14 through the distal portion 16 and exit distal to the chronic total occlusion cto , as shown in fig6 h . by then withdrawing the support catheter 10 , as shown in fig6 i , the guidewire is in place through the chronic total occlusion chronic total occlusion cto allowing for the introduction of additional therapeutic catheters , such as angioplasty catheters , atherectomy catheters , stent placement catheters , drug delivery catheters , and the like . alternatively , the cutting wire may be proximally retracted and optionally withdrawn from the support catheter . the guidewire gw may then be advanced from the proximal portion 14 , through the distal portion 16 , and ultimately through the passage p , allowing the support catheter to be withdrawn leaving the guidewire in place across the chronic total occlusion cto , as shown in fig6 i . while the above is a complete description of the preferred embodiments of the invention , various alternatives , modifications , and equivalents may be used . therefore , the above description should not be taken as limiting the scope of the invention which is defined by the appended claims .

a support catheter for stowing and exchanging guidewires and other working elements comprises a catheter body having a proximal region and a distal region . a single , contiguous lumen is formed from the proximal region through the distal region and has a larger proximal cross - sectional area than distal cross - sectional area .

the dirt container of the instant invention maybe used with an upright vacuum cleaner , a canister vacuum cleaner , a stick vacuum cleaner , a central vacuum cleaner , a carpet extractor or other surface cleaning apparatus of any configuration . as shown in fig1 , surface cleaning apparatus 10 comprises a surface cleaning head 12 and handle 14 pivotally mounted thereto . surface cleaning apparatus 10 has rear wheels 16 and may optionally have front wheels ( not shown ) if desired . surface cleaning head 12 has a front end 18 and a rear end 20 . the dirt container 28 collects particulate matter that enters surface cleaning head 12 . accordingly , dirt container 28 is removable from surface cleaning apparatus 10 for emptying or disposal . dirt container 28 may be removably mounted on or in surface cleaning apparatus 10 by any means known in the surface cleaning art . in the preferred embodiment of fig1 , a top cover 22 is provided . top cover 22 is removably upwardly , e . g ., by means of handle 24 , so as to reveal recess 26 ( see fig5 ). dirt container 28 is removably receivable in recess 26 and may be removably mounted on the lower surface of top cover 22 ( see fig6 and 7 ). as shown in fig2 and 3 , surface cleaning head 12 may be provided with a brush 30 which is rotatably driven by brush motor 32 via drive belt 34 . brush 30 sweeps particulate matter up ramp 36 into settling chamber 38 of dirt container 28 . to this end , surface cleaning head 12 is provided with inlet 40 adjacent brush 30 . surface cleaning head 12 is also provided with a second inlet 42 which is in fluid flow communication with cyclone chamber 44 via inlet passage 46 and cyclone inlet 48 . accordingly , dirt container 28 comprises settling chamber 38 and cyclone chamber 44 . further , each of settling chamber 38 and cyclone chamber 44 are provided with a separate inlet . inlet 42 for the lighter dirt is positioned rearward ( in the normal direction of travel of surface cleaning head 12 ) from the first inlet 40 . in this construction , cyclone chamber 44 is not in fluid flow communication with settling chamber 38 . accordingly , in operation , heavier or larger particulate matter is swept up by brush 30 and deposited in settling chamber 38 . lighter and finer particulate matter is entrained in an air stream entering second inlet 42 and is separated from the dirty air via the cyclonic action in cyclone chamber 44 . optionally , it will be appreciated that some bleed air may be drawn from settling chamber 38 into cyclone chamber 44 . cyclone chamber 44 is provided with an outlet 50 which is in fluid flow communication with motor and fan blade assembly 52 via passage 54 . an optional air filter 56 may be provided downstream from motor and fan blade assembly 52 so as to further filter the air prior to the air being exhausted from surface cleaning apparatus 10 . in the alternate embodiment shown in fig4 , surface cleaning apparatus 10 comprises a vacuum cleaner . in this particular embodiment , the dirt container 38 in surface cleaning head 12 comprises a single settling chamber 38 . second inlet 42 is upstream from cyclone chamber 44 which is mounted on handle 14 . as dirt is conveyed through second inlet 42 due to air flow therethrouh , it will be appreciated that the filtration means for treating the dirty air entering through inlet 42 need not be located in the cleaning head 12 . in this particular embodiment , vacuum cleaner 10 is designed as a clean air system and , accordingly , motor and fan blade assembly 52 is positioned downstream from cyclone 44 . it will be appreciated that motor and fan blade assembly 52 may be positioned upstream from the cyclone 44 as is known in dirty air systems . accordingly , the embodiment of the vacuum cleaner shown in fig4 utilizes two separate dirt containers 28 , each of which is may removed by the user for emptying or disposal . as shown in fig5 and 6 , dirt container 28 of fig2 and 3 is vertically removable from recess 26 of surface cleaning apparatus 10 . alternately , dirt container 28 may be inserted into surface cleaning head 12 such as by sliding dirt container 28 laterally through an opening provided in a sidewall surface cleaning head 12 . in order to assist the removal of dirt container 28 from surface cleaning apparatus 10 , a handle may be provided on dirt container 28 . alternately , as shown in fig5 , dirt container 38 may be removably received in a cover 22 which is provided with a handle 24 . in accordance such an embodiment , dirt container 28 may be removably mounted to cover 22 of recess . cover 22 may be of any particular construction which will permit dirt container 28 to be a removably fixed thereto . dirt container 28 may be removably affixed thereto by any mechanical or adhesive means known in the mechanical or chemical arts . as shown in fig6 and 7 , cover 22 is provided with sidewalls 58 having flanges 60 . lower surface 62 of cover 22 is preferable also provided with a support member 64 having a curved engagement surface 66 . dirt container 28 is provided with forward and rearward flanges 68 . accordingly , as shown in fig6 , dirt container 28 may be slidably received in cover 22 . as shown in fig7 , cyclone 44 of dirt container 28 may abut against curved engagement surface 66 of support member 64 . dirt container 28 is held in position in cover 22 by means of the engagement between flanges 60 and 66 ( see fig7 ). it will be appreciated by those skilled in the art that various modifications and variations of the dirt container and its method of use may be utilized and each of those is within the scope of the following claims . in particular , it will be appreciated that the shape , size , configuration , the type and number of filtration members included in the dirt container , as well as the number of dirt containers which are utilized in a single surface cleaning apparatus may be varied . in addition , while the dirt container may be transparent , it will also be appreciated that the exterior walls of the dirt container may be translucent or opaque .

a cleaning head for a surface cleaning apparatus comprises a housing having a surface contacting surface , a first inlet provided in the surface contacting surface and in communication with a first treatment stage and a second inlet spaced from the first inlet and provided in the surface contacting surface and , in use , in communication with a second treatment stage and a source of suction .

where each of x and x ′ are individually nitrogen , n — o or carbon bonded to a substituent species characterized as having a sigma m value greater than 0 , often greater than 0 . 1 , and generally greater than 0 . 2 , and even greater than 0 . 3 ; less than 0 and generally less than − 0 . 1 ; or 0 ; as determined in accordance with hansch et al ., chem . rev . 91 : 165 ( 1991 ); and m is an integer and n is an integer such that the sum of m plus n is 1 , 2 , 3 , 4 , 5 , 6 , 7 , or 8 , preferably is 1 , 2 , or 3 , and more preferably is 2 or 3 , and most preferably 3 . b ′ is oxygen or sulfur , but most preferably is oxygen . z ′ and z ″ individually represent hydrogen or lower alkyl ( e . g ., straight chain or branched alkyl including c 1 - c 8 , preferably c 1 - c 5 , such as methyl , ethyl , or isopropyl ), z ′ and z ″ individually represent hydrogen , alkyl ( e . g ., straight chain or branched alkyl including c 1 - c 8 , preferably c 1 - c 5 , such as methyl , ethyl , or isopropyl ), substituted alkyl , acyl , alkoxycarbonyl , or aryloxycarbonyl ; and preferably at least one of z ′ and z ″ is hydrogen or both of z ′ and z ″ are hydrogen , and most preferably z ′ is hydrogen and z ″ is methyl . alternatively , z ′ is hydrogen and z ″ represents a ring structure ( cycloalkyl , heterocyclyl or aryl ), such as cyclopropyl , cyclobutyl , cyclopentyl , cyclohexyl , cycloheptyl , adamantyl , quinuclidinyl , pyridinyl , quinolinyl , pyrimidinyl , phenyl , benzyl , thiazolyl or oxazolyl ( where any of the foregoing can be suitably substituted with at least one substituent group , such as alkyl , alkoxyl , halo , or amino substituents ); alternatively z ′ is hydrogen and z ″ is propargyl ; alternatively z ′, z ″, and the associated nitrogen atom can form a ring structure such as aziridinyl , azetidinyl , pyrrolidinyl , piperidinyl , morpholinyl , 2 - imino - 2 , 3 - dihydrothiazolyl or 2 - imino - 2 , 3 - dihydrooxazolyl , and in certain situations , piperazinyl ( e . g ., piperazine ); z ′ and e ′″ ( when n is 1 ) and the associated carbon and nitrogen atoms can combine to form a monocyclic ring structure such as azetidinyl , pyrrolidinyl , piperidinyl , piperazinyl , or a bicyclic ring structure such as 3 -( 2 - azabicyclo [ 4 . 2 . 0 ] octyl ), 3 -( 2 - azabicyclo [ 2 . 2 . 2 ] octyl ), or 3 -( 2 - azabicyclo [ 2 . 2 . 1 ] heptyl ); however it is preferred that when z ′ and e ′″ and the associated carbon and nitrogen atoms combine to form such a ring , neither e ″ nor e ′ are substituted or unsubstituted aryl , heteroaryl , benzhydryl or benzyl ; z ′, z ″ and e ″ ( when n is 1 ) and the associated carbon and nitrogen atoms can combine to form a bicyclic ring structure such as quinuclidinyl , 2 -( 1 - azabicyclo [ 2 . 2 . 1 ]- heptyl ), or 2 -( 1 - azabicyclo [ 3 . 3 . 0 ] octyl ), or a tricyclic ring structure such as azaadamantyl ; z ′, e ″ and e ′″ n is 1 ) and the associated carbon and nitrogen atoms can combine to form a bicyclic ring structure such as 1 -( 2 - azabicyclo [ 2 . 2 . 1 ] heptyl ); and z ′, z ″, e ″ and e ′″ ( when n is 1 ) and the associated carbon and nitrogen atoms can combine to form a tricyclic ring structure . e , e ′, e ″ and e ′″ individually represent hydrogen or a suitable non - hydrogen substituent ( e . g ., alkyl , substituted alkyl , halo substituted alkyl , cycloalkyl , substituted cycloalkyl , heterocyclyl , substituted heterocyclyl , aryl , substituted aryl , alkylaryl , substituted alkylaryl , arylalkyl or substituted arylalkyl ), preferably lower alkyl ( e . g ., straight chain or branched alkyl including c 1 - c 8 , preferably c 1 - c 5 , such as methyl , ethyl , or isopropyl ) or halo substituted lower alkyl ( e . g ., straight chain or branched alkyl including c 1 - c 8 , preferably c 1 - c 5 , such as trifluoromethyl or trichloromethyl ). generally all of e , e ′, e ″ and e ′″ are hydrogen , or at least one of e , e ′, e ″ and e ′″ is non - hydrogen and the remaining e , e ′, e ″ and e ′″ are hydrogen . in addition , e and e ′ or e ″ and e ′″ and their associated carbon atom can combine to form a ring structure such as cyclopentyl , cyclohexyl or cycloheptyl ; or e ′″ and e ′ ( when located on immediately adjacent carbon atoms ) and their associated carbon atoms can combine to form a ring structure such as cyclopentyl , cyclohexyl or cycloheptyl . depending upon the selection of e , e ′, e ″ and e ′″, compounds of the present invention have chiral centers , and the present invention relates to racemic mixtures of such compounds as well as enamiomeric compounds . for certain compounds , x is nitrogen ; for other compounds x ′ is nitrogen or n — o ; and for other compounds x and x ′ both are nitrogen . most preferably , x ′ is nitrogen . adjacent substituents of a , a ′ or a ″ ( when x or x ′ are carbon bonded to a substituent component ) can combine to form one or more saturated or unsaturated , substituted or unsubstituted carbocyclic or heterocyclic rings containing , but not limited to , ether , acetal , ketal , amine , ketone , lactone , lactam , carbamate , or urea functionalities . for certain preferred compounds x ′ is c — nr ′ r ″, c — or ′ or c — no 2 , more preferably c — nh 2 , c — nhch 2 or c — n ( ch 3 ) 2 , with c — nh 2 being most preferred . in addition , when x is carbon bonded to a substituent species , it is preferred that the substituent species is h , br or or ′, where r ′ preferably is benzyl , methyl , ethyl , isopropyl , isobutyl or tertiary butyl . a , a ′, a ″ and the substituents of either x or x ′ ( when each respective x and x ′ is carbon ) can include h , alkyl , substituted alkyl , alkenyl , substituted alkenyl , heterocyclyl , substituted heterocyclyl , cycloalkyl , substituted cycloalkyl , aryl , substituted aryl , alkylaryl , substituted alkylaryl , arylalkyl and substituted arylalkyl functionalities . more specifically , x and x ′ include n , n — o , c — h , c — f , c — cl , c — br , c — l , c — r ′, c — nr ′ r ″, c — cf 3 , c — oh , c — cn , c — no 2 , c — c 2 r ′, c — sh , c — sch 3 , c — n 3 , c — so 2 ch 3 , c — or ′, c — sr ′, c — c (═ o ) nr ′ r ″, c — nr ′ c (═ o ) r ′, c — c (═ o ) r ′, c — c (═ o ) or ′, c ( ch 2 ) q or ′, c — oc (═ o ) r ′, coc (═ o ) nr ′ r ″ and c — nr ′ c (═ o ) or ′ where r ′ and r ″ are individually hydrogen or lower alkyl ( e . g ., c 1 - c 10 alkyl , preferably c 1 - c 5 alkyl , and more preferably methyl , ethyl , isopropyl or isobutyl ), an aromatic group - containing species or a substituted aromatic group - containing species , and q is an integer from 1 to 6 . r ′ and r ″ can be straight chain or branched alkyl , or r ′ and r ″ can form a cycloalkyl funtionality ( e . g ., cyclopropyl cyclobutyl , cyclopentyl , cyclohexyl , cycloheptyl , adamantyl , and quinuclidinyl ). representative aromatic group - containing species include pyridinyl , quinolinyl , pyrimidinyl , phenyl , and benzyl ( where any of the foregoing can be suitably substituted with at least one substituent group , such as alkyl , halo , or amino substituents ). other representative aromatic ring systems are set forth in gibson et al ., j . med . chem . 39 : 4065 ( 1996 ). when x and x ′ represent a carbon atom bonded to a substituent species , that substituent species often has a sigma m value which is between about − 0 . 3 and about 0 . 75 , and frequently between about − 0 . 25 and about 0 . 6 . in certain circumstances the substituent species is characterized as having a sigma m value not equal to 0 . a , a ′ and a ″ individually represent those species described as substituent species to the aromatic carbon atom previously described for x and x ′; and usually include hydrogen , halo ( e . g ., f , cl , br , or i ), alkyl ( e . g ., lower straight chain or branched c 1 - 8 alkyl , but preferably methyl or ethyl ), or nx ″ x ′″ where x ″ and x ′″ are individually hydrogen or lower alkyl , including c 1 - c 8 , preferably c 1 - c 5 alkyl . in addition , it is highly preferred that a is hydrogen , it is preferred that a ′ is hydrogen , and normally a ″ is hydrogen . generally , both a and a ′ are hydrogen ; sometimes a and a ′ are hydrogen , and a ″ is amino , methyl or ethyl ; and often a , a ′ and a ″ are all hydrogen . depending upon the identity and positioning of each individual e , e , e ″ and e ′″, certain compounds can be optically active . typically , the selection of e , e ′, e ″ and e ′″ is such that up to about 4 , and frequently up to 3 , and usually 0 , 1 or 2 , of the substituents designated as e , e ′, e ″ and e ′″ are non - hydrogen substituents ( i . e ., substituents such as lower alkyl or halo - substituted lower alkyl ). typically , x is ch , cbr or cor . most preferably , x ′ is nitrogen . as employed herein , “ alkyl ” refers to straight chain or branched alkyl radicals including c 1 - c 8 , preferably c 1 - c 5 , such as methyl , ethyl , or isopropyl ; “ substituted alkyl ” refers to alkyl radicals further bearing one or more substituent groups such as hydroxy , alkoxy , mercapto , aryl , heterocyclo , halo , amino , carboxyl , carbamyl , cyano , and the like ; “ alkenyl ” refers to straight chain or branched hydrocarbon radicals including c 1 - c 8 , preferably c 1 - c 5 and having at least one carbon - carbon double bond ; “ substituted alkenyl ” refers to alkenyl radicals further bearing one or more substituent groups as defined above ; “ cycloalkyl ” refers to saturated or unsaturated cyclic ring - containing radicals containing three to eight carbon atoms , preferably three to six carbon atoms ; “ substituted cycloalkyl ” refers to cycloalkyl radicals further bearing one or more substituent groups as defined above ; “ aryl ” refers to aromatic radicals having six to ten carbon atoms ; “ substituted aryl ” refers to aryl radicals further bearing one or more substituent groups as defined above ; “ alkylaryl ” refers to alkyl - substituted aryl radicals ; “ substituted alkylaryl ” refers to alkylaryl radicals further bearing one or more substituent groups as defined above ; “ arylalkyl ” refers to aryl - substituted alkyl radicals ; “ substituted arylalkyl ” refers to arylalkyl radicals further bearing one or more substituent groups as defined above ; “ heterocyclyl ” refers to saturated or unsaturated cyclic radicals containing one or more heteroatoms ( e . g ., o , n , s ) as part of the ring structure and having two to seven carbon atoms in the ring ; “ substituted heterocyclyl ” refers to heterocyclyl radicals further bearing one or more substituent groups as defined above ; “ acyl ” refers to straight chain or branched alkyl - or substituted alkyl - carbonyl radicals including c 1 - c 8 , preferably c 1 - c 5 , such as formyl , acetyl , or propanoyl ; “ alkoxycarbonyl ” refers to an alkyl or substituted alkyl radical attached to an o - carbonyl moiety ; and “ aryloxycarbonyl ” refers to an aryl or substituted aryl radical attached to an o - carbonyl moiety . one representative compound is ( 3 -( 3 - pyridyloxy ) propyl ) amine , for which x is ch , x ′ is n , b ′ is o , n is 0 , m is 3 , and a , a ′, a ″, e , e ′, z ′ and z ″ are each h . one representative compound is ( 3 -( 5 - bromo -( 3 - pyridyloxy ) propyl )- methylamine , for which x is c — br , x ′ is n , b ′ is o , n is 0 , m is 3 , a , a ′, a ″, e , e ′ and z ′ are each h , and z ″ is methyl . one representative compound is ( 1 - methyl - 3 -( 3 - pyridyloxy ) propyl ) methylamine , for which x is ch , x ′ is n , b ′ is o , n is 1 , m is 2 , a , a ′, a ″, e , e ′, e ″ and z ′ are each h , and e ′″ and z ″ are methyl . one representative compound is ( 3 -( 5 - ethoxy -( 3 - pyridyloxy ) propyl ) methylamine , for which x is c — och 2 ch 3 , x ′ is n , b ′ is o , n is 0 , m is 3 , a , a ′, a ″, e , e ′ and z ′ are each h , and z ″ is methyl . one representative compound is ( 3 -( 6 - methyl -( 3 - pyridyloxy ) propyl )- methylamine , for which x is ch , x ′ is n , b ′ is o , n is 0 , m is 3 , a , a ′, e , e ′ and z ′ are each h , and a ″ and z ″ each are methyl . one representative compound is ( 3 -( 5 - chloro -( 3 - pyridyloxy ) propyl ) methylamine , for which x is c — cl , x ′ is n , b ′ is o , n is 0 , m is 3 , a , a ′, a ″, e , e ′ and z ′ are each h , and z ″ is methyl . one representative compound is ( 3 -( 2 - bromo ( 3 - pyridyloxy ) propyl )- methylamine , for which x is ch , x ′ is n , b ′ is o , n is 0 , m is 3 , a is br , a ′, a ″, e , e ′ and z ′ are each h , and z ″ is methyl . one representative compound is ( 1 - methyl - 3 -( 5 - methoxy -( 3 - pyridyloxy ) propyl )) methylamine , for which x is c — och 3 , x ′ is n , b ′ is o , n is 1 , m is 2 , a , a ′, a ″, e , e ′, e ″ and z ′ are each h , and e ′″ and z ″ are each methyl . one representative compound is ( 4 -( 3 - pyridyloxy ) butyl )) methylamine , for which x is ch , x ′ is n , b ′ is o , n is 0 , m is 4 , a , a ′, a ″, e , e ′, and z ′ are each h , and z ″ is methyl . one representative example is ( 3 - phenoxypropyl ) methylamine , for which x and x ′ are each ch , b ′ is o , n is 0 , m is 3 , a , a ′, a ″, e , e ′ and z ′ are each h , and z ″ is methyl . one representative example is ( 3 -( 3 - aminophenoxy ) propyl ) methylamine , for which x is ch , x ′ is c — n h 2 , b ′ is o , n is 0 , m is 3 , a , a ′, a ″, e , e ′ and z ′ are each h , and z ″ is methyl . one representative example is ( 3 -( 4 - methoxyphenoxy ) propyl )- methylamine , for which x and x ′ are each ch , b ′ is o , n is 0 , m is 3 , a , a ′, e , e ′ and z ′ are each h , a ″ is och 3 , and z ″ is methyl . exemplary other compounds that can be made in accordance with the present invention include ( 2 -( 5 - bromo ( 3 - pyridylthio )) ethyl ) methylamine , ( 2 -( 5 - bromo ( 3 - pyridylthio )) isopropyl ) methylamine , ( 2 -( 5 - bromo ( 3 - pyridylthio ))- propyl ) methylamine and ( 3 -( 5 - bromo ( 3 - pyridylthio )) propyl )- methylamine , dimethyl ( 2 -( 3 - pyridyloxy ) ethylamine , dimethyl ( 4 -( 3 - pyridyloxy ) butyl ) amine , 2 -( 3 - pyridyloxy ) ethylamine , 4 -( 3 - pyridyloxy )- butylamine , methyl ( 3 -( 5 - methoxy - 3 - pyridyloxy ) propyl ) amine , ethyl ( 3 -( 3 - pyridyloxy ) propyl ) amine , methyl ( 2 -( 3 - pyridyloxy ) ethyl ) amine , methyl ( 3 -( 6 - methyl ( 3 - pyridyloxy )) propyl ) amine , ( 3 -( 3 - methoxyphenoxy ) propyl )- methylamine , ( 3 -( 5 - chloro ( 3 - pyridyloxy ))- 1 - methylpropyl ) methylamine , dimethyl ( 3 -( 3 - pyridyloxy ) propyl ) amine , 3 -( 3 - pyridyloxy ) propylamine , methyl ( 4 -( 3 - pyridyloxy ) butyl ) amine , 3 -( 5 - chloro - 3 - pyridyloxy ) propylamine , methyl ( 3 -( 5 - isopropoxy - 3 - pyridyl oxy ) propyl ) amine , ( 3 -( 5 - chloro ( 3 - pyridyloxy )) propyl ) methylamine , methyl ( 3 -( 5 -( phenyl methoxy ) ( 3 - pyridyloxy )) propyl ) amine , methyl ( 3 -( 2 - methyl ( 3 - pyridyloxy )) propyl ) amine ,( methylethyl )( 3 -( 3 - pyridyloxy ) propyl ) amine , benzyl ( 3 -( 3 - pyridyloxy ) propyl )- amine , cyclopropyl ( 3 -( 3 - pyridyloxy ) propyl ) amine , methyl ( 1 - methyl - 3 -( 3 - pyridyloxy ) propyl ) amine , methyl ( 3 -( 3 - nitrophenoxy ) propyl ) amine , 1 -( 3 - chloropropoxy )- 3 - nitrobenzene , ( 3 -( 3 - aminophenoxy ) propyl ) methylamine , dimethyl ( 3 -( 3 -( methylamino ) propoxy ) phenyl ) amine , methyl ( 3 - tricyclo [ 7 . 3 . 1 . 0 & lt ; 5 , 13 & gt ;] tridec - 2 - yloxypropyl ) amine , ( 3 - benzo [ 3 , 4 - d ] 1 , 3 - dioxolan - 5 - yloxypropyl ) methylamine , 3 -( 4 - piperidinyloxy ) pyridine , 3 -(( 3s )- 3 - pyrrolidinyloxy ) pyridine , methyl ( 3 -( 5 -( 3 , 4 - dimethoxybenzyloxy )( 3 - pyridyloxy )) propyl ) methylamine , methyl ( 3 -( 3 - quinolyloxy ) propyl ) amine , 3 -( 5 - bromo - 3 - pyridylthio )) propyl ) methylamine and 3 -(( 3s )-( 1 - methyl - 3 - pyrrolidinyloxy ) pyridin . the manner in which certain phenoxyalkylamine compounds of the present invention are provided can vary . certain phenoxyalkylamine compounds can be prepared by the alkylation of phenol with a 1 , 3 - dihalopropane , such as 1 , 3 - dichloropropane , 1 , 3 - dibromopropane , 1 , 3 - diiodopropane , or 1 - chloro - 3 - iodopropane , which are commercially available from aldrich chemical company , in the presence of a base ( e . g ., sodium hydride ) in dry n , n - dimethylformamide . the resulting 3 - halo - 1 - phenoxypropane can be converted to a phenoxyalkylamine , such as methyl ( 3 - phenoxypropyl ) amine , by treatment with methylamine in a solvent , such as tetrahydrofuran or aqueous methanol . the manner in which certain 3 - substituted - phenyl analogs of ( 3 - phenoxypropyl ) methylamine of the present invention can be synthetically prepared is analogous to that described for the preparation of methyl ( 3 - phenoxypropyl ) amine with the exception that 3 - substituted - phenols are employed rather than phenol . in some instances , protecting groups may be employed when necessary . for example , one representative compound , ( 3 -( 3 - aminophenoxy ) propyl ) methylamine can be prepared by the alkylation of an n - phthalamido - protected phenol , 2 -( 3 - hydroxyphenyl ) isoindoline - 1 , 3 - dione ( prepared by treatment of 3 - aminophenol with phthalic anhydride ) with 1 - chloro - 3 - iodopropane . the resulting intermediate , 2 -( 3 -( 3 - chloropropoxy )- phenyl ) isoindoline - 1 , 3 - dione can be converted to ( 3 -( 3 - aminophenoxy )- propyl ) methylamine by treatment with methanolic methylamine . the manner in which certain 4 - substituted - phenyl analogs of methyl ( 3 - phenoxypropyl ) amine of the present invention can be synthetically prepared is analogous to that described for the preparation of methyl ( 3 - phenoxypropyl ) amine with the exception that 4 - substituted - phenols are employed rather than phenol . for example , 4 - methoxyphenol can be converted to ( 3 -( 4 - methoxyphenoxy ) propyl )- methylamine . the manner by which pyridyloxyalkylamine compounds of the present invention are provided can vary . certain pyridyloxyalkylamine compounds can be prepared by the alkylation of 3 - hydroxypyridine with a 1 , 3 - dihalopropane , such as 1 , 3 - dichloropropane , 1 , 3 - dibromopropane , 1 , 3 - diodopropane or 1 - chloro - 3 - iodopropane , which are commercially available from aldrich chemical company , in the presence of a base ( e . g ., sodium hydride ) in dry n , n - dimethylformamide . the resulting 3 - halo - 1 -( 3 - pyridyloxy ) propane can be converted to a pyridyloxyalkylamine , such as ( 3 -( 3 - pyridyloxy ) propyl )- methylamine , by treatment with methylamine in a solvent , such as tetrahydrofuran or aqueous methanol . one representative compound , ( 3 -( 3 - pyridyloxy ) propyl ) methylamine is prepared by the reaction of 3 - hydroxypyridine with 1 . 2 molar equivalents of 1 - chloro - 3 - iodopropane and 1 . 6 molar equivalents of sodium hydride in dry n , n - dimethylformamide at ambient temperature . the resulting intermediate , 3 - chloro - 1 -( 3 - pyridyloxy ) propane , obtained in about 54 % yield , is converted to ( 3 -( 3 - pyridyloxy ) propyl ) methylamine in about 40 % yield , by treatment with an excess ( 25 molar equivalents ) of aqueous methylamine in methanol , assisted by heating . certain pyridyloxyalkylamine compounds , such as ( 4 -( 3 - pyridyloxy )- butyl ) methylamine , can be prepared by alkylating 3 - hydoxypyridine with a 1 , 4 - dihalobutane , such as 1 , 4 - diiodobutane , 1 , 4 - dibromobutane , 1 , 4 - dichlorobutane or 1 - chloro - 4 - iodobutane , which are commercially available from aldrich chemical company , in the presence of a base ( e . g ., sodium hydride ) in n , n - dimethylformamide . the resulting 4 - halo - 1 -( 3 - pyridyloxy ) butane can be converted to a pyridyloxyalkylamine , such as ( 4 -( 3 - pyridyloxy ) butyl ) methylamine , by treatment with methylamine in a solvent , such as tetrahydrofuran or aqueous methanol . the manner by which certain 2 - substituted - 3 - pyridyl analogs of ( 3 -( 3 - pyridyloxy ) propyl ) methylamine and certain 6 - substituted - 3 - pyridyl analogs of ( 3 -( 3 - pyridyloxy ) propyl ) methylamine of the present invention can be synthetically prepared is analogous to that described for the preparation of ( 3 -( 3 - pyridyloxy )- propyl ) methylamine with the exception that 2 - substituted - 3 - hydroxypyridines and 6 - substituted - 3 - hydroxypyridines are employed rather than 3 - hydroxypyridine . for example , using such methodology , commercially available 2 - bromo - 3 - hydroxypyridine and 3 - hydroxy - 2 - nitropyridine can be converted to 3 -( 2 - bromo ( 3 - pyridyloxy )) propyl )- methylamine and 3 -( 2 - nitro ( 3 - pyridyloxy ))- propyl ) methylamine , respectively . similarly , commercially available 3 - hydroxy - 6 - methylpyridine can be converted to 3 -( 6 - methyl ( 3 - pyridyloxy )) propyl )- methylamine . the manner by which certain 5 - substituted - 3 - pyridyl analogs of ( 3 -( 3 - pyridyloxy ) propyl ) methylamine of the present invention can be synthesized is analogous to that described for ( 3 -( 3 - pyridyloxy ) propyl ) methylamine , with the exception that 5 - substituted - 3 - hydroxypyridines are employed rather than 3 - hydroxypyridine . for example , using such a methodology , 5 - bromo - 3 - hydroxypyridine can be converted to the intermediate , 3 - chloro - 1 -( 5 - bromo - 3 - pyridyloxy ) propane , which is converted to 3 -( 5 - bromo ( 3 - pyridyloxy ))- propyl ) methylamine . 5 - bromo - 3 - hydroxypyridine can be prepared form 2 - furfurylamine using the procedure described in u . s . pat . no . 4 , 192 , 946 to clauson - kaas et al . the disclosure of which is incorporated herein by reference in its entirety . in a similar manner , 5 - chloro - 3 - hydroxypyridine , which is commercially available from aldrich chemical company , can be converted to 3 -( 5 - chloro ( 3 - pyridyloxy )) propyl ) methylamine . similarly , 5 - methoxy - 3 - hydroxypyridine , prepared according to the procedures set forth in chen et al ., heterocycles 24 ( 12 ): 3411 ( 1986 ), can be converted to 3 -( 5 - methoxy ( 3 - pyridyloxy )) propyl ) methylamine . similarly , 5 - ethoxy - 3 - hydroxypyridine can be converted to 3 -( 5 - ethoxy ( 3 - pyridyloxy )) propyl )- methylamine . similarly , 5 - amino - 3 - hydroxypyridine , prepared according to the procedures set forth in tamura et al ., heterocycles 15 ( 2 ): 871 ( 1981 ), can be converted to 3 -( 5 - amino ( 3 - pyridyloxy )) propyl ) methylamine . in a similar manner , 3 - hydroxy - 5 - trifluoromethylpyridine and 2 - fluoro - 5 - hydroxy - 3 - methylpyridine , each prepared using methods set forth in pct wo 96 / 40682 , can be converted to 3 -( 5 - trifluoromethyl ( 3 - pyridyloxy )) propyl ) methyl amine and 3 -( 6 - fluoro - 5 - methyl ( 3 - pyridyloxy )) propyl ) methylamine , respectively . a number of 5 - substituted analogs , such as ( 3 -( 5 - substituted ( 3 - pyridyloxy )) propyl ) methylamine , can be synthesized from 5 - substituted 3 - hydroxypyridines , which can be prepared from 5 - amino - 3 - hydroxypyridine via a diazonium salt intermediate . for example , 5 - amino - 3 - hydroxypyridine can be converted to 5 - fluoro - 3 - hydroxypyridine , 5 - chloro - 3 - hydroxypyridine , 5 - bromo - 3 - hydroxypyridine , 5 - iodo - 3 - hydroxypyridine or 5 - cyano - 3 - hydroxypyridine , using the general techniques set forth in zwart et al ., recueil trav . chim . pays - bas 74 : 1062 ( 1955 ). furthermore , 5 - hydroxy - substituted analogs can be prepared from the reaction of the corresponding 5 - diazonium salt intermediate with water . the 5 - fluoro - substituted analogs can be prepared from the reaction of the 5 - diazonium salt intermediate with fluoroboric acid . 5 - chloro - substituted analogs can be prepared from the reaction of 5 - amino - 3 - hydroxypyridine with sodium nitrite and hydrochloric acid in the presence of copper chloride . the 5 - cyano - substituted analogs can be prepared from the reaction of the corresponding diazonium salt intermediate with potassium copper cyanide . the 5 - amino - substituted analogs can be converted to the corresponding 5 - nitro analogs by reaction with fuming sulfuric acid and peroxide according to the general techniques described in morisawa , j . med . chem . 20 : 129 ( 1977 ), for converting an amino pyridine to a nitropyridine . certain pyridyloxyalklylamines that possess a branched side chain , such as ( 1 - methyl - 3 -( 3 - pyridyloxy ) propyl ) methylamine , can be prepared by alkylating 3 - hydroxypyridine with a protected 3 - hydroxy - 1 - halobutane , such as 3 -[( tert - butyl ) dimethylsilyloxy ]- 1 - bromobutane ( prepared according to the procedures set forth in gerlach et al ., helv . chim . acta . 60 ( 8 ): 2860 ( 1977 )), thereby producing a ( tert - butyl ) dimethylsilyl protected 4 -( 3 - pyridyloxy ) butan - 2 - ol . the ( tert - butyl ) dimethylsilyl group can be removed by treatment with ammonium fluoride or aqueous acetic acid to give 4 -( 3 - pyridyloxy ) butan - 2 - ol . mesylation or tosylation of that compound with methanesulfonyl chloride in triethylamine or p - toluenesulfonyl chloride in pyridine , followed by treatment with methylamine in tetrahydrofuran or aqueous methanol , provides a compound having a methyl branched side chain ( e . g ., ( 1 - methyl - 3 -( 3 - pyridyloxy ) propyl ) methylamine ). alternatively , pyridyloxyalkylamines possessing a branched side chain , such as ( 1 - methyl - 3 -( 3 - pyridyloxy ) propyl ) methylamine , can be synthesized by alkylating 3 - hydroxypyridine with a protected 1 - iodo - 3 - butanone , namely 2 - methyl - 2 -( 2 - iodoethyl )- 1 , 3 - dioxolane , with is prepared according to the procedures set forth in stowell et al ., j . org . chem . 48 : 5381 ( 1983 ). the resulting ketal , 3 -( 2 -( 1 - methyl - 2 , 5 - dioxolanyl ) ethoxy ) pyridine , can be protected by treatment with aqueous acetic acid or p - toluenesulfonic acid in methanol to yield 4 -( 3 - pyridyloxy ) butan - 2 - one . reductive amination of the resulting ketone using methylamine and sodium cyanoborohydride according to the methodology set forth in borch , org . syn . 52 : 124 ( 1972 ) provides ( 1 - methyl - 3 -( 3 - pyridyloxy ) propyl ) methylamine . alternatively , the intermediate , 4 -( 3 - pyridyloxy ) butan - 2 - one , can be reduced with sodium borohydride to yield an alcohol , 4 -( 3 - pyridyloxy ) butan - 2 - ol . mesylation or tosylation of that alcohol , followed by mesylation or tosylation displacement using methylamine , provides the branched chain pyridyloxyalkylamine , ( 1 - methyl - 3 -( 3 - pyridyloxy ) propyl )- methylamine . chiral starting materials are available for the synthesis of the pure enantiomers of the branched chain pyridyloxyalkylamines , such a ( 1 - methyl - 3 -( 3 - pyridyloxy ) proyl ) methylamine . one approach can be carried out using either methyl ( r )-(−)- 3 - hydroxybutyrate or the (+)- enantiomer , ( s )-(+)- 3 - hydroxybutyrate , both of which are available from aldrich chemical company . for example , ( r )-(−)- 3 - hydroxybutyrate can be converted to ( r )-(−)- 3 - tetrahydropyranyloxybutyl bromide , using the procedures set forth in yuasa et al ., j . chem . soc ., perk . trans . 1 ( 5 ): 465 ( 1996 ). alkylation of 3 - hyroxypyridine with ( r )-(−)- 3 - tetrahydropyranyloxybutyl bromide using sodium hydride in n , n - dimethylformamide produces the tetrahydropyranyl ether of 4 -( 3 - pyridyloxy ) butan - 2r - ol . removal of the tetrahydropyranyl protecting group of that compound using p - toluenesulfonic acid monohydrate in methanol affords 4 -( 3 - pyridyloxy ) butan - 2r - ol . the resulting chiral alcohol can be elaborated to the chiral pyridyloxyalkylamine , ( 1s - 3 -( 3 - pyridyloxy ) propyl )- methylamine using a two - step sequence involving tosylation and methylamine displacement of the intermediate tosylate . in a similar process , ( s )-(+)- 3 - hydroxybutyrate can be converted to ( s )-(+)- 3 - tetrahydropyranyloxybutyl bromide using the procedures set forth in sakai et al ., agric . biol . chem . 50 ( 6 ): 1621 ( 1986 ). this protected bromo alcohol can be converted to the corresponding chiral pyridyloxyalkylamine , methyl ( 1r - 3 -( 3 - pyridyloxy )- propyl ) amine , using a sequence involving alkylation of 3 - hydroxypyridine , removal of the tetrahydropyranyl group , tosylation , and methylamine displacement of the intermediate tosylate . the manner by which certain 5 - alkoxy - 3 - pyridyl analogs of methyl ( 3 -( 3 - pyridyloxy ) propyl ) amine of the present invention can be synthesized is analogous to that described for the synthesis of methyl ( 3 -( 3 - pyridyloxy )- propyl ) amine with the exception that 5 - alkoxy - 3 - hydroxypyridines are employed rather than 3 - hydroxypyridine . for example , 3 , 5 - dibromopyridine ( commercially available from aldrich chemical company and lancaster synthesis inc .) can be converted to the synthetic intermediate , 5 -( 3 , 4 - dimethoxybenzyloxy )- 3 - bromopyridine by heating at 100 ° c . with veratryl alcohol ( 3 , 4 - dimethoxybenzyl alcohol ) in the presence of sodium and copper powder . the resulting 5 -( 3 , 4 - dimethoxybenzyloxy )- 3 - bromopyridine can be heated at 180 ° c . with concentrated aqueous ammonia in the presence of copper ( ii ) sulfate or copper ( i ) bromide to produce the aminopyridine compound , 5 -( 3 , 4 - dimethoxybenzyloxy )- 3 - aminopyridine . the latter compound can be diazotized and the diazonium salt hydrolyzed by treatment with sodium nitrite and aqueous sulfuric acid to give the hydroxypyridine , 5 -( 3 , 4 - dimethoxybenzyloxy )- 3 - hydroxypyridine . this 5 - substituted - 3 - hydroxypyridine can be alkylated with 1 - chloro - 3 - iodopyridine in the presence of sodium hydride in n , n - dimethylformamide to yield 3 - chloro - 1 -( 5 -( 3 , 4 - dimethoxybenzyloxy )- 3 - pyridyloxy ) propane . treatment of the latter compound with an excess of methylamine in methanol will afford methyl ( 3 -( 5 -( 3 , 4 - dimethoxybenzyloxy )( 3 - pyridyloxy )) propyl ) methylamine . certain commercially available fused polycyclic haloaromatics can be used as starting materials to prepare compounds of the present invention which possess fused rings . for example , 3 - bromoquinoline ( commercially available from aldrich chemical company ) can be converted to 3 - aminoquinoline by heating at ˜ 180 ° c . with aqueous ammonia in the presence of copper ( ii ) sulfate or copper ( l ) bromide . the resulting 3 - aminoquinoline ( commercially available from aldrich chemical company ) can be diazotized and subsequently hydrolyzed by treatment with sodium nitrite and aqueous sulfuric acid to produce 3 - hydroxyquinoline according to the methodology of c . naumann and h . langhals , synthesis ( 4 ): 279 - 281 ( 1990 ). 3 - hydroxyquinoline can be alkylated with 1 - chloro - 3 - iodopyridine in the presence of sodium hydride and n , n - dimethylformamide to give 3 - chloro - 1 -( 3 - quinolyloxy ) propane . treatment of the latter compound with aqueous methylamine will give methyl ( 3 -( 3 - quinolyloxy ) propyl ) amine . compounds of the present invention possessing a thioether moiety can be prepared from an appropriately substituted pyridine such as 3 , 5 - dibromopyridine ( commercially available from aldrich chemical company and lancaster synthesis inc .). as an example , 3 , 5 - dibromopyridine can be treated with 3 - mercapto - 1 - propanol in the presence of sodium hydroxide and n , n - dimethylformamide to give 3 -( 5 - bromo - 3 - pyridylthio ) propan - 1 - ol . treatment of the latter compound with p - toluenesulfonyl chloride , followed by treatment of the intermediate tosylate with aqueous methylamine will afford 3 -( 5 - bromo - 3 - pyridylthio )) propyl ) methylamine . compounds of the present invention that are ethers and possess a cyclic amine functionality can be prepared from hydroxypyridines and hydroxylated cyclic amines using the general coupling method of o . mitsunobu , synthesis : 1 ( 1981 ). for example , 3 -(( 3s )-( 1 - methyl - 3 - pyrrolidinyloxy ) pyridine can be synthesized by the coupling of 3 - hydroxypyridine and ( 3r )- n -( tert - butoxycarbonyl )- 3 - hydroxypyrrolidine in the presence of triphenylphosphine and diethyl azodicarboxylate in tetrahydrofuran . the resulting intermediate , 3 -(( 3s )- n -( tert - butoxycarbonyl )- 3 - pyrrolidinyloxy ) pyridine can then be treated with a strong acid such as trifluoroacetic acid to remove the tert - butoxycarbonyl protecting group to produce 3 -(( 3s )- 3 - pyrrolidinyloxy ) pyridine . the latter compound can be n - methylated to afford 3 -(( 3s )-( 1 - methyl - 3 - pyrrolidinyloxy ) pyridine . methylation methods employing aqueous formaldehyde and sodium cyanoborohydride as described by m . a . abreo et al ., j . med . chem . 39 : 817 - 825 ( 1996 ) can be used . the n - protected starting material , ( 3 r )- n -( tert - butoxycarbonyl )- 3 - hydroxypyrrolidine can be prepared from ( r )-(+)- 3 - pyrrolidinol ( commercially available from aldrich chemical company ) according to the general techniques described by p . g . houghton et al ., j . chem . soc . perkin trans 1 ( issue 13 ): 1421 - 1424 ( 1993 ). such a compound is exemplary of a compound whereby e and z ′ combine to form a ring ; and in a similar manner , if m = 0 , z ′ and e ′″ can combine to form a ring . the present invention relates to a method for providing prevention of a condition or disorder to a subject susceptible to such a condition or disorder , and for providing treatment to a subject suffering therefrom . for example , the method comprises administering to a patient an amount of a compound effective for providing some degree of prevention of the progression of a cns disorder ( i . e ., provide protective effects ), amelioration of the symptoms of a cns disorder , and amelioration of the reoccurrence of a cns disorder . the method involves administering an effective amount of a compound selected from the general formulae which are set forth hereinbefore . the present invention relates to a pharmaceutical composition incorporating a compound selected from the general formulae which are set forth hereinbefore . the present invention also relates to prodrug derivatives of the compounds of the present invention . the compounds normally are not optically active . however , certain compounds can possess substituent groups of a character so that those compounds possess optical activity . optically active compounds can be employed as racemic mixtures or as enantiomers . the compounds can be employed in a free base form or in a salt form ( e . g ., as pharmaceutically acceptable salts ). examples of suitable pharmaceutically acceptable salts include inorganic acid addition salts such as hydrochloride , hydrobromide , sulfate , phosphate , and nitrate ; organic acid addition salts such as acetate , galactarate , propionate , succinate , lactate , glycolate , malate , tartrate , citrate , maleate , fumarate , methanesulfonate , p - toluenesulfonate , and ascorbate ; salts with acidic amino acid such as aspartate and glutamate ; alkali metal salts such as sodium salt and potassium salt ; alkaline earth metal salts such as magnesium salt and calcium salt ; ammonium salt ; organic basic salts such as trimethylamine salt , triethylamine salt , pyridine salt , picoline salt , dicyclohexylamine salt , and n , n ′- dibenzylethylenediamine salt ; and salts with basic amino acid such as lysine salt and arginine salt . the salts may be in some cases hydrates or ethanol solvates . compounds of the present invention are useful for treating those types of conditions and disorders for which other types of nicotinic compounds have been proposed as therapeutics . see , for example , williams et al . dn & amp ; p 7 ( 4 ): 205 - 227 ( 1994 ), arneric et al ., cns drug rev . 1 ( 1 ): 1 - 26 ( 1995 ), arneric et al ., exp . opin . invest . drugs 5 ( 1 ): 79 - 100 ( 1996 ), bencherif et al ., jpet 279 : 1413 ( 1996 ), lippiello et al ., jpet 279 : 1422 ( 1996 ), damaj et al ., neuroscience ( 1997 ), holladay et al ., j . med . chem 40 ( 28 ): 41694194 ( 1997 ), bannon et al ., science 279 : 77 - 80 ( 1998 ), pct wo 94 / 08992 , pct wo 96 / 31475 , and u . s . pat . nos . 5 , 583 , 140 to bencherif et al ., 5 , 597 , 919 to dull et al ., and 5 , 604 , 231 to smith et al the disclosures of which are incorporated herein by reference in their entirety . compounds of the present invention can be used as analgesics , to treat ulcerative colitis , to treat a variety of neurodegenerative diseases , and to treat convulsions such as those that are symtematic of epilepsy . cns disorders which can be treated in accordance with the present invention include presenile dementia ( early onset alzheimer &# 39 ; s disease ), senile dementia ( dementia of the alzheimer &# 39 ; s type ), hiv - dementia , multiple cerebral infarcts , parkinsonism including parkinson &# 39 ; s disease , pick &# 39 ; s disease , huntington &# 39 ; s chorea , tardive dyskinesia , hyperkinesia , mania , attention deficit disorder , anxiety , depression , mild cognitive impairment , dyslexia , schizophrenia and tourette &# 39 ; s syndrome . compounds of the present invention also can be used to treat conditions such as syphillis and creutzfeld - jakob disease . the pharmaceutical composition also can include various other components as additives or adjuncts . exemplary pharmaceutically acceptable components or adjuncts which are employed in relevant circumstances include antioxidants , free radical scavenging agents , peptides , growth factors , antibiotics , bacteriostatic agents , immunosuppressives , anticoagulants , buffering agents , anti - inflammatory agents , anti - pyretics , time release binders , anaesthetics , steroids and corticosteroids . such components can provide additional therapeutic benefit , act to affect the therapeutic action of the pharmaceutical composition , or act towards preventing any potential side effects which may be posed as a result of administration of the pharmaceutical composition . in certain circumstances , a compound of the present invention can be employed as part of a pharmaceutical composition with other compounds intended to prevent or treat a particular disorder . the manner in which the compounds are administered can vary . the compounds can be administered by inhalation ( e . g ., in the form of an aerosol either nasally or using delivery articles of the type set forth in u . s . pat . no . 4 , 922 , 901 to brooks et al ., the disclosure of which is incorporated herein in its entirety ); topically ( e . g ., in lotion form ); orally ( e . g ., in liquid form within a solvent such as an aqueous or non - aqueous liquid , or within a solid carrier ); intravenously ( e . g ., within a dextrose or saline solution ); as an infusion or injection ( e . g ., as a suspension or as an emulsion in a pharmaceutically acceptable liquid or mixture of liquids ); intrathecally ; intracerebro ventricularly ; or transdermally ( e . g ., using a transdermal patch ). although it is possible to administer the compounds in the form of a bulk active chemical , it is preferred to present each compound in the form of a pharmaceutical composition or formulation for efficient and effective administration . exemplary methods for administering such compounds will be apparent to the skilled artisan . for example , the compounds can be administered in the form of a tablet , a hard gelatin capsule or as a time release capsule . as another example , the compounds can be delivered transdermally using the types of patch technologies available , for example , from novartis and alza corporation . the administration of the pharmaceutical compositions of the present invention can be intermittent , or at a gradual , continuous , constant or controlled rate to a warm - blooded animal , ( e . g ., a mammal such as a mouse , rat , cat , rabbit , dog , pig , cow , or monkey ); but advantageously is preferably administered to a human being . in addition , the time of day and the number of times per day that the pharmaceutical formulation is administered can vary . administration preferably is such that the active ingredients of the pharmaceutical formulation interact with receptor sites within the body of the subject that effect the functioning of the cns . more specifically , in treating a cns disorder administration preferably is such so as to optimize the effect upon those relevant receptor subtypes which have an effect upon the functioning of the cns , while minimizing the effects upon muscle - type receptor subtypes . other suitable methods for administering the compounds of the present invention are described in u . s . pat . no . 5 , 604 , 231 to smith et al . the appropriate dose of the compound is that amount effective to prevent occurrence of the symptoms of the disorder or to treat some symptoms of the disorder from which the patient suffers . by “ effective amount ”, “ therapeutic amount ” or “ effective dose ” is meant that amount sufficient to elicit the desired pharmacological or therapeutic effects , thus resulting in effective prevention or treatment of the disorder . thus , when treating a cns disorder , an effective amount of compound is an amount sufficient to pass across the blood - brain barrier of the subject , to bind to relevant receptor sites in the brain of the subject , and to activatie relevant nicotinic receptor subtypes ( e . g ., provide neurotransmitter secretion , thus resulting in effective prevention or treatment of the disorder ). prevention of the disorder is manifested by delaying the onset of the symptoms of the disorder . treatment of the disorder is manifested by a decrease in the symptoms associated with the disorder or an amelioration of the reoccurrence of the symptoms of the disorder . the effective dose can vary , depending upon factors such as the condition of the patient , the severity of the symptoms of the disorder , and the manner in which the pharmaceutical composition is administered . for human patients , the effective dose of typical compounds generally requires administering the compound in an amount sufficient to activate relevant receptors to effect neurotransmitter ( e . g ., dopamine ) release but the amount should be insufficient to induce effects on skeletal muscles and ganglia to any significant degree . the effective dose of compounds will of course differ from patient to patient but in general includes amounts starting where cns effects or other desired therapeutic effects occur , but below the amount where muscular effects are observed . typically , the effective dose of compounds generally requires administering the compound in an amount of less than 1 ug / kg of patient weight . often , the compounds of the present invention are administered in an amount from 10 ng to less than 1 ug / kg of patient weight , frequently between about 0 . 1 ug to less than 1 ug / kg of patient weight , and preferably between about 0 . 1 ug to about 0 . 5 ug / kg of patient weight . compounds of the present invention can be administered in an amount of 0 . 3 to 0 . 5 ug / kg of patient weight . for compounds of the present invention that do not induce effects on muscle type nicotinic receptors at low concentrations , the effective dose is less than 50 ug / kg of patient weight ; and often such compounds are administered in an amount from 0 . 5 ug to less than 50 ug / kg of patient weight . the foregoing effective doses typically represent that amount administered as a single dose , or as one or more doses administered over a 24 hour period . for human patients , the effective dose of typical compounds generally requires administering the compound in an amount of at least about 1 , often at least about 10 , and frequently at least about 25 ug / 24 hr ./ patient . for human patients , the effective dose of typical compounds requires administering the compound which generally does not exceed about 500 , often does not exceed about 400 , and frequently does not exceed about 300 ug / 24 hr ./ patient . in addition , administration of the effective dose is such that the concentration of the compound within the plasma of the patient normally does not exceed 500 ng / ml , and frequently does not exceed 100 ng / ml . the compounds useful according to the method of the present invention have the ability to pass across the blood - brain barrier of the patient . as such , such compounds have the ability to enter the central nervous system of the patient . the log p values of typical compounds , which are useful in carrying out the present invention are generally greater than about − 0 . 5 , often are greater than about 0 , and frequently are greater than about 0 . 5 . the log p values of such typical compounds generally are less than about 3 , often are less than about 2 , and frequently are less than about 1 . log p values provide a measure of the ability of a compound to pass across a diffusion barrier , such as a biological membrane . see , hansch , et al ., j . med . chem . 11 : 1 ( 1968 ). the compounds useful according to the method of the present invention have the ability to bind to , and in most circumstances , cause activation of , nicotinic dopaminergic receptors of the brain of the patient . as such , such compounds have the ability to express nicotinic pharmacology , and in particular , to act as nicotinic agonists . the receptor binding constants of typical compounds useful in carrying out the present invention generally exceed about 0 . 1 nm , often exceed about 1 nm , and frequently exceed about 10 nm . the receptor binding constants of certain compounds are less than about 100 um , often are less than about 10 um and frequently are less than about 5 um ; and of preferred compounds generally are less than about 1 um , often are less than about 100 nm , and frequently are less than about 50 nm . though not preferred , certain compounds possess receptor binding constants of less than 10 um , and even less than 100 um . receptor binding constants provide a measure of the ability of the compound to bind to half of the relevant receptor sites of certain brain cells of the patient . see , cheng , et al ., biochem . pharmacol . 22 : 3099 ( 1973 ). the compounds useful according to the method of the present invention have the ability to demonstrate a nicotinic function by effectively activating neurotransmitter secretion from nerve ending preparations ( i . e ., synaptosomes ). as such , such compounds have the ability to activate relevant neurons to release or secrete acetylcholine , dopamine , and other neurotransmitters . generally , typical compounds useful in carrying out the present invention provide for the activation of dopamine secretion in amounts of at least one third , typically at least about 10 times less , frequently at least about 100 times less , and sometimes at least about 1 , 000 times less , than those required for activation of muscle - type nicotinic receptors . certain compounds of the present invention can provide secretion of dopamine in an amount which is comparable to that elicited by an equal molar amount of ( s )-(−)- nicotine . the compounds of the present invention , when employed in effective amounts in accordance with the method of the present invention , are selective to certain relevant nicotinic receptors , but do not cause significant activation of receptors associated with undesirable side effects at concentrations at least greater than those required for activation of dopamine release . by this is meant that a particular dose of compound resulting in prevention and / or treatment of a cns disorder , is essentially ineffective in eliciting activation of certain muscle - type nicotinic receptors at concentration higher than 5 times , preferably higher than 100 times , and more preferably higher than 1 , 000 times , than those required for activation of dopamine release . this selectivity of certain compounds of the present invention against those ganglia - type receptors responsible for cardiovascular side effects is demonstrated by a lack of the ability of those compounds to activate nicotinic function of adrenal chromaffin tissue at concentrations greater than those required for activation of dopamine release . compounds of the present invention , when employed in effective amounts in accordance with the method of the present invention , are effective towards providing some degree of prevention of the progression of cns disorders , amelioration of the symptoms of cns disorders , an amelioration to some degree of the reoccurrence of cns disorders . however , such effective amounts of those compounds are not sufficient to elicit any appreciable side effects , as demonstrated by increased effects relating to skeletal muscle . as such , administration of certain compounds of the present invention provides a therapeutic window in which treatment of certain cns disorders is provided , and certain side effects are avoided . that is , an effective dose of a compound of the present invention is sufficient to provide the desired effects upon the cns , but is insufficient ( i . e ., is not at a high enough level ) to provide undesirable side effects . preferably , effective administration of a compound of the present invention resulting in treatment of cns disorders occurs upon administration of less than ⅕ , and often less than { fraction ( 1 / 10 )} that amount sufficient to cause certain side effects to any significant degree . the pharmaceutical compositions of the present invention can be employed to prevent or treat certain other conditions , diseases and disorders . exemplary of such diseases and disorders include inflammatory bowel disease , acute cholangitis , aphteous stomatitis , arthritis ( e . g ., rheumatoid arthritis and ostearthritis ), neurodegenerative diseases , cachexia secondary to infection ( e . g ., as occurs in aids , aids related complex and neoplasia ), as well as those indications set forth in pct wo 98 / 25619 . the pharmaceutical compositions of the present invention can be employed in order to ameliorate may of the symptoms associated with those conditions , diseases and disorders . thus , pharmaceutical compositions of the present invention can be used in treating genetic diseases and disorders , in treating autoimmune disorders such as lupus , as anti - infectious agents ( e . g , for treating bacterial , fungal and viral infections , as well as the effects of other types of toxins such as sepsis ), as anti - inflammatory agents ( e . g ., for treating acute cholangitis , aphteous stomatitis , asthma , and ulcerative colitis ), and as inhibitors of cytokines release ( e . g ., as is desirable in the treatment of cachexia , inflammation , neurodegenerative diseases , viral infection , and neoplasia ), the compounds of the present invention can also be used as adjunct therapy in combination with existing therapies in the management of the aforementioned types of diseases and disorders . in such situations , administration preferably is such that the active ingredients of the pharmaceutical formulation act to optimize effects upon abnormal cytokine production , while minimizing effects upon receptor subtypes such as those that are associated with muscle and ganglia . administration preferably is such that active ingredients interact with regions where cytokine production is affected or occurs . for the treatment of such conditions or disorders , compounds of the present invention are very potent ( i . e ., affect cytokine production and / or secretion at very low concentrations ), and are very efficacious ( i . e ., significantly inhibit cytokine production and / or secretion to a relatively high degree ). effective doses are most preferably at very low concentrations , where maximal effects are observed to occur . concentrations , determined as the amount of compound per volume of relevant tissue , typically provide a measure of the degree to which that compound affects cytokine production . for human patients , the effective dose of typical compounds generally requires administering the compound in an amount of at least about 1 , often at least about 10 , and frequently at least about 25 ug / 24 hr ./ patient . for human patients , the effective dose of typical compounds requires administering the compound which generally does not exceed about 1 , often does not exceed about 0 . 75 , often does not exceed about 0 . 5 , frequently does not exceed about 0 . 25 mg / 24 hr ./ patient . in addition , administration of the effective dose is such that the concentration of the compound within the plasma of the patient normally does not exceed 500 pg / ml , often does not exceed 300 pg / ml , and frequently does not exceed 100 pg / ml . when employed in such a manner , compounds of the present invention are dose dependent , and as such , cause inhibition of cytokine production and / or secretion when employed at low concentrations but do not exhibit those inhibiting effects at higher concentrations . compounds of the present invention exhibit inhibitory effects upon cytokine production and / or secretion when employed in amounts less than those amounts necessary to elicit activation of relevant nicotinic receptor subtypes to any significant degree . the following examples are provided to illustrate the present invention , and should not be construed as limiting thereof . in these examples , all parts and percentages are by weight , unless otherwise noted . binding of the compounds to relevant receptor sites was determined in accordance with the techniques described in u . s . pat . no . 5 , 597 , 919 to dull et al . inhibition constants ( ki values ), reported in nm , were calculated from the ic 50 values using the method of cheng et al ., biochem , pharmacol . 22 : 3099 ( 1973 ). low binding constants indicate that the compounds of the present invention exhibit good high affinity binding to certain cns nicotinic receptors . neurotransmitter release was measured using techniques similar to those previously published ( bencherif m , et al .:. jpet 279 : 1413 - 1421 , 1996 ). rat brain synaptosomes were prepared as follows : female sprague dawley rats ( 100 - 200 g ) were killed by decapitation after anesthesia with 70 % co 2 . brains are dissected , and hippocampus , striatum , and thalamus isolated , and homogenized in 0 . 32 m sucrose containing 5 mm hepes ph 7 . 4 using a glass / glass homogenizer . the tissue was then centrifuged for 1000 × g for 10 minutes and the pellet discarded . the supernatant was centrifuged at 12000 × g for 20 minutes . the resultant pellet was re - suspended in perfusion buffer ( 128 mm nacl , 1 . 2 mm kh 2 po 4 , 2 . 4 mm kcl , 3 . 2 mm cacl 2 , 1 . 2 mm mgso 4 , 25 mm hepes , 1 mm ascorbic acid , 0 . 01 mm pargyline hcl and 10 mm glucose ph 7 . 4 ) and centrifuged for 15 minutes at 25000 × g . the final pellet was resuspended in perfusion buffer and placed in a water bath ( 37 ° c .) for 10 minutes . radiolabeled neurotransmitter is added ( 30 l 3 h da , 20 l 3 h ne , 10 l 3 h glutamate ) to achieve a final concentration of 100 nm , vortexed and placed in a water bath for additional 10 minutes . tissue - loaded filters is placed onto 11 - mm diameter gelman a / e filters on an open - air support . after a 10 - minute wash period , fractions are collected to establish the basal release and agonist applied in the perfusion stream . further fractions were collected after agonist application to re - establish the baseline . the perfusate was collected directly into scintillation vials and released radioactivity was quantified using conventional liquid scintillation techniques . release of neurotransmitter was determined in the presence of 10 m of various ligands and was expressedas a percentage of release obtained with a concentration of 10 m ( s )-(−)- nicotine or 300 mtma resulting in maximal effects . the determination of the interaction of the compounds with muscle receptors was carried out in accordance with the techniques described in u . s . pat . no . 5 , 597 , 919 to dull et al . the maximal activation for individual compounds ( e max ) was determined as a percentage of the maximal activation induced by ( s )-(−)- nicotine . reported e max values represent the amount released relative to ( s )-(−)- nicotine on a percentage basis . low e max values at muscle - type receptors indicate that the compounds of the present invention do not induce activation of muscle - type receptors . such preferable compounds have the capability to activate human cns receptors without activating muscle - type nicotinic acetylcholine receptors . thus , there is provided a therapeutic window for utilization in the treatment of cns disorders . that is , at certain levels the compounds show cns effects to a significant degree but do not show undesirable muscle effects to any significant degree . the compounds begin to cause muscle effects only when employed in amounts of many times those required to activate dopamine release . the determination of the interaction of the compounds with ganglionic receptors was carried out in accordance with the techniques described in u . s . pat . no . 5 , 597 , 919 to dull et al . the maximal activation for individual compounds ( e max ) was determined as a percentage of the maximal activation induced by ( s )-(−)- nicotine . reported e max values represent the amount released relative to ( s )-(−)- nicotine on a percentage basis . low e max values at ganglia - type receptors indicate that the compounds of the present invention do not induce activation of ganglia - type receptors . such preferable compounds have the capability to activate human cns receptors without activating ganglia - type nicotinic acetylcholine receptors . thus , there is provided a therapeutic window for utilization in the treatment of cns disorders . that is , at certain levels the compounds show cns effects to a significant degree but do not show certain undesirable side effects to any significant degree . the compounds begin to cause effects at ganglia only when employed in amounts of many times those required to activate dopamine release . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 5 . 00 g , 52 . 58 mmol ) in n , n - dimethylformamide ( dmf ) ( 55 ml ) was slowly added to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 2 . 52 g of an 80 % dispersion in mineral oil , 84 . 0 mmol ) in dmf ( 10 ml ). the mixture was allowed to warm to ambient temperature and further stirred for 1 h . to this slurry was added 1 - choro - 3 - iodopropane ( 12 . 90 g , 63 . 10 mmol ), and the resulting dark - brown mixture was stirred at ambient temperature for 48 h . cold water was added and the mixture was extracted with chloroform ( 4 × 100 ml ). the combined chloroform extracts were washed with water ( 2 × 50 ml ), dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation . water ( 150 ml ) was added , and the mixture was basified with 20 % naoh solution ( 5 . 0 ml ). the alkaline solution was extracted with methyl t - butyl ether ( mtbe ) ( 5 × 100 ml ). the combined mtbe extracts were washed with water ( 4 × 100 ml ), dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to give 4 . 90 g ( 54 . 3 %) of an oil . the 3 - chloro - 1 -( 3 - pyridyloxy ) propane ( 4 . 90 g , 28 . 55 mmol ) was dissolved in methanol ( 60 ml ) and added to a 40 wt % solution of methylamine ( 60 ml ) in a heavy - walled pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 80 ° c . for 15 h . after cooling , the mixture was concentrated by rotary evaporation , a saturated nacl solution ( 25 ml ) was added , and the mixture was basified with 20 % naoh solution ( 5 . 0 ml ). the mixture was extracted with chloroform ( 4 × 30 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to give 3 . 64 g of a brown oil . the product was purified by column chromatography on silica gel ( 100 g ) eluting with chloroform - methanol - triethylamine ( 70 : 30 : 2 . 5 , v / v / v ). selected fractions containing the product ( r f 0 . 30 ) were combined and concentrated by rotary evaporation . the resulting residue was dissolved in chloroform ( 15 ml ), dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to give 1 . 92 g ( 40 . 4 %) of a brown oil . to a solution of ( 3 -( 3 - pyridyloxy ) propyl ) methylamine ( 800 . 0 mg , 4 . 81 mmol ) in ethanol ( 12 ml ) was added galactaric acid ( 505 . 7 mg , 2 . 41 mmol ). water ( 2 . 5 ml ) was added dropwise , while gently warming the light - yellow solution . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 4 ml ). the filtrate was diluted with ethanol ( 18 ml ), producing a white precipitate . the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 15 h . the precipitate was filtered , washed with ethanol ( 6 ml ), vacuum dried at 45 ° c . for 10 h , followed by further vacuum drying at ambient temperature for 48 h to give 994 . 4 mg ( 76 . 1 %) of an off - white , crystalline powder , mp 161 - 165 . 5 ° c . log p values , which have been used to assess the relative abilities of compounds to pass across the blood - brain barrier ( hansch , et al ., j . med . chem . ii : 1 ( 1968 )), were calculated according using the cerius 2 software package version 3 . 0 by molecular simulations , inc . the compound exhibits a log p of 0 . 562 , and such a favorable log p value indicates that the compound has the capability of passing the blood - brain barrier . the compound exhibits a ki of 13 nm . the low binding constant indicates that the compound exhibits good high affinity binding to certain cns nicotinic receptors . dopamine release was measured using the techniques described in u . s . pat . no . 5 , 597 , 919 to dull et al . release is expressed as a percentage of release obtained with a concentration of ( s )-(−)- nicotine resulting in maximal effects . reported ec 50 values are expressed in nm , and e max values represent the amount released relative to ( s )-(−)- nicotine on a percentage basis . the compound exhibits an ec 50 value of 369 nm and an e max value of 96 %, indicating that the compound effectively induces neurotransmitter release thereby exhibiting known nicotinic pharmacology . rubidium release was measured using the techniques described in bencherif et al ., jpet , 279 : 1413 - 1421 ( 1996 ). reported ec 50 values are expressed in nm , and e max values represent the amount of rubidium ion released relative to 300 um tetranmethylammonium ion , on a percentage basis . the compound exhibits an ec 50 value of 960 nm and an e max value of 83 %, indicating that the compound effectively induces activation of cns nicotinic receptors . the compound exhibits an e max of 0 % at muscle - type receptors , indicating that the compound does not induce activation of muscle - type receptors . the compound has the capability to activate human cns receptors without activating muscle - type nicotinic acetylcholine receptors . thus , there is provided a therapeutic window for utilization in the treatment of cns disorders . that is , at certain levels the compound shows cns effects to a significant degree but do not show undesirable muscle effects to any significant degree . the compound begins to cause muscle effects only when employed in amounts of many times those required to activate dopamine release . the determination of the interaction of the compounds with ganglionic receptors was carried out in accordance with the techniques described in u . s . pat . no . 5 , 597 , 919 to dull et al . the maximal activation for individual compounds ( e max ) was determined as a percentage of the maximal activation induced by ( s )-(−)- nicotine . reported e max values represent the amount released relative to ( s )-(−)- nicotine on a percentage basis . the compound exhibits an e max of 93 % at ganglionic - type receptors . a gemini avoidance system ( san diego instruments ) were used to evaluate animals in a passive avoidance experiment . during the period of habituation , laboratory rats received a subcutaneous injection of saline . on the acquisition day , each rat received a subcutaneous injection of 0 . 5 umol / kg scopolamine ( or saline in the case of the vehicle control group ) 30 minutes prior to being placed in the chambers . five minutes following scopolamine injection , ( or 25 minutes before being placed in the chamber ), each rat was administered a subcutaneous injection with one of four doses of the compound . thirty minutes following the scopolamine or vehicle injection , each rat was placed in the brightly illuminated chamber , facing away from the sliding door . after 10 seconds , the door separating the chambers opened allowing access to the dark chamber . the time to enter the dark chamber was measured . immediately upon entering the dark chamber , the rat received a mild foot shock ( 0 . 5 mamp ) for 2 seconds . twenty four hours following training , each rat was placed in the light chamber facing away from the sliding door . thirty seconds later the door was opened and each rat was allowed to enter the dark chamber . upon entering the dark chamber the sliding door was closed and the rat was removed from the apparatus ( no shock was administered ). if the rat did not enter the dark chamber within 300 seconds , a ceiling score of 300 seconds was recorded for that rat , and the rat was removed from the apparatus and returned to its home cage . statistical differences in latencies ( latency during acquisition and retention trials ) were analyzed by kruskal - wallis one - way analysis of variance on ranks followed by the either of two - tailed mann - whitney u - test or newman - keuls analog test if values of p less than 0 . 05 were obtained . the compound , at concentrations of 0 . 3 to 3 umol / kg , resulted in significant reversal of scopolamine induced amnesia in the step - through passive avoidance paradigm using laboratory rats . thus , the compound has potential cognition enhancing effects , an end - point relevant to certain cns disorders . 5 - bromo - 3 - hydroxypyridine was prepared from 2 - furfurylamine according to the procedure described in u . s . pat . no . 4 , 192 , 946 to clauson - kaas et al . under a nitrogen atmosphere , a solution of 5 - bromo - 3 - hydroxypyridine ( 1 . 90 g , 10 . 92 mmol ) in dmf ( 10 ml ) was slowly added over 10 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 52 g of an 80 % dispersion in mineral oil , 17 . 47 mmol ) in dmf ( 14 ml ). the mixture was allowed to warm to ambient temperature and further stirred for 1 h . to this slurry was added dropwise over 5 min 1 - choro - 3 - iodopropane ( 2 . 68 g , 13 . 10 mmol ), and the resulting dark - brown mixture was stirred at ambient temperature for 48 h . cold water ( 30 ml ) was carefully added , followed by saturated nacl solution ( 20 ml ). the resulting mixture was extracted with ether ( 5 × 25 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation producing a dark - brown oil ( 4 . 07 g ). the product was used in the next step without further purification . crude 3 - bromo - 5 -( 3 - chloropropoxy ) pyridine ( 4 . 07 g ) from the previous step was dissolved in ch 3 oh ( 28 ml ) and added to a 40 wt % solution of methylamine ( 35 ml ) in a heavy - walled pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 102 ° c . for 4 h . after cooling , the solution was concentrated by rotary evaporation , a saturated nacl solution ( 15 ml ) was added , and the mixture was basified with 10 % naoh solution ( 5 ml ). the mixture was extracted with chcl 3 ( 4 × 30 ml ). the combined chcl 3 extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to give 2 . 07 g of a brown oil . the product was purified by column chromatography on silica gel ( 100 g ) eluting with chcl 3 - ch 3 oh ( 9 : 1 , v / v ) to remove impurities , followed by chcl 3 - ch 3 oh - et 3 n ( 75 : 25 : 2 , v / v / v ) to collect the product . selected fractions containing the product ( r f 0 . 1 3 ) were combined and concentrated by rotary evaporation . the resulting brown oil was dissolved in chcl 3 ( 25 ml ), dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to give 0 . 79 g ( 29 . 5 % based upon 5 - bromo - 3 - hydroxypyridine ) of an amber - brown oil , which tended to crystallize as light amber crystals . to a solution of ( 3 -( 5 - bromo ( 3 - pyridyloxy )) propyl ) methylamine ( 0 . 790 g , 3 . 22 mmol ) in ethanol ( 12 ml ) was added galactaric acid ( 339 . 0 mg , 1 . 61 mmol ). water ( 3 . 4 ml ) was added dropwise , while warming the light - yellow solution to near reflux . to remove some white , insoluble crystals , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 3 . 8 ml ). the filtrate was diluted with ethanol ( 18 ml ), producing a light - beige precipitate . the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . the precipitate was filtered , washed with ethanol ( 5 ml ), vacuum dried at 40 ° c . for 24 h to give 983 . 3 mg ( 68 . 8 %) of a glassy , beige powder , mp 166 - 173 . 5 ° c . log p values , which have been used to assess the relative abilities of compounds to pass across the blood - brain barrier ( hansch , et al ., j . med . chem . ii : 1 ( 1968 )), were calculated according using the cerius ′ software package version 3 . 0 by molecular simulations , inc . the compound exhibits a log p of 0 . 662 , and such a favorable log p value indicates that the compound has the capability of passing the blood - brain barrier the compound exhibits a ki of 44 nm . the low binding constant indicates that the compound exhibits good high affinity binding to certain cns nicotinic receptors . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 12 . 00 g , 126 . 18 mmol ) in n , n - dimethylformamide ( dmf ) ( 63 ml ) was added drop - wise over 25 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 6 . 17 g of an 80 % dispersion in mineral oil , 205 . 7 mmol ) in dmf ( 130 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . next , 1 - bromo - 2 - chloroethane ( 21 . 71 g , 151 . 37 mmol ) was added drop - wise over 45 min . the resulting dark - brown mixture was stirred at ambient temperature for 24 h . gas chromatographic analysis indicated an incomplete reaction ; therefore , more 1 - bromo - 2 - chloroethane ( 8 . 65 g , 60 . 3 mmol ) and sodium hydride ( 2 . 09 g of an 80 % dispersion in mineral oil , 69 . 7 mmol ) were added . the mixture was stirred at ambient temperature for 40 h . water ( 60 ml ) was carefully added over 30 min , followed by saturated nacl solution ( 40 ml ), and the mixture was extracted with ether ( 6 × 50 ml ). the combined orange - yellow ether extracts were washed with saturated nacl solution ( 75 ml ). the ether layer was dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 2 . 87 g ( 14 . 4 %) of a light - brown oil . the 2 - chloro - 1 -( 3 - pyridyloxy ) ethane ( 1 . 23 g , 7 . 80 mmol ) was dissolved in methanol ( 25 ml ) and added to concentrated ammonium hydroxide solution ( 29 . 7 %, 14 . 8 m , 55 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 125 ° c . ( oil bath temperature ) for 42 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 10 ml ) was added to the residue , and the solution ( ph 6 ) was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was diluted with saturated nacl solution ( 15 ml ) and basified to ph 12 with 10 % naoh solution ( 5 ml ). the mixture was extracted with chloroform ( 4 × 50 ml ). the combined light - yellow chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 0 . 390 g ( 36 . 2 %) of a light - yellow oil . to a solution of 2 -( 3 - pyridyloxy ) ethylamine ( 0 . 390 g , 2 . 823 mmol ) in ethanol ( 6 ml ) was added galactaric acid ( 0 . 276 g , 1 . 312 mmol ). water ( 1 . 7 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 1 . 9 ml ). the filtrate was diluted with ethanol ( 9 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 12 days . the product had precipitated as a semi - crystalline oil . the solvent was removed by rotary evaporation , and the resulting solids were vacuum dried at 40 ° c . for 24 h . the resulting solids were slurried in 2 - propanol , and subsequently diluted with anhydrous ether . the solids were filtered , washed with ether , and vacuum dried at 40 ° c . for 24 h to give 0 . 598 g ( 87 . 1 %) of a fluffy , off - white powder , mp 151 - 156 ° c . the compound exhibits a ki of 1600 nm . the compound exhibits neurotransmitter release of 30 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 2 . 00 g , 21 . 0 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 756 g of an 80 % dispersion in mineral oil , 27 . 5 mmol ) in dmf ( 15 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . next , 1 - bromo - 2 - chloroethane ( 3 . 60 g , 25 . 2 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 4 h . water ( 30 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 3 . 96 g ( 66 . 1 %) of a light - brown oil . the 2 - chloro - 1 -( 3 - pyridyloxy ) ethane ( 2 . 17 g , 13 . 8 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph was adjusted to 1 with 10 % hcl solution and impurities were extracted with chloroform ( 2 × 50 ml ). the ph of the aqueous phase was raised to 6 with 100 % naoh solution and other impurities were extracted with ether ( 3 × 25 ml ). the aqueous layer was basified to ph 10 with 10 % naoh solution and extracted with chloroform ( 4 × 50 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 0 . 253 g ( 12 . 0 %) of an oil . to a solution of methyl ( 2 -( 3 - pyridyloxy ) ethyl ) amine ( 0 . 233 g , 1 . 53 mmol ) in ethanol ( 4 ml ) was added galactaric acid ( 0 . 161 g , 0 . 775 mmol ). water ( 1 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ). the filtrate was diluted with ethanol ( 20 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . the resulting solids were filtered , washed with cold ethanol ( 4 ml ), and vacuum dried at 40 ° c . to give 0 . 307 g ( 77 . 9 %) of a white to off - white , crystalline powder , mp 148 . 5 - 151 . 5 ° c . ( d ). the compound exhibits a ki of 65 nm ; the effect at muscle sites is 0 percent ; and the effect at ganglia sites is 0 percent . the compound exhibits neurotransmitter release of 143 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 12 . 00 g , 126 . 18 mmol ) in n , n - dimethylformamide ( dmf ) ( 63 ml ) was added drop - wise over 25 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 6 . 17 g of an 80 % dispersion in mineral oil , 205 . 7 mmol ) in dmf ( 130 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . next , 1 - bromo - 2 - chloroethane ( 21 . 71 g , 151 . 37 mmol ) was added drop - wise over 45 min . the resulting dark - brown mixture was stirred at ambient temperature for 24 h . gas chromatographic analysis indicated an incomplete reaction ; therefore , more 1 - bromo - 2 - chloroethane ( 8 . 65 g , 60 . 3 mmol ) and sodium hydride ( 2 . 09 g of an 80 % dispersion in mineral oil , 69 . 7 mmol ) were added . the mixture was stirred at ambient temperature for 40 h . water ( 60 ml ) was carefully added over 30 min , followed by saturated nacl solution ( 40 ml ), and the mixture was extracted with ether ( 6 × 50 ml ). the combined orange - yellow ether extracts were washed with saturated nacl solution ( 75 ml ). the ether layer was dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 2 . 87 g ( 14 . 4 %) of a light - brown oil . the 2 - chloro - 1 -( 3 - pyridyloxy ) ethane ( 2 . 21 g , 10 . 41 mmol ) was dissolved in methanol ( 14 ml ) and added to a 40 wt % aqueous solution of dimethylamine ( 22 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 7 ml ) and 10 % naoh solution were added to the residue ( brown liquid ), giving ph 12 . the mixture was extracted with chloroform ( 4 × 20 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 1 . 184 g of a brown oil . further purification was accomplished as follows : the oil was diluted with water ( 10 ml ) and acidified to ph 6 with 10 % hcl solution ( 6 ml ). the mixture was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous phase was treated with saturated nacl solution ( 15 ml ) and basified with 10 % naoh solution to ph 12 . the product was extracted with chloroform ( 4 × 20 ml ). the combined light - yellow chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 0 . 727 g ( 42 . 0 %) of a light - yellow oil . to a solution of dimethyl ( 2 -( 3 - pyridyloxy ) ethylamine ( 0 . 727 g , 4 . 37 mmol ) in ethanol ( 11 ml ) was added galactaric acid ( 0 . 46 g , 2 . 19 mmol ). water ( 3 . 5 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 3 . 5 ml ). the filtrate was diluted with ethanol ( 17 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 10 days . very few solids precipitated . consequently , the solution was concentrated to a residue that was vacuum dried for 20 h . the solids were slurried in 2 - propanol and diluted with anhydrous ether . the precipitate was filtered , washed with ether , and vacuum dried at 40 ° c . to give 0 . 818 g ( 68 . 9 %) of an off - white , slightly beige powder , mp 113 - 117 ° c . the compound exhibits a ki of 151 nm ; the effect at muscle sites is 0 percent ; and the effect at ganglia sites is 0 percent . the compound exhibits neurotransmitter release of 0 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 35 . 00 g , 0 . 368 mmol ) in n , n - dimethylformamide ( dmf ) ( 150 ml ) was slowly added drop - wise over 15 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 17 . 64 g of an 80 % dispersion in mineral oil , 0 . 588 mol ) in dmf ( 250 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the gray slurry was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 90 . 3 g , 0 . 442 mol ) was added drop - wise over 30 min . the resulting dark - brown mixture was allowed to stir and warm to ambient temperature over 16 h . water ( 500 ml ) was added and the mixture was divided into equal parts . each half was diluted with saturated nacl solution ( 200 ml ) and extracted with ether ( 5 × 200 ml ). all ether extracts were combined and concentrated to give 55 . 1 g ( 87 . 3 %) of a dark - brown oil . the 3 - chloro - 1 -( 3 - pyridyloxy ) propane ( 1 . 98 g , 11 . 6 mmol ) was dissolved in methanol ( 25 ml ) and added to concentrated ammonium hydroxide solution ( 29 . 7 %, 14 . 8 m , 55 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 6 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 10 ml ) was added to the residue , and the solution ( ph 6 ) was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 10 % naoh solution , and the mixture was extracted with chloroform ( 4 × 25 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 0 . 354 g ( 20 . 1 %) of an oil . to a solution of 3 -( 3 - pyridyloxy ) propylamine ( 0 . 354 g , 2 . 30 mmol ) in ethanol ( 5 ml ) was added galactaric acid ( 0 . 244 g , 1 . 16 mmol ). water ( 1 . 5 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ). the filtrate was diluted with ethanol ( 25 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 16 h . the solids were filtered , washed with cold ethanol ( 5 ml ), and vacuum dried at 40 ° c . to give 344 . 8 mg ( 58 . 3 %) of light - yellow crystals , mp 176 - 178 ° c . the compound exhibits a ki of 65 nm ; the effect at muscle sites is 0 percent ; and the effect at ganglia sites is 0 percent . the compound exhibits a ki of 12 nm ; the effect at muscle sites is 0 percent ; and the effect at ganglia sites is 0 percent . the compound exhibits neurotransmitter release of 0 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 35 . 00 g , 0 . 368 mmol ) in n , n - dimethylformamide ( dmf ) ( 150 ml ) was slowly added drop - wise over 15 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 17 . 64 g of an 80 % dispersion in mineral oil , 0 . 588 mol ) in dmf ( 250 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the gray slurry was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 90 . 3 g , 0 . 442 mol ) was added drop - wise over 30 min . the resulting dark - brown mixture was allowed to stir and warm to ambient temperature over 16 h . water ( 500 ml ) was added and the mixture was divided into equal parts . each half was diluted with saturated nacl solution ( 200 ml ) and extracted with ether ( 5 × 200 ml ). all ether extracts were combined and concentrated to give 55 . 1 g ( 87 . 3 %) of a dark - brown oil . the 3 - chloro - 1 -( 3 - pyridyloxy ) propane ( 2 . 00 g , 11 . 65 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of dimethylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph of the solution was adjusted to 6 , and the mixture was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 100 % naoh solution and extracted with chloroform ( 4 × 50 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated to give 1 . 95 g ( 92 . 9 %) of an oil . to a solution of dimethyl ( 3 -( 3 - pyridyloxy ) propyl ) amine ( 1 . 95 g , 10 . 8 mmol ) in ethanol ( 15 ml ) was added galactaric acid ( 0 . 696 g , 3 . 30 mmol ). water ( 4 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ). the filtrate was diluted with ethanol ( 80 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 16 h . no solids precipitated . consequently , the solution was concentrated to a crystalline solid . the solid was slurried in ether , filtered , washed with ether , and vacuum dried at 40 ° c . to give 1 . 94 g ( 62 . 7 %) of brown powdery crystals , mp 137 - 140 ° c . the compound exhibits a ki of 126 nm ; the effect at muscle sites is 8 percent ; and the effect at ganglia sites is 5 percent . the compound exhibits neurotransmitter release of 32 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 3 . 50 g , 36 . 8 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 1 . 16 g of an 80 % dispersion in mineral oil , 38 . 6 mmol ) in dmf ( 40 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the mixture was then cooled to 0 - 5 ° c ., and 1 - chloro4 - iodobutane ( 9 . 67 g , 44 . 2 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 2 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 6 . 89 g ( quantitative yield ) of an oil . the 4 - chloro - 1 -( 3 - pyridyloxy ) butane ( 2 . 00 g , 10 . 8 mmol ) was dissolved in methanol ( 25 ml ) and added to concentrated ammonium hydroxide solution ( 29 . 7 %, 14 . 8 m , 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 6 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 10 ml ) was added to the residue , and the solution ( ph 6 ) was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 10 % naoh solution , and the mixture was extracted with chloroform ( 4 × 25 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 1 . 25 g ( 74 . 2 %) of an oil . to a solution of 4 -( 3 - pyridyloxy ) butylamine ( 1 . 25 g , 7 . 50 mmol ) in ethanol ( 12 ml ) was added galactaric acid ( 0 . 791 g , 3 . 76 mmol ). water ( 3 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 4 ml ). the filtrate was diluted with ethanol ( 30 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . very few solids precipitated . consequently , the solution was concentrated to a flaky solid . the product was slurried in 2 - propanol , and the 2 - propanol was decanted . the product was vacuum dried at 40 ° c . to give 1 . 28 g ( 62 . 7 %) of fine , white powder , mp 177 - 180 ° c . the compound exhibits a ki of 232 nm ; the effect at muscle sites is 0 percent ; and the effect at ganglia sites is 11 percent . the compound exhibits neurotransmitter release of 100 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 3 . 50 g , 36 . 8 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 1 . 16 g of an 80 % dispersion in mineral oil , 38 . 6 mmol ) in dmf ( 40 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the mixture was then cooled to 0 - 5 ° c ., and 1 - chloro - 4 - iodobutane ( 9 . 67 g , 44 . 2 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 2 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 6 . 89 g ( quantitative yield ) of an oil . the 4 - chloro - 1 -( 3 - pyridyloxy ) butane ( 2 . 00 g , 10 . 8 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 10 ml ) was added to the residue , and the solution ( ph 6 ) was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 10 % naoh solution , and the mixture was extracted with chloroform ( 4 × 25 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 1 . 47 g ( 75 . 5 %) of an oil . to a solution of methyl ( 4 -( 3 - pyridyloxy ) butyl ) amine ( 1 . 25 g , 7 . 50 mmol ) in ethanol ( 15 ml ) was added galactaric acid ( 0 . 858 g , 4 . 08 mmol ). water ( 4 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 4 ml ). the filtrate was diluted with ethanol ( 40 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 16 h . the solids were filtered , washed with cold ethanol and vacuum dried at 40 ° c . to give 1 . 69 g ( 72 . 8 %) of a fine , white , crystalline powder , mp 173 - 1 75 ° c . the compound exhibits a ki of 5523 nm . the compound exhibits neurotransmitter release of 56 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 3 . 50 g , 36 . 8 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 1 . 16 g of an 80 % dispersion in mineral oil , 38 . 6 mmol ) in dmf ( 40 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the mixture was then cooled to 0 - 5 ° c ., and 1 - chloro - 4 - iodobutane ( 9 . 67 g , 44 . 2 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 2 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 6 . 89 g ( quantitative yield ) of an oil . a portion of the 4 - chloro - 1 -( 3 - pyridyloxy ) butane was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of dimethylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 10 ml ) was added to the residue , and the solution ( ph 6 ) was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 10 % naoh solution , and the mixture was extracted with chloroform ( 4 × 25 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 1 . 26 g of an oil . to a solution of dimethyl ( 4 -( 3 - pyridyloxy )) butylamine ( 1 . 26 g , 6 . 49 mmol ) in ethanol ( 10 ml ) was added galactaric acid ( 0 . 682 g , 3 . 25 mmol ). water ( 3 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 4 ml ). the filtrate was diluted with ethanol ( 80 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 16 h . very few solids precipitated . consequently , the solution was concentrated , and the residue was slurried in ether . the solids were filtered , washed with ether and vacuum dried at 40 ° c . to give 1 . 06 g ( 54 . 7 %) of a light - brown , flaky powder , mp 127 - 130 ° c . the compound exhibits a ki of 3410 nm . the compound exhibits neurotransmitter release of 24 percent . under a nitrogen atmosphere , a solution of 5 - chloro - 3 - pyridinol ( 15 . 00 g , 115 . 8 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 3 . 69 g of an 80 % dispersion in mineral oil , 123 . 0 mmol ) in dmf ( 15 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . next , 1 - chloro - 3 - iodopropane ( 28 . 4 g , 138 . 9 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 4 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 17 . 22 g ( 73 . 0 %) of an oil . the 3 - chloro - 5 -( 3 - chloropropoxy ) pyridine ( 5 . 74 g , 28 . 0 mmol ) was dissolved in methanol ( 25 ml ) and added to concentrated ammonium hydroxide solution ( 29 . 7 %, 14 . 8 m , 55 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 10 ° c . ( oil bath temperature ) for 6 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 10 ml ) was added to the residue , and the solution ( ph 6 ) was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 10 % naoh solution , and the mixture was extracted with chloroform ( 4 × 25 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 3 . 30 g ( 63 . 4 %) of an oil . to a solution of 3 -( 5 - chloro - 3 - pyridyloxy ) propylamine ( 1 . 00 g , 5 . 38 mmol ) in ethanol ( 12 ml ) was added galactaric acid ( 0 . 564 g , 2 . 688 mmol ). water ( 3 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 4 ml ). the filtrate was diluted with ethanol ( 80 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . no solids had formed . consequently , the solution was concentrated to a residue that was vacuum dried . the solids were slurried in 2 - propanol , and the 2 - propanol was evaporated . the resulting solids were slurried in anhydrous ether . the product was filtered , washed with ether and vacuum dried at 40 ° c . to give 0 . 996 g ( 63 . 5 %) of a brown , flaky powder , mp 170 - 173 ° c . the compound exhibits a ki of 46 nm ; the effect at muscle sites is 0 percent ; and the effect at ganglia sites is 4 percent . the compound exhibits neurotransmitter release of 110 percent . under a nitrogen atmosphere , a solution of 5 - chloro - 3 - pyridinol ( 15 . 00 g , 115 . 8 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 3 . 69 g of an 80 % dispersion in mineral oil , 123 . 0 mmol ) in dmf ( 15 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . next , 1 - chloro - 3 - iodopropane ( 28 . 4 g , 138 . 9 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 4 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 17 . 22 g ( 73 . 0 %) of an oil . the 3 - chloro - 5 -( 3 - chloropropoxy ) pyridine ( 5 . 74 g , 28 . 0 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph of the solution was adjusted to 6 , and impurities were extracted with ether ( 3 × 15 ml ). the aqueous layer was basified to ph 10 with 10 % naoh solution and extracted with chloroform ( 4 × 15 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 4 . 02 g ( 71 . 8 %) of an oil . to a solution of ( 3 -( 5 - chloro ( 3 - pyridyloxy )) propyl ) methylamine ( 1 . 00 g , 5 . 00 mmol ) in ethanol ( 12 ml ) was added galactaric acid ( 0 . 791 g , 3 . 76 mmol ). water ( 3 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 4 ml ). the filtrate was diluted with ethanol ( 30 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . the solids were filtered , washed and vacuum dried at 40 ° c . to give 1 . 163 g ( 76 . 3 %) of off - white , powdery crystals , mp 173 - 174 ° c . the compound exhibits a ki of 11 nm ; the effect at muscle sites is 16 percent ; and the effect at ganglia sites is 7 percent . the compound exhibits neurotransmitter release of 100 percent . this compound was prepared in 64 . 7 % yield as a white , crystalline powder ( mp 28 - 30 ° c .) using the general procedure of d . l . comins and m . o . killpack , j . org . chem . 55 : 69 - 73 ( 1990 ). crude 5 - bromo - 3 - methoxypyridine ( 3 . 50 g , 18 . 62 mmol ) was dissolved in methanol ( 50 ml ) and added to concentrated ammonium hydroxide ( 29 . 7 %, 14 . 8 m , 50 ml ) and copper ( l ) bromide ( 2 . 67 g , 18 . 62 mmol ) in a heavy - walled glass pressure - tube apparatus . the tube was flushed with nitrogen and sealed . the mixture was stirred and heated at 170 - 172 ° c . ( oil bath temperature ) for 24 h . after cooling , the solution was concentrated by rotary evaporation to a gummy residue . the residue was diluted with sodium carbonate solution ( 17 . 6 %, 200 ml ) and extracted with ch 2 cl 2 ( 4 × 50 ml ). the combined ch 2 cl 2 extracts were dried ( mgso 4 ), filtered , and concentrated by rotary evaporation to give 1 . 26 g of a cream - brown solid . the aqueous phase was re - extracted with ch 2 cl 2 ( 4 × 50 ml ). the combined ch 2 cl 2 extracts were similarly dried and concentrated to give an additional 0 . 34 g of a cream - brown solid , bringing the total yield to 1 . 60 g ( 69 . 2 %). a mixture of concentrated sulfuric acid ( 18 m , 2 . 83 ml ), water ( 3 . 84 ml ) and crushed ice ( 6 . 60 g ) was added to 5 - methoxy - 3 - pyridylamine ( 1 . 64 g , 13 . 23 mmol ). the cold mixture ( 0 - 5 ° c .) was stirred for 10 min and a solution of sodium nitrite ( 0 . 91 g , 13 . 23 mmol ) in water ( 2 . 7 ml ) was then added . after stirring for 10 min , a boiling solution of concentrated sulfuric acid ( 8 . 6 ml ) and water ( 6 . 6 ml ) was added . the mixture was heated until all solids dissolved . ice ( 5 . 0 g ) was added to cool the solution . the ph was adjusted to 8 with 10 % naoh solution . saturated nacl solution ( 100 ml ) was added , and the mixture was extracted with ethyl acetate ( 4 × 100 ml ). the combined ethyl acetate extracts were dried ( mgso 4 ), filtered and concentrated by rotary evaporation to give 0 . 50 g ( 30 . 1 %) of a brown oil . under a nitrogen atmosphere , a solution of 5 - methoxypyridin - 3 - ol ( 0 . 50 g , 4 . 01 mmol ) in dmf ( 10 ml ) was slowly added over 10 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 19 g of an 80 % dispersion in mineral oil , 6 . 33 mmol ) in dmf ( 15 ml ). the mixture was allowed to warm to ambient temperature and further stirred for 1 h . to this slurry was added drop - wise over 5 min , 1 - chloro - 3 - iodopropane ( 0 . 98 g , 4 . 81 mmol ), and the resulting dark brown mixture was stirred at ambient temperature for 4 h . cold water ( 25 ml ) was carefully added , followed by saturated nacl solution ( 25 ml ). the resulting mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered , and concentrated by rotary evaporation producing a dark - brown oil ( 0 . 75 g , 92 . 8 %). crude 5 -( 3 - chloropropoxy )- 3 - methoxypyridine ( 0 . 75 g , 3 . 73 mmol ) was dissolved in methanol ( 10 . 5 ml ) and added to a 40 wt % aqueous solution of methylamine ( 10 . 6 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the solution was concentrated by rotary evaporation . saturated nacl solution ( 50 ml ) was added , and the mixture was basified with 10 % naoh solution to ph 11 . the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered and concentrated by rotary evaporation to give 0 . 54 g of a brown oil . the product was purified by column chromatography on silica gel ( 18 g ) eluting with chcl 3 - ch 3 oh ( 1 : 1 , v / v ) to remove impurities , followed by chcl 3 - ch 3 oh - et 3 n ( 50 : 50 : 2 , v / v / v ) to collect the product . selected fractions containing the product were combined and concentrated by rotary evaporation . the resulting brown oil was dissolved in chcl 3 ( 25 ml ), dried ( mgso 4 ), filtered , and concentrated by rotary evaporation to give 0 . 228 g ( 31 . 2 %) of a brown oil . to a solution of methyl ( 3 -( 5 - methoxy - 3 - pyridyloxy ) propyl ) amine ( 0 . 228 g , 1 . 16 mmol ) in ethanol ( 4 . 3 ml ) was added galactaric acid ( 122 . 0 mg , 0 . 58 mmol ). water ( 1 . 2 ml ) was added drop - wise , while warming the solution to near reflux . to remove some white , insoluble crystals , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 1 . 4 ml ). the filtrate was diluted with ethanol ( 6 . 5 ml ), producing a white precipitate . the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . the precipitate was filtered , washed with ethanol ( 10 ml ), and vacuum dried at 40 ° c . for 24 h to give 141 . 2 mg ( 80 . 7 %) of a white , crystalline solid , mp 140 - 141 ° c . the compound exhibits a ki of 15 nm ; the effect at muscle sites is 10 percent ; and the effect at ganglia sites is 5 percent . the compound exhibits neurotransmitter release of 54 percent . potassium metal ( 6 . 59 g , 168 . 84 mmol ) was dissolved in dry 2 - propanol ( 60 . 0 ml ) under nitrogen . the resulting potassium isopropoxide was heated with 3 , 5 - dibromopyridine ( 20 . 00 g , 84 . 42 mmol ) and copper powder ( 1 g , 5 % by weight of 3 , 5 - dibromopyridine ) at 140 ° c . ( oil bath temperature ) in a sealed glass tube for 14 h . the reaction mixture was cooled to ambient temperature and extracted with diethyl ether ( 4 × 200 ml ). the combined ether extracts were dried over sodium sulfate , filtered , and concentrated by rotary evaporation . the crude product obtained was purified by column chromatography over aluminum oxide , eluting with ethyl acetate - hexane ( 1 : 9 , v / v ). selected fractions were combined and concentrated by rotary evaporation , producing a pale - yellow oil ( 12 . 99 g , 71 . 2 %). crude 5 - bromo - 3 - isopropoxypyridine ( 3 . 71 g , 17 . 18 mmol ) was dissolved in methanol ( 46 ml ) and added to concentrated ammonium hydroxide ( 29 . 7 %, 14 . 8 m , 50 ml ) and copper ( i ) bromide ( 2 . 46 g , 17 . 18 mmol ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 170 ° c . ( oil bath temperature ) for 24 h . after cooling , the solution was concentrated by rotary evaporation . sodium carbonate solution ( 17 . 6 %, 200 ml ) was added , and the mixture was extracted with ch 2 cl 2 ( 4 × 50 ml ). the combined ch 2 cl 2 extracts were dried ( mgso 4 ), filtered , and concentrated by rotary evaporation to give 1 . 88 g ( 72 . 0 %) of a brown oil . a mixture of concentrated sulfuric acid ( 18 m , 2 . 64 ml ), water ( 3 . 59 ml ) and crushed ice ( 6 . 20 g ) was added to 5 - isopropoxy - 3 - pyridylamine ( 1 . 88 g , 12 . 38 mmol ). the cold mixture ( 0 - 5 ° c .) was stirred for 10 min and a solution of sodium nitrite ( 0 . 85 g , 12 . 38 mmol ) in water ( 2 . 5 ml ) was then added . after stirring for 10 min , a boiling solution of concentrated sulfuric acid ( 8 . 0 ml ) and water ( 6 . 2 ml ) was added . the mixture was heated until all solids dissolved . ice ( 5 . 0 g ) was added to cool the solution . the ph was adjusted to 8 with 10 % naoh solution . saturated nacl solution ( 100 ml ) was added , and the mixture was extracted with ethyl acetate ( 4 × 100 ml ). the combined ethyl acetate extracts were dried ( mgso 4 ), filtered and concentrated by rotary evaporation to give 1 . 69 g ( 89 . 4 %) of a brown oil . under a nitrogen atmosphere , a solution of 5 - isopropoxypyridin - 3 - ol ( 1 . 04 g , 6 . 80 mmol ) in dmf ( 10 ml ) was slowly added over 10 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 25 g of an 80 % dispersion in mineral oil , 8 . 33 mmol ) in dmf ( 15 ml ). the mixture was allowed to warm to ambient temperature and further stirred for 1 h . to this slurry was added drop - wise over 5 min , 1 - chloro - 3 - iodopropane ( 1 . 67 g , 8 . 16 mmol ), and the resulting dark brown mixture was stirred at ambient temperature for 4 h . cold water ( 25 ml ) was carefully added , followed by saturated nacl solution ( 25 ml ). the resulting mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered , and concentrated by rotary evaporation producing a dark - brown oil ( 0 . 92 g , 59 . 0 %). crude 5 -( 3 - chloropropoxy )- 3 - isopropoxypyridine ( 0 . 92 g , 4 . 01 mmol ) was dissolved in methanol ( 10 ml ) and added to a 40 wt % aqueous solution of methylamine ( 10 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the solution was concentrated by rotary evaporation . saturated nacl solution ( 50 ml ) was added , and the mixture was basified with 100 % naoh solution to ph 11 . the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered and concentrated by rotary evaporation to give 1 . 98 g of a brown oil . the product was purified by column chromatography on silica gel ( 60 g ) eluting with hexane to remove impurities , followed by chcl 3 — ch 3 oh - et 3 n ( 50 : 50 : 2 , v / v / v ) to collect the product . selected fractions containing the product were combined and concentrated by rotary evaporation . the resulting brown oil was dissolved in chcl 3 ( 25 ml ), dried ( mgso 4 ), filtered , and concentrated by rotary evaporation to give 0 . 64 g ( 71 . 6 %) of a brown oil . to a solution of methyl ( 3 -( 5 - isopropoxy - 3 - pyridyloxy ) propyl ) amine ( 0 . 643 g , 2 . 87 mmol ) in ethanol ( 10 . 7 ml ) was added galactaric acid ( 302 . 0 mg , 1 . 44 mmol ). water ( 3 . 0 ml ) was added drop - wise , while warming the solution to near reflux . to remove some white , insoluble crystals , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 3 . 4 ml ). the filtrate was diluted with ethanol ( 16 ml ), producing a white precipitate . the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . the precipitate was filtered , washed with ethanol ( 10 ml ), and vacuum dried at 40 ° c . for 24 h to give 251 . 1 mg ( 53 . 2 %) of a white , crystalline solid , mp 118 - 120 ° c . the compound exhibits a ki of 21 nm ; the effect at muscle sites is 22 percent ; and the effect at ganglia sites is 0 percent . the compound exhibits neurotransmitter release of 36 percent . under a nitrogen atmosphere , small pieces of sodium ( 1 . 48 g , 64 . 4 mmol ) were added to benzyl alcohol ( 17 . 11 g , 158 mmol ), and the mixture was stirred and heated at 70 ° c . for 18 h . to the stirring , viscous mixture was added 3 , 5 - dibromopyridine ( 5 . 00 g , 21 . 1 mmol ), copper powder ( 0 . 255 g , 4 . 0 mmol ) and benzyl alcohol ( 15 ml ). the mixture was further heated at 100 ° c . for 48 h . the reaction mixture was allowed to cool to ambient temperature , diluted with water ( 50 ml ), and extracted with ethyl ether ( 5 × 50 ml ). the combined ether layers were dried ( na 2 so 4 ), filtered , and concentrated . distillation at 68 - 72 ° c . and 2 . 6 mm hg removed excess benzyl alcohol . the remaining yellowish , brown residue was purified by vacuum distillation at 0 . 05 mm hg to yield 3 . 17 g ( 38 . 0 %) of a white , crystalline solid , mp 64 - 66 ° c . a thick - walled glass pressure tube was charged with copper ( ii ) sulfate pentahydrate ( 1 . 96 g , 7 . 85 mmol ), 5 - bromo - 3 -( phenylmethoxy ) pyridine ( 4 . 00 g , 15 . 15 mmol ) and concentrated aqueous ammonia ( 29 . 7 %, 14 . 8 m , 37 ml ). the tube was sealed and the dark blue suspension was stirred and heated at ˜ 180 ° c . ( oil bath temperature ) for 24 h . the mixture was allowed to cool to ambient temperature . after further cooling in an ice - water bath , the mixture was concentrated on a rotary evaporator to a small volume (˜ 20 ml ) of a dark - blue solution . the solution was diluted with water ( 40 ml ) and saturated k 2 co 3 solution ( 40 ml ) and extracted with chcl 3 ( 4 × 40 ml ). the combined , turbid - brown chcl 3 extracts were washed with saturated nacl solution ( 2 × 100 ml ), dried ( na 2 so 4 ), filtered and concentrated ( rotary evaporator ). the resulting dark - brown oil , was briefly dried on the vacuum pump to give a dark - brown solid ( 2 . 06 g ). the product was purified by column chromatography on silica gel ( 100 g ) eluting with chcl 3 - meoh ( 3 : 1 , v / v ). selected fractions , based on tlc ( r f 0 . 65 ) analysis , were combined and concentrated to give a 1 . 64 g ( 54 . 1 %) of a tan - brown solid . the 5 -( phenylmethoxy )- 3 - pyridylamine ( 1 . 61 g , 8 . 00 mmol ) was stirred into concentrated sulfuric acid ( 1 . 7 ml ), water ( 2 . 5 ml ) and ice ( 4 g ). this mixture was allowed to stir for 10 min until the solution became homogeneous . to this cold , stirring solution was added a solution of sodium nitrite ( 552 mg , 8 . 00 mmol ) in water ( 2 ml ). the mixture was allowed to stir for 10 min . a boiling solution of concentrated sulfuric acid ( 5 ml ) and water ( 4 ml ) was added . the mixture was heated until all solids dissolved . ice was added to cool the reaction . the ph was adjusted to 8 with 10 % naoh solution and saturated nacl solution was added . the product was extracted with ethyl acetate ( 4 × 100 ml ). the combined ethyl acetate extracts were dried ( na 2 so 4 ), filtered , concentrated by rotary evaporation and briefly vacuum to give 1 . 52 g ( 94 . 4 %). under a nitrogen atmosphere , a solution of 5 -( phenylmethoxy )- pyridine - 3 - ol ( 1 . 52 g , 7 . 56 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 238 g of an 80 % dispersion in mineral oil , 7 . 94 mmol ) in dmf ( 15 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . next , 1 - chloro - 3 - iodopropane ( 1 . 85 g , 9 . 07 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 4 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give an oil . the 5 -( 3 - chloropropoxy )- 3 -( phenylmethoxy ) pyridine ( 1 . 52 g , 5 . 49 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph of the solution was adjusted to 6 , and impurities were extracted with ether ( 3 × 15 ml ). the aqueous layer was basified to ph 10 with 100 % naoh solution and extracted with chloroform ( 4 × 15 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 1 . 07 g ( 71 . 7 %) of an oil . to a solution of methyl ( 3 -( 5 -( phenyl methoxy )( 3 - pyridyloxy )) propyl )- amine ( 1 . 07 g , 3 . 929 mmol ) in ethanol ( 15 ml ) was added galactaric acid ( 0 . 413 g , 1 . 964 mmol ). water ( 1 . 5 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 5 ml ). the filtrate was diluted with ethanol ( 23 ml ). the mixture was allowed to cool to ambient temperature ; however , no solids precipitated . the solution was concentrated by rotary evaporation and briefly dried under high vacuum . the resulting brown solids were dissolved in a mixture of hot 2 - propanol (˜ 15 ml ) and water ( 0 . 8 ml ); the dark - brown solution was allowed to cool to ambient temperature . after 30 min of precipitation , the batch was diluted with 2 - propanol ( 30 ml ) and stored at 5 ° c . for 16 h . the resulting solids were filtered , washed with cold 2 - propanol ( 3 × 5 ml ) and vacuum dried at 45 ° c . to give 0 . 967 g ( 65 . 2 %) of a beige powder , mp 137 - 140 ° c . the compound exhibits a ki of 2 nm ; the effect at muscle sites is 1 percent ; and the effect at ganglia sites is 3 percent . the compound exhibits neurotransmitter release of 38 percent . under a nitrogen atmosphere , a solution of 5 - hydroxy - 2 - methylpyridine ( 2 . 00 g , 18 . 3 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 825 g of an 80 % dispersion in mineral oil , 27 . 5 mmol ) in dmf ( 15 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . next , 1 - chloro - 3 - iodopropane ( 4 . 49 g , 22 . 0 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 4 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 4 . 57 g of an oil . the 3 - chloro - 1 -( 6 - methyl ( 3 - pyridyloxy )) propane ( 2 . 78 g , 18 . 3 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph was adjusted to 1 with 10 % hcl solution and impurities were extracted with chloroform ( 4 × 25 ml ). the ph of the aqueous phase was raised to 7 with 10 % naoh solution and other impurities were extracted with ether ( 4 × 30 ml ). the aqueous layer was basified to ph 11 with 10 % naoh solution and extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 1 . 224 g ( 45 . 3 %) of an oil . to a solution of methyl ( 3 -( 6 - methyl ( 3 - pyridyloxy )) propyl ) amine ( 1 . 224 g , 6 . 80 mmol ) in ethanol ( 15 ml ) was added galactaric acid ( 0 . 714 g , 3 . 40 mmol ). water ( 4 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ). the filtrate was diluted with ethanol ( 20 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 72 h . the resulting solids were filtered , washed with cold ethanol , and vacuum dried at 40 ° c . to give 1 . 596 g ( 82 . 3 %) of a white , fluffy crystalline powder , mp 152 - 155 ° c . the compound exhibits a ki of 12 nm ; and the effect at muscle sites is 0 percent . the compound exhibits neurotransmitter release of 77 percent . under a nitrogen atmosphere , a solution of 3 - hydroxy - 2 - methylpyridine ( 2 . 00 g , 18 . 3 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 576 g of an 80 % dispersion in mineral oil , 19 . 2 mmol ) in dmf ( 40 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the slurry was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 4 . 49 g , 22 . 0 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 2 h . cold water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 100 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 3 . 25 g ( 96 . 2 %) of an oil . the 3 - chloro - 1 -( 2 - methyl ( 3 - pyridyloxy )) propane ( 2 . 00 g , 10 . 8 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oi i bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph of the solution was adjusted to 6 , and the mixture was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 10 % naoh solution and extracted with chloroform ( 4 × 50 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated to give 1 . 19 g ( 61 . 0 %) of an oil . to a solution of methyl ( 3 -( 2 - methyl ( 3 - pyridyloxy )) propyl ) amine ( 1 . 19 g , 6 . 61 mmol ) in ethanol ( 12 ml ) was added galactaric acid ( 0 . 696 g , 3 . 30 mmol ). water ( 3 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 4 ml ). the filtrate was diluted with ethanol ( 30 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . no solids precipitated . consequently , the solution was concentrated to a flaky solid . the solid was slurried in 2 - propanol , filtered , washed with 2 - propanol , and vacuum dried at 40 ° c . to give 1 . 37 g ( 72 . 8 %) of an off - white , flaky powder , mp 145 - 148 ° c . the compound exhibits a ki of 236 nm ; the effect at muscle sites is 0 percent ; and the effect at ganglia sites is 15 percent . the compound exhibits neurotransmitter release of 69 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 35 . 00 g , 0 . 368 mmol ) in n , n - dimethylformamide ( dmf ) ( 150 ml ) was slowly added drop - wise over 15 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 17 . 64 g of an 80 % dispersion in mineral oil , 0 . 588 mol ) in dmf ( 250 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the gray slurry was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 90 . 3 g , 0 . 442 mol ) was added drop - wise over 30 min . the resulting dark - brown mixture was allowed to stir and warm to ambient temperature over 16 h . water ( 500 ml ) was added and the mixture was divided into equal parts . each half was diluted with saturated nacl solution ( 200 ml ) and extracted with ether ( 5 × 200 ml ). all ether extracts were combined and concentrated to give 55 . 1 g ( 87 . 3 %) of a dark - brown oil . the 3 - chloro - 1 -( 3 - pyridyloxy ) propane ( 1 . 00 g , 5 . 84 mmol ) was dissolved in methanol ( 50 ml ) and added to a 2 . 0 m solution of ethylamine in tetrahydrofuran ( 5 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph of the solution was adjusted to 6 , and impurities were extracted with ether ( 3 × 15 ml ). the aqueous layer was basified to ph 10 with 10 % naoh solution and extracted with chloroform ( 4 × 15 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 400 mg ( 38 . 1 %) of an oil . to a solution of ethyl ( 3 -( 3 - pyridyloxy ) propyl ) amine ( 400 mg , 2 . 20 mmol ) in ethanol ( 11 ml ) was added galactaric acid ( 233 mg , 1 . 10 mmol ). water ( 3 . 5 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 3 . 5 ml ). the filtrate was diluted with ethanol ( 17 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . very few solids precipitated . consequently , the solution was concentrated to a residue that was vacuum dried . the solids were slurried in 2 - propanol , and the 2 - propanol was evaporated . the resulting solids were slurried in anhydrous ether . the product was filtered , washed with ether , and vacuum dried at 40 ° c . to give 348 mg ( 55 . 0 %) of a brown , flaky powder , mp 147 - 150 ° c . the compound exhibits a ki of 66 nm ; the effect at muscle sites is 13 percent ; and the effect at ganglia sites is 13 percent . the compound exhibits neurotransmitter release of 57 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 35 . 00 g , 0 . 368 mmol ) in n , n - dimethylformamide ( dmf ) ( 150 ml ) was slowly added drop - wise over 15 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 17 . 64 g of an 80 % dispersion in mineral oil , 0 . 588 mol ) in dmf ( 250 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the gray slurry was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 90 . 3 g , 0 . 442 mol ) was added drop - wise over 30 min . the resulting dark - brown mixture was allowed to stir and warm to ambient temperature over 16 h . water ( 500 ml ) was added and the mixture was divided into equal parts . each half was diluted with saturated nacl solution ( 200 ml ) and extracted with ether ( 5 × 200 ml ). all ether extracts were combined and concentrated to give 55 . 1 g ( 87 . 3 %) of a dark - brown oil . the 3 - chloro - 1 -( 3 - pyridyloxy ) propane ( 0 . 80 g , 4 . 66 mmol ) was dissolved in methanol ( 25 ml ) and added to diisopropylamine ( 25 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 10 ml ) was added to the residue , and the solution ( ph 6 ) was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 10 % naoh solution , and the mixture was extracted with chloroform ( 4 × 25 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 0 . 531 g ( 58 . 6 %) of a dark - brown oil . the compound exhibits a ki of 8500 nm . the compound exhibits neurotransmitter release of 16 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 35 . 00 g , 0 . 368 mmol ) in n , n - dimethylformamide ( dmf ) ( 150 ml ) was slowly added drop - wise over 15 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 17 . 64 g of an 80 % dispersion in mineral oil , 0 . 588 mol ) in dmf ( 250 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the gray slurry was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 90 . 3 g , 0 . 442 mol ) was added drop - wise over 30 min . the resulting dark - brown mixture was allowed to stir and warm to ambient temperature over 16 h . water ( 500 ml ) was added and the mixture was divided into equal parts . each half was diluted with saturated nacl solution ( 200 ml ) and extracted with ether ( 5 × 200 ml ). all ether extracts were combined and concentrated to give 55 . 1 g ( 87 . 3 %) of a dark - brown oil . the 3 - chloro - 1 -( 3 - pyridyloxy ) propane ( 0 . 65 g , 3 . 78 mmol ) was dissolved in methanol ( 20 ml ) and added to a mixture of benzylamine ( 13 . 5 ml ) in water ( 20 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 120 ° c . ( oil bath temperature ) for 3 h . after cooling , the mixture was concentrated by rotary evaporation , and saturated nacl solution ( 25 ml ) was added to the residue . the mixture was acidified to ph 1 with 10 % hcl solution and extracted with chcl 3 ( 2 × 35 ml ) to remove impurities . the aqueous phase was basified to ph 10 with 10 % naoh solution , and the mixture was extracted with chloroform ( 4 × 50 ml ). the combined chloroform extracts were dried ( mgso 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give a brown oil . the oil was concentrated by vacuum distillation to remove excess benzylamine ( bp 85 ° c . at 15 mm hg ). the remaining residue ( 0 . 483 g ) was purified by column chromatography on silica gel ( 25 g ) eluting with ch 3 oh — nh 4 oh ( 50 : 1 , v / v ). fractions containing the product ( r f 0 . 39 ) were combined and concentrated on a rotary evaporator . the residue was re - chromatographed on silica gel ( 10 g ). fractions containing the product were combined and concentrated on a rotary evaporator . the residue was dissolved in chcl 3 and the chcl 3 solution was dried ( mgso 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 20 mg ( 2 . 2 %) of a light - brown oil . the compound exhibits a ki of 3000 nm . the compound exhibits neurotransmitter release of 29 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 35 . 00 g , 0 . 368 mmol ) in n , n - dimethylformamide ( dmf ) ( 150 ml ) was slowly added drop - wise over 15 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 17 . 64 g of an 80 % dispersion in mineral oil , 0 . 588 mol ) in dmf ( 250 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the gray slurry was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 90 . 3 g , 0 . 442 mol ) was added drop - wise over 30 min . the resulting dark - brown mixture was allowed to stir and warm to ambient temperature over 16 h . water ( 500 ml ) was added and the mixture was divided into equal parts . each half was diluted with saturated nacl solution ( 200 ml ) and extracted with ether ( 5 × 200 ml ). all ether extracts were combined and concentrated to give 55 . 1 g ( 87 . 3 %) of a dark - brown oil . an ace glass pressure tube ( 185 ml ) was charged with 3 - chloro - 1 -( 3 - pyridyloxy ) propane ( 0 . 762 g , 4 . 437 mmol ), cyclopropylamine ( 8 . 24 g , 194 . 3 mmol ), water ( 20 ml ) and methanol ( 20 ml ). the resulting light - brown solution was heated at 120 ° c . ( oil bath temperature ) for 2 . 5 h and allowed to cool to ambient temperature over 16 h . the solution was concentrated by rotary evaporation to an oily residue that was diluted with saturated nacl solution ( 25 ml ). the mixture was acidified to ph 1 . 0 with 10 % hcl solution and extracted with chcl 3 ( 2 × 35 ml ) to remove impurities . the aqueous phase was basified to ph 6 with 10 % naoh solution and extracted ( 4 × 25 ml ) to remove other impurities . the aqueous phase was basified to ph 10 with 10 % naoh solution and extracted with chcl 3 ( 4 × 50 ml ). the combined chcl 3 extracts were dried ( na 2 so 4 ), filtered , concentrated ( rotary evaporator ) and briefly dried under high vacuum to give 0 . 250 g of a brown oil . the oil was purified by column chromatography on silica gel ( 20 g ) eluting with chcl 3 - ch 3 oh ( 100 : 2 ) to remove impurities , followed by chcl 3 - ch 3 oh - et 3 n ( 50 : 50 : 2 ) to remove the product . selected fractions were combined to give 220 mg ( 25 . 8 %) of a brown semi - solid . to a solution of cyclopropyl ( 3 -( 3 - pyridyloxy ) propyl ) amine ( 0 . 239 g , 1 . 244 mmol ) in ethanol ( 4 ml ) was added galactaric acid ( 130 . 7 mg , 622 mmol ). water ( 1 . 0 ml ) was added drop - wise , while warming the solution to near reflux . to remove some white , insoluble crystals , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 1 ml ). the filtrate was diluted with ethanol ( 6 ml ), cooled to ambient temperature and kept at 5 ° c . for 24 h . crystallization did not occur . consequently , the solution was concentrated by rotary evaporation to a brown , glassy residue . the residue was dissolved in 2 - propanol containing a few drops of water , and the solution was concentrated to a syrup . the syrup was slurried in a mixture of 2 - propanol - diethyl ether , producing a somewhat powdery solid . the solvents were evaporated on a rotary evaporator , and the resulting solids were slurried in a mixture of 2 - propanol - diethyl ether . the mixture was stored at 5 ° c . for 24 h . the solvent was decanted ; the tan solids were washed with ether ( 3 × 5 ml ), decanting the wash each time . the tan solids were dried under a stream of nitrogen and under high vacuum to give 0 . 246 g ( 66 . 5 %) of a light - beige powder , mp 124 - 1 30 ° c . the compound exhibits a ki of 165 nm ; the effect at muscle sites is 9 percent ; and the effect at ganglia sites is 10 percent . the compound exhibits neurotransmitter release of 51 percent . under a nitrogen atmosphere , a solution of 3 - hydroxypyridine ( 1 . 00 g , 10 . 52 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was slowly added to a cold ( 0 ° c . ), stirring slurry of sodium hydride ( 0 . 50 g of an 60 % dispersion in mineral oil , 12 . 63 mmol ) in dmf ( 5 ml ). after stirring 30 min , 1 , 3 - dibromobutane ( 2 . 50 g , 11 . 57 mmol ) was slowly added drop - wise . the resulting mixture was stirred at 0 - 4 ° c . for 16 h . cold water ( 10 ml ) was added , and the mixture was extracted with ether ( 3 × 100 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered and concentrated by rotary evaporation to give 2 . 23 g ( 92 . 5 %) of an oil . crude 3 - bromo - 1 -( 3 - pyridyloxy ) butane ( 2 . 00 g , 8 . 69 mmol ) from the previous step was dissolved in methanol ( 10 ml ) and added to a 40 wt % aqueous solution of methylamine ( 30 ml ) in a heavy - walled glass pressure - tube apparatus . the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 16 h . after cooling , the mixture was concentrated by rotary evaporation , and the product was extracted with chloroform ( 4 × 50 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered and concentrated by rotary evaporation to give 1 . 25 g of a pale - yellow oil . purification by vacuum distillation yielded 0 . 94 g ( 60 . 3 %) of a colorless oil , bp 65 - 67 ° c . at 0 . 5 mm hg . to a solution of methyl ( 1 - methyl - 3 -( 3 - pyridyloxy ) propyl ) amine ( 0 . 92 g , 5 . 11 mmol ) in ethanol ( 25 ml ) at 70 ° c . was added galactaric acid ( 0 . 537 g , 2 . 55 mmol ). water ( 0 . 5 ml ) was added drop - wise , while stirring producing a clear solution . some white , insoluble solids were removed by filtration . the filtrate was concentrated to 15 ml , and was allowed to cool to ambient temperature . after standing for 16 h , the precipitate was filtered , washed with ether ( 10 ml ) and vacuum dried at 45 ° c . for 18 h to give 1 . 15 g ( 78 . 9 %) of an off - white , amorphous powder , mp 134 - 136 ° c . the compound exhibits a ki of 138 nm ; the effect at muscle sites is 16 percent ; and the effect at ganglia sites is 20 percent . the compound exhibits neurotransmitter release of 49 percent . under a nitrogen atmosphere , a solution of 5 - chloro - 3 - hydroxypyridine ( 1 . 00 g , 7 . 72 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was slowly added to a cold ( 0 ° c . ), stirring slurry of sodium hydride ( 0 . 40 g of an 60 % dispersion in mineral oil , 11 . 58 mmol ) in dmf ( 5 ml ). after stirring 30 min , 1 , 3 - dibromobutane ( 1 . 83 g , 8 . 49 mmol ) was added drop - wise . the resulting mixture was stirred at 0 ° c . for 14 h . cold water ( 10 ml ) was added , and the mixture was extracted with ether ( 3 × 100 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered and concentrated by rotary evaporation to give 1 . 80 g ( 88 . 50 %) of pale - yellow oil . crude 3 - bromo - 1 -( 5 - chloro ( 3 - pyridyloxy ) butane ( 1 . 50 g , 5 . 67 mmol ) from the previous step was dissolved in methanol ( 10 ml ) and added to a 40 wt % aqueous solution of methylamine ( 40 ml ) in a heavy - walled glass pressure - tube apparatus . the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 14 h . after cooling , the mixture was concentrated by rotary evaporation , and the product was extracted with chloroform ( 3 × 100 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to give a pale - brown oil . the product was dissolved in cold , 15 % aqueous hcl ( 15 ml ), stirred at 0 ° c . for 45 min and extracted with chloroform ( 50 ml ). the aqueous layer was cooled to 0 ° c ., basified with 15 % aqueous naoh solution to ph 8 - 9 and extracted with chloroform ( 3 × 75 ml ). the combined extracts were dried ( na 2 so 4 ), filtered and concentrated by rotary evaporation to give 0 . 929 g ( 76 . 6 %) of a pale - yellow oil . to a solution of ( 3 -( 5 - chloro ( 3 - pyridyloxy ))- 1 - methylpropyl )- methylamine ( 0 . 70 g , 3 . 27 mmol ) in ethanol ( 20 ml ) at 70 ° c . was added galactaric acid ( 0 . 343 g , 1 . 63 mmol ). water ( 0 . 5 ml ) was added drop - wise while stirring , producing a clear solution . some white , insoluble solids were removed by filtration . the filtrate was concentrated to 10 ml and was allowed to cool to ambient temperature . after standing 16 h , the precipitate was filtered , washed with ether ( 10 ml ) and vacuum dried at 45 ° c . for 24 h to give 0 . 775 g ( 74 . 3 %) of a light - beige , amorphous powder , mp 155 - 157 ° c . the compound exhibits a ki of 1601 nm . the compound exhibits neurotransmitter release of 30 percent . under a nitrogen atmosphere , a solution of 3 - nitrophenol ( 15 . 00 g , 108 . 0 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 3 . 42 g of an 80 % dispersion in mineral oil , 114 . 0 mmol ) in dmf ( 40 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the mixture was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 26 . 37 g , 127 . 0 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 2 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 19 . 75 g ( 85 . 1 %) of an oil . the 1 -( 3 - chloropropoxy )- 3 - nitrobenzene ( 1 . 00 g , 4 . 65 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph of the solution was adjusted to 6 , and impurities were extracted with ether ( 3 × 15 ml ). the aqueous layer was basified to ph 10 with 10 % naoh solution and extracted with chloroform ( 4 × 15 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 493 mg ( 50 . 6 %) of an oil . to a solution of methyl ( 3 -( 3 - nitrophenoxy ) propyl ) amine ( 493 mg , 2 . 35 mmol ) in ethanol ( 10 ml ) was added galactaric acid ( 247 mg , 1 . 17 mmol ). water ( 3 . 0 ml ) was added drop - wise , while warming the solution to near reflux . to remove some white , insoluble crystals , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ). the filtrate was diluted with ethanol ( 15 ml ), producing a white precipitate . the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . the precipitate was filtered , washed with ethanol ( 10 ml ), and vacuum dried at 40 ° c . for 24 h to give 617 mg ( 83 . 5 %) of white , fluffy , crystals , mp 186 - 187 ° c . the compound exhibits a ki of 392 nm ; the effect at muscle sites is 10 percent ; and the effect at ganglia sites is 9 percent . the compound exhibits neurotransmitter release of 67 percent . under a nitrogen atmosphere , a solution of 3 - nitrophenol ( 15 . 00 g , 108 . 0 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 3 . 42 g of an 80 % dispersion in mineral oil , 114 . 0 mmol ) in dmf ( 40 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the mixture was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 26 . 37 g , 127 . 0 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 2 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 19 . 75 g ( 85 . 1 %) of an oil . under a nitrogen atmosphere , a solution of 1 -( 3 - chloropropoxy )- 3 - nitrobenzene ( 7 . 90 g , 36 . 64 mmol ) in ethanol was added to 10 % palladium on carbon in a parr hydrogenation bottle . the mixture was hydrogenated on a parr shaker . because of very little hydrogen uptake , raney ® nickel ( 50 % slurry in water ) was carefully added to the reaction mixture and hydrogenation continued . when hydrogenation was complete the mixture was filtered through a mat of celite ® filter aid . the filtrate was concentrated on a rotary evaporator to an oil . the 3 -( 3 - chloropropoxy ) phenylamine ( 1 . 98 g , 11 . 6 mmol ) was dissolved in methanol ( 25 ml ) and added to concentrated ammonium hydroxide solution ( 29 . 7 %, 14 . 8 m , 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 6 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 10 ml ) was added to the residue , and the solution ( ph 6 ) was extracted with ether ( 3 × 25 ml ) to remove impurities . the aqueous layer was basified to ph 10 with 10 % naoh solution , and the mixture was extracted with chloroform ( 4 × 25 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 1 . 37 g of an oil . to a solution of 3 -( 3 - aminopropoxy ) phenylamine ( 1 . 37 g , 8 . 25 mmol ) in ethanol ( 12 ml ) was added galactaric acid ( 0 . 867 g , 4 . 13 mmol ). water ( 3 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 4 ml ). the filtrate was diluted with ethanol ( 80 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . no solids had formed . consequently , the solution was concentrated to a residue that was vacuum dried . the solids were slurried in hot 2 - propanol and cooled to ambient temperature . the product was filtered , washed with 2 - propanol and vacuum dried at 40 ° c . to give 1 . 462 g ( 65 . 4 %) of a beige , crystalline powder , mp 182 - 185 ° c . the compound exhibits a ki of 442 nm . the compound exhibits neurotransmitter release of 14 percent . under a nitrogen atmosphere , a solution of 3 - nitrophenol ( 15 . 00 g , 108 . 0 mmol ) in n , n - dimethylformamide ( dmf ) ( 10 ml ) was added drop - wise over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 3 . 42 g of an 80 % dispersion in mineral oil , 114 . 0 mmol ) in dmf ( 40 ml ). the mixture was allowed to stir and warm to ambient temperature over 1 h . the mixture was cooled to 0 - 5 ° c ., and 1 - chloro - 3 - iodopropane ( 26 . 37 g , 127 . 0 mmol ) was added drop - wise over 5 min . the resulting dark - brown mixture was stirred at ambient temperature for 2 h . water ( 25 ml ) was added , followed by saturated nacl solution ( 25 ml ), and the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 19 . 75 g ( 85 . 1 %) of an oil . under a nitrogen atmosphere , a solution of 1 -( 3 - chloropropoxy )- 3 - nitrobenzene ( 7 . 90 g , 36 . 64 mmol ) in ethanol was added to 10 % palladium on carbon in a parr hydrogenation bottle . the mixture was hydrogenated on a parr shaker . because of very little hydrogen uptake , raney ® nickel ( 50 % slurry in water ) was carefully added to the reaction mixture and hydrogenation continued . when hydrogenation was complete the mixture was filtered through a mat of celite ® filter aid . the filtrate was concentrated on a rotary evaporator to an oil . the 3 -( 3 - chloropropoxy ) phenylamine was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 50 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the mixture was concentrated by rotary evaporation . saturated nacl solution ( 25 ml ) was added to the residue . the ph of the solution was adjusted to 6 , and impurities were extracted with ether ( 4 × 30 ml ). the aqueous layer was basified to ph 11 with 10 % naoh solution and extracted with chloroform ( 4 × 50 ml ). the combined chloroform extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation to a residue that was dried briefly under high vacuum to give 2 . 77 g of an oil . to a solution of ( 3 -( 3 - aminophenoxy ) propyl ) methylamine ( 2 . 77 g , 15 . 30 mmol ) in ethanol was added galactaric acid ( 1 . 61 g , 7 . 65 mmol ). water was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ). the filtrate was diluted with ethanol . the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . no solids had formed . consequently , the solution was concentrated to a residue that was vacuum dried . the solids were slurried in 2 - propanol , and the 2 - propanol was evaporated . the resulting solids were slurried in anhydrous ether . the product was filtered , washed with ether and vacuum dried at 40 ° c . to give 3 . 928 g ( 89 . 6 %) of brown , powdery crystals , mp 160 - 170 ° c . the compound exhibits a ki of 64 nm ; the effect at muscle sites is 11 percent ; and the effect at ganglia sites is 5 percent . the compound exhibits neurotransmitter release of 30 percent . the compound exhibits neurotransmitter release of 60 percent . under a nitrogen atmosphere , a solution of 3 -( dimethylamino ) phenol ( 3 . 50 g , 25 . 51 mmol ) in dmf ( 30 ml ) was slowly added over 10 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 80 g of an 80 % dispersion in mineral oil , 26 . 79 mmol ) in dmf ( 40 ml ). the mixture was allowed to warm to ambient temperature and further stirred for 1 . 25 h . the resulting brown mixture was cooled to 0 - 5 ° c . to this slurry was added drop - wise over 5 min , 1 - chloro - 3 - iodopropane ( 6 . 26 g , 30 . 62 mmol ). the resulting reddish brown mixture was stirred at ambient temperature for 4 . 25 h . cold water ( 35 ml ) was carefully added , followed by saturated nacl solution ( 35 ml ). the resulting mixture was extracted with ether ( 4 × 50 ml ). the combined dull - yellow ether extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation producing a light - brown oil ( 5 . 65 g ). the crude ( 3 -( 3 - chloropropoxy ) phenyl ) dimethylamine ( 4 . 06 g , 19 . 01 mmol ) was dissolved in methanol ( 30 ml ) and added to a 40 wt % aqueous solution of methylamine ( 75 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred at ambient temperature for 16 h , followed by heating at 87 ° c . ( oil bath temperature ) for 3 h . after cooling , the solution was concentrated by rotary evaporation to a lavender - brown semi - solid . saturated nacl solution ( 35 ml ) was added . the mixture was acidified to ph 1 with 10 % hcl solution and extracted with chcl 3 ( 5 × 30 ml ) to remove impurities . the dark - brown aqueous layer was basified to ph 7 with 30 % naoh solution and extracted with ether ( 4 × 40 ml ) to remove impurities . the brown aqueous layer was basified with 30 % naoh solution to ph 12 and extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered and concentrated by rotary evaporation , producing an oil . the product was dried briefly under high vacuum to afford 2 . 24 g ( 56 . 6 %) of a dark - brown oil . to a solution of dimethyl ( 3 -( 3 -( methylamino ) propoxy ) phenyl ) amine ( 2 . 23 g , 10 . 71 mmol ) in ethanol ( 34 ml ) was added galactaric acid ( 1 . 13 g , 5 . 35 mmol ). water ( 4 . 8 ml ) was added drop - wise , while warming the solution to near reflux . to remove some white , insoluble crystals , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 10 ml ). the filtrate was diluted with ethanol ( 50 ml ), producing a precipitate . the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 16 h . the precipitate was filtered , washed with ethanol ( 3 × 10 ml ) and vacuum dried at 40 ° c . for 48 h to give 2 . 95 g ( 87 . 9 %) of a fluffy , light - gray to off - white powder , mp 159 . 5 - 162 . 5 ° c . ( d ). the compound exhibits a ki of 10000 nm . the compound exhibits neurotransmitter release of 16 percent . under a nitrogen atmosphere , a solution of 8 - hydroxyjulolidine ( tetrahydro - 1h , 5h - benzo [ ij ] quinolizin - 8 - ol ) ( 2 . 00 g , 10 . 57 mmol ) in dmf ( 15 ml ) was slowly added over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 38 g of an 80 % dispersion in mineral oil , 12 . 67 mmol ) in dmf ( 15 ml ). the mixture was allowed to warm to ambient temperature and further stirred for 1 h . to this slurry was added drop - wise over 5 min , 1 - chloro - 3 - iodopropane ( 2 . 59 g , 12 . 67 mmol ), and the resulting brown mixture was stirred at ambient temperature for 4 h . cold water ( 25 ml ) was carefully added , followed by saturated nacl solution ( 25 ml ). the resulting mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered , concentrated by rotary evaporation to a residue that was dried briefly under high vacuum producing 1 . 90 g ( 67 . 6 %) of an oil . crude 3 - chloro - 1 - tricyclo [ 7 . 3 . 1 . 0 & lt ; 5 , 13 & gt ; tridec - 2 - yloxypropane ( 1 . 90 g , 7 . 15 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 20 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the solution was concentrated by rotary evaporation , and saturated nacl solution ( 50 ml ) was added . the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered and concentrated by rotary evaporation to give a residue ( 2 . 60 g ). the residue was purified by column chromatography on silica gel ( 60 g ) eluting with chcl 3 - ch 3 oh ( 1 : 1 , v / v ) to remove impurities , followed by chcl 3 - ch 3 oh - et 3 n ( 50 : 50 : 2 , v / v / v ) to collect the product . selected fractions containing the product were combined and concentrated by rotary evaporation to afford 1 . 694 g ( 91 . 0 %) of material . to a solution of methyl ( 3 - tricyclo [ 7 . 3 . 1 . 0 & lt ; 5 , 13 & gt ;] tridec - 2 - yloxypropyl ) amine ( 1 . 694 g , 6 . 51 mmol ) in ethanol ( 23 ml ) was added galactaric acid ( 0 . 656 g , 3 . 12 mmol ). water ( 6 . 6 ml ) was added drop - wise , while warming the solution to near reflux . upon cooling the mixture to ambient temperature , the resulting precipitate was filtered . the solids were collected and dissolved in a mixture of methanol ( 50 ml ) and water ( 75 ml ), while warming the solution to near reflux . the warm solution was filtered to remove a few insoluble solids and cooled . however , crystallization did not occur . the solution was concentrated , and the resulting solids were recrystallized from ethanol - water . after cooling at 5 ° c . for 48 h , the precipitate was filtered , washed with ethanol and vacuum dried at 40 ° c . for 16 h to give 0 . 699 g ( 29 . 4 %) of a yellow , crystalline solid , mp 169 - 171 ° c . the compound exhibits a ki of 100000 nm . under a nitrogen atmosphere , a solution of 3 - methoxyphenol ( 2 . 00 g , 16 . 11 mmol ) in dmf ( 10 ml ) was slowly added over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 70 g of an 80 % dispersion in mineral oil , 23 . 33 mmol ) in dmf ( 15 ml ). the mixture was allowed to warm to ambient temperature and further stirred for 1 h . to this slurry was added drop - wise over 5 min , 1 - chloro - 3 - iodopropane ( 3 . 95 g , 19 . 32 mmol ), and the resulting brown mixture was stirred at ambient temperature for 4 h . cold water ( 25 ml ) was carefully added , followed by saturated nacl solution ( 25 ml ). the resulting mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered , concentrated by rotary evaporation to a residue that was dried briefly under high vacuum producing a light - brown oil ( 3 . 27 g , quantitative yield ). crude 3 - chloro - 1 -( 3 - methoxyphenoxy ) propane ( 1 . 27 g , 6 . 33 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 25 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the solution was concentrated by rotary evaporation , and saturated nacl solution ( 50 ml ) was added . the mixture was acidified to ph 1 with 10 % hcl solution , and extracted with chcl 3 ( 4 × 25 ml ) to remove impurities . the ph of the aqueous phase was adjusted to 7 with 10 % naoh solution , and the mixture was extracted with ether ( 4 × 30 ml ) to remove impurities . the aqueous phase was basified with 100 % naoh solution to ph 11 . the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered and concentrated by rotary evaporation to give a residue . the residue was briefly dried under high vacuum producing a light - brown oil ( 0 . 11 g ). the oil was purified by column chromatography on silica gel ( 10 g ) eluting with chcl 3 - ch 3 oh ( 1 : 1 , v / v ) to remove impurities , followed by chcl 3 - ch 3 oh - et 3 n ( 50 : 50 : 2 , v / v / v ) to collect the product ( r f 0 . 27 ). selected fractions containing the product were combined and concentrated by rotary evaporation . the resulting brown oil was dissolved in chcl 3 , and the chcl 3 solution was dried ( mgso 4 ), filtered and concentrated by rotary evaporation to a residue . the residue was dried briefly under vacuum to give 0 . 021 g ( 1 . 7 %) of a light - brown oil . the compound exhibits a ki of 5300 nm . under a nitrogen atmosphere , a solution of sesamol ( 2 . 00 g , 14 . 48 mmol ) in dmf ( 15 ml ) was slowly added over 5 min to a cold ( 0 - 5 ° c . ), stirring slurry of sodium hydride ( 0 . 65 g of an 80 % dispersion in mineral oil , 21 . 67 mmol ) in dmf ( 10 ml ). the mixture was allowed to warm to ambient temperature and further stirred for 1 h . to this slurry was added drop - wise over 5 min , 1 - chloro - 3 - iodopropane ( 3 . 55 g , 17 . 37 mmol ), and the resulting brown mixture was stirred at ambient temperature for 4 h . cold water ( 25 ml ) was carefully added , followed by saturated nacl solution ( 25 ml ). the resulting mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered , concentrated by rotary evaporation to a residue that was dried briefly under high vacuum producing a brown oil . crude 1 - benzo [ 3 , 4 - d ] 1 , 3 - dioxolan - 5 - yloxy - 3 - chloropropane ( 1 . 95 g , 9 . 1 mmol ) was dissolved in methanol ( 25 ml ) and added to a 40 wt % aqueous solution of methylamine ( 25 ml ) in a heavy - walled glass pressure - tube apparatus . the tube was sealed and the mixture was stirred and heated at 100 ° c . ( oil bath temperature ) for 4 h . after cooling , the solution was concentrated by rotary evaporation , and saturated nacl solution ( 50 ml ) was added . the mixture was acidified to ph 1 with 10 % hcl solution , and extracted with chcl 3 ( 4 × 25 ml ) to remove impurities . the ph of the aqueous phase was adjusted to 7 with 10 % naoh solution , and the mixture was extracted with ether ( 4 × 30 ml ) to remove impurities . the aqueous phase was basified with 10 % naoh solution to ph 11 . the mixture was extracted with ether ( 4 × 50 ml ). the combined ether extracts were dried ( mgso 4 ), filtered and concentrated by rotary evaporation to give a residue . the residue was briefly dried under high vacuum producing a light - brown oil ( 0 . 286 g ). the oil was purified by column chromatography on silica gel ( 20 g ) eluting with chcl 3 - ch 3 oh ( 1 : 1 , v / v ) to remove impurities , followed by chcl 3 - ch 3 oh - et 3 n ( 50 : 50 : 2 , v / v / v ) to collect the product ( r f 0 . 14 ). selected fractions containing the product were combined and concentrated by rotary evaporation . the resulting brown oil was dissolved in chcl 3 and the chcl 3 solution was dried ( mgso 4 ), filtered and concentrated by rotary evaporation to a residue . the residue was dried under vacuum at 40 ° c . to give 0 . 274 g ( 14 . 4 %) of a brown oil . to a solution of ( 3 - benzo [ 3 , 4 - d ] 1 , 3 - dioxolan - 5 - yloxypropyl ) methylamine ( 0 . 252 g , 1 . 21 mmol ) in ethanol ( 6 ml ) was added galactaric acid ( 140 . 0 mg , 0 . 67 mmol ). water ( 1 . 5 ml ) was added drop - wise , while warming the solution to near reflux . to remove some white , insoluble crystals , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 1 . 5 ml ). the filtrate was diluted with ethanol ( 7 . 5 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . the precipitate was filtered , washed with ether , and vacuum dried at 40 ° c . for 16 h to give 301 mg ( 79 . 4 %) of a white , crystalline solid , mp 158 - 160 ° c . the compound exhibits a ki of 16600 nm . the compound exhibits neurotransmitter release of 41 percent . this compound was prepared as light - yellow , crystalline plates , mp 71 - 73 . 5 ° c . ( literature mp 74 - 75 °) using the general procedure of p . houghton and g . r . humphrey , european patent application no . 0470668 a1 ( merck sharp and dohme , inc .). a mixture of n -( tert - butoxycarbonyl )- piperidin - 4 - one ( 4 . 90 g , 24 . 59 mmol ), sodium borohydride ( 1 . 52 g , 40 . 18 mmol ) and methanol was stirred for 10 h . the solvent was removed by rotary evaporation . the residue was treated with portions of acetone ( 4 × 20 ml ) and evaporated each time on a rotary evaporator . water ( 10 ml ) was added and the product was extracted with chcl 3 ( 4 × 20 ml ). the combined chcl 3 extracts were dried ( k 2 co 3 ), filtered and concentrated to afford 3 . 80 g ( 76 . 8 %) of a thick syrup , that solidified upon standing . under a nitrogen atmosphere , a cold ( 0 - 5 ° c . ), stirring solution of n -( tert - butoxycarbonyl )- piperidin - 4 - ol ( 800 mg , 3 . 98 mmol ), 3 - hydroxypyridine ( 378 mg , 3 . 98 mmol ) and triphenylphosphine ( 1 . 148 g , 4 . 38 mmol ) in dry tetrahydrofuran ( 20 ml ) was treated drop - wise via syringe with diethyl azodicarboxylate ( 0 . 75 ml , 830 mg , 4 . 76 mmol ). the mixture was allowed to stir and warm to ambient temperature over 16 h . the solvent was removed by rotary evaporation , and the crude product was purified by column chromatography over silica gel , eluting with hexane - ethyl acetate ( 9 : 1 , v / v ). selected fractions were collected and concentrated to produce 800 mg ( 72 . 2 %) of a thick syrup . a cold ( 0 - 5 ° c . ), stirring solution of 3 -( n -( tert - butoxycarbonyl )- 4 - piperidinyloxy ) pyridine ( 500 mg , 1 . 796 mmol ) in anisole ( 8 ml ) was treated with trifluoroacetic acid ( 8 ml , 11 . 84 g , 103 . 8 mmol ). the resulting solution was stirred for 30 min . the volatiles were removed on a rotary evaporator , and the residue was neutralized and basified to ph 9 with solid k 2 co 3 and water . the mixture was extracted with chloroform ( 4 × 20 ml ). the combined chloroform extracts were dried ( k 2 co 3 ), filtered and concentrated . the crude product was purified by column chromatography over silica gel , eluting with chloroform - acetone ( 9 : 1 , v / v ). selected fractions were collected and concentrated to give 260 mg ( 81 . 2 %) of an off - white , viscous liquid . concentrated hcl ( 2 ml ) was added to 3 -( 4 - piperidinyloxy ) pyridine ( 260 mg , 1 . 459 mmol ), and the resulting solution was concentrated by rotary evaporation . ethanol was added to the residue and removed by rotary evaporation to dry the product . the procedure was repeated several times until a solid was obtained . the resulting material was recrystallized from 2 - propanol . the solids were filtered and dried under vacuum to afford 233 mg ( 63 . 7 %) of an off - white solid , mp 152 - 155 ° c . the compound exhibits a ki of 592 nm ; the effect at muscle sites is 16 percent ; and the effect at ganglia sites is 9 percent . under a nitrogen atmosphere , di - tert - butyl dicarbonate ( 12 . 53 g , 57 . 39 mmol ) was slowly added in portions to a cold ( 0 - 5 ° c . ), stirring solution of ( r )-(+)- 3 - pyrrolidinol ( 5 . 00 g , 57 . 39 mmol ) in tetrahydrofuran ( 30 ml ). the light yellow solution was allowed to stir and warm to ambient temperature over several hours . the solution was concentrated ( rotary evaporation and high vacuum ) to give a yellow oil . the oil was treated with saturated nahco 3 solution ( 100 ml ) and extracted with etoac ( 3 × 75 ml ). the combined etoac extracts were dried ( na 2 so 4 ), filtered , concentrated by rotary evaporation and vacuum dried to give a yellow oil containing colorless crystals . the product was recrystallized from etoac - cyclohexane (˜ 1 : 1 - 1 : 2 ). the mixture was cooled at 5 ° c . for 16 h . the off - white crystals were filtered , washed with cyclohexane ( 2 × 5 ml ) and vacuum dried at 40 ° c . for 16 h affording 7 . 36 g ( 68 . 5 %) of off - white , slightly yellow crystals , mp 62 . 5 - 65 . 5 ° c ., literature mp 62 - 65 ° c . ( p . g . houghton et al ., j . chem . soc . perkin trans 1 ( issue 13 ): 1421 - 1424 ( 1993 ), [ α ] 20 . 5 d − 25 . 0 ° ( c 1 . 0 , ch 2 cl 2 ), literature [ α ] d − 22 . 7 ° ( c 1 . 0 , ch 2 cl 2 ). the crystallization liquors were concentrated , and the syrup was cooled at 5 ° c . the resulting yellow crystals were filtered , washed with cyclohexane and vacuum dried at 40 ° c . producing an additional 2 . 98 g of a yellow powder , mp 60 . 5 - 62 . 5 ° c . bringing the total yield to 10 . 34 g ( 96 . 2 %). under a nitrogen atmosphere , diethyl azodicarboxylate ( 4 . 65 g , 26 . 70 mmol ) was added to a cold ( 0 - 5 ° c . ), stirring solution of triphenylphosphine ( 7 . 00 g , 26 . 70 mmol ) in dry tetrahydrofuran ( 60 ml , distilled from sodium and benzophenone ). the mixture was stirred at 0 - 5 ° c . for 15 min . the resulting yellow solution was treated drop - wise at 0 - 5 ° c . with a solution of ( 3r )- n -( tert - butoxycarbonyl )- 3 - hydroxypyrrolidine ( 2 . 50 g , 13 . 35 mmol ) in dry thf ( 20 ml ) producing a thick yellow mixture . at 0 - 5 ° c ., 3 - hydroxypyridine ( 2 . 54 g , 26 . 70 mmol ) was added in one portion . the resulting yellow solution was allowed to stir and warm to ambient temperature over 24 h . the solution was diluted with ch 2 cl 2 ( 150 ml ) and washed with saturated k 2 co 3 solution ( 2 × 100 ml ). the combined ch 2 cl 2 extracts were dried ( na 2 so 4 ), filtered , concentrated by rotary evaporation and briefly dried under high vacuum to give a viscous , light - yellow gel . the crude product was purified by column chromatography on silica gel ( 302 g ), eluting with chcl 3 - ch 3 oh ( 95 : 5 , v / v ). selected fractions containing the product ( r f 0 . 44 ) were combined and concentrated to afford 2 . 50 g of a light - yellow oil , that contained solids . impure fractions were combined and concentrated to give 16 g of solids . the solids were triturated with pentane ( 4 × 75 ml ) in an ultrasonic bath , and the pentane filtrate was concentrated to give 3 . 40 g of an oil . the oil was chromatographed on siica gel ( 180 g ), eluting with chcl 3 - acetone ( 4 : 1 , v / v ). selected fractions containing the product ( r f 0 . 29 ) were combined and concentrated to afford 1 . 23 g of a light - yellow oil . the 2 . 50 g lot was triturated with pentane ( 2 × 50 ml ) in an ultrasonic bath and the pentane filtrate was concentrated . the resulting oil was purified by column chromatography on silica gel ( 50 g ), eluting with chcl 3 - acetone ( 4 : 1 , v / v ). selected fractions containing the product were combined and concentrated to give 0 . 58 g of a light - yellow oil . impure fractions from the latter column were combined and concentrated , and the residue was chromatographed on silica gel ( 50 g ) to give 0 . 28 g of a light - yellow oil . all purified materials were combined , concentrated and dried under high vacuum to yield 1 . 83 g ( 51 . 9 %) of a light - yellow oil . under a nitrogen atmosphere , a cold ( 0 - 5 ° c . ), stirring solution of 3 -(( 3s )- n -( tert - butoxycarbonyl )- 3 - pyrrolidinyloxy ) pyridine ( 0 . 535 g , 2 . 024 mmol ) in dry ch 2 cl 2 ( 5 ml , distilled from lialh 4 ) was treated drop - wise with trifluoroacetic acid ( 3 ml , 4 . 44 g , 38 . 94 mmol ). after stirring 30 min at 0 - 5 ° c ., the solution was concentrated by rotary evaporation . the residue was acidified with 1 m hcl solution ( 15 ml ) and extracted with toluene ( 4 × 25 ml ) to remove impurities ( triphenylphosphine oxide ). at 0 - 5 ° c ., the aqueous layer was basified with 1 m naoh solution to ph 12 . the mixture was saturated with nacl and extracted with chcl 3 ( 8 × 20 ml ). the combined chcl 3 extracts were dried ( na 2 so 4 ), filtered , concentrated by rotary evaporation and briefly dried under high vacuum to give 240 mg ( 72 . 3 %) of a light - yellow oil . concentrated hcl ( 2 ml ) was added drop - wise to 3 -(( 3s )- 3 - pyrrolidinyloxy ) pyridine ( 240 mg , 1 . 462 mmol ), and the resulting solution was concentrated by rotary evaporation . ethanol was added to the residue and removed by rotary evaporation to dry the product . the procedure was repeated several times until a solid was obtained . ethanol ( 1 ml ) was added , and the resulting solution was treated with hot 2 - propanol producing a precipitate . the solution was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . the solids were filtered and dried under vacuum at 40 ° c . for 16 h to afford 215 mg ( 62 . 0 %) of a hygroscopic , light - brown , granular solid , mp 145 - 148 ° c ., [ α ] 20 . 5 d + 26 . 67 ° ( c 1 . 0 , meoh ). the compound exhibits a ki of 230 nm . under a nitrogen atmosphere , a solution of diethyl azodicarboxylate ( 6 . 80 g . 39 . 0 mmol ) in tetrahydrofuran ( thf ) ( 25 ml ) was added drop - wise at ambient temperature to a stirring solution of triphenylphosphine ( 10 . 23 g , 390 mmol ) in thf ( 100 ml ). the resulting solution was allowed to stir at ambient temperature for 30 min . 4 - hydroxy - 1 - methylpiperidine ( 3 . 05 g , 26 . 5 mmol ) and 3 - hydroxypyridine ( 3 . 71 g , 39 . 0 mmol ) were added , and the reaction mixture was stirred at ambient temperature for 18 h . the solution was concentrated by rotary evaporation , and the resulting residue was dissolved in chcl 3 ( 100 ml ). the suspension was cooled in an ice - water bath , and a solution of 1 m hcl ( 75 ml ) was added with stirring . the aqueous phase was separated . the organic phase was extracted with water ( 3 × 75 ml ). the combined aqueous extracts were cooled in an ice - water bath , basified with 1 m naoh solution ( 125 ml ) to ph ˜ 11 and extracted with chcl 3 ( 6 × 50 ml ). the combined organic extracts were dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation . the crude product was dissolved in chcl 3 ( 75 ml ), and the chcl 3 solution was extracted with 1 m naoh solution ( 4 × 25 ml ) to remove residual 3 - hydroxypyridine . the chcl 3 phase was separated , and the combined naoh layers were back extracted with chcl 3 ( 3 × 50 ml ). all chcl 3 extracts were combined , dried ( na 2 so 4 ), filtered , and concentrated by rotary evaporation . the resulting oil was purified by vacuum distillation using a test - tube distillation apparatus , collecting the fraction with bp 83 - 93 ° c . at 0 . 10 - 0 . 075 mm hg . further purification by a second vacuum distillation yielded 120 mg ( 2 . 4 %) of a colorless oil , bp 72 - 75 ° c . at 0 . 75 mm hg . the compound exhibits a ki of 4897 nm . under a nitrogen atmosphere , a mixture of 2 - mercaptoethanol ( 3 . 30 g , 42 . 21 mmol ), sodium hydroxide ( 1 . 69 g , 42 . 21 mmol ) and n , n - dimethylformamide ( 50 ml ) was stirred at ambient temperature for 4 h . the resulting solution was cooled to 0 - 5 ° c . and 3 , 5 - dibromopyridine ( 8 . 00 g , 33 . 77 mmol ) was added in one portion . the mixture was stirred at 0 - 5 ° c . for 20 min , warmed to ambient temperature and further stirred for 1 h . tlc analysis on silica gel eluting with etoac - hexane ( 3 : 1 ) indicated an incomplete reaction . therefore , the mixture was heated at 75 ° c . ( oil bath temperature ) for 17 h . after cooling to ambient temperature , the mixture was poured into water ( 250 ml ) and extracted with ether ( 3 × 75 ml ). the combined ether extracts were dried ( na 2 so 4 ), filtered and concentrated ( rotary evaporator ) to a light - yellow oil . the oil was vacuum distilled using a short - path distillation apparatus to afford 4 . 55 g ( 57 . 5 %) of a light - yellow oil , bp 138 - 140 ° c . at 0 . 35 mm hg . under a nitrogen atmosphere , a cold ( 0 - 5 ° c . ), stirring solution of 2 -( 5 - bromo - 3 - pyridylthio ) ethan - 1 - ol ( 1 . 00 g , 4 . 27 mmol ) in dichloromethane ( 4 ml ) containing pyridine ( 3 drops ) was treated in one portion with p - toluenesulfonyl chloride ( 0 . 855 g , 4 . 49 mmol ). the resulting solution was allowed to warm to ambient temperature over 16 h . the solution was concentrated on a rotary evaporator , and the oily residue was dried under high vacuum to give a light - beige solid . the solid was partitioned between saturated k 2 co 3 solution ( 12 ml ) and chcl 3 ( 10 ml ). the chcl 3 phase was separated and the aqueous phase was extracted with chcl 3 ( 3 × 10 ml ). all chcl 3 extracts were combined and washed with saturated nacl solution ( 10 ml ). the chcl 3 extracts were concentrated ( rotary evaporator ) to an oil that was dried under high vacuum to yield a light beige solid ( 1 . 83 g ). the solid was transferred to a heavy - walled glass pressure - tube apparatus with methanol ( 10 ml ), and a 40 wt % aqueous solution of methylamine ( 26 ml ) was added . the tube was sealed and the mixture was stirred and heated at 115 ° c . ( oil bath temperature ) for 45 min . the resulting solution was allowed to cool to ambient temperature and was further stirred for 16 h . the solution was concentrated on a rotary evaporator . the resulting oil was basified with 1 m naoh solution ( 10 ml ) and extracted with chcl 3 ( 4 × 10 ml ). the combined chcl 3 extracts were washed with saturated nacl solution ( 10 ml ), dried ( na 2 so 4 ), filtered and concentrated to a brown oil ( 1 . 22 g ). the crude product was purified by column chromatography on silica gel ( 50 g ), eluting with etoac - hexane ( 3 : 1 , v / v ) to collect 2 -( 5 - bromo - 3 - pyridylthio ) ethan - 1 - ol ( r f 0 . 25 ) ( 0 . 47 g ). further elution with meoh - et 3 n ( 97 : 3 , v / v ) afforded 0 . 38 g ( 35 . 6 %) of ( 2 -( 5 - bromo ( 3 - pyridylthio )) ethyl ) methylamine ( r f 0 . 49 ) as a light - yellow oil . to a solution of ( 2 -( 5 - bromo ( 3 - pyridylthio )) ethyl ) methylamine ( 352 . 3 mg , 1 . 43 mmol ) in ethanol ( 5 ml ) was added galactaric acid ( 150 . 0 mg , 0 . 71 mmol ). water ( 2 ml ) was added drop - wise , while gently warming the solution . to remove some white , insoluble crystals , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 2 ml ). the filtrate was diluted with ethanol ( 9 . 5 ml ), producing a white precipitate . the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 48 h . the precipitate was filtered , washed with ethanol ( 4 ml ) and vacuum dried at 45 ° c . for 18 h to give 437 . 5 mg ( 87 . 2 %) of a white , crystalline powder , mp 161 . 5 - 166 ° c . ( d ). the compound exhibits a ki of 3400 nm . under a nitrogen atmosphere , a mixture of 1 - mercapto - 2 - propanol ( 3 . 89 g , 42 . 21 mmol ), sodium hydroxide ( 1 . 69 g , 42 . 21 mmol ) and n , n - dimethylformamide ( dmf ) ( 40 ml ) was heated at 105 ° c . ( oil bath temperature ) for 2 h . the resulting solution was cooled to ambient temperature and 3 , 5 - dibromopyridine ( 8 . 00 g , 33 . 77 mmol ) was added in one portion using additional dmf ( 10 ml ). the mixture was stirred at ambient temperature for 48 h . the turbid mixture was then heated under nitrogen at 85 ° c . ( oil bath temperature ) for 18 h . the mixture was cooled to ambient temperature , diluted with water ( 250 ml ) and extracted with ether ( 3 × 75 ml ). the combined ether extracts were washed with saturated nacl solution ( 100 ml ), dried ( na 2 so 4 ), filtered and concentrated to a light - yellow foam ( 9 . 19 g ). the crude product was purified by column chromatography on silica gel ( 225 g ), eluting with etoac - hexane ( 3 : 1 , v / v ). fractions containing the product ( r f 0 . 38 ) were combined and concentrated to give 3 . 78 g ( 45 . 1 %) of a light - yellow oil . under a nitrogen atmosphere , a cold ( 0 - 5 ° c . ), stirring solution of 1 -( 5 - bromo - 3 - pyridylthio ) propan - 2 - ol ( 1 . 80 g , 7 . 25 mmol ) in dichloromethane ( 8 ml ) containing pyridine ( 3 drops ) was treated in one portion with p - toluenesulfonyl chloride ( 1 . 452 g , 7 . 07 mmol ). the resulting solution was allowed to warm to ambient temperature over 16 h . tlc analysis on silica gel eluting with etoac - hexane ( 3 : 1 , v / v ) indicated an incomplete reaction . therefore , additional p - toluenesulfonyl chloride ( 0 . 28 g , 1 . 45 mmol ), triethylamine ( 1 ml ) and pyridine ( 1 ml ) were added . the mixture was allowed to stir under nitrogen for 48 h . the solution was concentrated on a rotary evaporator to a red oil . the oil was cooled to 0 - 5 ° c ., basified with saturated k 2 co 3 solution ( 40 ml ) and extracted with ch 2 cl 2 ( 3 × 25 ml ). the combined ch 2 cl 2 extracts were washed with saturated nacl solution ( 50 ml ), dried ( na 2 so 4 ), filtered , concentrated ( rotary evaporator , using toluene ( 3 × 20 ml ) to azeotropically remove pyridine ) and further dried under high vacuum to afford a dark - red oil ( 2 . 65 g ). the oil was dissolved in methanol ( 20 ml ) and transferred to a heavy - walled glass pressure - tube apparatus . a 40 wt % aqueous solution of methylamine ( 80 ml ) was added . the tube was sealed and the mixture was stirred and heated at 1 20 ° c . for 2 . 5 h . the resulting brown solution was allowed to cool to ambient temperature and was further stirred for 16 h . the solution was concentrated to a dark - brown oil . at 0 - 5 ° c ., the oil was basified with 1 m naoh solution ( 20 ml ) and extracted with chcl 3 ( 6 × 20 ml ). the combined chcl 3 extracts were washed with saturated nacl solution ( 10 ml ), dried ( na 2 so 4 ), filtered , concentrated and further dried under high vacuum to yield a brown oil ( 1 . 56 g ). the crude product was purified by column chromatography on silica gel ( 80 g ), eluting with etoac - hexane ( 3 : 1 , v / v ) to collect 1 -( 5 - bromo - 3 - pyridylthio ) propan - 2 - ol ( r f 0 . 38 ) ( 0 . 05 g ). further elution with meoh - et 3 n ( 97 : 3 , v / v ) afforded a brown oil ( r f 0 . 58 ). the oil was dissolved in chcl 3 . the chcl 3 solution was dried ( na 2 so 4 ), filtered , concentrated and further dried under high vacuum to yield 1 . 01 g of ( 2 -( 5 - bromo ( 3 - pyridylthio ))- isopropyl ) methylamine and ( 2 -( 5 - bromo ( 3 - pyridylthio )) propyl ) methylamine as a 56 : 38 mixture , respectively . the mixture was used without further purification . a hot solution of the mixture of ( 2 -( 5 - bromo ( 3 - pyridylthio ))- isopropyl ) methylamine and ( 2 -( 5 - bromo ( 3 - pyridylthio )) propyl ) methylamine ( 1 . 01 g , 3 . 867 mmol ) in ethanol ( 15 ml ) was treated in one portion with galactaric acid ( 0 . 406 g , 1 . 937 mmol ). water ( 3 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 5 ml ). the filtrate was diluted with ethanol ( 22 . 5 ml ). the mixture was allowed to cool to ambient temperature and was allowed to stand for 16 h . the resulting solids were filtered , washed with ethanol ( 2 × 5 ml ), and vacuum dried at 45 ° c . to give 0 . 512 g ( 36 . 1 %) of light - beige , crystalline flakes , mp 146 . 5 - 149 . 5 ° c . analysis indicated a 57 : 41 mixture of ( 2 -( 5 - bromo ( 3 - pyridylthio ))- isopropyl ) methylamine hemigal actarate and ( 2 -( 5 - bromo ( 3 - pyridylthio ))- propyl ) methylamine hemigalactarate . the compound exhibits a ki of 5500 nm . under a nitrogen atmosphere , a mixture of 3 - mercapto - 1 - propanol ( 3 . 89 g , 42 . 21 mmol ), sodium hydroxide ( 1 . 69 g , 42 . 21 mmol ) and n , n - dimethylformamide ( dmf ) ( 40 ml ) was heated at 45 ° c . ( oil bath temperature ) for 4 h . the resulting solution was cooled to ambient temperature and 3 , 5 - dibromopyridine ( 8 . 00 g , 33 . 77 mmol ) was added in one portion . the mixture was stirred and heated at 55 ° c . ( oil bath temperature ) for 60 h . the mixture was cooled to ambient temperature , diluted with water ( 250 ml ), treated with saturated nacl solution and extracted with ether ( 4 × 75 ml ). the combined ether extracts were washed with saturated nacl solution ( 100 ml ), dried ( na 2 so 4 ), filtered and concentrated . the residue was dried under high vacuum to give a light - yellow oil ( 8 . 25 g ). the crude product was purified by vacuum distillation to afford 6 . 79 g ( 81 . 0 %) of a very pale - yellow oil , bp 148 - 152 ° c . at 0 . 5 mm hg . under a nitrogen atmosphere , a cold ( 0 - 5 ° c . ), stirring solution of 3 -( 5 - bromo - 3 - pyridylthio ) propan - 1 - ol ( 6 . 64 g , 26 . 77 mmol ) in dichloromethane ( 35 ml ) and triethylamine ( 35 ml ) was treated in one portion with p - toluenesulfonyl chloride ( 5 . 36 g , 28 . 11 mmol ). the resulting solution was allowed to warm to ambient temperature and was further stirred for 48 h . the solution was concentrated on a rotary evaporator . the residue was basified at 0 - 5 ° c . with saturated k 2 co 3 solution ( 75 ml ) and extracted with ch 2 cl 2 ( 4 × 10 ml ). the combined ch 2 cl 2 extracts were washed with saturated nacl solution ( 100 ml ), dried ( na 2 so 4 ), filtered and concentrated ( rotary evaporator ) to a dark red oil ( 10 . 22 g ). the oil was transferred to a heavy - walled glass pressure - tube apparatus with methanol ( 25 ml ), and a 40 wt % aqueous solution of methylamine ( 100 ml ) was added . the tube was sealed and the mixture was stirred and heated at 120 ° c . ( oil bath temperature ) for 2 h . the resulting solution was allowed to cool to ambient temperature and was further stirred for 16 h . the solution was concentrated on a rotary evaporator . the resulting oil was basified with 1 m naoh solution ( 30 ml ) and extracted with chcl 3 ( 5 × 30 ml ). the combined chcl 3 extracts were washed with saturated nacl solution ( 50 ml ), dried ( na 2 so 4 ), filtered and concentrated to a brown oil . the crude product was purified by column chromatography on silica gel ( 190 g ), eluting with etoac - hexane ( 3 : 1 , v / v ) to collect 3 -( 5 - bromo - 3 - pyridylthio ) propan - 1 - ol ( r f 0 . 40 ) ( 0 . 46 g ). further elution with meoh - et 3 n ( 97 : 3 , v / v ) afforded 4 . 52 g ( 64 . 6 %) of 3 -( 5 - bromo - 3 - pyridylthio )) propyl ) methylamine ( r f 0 . 27 ) as a light - yellow oil . a hot solution of 3 -( 5 - bromo - 3 - pyridylthio )) propyl ) methylamine ( 1 . 00 g , 3 . 828 mmol ) in ethanol ( 15 ml ) was treated in one portion with galactaric acid ( 0 . 402 g , 1 . 914 mmol ). water ( 3 ml ) was added drop - wise , while warming the solution to reflux . to remove some white , insoluble solids , the warm solution was filtered through a glass wool plug , washing the filter plug with a warm solution of ethanol - water ( 4 : 1 , v / v ) ( 5 ml ). the filtrate was diluted with ethanol ( 22 . 5 ml ). the mixture was allowed to cool to ambient temperature and was further cooled at 5 ° c . for 16 h . the resulting solids were filtered , washed with ethanol ( 5 ml ), and vacuum dried at 40 ° c . to give 1 . 28 g ( 91 . 3 %) of an off - white , crystalline powder , mp 152 . 5 - 154 . 5 ° c . the compound exhibits a ki of 39950 nm . the foregoing is illustrative of the present invention and is not to be construed as limiting thereof . the invention is defined by the following claims , with equivalents of the claims to be included therein .

patients susceptible to or suffering from conditions and disorders , such as central nervous system disorders , are treated by administering to a patient in need thereof aryloxyalkylamines , including pyridyloxylalkylamines and phenoxyalkylamines . exemplary compounds include dimethylethylamine , dimethylbutyl ) amine , 2 - ethylamine , 4 - butylamine , methylpropyl ) amine , ethylpropyl ) amine , methylethyl ) amine , methyl ) propyl ) amine , propyl ) methylamine , )- 1 - methylpropyl ) methylamine , dimethylpropyl ) amine , 3 - propylamine , methylbutyl ) amine , 3 - propyl amine , methylpropyl ) amine , ) propyl ) methylamine , methyl ) propyl ) amine , methyl ) propyl ) amine , propyl ) amine , benzylpropyl ) amine , cyclopropyl - propyl ) amine , methylpropyl ) amine , methylpropyl ) amine , 1 -- 3 - nitrobenzene , propyl ) methylamine , dimethyl - propoxy ) phenyl ) amine , methyltridec - 2 - yloxypropyl ) amine , 1 , 3 - dioxolan - 5 - yloxypropyl ) methylamine , 3 - pyridine and 3 -- 3 - pyrrolidinyloxy ) pyridine .

the invention is based upon the manner in which the body processes solid food for ingestion . when solid foods are taken into the mouth , the tongue automatically pushes the food onto the chewing surfaces of the premolars and molars . the idea of the invention is to interfere with the tongue &# 39 ; s positioning of food on the teeth , thus preventing chewing , thus preventing the wearer of the invention from ingesting solid food . this allows the utilization of an all liquid diet without the problem of having to use willpower alone to refrain from eating solid foods . the invention accomplishes this objective by the placement of a food barrier located between the lingual side of the teeth and the tongue . there are a number of shapes for such a barrier and there are a number of ways of mounting such a barrier . in addition , there are a number of materials which could be used for such a barrier . among the materials available are plastic , metal , nylon , etc . the preferred material is a soft plastic . the preferred embodiment is that set forth and shown in fig1 - 7 . fig1 is a side view of the mouth with the jaws in the open position looking from outside the mouth to the inside of the mouth . teeth ( 1 ) are covered by retainer support elements ( 2 ) and ( 2 a ). the retainer support elements are preferably made of clear plastic and are similar to the kind of elements that are used generally to retain teeth . in this embodiment , the retainer support elements ( 2 ) and ( 2 a ) are held in place on the teeth by retainers attachments ( 3 ). these retainer attachments are attached to the teeth on their buccal side as well as the lingual and palatal side and are preferably implanted by a dentist . retainer attachments ( 3 ) prevent the removal of the retainer support elements ( 2 ) and ( 2 a ) by the patient . they are preferably removed by a dentist , which prevents the easy avoidance of the strictly liquid diet imposed by the invention . it is known to those skilled in the art to also use cement to hold the retainer support element in place . the retainer support elements provide the dual function of providing the support for the food barriers as well as insuring that the teeth are retained while the product is being worn . food barrier ( 4 ) is attached to the upper retainer support element ( 2 ) and to the lower retainer support element ( 2 a ). fig2 is a view from inside the mouth of the lingual side of the teeth , showing food barrier ( 4 ) as it is attached to upper retainer support element ( 2 ) and lower retainer support element ( 2 a ). in this embodiment , the upper portion of food barrier ( 4 ) is slidably affixed to the upper retainer support element ( 2 ) and the lower retainer support element ( 2 a ). the slits ( 5 ) fit over peg ( 6 ), thus allowing food barrier ( 4 ) to move up and down as the jaws are opened and closed . the jaws are able to be fully opened and closed . fig3 is a front view of the mouth in the open position with food barrier ( 4 ) and upper retainer support element ( 2 ) and lower retainer support element ( 2 a ) in place . as can be seen in fig3 , food barrier ( 4 ) is very thin so as to ensure maximum comfort . while the retainer support elements are shown covering all the teeth , they may in fact be structured so as to cover only a portion of the teeth . fig4 , 5 and 6 are alternate embodiments of the invention wherein the food barrier is made of an elastic material ( 5 ) that can be stretched when the jaws are opened . fig4 is a side view of the jaws in the open position from the outside . fig5 is a side view of the jaws in the open position taken from the inside looking outward , and fig6 is a front view of the jaws in the open position . fig7 illustrates the mechanism for attaching a support member to the teeth . the clear retainer support element ( 2 ) is attached to the teeth ( 1 ) by retainer attachments ( 3 ) and by clear cement ( 6 ). the retainer attachments ( 3 ) are on both the lingual and buccal surfaces of the teeth so that the retainer support element ( 2 ) will not come off when the wearer opens or closes the jaw and so that it cannot be removed by the wearer without outside assistance such as from a dentist . the embodiments set forth above are not intended to be exclusive as there may be numerous alternative methods which embody the inventive elements . the essential ingredient of all such products is that there is a barrier which prevents solid food from reaching the chewing surfaces of the teeth . while the invention herein disclosed has been described by means of specific embodiments and applications thereof , numerous modifications and variations could be made thereto by those skilled in the art without departing from the spirit and scope of the appended claims , the invention may be practiced otherwise than as specifically described herein .

a device to prevent the mastication of food , consisting of top and bottom retainer elements which are attached to the top and bottom teeth so that they cannot be easily removed , and food barriers extending between the top and bottom retainer elements which prevent food from reaching the chewing surfaces of the teeth , said food barriers allowing the jaws to be fully opened and closed .

the ophthalmic aqueous gel formulation of the present invention for treating myopia comprises a pharmaceutically effective amount of pirenzepine in combination with a water soluble cellulose derivative . the concentration of the pirenzepine in the present formulation may range from about 0 . 001 to 3 % ( w / v ), preferably about 0 . 005 to 2 % ( w / v ). pirenzepine and its dihydrochloride salt are known in the art . molecular formula : c 19 h 21 n 5 o 2 . 2 hcl . h 2 o cellulose derivatives are used as gelling agents in the formulation of this invention . most preferred is hydroxypropyl methylcellulose . any cellulose derived gelling agent , however , that forms an aqueous gel at the desired viscosity , i . e ., is soluble in water and forms a gel , can be used . such derivatives are well known , as are their properties , and are described , e . g ., in the u . s . pharmacopeia ( 2000 ) ( united states pharmacopeial convention , inc ., the united states pharmacopeia / the national formulary ( 2000 )). such gelling agents include , but are not limited to , methyl cellulose , hydroxypropyl cellulose , carboxymethyl cellulose , hydroxyethyl cellulose , and cellulose gum . combinations of various derivatives may also be used . cellulose based gelling agents are advantageous over , for example , cross - linked acrylic polymers . for example , carbopol ™, a cross - linked acrylic polymer , has been used to form an aqueous gel containing pilocarpine hydrochloride for ophthalmic use . cellulose based gelling agents , however , are less likely to cause adverse reactions . the formulations of the invention are substantially viscous enough to form a viscous gel . the viscosity preferably is in the range of 10 , 000 to 300 , 000 centipoise ( cps ), most preferably 15 , 000 - 200 , 000 cps , at about 20 ° c . and shear rate of 1 s − 1 based on brookfield rvdv analysis . in the aqueous gel for ophthalmic use , the amount of cellulose based gelling agent is preferably from about 0 . 5 wt . % to 5 wt . %, most preferably from about 1 wt . % to 5 wt . %. suitable cellulose based preparations for use in the invention are commonly commercially available . for example , sources of hydroxypropyl methylcellulose that are suitable for making a cellulose based ophthalmic gel according to the invention include ashland distribution co ., asiaamerica international inc ., biddle sawyer corp ., carbomer inc ., colorcon inc ., dow chemical co ., fob chemicals , hercules inc ., mutchler inc ., penta mfg co ., spectrum laboratory products inc ., van waters & amp ; rogers inc ., and warner jenkinson . the formulation may contain additional pharmaceutically inactive substances . for example , it may contain one or more solubilizing agents , such as polysorbate 20 , polysorbate 40 , polysorbate 60 , or polysorbate 80 . the formulation may also contain a dispersant , such as lecithin or glycerin . collagen can also be added . other additives include cyclodextrins , in particular alpha , beta , and gamma cyclodextrins . also , vitamin e , particularly in solubilized form , or other antioxidants , including butylate hydroxyanisole ( bha ) and butylate hydroxytoluene ( bht ), may be added . some additional examples of inactives follow : sodium chloride , cetrimide , thimerosal , benzalkonium chloride , boric acid , sodium carbonate , potassium chloride , propylene glycol , polyoxyethylene , polyoxypropylene , polyoxyl 40 stereate , polyvinyl alcohol , poloxamer 188 , sodium citrate , sodium thiosulfate , sodium bisulfite , dextran 70 , acetic acid , polyethylene glycol , povidone , dextrose , magnesium chloride , alginic acid , sodium acetate , sodium borate , edetate disodium , sodium hydroxide , and hydrochloric acid . the optimal amount of inactive ingredient employed in the formulation can be conventionally determined based on the particular active pharmaceutical , and the intended use . the formulation of the invention can be placed in any desired dispensing device suitable for an ophthalmic formulation . the device can be an ophthalmic delivery system such as a sterile ophthalmic tube , for example , a conventional 3 . 5 - 5 g tube having an ophthalmic tip and containing the ophthalmic formulation of the invention , or a sterile , single or daily use container containing 0 . 1 - 0 . 5 g of the formulation . the pharmaceutical formulations can be administered via various routes including ocular instillation , subconjunctival administration , and intravitreal administration . a typical daily dose of pirenzepine may range 6 mg or less / whole body weight , preferably 4 mg or less / whole body weight , and can be administered in a single dose or in divided doses . however , it should be understood that the amount of pirenzepine actually administered ought to be determined in light of various relevant factors including the myopia to be treated , the chosen route of administration and the severity of the patient &# 39 ; s symptom ; and , therefore , the above dose should not be intended to limit the scope of the invention in any way . the stability data generated on the gel and solution dosage forms show the superiority of the gel over the solution in maintaining an acceptable physical appearance in the presence of the small amounts of the water - insoluble degradation product referred to in the background of the invention . the following examples are intended to further illustrate the scope of the invention without limiting its scope . an aqueous ophthalmic gel of 2 . 0 % pirenzepine for the treatment of myopia according to the present invention was prepared as follows : part 1 : purified water was heated to 80 - 90 ° c . hydroxypropyl methylcellulose ( hpmc ) was added and mixed until it was uniformly dispersed . the ph was adjusted to 5 . 0 ± 1 . 0 with sodium hydroxide , but this was not a critical step and can be eliminated . after being placed in a pressure vessel , the mixture was sterilized at 121 ° c . for 30 - 45 minutes . in another embodiment , autoclaving is conducted under nitrogen when oxygen plays a role in viscosity loss upon autoclaving . the mixture was cooled to 25 ° to 30 ° c . and mixed for several hours to yield a homogenous viscous gel . batches manufactured in the appropriate jacketed pressure vessel showed that chilling part 1 ( the hydroxypropyl methylcellulose phase ) to about 10 ° c . rather than to 25 ° to 30 ° c . after autoclaving greatly enhanced the hydration and consequently the viscosity of the gel . the gel was stored at 25 ° to 30 ° c . for several hours to aid in dissolution and then maintained at 25 ° to 30 ° c . for storage . part 2 : the rest of the ingredients were mixed and dissolved in water until a clear solution was obtained . the ph was adjusted to 5 . 0 ± 1 . 0 with sodium hydroxide . the solution was sterilized by membrane filtration ( 0 . 2 microns ). the concentration of pirenzepine is calculated based on the free base . however , we added its dihydrochloride salt . by adjusting the ph to 5 . 0 ± 1 . 0 with sodium hydroxide , the dihydrochloride salt is partially or completely converted to the monohydrochloride salt . the solution of part 2 was aseptically added to the gel of part 1 . sufficient sterile water was added to q . s . to the final weight of the batch . a final ph adjustment was made , if necessary . the batch was mixed for about 48 hours to achieve homogeneity . a gel resulted that was used to aseptically fill pre - sterilized ophthalmic containers . the ophthalmic pirenzepine gel preparation made in example 1 was administered as follows ( the ophthalmic tip of the dispensing mechanism did not touch any surface to avoid contamination ). the lower lid of the eye to be administered was pulled down and a small amount of gel ( approximately 0 . 25 inches ) was applied to the inside of the eyelid . the gel was applied to the afflicted eye twice per day . a gel formulation in a target population of pediatric subjects was well tolerated . procedure for viscosity measurement : a brookfield cone and plate viscometer ( model rvdv - iii +) was used to measure viscosity at about 20 ° c . and shear rate of 1 s − 1 . the viscosities of 0 . 5 - 2 g samples of various gels were measured . gels with viscosities of 5 , 000 to less than 600 , 000 cps were tested with a cp52 spindle , and other spindles are used depending on the viscosities of the gels . while the present invention has been described in some detail for purposes of clarity and understanding , one skilled in the art will appreciate that various changes in form and detail can be made without departing from the true scope of the invention . all patents , applications , and publications , referred to above , are hereby incorporated by reference .

it is a primary object of the present invention to provide an aqueous ophthalmic formulation , for treating myopia , comprising pirenzepine in combination with a pharmaceutically acceptable gel carrier .

[ 0057 ] fig1 a , 1b and 2 a , 2 b illustrate alternate embodiments of a pre - filled syringe assembly 10 comprising the present invention . in each embodiment , the assembly 10 includes a syringe 20 filled with a medical liquid 30 , and a tubing length 40 interconnected with or interconnectable to the pre - filled syringe 20 . the assembly 10 further includes a packaging enclosure 50 for sealably receiving the pre - filled syringe 20 and tubing length 40 . the syringe 20 includes a barrel 22 and plunger 24 slidably disposed therewithin . as shown in fig1 plunger 24 is located in a retracted position and barrel 22 is filled with medical liquid 30 as packaged . consequently , assembly 10 may be readily employed by medical personnel when unpackaged . barrel 22 may be provided with volumetric gradation indicators thereupon and / or a contents description provided thereupon ( e . g . via printing and / or labeling ). plunger 24 and barrel 22 may be sized to accommodate a relatively large volume of medical 2 liquid 30 , e . g . in one arrangement plunger 24 presents a liquid interface of about 1 in . in primary applications , medical liquid 30 may comprise a relatively large volume of a vascular catheter flush solution . more particularly , a volume of at least about 40 ml . of flush solution , and most preferably about 60 ml . of flush solution is provided for use in successive flushing procedures over the course of extended patient care . by way of primary example , the flush solution may be a saline solution or heparin - containing solution . the tubing length 40 is preferably of a “ microbore ” type , e . g . having an inside diameter of between about 0 . 75 mm and 1 . 50 mm . further , for common arrangements the tubing length may be between about 30 in . and 75 in ., and most typically about 60 inches . the tubing length 40 may be preferably provided with an outlet connector 42 at a distal end thereof , wherein the outlet connector 42 is adapted for ready interconnection with a vascular catheter access port . for example , outlet connector 42 may be a male luer connector sized for screw - on / off interconnection with a complimentary female luer connector defining a vascular catheter access port . to facilitate the visual inspection of fluids therein , outlet connector 42 and / or tubing length 40 may be at least partially transparent . to maintain the sterility of outlet connector 42 , a protective cap 44 may also be provided . further , a line clip 46 ( e . g . having a key - hole slot ) may be included about tubing length 40 for selective occlusive positioning during use . as shown , tubing length 40 may be interconnected to barrel 22 prior to packaging . for example , the proximal end of tubing length 40 may be provided with a female luer connector 48 that is rotatably secured to a male luer fitting of syringe 20 . alternatively , the proximal end of tubing length 40 may be fixedly interconnected to syringe 20 prior to packaging . in one arrangement , the tubing length 40 may be both interconnected to syringe 20 and primed prior to packaging . to prime the tubing length 40 , the syringe 20 may be initially overfilled with a volume of medical liquid 30 . then , with cap 44 removed , plunger 24 may be advanced so that a small portion of the medical liquid 30 is dispensed from syringe 20 to prime tubing line 40 . thereafter , cap 44 may be placed on connector end 42 prior to packaging of assembly 10 in enclosure 50 . in another arrangement , the tubing length 40 may be provided with a proximal female luer connector 48 and protective end cap thereupon ( not shown ), wherein the tubing length 40 is packaged with the pre - filled syringe 30 in a disconnected state . the syringe 30 may be slightly overfilled with medical liquid 30 , wherein tubing length 40 may be interconnected to and primed from syringe 20 after unpackaging . more particularly , after unpackaging the protective caps on each end of the tubing length 40 may be removed and the proximal female luer connector 48 connected to the complimentary outlet end of syringe 20 . then , plunger 24 may be advanced so that a small portion of medical liquid 30 is dispensed from syringe 20 to prime the tubing line 40 . in the embodiment of fig2 a , 2b a y - site member 60 is interconnected ( e . g . fixedly bonded ) to the distal end of tubing length 40 . the y - site member 60 includes an outlet connector 42 and an inlet connector 62 . more particularly , inlet connector 62 may be a female luer connector employable for ready interconnection with a liquid medication source . for example , inlet connector 62 may be provided for ready interconnection with an outlet connector ( e . g . a male luer connector ) of a tubing line that is interconnected to a multi - dose reservoir of liquid medication ( e . g . either directly for use with an infusion pump or via a gravity - fed drip chamber interposed therebetween ), or to a multi - dose syringe of liquid medication that is located in an auto - infuser device . alternatively , the inlet connector 62 may be readily interconnected directly with a syringe containing liquid medication . as may be appreciated , pre - filled syringe assembly 10 may be sterilized prior to transport , storage and use . in a primary approach , such sterilization may be completed by exposing syringe 20 to gamma radiation after filling with the medical liquid 20 . further , gamma radiation exposure may be utilized for sterilization of tubing length 40 . where tubing length 40 is connected to syringe 20 prior to packaging , the pre - filled syringe 20 and tubing length 40 may be exposed to gamma radiation simultaneously ( e . g . after priming of the tubing length 40 as noted above ). as will be appreciated , sterilization via gamma radiation exposure may be completed prior to , or after the sealed disposition of pre - filled syringe 20 and tubing length 40 within the packaging enclosure 50 , as shown in fig2 . by way of summary , fig3 illustrates steps of an exemplary method 100 for providing the syringe assembly 10 described above . the method 100 optionally provides for the interconnection of a tubing length 40 to syringe 20 ( step 102 ), e . g . via female luer connector 48 . the method 100 further includes the step of filling the syringe 20 with flush solution 30 ( step 104 ). in conjunction with such filling , the method may optionally include priming of the tubing length 40 with the flush solution 30 ( step 106 ). as previously indicated , such priming may be achieved by simply advancing the plunger 24 of syringe 20 so as to dispense a small portion of flush solution 30 through tubing length 40 . after priming , the method may further provide for the optional placement of a protective cap 44 on an outlet connector 42 of the tubing length 40 ( step 108 ). the pre - filled syringe with interconnected tubing length 40 may then be inserted into the enclosure packaging 50 ( step 110 ). thereafter , the enclosure packaging 50 may be sealed ( e . g . via heat sealing ). then , the assembly 10 may be sterilized via exposure of the packaged assembly to gamma radiation ( step 112 ). after sterilization , the packaged assembly 10 is ready for transport , storage and use . assembly 10 yields a number of advantages in use . to facilitate an understanding of such advantages reference is now made to fig4 and 5 which illustrate steps of one method embodiment in which assembly 10 is utilized by medical personnel at a patient care site ( e . g . after transport and storage of assembly 10 ). with particular reference to fig4 use of assembly 10 may be initiated by removing the pre - filled syringe 20 and an interconnected tubing length 40 from the sealed enclosure 50 ( step 202 ). in embodiments where pre - filled syringe 20 and tubing length 40 are packaged in a disconnected state , the two may be readily interconnected upon removal from enclosure 50 ( e . g . via use of a female inerconnector 48 noted above ). next , protective cap 44 may be removed from the outlet connector 42 of tubing length 40 ( step 204 ). to prime or otherwise ensure that the tubing length 40 is properly primed with the flush solution 30 , the plunger 24 of pre - filled syringe 20 may be advanced until a small amount of the flush solution 30 is dispensed from the outlet connector 42 ( step 206 ). additionally , when a y - site member 60 is provided at the distal end of tubing length 40 , the inlet connector 62 thereof may be interconnected to a liquid medication source as noted above . in particular , where such interconnection is made to an outlet connector of a tubing line , such tubing line may be primed from the liquid medication source after interconnection . at this point , assembly 10 is ready for interconnection to a vascular catheter , e . g . wherein the catheter is already inserted in a patient ( step 208 ). such interconnection may be made by attachment of the outlet connector 42 to an access port to the vascular catheter ( e . g . via a screwon connection between complementary luer connector ends ). the illustrated method further comprises the step of administering the flush solution 30 from pre - filled syringe 20 to the patient through the tubing length 40 and interconnected vascular catheter ( step 209 ). of note , the administration of flush solution 30 may entail a number of optional steps carried out in connection with multiple liquid medication infusions and corresponding flush solution administrations over an extended period of patient care . such options will be described with reference to fig5 . as shown , upon interconnection of assembly 10 to a vascular catheter , medical personnel may want to aspirate the vascular catheter ( step 210 ), e . g . to insure that the vascular catheter is properly inserted into the patient . to do so , plunger 22 of pre - filled syringe 20 may be slightly retracted / advanced to draw / infuse a small portion of blood through the vascular catheter ( step 212 ). then , medical personnel may desire to flush the vascular catheter with an increment of flush solution 30 from syringe 20 ( step 214 ). to do so , the plunger 24 of syringe 20 may be advanced to dispense the desired increment of flush solution 30 ( step 216 ). next , medical personnel may infuse a liquid medication through the vascular catheter ( step 218 ). by way of example , the liquid medication may be passed into an inlet connector 62 of a y - site member 60 provided on tubing length 40 . after infusion of the liquid medication through the vascular catheter , medical personnel may selectively flush the vascular catheter ( step 220 ), e . g . to complete infusion of the desired infusion dosage and otherwise reduce subsequent potential blood clotting in the vascular catheter . to do so , plunger 22 of pre - filled syringe 20 may be further advanced to dispense an increment of the flush solution 30 from the syringe 20 ( step 222 ). as may be appreciated , the flushing of vascular catheter as per step 222 may be particularly desirable in situations where the infusion of liquid medication through the vascular catheter is to be repeated ( step 224 ). when no additional liquid medication infusion is desired , tubing length 40 may be disconnected from the access port to the vascular catheter and assembly 10 properly disposed ( step 226 ). where further infusion of a liquid medication is desired , medical personnel may optionally determine whether tubing length 40 is to be disconnected from the vascular catheter ( step 228 ), e . g . to facilitate patient movement in the interim time period before the next infusion of liquid medication . when the tubing length 40 is disconnected , the tubing length 40 will need to be selectively reconnected to the vascular catheter prior to the next liquid medication infusion ( step 230 ). however , it should be appreciated that , when a y - site member 60 is utilized , the interconnections between the y - site member 60 and syringe 20 and between the y - site member 60 and a liquid medication source may be maintained , i . e . while outlet connector 42 is disconnected from the vascular catheter access port . prior to the next medical liquid infusion , medical personnel may desire to aspirate the vascular catheter ( step 210 ), e . g . to insure that the vascular catheter is properly located and / or to insure that a blood clot has not formed within the vascular catheter . to do so , plunger 22 of syringe 20 may be slightly retracted / advanced so as to draw / return a small portion of blood through the vascular catheter ( step 212 ). it should be noted that such aspiration is particularly facilitated by an administration apparatus described hereinbelow . prior to the further infusion of liquid medication through the vascular catheter , medical personnel may again desire to flush the vascular catheter thereof ( step 214 ). for such purposes , plunger 22 of syringe 20 may again be advanced to dispense another increment of flush solution 30 from the syringe 20 ( step 216 ). thereafter , medical liquid infusion and further flushing may continue in a repeated fashion as indicated by fig5 . reference is now made to fig6 - 9 and fig1 - 13 which illustrate alternate embodiments 300 and 400 of an apparatus for use in the administration of flush solution 30 of syringe assembly 10 . as will be appreciated , apparatus embodiments 300 and 400 may be advantageously employed to facilitate and otherwise simplify the execution of the various steps described in relation to fig5 above . in fig6 and 10 , syringe assembly 10 is shown loaded in the administration apparatus 300 and 400 , respectively , with outlet connector 42 positioned for ready , rotatable connection to a female luer access port 500 that is fluidly connected by a tubing line 504 to a vascular catheter 510 inserted into the arm of a patient . further , an inlet connector 62 of a y - site member 60 is positioned for interconnection to a liquid medication source such as the illustrated syringe 520 . of course , other liquid medication source arrangements may also be employed . in particular , multi - dose liquid medication sources may be interconnected via a tubing line having an outlet connector ( e . g . a male inerconnector ). as shown in fig6 - 9 , administrative apparatus 300 includes first and second holder members 310 , 320 for holding the plunger 24 and barrel 22 of syringe 20 , respectively . the first and second holder members 310 , 320 are disposed relative to a housing 330 in a manner that facilitates controlled relative movement therebetween , thereby providing for the metered administration of flush solution 30 from syringe assembly 10 . more particularly , the first holder member 310 supports a catch assembly 340 that is adapted to successively engage a plurality of stops 350 provided with housing 330 along a travel path of the first holder member 310 . as best shown by fig8 the plurality of stops 350 may be defined by downwardly angled teeth of a stop member 352 disposed on one side of a housing slot 332 along which first holder member 310 travels during use . another stop member of common configuration ( not shown ) may be provided on the other side of housing slot 332 . the catch assembly 340 includes a catch member 342 and at least one spring 344 that spring - loads the catch member 342 towards the noted plurality of stops 350 . as such , when catch member 342 is in spring - loaded engagement with one of the plurality of stops 350 , movement of the first holder member 310 away from the second holder member 320 is restricted . preferably , spring ( s ) 344 provide a spring - loading of between about 2 psi and 5 psi , and most preferably about 3 psi . administrative apparatus 300 also includes a drive assembly 360 supported by first holder member 310 and having first and second drive arms 361 , 362 for driving the first holder member 310 towards the second holder member 320 , as will be further discussed . further , the second holder member 320 is spring - loaded towards the first holder member 310 . more particularly , the second holder member 320 includes opposing , u - shaped bottom and top members 321 , 322 , respectively . the side arms of the bottom member 322 are configured to define side shelves , or seats , which together with the top member 321 combinatively define a slot that is configured to support and retain a complimentary flange located at the top end of the barrel 22 of syringe 20 . in this regard , the outside of each side arm of the bottom member 322 may be notched to slidably engage guide tracks ( not shown ) on the housing 330 and may be spring - loaded towards the top member 321 by one or more coil spring ( s ) 324 to assume a biased “ home ” position as shown in fig6 - 9 . at the home position movement of the top member 322 away from the spring - loading may be restricted by the housing 330 . preferably , coil spring ( s ) 324 apply a spring force of between about 5 psi and 15 psi to the second holder when attached . further , such spring force is preferably relatively constant across the intended actuation range . when one of the drive arms 361 , 362 of drive assembly 360 is employed to advance the first holder member 310 and plunger 24 towards the second holder member 320 and barrel 22 , the second holder member 320 and barrel 22 may move downward and away from the first holder member 310 and plunger 24 against the noted spring - loading . such movement of the second holder member 320 allows the catch assembly 340 to engage one of the plurality of stops 350 . then , second holder member 320 moves back into its home position in response to coil spring ( s ) 324 as plunger 24 moves towards barrel 22 to effect the metered administration of flush solution 30 from the outlet of barrel 22 . in this regard , it should be appreciated that the amount of flush solution 30 metered will be a direct relation to the amount of linear travel of the first holder member 310 between the different locations , or stop positions , at which catch assembly 340 restrainedly engages different ones of the plurality of stop members 350 . as such , the first and second drive arms 361 , 362 may be provided to effect differing amounts of linear travel of the firsts holder 310 when pivoted . in turn , differing increments of flush solution administration may be realized . of further note , the top member 322 of the second holder number 320 may be pivotably connected along its back to housing 330 and may include lever arms on each side that extend outward beyond housing 330 for convenient control by a user . specifically , such lever arms may be manually pivoted towards the bottom member 322 by a user against the noted spring - loading , wherein the coil spring ( s ) 324 is compressed . as may be appreciated , this feature allows a user to selectively aspirate a vascular catheter 520 that is interconnected to a pre - filled syringe 20 . for example , a user may slightly pivot the top member 322 against the spring - loading , wherein the second holder member 320 moves the barrel 24 of syringe 20 away from the plunger 22 held by the first holder member 310 . such movement may be controlled with a high degree sensitivity to draw blood from a patient through a vascular catheter 520 connected to pre - filled syringe 20 . in turn , upon release of the lever arms , the spring - loaded second holder member 320 will assume its home position as the blood is returned to the patient . reference is now made to fig9 a , 9b , 9 c and 9 d which illustrate in greater detail the first holder member 310 , catch assembly 340 and drive assembly 360 . for purposes of illustration , the second drive arm 362 of drive assembly 360 is shown in phantom lines . first holder member 310 includes a bottom portion 311 having a slot 312 configured to receive a complimentary at the top end of plunger 24 of pre - filled syringe 20 . additionally , the first holder member 310 includes an upstanding yoke portion 314 to which the catch assembly 340 and drive assembly 360 are supportably mounted . the first holder member 310 also includes arms 326 extending on each side and configured for sliding receipt within slots 337 provided on each side of the housing 330 ( see fig8 ). drive assembly 360 includes a shaft member 363 that is rotatably carried by the yoke portion 314 of the first holder member 310 . each end of the shaft member 363 is configured for sliding receipt positioning within the slots 337 of the housing 330 . further , toothed drive wheels 364 are interconnected near each end of shaft member 363 and disposed to rotatably engage corresponding drive tracks 335 disposed within housing 330 along the travel path of the first holder member 320 . drive assembly 360 further includes a central ratchet member 365 interconnected to shaft member 363 for co - rotation therewith . additionally , outer ratchet members 366 are rotatably carried by shaft member 363 on opposing sides of central ratchet members 365 . each of the outer ratchet members 366 are interconnected to a corresponding one of the drive arms 361 , 362 , respectively , for co - rotation therewith . the outer ratchet members 366 are also disposed in spring - loaded engagement with central ratchet member 365 by corresponding coil springs 367 mounted on shaft member 363 . for example , one end of each coil springs 367 may be interconnected to a corresponding , adjacent outer ratchet member 366 while the other end of the coil spring 367 is retainably positioned within a slot of the corresponding drive arm 361 or 362 . catch assembly 340 includes support arms 342 which are rotatably interconnected to and supported by shaft member 363 . the above - noted spring member ( s ) 344 is disposed between catch member 342 and the yoke portion 314 of the second holder member 320 . the pivot range of drive arms 361 , 362 is restricted to define a corresponding maximum , or full stroke length for each , wherein such full stroke lengths may be established to be different . in turn , differing predetermined increments or amounts of flush solution 30 may be administered from syringe 20 when drive arms 361 , 362 are separately pivoted . for example , in one arrangement the full stroke lengths may be set to provide for selective administration increments of 2 . 5 ml . and 5 ml . a brief summary of the use of administration apparatus with 300 syringe assembly 10 will now be provided . initially , a user may remove the pre - filled syringe 20 and tubing length 40 from a sealed enclosure 50 , e . g . at a patient care site . then , the user may locate the first holder member 310 at an appropriate stop position along the plurality of stops 350 , e . g . via manual depression of the catch member 342 and movement thereof with the first holder member 310 in housing slot 332 . subsequently , the user may load the pre - filled syringe 20 into the administration apparatus 300 . to do so , the flange of barrel 24 is properly oriented and slid into the slot of the second holder member 320 and the flange of the plunger 22 is properly oriented and slid into the slot of the top holder member 310 . at this point , it may be pointed out that the administration apparatus 300 may be provided so that when the first holder member 310 is located at a predetermined stop position , e . g . a stop position furthest from the second holder member 320 , the spacing between the first holder member 310 and second member 320 corresponds with the spacing between the flanges of barrel 24 and plunger 22 of pre - filled syringe 20 . such complimentary design further facilitates use of the syringe assembly 10 and administration apparatus 300 . prior to or after loading of the pre - filled syringe 20 into the administration apparatus 300 , the user may insure the interconnection of tubing length 40 with pre - filled syringe 20 and prime the same . after priming the tubing length 40 may be fluidly interconnected to a vascular catheter 520 inserted into a patient , e . g . via an outlet connector 42 and vascular catheter access port 500 . to administer the flush solution 30 , a user simply pivots drive arm 361 or 362 , depending on the desired increment . to aspirate the vascular catheter 520 , a user simply pivots one of the lever arms of the second holder member 320 . such steps may be repeated as desired to facilitate the various method steps described hereinabove , e . g . in connection with fig5 . referring now to fig1 - 13 , administration apparatus 400 includes first and second holder members 410 , 420 for holding the barrel 22 and plunger 24 of syringe 20 , respectively , relative to a dispenser housing 430 . the first and second holder members 410 , 420 are disposed relative to a housing 430 in a manner that again facilitates controlled relative movement therebetween , thereby providing for the metered administration of flush solution 30 from syringe assembly 10 . in this regard , the first holder member 410 supports a catch assembly 440 that is adapted to successively engage a plurality of stops 450 provided by housing 430 along a travel path of the first holder member 410 . as best shown by fig1 and 13 , the plurality of stops 450 may be defined by upwardly angled teeth of a stop member 452 disposed parallel to a housing slot 432 along which the first holder member 410 travels during use . the stop member 452 may be selectively moved within housing 430 to present different sets or columns of stops 450 , each having different stop spacings . for example , the stop member 452 may be journaled to housing 430 so that a selection lever 453 may be rotated to rotate the desired column of stops 450 into position for engagement with catch assembly 440 . as will be appreciated , the selected column of stop members 450 will establish the increment or amount of flush solution 30 administered when the first holder member 410 is between successive stop positions . the catch assembly 440 includes a catch member 442 in the form of a pawl that is pivotably interconnected to the first holder member 410 and spring - loaded towards the noted plurality of stops 450 , e . g . wherein the spring - loading is preferably between about 2 psi and 5 psi , and most preferably about 3 psi . as such , when catch member 442 is in spring - loaded engagement with one of the plurality of stops 450 , movement of the first holder member 410 towards the second holder member 420 is restricted . as shown , the catch assembly 440 also includes a selectively depressible actuator 444 that functions to pivot the catch member 442 against the spring - loading and out of engagement with the plurality of stops 450 , thereby allowing for movement of the first holder member 410 relative to the second holder member 420 . to help maintain the desired orientation of the first holder member 410 , side arms 411 may be provided on either side to follow complimentary recess tracks 431 provided by housing 430 . as also shown , a toothed track 433 is disposed in opposing relation to the plurality of stops 450 to engage catch member 442 and thereby facilitate controlled movement of the first holder member 410 . in this regard , the administration apparatus 400 includes a drive assembly 460 for driving the first holder member 410 towards the second holder member 420 . the drive assembly 460 includes a self - winding spring 461 ( e . g . a negator - type spring ). more particularly , the spring 461 is anchored to housing 430 at its wound end and interconnected to the first holder member 410 at its free end to pull the first holder member 410 towards the second holder member 420 upon a single activation , i . e . a single unwinding which occurs upon loading of a pre - filled syringe 20 . preferably , a spring - loading of between 5 and 15 psi is provided by spring 461 . as may be appreciated , after loading of a pre - filled syringe 20 , actuator 444 may be pushed to pivot catch member 442 out of engagement with one of the plurality of stops 450 and into engagement with toothed track 433 as the first holder member 410 is pulled toward the second holder member 420 . upon release of the actuator 444 , the spring - loaded catch member 442 will once again pivot to engage another one of the plurality of stops 450 . such sequence effects the administration of one increment of flush solution 30 . the second holder member 420 of administration apparatus 400 is preferably springloaded towards the first holder member 410 . more particularly , the second holder member 420 is pivotably connected by lever arms 422 to housing 430 and spring - loaded by one or more spring ( s ) ( not shown ) located along its pivot axis to assume a “ home ” position as shown in fig1 - 13 . lever arms 422 extend beyond housing 430 and are accessible for manual operation . further , another arm 425 is pivotably mounted to housing 430 so that it engages , and thereby pivots lever arms 422 when manually pivoted . such feature may be utilized for vascular catheter 520 aspiration , as previously discussed . the embodiments described above are for exemplary purposes only and are not intended to limit the scope of the present invention . various adaptations , modifications and extensions of the embodiment will be apparent to those skilled in the art and are intended to be within the scope of the invention as defined by the claims which follow .

a system , method and apparatus are provided for administering medical liquids to a patient . the invention is particularly apt for use in the intravenous administration of multiple doses of a flush solution over an extended period of therapy . in certain aspects of the invention methods and apparatus are directed to the provision and utilization of a packaged syringe filled with a medical liquid and having a tubing length interconnected thereto , wherein the volume of pre - filled medical liquid is sufficient to allow for multiple administrations to a given patient . by way of primary example , where the syringe is pre - filled with a flush solution , a volume of at least about 40 ml . is preferred . in other aspects , methods and apparatus are directed to the administration of medical liquids from a pre - filled syringe utilizing an apparatus that is particularly adapted for administering a medical liquid in successive increments over a plurality of separated time intervals .

embodiments of the present invention will be described with reference to the drawings . fig1 is a perspective view showing one example of a pillow 1 based on the present invention , fig2 is a plain view of the pillow of the present example , fig4 is a side view of the pillow 1 of the present example , fig5 is a cross - sectional view taken along line a - a in fig2 of the pillow of the present example , fig6 is a plain view corresponding to fig2 of the pillow 1 having a pillow body 2 formed with a head depression part 5 of another example , fig7 is a plain view showing a usage state of the pillow 1 of the present example , and fig8 is a cross - sectional view taken along line b - b of fig7 showing the usage state of the pillow 1 of the present example . the pillow 1 of the present example has a pillow body 2 of a rectangular shape in plain view , and has an appearance when attached with a pillowcase 3 similar to a conventionally known general pillow , which alleviates the psychological resistance ( resistance on he / she being the only one using a specific article ) when the patient with whiplash syndrome uses the pillow 1 of the present example . as shown in fig1 to 5 , the pillow 1 of the present example is the pillow body 2 having a rectangular shape in plain view in which an upper surface and a lower surface with an edge cloth 23 ( outer edge ) as a boundary are configured by an upper surface cloth 21 and a lower surface cloth 22 sewed at the edge cloth 23 of the outer periphery . the pillow 1 comprising a head depression part 4 having the lower surface cloth 22 as the bottom surface 41 of bell - shape in plain view at the position depressed from the upper surface at the middle to the lower surface at the middle of the pillow body 2 , and a groove part 6 extending from the head depression part 4 to the edge cloth 23 of the pillow body 2 and being formed by sewing the upper surface cloth 21 to the lower surface cloth 22 . thus , the sewing line of the upper surface cloth 21 and the lower surface cloth 22 becomes close to a ground surface ( surface of the mattress or the bed ) of the pillow 1 , and the sewing line is less likely to contact the neck of the patient with whiplash syndrome . the pillow body 2 is formed to a bag in which the interior is communicated excluding the head depression part and the groove part 6 , and filler 24 ( pipe , beads , buckwheat chaff , etc .) is filled in the interior . the pillow body 2 is freely deformable as the filler 24 moves in the interior . in particular , since the pillow body 2 has the upper part ( opposite side with respect to lower part which is defined as the groove part 6 to which the neck lies along ) of the head depression part 4 connected at the left and the right , the filler 24 can move greatly to the left and the right . therefore , in addition to high and low , and left and right inclination of a supporting surface formed as a continuous peripheral surface surrounding the head depression part 4 , an inclination degree of an inclined surface 61 extending along the groove part 6 from a lower edge 411 of the head depression part 4 and others can be easily adjusted . although not shown , the entire pillow body may be formed by low repulsive urethane foam in place of the filler . in this case , the low repulsive foamed polyurethane itself deforms and the entire pillow body becomes freely deformable . as another example , as shown in fig3 , for example , a separation part 25 extending from the head depression part 4 to the edge cloth 23 of the pillow body 2 and being formed by sewing the upper surface cloth 21 to the lower surface cloth 22 may be formed in a symmetric position with respect to the groove part 6 , thereby completely separating the pillow body 2 to the left and the right . the pillow body 2 of another example has an overall configuration in which two parts having a c - shape in plain view and having the head depression part 4 are connected via upper and lower groove part 6 and the separation part 25 . the supporting surfaces 42 of another example are formed as discontinuous peripheral surfaces including a plurality of inclined surfaces having a falling gradient towards the head depression part 4 . the filler 24 is filled into each of the pair of bags completely separated by the head depression part 4 , the groove part 6 and the separation part 25 , and thus is movable only within each bag and is prevented from moving between the bags . accordingly , height or inclination of the each opposing supporting surface 42 of another example is adjusted by each bag . although it is not shown in the figures , a pair of the left part and the right part having c - shape in plain view may be respectively formed by low repulsive urethane form instead of the filler . the pillow 1 of the present example includes a tubular pillowcase 3 for covering the pillow body 2 , and a thin cushion sheet 43 used by being accommodated at the bottom surface 41 of the head depression part 4 . as shown in fig1 and 2 , the cushion sheet 43 of the present example has a straw rice bag shape in plain view of a size enveloping the back of the head , that is , a size covering the bottom surface 41 with a width ( about 16 cm in present example ) slightly wider than the bottom surface 41 of the head depression part 4 . the present example is an example using only one cushion sheet 43 . the cushion sheet 43 is used in piles on the bottom surface 41 of the head depression part 4 in order to reduce the uncomfortable feeling that arises when the back of the head directly touches the bottom surface 41 of the head depression part 4 . the cushion sheet 43 may be sewed to the bottom surface 41 so as to be prevented from shifting with respect to the bottom surface 41 . greater number of cushion sheets 43 may be accommodated in piles at the bottom surface 41 of the head depression part 4 for every patient with whiplash syndrome , or a thick cushion sheet may be accommodated at the bottom surface 41 of the head depression part 4 . the pillow 1 of the present invention has features in the head depression part 4 and the groove part 6 extending from the head depression part 4 . the head depression part 4 of the present example is formed with the bottom surface 41 , which is in plane with the lower surface cloth 22 of the pillow body 2 , surrounded by the supporting surface 42 which is the continuous peripheral surface comprising the upper surface cloth 21 rising from the periphery of the bottom surface 41 . in the present example , the bottom surface 41 of the head depression part 4 is formed with the lower surface cloth 22 , and the bottom surface 41 and the lower surface are in plane , and thus the back of the head can deeply sink in . furthermore , since the bottom surface ties down the supporting surface 42 , the supporting surface 42 is maintained to a continuous peripheral surface surrounding the bottom surface 41 thereby supporting the back of the head from the periphery , and fixing the position and the orientation of the back of the head of the patient with whiplash syndrome . if the pillow body is formed with low repulsive urethane foam , the head depression part can be configured as a concave part formed with the low repulsive urethane foam . the bottom surface 41 of the head depression part 4 has a bell shape in plain view surrounded by a linear lower edge 411 orthogonal to an extending direction of the groove part 6 , linear side edges 412 extending orthogonal to the lower edge 411 from both ends of the lower edge 411 , and an arch - shaped upper edge 413 of semicircular arc bridged between the ends of the side edges 412 . the inclined surface 61 of rising gradient formed along the groove part 6 from the lower edge 411 of the bottom surface 41 may be formed at the width of the lower edge 411 ( see fig5 ). by forming the inclined surface 61 in said width , the inclined surface 61 which does not place a strain on the neck even if the patient with whiplash syndrome moves to the right or left is provided . the function in which the head depression part 4 supports the back of the head with the supporting surface 42 formed as a continuous peripheral surface is influenced by the size of the bottom surface 41 . specifically , the head depression part 4 which stably supports the back of the head with the supporting surface 42 while accepting the back of the head deeply sunk in preferably has the width of the bottom surface 41 to about 12 cm . the width of the bottom surface 41 is determined in the range of between 65 % and 80 %, and preferably between 70 % and 75 % of the width of the head of an average person . the length from the linear lower edge 411 to the apex of the arch - shaped upper edge 413 is preferably to be about 15 cm , and is determined in the range of between 40 % and 65 %, and preferably between 45 % and 55 % of the length of the head of an average person . as shown in fig6 , a head depression part 5 may have a bottom surface 51 formed to an elliptical shape in plain view surrounded by an arcuate lower edge 511 orthogonal to an extending direction of the groove part 6 , linear side edges 512 extending in continuation to the lower edge 511 from both ends of the lower edge 511 , and an arch - shaped upper edge 513 bridged between the ends of the side edges 512 . the head depression part 5 forms the inclined surface 61 of rising gradient formed along the groove part 6 from the arcuate lower edge 511 so as to envelope the neck of the patient with whiplash syndrome , and restrains the back of the head of the patient with whiplash syndrome without placing a strain on the neck of the patient with whiplash syndrome . similar to the above , the head depression part 5 preferably has the width of the bottom surface 51 to about 12 cm . the width of the bottom surface 51 is determined in the range of between 65 % and 80 %, and preferably between 70 % and 75 % of the head of an average person . the length from the apex of the arcuate lower edge 511 to the apex of the arch - shaped upper edge 513 is preferably to be about 15 cm , and is determined in the range of between 30 % and 65 %, and preferably between 35 % and 55 % of the length of the head of an average person . the groove part 6 is formed by sewing the upper surface cloth 21 depressed towards the lower surface cloth and the lower surface cloth 22 , and the inclined surfaces 61 extending from the lower edge 411 of the head depression part 4 are formed on the left side and the right side . when the pillow body is formed with low repulsive urethane foam , the groove part 6 can be formed as a groove having a v - shaped cross - section or a u - shaped cross - section formed with the low repulsive urethane foam . the pillow body 2 of the present example is interiorly filled with movable filler 24 , and thus the angle of inclination and planarity , as well as the direction of inclination of the inclined surface 61 raised along the groove part 6 from the lower edge 411 of the bottom surface 41 can be freely adjusted . the groove part 6 thus only has the inclined surfaces 61 formed on the left side and the right side . the inclined surfaces 61 support the left and the right of the neck of the patient with whiplash syndrome . the groove part 6 does not contact , in particular , the middle of the neck along the cervical spine . the groove part 6 of the present example has a cutout portion 62 formed by cutting both sides of the terminating ends intersecting the edge cloth 23 of the pillow body 2 to the left and the right , so that the portion where the edge cloth 23 and the groove part 6 intersect does not project out and the intersecting portion does not contact the middle of the neck along the cervical spine . the inclined surfaces 61 formed along the groove part 6 support the left and the right of the neck while the groove part 6 forms a portion that does not contact the middle of the neck along the cervical spine on the upper surface of the pillow body 2 . thus , the groove part 6 which restrains the position relation of the left and right inclined surfaces 61 is preferably long while absorbing the tension on both sides of the terminating ends where the edge cloth 23 and the groove part 6 intersect with the cutout portion 62 . the length of the cutout portion 62 , that is , the length of cutting both sides of the terminating end of the groove part 6 is thus about a few cm , specifically , about 3 cm . with the length of the neck of an average person ( length obtained by adding the length from the first cervical spine to the seventh cervical spine ) as about 10 cm , the length of the groove part 6 from the lower edge 411 of the bottom surface 41 of the head depression part 4 to the cutout portion 62 is preferably about 15 cm , which is obtained by adding the length of the back of the head to which the inclined surface 61 contacts to the length of the neck . similar to the prior art , the pillowcase 3 prevents the pillow body 2 from becoming dirty . the pillowcase 3 of the present example has a tubular shape , and is attached from an open end on both left and right ends to cover the pillow body 2 . the positioning in the left and right direction of the pillowcase 3 with respect to the pillow body 2 is facilitated with an annular cutout 31 ( closed cutout 31 ) as a mark with respect to the cutout portion 62 . when the tubular pillowcase 3 is formed by wrapping one sheet of cloth , the sewing line extending in the left and right direction forms in the pillowcase 3 , which sewing line may be matched with the edge cloth 23 of the pillow body 2 to help the alignment by the cutout 31 . the cutout 31 of the pillowcase 3 is preferably the length obtained by adding the length of cutting both edges of the terminating ends of the groove part 6 to the length of the neck , specifically , about 13 cm obtained by adding the cutting length of 3 cm to the length of the neck of an average person of about 10 cm . in this case , the pillowcase 3 can be opened to the left or the right by matching the lower end side of the cutout 31 , which goes around to the lower surface side of the pillow body 2 , to the opened edges of the terminating ends of the groove part 6 . owing to the cutout 31 on the pillowcase , the pillowcase 3 does not fill the groove part 6 of the pillow body 2 and does not make pillowcase 3 tense . the pillowcase 3 is tucked in towards the groove part 6 thereby ensuring the function of the groove part 6 . in addition , although not shown , the positioning with respect to the pillow body is similarly facilitated and the function of the groove part is ensured by forming the cutout in the pillowcase covering only the upper surface of the pillow body and the bag - shaped pillowcase . as shown in fig7 and 8 , in the pillow 1 of the present invention , the back of the head 71 of a patient 7 with whiplash syndrome sinks into the head depression part 4 , the back of the head 71 is supported with the supporting surface 42 having continuous peripheral surface , the neck 72 of the patient 7 with whiplash syndrome , in particular , the middle of the neck 72 along the cervical spine is laid along the groove part 6 , and the neck 72 is supported from the &# 39 ; left and the right by the inclined surfaces 61 raised gradually from the bottom surface 41 of the head depression part 4 . if the pillow body 2 is filled with the filler 24 , the angle of inclination , the direction of inclination of the inclined surface 61 supporting the neck 72 from the left and the right can be adjusted by the movement of the filler 24 by the patient 7 with whiplash syndrome himself / herself so as to fit to the patient &# 39 ; s condition , and thus the restraint of the back of the head 71 and the neck 72 of the patient 7 with whiplash syndrome by the head depression part 4 and the groove part 6 does not become too strong , and the neck 72 is merely suppressed to an extent it is not stimulated during sleep . the back of the head 71 and the neck 72 of the patient 7 with whiplash syndrome are thereby prevented from moving with respect to the pillow body 2 during sleep , and a state in which the neck 72 is not applied with pressure can be maintained for a long period of time , whereby a peaceful sleep can be provided to the patient 7 with whiplash syndrome .

considering a case where a patient with whiplash syndrome can sleep safely , it is when the patient is sleeping at an appropriate orientation , whereby if a pillow enabling sleep while maintaining an appropriate orientation exists , a sick person can sleep peacefully , and furthermore , the pillow may be useful in treating the whiplash syndrome . a pillow enabling the patient with whiplash syndrome to sleep peacefully is thus developed . a pillow 1 of the present invention has a deformable pillow body 2 including an upper surface cloth 21 and a lower surface cloth 22 having an edge cloth 23 as a boundary , formed with a head depression part 4 including a bottom surface 41 at a position depressed from the upper surface cloth 21 to the lower surface cloth 22 of the pillow body 2 , and a groove part 6 extending from the head depression part 4 to the edge cloth 23 of the pillow body 2 and being formed by joining the upper surface cloth 21 to the lower surface cloth 22 .

the present invention is a hand worn device and associated system to allow a user to remotely control the speed of an electric motor using wireless technology , such as radio frequency or infrared signals . a key element of the device and system is worn on the user &# 39 ; s hand and is designed to provide an intuitive means for the user to increase or decrease the speed of the motor , or to stop the motor completely . in certain preferred embodiments , the inventive device and system may be used by an athlete to control the speed of a treadmill ( for a walker or runner ), or the current speed of a swim spa ( for a swimmer ). another element of the system , in an enhanced embodiment , is a computer processor with associated memory to record one or more time histories of the speed of the exercise equipment motor . as recorded , the motor speed time histories may be later recalled and “ replayed ” to control the equipment motor speed thereby allowing the athlete or user to repeat the exercise exertion level previously recorded . in an exemplary embodiment , as illustrated in fig1 a , 1 b , and 2 , the control device 10 may be a glove or partial glove to be worn on the user &# 39 ; s hand . the control device 10 may be , as shown , configured to be a glove that may be worn on a user &# 39 ; s left or right hand . in terms of operation , in one preferred embodiment , the glove has incorporated into the glove material , in particular locations , a plurality of radio frequency identification (“ rfid ”) passive tags 30 that are intermittently or continuously polled by a remote rfid receiver or reader 50 . the rifd receiver or reader 50 should be located within close proximity of the user or athlete 90 and the glove 10 . because the environment in which the glove 10 is intended to be used may be in or near water , or in a sweat prevalent area , it is desired that the glove 10 not have any electrical power source , including any battery , incorporated into the glove 10 . such power sources , or electricity connected to the glove 10 could cause an undesired electrical pulse or charge being felt by the user 90 . while various wireless technology signals , other than radio frequency (“ rf ”) or rfid , could be used for the inventive control system , several of these signal technologies require a power source to operate . for example , while infrared (“ ir ”) signals could also be used to provide control signals from the glove 10 to a receiving unit 50 , such signals generally require a power source . moreover , ir transmissions typically require an approximately clear line - of - sight between the transmitting and receiving elements to be fully effective . by contrast rf or rfid signals , and in particular low frequency (“ lf ”), high frequency (“ hf ”), and ultra - high frequency (“ uhf ”) passive rfid tags do not need or have electrical power sources , and are not limited to having a clear line - of - sight between the sending and receiving units . such rfid devices are accordingly more likely to be useful for certain of the exemplary embodiments . still further alternative technology , being near field communication or “ nfc ” offers another variant of wireless technology ( similar to rfid ) that is currently being incorporated for use with smartphones . while nfc wireless technology may be , in the future , useful for wireless remote motor control , current nfc technology is likely not acceptable with respect to proximity limitations . more particularly , nfc require a very close proximity between a reader and the tag to be workable . more specifically , while the theoretical working distance for nfc tags with compact standard antennas is indicated to be up to 20 cm , the acknowledged practical working distance of such tags is more in range of 4 cm . as such nfc technology may provide an alternative communication means in the future with improved antenna technology , but is not likely to be reasonable feasible or workable for the exemplary embodiments at the time of the filing of this application . in further operational detail , using rfid technology for an exemplary embodiment , fig2 illustrates the inventive system used for a swim spa . more specifically , the proximity of the reader or receiver 50 must be close enough to the passive tags 30 such that when the reader 50 interrogates ( by emitting radio waves 51 ) the passive tags 30 , the tag or tags 30 are within the reader &# 39 ; s range 60 to be energized , and then provide a return signal back to the reader 50 . the way passive rfid tags 30 operate is that when radio waves 51 from an rfid interrogator / reader 50 reach the passive tag &# 39 ; s antenna , the rf energy is converted into electricity to power the passive tag &# 39 ; s microchip . the passive tag 30 can then transmit the chip &# 39 ; s stored data back to the reader / interrogator 50 . while the read range of passive rfid tags 30 depends on several factors , including the frequency of radio waves used for the tag - reader communication , the size of the tag antenna , the power of the reader , and interference from metal objects or other rf devices , it is acknowledged that certain passive tags , which have no power source , can be read by a reader or receiver 50 at up to approximately 15 to 20 feet . active rfid tags , as compared to passive rfid tags 30 , require an installed power source , but can be read at significantly larger distances , up to , by way of example , 300 feet or more . such active tags are often used for roadway toll collection systems . given the desire to not have an electrical power source incorporated into the glove element 10 , it is not anticipated that active rfid tags would or should be used in certain exemplary embodiments . with respect to the frequency of operation , rfid readers and tags generally have four ranges of radio frequency for operation , being low , high , ultrahigh and microwave . low - frequency (“ lf ”) tags operate between 125 khz to 134 khz , are less subject to interference , and are generally better suited for environments with metal or high moisture or water . however , lf tags have a read range of about one foot . high - frequency (“ hf ”) tags operate at between 13 to 14 mhz and have a read range of approximately 3 feet . moreover , hf tags transmit data faster than lf tags , and are often used in smart cards . ultra - high frequency (“ uhf ”) tags operate between 860 mhz to 960 mhz , and can transmit data faster and farther — 15 to 30 feet — than either hf or lf tags . uhf tag signals may however be absorbed or dissipated in high moisture or water environments . finally , microwave tags operate at about 5 . 8 ghz , have high transfer rates , and can be read from as far as 30 feet . however , such tags require substantial power sources and are costly . accordingly , in preferred exemplary embodiments , hf to uhf rfid readers and tags should provide sufficient range to interrogate and receive a return signal as operated in the anticipated environments . finally , those skilled in the art realize that the size of the tag antenna may impact read range , such that if the antenna is reduced in size , the read range similarly will be reduced . as such , as antenna technology evolves and improves , lf or hf rfid readers and tags may provide ample read range for the anticipated control applications . as further shown in fig1 a and 1b , the control device / glove 10 would have a plurality of intuitive control or activation points with passive rfid tags 30 embedded at some of those locations or points , to control the motor 100 . more particularly , as illustrated in fig1 a and 1b , a passive tag 31 would be located at the tip of the glove &# 39 ; s 10 index finger ( shown with an encircled “+” sign at the end of the index finger ), and would be used to increase motor speed . similarly , a passive tag 32 would be located at the tip of the glove &# 39 ; s 10 little finger ( shown with an encircled “−” sign at the end of the little finger ), and would be used to decrease motor speed . further , a passive tag 33 would be located in the palm area of the glove 10 ( shown with a “ stop ” sign on the palm area of the glove ), and would be used to stop the motor . in operation , in an exemplary embodiment , to increase the speed of the motor , the user / athlete 90 would simply touch the tip of his or her thumb 40 to the tip of his or her index finger to activate the increase speed passive tag 31 . to decrease the motor speed , the user / athlete would touch the tip of his or her thumb 40 to the tip of his or her little finger to activate the decrease speed passive tag 32 . finally , to signal a motor stop , the user 90 need only touch the tip of his or her ring or middle finger against the palm section of his or her hand to activate the stop motor passive tag 33 . more specifically , the passive rfid tags 31 , 32 , and 33 are located in distinct areas or sections of the device or glove , such that touching the thumb and index finger activates the increase speed rfid tag 31 so that as reader 50 polls the passive tag , the tag responds and provides an id signal to increase the motor speed . similarly touching the thumb and little finger activates a different rfid tag ( to decrease motor speed ) so that as the reader 50 polls the passive tag 32 , the tag responds and provides an id signal to decrease the motor speed . in the same manner , touching the ring or middle finger of the user &# 39 ; s hand to the palm of the glove activates a different rfid passive tag ( to stop the motor ) so that as the reader 50 polls the passive tag 33 , the tag generates and provides an id signal to stop the motor . while fig1 a and 1b show a left and right glove 10 , it is expected that the user or athlete 90 would only wear one glove 10 . in an exemplary embodiment , using the described passive rfid tags 30 , the control inputs operate as follows . an rfid reader or receiver 50 is located in close proximity to the user 90 . for a treadmill , the reader 50 could be near or in the front display panel . alternatively , the reader 50 could be positioned in the front of the treadmill proximate to the motor 100 . for a swim spa , as specifically illustrated in fig2 , the rfid reader 50 could be located near the front of the spa / pool and within 2 to 6 feet of head of the swimmer . in either of these embodiments , the location of the rfid reader 50 is such that the user &# 39 ; s hand with the glove 10 is at some points during the exercise motion , within the range or zone 60 through which the rfid reader signals 51 are projected from the reader 50 so that the reader 50 is able to interrogate the passive tags 31 , 32 , and 33 during the athlete &# 39 ; s exercise routine swimming against the current 103 . more particularly , as the athlete &# 39 ; s hand and glove 10 enters the rfid reader read zone 60 , if the user / athlete has not activated either the increase speed 31 , decrease speed 32 , or motor stop 33 passive tags , then the reader interrogation of the passive tags results in no signal being generated by any of the passive tags 30 , and no signal is sent back to the receiver 50 . accordingly , no signal would be sent by the receiver 50 to the motor 100 or motor controller 120 . if however , the swimmer / athlete 90 has activated either the increase speed 31 , decrease speed 32 , or motor stop 33 tag signal , by either touching his or her thumb to his or her index finger ( to increase speed ), or touching his or her thumb to his or her little finger ( to decrease speed ), or touching his or her ring and / or middle fingers to the palm of the gloved hand ( to signal a motor stop ), then the reader 50 interrogation of the passive tags 30 results in the activated passive tag generating a return identification signal that is sent back to the reader 50 . the rfid reader 50 accordingly receives the respective passive tag signal ( increase speed , decrease speed , or motor stop ), and , as shown in the fig3 block diagram , transmits that respective signal in turn to a decoder 330 , the motor controller 350 , the motor driver 360 , and finally to the motor 100 to either increase or decrease speed , or stop the motor 100 . an example of the above described controllable passive rfid tags are described in further detail in a capacitive touch interface for passive rfid tags as presented at the 2009 ieee international conference on rfid , and published in the conference proceedings as pages 103 to 109 , which such pages are incorporated herein by reference . in other embodiments , as suggested above , instead of passive rfid tags 30 , active rfid tags having a power source could alternatively be used in the glove 10 . similarly , other rf or ir circuits and signal generators , again with an appropriate power source in the glove , could likewise be used as an alternative to the passive tags . finally , other wireless signal generators could be used to create the motor control signals , however , such signal generators would probably need to have a power source in the glove 10 . while such systems could be manufactured , they may not be suitable for certain water immersed embodiments of the invention , because of the need for a power source within the glove 10 . because in the above disclosed exemplary embodiment , only the thumb , index finger , little finger , and palm area of the user &# 39 ; s hand are used for control inputs , a partial or cutaway glove 10 , such as illustrated in fig1 b , may be used , and thereby provide the user with substantial sections of his or her hand that are open to the air or water . with such sections of the glove 10 removed , the user is able to sense the outside environment , be it air or water or a solid object ( such as a touch screen ), through the parts of the user &# 39 ; s hand that are not covered by the glove 10 . other different variants of cut - away gloves can be used and are equally effective as a control device 10 , including having a cut - away for the thumb of the user ( not shown ), and still provide the user with the ability to have direct sensation of the outside environment with the part of his or her hand that is not covered by the glove 10 . in further detail , the method and operation of the device and system , in an exemplary embodiment , is illustrated in the fig3 block diagram . as shown , when the user activates one of the passive rfid tags 31 , 32 , and 33 incorporated into the glove 10 , the respective passive tag signal 39 , to either increase speed , decrease speed , or stop the motor , each as described above with reference to fig1 a , 1 b , and 2 , is able to be activated and read by the rfid reader / receiver 50 . when that passive tag 30 signal 39 is read by the reader 50 , the signal is wirelessly transmitted 320 to the rf receiver 50 . the respective signal is then decoded 330 after receipt by the rf receiver 50 , and is then transmitted 340 to the motor controller 350 . the motor controller 350 then passes 360 the respective control signal to the motor driver 370 , which in turn controls the motor speed based upon the rf signal input 39 . specifically , an increase speed signal increases the motor speed ; a decrease speed signal decreases the motor speed ; and a stop motor signal stops the motor 100 . in one exemplary embodiment of the operation of the remote control system , so long as the user &# 39 ; s thumb and index finger are touching , the rfid passive tag 31 is activated and an increase speed signal ( transmitted to the motor controller 350 ) will remain , thereby instructing the controller 350 to continue to increase the speed of the motor 100 . similarly , as long as the user &# 39 ; s thumb and little finger are touching and the rfid decrease speed passive tag 32 is activated , the signal to the motor controller 350 to decrease the motor speed will continuously decrease the motor speed . in an alternative embodiment , providing for discrete step control , upon the user touching his or her thumb tip with his or her index finger tip , a single increase motor speed signal is generated by the passive tag 31 and sensed by the reader 50 . to increase the motor speed further would require the user to release his or her thumb and index finger , and then retouch his or her thumb and index finger . accordingly , in this manner and embodiment , the user has the ability to increase or decrease the motor speed in discrete increments . with appropriate calibration of the single signal sent from the rfid passive tags 30 as applied to the motor controller 350 , the glove control device 10 can be used to increase or decrease the exercise exertion by a specific amount , for example , by 0 . 1 miles per hour . with differing calibration , the incremental increase or decrease could be a larger or smaller amount . such calibration could be set when the glove 10 and motor controller 350 are manufactured , or in an alternative embodiment , the calibration , or amount of speed increase or decrease with each activation of an rfid signal could be set and varied by the end - user . while the microchip within the passive tag typically carries a limited amount of data , usually a maximum of 2 kb of data , such amount of data is more than adequate to store basic information required about the tag , including in the exemplary embodiments , whether the rfid tag 30 is to increase motor speed , decrease motor speed , or provide for a full motor stop . moreover , some rfid tags have chips with read - only capabilities , with information stored on the tag during manufacturing that cannot be revised or updated . still other tags have chips that have read - write functionality , thereby allowing data to be modified or updated from time to time . such latter tags and chips could be used for calibration of the discrete increase / decrease motor speed increments . in a further exemplary embodiment of the inventive system , as shown in fig4 , a computer processor 500 with associated data memory 510 is communicatively connected to the motor controller 350 . the computer processor 500 records and saves to the data memory 550 a time history of the motor controller signals as a function of time , illustrated in fig4 next to the memory 510 . in other words , the computer processor 500 records and saves a time history record of the controller speed input to the motor driver 360 . the data memory 510 of the computer processor 500 can be sized to record multiple time histories of the motor speed . where multiple time histories are stored , the computer processor 50 automatically saves each time history file under a unique file identifier . in a preferred embodiment , the user is able to recall and rename any of the recorded and saved time histories , thereby making it easier to recall any particular desired recorded motor speed time history . by saving or recording a time history of the motor speed control , the user can later recall the recorded time history , and select to drive the motor using the recorded time history . this allows the athlete / user 90 to repeat the same exertion level as a function of time , and thereby monitor his or her performance at different times , or on different days . as shown in the fig5 block diagram , for the embodiment allowing the motor to be controlled by a recorded and saved time history , a switch 400 is implemented to take input from either the rf decoder 330 or the output from the computer processor 500 depending upon whether the user 90 desires to directly control the motor speed , or have a prior recorded time history control the motor speed . based upon the user &# 39 ; s decision , the switch 400 is either set to transmit direct control input from the user 90 ( through the rf reader 50 and decoder 330 ), or to transmit the previously recorded time history to the motor controller 350 from the computer processor 500 . in this fashion , as described above , the user or athlete 90 can “ replay ” a previously recorded motor speed profile to repeat exercise against , and thereby monitor his or her fitness level at different times . in a further exemplary embodiment , as illustrated in fig5 , the recorded time history could be transmitted by the computer processor 500 to a remote electronic device 570 , such as a smartphone that can undertake various analytics , such as comparison to prior exercise routines , or simply provide information that can be transmitted through social media . by way of example , the above described embodiment having a computer processor 500 and associated memory 510 , could be used for physical rehabilitation to allow the user and / or physical therapist to monitor and measure improvement or degradation of rehabilitation or an injury based upon the patient &# 39 ; s repeat of a recorded exertion time history . alternatively , the described embodiment could be used by swim instructors or swim teams , such as swim clubs , colleges , or olympic training facilities , to monitor an athlete &# 39 ; s training as a function of time . in a further enhancement and preferred embodiment to the inventive system , the glove device 10 could also comprise a stopwatch activated by touching a start / stop ( shown with a “ s / s ” label ) location 61 on the glove 10 , as shown in fig6 a , being near the wrist of the user &# 39 ; s glove 10 so as not to be confused with the motor increase or decrease signals at the finger tips . the stopwatch would allow the user to record the duration or length of time of the exercise . a lap function 62 could also be included on the glove 10 , as shown in fig6 a , to allow the athlete to record the time for particular laps or segments of the exercise . the lap activation tag 62 is shown in an exemplary embodiment near the middle section of the user &# 39 ; s middle finger to ensure it is not inadvertently activated or confused with the increase or decrease motor speed tags . other locations for the lap tag could be used on the glove 10 . the stopwatch output would be readable by the athlete 90 , or displayed to the athlete , from a separate device , as described below . in an alternative embodiment , the stopwatch readout could be included as a digital readout 67 , as shown in fig6 b , located on the back section of the glove 10 near the wrist area of the glove . additional features that may be included with the glove control system are a swim stroke counter , and / or a heartrate monitor . the stroke counter would work through at least one accelerometer 70 embedded in the glove 10 . the accelerometer 70 in the glove 10 senses the rotation of the swimmer &# 39 ; s arm and hand as the swimmer lifts his or her arm over his head to start the swim stroke and then pulls his or her arm back through the water to the starting position . the accelerometer / stroke count data can be transmitted to the computer processor 500 , for later read out , or can be displayed to the swimmer through various means as described below . such display means could also be a digital readout located in the wrist region of the glove , or on the back of the glove , similar to the stopwatch display , as illustrated in fig6 b . the swimmer &# 39 ; s heartrate could also be sensed by measuring the blood flow and a pulse from the wearer &# 39 ; s thumb or wrist area . in alternative embodiments , the swimmer &# 39 ; s heart rate can be determined by sensing blood flow and pulse from one or more of the wearer &# 39 ; s fingers , using , in one embodiment , optical sensors . similar to the swim stroke data , the heartrate data can be transmitted to the computer processor 500 for recording and later readout . alternatively , the heartrate data can be displayed directly to the swimmer through various display means such as , similar to as described above , a digital readout located in the wrist region of the glove 10 , or on the back of the glove . with the potential for multiple data readouts , such as elapsed time , swim stroke , and / or heartrate , in an exemplary embodiment , a single display 67 could be incorporated in the glove 10 , such as shown in fig6 b , and the data to be displayed could be cycled through as a function of time . in such an embodiment , the display for each data output could be shown for approximately 2 to 3 seconds , before the next data output is shown . the athlete 90 could then see the respective data output for elapsed time , swim stroke , and / or heartrate by viewing the same display on the back of the glove 10 . in still a further enhancement and providing an additional element and feature to the glove control system where used in a swim spa setting , the data measured at the glove , along with separately measured data , such as current speed , can be displayed on a mirror 710 positioned at the front of the pool , such that it can be easily observed and read by the swimmer 90 during the swim exercise . in an exemplary embodiment of the mirror display , fig7 shows how the data can be shown without impairing the swimmer &# 39 ; s view of his or her image in the mirror 710 . the mirror 710 essentially becomes the equivalent of a heads - up display allowing the swimmer 90 to monitor various sensed data , in real - time , including without limitation , current / swim speed , duration of exercise , total distance or laps completed , average stroke rate per lap , average stroke rate per minute , total strokes , and heartrate where such data is being monitored or sensed . in still a further preferred embodiment , the information transmitted to the mirror 710 , as described above , could also or alternatively be displayed on the swimmer &# 39 ; s goggles 810 as a heads - up - display (“ hud ”). an exemplary illustration of such display in a pair of swimmer &# 39 ; s goggles is shown in fig8 . wireless methods and systems for displaying information on swimmer &# 39 ; s goggles have been described in u . s . pat . no . 4 , 796 , 987 for a digital display for head mounted protection , and u . s . pat . no . 7 , 185 , 983 for a system and method for displaying information on athletic eyewear which are both incorporated by reference herein . while various preferred embodiments have been disclosed herein showing use of a glove to remotely control a swim spa current motor , in another preferred embodiments , the remote control device could be used to control other types of motors , including for example , for treadmills , a crane or other types of lift or movement motors . as disclosed , while the various exemplary embodiments show use of passive rfid technology and signals to control the motor , in other embodiments of the inventive system and method , other wireless technologies could be used , such as active rfid , rf , ir , nfc , or other wireless signals . the above detailed description teaches certain preferred embodiments for the present inventive remote control device , system and method to control motor speed . while preferred embodiments have been described and disclosed , it will be recognized by those skilled in the art that modifications and / or substitutions are possible and such modifications and substitutions are within the true scope and spirit of the present invention . it is likewise understood that the attached claims are intended to cover all such modifications and / or substitutions .

a radio frequency remote control device for use to control the speed of a motor is disclosed . in one preferred embodiment , the device may be used by a swimmer in a swim spa . the rf device can be preferably formed in shape of a glove to be worn by the athlete / swimmer , such that he or she can readily change the speed of the swim spa current motor , and in turn the speed of the current he or she is swimming against simply by activating respective increase or decrease motor speed signals . in further embodiments , the rf device can also include a stop watch to record duration of exercise , and / or an automatic stroke counter to record the number of strokes during the exercise .

referring to fig1 a system or device 10 made in accordance with the preferred embodiment may be implanted below the skin of a patient . the device has a port 14 into which a hypodermic needle can be inserted through the skin to inject a quantity of a liquid agent , such as a medication or drug . the liquid agent is delivered from device 10 through a catheter port 20 into a catheter 22 . catheter 22 is positioned to deliver the agent to specific infusion sites in a brain ( b ). device 10 may take the form of the like - numbered device shown in u . s . pat . no . 4 , 692 , 147 ( duggan ), assigned to medtronic , inc ., minneapolis , minn ., which is incorporated by reference . the distal end of catheter 22 terminates in a cylindrical hollow tube 22a having a distal end 115 implanted into a portion of the basal ganglia of the brain by conventional stereotactic surgical techniques . additional details about end 115 may be obtained from pending u . s . application ser . no . 08 / 912 , 379 entitled &# 34 ; intraparenchymal infusion catheter system ,&# 34 ; filed aug . 18 , 1997 in the name of dennis elsberry et al . and assigned to the same assignee as the present application . tube 22a is surgically implanted through a hole in the skull 123 and catheter 22 is implanted between the skull and the scalp 125 as shown in fig1 . catheter 22 is joined to implanted device 10 in the manner shown , and may be secured to the device 10 by , for example , screwing catheter 22 onto catheter port 20 . referring to fig2 device 10 is implanted in a human body 120 in the location shown . body 120 includes arms 122 and 123 . alternatively , device 10 may be implanted in the abdomen . catheter 22 may be divided into twin tubes 22a and 22b that are implanted into the brain bilaterally . alternatively , tube 22b may be supplied with drugs from a separate catheter and pump . a sensor 130 is implanted into a portion of a patient &# 39 ; s body suitable for detecting motion disorder symptoms or abnormal motor behavior . in this specification and claims , abnormal motor behavior includes abnormal motor response . sensor 130 is adapted to sense an attribute of the symptom to be controlled or an important related symptom . for motion disorders that result in abnormal movement of an arm , such as arm 122 , sensor 130 may be a motion detector implanted in arm 122 as shown . for example , sensor 130 may sense three - dimensional or two - dimensional motion ( linear rotational or joint motion ), such as by an accelerometer . one such sensor suitable for use with the present invention is described in u . s . pat . no . 5 , 293 , 879 ( vonk et al .). another suitable accelerometer is found in a pacemaker manufactured by medtronic , inc ., which is described in u . s . application ser . no . 08 / 399 , 072 , entitled &# 34 ; package integrated accelerometer &# 34 ;, filed mar . 8 , 1995 in the names of james m . sikorski and larry r . larson and assigned to the same assignee as the present invention , which is incorporated by reference . sensor 130 also may be placed in device 10 in order to detect abnormal movement resulting from the motion disorder being treated . sensor 130 also may be capable of detecting gravity direction or motion relative to some object ( e . g ., a magnet ) either implanted or fixed nearby . sensor 130 also may take the form of a device capable of detecting force in muscles or at joints , or pressure . sensor 130 may detect muscle emg in one , two or more muscles , or in reciprocal muscles at one joint . for such detection , sensor 130 may take the form of a lead with one or more recording electrodes inserted into the muscle of interest . brain eeg ( e . g ., motor cortex potentials recorded above the motor neurons controlling specific muscle groups ) also may be detected by sensor 130 . yet another form of sensor 130 would include a device capable of detecting nerve compound action potentials ( e . g ., either sensory afferent information from muscle or skin receptors or efferent motor potentials controlling a muscle of interest ). for certain types of patients , sensor 130 may take the form of a device detecting the posture of the patient . sensor 130 also may take the form of a device capable of detecting nerve cell or axon activity that is related to the pathways at the cause of the symptom , or that reflects sensations which are elicited by the symptom . such a sensor may be located deep in the brain . for such detecting , sensor 130 may take the form of an electrode inserted into the internal capsule of the brain . signals that are received by the sensor may by amplified before transmission to circuitry contained within device 10 . sensor 130 may electronically transduce the concentration of a transmitter substance present in a particular location of the brain . a paper describing such a sensor is entitled &# 34 ; multichannel semiconductor - based electrodes for in vivo electrochemical and electrophysiological studies in rat cns &# 34 ;, by van horne et al ., 120 neuroscience letters 249 - 252 ( elsevier scientific publishers ireland ltd . 1990 ). for tremor , the relative motion of a joint or limb or muscle emg may be productively sensed . sensing electrical activity of neurons in various locations of the motor circuitry also is helpful . recording the electrical activity in the thalamus will reveal a characteristic oscillating electrical activity when tremor is present . for ballism , hemiballism or tremor , sensor 130 may take the form of an accelerometer detecting relative motion of a joint or limb or muscle emg . for dystonia , sensor 130 may take the form of a device for detecting relative motion of a joint or limb or muscle emg . referring to fig3 the output of sensor 130 is coupled by a cable 132 comprising conductors 134 and 135 to the input of analog to digital converter 140 . the output of the analog to digital converter is connected to terminals ef2 bar and ef3 bar as disclosed in u . s . pat . no . 4 , 692 , 147 (&# 34 ;&# 39 ; 147 patent &# 34 ;). before converter 140 is connected to the terminals , any demodulators ( not shown ) would be disconnected . the present invention may be implemented by providing seven different drug dosages from 0 dosage to a 1 . 0 ml dosage with 0 . 1 ml increments between choices . the time interval between dosages can be selected between one and twelve hours in seven choices . this is the same type of dosage and interval described in connection with device 10 shown in the &# 39 ; 147 patent ( column 5 , beginning at line 63 ). the seven drug dosages and corresponding time increments may be loaded into ram memory 102a as disclosed in the &# 39 ; 147 patent . the appropriate drug dosage and interval is selected by a computer algorithm that reads the output of converter 140 and makes the appropriate selection . one exemplary computer algorithm is shown herein at fig4 and is described as follows with particular reference to fig3 and 4 herein . microprocessor 100 included within device 10 reads converter 140 in step 150 , and stores one or more values in ram 102a in step 152 . one of seven dosages is selected in step 154 , and an appropriate time interval is selected in step 156 . the selected dosage and interval of a drug is then delivered through catheter 22 and tube 22a to the basal ganglia of the brain as described in the &# 39 ; 147 patent . for some types of motion disorders , a microprocessor and analog to digital converter will not be necessary . the output from sensor 130 can be filtered by an appropriate electronic filter in order to provide a control signal for a pump of the type shown in the &# 39 ; 147 patent . the type of drugs administered by device 10 into the brain depend on the specific location at which distal end 115 of tube 22a is surgically implanted . the appropriate drugs for use in connection with the portion of the basal ganglia or thalamus in which tube 22a terminates , together with the effect of the drug on that portion of the brain for hyperkinetic motion disorders is provided in the following table i : table i______________________________________effect portion of brain drug______________________________________decrease vl thalamus glutamateexcitation antagonist / degrading enzymeincrease vl thalamus gaba agonist / inhibition reuptake blockerincrease gpi / snr glutamate agonist / excitation reuptake blockerdecrease gpi / snr gaba antagonist / inhibition degrading enzymeincrease stn glutamate agonist / excitation reuptake blockerdecrease stn gaba antagonist / inhibition degrading enzymedecrease gpe glutamateexcitation antagonist / degrading enzymeincrease gpe gaba agonist / inhibition reuptake blockerincrease neostriatum ( indirect glutamate agonist / excitation pathway ) reuptake blockerdecrease neostriatum ( indirect dopamineinhibition pathway ) antagonist / degrading enzymedecrease neostriatum ( indirect glutamateexcitation pathway ) antagonist / degrading enzymedecrease neostriatum ( indirect dopamineexcitation pathway ) antagonist / degrading enzyme______________________________________ the appropriate drugs for use in connection with the portion of the basal ganglia or thalamus in which tube 22a terminates , together with the effect of the drug on that portion of the brain for hypokinetic motion disorders is provided in the following table ii : table ii______________________________________effect portion of brain drug______________________________________increase vl thalamus glutamate agonist / reuptakeexcitation blockerdecrease vl thalamus gaba antagonist / degradinginhibition enzymeincrease gpi / snr gaba agonist / reuptakeinhibition blockerdecrease gpi / snr glutamateexcitation antagonist / degrading enzymeincrease stn gaba agonist / reuptakeinhibition blockerdecrease stn glutamateexcitation antagonist / degrading enzymeincrease gpe glutamate agonist / reuptakeexcitation blockerdecrease gpe gaba antagonist / degradinginhibition enzymeincrease neostriatum dopamine agonist / reuptakedopamine blocker______________________________________ in the foregoing tables i and ii , vl thalamus means ventrolateral thalamus ; gpi means internal segment of globus pallidus ; snr means substantia nigra pars reticulata , stn means subthalamic nucleus ; and gpe means external segment of globus pallidus . typical stereotaxic coordinates based on a normal brain for the portions of the brain described in tables i and ii are identified in the following table iii : table iii______________________________________ medial - dorsal - anterior - lateral ventral posteriorbrain region dimension dimension dimension______________________________________vl thalamus 0 . 7 to 1 . 8 1 . 5 to - 0 . 2 0 . 0 to - 1 . 0gpi 0 . 5 to 2 . 0 0 . 5 to - 0 . 7 0 . 7 to 2 . 0snr 0 . 5 to 1 . 5 - 0 . 6 to - 1 . 5 0 . 7 to - 0 . 7stn 0 . 5 to 2 . 0 0 . 0 to - 1 . 0 0 . 6 to - 1 . 0gpe 1 . 6 to 2 . 7 1 . 0 to - 1 . 0 2 . 0 to - 1 . 0striatum : caudate 0 . 5 to 2 . 0 1 . 5 to 3 . 0 1 . 5 to 3 . 0putamen 1 . 2 to 3 . 3 1 . 5 to - 1 . 0 2 . 5 to - 1 . 2______________________________________ in the foregoing table : the medial - lateral dimensions are relative to midline of the brain ; the anterior - posterior dimensions are relative to the midpoint between the anterior commissure and posterior commissure with negative indicating the posterior direction ; the dorsal - ventral dimensions are relative to a line connecting the midpoints of the anterior and posterior commissures with negative being ventral to ; all dimension are in centimeters . examples of specific drugs for the brain infusion sites identified in tables i and ii and preferred ranges of dosages are provided in the following table iv : table iv__________________________________________________________________________ braindesired target or drug specific dosingeffect targets class drug range__________________________________________________________________________decrease ventrolateral glutamate mk801 1 - 20 mumexcitation thalamus antagonists ( dizocilpine ) 5 - 50 mum ketamine hclincrease excitation ventrolateral gaba agonists baclofen 1 - 10 mum thalamus muscinol hbr 100 - 500 mumincrease excitation globus pallidus glutamate agonist d - cycloserine 1 - 10 mum interna / substantia l - ap4 1 - 10 mum nigra reticulatadecrease globus pallidus gaba gabazine 1 - 50 muminhibition interna / substantia antagonists saclofen 0 . 5 - 25 mum nigra reticulataincrease excitation nucleus glutamate agonist carboxyphenylgly 10 - 500 mum subthalamic cine 1 - 100 mum l - glutamic aciddecrease nucleus gaba bicuulline 1 - 100 muminhibition subthalamic antagonists picrotoxin 10 - 100 mumdecrease globus pallidus glutamate cnqx 1 - 100 mumexcitation externa antagonist ap - 3 1 - 10 mum dextromethorphan 1 - 100 mumincreae globus pallidus gaba agonists baclofen 0 . 1 - 10 muminhibition externa muscimol hbr 100 - 500 mumincrease neostriatum glutamate cis - piperidine - 1 - 10 mumexcitation ( indirect agonists 2 , 3 - dicarboxylic 1 - 10 mum pathway ) acid d - cycloserinedecrease neostriatum dopamine (+) apomorphine 5 - 20 muminhibition ( indirect antagonist hcl 0 . 05 - 1 mum pathway ) (-) sulpiridedecrease neostriatum glutamate mcpd 0 . 02 - 10 mumexcitation ( indirect antagonist dextrorphan 1 - 100 mum pathway ) tartratedecrease neostriatum dopamine spiperone hcl 0 . 1 - 10 mumexcitation ( indirect antagonist haloperidol 10 - 100 mum pathway ) increase neostriatum dopamine (-) apomorphine 10 - 30 mumexcitation agonist pergolide 1 - 10 mum methanesulfonateincrease motor cortex glutamate (+/-)- trans - 1 - 10 mumexcitation agonists acpd 1 - 10 mum l - ap4decrease globus pallidus , lidocaine lidocaine 5 - 20 mumexcitation neostriatum hydrochloride__________________________________________________________________________ in the preceding table , mum means micromolar . other agents not listed but of the same class could also be used . microprocessor 100 within device 10 can be programmed so that a controlled amount of drug can be delivered to the specific brain sites described in table i . alternatively , sensor 130 can be used with a closed loop feedback system in order to automatically determine the level of drug delivery necessary to alleviate motor disorder symptoms as described in connection with fig4 . by using the foregoing techniques , motor disorders can be controlled with a degree of accuracy previously unattainable . those skilled in that art will recognize that the preferred embodiments may be altered or amended without departing from the true spirit and scope of the invention , as defined in the accompanying claims .

the present invention is directed to techniques and apparatus for infusing drugs into the brain to treat movement disorders resulting in abnormal motor behavior . the invention employs an implantable pump and a catheter , the catheter having a proximal end coupled to the pump and a discharge portion for placement adjacent a predetermined infusion site in the brain for infusing therapeutic dosages of the one or more drugs into the brain . the pump is operated to discharge a predetermined dosage of the one or more drugs through the discharge portion of the catheter into the infusion site . a sensor may be used in combination with the implantable pump and catheter , whereby the sensor generates a signal relating to the extent of the abnormal motor behavior . the therapeutic dosage is regulated so that the dosage is adjusted in response to an increase in the abnormal behavior to decrease the abnormal motor behavior .

embodiments of the present invention will now be described in detail with reference to the drawings and pictures , which are provided as illustrative examples so as to enable those skilled in the art to practice the invention . notably , the figures and examples below are not meant to limit the scope of the present invention to a single embodiment , but other embodiments are possible by way of interchange of some or all of the described or illustrated elements . wherever convenient , the same reference numbers will be used throughout the drawings to refer to same or like parts . where certain elements of these embodiments can be partially or fully implemented using known components , only those portions of such known components that are necessary for an understanding of the present invention will be described , and detailed descriptions of other portions of such known components will be omitted so as not to obscure the invention . in the present specification , an embodiment showing a singular component should not be considered limiting ; rather , the invention is intended to encompass other embodiments including a plurality of the same component , and vice - versa , unless explicitly stated otherwise herein . moreover , applicants do not intend for any term in the specification or claims to be ascribed an uncommon or special meaning unless explicitly set forth as such . further , the present invention encompasses present and future known equivalents to the components referred to herein by way of illustration . referring to the embodiment depicted in fig1 a - e , an absorbable vascular filter 1 consists of an outer , circumferential element 2 for supporting a plurality of absorbable filter capture elements ( 30 - 32 , 40 - 41 ). the capture elements are purposely designed to be biologically absorbed and / or degraded preferably in a sequential manner to avoid simultaneous detachment of the entire filter causing an unexpected embolus . sequential degradation can be controlled by the choice of absorbable polymers that possess different absorption profiles , diameter , and / or expiration dates . additionally , absorptive linkages may be incorporated to serves as detachment points during absorption . the sequential bioabsorption / biodegradation is illustrated in fig1 b - e where decomposition begins with the proximal capture elements 30 , progressing to the middle section capture elements 31 , and finally full bioabsorption / biodegradation as depicted in fig1 e . such engineered , sequential bioabsorption / biodegradation of the capture elements can be achieved with numerous synthetic materials . the goal is to select the absorbable filter materials to match a desired filter indwell time . per the prior background section , a filter indwell time of 6 weeks would be suitable for an ivc filter to prevent pe following trauma or in conjunction with major surgeries . synthetic materials which can be used to form the capture elements include : polydioxanone ( pdo , pds )— colorless , crystalline , biodegradable synthetic polymer of multiple repeating ether - ester units . in suture form , pds ii ( ethicon , somerville , n . j .) size 4 / 0 and smaller maintains 60 %, 40 %, and 35 % of its tensile strength at 2 , 4 , and 6 weeks respectively . for pds ii size 3 / 0 and larger , it retains 80 %, 70 %, and 60 % of its tensile strength at 2 , 4 , and 6 weeks respectively . in addition to providing wound support for 6 weeks , pds ii suture is fully absorbed in 183 - 238 days via hydrolysis making it a strong candidate for ivc filter applications . basically absorption is minimal in the first 90 days and is essentially complete in 6 months . finally , pds has a low affinity for microorganisms and possesses minimal tissue reaction . polytrimethylene carbonate ( maxon )— similar to pds in absorption profile yet with slightly higher breaking strength . maxon ( covidien , mansfield , mass .) maintains 81 %, 59 %, and 30 % of its tensile strength at 2 , 4 , and 6 weeks respectively , and is fully hydrolyzed in 180 - 210 days . polyglactin 910 ( vicryl )— braided multifilament coated with a copolymer of lactide and glycolide ( polyglactin 370 ). in suture form , vicryl ( ethicon ) size 6 / 0 and larger maintains 75 %, 50 %, and 25 % of its tensile strength at 2 , 3 , and 4 weeks respectively and is fully absorbed in 56 - 70 days . polyglycolic acid ( dexon )— similar to polyglactin , made from polyglycolic acid and coated with polycaprolate . dexon has similar tensile strength and absorption profile as polyglactin . poliglecaprone 25 ( monocryl )— synthetic copolymer of glycolide and e - caprolactone . monocryl ( ethicon ) maintains 50 %- 70 % and 20 %- 40 % of its tensile strength at 1 and 2 weeks respectively and is fully absorbed in 91 - 119 days . polylacticoglycolic acid ( plga ) copolymer of monomers glycolic acid and lactic acid . different forms and properties of plga can be fabricated by controlling the ratio of lactide to glycolide for polymerization . like the other synthetic absorbable materials , plga degrades by hydrolysis with the absorption profile dependent on the monomer ratio ; the higher content of glycolide , the faster degradation . however , the 50 : 50 copolymer exhibits the fastest degradation at 2 months . since the polymer degrades in the body to produce lactic acid and glycolic acid , both being normal physiological substances , plga poses minimal systemic toxicity . poly l - lactic acid ( pla ) is also a polymer made from lactic acid yet with considerable longevity . in soft tissue approximation , pla remains intact for 28 weeks , and is fully absorbed within 52 weeks . as an example of engineering capture elements to sequentially degrade following the period of pe protection , the proximal capture elements 30 , 41 could be fabricated with pds ii size 4 / 0 ( 0 . 15 mm dia . ), while the middle capture elements 31 , 40 fabricated with size 2 / 0 ( 0 . 3 mm dia . ), and finally the distal capture elements 32 fabricated with size 2 ( 0 . 5 mm ) pds ii suture . as an alternative to assembling a plurality of capture elements , the vascular filter can be fabricated with absorbable or non - absorbable composite mesh . candidates for a mesh capture system include polypropylene such as c - qur ( atrium medical corp . hudson n . h . ), polypropylene encapsulated by polydioxanone as in proceed ( ethicon , somerville , n . j . ), polypropylene co - knitted with polyglycolic acid fibers as in bard sepramesh ip composite ( davol , inc ., warwick , r . i . ), polyethylene terephathalate as in parietiex composite ( covidien , mansfield , mass . ), and eptfe used in dualamesh ( w . gore & amp ; assoc . inc ., flagstaff , ariz .). regarding the circumferential element 2 in fig1 , 2 , and 3 that serves to support the capture elements of the absorbable vascular filter and maintain filter positioning within the vessel upon expansion from a catheter , either an absorbable material such as described above or non - absorbable material can be utilized . a non - absorbable material would essentially serve as a permanent stent , lasting well beyond the life of the absorbable capture elements . this may be an important option in cases where the vessel needs assistance in maintaining patency . both types of circumferential elements 2 may incorporate barbs 79 ( refer fig2 ) to maintain filter positioning upon deployment . plausible non - absorbing materials for constructing the circumferential element include : nitinol , elgiloy , phynox , 316 stainless steel , mp35n alloy , titanium alloy , platinum alloy , niobium alloys , cobalt alloys , and tantalum wire . fig2 a - 2 h illustrate another embodiment of the absorbable vascular filter wherein the absorbable capture elements 60 - 64 are mounted to a simple circumferential element 2 held against the vessel wall 70 with optional barbs 79 . here again the circumferential element 2 can be fabricated with absorbable or non - absorbable materials of the like described above . an enlarged cross - sectional view of the capture element assembly 65 is shown in fig2 b . notice that the sequential degradation of the capture elements is achieved by varying the diameter of the chosen absorbable material . for example , the inner capture element 60 could be pds ii 4 / 0 ( 0 . 15 mm dia .) resulting in the fastest absorption as illustrated in fig2 d at time t 1 , followed by capture element 61 degradation being pds ii 3 / 0 ( 0 . 20 mm dia .) at time t 2 in fig2 e , followed by capture element 62 degradation being pds ii 2 / 0 ( 0 . 30 mm dia .) at time t 3 in fig2 f , followed by capture element 63 degradation being pds ii 0 ( 0 . 35 mm dia .) at time t 4 in fig2 g , and finally the degradation of the last capture element 64 constructed of pds ii 1 ( 0 . 40 mm dia .) at time t 5 in fig2 h . although these dimensions represent a specific example , any diameters within approximately 0 . 1 mm to 0 . 7 mm would suffice . overall , a gradual progression of degradation is designed purposely following a prophylactic window of 6 weeks for trauma and major surgery applications . referring to the embodiment depicted in fig3 a and b , a vascular filter 1 consists of an outer , circumferential stent 2 for supporting a plurality of collapsible filter capture elements ( 60 - 64 ) and to maintain vessel patency . the capture elements are purposely designed to be collapsible for catheter - based installation and to avoid end organ damage . the supporting stent 2 is shown to be fabricated as an artificial vascular graft supported by undulating supporting structures 3 . this vascular filter , which can be comprised of absorbable or non - absorbable filter capture elements , possesses various advantages over all conventional vascular filters , including permanent , temporary , and optional ivc filters . most importantly , the vascular filter is fabricated with a stent that serves as a circumferential mount for the capture elements in addition to providing vessel patency , and avoids endothelialization characteristic of metal filters with barbed struts . hence the increased incidence of dvt observed with metal ivc filters due to inherent vessel damage from the metal struts is likely obviated . the circumferential stent element 2 in fig3 a serves to support the capture elements of the vascular filter , in addition to maintaining vessel patency and maintaining stationary filter positioning within the vessel upon expansion . numerous types of stents conventionally employed as thoracic endoprostheses can be utilized . such stents would include gore tag , medtronic talent and valiant systems , and cook zenith tx2 system . in particular , the gore tag is comprised of an artificial vascular graft fabricated with a fluoropolymer ( expanded polytetrafluoroethylenee ptfe and fluorinated ethylene propylene or fep ) combined with a nitinol supporting structure . alternatively , the stent component of the vascular filter can be fabricated with only the supporting structure ( without the artificial vascular graft ) utilizing nickel - titanium alloy ( nitinol ), cobalt - chromium - nickel alloy ( elgiloy ), cobalt - chromium - nickel - molybdenum alloy ( phynox ), 316 stainless steel , mp35n alloy , titanium alloy , platinum alloy , niobium alloys , cobalt alloys , and tantalum wire . a specific embodiment of an absorbable vascular filter with sequential degradation was constructed , tested , and evaluated with assorted polydioxanone sutures ( sizes 3 - 0 , 2 - 0 , 0 , and 1 ) and is shown in fig4 a . the filter featured higher density webbing than shown in fig2 b to catch smaller emboli . polydioxanone was the preferred candidate polymer based on tension retention and absorption properties proven in wound approximation applications . tygon long flex lifetime tubing ( saint - gobain performance plastics , akron , ohio ) with 25 . 4 mm id similar to the ivc was utilized for the vessel wall wherein polydioxanone was fabricated into the various filter patterns shown . fig4 a sports webbed capture elements that are purposely designed for sequential or phased absorption to avoid simultaneous detachment of the entire filter during absorption . here varying diameter strands of polydioxanone ( size 3 - 0 , 2 - 0 , 0 and 1 ) were utilized to vary the time to complete absorption , in addition to varying the expiration dates . since the absorbable polymers initially break at the stress points during absorption , the webbed filters were designed to disintegrate into 8 pieces at length d / 2 , and 8 pieces sized d / 4 , where d is the inside diameter of the vessel . the objective is piecemeal disintegration , phased or sequential , to minimize free floating exposure of the polymer filter capture elements in circulation . fig4 b is the same webbed design but with uniformly sized polydioxanone suture for comparison . fig4 c is a radial filter design similar to conventional metal ivc filters yet sports the varying diameter sutures for sequential absorption . finally , fig4 d is a radial design constructed exclusively with polydioxanone size 2 - 0 . the primary endpoint for evaluating the absorbable polymers for vascular filter application was load at break as a function of time . in addition to the absorbable filters pictured in fig4 , several test cells were fabricated with the various absorbable polymer candidates for weekly destructive tensile testing . polymer characterization was performed utilizing the admet expert 7601 tensile testing machine with mtestquattro software ( norwood , mass .) at weekly intervals to yield stress vs . strain graphs in addition to the primary endpoint of load at break , and several secondary endpoints : ( i ) maximum stress ( tensile strength ), ( ii ) maximum strain (% elongation at break ), ( iii ) energy at break , and ( iv ) young &# 39 ; s modulus of elasticity . the admet machine was operated with a crosshead speed of 3 cm / min and outfitted with a high resolution 100 lb load cell and 2kn pneumatic grippers . the candidate absorbable polymers ( representing capture elements ) sewn into the test cells were embedded in a closed circulation system engineered to mimic human cardio physiology . at weekly intervals , the system was shut down to extract sutures of each size and type to perform destructive tensile testing . as a control , identical absorbable sutures were submerged into a static buffer bath ( stabletemp digital utility bath , cole - parmer , vernon hill , ill .) held at 37 ° c . and also tested on a weekly basis . the hypothesis being that the increased thermodynamics of the circulation system accelerates both absorption rate and tensile strength loss of the capture elements . the closed circulation system was constructed with thin walled ¾ ″ pvc with od 26 . 7 mm that fit snug inside the flexible 25 . 4 mm id tygon tubing that simulated the ivc . the heart of the system was a harvard apparatus large animal pulsatile blood pump ( holliston , mass .) that simulated the ventricular action of the heart . the harvard apparatus blood pump was operated near continuously for 22 weeks ( 913k l pumped ) with minor preventative maintenance . the heart rate was adjusted to 60 bpm , stroke volume between 60 and 70 ml , systolic / diastolic duration ratio 35 %/ 65 %, and systolic blood pressure varied from 120 mmhg ( simulated conditions for an arterial filter to prevent cerebral and systemic embolism ) to 5 mmhg ( simulated conditions for an ivc filter to prevent pe ). real time measurements were available from the upstream and downstream sensor manifolds . the sensors upstream from the absorbable filters under test included digital temperature , flow rate ( l / min ), total flow ( l ), and pressure ( mmhg ). downstream instrumentation included real time measurement of % oxygen , total dissolved solids ( tds in ppt ), and ph . tds monitoring was included to evaluate the absorption by - products less than 20 microns in size , while the downstream 80 micron in - line filter would catch fragments of suture from the filters and test cells . the 4 candidate absorbable vascular filters introduced in fig4 were installed in series along the upstream tubing , whereas 5 test cells containing absorbable suture for weekly destructive testing were installed in series along the downstream section of the in - vitro cardio test system . a 288w heating tape with thermostat was utilized to maintain 37 ° c . within the closed circulation system . finally , the circulating fluid was ph 7 . 4 phosphate buffer ( invitrogen , carlsbad , calif .) with a similar electrolyte profile as human blood . buffer was replaced weekly in an effort to maintain stable ph . absorption and tensile properties of the selected polymers were determined as a function of time until compete strength degradation in both the circulation system and control bath . the phosphate buffer in the circulation system was changed weekly as the ph decreased from 7 . 4 to an average 6 . 6 during each week . buffer was changed in the control bath only monthly due to better ph stability in the static environment . mean flow was 4 . 7 l / min while oxygen averaged 30 % and tds 8 . 8 ppt . the phased or sequential absorption of the webbed absorbable filter design is illustrated in the collage of fig5 . notice the filter begins to disintegrate during the 13th week and continues in a phased manner , losing only 1 or 2 capture elements per week thereafter , until complete disintegration in 22 weeks . initial fractures detected in the 13th week were located at the high stress points within the capture elements . since the apex of a capture element mounted to the circumferential support experiences twice the stress in comparison to the base of the capture element , the initial break will be at the apex . the capture elements that formed loops extending from the vessel wall to the center of the filter were constructed of polydioxanone size 1 and 0 with expiration date january 2012 , while the shorter capture elements that extended a quarter of the diameter were constructed of size 3 - 0 polydioxanone suture with an expiration date of january 2015 . the expiration date was seen to play a greater role than suture diameter in the rate of absorption since the smaller diameter suture fractured in week 17 , versus the larger diameter suture that fractured in week 13 . the planned disintegration of 8 elements of length d / 2 and 8 elements of length d / 4 for the webbed filter actually yielded smaller brittle fragments due to splintering and fragmenting . in fact the largest filter element captured from the webbed design by the downstream 80 um filter revealed a maximum sized fragment of 5 mm × 0 . 3 mm . perhaps the paramount characteristic under consideration for use in an absorbable vascular filter is the strength retention profile of the absorbable polymers as depicted in fig6 for polydioxanone in the in - vitro circulation system . as shown , polydioxanone initially exhibits moderate strength degradation , less than approximately 5 % per week for the initial 5 to 6 weeks , followed by rapid decline approaching 20 % per week thereafter . as a conservative summary for the initial 5 weeks in circulation , polydioxanone size 1 maintained about 10 kg strength , size 0 maintained 6 kg , size 2 - 0 maintained 4 kg , and size 4 - 0 maintained 1 . 5 kg . similar results were obtained from a buffer bath control for the initial 5 weeks . however , statistical difference was achieved at week 5 for size 0 ( p & lt ; 0 . 014 ), week 6 for sizes 2 - 0 and 1 ( p & lt ; 0 . 021 ), and week 7 p & lt ; 0 . 011 ). the proposed filter designs employ multiple strands serving as capture elements , hence the emboli load is distributed across n strands . therefore assuming equal distribution , the net emboli load that can be accommodated by the filter is a multiple , n , of the per strand load at break . consequently , a polydioxanone size 2 - 0 filter with 8 capture elements secured at the circumferential support would accommodate a net emboli load of 32 kg . an alternative method for accessing strength retention for the polymers is to chart the percentage strength retention as a function of time as shown in fig7 . here all polydioxanone sizes slowly lost strength for the first 5 weeks , then rapidly absorbed to negligible strength by the 10th week . specifically , polydioxanone within the in - vitro circulation system retained average strength for sizes 2 - 0 and larger of 88 % at 2 weeks , 85 % at 4 weeks , and 68 % at 6 weeks vs . ethicon &# 39 ; s in - vivo animal tissue approximation applications that yielded 80 % at 2 weeks , 70 % at 4 weeks and 60 % at 6 weeks per ethicon product literature . young &# 39 ; s modulus of elasticity ranged from 1 . 0 - 2 . 3 gpa for polydioxanone as shown in fig8 for the absorbable filter elements . notice that young &# 39 ; s modulus initially decreased ( polymer became more elastic ) as it was subjected to the buffer , reached a minimum at 6 weeks , then increased to approximately twice the initial value . this increase in young &# 39 ; s modulus for polydioxanone is indicative of the increased brittleness as it reached zero terminal strength , and was further observed during disintegration . this property may well be advantageous for the absorbable filter application . for example , as polydioxanone reached zero terminal strength and disintegrated , it splintered and fractured into smaller , brittle fragments thereby being potentially less harmful to downstream organs . further studies are required to determine the exact size of the terminal fragments in - vivo and evaluate potential pulmonary micro - infarcts . in conclusion from the in - vitro absorbable filter study , polydioxanone appears to be a strong candidate for absorbable vascular filters with sufficient strength retention to capture emboli for at least 6 weeks , then absorb rapidly over the next 16 weeks via hydrolysis into carbon dioxide and water . specifically polydioxanone size 2 - 0 was shown to conservatively maintain 4 kg load at break per strand throughout 5 weeks in circulation . hence a filter incorporating 8 capture elements would trap an embolus load of 32 kg ; or equivalently , an embolism would have to deliver 1600 kgmm of energy to break through the filter which is highly unlikely given that the pressure in the ivc is a mere 5 mmhg ( about 0 . 1 psi ). moreover , the webbed filter geometry with varied diameter capture elements and expiration dates was shown to disintegrate in a sequential or phased manner , releasing 1 or 2 small brittle filter fragments ( less than 5 mm × 0 . 3 mm each ) weekly in circulation from weeks 14 through 22 . together with polydioxanone being fda - approved and proven to be nonallergenic and nonpyrogenic , a catheter - deployed polydioxanone absorbable vascular filter would likely be an efficient and effective device for the prevention of pulmonary embolism . a preferred installation of the absorbable vascular filter is via intravenous insertion with a catheter requiring only a local anesthetic as illustrated in fig9 a - e . here the filter is collapsed and compressed within a delivery catheter comprised of an outer sheath 71 and internal applicator or stabilizer piston 73 on a central rod as illustrated in fig9 a . for ivc filter deployment , the delivery catheter is inserted into the patient &# 39 ; s vasculature of convenient location , such as the femoral vein or internal jugular . subsequently , the delivery catheter is fed through the vasculature typically over a guide wire until reaching the desired deployment location , often inferior to the renal veins . next the compressed filter 50 is allowed to expand upon sliding the exterior sheath 71 in the proximal direction while simultaneously pushing the stabilizer rod and piston 72 in the distal direction ( refer fig9 b ). once the exterior sheath 71 is withdrawn away from the filter , the stabilizing piston 73 can also be retracted as depicted in fig9 c . consequently as a thrombosis event releases an embolus 80 , the embolus is captured by the vascular filter and is prevented from traveling to the heart and lungs thereby preventing a potentially fatal pe ( refer fig9 d ). following the desired prophylactic time window for filter utilization ( approximately 6 weeks in many applications ), the filter is biologically absorbed resulting in the absence of any foreign material in the vessel as depicted in fig9 e . an alternative embodiment of the absorbable vascular filter 1 is portrayed in fig1 a with an integrated circumferential support 102 and capture basket 101 . here the circumferential support 102 and capture basket 101 are braided or woven much like a radial expansible stent that can be compressed in a catheter as described above prior to deployment . fig1 b is a top view of the absorbable vascular filter that displays the weave or braid of the capture basket 101 . the weave is shown to maintain a patent center 104 to allow insertion of a guide wire during catheter deployment . the appeal of this particular embodiment is that the entire absorbable vascular filter ( circumferential support and capture basket composed of the capture elements ) can be fabricated from a single filament with a designed radial force to prevent filter migration as described below . the integrated absorbable vascular filter shown in fig1 a and b yields a diametrically expandable and compressible tubular filter that exhibits a radial force with magnitude dependent on the materials chosen , angle phi ( φ ) of the crossing elements of the weave , and the amount of diameter over sizing employed . specifically , the angle important to establishing radial force is depicted as φ in fig1 . the larger the angle φ as it approaches 180 °, the greater the amount of radial force provided by the weave . typically φ is an obtuse angle , chosen between 90 and 180 °. for illustration , a simple cylindrical braided weave ( l = 7 , p = 4 ) is shown in fig1 cut in the longitudinal direction and placed flat on a surface revealing the looping pins 110 and braiding filament 103 . considering the weave as a series of sinusoid waveforms of period pτ ( see bold section of weave in fig1 ), where p is the number of looping pins traversed for one cycle of the sinusoid and τ is the pin - to - pin spacing , an algorithm can be derived to ensure that for a given set of parallel looping pins l that equidistantly span the circumference of the intended diameter of the vascular filter , each pin will be looped once and the final loop ending at the origin . the algorithm can be visualized by a table as shown in table 1 to indicate the relationship between l , p and the angle φ for any desired number of circumferential loops ( l ). l / p represents the fractional number of sinusoids traversed per circumference , and n represents the total number of turns around the circumference of the cylinder . essentially the weave creates sinusoids that are out of phase by a fixed increment until the final loop is achieved for which the final sinusoid is desired to be in - phase with the initial sinusoid . the in - phase condition requires the product n ×( l / p ) to be an integer . moreover , to ensure all pins are looped , the first integer to be formed by the product n ×( l / p ) must occur where n = p . for example with l = 7 and p = 4 , the first integer that appears in the row corresponding to p = 4 of table 1 is where n = 4 so this combination of l , p , and n will provide a successful braid wherein all pins will be utilized ( 7 across the top , 7 across the bottom ) and the final weave will terminate at the origin . it can be demonstrated that l must be an odd integer for a successful braid . it can further be shown that the angle φ can be expressed as φ = 2 tan − 1 ( pπr / l1 ) where r and l is the radius and length of the desired filter circumferential support 102 . the values for r and l used for calculating φ in table 1 were 0 . 625 and 1 . 5 inches respectively . also τ is easily computed from the relationship lτ = 2πr or τ = 2πr / l . fig1 depicts another braid combination where l = 7 and p = 6 . notice that the first integer to appear in the row for p = 6 in table 1 corresponds to n = 6 hence the braid will terminate successfully at the origin and all l pins looped once . further fig1 illustrates a method for forming the capture basket 101 as a simple continuous extension of the filament beyond the circumferential support 102 . as shown at the alternating looping points across the top of the circumferential support , the conical capture basket 101 is weaved by sequentially interlocking loops from adjacent loops 105 and extending a loop to the apex 106 . the apical loops from each extension 106 can be bonded together revealing a conical capture basket as shown in fig1 b with a patent center apex 104 . clearly other braided patterns can be employed to yield the pattern resolution sufficient to trap emboli of a desired size . although only a set of 7 looping pins were considered for simplicity in the above illustrations , a more likely number useful for an absorbable vascular filter for the ivc may well be 17 or 19 with φ & gt ; 100 °. specifically , an absorbable ivc filter with integrated circumferential support and capture basket was fabricated with a single 10 ft synthetic filament ( 0 . 5 mm diameter ) as shown in fig1 a and b with l = 17 , p = 16 , φ = 102 °, l = 1 . 5 ″, r = 0 . 625 ″, and τ = 0 . 23 ″. the self expandable ivc filter provides sufficient radial force to maintain placement in the ivc by the choice of the obtuse weave angle , 25 % oversized diameter ( to fit 1 ″ ivc diameter ), and wide diameter filament ( 0 . 5 mm ). alternatively , the above described integrated absorbable vascular filter can be constructed with multiple bonded filaments , although a single continuous filament may be preferable . although the present invention has been described with reference to specific exemplary embodiments , it will be evident to one of ordinary skill in the art that various modifications and changes may be made to these embodiments without departing from the broader spirit and scope of the invention . accordingly , the specification and drawings are to be regarded in an illustrative rather than a restrictive sense . goldhaber s z , ortel t l . the surgeon general &# 39 ; s call to action to prevent deep vein thrombosis and pulmonary embolism , office of the surgeon general ( us ), national heart , lung , and blood institute ( us ). rockville ( md ). 2008 spencer f a , emery c , lessard d , anderson f , emani s , aragam j et al . the worcester venous thromboembolism study ; a population - 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5 . kaufman j a , kinney t b , streiff m d , et al . guidelines for the use of retrievable and convertible vena cava filters : report from the society of interventional radiology multidisciplinary consensus conference . j vasc intery radiol . 2006 ; 17 : 449 - 459 . rodriquez j l , lopez j m , proctor m c , et al . early placemen of prophylactic vena cava filters in injured patients at high risk for pulmonary embolism . j . trauma . 1996 ; 40 : 797 - 804 . langan e m iii , miller r s , caset w j iii , carsten c g iii , graham r m , taylor s m . prophylactic inferior vena cava filters in trauma patients at high risk : follow - up examination and risk / benefit assessment . j vasc surg . 1999 ; 30 : 484 - 90 . greenfield l j , proctor m c , rodriquez j l , luchette f a , cipolle m d , cho j . posttrauma thromboembolism prophylaxis . j . trauma . 1997 , 42 : 100 - 03 . young t , tang h , hughes r . vena cava filters for the prevention of pulmonary embolism ( review ). the cochrane library 2010 , issue 2 . decousus h , leizorovics a , parent f , et al . a clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep - vein thrombosis , n england j . med . 338 , 7 : 409 - 15 . the prepic study group . eight - year follow - up of patients with permanent vena cava filters in the prevention of pulmonary embolism : the prepic randomized study . circulation 2005 ; 112 : 416 - 22 . ray c e , kaufman j a . complications of vena cava filters . abdom imaging 1996 ; 21 : 368 - 74 . ballew k a , philbrick j t , becker d m . vena cava filter devices . clin chest med 1995 ; 16 : 295 - 305 . streiff m b . vena cava filters : a comprehensive review . blood 2000 ; 95 : 3669 - 77 . pons m , riglietti a , van den berg j c . the role of vena cava filters in the management of venous thromboembolism . j cardiovasc surg 2010 ; 51 : 355 - 64 . usoh f , hignorani a , ascher e , et al . long - term follow - up for superior vena cava filter placement . ann vasc surg . 2009 ; 23 : 350 - 4 . turba u c , arsian b , meuse m , et al . gunther tulip filter retrieval experience : predictors of successful retrieval . cardiovasc intervent radiol . 2009 kinney t b . update on inferior vena cava filters . j vasc intery radiol . 2003 ; 14 : 425 - 40 . grande w j , trerotola s o , reilly p m , et al . experience with the recovery filter as a retrievable inferior vena cava filter . j vasc intery radiol 2005 ; 16 : 1189 - 93 . kirilcuk n n , herget e j , dicker r a , et al . are temporary inferior vena cava filters really temporary ? am j surg 2005 ; 190 : 858 - 63 . kumar b c , chakraverty z , zealley i . failed retrieval of potentially retrievable ivc filters : a report of two cases . cardiovasc intervent radiol 2006 ; 29 : 126 - 7 . removing retrievable inferior vena cava filters : initial communication . fda division of small manufacturers , international and consumer assistance , aug . 9 , 2010 . nicholson w , nicholson w j , tolerico p , et al . prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade . arch intern med . 2010 . karmy - jones r , jurkovich g h , velmahos g c , et al . practice patterns and outcomes of retrievable vena cava filters in trauma patients : an aast multicenter study . j . trauma . 2007 ; 62 : 17 - 25 . tschoe m , kim h s , brotman d j , et al . retrievable vena cava filters : a clinical review . j hosp med 2009 , 4 ; 7 : 441 - 8 . dabbagh o , nagam n , chitima - matsiga r , et al . retrievable inferior vena cava filters are not getting retrieved where is the gap ? thrombosis rsch 2010 . 126 : 493 - 7 .

an absorbable vascular filter is disclosed for deployment within a vessel for temporary filtering of body fluids . a preferred embodiment is the placement of such absorbable vascular filter within the inferior vena cava to filter emboli for the prevention of pulmonary embolism for a limited duration in time . once protection from pe is complete , the filter is biodegraded according to a planned schedule determined by the absorption properties of the filter components . hence the temporary absorbable vascular filter obviates the long term complications of permanent ivc filters such as increased deep vein thrombosis , neighboring organ puncture from filter fracture and embolization while also circumventing the removal requirement of metal retrievable ivc filters .

referring to fig1 - 4 a personal carrying product is shown as backpack 10 , although it will be understood that in other embodiments different types of carriers ( personal or otherwise ) may be used . backpack 10 has a pair of conventional shoulder straps 12 , located along the right edge 14 b and left edge 14 c of inside panel 14 ( panel 14 also being referred to as a pliable face ). the lower ends 12 b of carrying straps 12 are attached near the lower edge 14 d of panel 14 , and top ends 12 a are attached near the upper edge 14 a of panel 14 . another panel 16 is stitched or otherwise secured around inside panel 14 and is part of a structure for holding objects . the front of backpack 10 is constructed in a conventional manner and will include zippers or other means for opening and closing the backpack . tab 20 is attached to panel 14 near upper edge 14 a . tab 20 is shown centered between right and left edges 14 b and 14 c , although in other embodiments the tab need not be centered . even though the upper and lower ends of the right and left edges 14 b and 14 c are somewhat indistinct , tab 20 will be considered between the right and left edges by construing those edges broadly and , if necessary , extending them as imaginary lines to determine whether the tab is lying between them . similarly , tab 20 may also be considered located between the upper ends 12 a of straps 12 . in this embodiment tab 20 is shown as a plastic or elastomeric plate with an outside face 20 - 1 and a parallel inside face 20 - 2 , which faces are both flat from their upper to lower ends 20 a , 20 b . tab 20 has in this instance a thickness of about ⅛ inch ( 3 . 2 mm ), an overall longitudinal dimension of about 2¼ inches ( 5 . 7 cm ) and an overall width of about 1 . 5 inches ( 3 . 8 cm ), although other embodiments may employ different materials and may have different dimensions depending upon the desired strength , capacity , size , reliability , rigidity , etc . in this embodiment , tab 20 has a straight edge 20 a at its upper end merging through a rounded corner with two lateral edges 20 b , which are initially parallel but begin converging together about two thirds of the way toward the tapered lower end 20 d . tab 20 is secured onto panel 14 by stitches 22 laid down in a rectangular pattern . in some cases a reinforcing backer of leather , fabric , plastic , or the like , may be placed on the opposite side of panel 14 before stitching tab 20 to panel 14 30 and the backer . as shown in this embodiment tab 20 is secured with ( 1 ) a proximal course of stitches 22 a located at a position about one quarter of the way from the upper end 20 a to the lower end 20 d ,( 2 ) a distal course of stitches 22 b located at a position about one half of the way from the upper end 20 a to the lower end 20 d , and ( 3 ) two other courses connecting the first two . accordingly , tab 20 is free to lift away from underlying panel 14 along about half of the tab &# 39 ; s length , that is , the length between stitch course 22 b and lower end 20 d . in some embodiments the stitching of course 22 a can be located closer to or further from the upper end 20 a . in other embodiments tab 20 may be free to lift over a different length . for example , tab 20 may be secured at a location at least one quarter of the way from the upper end 20 a to the lower end 20 b , leaving the tab free to lift below that location . alternatively , tab 20 may be secured at a location at least one third of the way from the upper end 20 a to the lower end 20 b , leaving the tab free to lift below that location . the amount of freedom given to tab 20 will affect its ability to act as a device for hanging an article , in a manner to be described presently . to facilitate an understanding of the principles associated with the foregoing apparatus , its operation will be briefly described in connection with illustrated locker 22 , which has an ordinary door 24 with three conventional vents 26 . vents 26 are preexisting and are made by the manufacturer by punching out an overhanging section 26 a from the main door panel to create vent slot 28 . tab 20 can be lifted somewhat from panel 14 of backpack 10 , which lifting is possible because the tab is secured only over a portion of its overall length . in fig2 tab 20 is shown inserted in one of the vent slots 28 , having been articulated about 15 °. this articulation is accommodated by the flexibility of the fabric of panel 14 , which is shown with a wrinkle 32 caused by articulation of tab 20 . because tab 20 is secured by stitches 22 ( fig3 ) lying over an extended region , the attachment forces are distributed accordingly and there is a lesser likelihood of tearing the fabric of panel 14 . because section 26 a overhangs tab 20 , tab articulation is limited in this case to about 35 °, which limit is shown as ray 33 . therefore , even if panel 14 is highly flexible , tab 22 cannot invert and allow backpack 10 to fall out of vent slot 28 . the articulation of tab 20 can also be restricted by extending the region over which the tab is secured . basically , the lower the location on tab 20 that is secured to the panel 14 , the smaller the effective lever arm for lifting the tab and flexing panel 14 , and the less likely tab 20 is to articulate or even invert . for this reason , most embodiments will have the tab 20 secured at locations at least one quarter of the way from the upper end 20 a to lower end 20 d . to restrict articulation even more , some embodiments will secure tab 20 at locations at least one third of the way from the upper end 20 a to lower end 20 d . in any event , slot 28 or the tab 20 can be configured to prevent undesired disengagement of the tab from the slot . backpack 10 may be used to carry exercise clothing and equipment to a gym . alternatively , the backpack 10 may be used by a student to carry books to a school . other cargo and destinations are also contemplated . on arrival the user can open locker door 24 and insert tab 20 through one of the vent slots 28 . backpack 10 can either be opened in advance or opened after being hung on tab 20 on the back of locker door 24 . once backpack 10 is hung in this fashion and the backpack is open , the user can retrieve the various stored objects . since backpack 10 is elevated to make its contents more visible and since the user &# 39 ; s hands are free , rummaging through the backpack is convenient . at this time , articles of clothing or other personal items on the user may also be transferred into backpack 10 . with this accomplished , the user can close locker door 24 with the backpack 10 still hanging on tab 20 , if desired . backpack 10 can either be kept open or closed , when locker door 24 is closed . as many times as desired , the user can return and open locker door 24 , thereby regaining access to backpack 10 . for example , the user may wish to access backpack 10 in order to prepare for a shower or simply to leave . accordingly , the user can reopen the backpack 10 and insert and remove objects as desired at this time . when the user wishes to leave , backpack 10 can be lifted to remove tab 20 from vent slot 28 , the lifting occurring either before or after the closing of the backpack . backpack 10 can then be carried away in the usual fashion . referring to fig5 , the illustrated bracket 34 may be used in place of a locker doors with vent slots of the type of the type just described . bracket 34 is shown as a metal stamping having a rectangular face 34 a with longitudinal slot 36 . perpendicular to face 34 a are an integral pair of rectangular support legs 34 b extending to a coplanar pair of rectangular , integral feet 34 c . feet 34 c are parallel to face 34 a with each foot having a pair of mounting holes 38 . bracket 34 can be mounted to a wall with its longitudinal slot 36 horizontal by inserting fasteners such screws or nails through mounting holes 38 . thereafter , tab 20 of backpack 110 of fig1 can be inserted into slot 36 to extend downwardly using the wall clearance provided by legs 34 b . the length of legs 34 b can be chosen so that tab 22 can articulate only a limited amount before its lower end 20 d hits the wall on which bracket 34 is mounted . restricting articulation of tab 20 in this manner prevents undesired disengagement of the tab . it will be understood , however , that tab 20 can be secured over so much of its length that it cannot articulate an amount sufficient to disengage from slot 36 , regardless of the wall clearance provided by legs 34 b . referring to fig1 and 12 , an alternate bracket 60 is shown as a wooden block with a pair of mounting holes 64 that may be used to attach the bracket to a wall with a screw or other fastener . bracket 60 has a downwardly directed slot 62 , specifically a mortise descending at about 45 °, although other angles of descent are contemplated . once mounted on a wall or other surface , the previously mentioned tab ( for example , tab 20 of fig1 ) can be inserted into slot 62 to hang an article such as backpack 10 of fig1 . referring to fig6 , alternate tab 120 is the same as the previously illustrated tab except that its outside face 120 - 1 and inside face 120 - 2 converge at a non - zero acute angle from upper end 120 a to lower end 120 d . elements corresponding to those previously described in connection with tab 20 of fig1 - 4 have the same reference numerals but increased by 100 . since tab 120 is tapered , its lower end 120 d will have added flexibility to facilitate insertion into a slot . on the other hand , the thicker portions of tab 120 will restrict the net overall articulation of the tab to guard against undesired disengagement . referring to fig7 , alternative tab 220 is an aluminum plate with outside and inside faces that are parallel . elements corresponding to those previously described in connection with tab 20 of fig1 - 4 have the same reference numerals but increased by 200 . the outline of tab 220 is essentially a rectangle with rounded corners , although in some embodiments the outline may be trapezoidal with rounded corners and with lateral edges 220 b and 220 c tapering slightly towards lower end 220 d . as before tab 220 may employ various materials and may have different dimensions depending upon the desired strength , capacity , size , reliability , rigidity , etc . instead of stitches , tab 220 is fastened using a trio of rivets 240 that are driven through the tab and the underlying pliable fabric ( not shown ) before being deformed in the usual fashion . again , the underlying pliable fabric can be sandwiched between tab 220 and a reinforcing backer ( not shown ). referring to fig8 , alternative tab 320 is a plastic plate with outside and inside faces that are parallel . elements corresponding to those previously described in connection with tab 20 of fig1 - 4 have the same reference numerals but increased by 300 . the outline of tab 320 is essentially a triangle with rounded corners . as before tab 320 may employ various materials and may have different dimensions depending upon the desired strength , capacity , size , reliability , rigidity , etc . instead of stitches , tab 320 is fastened using a pair of staples 342 that are driven through the tab and the underlying pliable fabric ( not shown ) before being deformed in the usual fashion . again , the pliable fabric can be sandwiched between tab 220 and a reinforcing backer ( not shown ). referring to fig9 , previously described tab 20 is shown attached to another article , namely , cloth bag 44 . bag 44 is shown with a pair of handle loops 46 and 48 , each having a pair of ends 46 a and 48 a , respectively . each of the pair of ends 46 a and 48 b are attached at spaced positions along opposite sides of rim 44 a of bag 44 . tab 20 is shown mounted near rim 44 a equidistant from the spaced positions of the ends 46 a of handle loop 46 . in this embodiment an identical tab ( not shown ) is mounted on the opposite side of bag 44 near rim 44 a and equidistant from the ends 48 a of handle loop 48 . in a manner just described in connection with fig1 - 4 or fig5 , tab 20 can be used to hang bag 44 . instead of tab 20 , bag 44 can employ any one of the tabs shown in fig6 - 8 . referring to fig1 , gym bag 50 has roughly the shape of a rectangular prism , is formed from fabric and is fitted with a carrying strap 52 attached between opposite ends 50 a of the bag . pliable face 50 b of bag 50 is approximately rectangular and a pair of the previously described tabs 20 are mounted symmetrically near the top edge of face 50 b . in a manner just described in connection with fig1 - 4 , the pair of tabs 20 can be inserted together into one of the vent slots 28 of fig1 in order to hang gym bag 50 . for the embodiment of fig5 , a pair of brackets 34 can be mounted side - by - side to accommodate the pair of tabs 20 of fig1 . alternatively , face 34 a and slot 36 can be lengthened sufficiently to accept together the pair of tabs 20 . again , instead of tab 20 , bag 50 can employ any one of the tabs shown in fig6 - 8 . also , tabs can be mounted as well on the face of bag 50 opposite face 50 b . obviously , many modifications and variations of the present invention are possible in light of the above teachings . it is therefore to be understood that within the scope of the appended claims , the invention may be practiced otherwise than as specifically described .

a tab can be secured to the pliable face of a carrier or other article in order to hang the carrier or article from a slot . the carrier may be a personal carrier with carrying straps , such as a backpack or a bag with carrying handles . the slot can be furnished by a downwardly directed vent slot on a locker door , by a slotted bracket , or by some other slotted device . the disclosed tab is secured at its upper end , reaching a location on the tab at least one quarter of the way from the upper end toward the lower end . the tab normally lies flat against the pliable face , but this face is flexible to allow the lower end of the tab to articulate away from the pliable face . in some cases clothes can be loaded into the personal carrier before inserting its tab into a vent slot in a locker door . the tab is inserted to a depth sufficient to prevent the lower end of the tab from articulating upwardly enough to allow the tab to disengage the vent slot . then a user can retrieve clothes , books , and other articles from the carrier while the carrier is hung on the locker door .

referring first to fig1 an item of furniture 10 is shown and includes a stationary base frame 12 having an arm frame portion 14 . furniture item 10 further includes a moveable backrest 16 and a moveable seat 17 and footrest 18 . furniture item 10 may be a reclining chair or sofa or any type of so - called action furniture which utilizes a seat , backrest and footrest moveable between upright , intermediate or t . v . and fully reclined positions . to accomplish the movement of furniture item 10 between these three positions , the furniture item 10 incorporates an improved linkage mechanism 20 constructed in accordance with the present invention . only one mechanism 20 is shown and described with the understanding that furniture item 10 includes another mechanism on the other side being a mirror image of mechanism 20 . a first embodiment of linkage mechanism 20 includes a moveable seat link 22 and a stationary base member or link 24 . base member 24 is rigidly affixed to chair frame 12 by suitable threaded fasteners 26 , 28 . a pair of rollers 30 , 32 are mounted between seat link 22 and base member 24 to form a rolling connection therebetween . specifically , rollers 30 , 32 roll along a pair of tracks 34 , 36 formed on stationary base member 24 . each track 34 , 36 has first and second track sections 34a , 34b and 36a , 36b separated by respective generally angled intersections 34c , 36c . it will be appreciated that stationary base member 24 is shown as a separate link in this first embodiment , however , base member 24 may instead be an integral part of chair frame 12 or , more specifically , arm frame structure 14 . in the first embodiment as shown in fig1 and 1a , rollers 30 , 32 are connected for rotation with respect to seat link 22 by respective roller mounts 38 , 40 . respective guide members 42 , 44 extend from pivot mounts 38 , 40 and include rolling followers ( only one follower 46 being shown in fig1 a ) at opposite ends thereof . it will therefore be appreciated that rollers 30 , 32 respectively engage and roll along an upper surface of the respective tracks 34 , 36 while rolling followers 46 may engage and roll along the respective lower surfaces of tracks 34 , 36 . as shown , the followers 46 do not normally contact base member 24 since their main function is to keep the seat 17 from being lifted from furniture item 10 . linkage mechanism 20 further includes backrest linkage 50 generally connected between backrest 16 , seat link 22 and base member 24 . backrest linkage 50 supports the backrest frame 16 for pivotal movement relative to seat link 22 and an attached seat 17 . backrest linkage 50 includes a backrest link 52 rigidly affixed to backrest frame 16 by suitable fasteners 54 , 56 . many different configurations for backrest linkage 50 may be chosen and utilized in linkage mechanism 20 of the present invention , however , the presently contemplated linkage includes a pair of support members 58 , 60 rigidly affixed to a rear end of seat link 22 . an upper end of support link 58 is connected to backrest link 52 by a pivot connection 62 . an upper end of support link 60 is connected to a backrest actuating link 64 by a pivot connection 66 . backrest actuating link is part of further actuating and supporting linkage including upper and lower links 68 , 70 connected by respective pivot connections 72 , 74 at opposite ends of actuating link 64 . upper actuating link 68 is also connected to backrest link 52 by a pivot connection 76 and lower actuating link 70 is also connected to base member 24 by a lower pivot connection 78 to complete the connection between backrest frame 16 , seat link 22 and base member 24 or frame 12 . backrest actuating link 64 further includes a stop stud 80 for limiting reclining motion of backrest frame 16 in a manner to be described . footrest linkage 90 is suspended from the front of seat link 22 as perhaps best shown in fig2 and 3 . footrest linkage 90 comprises conventional scissor - type linkage which is only representative of the various types of footrest actuating mechanisms which may be employed in the present invention . footrest linkage 90 comprises a rear footrest link 92 and a front footrest link 94 connected together at a pivot connection 96 . rear footrest link 92 is further connected to seat link 22 at a pivot connection 98 and front footrest link 94 is further connected to a footrest support link 100 at a pivot connection 102 . footrest linkage 90 further comprises footrest support links 104 , 106 connected together at a pivot connection 108 . rear footrest support link 104 is further connected to seat link 22 at a pivot connection 110 and front footrest support link 106 is further connected to footrest link 100 at a pivot connection 112 . the pairs of footrest links 92 , 94 and 104 , 106 are pivotally connected together at a pivot connection 114 between links 94 and 104 . stop studs 116 , 118 are provided for respectively providing stops for footrest linkage 90 in the retracted position as shown in fig1 and the extended position as shown in fig2 . in this regard , stop stud 116 engages footrest link 100 in the retracted position and stop stud 118 engages front footrest link 94 in the extended position . a legrest support 120 is also provided and pivotally connected to front footrest support link 106 at a pivot connection 122 and actuated into position by a connecting 10 link 124 attached to legrest support link 120 at a pivot connection 126 and to footrest link 100 at a pivot connection 128 . footrest actuating linkage 130 is provided and generally connected between seat link 22 , base member 24 and footrest linkage 90 for actuating footrest linkage 90 into an extended position in going from the fully upright position shown in fig1 to the intermediate or t . v . position shown in fig2 . specifically , footrest actuating linkage 130 comprises link members 132 , 134 , 136 connected between seat link 22 , base member 24 and rear footrest link 92 . link member 132 is connected by a pivot connection 138 to rear footrest link 92 and connected to link members 134 , 136 at a pivot connection 140 . pivot connection 140 is directly connected to one end of each of link members 132 and 134 and connected to a slot 142 in link member 136 by a pin 144 . pin 144 essentially allows movement of the ends of link members 132 and 134 with respect to link member 136 during actuation of footrest linkage 90 . a lower end of link member 136 is connected to base member 24 by a pivot connection 146 and an upper end of link member 134 is connected to seat link 22 by a pivot connection 148 . fig4 - 7 illustrate a second embodiment of the present invention . fig4 shows a reclining furniture item 10a which again may be a chair , sofa , sectional or the like and which generally comprises a stationary frame structure 12 including an arm frame portion 14 and a backrest 16 which is moveable with respect to a seat ( see fig1 ). the furniture item 10 &# 39 ; further includes an extendable and retractable footrest 18 . the footrest and backrest linkage associated with furniture item 10a is the same as that described above in connection with the first embodiment and therefore like numbers have been shown in fig4 - 6 . it will be noted , however , that the seat supporting member 202 in this embodiment requires a front plate 203 affixed thereto as shown to provide connection points for links 92 and 104 . the description of backrest linkage 50 , footrest linkage 90 and footrest actuating linkage 130 found above with reference to fig1 - 3 may be referred to and will therefore not be repeated here . the main difference between the first and second embodiments lies in the roller and track system . in the second embodiment , a moveable seat member 202 is provided as well as a stationary base member 204 which may be rigidly affixed to arm frame portion 14 as in the first embodiment . in the second embodiment , however , seat member 202 includes a pair of tracks 206 , 208 each including first and second sloped track sections 206a , 206b and 208a , 208b each separated by respective generally angled intersections 206c , 208c . rollers 210 , 212 are mounted for rotation on stationary base member 204 by respective roller mounts 214 , 216 . like the first embodiment , each roller 210 , 212 includes a respective guide member 218 , 220 . roller followers 222 , 224 are mounted for rotation at the upper ends of each guide member 218 , 220 . it will therefore be appreciated that rollers 210 , 212 roll along lower surfaces of tracks 206 , 208 while roller followers 222 , 224 travel along corresponding upper surfaces of seat member 202 during movement between the fully upright , intermediate and fully reclined positions to be described below . also like the first embodiment , followers 222 , 224 may , but do not have to , contact the upper surface of seat member 202 . their main function is to prevent lifting of the seat . as shown in fig7 seat member 202 , which forms part of reclining mechanism 200 on each side of furniture item 10a is preferably formed for adjustable connection to another seat member 230 which is a mirror image of seat member 202 for use in connection with another reclining mechanism on the opposite side of furniture item 10a . as mentioned above , these mechanisms are also mirror images of each other and therefore the full description of each mechanism is not necessary . the adjustable connection made between seat member 202 , 230 is preferably formed through telescopic connections 232 , 234 . this type of connection is preferred because seat members 202 , 230 are formed from steel tubular members which may be easily bent to the required shape and with the necessary angled track sections described above . each adjustable connection 232 , 234 may be formed with respective telescopic portions 236 , 238 of seat members 202 , 230 connected by way of a pin 242 extending through one of a series of aligned holes 240 extending through both telescopic portions 236 , 238 . of course , other adjustable connections may be used which allow seat members 202 , 230 to be adjusted with respect to each other to correspond in size to the particular furniture item 10a utilizing mechanism 200 ( fig4 ). fig8 illustrates a seat actuating mechanism 250 which is the presently preferred manner of actuating each of the linkage mechanisms 20 , 200 described hereinabove . it will be appreciated that other types of conventional actuating or latching mechanisms may be substituted for mechanism 250 . although mechanism 250 is specifically shown and will be described in connection with linkage mechanism 20 , the same actuating mechanism 250 is utilized and mounted to the same components in mechanism 200 . latch or mechanism 250 comprises a hook latch 252 which engages a pin 254 when footrest linkage 90 is in the retracted position shown in fig8 . this corresponds to furniture item 10 ( fig1 ) being in a fully upright position . pin 254 is attached to a mounting bracket 256 which , in turn , is attached to a mounting tube 258 . tube 258 is secured to rear footrest link 92 by a bracket 260 . the opposite end of tube 258 is secured to the corresponding rear footrest link of the linkage mechanism ( not shown ) on the opposite side of the furniture item . hook latch 252 is attached to a mounting bracket 262 at a pivot connection 264 and is normally biased downward by a torsion spring 266 connected between hook latch 252 and bracket 262 . bracket 262 is mounted to a tube 268 connected to base member 24 and to the corresponding base member of the linkage mechanism ( not shown ) located on the opposite side of the furniture item . a cable 270 forming part of a conventional cable assembly 272 is attached to a pin 274 at the upper end of hook latch 252 . a conventional operating handle ( not shown ) is mounted on the side of the furniture item and is operative to pull cable 270 thereby pivoting hook latch 252 upwardly or counter - clockwise about pivot connection 264 as shown in phantom to release engagement with pin 254 . this allows footrest linkage 90 to extend to the position shown in fig2 as will be described below . a stop pin 276 is provided on hook latch 252 and contacts bracket 262 to limit upward movement of hook latch 252 . when hook latch 252 is subsequently released by the seat occupant , it is biased downwardly to the position shown in solid in fig8 . when the seat occupant then pushes the footrest and footrest linkage 90 into the retracted position shown in fig8 pin 254 engages cam surface 252a moving hook latch 252 upwardly until pin 254 moves behind the lower end 252b thereof as shown . at this point , latch 252 is biased downwardly into the latched position by spring 266 . referring generally to fig9 an item of furniture 10 &# 39 ; is shown and includes a stationary base frame 12 &# 39 ; having an arm frame portion 14 &# 39 ;. furniture item 10 &# 39 ; further includes a movable backrest 16 &# 39 ; and a movable seat 17 &# 39 ; and footrest 18 &# 39 ;. furniture item 10 &# 39 ; may be a reclining chair or sofa or any type of so - called action furniture which utilizes a seat , backrest and footrest movable between upright , intermediate or tv , and fully reclined positions . to accomplish the movement of furniture item 10 &# 39 ; between these three positions , furniture item 10 &# 39 ; incorporates an improved linkage mechanism 20 &# 39 ; constructed in accordance with the present invention . only one mechanism 20 &# 39 ; is shown and described with the understanding that furniture item 10 &# 39 ; includes another such mechanism on the other side being a mirror image of mechanism 20 &# 39 ;. the preferred embodiment of linkage mechanism 20 &# 39 ; includes a movable seat link 22 &# 39 ; and a stationary base member or link 24 &# 39 ;. base member 24 &# 39 ; is rigidly affixed to chair frame 12 &# 39 ; by suitable fasteners 26 &# 39 ;. seat link 22 &# 39 ; is part of seat supporting linkage 30 &# 39 ; which further includes a front pivot link 32 &# 39 ;, a rear pivot link 34 &# 39 ; and a connecting link 36 &# 39 ;. front pivot link 32 &# 39 ; is pivotally connected to seat link 22 &# 39 ; and connecting link 36 &# 39 ; by respective pivots 38 &# 39 ;, 40 &# 39 ;. at a rear end of connecting link 36 &# 39 ;, rear pivot link 34 &# 39 ; is pivotally connected to seat link 22 &# 39 ; and to connecting link 36 &# 39 ; by respective pivots 42 &# 39 ;, 44 &# 39 ;. in accordance with the general principles of this invention , a first roller 46 &# 39 ; and first track 48 &# 39 ; are provided and generally connected to base member 24 &# 39 ; and to seat supporting linkage 30 &# 39 ;. first track 48 &# 39 ; includes first and second track sections 48a &# 39 ;, 48b &# 39 ;. first track section 48a &# 39 ; is sloped downwardly from rear to front while second track section 48b &# 39 ; is sloped upwardly from rear to front . roller 46 &# 39 ; is mounted for rotational movement to connecting link 36 &# 39 ; at a roller pivot mount 50 &# 39 ;. first track 48 &# 39 ; is rigidly affixed to base member 24 &# 39 ; by a mounting plate 52 &# 39 ; connected , for example , to base member 24 &# 39 ; by rivets 54 &# 39 ;. a second roller 60 &# 39 ; also generally connects seat supporting linkage 30 &# 39 ; to base member 24 &# 39 ;, and specifically is mounted by a pin 64 &# 39 ; to the lower end of link 32 &# 39 ;. in this regard , second roller 60 &# 39 ; is disposed within a second track 62 &# 39 ; located generally at the front of mechanism 20 &# 39 ;. second track 60 &# 39 ;, however , is simply a straight track that is upwardly sloped from rear to front . like first track 48 &# 39 ;, second track 60 &# 39 ; is rigidly affixed to base member 24 &# 39 ;, preferably by a mounting plate 66 &# 39 ; and rivets 68 &# 39 ;. linkage mechanism 20 &# 39 ; further includes backrest linkage 70 &# 39 ; generally connected between backrest 16 &# 39 ;, seat link 22 &# 39 ; and base member 24 &# 39 ;. backrest linkage 70 &# 39 ; supports the backrest frame 16 &# 39 ; for pivotal movement relative to seat link 22 &# 39 ; and seat 17 &# 39 ; attached thereto . backrest linkage 70 &# 39 ; includes a backrest link 72 &# 39 ; rigidly affixed to backrest frame 16 &# 39 ; by suitable fasteners 74 &# 39 ;. many different configurations for backrest linkage 70 &# 39 ; may be chosen and utilized in linkage mechanism 20 &# 39 ; of the present invention . as presently contemplated , backrest linkage 70 &# 39 ; includes a bracket , having a pair of support members 76 &# 39 ;, 78 &# 39 ;, and rigidly affixed to a rear end of seat link 22 &# 39 ;. this rigid fixation may be accomplished by welding or with rivets 77 &# 39 ; affixed to the bracket as shown . an upper end of support member 76 &# 39 ; is connected to backrest link 72 &# 39 ; by a pivot connection 80 &# 39 ;. an upper end of support member 78 &# 39 ; is connected to a backrest actuating link 82 &# 39 ; by a pivot connection 84 &# 39 ;. backrest actuating link 82 &# 39 ; is part of further actuating and supporting linkage including upper and lower links 86 &# 39 ;, 88 &# 39 ; connected by respective pivot connections 90 &# 39 ;, 92 &# 39 ; at opposite ends of actuating link 82 &# 39 ;. upper actuating link 86 &# 39 ; is also connected to backrest link 72 &# 39 ; by a pivot connection 94 &# 39 ; and lower actuating link 88 &# 39 ; is also connected to base member 24 &# 39 ; by a lower pivot connection 96 &# 39 ; to complete the connection between backrest frame 16 &# 39 ;, seat link 22 &# 39 ; and base member 24 &# 39 ; or frame 12 &# 39 ;. backrest actuating link 82 &# 39 ; further includes a stop member 98 &# 39 ; for limiting reclining motion of backrest frame 16 &# 39 ;. footrest linkage 100 &# 39 ; is suspended from the front of seat link 22 &# 39 ; as perhaps best shown in fig1 and 11 . footrest linkage 100 &# 39 ; comprises conventional scissor type linkage which is only representative of the various types of footrest actuating and supporting mechanisms which may be employed in practicing the present invention . footrest linkage 100 &# 39 ; comprises a rear footrest link 102 &# 39 ; and a front footrest link 104 &# 39 ; connected together at a pivot connection 106 &# 39 ;. rear footrest link 102 &# 39 ; is further connected to seat link 22 &# 39 ; at a pivot connection 108 &# 39 ; and front footrest link 104 &# 39 ; is further connected to a footrest support link 109 &# 39 ; at a pivot connection 110 &# 39 ;. footrest linkage 100 &# 39 ; further comprises footrest support links 112 &# 39 ;, 114 &# 39 ; connected together at a pivot connection 116 &# 39 ;. rear footrest support link 112 &# 39 ; is further connected to seat link 22 &# 39 ; at a pivot connection 118 &# 39 ; and front footrest support link 114 &# 39 ; is further connected to footrest support link 109 &# 39 ; at a pivot connection 120 &# 39 ;. the pairs of footrest links 102 &# 39 ;, 104 &# 39 ; and 112 &# 39 ;, 114 &# 39 ; are pivotally connected together at a pivot connection 122 &# 39 ; between links 104 &# 39 ; and 112 &# 39 ;. a stop stud 124 &# 39 ; is provided on link 104 &# 39 ; for stopping footrest linkage 100 &# 39 ; at the extended position shown in fig1 and 11 by bearing against stop portion 114a &# 39 ; of footrest support link 114 &# 39 ;. a leg rest support or mid ottoman link 126 &# 39 ; is provided and connected by respective pivot connections 128 &# 39 ;, 130 &# 39 ; to links 114 &# 39 ; and 104 &# 39 ;. footrest actuating linkage 140 &# 39 ; is provided and is generally connected between seat link 22 &# 39 ;, seat supporting linkage 30 &# 39 ; and footrest linkage 100 &# 39 ; for actuating footrest linkage 100 &# 39 ; into an extended position in going from the fully upright position shown in fig9 to the intermediate or tv position shown in fig1 . specifically , footrest actuating linkage 140 &# 39 ; includes link members 142 &# 39 ;, 144 &# 39 ; and 146 &# 39 ;. link member 142 &# 39 ; is connected by respective pivots 148 &# 39 ;, 150 &# 39 ; to rear footrest actuating link 102 &# 39 ; and to link member 146 &# 39 ; of footrest actuating linkage 140 &# 39 ;. link member 144 &# 39 ; is connected by respective pivots 152 &# 39 ; and 154 &# 39 ; to the rear end of rear footrest actuating link 102 &# 39 ;, on the other side of pivot 108 &# 39 ; from pivot 148 &# 39 ;. the opposite end of link member 144 &# 39 ; is connected by pivot 154 &# 39 ; to connecting link 36 &# 39 ; of seat supporting linkage 30 &# 39 ;. finally , link member 146 &# 39 ; of footrest actuating linkage 140 &# 39 ; is connected at one end to seat link 22 &# 39 ; by a pivot 156 &# 39 ;. a stop stud 158 &# 39 ; is provided on link member 146 &# 39 ; and acts as a stop against a stop portion 142a &# 39 ; of link member 142 &# 39 ; when footrest linkage 100 &# 39 ; is in the fully retracted position as shown in fig9 . link member 146 &# 39 ; is generally l - shaped and , at the end opposite to pivot 156 &# 39 ;, link member 146 &# 39 ; includes a mounting portion 160 &# 39 ; for attaching one end of a tube ( not shown ) which may have its other end attached to a like mechanism on the opposite side of furniture item 10 &# 39 ; ( fig9 ). finally , a coil spring 162 &# 39 ; is connected between a pin 163 &# 39 ; on a front portion of footrest actuating link 144 &# 39 ; and stop stud 158 &# 39 ; of footrest actuating link 146 &# 39 ;. as will be appreciated from the further description provided below , spring 162 &# 39 ; assists in opening mechanism 20 &# 39 ; up into the extended position shown in fig1 . to initiate the actuation of mechanism 20 &# 39 ;, a chair actuating link 166 &# 39 ; is pivotally connected to seat link 22 &# 39 ; by pivot connection 168 &# 39 ;. a pin 170 &# 39 ; normally rests against an end portion 142b &# 39 ; of footrest actuating link 142 &# 39 ; when mechanism 20 &# 39 ; is fully retracted and chair 10 &# 39 ; is fully upright as shown in fig9 . a cable 172 &# 39 ; is connected to the opposite end of chair actuating link 166 &# 39 ; from pin 170 &# 39 ; and is associated with a typical latch mechanism 174 &# 39 ;, for example , that may have a movable handle or latch on the outside of the chair for a seat occupant to grasp and pull . referring again to fig1 furniture item 10 is in an initial fully upright position with seat actuating mechanism 250 latched in place to prevent reclining motion . rollers 30 , 32 are positioned at the upper ends of the first sloped track sections 34a , 36a . when seat actuating mechanism 250 is released as described above , the weight of the seat occupant forces rollers 30 , 32 and the attached seat link 22 to move downwardly and forwardly until rollers 30 , 32 reach the respective intersections 34c , 36c of track sections 34a , 34b and 36a , 36b . during this same forward and upward movement , seat link 22 will rotate footrest actuating linkage 130 so as to extend footrest linkage 90 . specifically , link member 132 will pull rearwardly on pivot connection 138 thereby rotating rear footrest link 92 counter - clockwise about its pivot connection 98 to seat link 22 until stop stud 118 is engaged with front footrest link 94 as shown in fig2 . to move furniture item 10 into a fully reclined position , the seat occupant simply places rearward pressure on the seat back 16 ( fig1 ). this moves seat link 22 in a forward direction as rollers 30 , 32 roll upwardly along track sections 34b , 36b . to move mechanism 20 back into the intermediate position shown in fig2 the seat occupant simply releases pressure from the backrest 16 ( fig1 ). this allows rollers 30 , 32 to roll back down track sections 34b , 36b to angled intersections 34c , 36c . to move mechanism 20 back into the fully upright position shown in fig1 the seat occupant presses down on the footrest 18 to retract footrest linkage 90 and force rollers 30 , 32 up track sections 34a , 36a until latch mechanism 250 engages . the operation of the second embodiment shown in fig4 - 6 is very similar to the operation of the first embodiment . the difference is that the track sections are moving along stationary rollers instead of vice versa . thus , when seat actuating mechanism 250 is released by the seat occupant , seat member 202 will move downwardly and forwardly as track sections 206a , 208a move along stationary rollers 210 , 212 until intersections 206c , 208c reach rollers 210 , 212 , as shown in fig5 . like the first embodiment , to move from the intermediate or t . v . position , as shown in fig5 to the fully reclined position shown in fig6 the seat occupant places rearward pressure on the seat back ( fig4 ). this forces track sections 206b , 208b to move upwardly along rollers 210 , 212 until stop stud 80 contacts link 68 as shown in fig6 . movement back into the intermediate or t . v . position and into the fully upright position is initiated and accomplished in the same manner as described above with respect to the first embodiment . referring now to fig9 - 11 , the operation of furniture item 10 &# 39 ; as constructed in accordance with the third embodiment is initiated when the user actuates latch mechanism 174 &# 39 ; to pull cable 172 &# 39 ;. this rotates chair actuating link 166 &# 39 ; counterclockwise as shown in fig9 to move the rear end of footrest actuating link 142 &# 39 ; downwardly and pivot link 146 &# 39 ; clockwise about pivot connection 156 &# 39 ; with seat link 22 &# 39 ;. with the assistance of spring 162 &# 39 ; as well as the weight of the seat occupant , footrest actuating linkage 140 &# 39 ; and footrest linkage 100 &# 39 ; extends to the position shown in fig1 . during this movement , front and rear pivot links 32 &# 39 ;, 34 &# 39 ; of seat supporting linkage 30 &# 39 ; rotate counterclockwise about their respective bottom pivot points 64 &# 39 ; and 44 &# 39 ;. the upper ends of pivot links 32 &# 39 ;, 34 &# 39 ; move generally in a forward direction and thereby move seat link 22 &# 39 ; also in a forward direction . at the same time , backrest 16 &# 39 ; becomes further angled rearward from seat 17 &# 39 ; with the bottom of backrest 16 &# 39 ; also moving in a forward direction with seat 17 &# 39 ;. during this movement from the fully upright position to the intermediate or tv position , first roller 46 &# 39 ; moves down first track section 48a &# 39 ; of track 48 &# 39 ; as seat supporting linkage 30 &# 39 ; and , more specifically , connecting link 36 &# 39 ; moves generally in a forward direction with seat link 22 &# 39 ;. at the intermediate or tv position shown in fig1 , roller 46 &# 39 ; stops at the generally angled intersection of 48c &# 39 ; and stop stud 124 &# 39 ; bears against stop position 114a &# 39 ; of footrest link 114 &# 39 ; to stop further extension of mechanism 20 &# 39 ;. to move furniture item 10 &# 39 ; to a fully reclined position , as shown in fig1 , the seat occupant simply places rearward pressure on seat back 16 &# 39 ; ( fig9 ). this moves seat link 22 &# 39 ; in a forward direction and causes rollers 46 &# 39 ;, 60 &# 39 ; to respectively roll upwardly along section 48b &# 39 ; of first track 48 &# 39 ; and along the length of track 62 &# 39 ;. when stop stud 98 &# 39 ; engages against support member 78 &# 39 ;, mechanism 20 &# 39 ; is retained against further extension and rollers 46 &# 39 ;, 60 &# 39 ; stop at or near the forward ends of respective tracks 48 &# 39 ;, 62 &# 39 ;. to move mechanism 20 &# 39 ; back into the intermediate or tv position shown in fig1 , the seat occupant simply releases pressure from the backrest 16 &# 39 ; ( fig9 ). this allows rollers 46 &# 39 ;, 60 &# 39 ; to roll back down track section 48b &# 39 ; and track 62 &# 39 ; to the respective positions shown in fig1 . to move mechanism 20 &# 39 ; back into the fully upright position shown in fig9 the seat occupant applies downward pressure on footrest 18 &# 39 ; thereby retracting footrest linkage 100 &# 39 ; and reversing the motion of mechanism 20 &# 39 ; as described above in going from the fully upright to the intermediate or tv position . when front pivot link 32 &# 39 ; reaches its original over center position , linkage mechanism 20 &# 39 ; is retained in the position shown in fig9 . the present invention has many inventive concepts which , although described with respect to specific preferred mechanisms , may be employed in many different mechanisms having different configurations . for example , the footrest and backrest linkage assemblies described herein are essentially conventional ones and may be modified in many different manners while still retaining the spirit and scope of the inventive concepts which pertain mainly to the track and roller systems disclosed and claimed herein . thus , while a detailed description of various embodiments of this invention has been provided , applicant intends to be bound only by the scope of the claims appended hereto .

a reclining furniture item including a reclining mechanism employing a roller and track system which significantly reduce the number of linkages and provide a zero or near zero wall proximity feature . various embodiments are contemplated which include a moveable seat link mounted on rollers which move along angled track sections . these rollers form the major connection made between the moveable seat link and the stationary base member . at least one of the tracks is formed with two angled sections . the first angled section is sloped downwardly from rear to front and the second section is sloped upwardly from rear to front . backrest linkage is also provided for allowing angling of the backrest with respect to the seat during reclining movement . footrest linkage is connected to the front of the mechanism for extension and retraction in moving between a fully upright and a reclined t . v . position .

reference now should be made to the drawings which illustrate an embodiment of the invention and its operation . fig1 is a diagrammatic representation of the salient operating features of circuitry implementations which produce a unique triple waveform asymmetry useful for various transcranial electrostimulation applications combined with simultaneous electrostimulation applications to other portions of human anatomy for maximum therapeutic efficacy . the waveform which is described in detail in conjunction with fig2 produces little to no discomfort to the user of the device when applied to the head area for transcranial electrostimulation , and similarly , produces little or no discomfort when applied to other areas of the anatomy , as subsequently described . as illustrated in fig1 , the basic high frequency current signals are produced by a high frequency generator 10 , which may employ a frequency control 12 and a pulse duration control 14 to establish the basic frequency and to provide the desired asymmetry between the positive and negative portions of each of the pulses produced by the generator 10 . typically , the generator 10 may include a crystal oscillator operating at 1 , 000 to 1 , 200 khz , which then is divided down to the desired operating frequency of the alternating current pulses applied to the transcranial stimulation electrodes and to additional electrodes applied to the spinal cord area , and to a peripheral pain area , such as a knee , elbow or the like . typically , the division ratio may be a 1 : 4 ratio to produce signals which then are modulated by a low frequency generator 16 . as illustrated in the diagrammatic representation of fig1 , the output of the low frequency generator 16 may be established by means of a conventional frequency control 18 , a pulse duration control 20 , and a modulation depth control 22 to produce a composite modulated output signal at 24 . the signal 24 , which comprises the pulses from the output of the high frequency generator 10 modulated by the low frequency generator 16 then is provided to three different channel outputs 24 a , 24 b and 24 c . each of the channel outputs is further provided with a corresponding amplitude control 26 a , 26 b and 26 c , respectively , to establish the amplitude of the pulse train supplied to the system through three corresponding power amplifiers 28 a , 28 b and 28 c , respectively . the current at each of these power amplifiers 28 a , 28 b and 28 c may be varied in accordance with the treatment modality to be used by the system ; and this current is measured by the respective ammeters 34 a , 34 b and 34 c . the various power amplifiers 28 a , 28 b and 28 c then supply the appropriate alternating current pulses to multiple pairs of electrode outputs , illustrated as pairs 30 a / 32 a ; 30 b / 32 b ; and 30 c / 32 c in fig1 . as indicated in fig1 , the electrode outputs 30 a / 32 b are applied to the head area , or for transcranial electrostimulation ; the electrodes 30 b / 32 b are applied to the spinal cord area of a human anatomy ; and the electrodes 30 c and 32 c are applied to a peripheral area of a human anatomy , as mentioned above . it also should be noted in the circuit of fig1 that in addition to the amplitude control , the channel 2 output 24 b also is further modulated by a modulation frequency control 25 of dual frequencies . similarly , the channel 3 output 24 c is additionally controlled by a modulation frequency control 27 , which applies a diapason of modulation frequencies to the channel 3 output . the result is that while the three - channel outputs from the channel outputs 24 a , 24 b and 24 c all are supplied with an identical signal from the low frequency generator 16 , the outputs are not identical when they are finally applied to the respective power amplifiers 28 a , 28 b and 28 c to the corresponding output electrodes . the variations are made by the modulation frequency control circuits 25 and 27 , which are coupled with the channel 2 output 24 b and channel 3 output 24 c , respectively . the operation of the disclosed embodiment of the invention produces a waveform having triple asymmetry in order to produce effective transcranial stimulation and further effective stimulation to the spinal cord area and to a peripheral body area , such as an elbow , knee , finger , or the like . the waveform of fig2 and the block diagram of the system shown in fig3 further illustrate the nature of the signals , and the manner in which these signals are processed . the block diagram of the system shown in fig3 is typical of the manner of implementation of the various circuit functions required to produce the waveform of fig2 ; but other arrangements for producing the signal waveform also may be utilized . in fig3 , a crystal oscillator 50 is employed to provide the basic alternating current operating signals utilized for both the high frequency pulses and the modulating pulses , illustrated in fig1 as being produced by the high frequency generator 10 and the low frequency generator 16 , respectively . typically , the oscillator 50 may have an operating frequency in the order of 1 , 000 khz to 1 , 200 khz ( although other frequencies may be used ). in fig3 , the output of this oscillator is supplied in parallel to three dividers 52 a , 52 b and 52 c , which each may comprise multiple division stages , to produce the lower modulating frequency ( illustrated in fig1 as being generated by the low frequency generator 16 ). the output signals from the oscillator 50 also are supplied in parallel through three frequency dividers 54 a , 54 b and 54 c to produce the operating signal waveform shown as the squarewave signal in the waveform of fig2 , after being shaped by a pulse shaper 56 a , 56 b and 56 c , respectively , to achieve the generally squarewave configuration of the signal shown in fig2 . in the example given , these pulses occur at an alternating current rate of 100 khz ; although they could be at higher or lower frequencies in accordance with particular applications of the system . the pulses from the output of the dividers 54 a , 54 b and 54 c are respectively supplied to counters 60 a , 60 b and 60 c , which may be of any suitable type such as a cascade counter or a ring counter , for producing outputs on sets of leads 64 a / 66 a ; 64 b / 66 b ; and 64 c / 66 c , respectively , utilized in controlling the amplitude of the pulses from the corresponding pulse shapers 56 a , 56 b and 56 c . the counters 60 a , 60 b and 60 c are reset by the outputs of their respective dividers 52 a , 52 b and 52 c , applied over the respective leads 62 a , 62 b and 62 c , to reset the counters 60 a , 60 b and 60 c for each cycle of operation of the corresponding dividers 52 a , 52 b and 52 c . in the present example , the output of the dividers 52 a , 52 b and 52 c ( comprising the low frequency modulation control signal described previously in conjunction with fig1 ) is selected to be 77 . 5 hz , since this repetition frequency has been found to be highly effective in conjunction with transcranial electrostimulation devices . repetitive frequencies which are in the range of 70 hz to 85 hz have been found to be effective , but a frequency of 77 . 5 hz has been empirically ascertained as a general ideal operating frequency for producing the maximum efficacy of the system , particularly for the transcranial electrostimulation , which takes place from the channel 1 output electrodes 30 a / 32 / a applied to the head area of a person . the modulating or reset frequency , applied over the leads 62 a , 62 b and 62 c , could as well be supplied by a second independent crystal oscillator , operating at a lower initial frequency than the frequency of the oscillator 50 , if desired . if two different signal sources are employed , synchronization between the two should be effected to cause the various pulse transitions of the signals to be correlated with one another in order to produce the signal waveform of fig2 . the system shown in fig3 , however , is an effective way of accomplishing this purpose . assume , for the present example , that the counter 60 a has been reset to its initial or “ zero ” count . the system then operates to supply output pulses at the high frequency of the divided down signal from the divider 54 a to the counter input , which advances one count for each of the applied pulses . in the waveform shown in fig2 , the initial pulses ( the first four in fig2 ) cause the counter outputs on 64 a and 66 a to be such that , as these outputs are applied to the amplitude control 68 a , a maximum amplitude ( which may be adjusted if desired ) is produced . this is illustrated in the left - hand portion of the waveform signal of fig2 . when pulse no . 4 in the group or packet of pulses is applied , a signal is obtained from one or both of the outputs 64 a and 66 a of the counter 60 a and applied to the amplitude control circuit 68 a to switch it to a lower amplitude , as illustrated for the right - hand portion of the signal shown in fig2 . this causes the output of the amplitude control circuit 68 a , as applied to a regulator amplifier 58 a , to produce the signal waveforms in the asymmetrical pattern shown in fig2 , wherein the left - hand one - fourth ( 42 ) of each of the signal burst envelopes 40 is at a high amplitude ; and the right - hand portion ( 44 ) comprising the remainder of the pulses in the burst envelope 40 is at a lower amplitude . the ratio is such that one - fourth ( the initial amplitude ) is at the high amplitude range 42 , and that the remainder three - fourths of the signal burst is at the low amplitude range 44 . this is the first level of asymmetry of the applied signals . the regulator amplifier 58 a also operates on the squarewave shaped pulses from the pulse shaper 56 a to cause a second asymmetry in the positive and negative going aspects of the signal . as shown in fig2 , the negative going amplitude is one - fourth of the total excursion of the signal ; and the positive going portion is three - fourths of the total excursion . this is true of both the maximum amplitude pulse burst 42 at the beginning of each of the burst groups or packets , and the lower amplitude portion 44 at the end of each of the burst groups or envelopes . finally , a third asymmetry is produced within the thirteen millisecond squarewave burst envelope illustrated as 40 in fig2 . this is the result of the operation of the divider signal on the lead 62 a comprising the reset operation for the counter 60 a . the pulse time , or dwell time , for the positive - going aspect of the signal is one - fourth of the total pulse width ; while the pulse time for the negative - going aspect of the signal is three - fourths of the total pulse width . the composite asymmetrical signal illustrated in fig2 then is provided by the output of the regulator amplifier 58 a to a power amplifier 70 a . the amplification may be adjusted to change the amount of current applied by the system ( while maintaining the relative waveform shapes and patterns shown in fig2 ) in accordance with the treatment modality to be utilized by users of the system . the ammeter 74 a is employed to measure the magnitude of the current supplied by the system . the ammeter 74 a may be a simple analog ammeter , or it may be a digital ammeter providing separate readings of the maximum amplitude and minimum amplitude portions of the signal which is shown in fig2 . the output of the amplifier 70 a may be applied through a polarity switch 72 a which allows the polarity of the signals applied to the output electrodes to be reversed , if desired . the polarity switch 72 a supplies the signals across a pair of spaced output electrodes 76 a and 78 a which may be in the form of pairs of split anodes and split cathodes , or which may be a single “ anode ” and “ cathode ” pair , or any combination thereof . these are the electrodes which are applied to the head area of the user for transcranial electrostimulation . since no direct current components are present , the electrode paths connected to the outputs 76 a and 78 a are not really anodes and cathodes ; but , depending upon the treatment which is being effected , it may be desirable to apply the positive going portions of the pulses to one or the other of these electrodes and the negative going portions to the other of the two electrodes 76 a and 78 a to achieve specific results . it should be noted that in the system which is shown and described , there are no direct current components . it also should be noted that although the system essentially is illustrating 70 khz to 120 khz tone bursts in each of the burst envelopes 40 shown in fig2 , other frequencies could be employed . the 77 . 5 hz waveform derived through the timing cycle is used to complete each burst envelope 40 including first pulses of a relatively high amplitude , followed by a series of pulses of relatively low amplitude in accordance with the signal pattern shown in fig2 . the frequency of pulses comprising the asymmetrical tone burst is approximately 1 , 150 to 1 , 450 times the repetition frequency of the burst envelopes 40 . in the system which is described above , an individual squarewave pulse of 0 . 01 ms is utilized with 0 . 0075 ms in the negative portion of the pulse and 0 . 0025 ms in the positive portion of each of the pulses . the general asymmetrical waveform which is described above in conjunction with fig2 has been found to be effective when it is centered around three - to - one ratios throughout the system operation . these ratios of course may be varied , in accordance with corresponding variations of other ratios of the system ; but it has been found that the asymmetrical relationship which is disclosed replaces the formerly necessary , but unpleasant , dc portion of the operating protocol of earlier systems . it has been found that the utilization of the unique asymmetrical signal produced by the system shown in fig3 and illustrated in the waveform of fig2 effectively lowers the capacitive resistance of the epidermal layer to something on the order of 100 ohms . since less resistance is presented to the integrated 77 . 5 hz modulating frequency , lower current levels are capable of achieving the same desired result which previously required much higher current levels . the lower current levels translate into - a greater level of comfort for the patient or user of the device . the signals supplied to the channel 2 and channel 3 outputs , illustrated as 24 b and 24 c of fig1 , are processed through essentially identical circuitry in fig3 , with the exception that in conjunction with the channel 2 output 52 b through 78 b and the channel 3 output 52 c through 78 c , the additional modulation which is indicated as applied by the modulators 25 and 27 ( fig1 ), respectively , for the number 2 and number 3 channel outputs is employed . in all other respects , the operation of these additional channels employs the same basic signal shown in fig2 and described above in conjunction with fig1 . in conjunction with channel 2 , the power amplifier 70 b is provided with an additional or second modulation frequency control by the modulator 25 shown in fig1 , coupled to the power amplifier 70 b in any suitable manner . the additional modulation frequency switches between two frequencies in the range of 0 . 01 hz and 100 hz . two empirically chosen frequencies of 7 . 75 hz and 77 . 5 hz for modulating the signal pattern of the signal bursts of fig2 , have been found to produce satisfactory results . these modulation frequencies each are applied for a relatively long period of time , on the order of thirty to forty minutes during a treatment session . the system starts with the modulation frequency of 77 . 5 hz applied by the modulator 25 , which then is followed , after an appropriate interval , typically one - half of the session duration , with the lower modulating frequency of 7 . 75 hz for a similar length of time . the switching between the two modulating frequencies continues from the higher frequency to the lower frequency , and back again , over a therapy session , which typically lasts on the order of thirty to forty minutes . the output electrodes 76 b and 78 b ( or 30 b and 32 b of fig1 ) of channel 2 are applied to different locations on the back vertebrae , typically at the lower back . the amplitude of the channel 2 current ranges up to 150 ma . the channel 3 portion of the system , indicated from the divider 52 c through the output electrode 78 c , also is supplied with the signal of fig2 in the same manner as that signal is applied to the channel 1 and channel 2 portions of the system . the channel 3 output electrodes 76 c and 78 c ( or 30 c and 32 c of fig1 ) are used for peripheral stimulation . for example , if the therapeutic treatment is for pain in a knee or an elbow , the electrodes are placed across the appropriate areas for treatment . the signal frequency applied to the dividers 52 c and 54 c is obtained , as described above in detail for channel 1 . the 77 . 5 hz signal burst envelopes 40 are then further modulated with a third modulation frequency within a diapason of frequencies ( typically between 0 . 01 hz and 10 hz ). a range from 7 . 75 hz to 0 . 775 hz has been found effective . the basic modulation is 77 . 5 hz , as with the modulating frequency for channel 1 , and as with one of the modulating frequencies for channel 2 ( 52 b through 78 b ). the depth of the modulations is the same as used for channel 1 ( 52 a through 78 a ). the starting frequency for channel 3 is selected to be 77 . 5 hz , for the first portion of a treatment session , with the diapason frequencies of 7 . 75 hz to 0 . 775 hz then continuing for the second portion of a treatment session . as with channel 2 , the channel 3 current amplitude ranges up to 150 ma . a typical treatment session lasts between thirty minutes and forty minutes . for such a treatment session , the frequency of modulation for the burst envelope for channel 1 is 77 . 5 hz continuously , throughout the session . for channel 2 , the modulation frequency for the first half of the session ( 15 or 20 minutes , depending upon the session length ) is at 77 . 5 hz . during the second half of each treatment session , the modulating frequency for channel 2 drops to 7 . 75 hz . for channel 3 , the modulation frequency during the first half of the treatment session is the basic 77 . 5 hz frequency ; but during the second half of the treatment session , the modulating frequency for channel 3 switches to a frequency in the diapason of 7 . 75 hz to 0 . 775 hz for the remainder of the second half of the session . the frequency changes in this diapason are random change every two or three minutes . this typically completes a treatment session . for some situations , however , the entire session may be repeated , with everything going “ back again ” to the starting conditions mentioned above , and then repeating the operation described . the application of the signal of fig2 to the three channels ( with the additional modulation described for channels 2 and 3 ) used together with the 3 output electrode sets results in improved therapeutic relief over that which is obtained from tces ( channel 1 ) used alone . a synergism of the three signals appears to produce more lasting beneficial results . the foregoing description of an embodiment of the invention is to be considered as illustrative and not as limiting . various changes and modifications will occur to those skilled in the art for performing substantially the same function , in substantially the same way , to achieve substantially the same result without departing from the true scope of the invention as defined in the appended claims .

a therapeutic electrostimulation apparatus and method operates to supply electrostimulation signals to three channels . the basic electrostimulation signal for each of the channels is the same ; and this signal is applied to a transcranial electrostimulation set of output electrodes . a second channel provided with the same signal is further operated to modulate the signal with a dual frequency signal pattern for the application of the second channel signal to a second set of electrodes , typically applied to the body near the spinal area . a third channel supplied with the basic electrostimulation signal modulates the electrostimulation signal during a portion of a treatment session with a diapason of frequencies varying randomly , and the output of this channel is applied to a set of electrodes at a local area for therapeutic treatment .

referring again to the drawings , there is shown in fig1 a bed rest patient on a bed 10 having an orthopedic frame 12 extending thereabove . a horizontal frame member 14 of hexagon cross section , as shown in fig2 supports a pulley 16 for horizontal movement . vertical frame member 18 supports a second pulley 20 . the pulley 20 has a cord or cable 22 in engagement therewith , a weight 24 being attached to the lower end of the cord . the other end of the cord 22 is attached to a hook 26 supported by the pulley 16 . engaged with the lower end of the hook 26 is a cord 28 having hooks at its ends and having a spring 30 intermediate one of the ends and the hook 26 . the bed rest patient has on one leg an orthopedic upper and lower leg supporting apparatus , generally designated as 32 , and which is connected with respect to the upper leg by a loop 34 to the cord 28 and with respect to the lower leg by one of a plurality of loops 36 . the thigh or upper leg portion is surrounded by a plastic or canvas sleeve or cuff 38 , having a longitudinal cut 40 to permit the sleeve to be opened so as to slip it on the leg . in the position shown , the sleeve 38 is usually relatively loose on the leg but may be tightened or adjusted by means of velcro fasteners 42 , for example . the sleeve 38 is normally securely tightened on the leg for walking . laterally outwardly of the sleeve on opposite sides are rods or elongated hinge forming members 44 . as shown in fig3 - 6 , the members 44 have an eye 46 on the outer or upper ends . by means of a bolt 48 , nuts 50 and washers 52 , the hinge members 44 are tightly secured in a selected position on the sleeve with respect to the leg . slidably adjustable on the rods 44 are blocks 58 to which , as best seen in fig7 the ends of the loop 34 are secured therein by means of set screws 60 . longitudinally the blocks are secured be set screws 62 in engagement with the rods 44 . the distance between the ends of the loop 34 adjacent the leg is predetermined with respect to the diameter of the thigh so as to position the hinge member 44 laterally with respect to the leg . at the inner ends of each of the rods 44 are eyes 66 with which are engaged hooks 68 on the inner ends of elongated hinge members or rods 70 . the engaged rods 70 and 44 form the hinges , generally designated as 71 . the rods 70 have a returning bend 72 at their outer ends to aid in securing the rods in a plaster cast 76 encasing the lower leg . the loop 36 is also encased within the cast . in a substantial number of patients the thigh of the leg has a considerably larger diameter than the calf so that it is very desirable that the hinge connections be laterally adjustable with respect to the leg outwardly of the knee . this is made possible in the present invention by the hook and eye hinges 71 , coupled with the blocks 58 and the loop 34 , which serve to properly position the hinge laterally with respect to the leg , in addition to providing a connecting means for supporting the leg upwardly . in fig8 another embodiment of the invention is illustrated . here both the upper and lower legs are enclosed in plaster of paris casts 80 and 82 , respectively . on both sides secured within the cast 80 are hinge forming rods 84 , each having on its upper end a return bend 86 and on its lower end a hinge eye 88 . similarly , secured within the cast 82 on each side thereof is a hinge forming rod 90 , each having on its upper end a hinge hook 92 engaged with a respective hinge eye 88 . the lower ends each have a return bend 94 . the upper and lower rods are laterally and vertically positioned in the casts , adjustably spaced from that extending along the leg portions to be easily joined adjacent the knee to form the hinges . thus , irrespective of the differences of the diameters of the upper and lower leg portions , the rods are easily positioned to extend therealong and be at proper lateral distances therefrom to form hinges that permit easy bending of the knee . the leg is supported upwardly by a cord 28 , as shown in fig1 . each end of the cord is hooked to one of a plurality of loops 36 secured in both of the casts . the invention and its attendant advantages will be understood from the foregoing description and it will be apparent that various changes may be made in the form , construction and arrangements of the parts of the invention without departing from the spirit and scope thereof or sacrificing its material advantages , the arrangements hereinbefore described being merely by way of example . i do not wish to be restricted to the specific forms shown or uses mentioned except as defined in the accompanying claims , wherein various portions have been separated for clarity of reading and not for emphasis .

upper and lower leg supporting apparatus having hinge means articulated so as to be adjustable laterally toward and away from the leg and so as to be movable with the leg in accordance with the bending of the knee .

the coupler of the present invention may be used to couple any suitable object to any suitable support . the coupler of the present invention may be used to position ( e . g ., orient ) an object with respect to a support . in an implementation , the coupler of the present invention releasably couples a dvr to equipment ( e . g ., clothing , uniform , belt , glasses , hat , helmet , shirt , backpack , wristband , harness ) used and / or worn by a person ( e . g ., witness , participant , user , investigator , police officer ). in an implementation , coupler 200 of fig1 - 10 includes base 210 , cover 220 , and ring 310 . a base is the portion of the coupler that couples ( e . g ., attaches , connects ) to the object . the cover is the portion of the coupler that couples to the support . the base releasably couples to the cover thereby releasably coupling the object to the support . a releasable coupler enables a user to remove the object from the support . a base may be positioned ( e . g ., oriented ) with respect to a cover so that an object may be positioned with respect to a support . the base may be release from or coupled to the cover without the use of tools . so , an object may be coupled to a support manually by a person without the use of tools . because the coupler is releasable , an object may be released ( e . g ., removed ) from one support and coupled to another support that includes a cover for receiving the base coupled to the object . a base may be coupled to an object so that it may not be easily removed from the object . a cover may be coupled to a support so that it may not be easily removed from the support . the base may be coupled to an object at an orientation and the cover coupled to a support at an orientation so that when the base is releasably coupled to the cover , the object is positioned ( e . g ., oriented ) with respect to the support . the orientation of the object with respect to the support may facilitate the operation ( e . g ., use , function ) of the object . a base may move closer to ( e . g ., in , toward ) and away from ( out , outward ) from a cover . because the base couples to an object and a cover couples to a support , as the base moves toward and away from the cover , the object moves toward and away from the support . a base may move closer to and away from a cover along an axis . when the base moves toward the cover along the axis , a portion of the base may be inserted ( e . g ., enter ) into a portion of the cover . a base may rotate ( e . g ., turn ) with respect to a cover . because the base couples to an object and a cover couples to a support , the base may rotate as a result of a user rotating the object with respect to the support . as discussed herein , movement of the base with respect to the cover discloses movement of the object with respect to the support because the base couples to the object and the cover couples to the support . any discussion of movement of the base also describes movement of the object and vice versa . any discussion of the cover relates to the support because the cover couples to the support . in an implementation where the base couples to a dvr and the cover couples to the clothing of a user , the user does not directly contact the base to move and / or rotate the base . the user manually positions the object so that the base is positioned with respect to the cover and with respect to the clothing . the user manually rotates the object so that the base rotates with respect to the cover and with respect to the clothing . while the portion of the base is inserted into the cover , the base may rotate with respect to the cover . rotating the base after inserting portion of the base into the cover causes a portion of the cover to interfere with ( e . g ., obstruct , stop ) movement of the base away from the cover along the axis thereby coupling the base to the cover . the base remains coupled to the cover as long as the cover interferes with movement of the base away from the cover or vice versa . a ring positioned in the cover may retain ( e . g ., hold , interfere with ) a base that is inserted into a cover at a particular rotated position ( e . g ., orientation ). while a ring holds a base that is inserted into a cover at a rotated position , the base cannot be separated from ( e . g ., move away ) the cover , thereby coupling the base to the cover and in turn the object to the support . a ring may hold a base at one or more rotated positions ( e . g ., orientations ). a ring may hold a base , and therefore an object , at a position that provides an environment for proper operation of the object . a base may couple to an object using any conventional technique for coupling . in an implementation , base 210 includes bores 350 for coupling to an object by screw and / or bolt . a cover may couple to a support using any conventional technique for coupling . in an implementation , cover includes bores 332 for coupling to a support by screw and / or bolt . in another implementation , the cover is sewn to the support . in another implementation , the cover is coupled to a structure that is coupled to the support . in an implementation , the cover is coupled to a piece of material ( e . g ., plastic , cloth ) that in turn is sewn to the clothing of a user . in another implementation , the cover is coupled to magnetic material that magnetically couples to the support . in an implementation , the coupler of the present invention releasably couples a dvr to equipment worn by a person . the coupler retains the dvr coupled to the equipment , permits the dvr to be manually removed from or coupled to the equipment , and positions the dvr to record information that occurs in the vicinity of the person . in fig1 , dvr 120 ( e . g ., object ) couples to uniform 130 ( e . g ., support ) worn by officer 110 so that dvr 120 may record the events that occur in the vicinity of officer 110 thereby performing the function of a body - worn recording system . as shown in fig1 - 2 and 4 , coupler 200 couples dvr 120 to uniform 130 . base 210 that couples to the object includes post 340 having axis 360 , surface 380 , plate 392 , and bores 350 . cover 220 that couples to a support includes surface 336 , opening 330 in surface 336 , surface 338 , bores 332 , recess 334 , and axis 362 . ring 310 includes arm 312 , arm 314 , arm 316 , arm 318 , stop 372 , stop 374 , opening 320 , and axis 364 . end portion 610 of arm 312 includes ramp 612 and face 314 . end portion 620 of arm 314 includes ramp 622 and face 624 . end portion 630 of arm 316 includes ramp 632 and face 634 . end portion 640 of arm 318 includes ramp 642 and face 644 . because end portions 610 - 640 increase in width from ramp 612 - 642 to the end of each end portion , end portions 610 - 640 may be described as bulbous . base 210 performs the functions of a base discussed above . cover 220 performs the functions of a cover discussed above . ring 220 performs the functions of a ring discussed above . post 340 of base 210 couples to and projects away from plate 392 . as discussed above , bores 350 may be used to couple base to an object ( e . g ., dvr ). while base 210 is coupled to an object , surface 380 faces way from the object . post 340 includes protrusion 342 , protrusion 344 , protrusion 346 , and protrusion 348 . protrusions 342 - 348 project away from ( e . g ., out of ) post 340 . protrusions 342 - 348 , as discussed below , interfere with portions of cover 220 to couple base 210 to cover 220 . protrusions 342 - 348 extend a distance away from center portion 382 of post 340 . protrusions 342 and 344 extend farther away from center portion 382 than protrusions 346 and 348 . the length of the projection of protrusions 342 - 348 from post 340 may be measured with respect to axis 360 . protrusions 342 and 344 extend a distance 1030 from axis 360 . protrusions 346 and 348 extend a distance 1040 from axis 360 . underside ( e . g ., undersurface ) 1010 of protrusions 342 - 348 is positioned a distance 1020 away from surface 380 so that slot 410 is formed between undersurface 1010 and surface 380 . as discussed below , a portion of cover 220 enters ( e . g ., engages , interlocks ) slots 410 so that underside 1010 contacts surface 336 to couple base 210 to cover 220 . base 210 may be formed of any material or combination of materials that have suitable properties to perform the functions of a base . such materials may include metals , plastics , composite materials , or any combination thereof . in one implementation , base 210 is formed of aluminum . in another implementation , base 210 is formed of a durable plastic . preferably , the material that forms base 210 has sufficient strength so that when base 210 is rotated out of the decoupled position toward the intermediate position , the strength of protrusions 342 - 348 is sufficient to not break or deform , under normal use , so that base 210 separates from cover 220 and ring 310 . in an implementation in which base 210 is formed of aluminum , thickness 1022 of base 210 from surface 1024 opposite 380 to upper surface 384 is about 5 millimeters ( mm ). thickness 1026 of plate 392 of base 210 is about 1 . 4 mm . the distance between underside 1010 of protrusions 342 - 348 and surface 380 is about 1 mm . length 390 of each side of plate 392 is about 42 mm a side . arms 312 - 318 of ring 310 are formed of a resilient material so that when an arm is pushed ( e . g ., forced , moved ) outwardly ( e . g ., away from the center , away from the central axis , away from axis 364 ), the arm will return to its original position when the force is removed . further , when arms 312 - 318 are forced outwardly , the resilient nature of the material used to form arms 312 - 318 means that 312 - 318 will apply a force against the object that pushes the arm outwardly . recess ( e . g ., cavity , depression ) 334 of cover 220 is of a shape to accept ring 310 so that ring 310 may be positioned in recess 334 . the shape of recess 334 and the corresponding shape of ring 310 include surfaces that interfere with ( e . g ., block , collide with , hinder ) each other ( e . g ., edges of surface 334 , edges of ring 310 ) so that when a rotational force is applied to ring 310 , ring 310 will not turn ( e . g ., rotate ) in recess 334 . the depth ( e . g ., height ) of recess 334 is sufficient so that when ring 310 is positioned in recess 334 that upper surface 376 of ring 310 is flush with or below surface 338 of cover 220 . when cover 220 is coupled to a support , recess 334 with ring 310 positioned in recess 334 are oriented toward the support and surface 338 comes into contact with the surface of the support . if upper surface 376 of ring 310 is flush with surface 338 , the support will not interfere ( e . g ., block , collide with , hinder ) with movement of arms 312 - 318 . if the height of post 340 is less than the depth of recess 334 , the support will not interfere with the rotation of post 340 when it is inserted into cover 220 . openings 320 and 330 are of a shape and size so that post 340 with protrusions 342 - 348 may pass through openings 320 and 330 when base 210 is positioned in a position for insertion into opening 330 of cover 220 . the position of base 210 with respect to cover 220 and ring 310 when oriented so that post 340 may be inserted into openings 320 and 330 is referred to herein as the decoupled ( e . g ., insertion ) position . in the insertion position , axis 360 of base 210 is aligned with axis 362 of cover 220 and axis 364 of ring 310 . ring 310 is positioned in recess 334 . base 210 is rotated until protrusions 342 - 348 align with the sides of opening 330 and opening 320 . base 210 is then moved toward cover 220 so that post 340 passes into opening 330 and opening 320 . base 210 may be moved toward cover 220 until it stops when surface 380 touches cover 220 . the position of post 340 relative to opening 320 while in the decoupled position is show in fig7 . as discussed above , when base 210 is in the decoupled position and is move as close is it can to cover 220 , upper surface 384 of post 340 does not extend above ( e . g ., beyond , past ) surface 338 of cover 220 . in fig3 , post 340 is not in the decoupled position because protrusions 342 - 348 are rotated about 90 degrees with respect to cover 220 so that protrusions 342 - 348 cannot fit through opening 330 or opening 320 . when ring 310 is positioned in recess 334 , opening 320 aligns with opening 330 so that protrusions 342 - 348 may pass into openings 330 and 320 when base 210 is oriented in the decoupled position . when base 210 is in the decoupled position and inserted into openings 320 and 330 , cover 220 ( e . g ., edges around opening 330 ) are not positioned in slots 410 between underside 1010 and surface 380 . however , when base 210 is rotated , in this implementation counterclockwise from the perspective of fig5 and 7 - 9 , the edges of cover 220 around opening 330 enter slot 410 between protrusions 342 - 348 and surface 380 . once cover 220 is positioned in slots 410 , base 210 cannot be pulled away from cover 220 because underside 1010 of protrusions 342 - 348 interferes with ( e . g ., block , collide with , hinder , contacts ) surface 336 so base 210 cannot be extracted ( e . g ., decoupled , pulled away ) from cover 220 . in fig4 , base 210 is inserted through openings 320 and 330 and rotated out of the decoupled position . portions of cover 220 are positioned in slots 410 formed between underside 1010 of protrusions 342 - 348 and surface 380 . in fig5 , base 210 is show in the locked position , which is discussed below . because base 210 is not in the decoupled positioned , cover 220 is positioned in slots 410 . in fig5 , protrusions 342 - 348 are shown positioned over surface 336 of cover 220 . base 210 cannot be pulled out of opening 330 because protrusions 342 - 348 contact surface 336 and interfere with the removal of base 210 . rotating base 210 back to the decoupled position moves protrusions 342 - 348 so that cover 220 exits slots 410 . once cover 220 exits slots 410 , base 210 is in the decoupled position and base 210 may be extracted from holes 320 and 330 by moving base 210 along axis 360 / 362 / 364 , ( axis are aligned in decoupled position ) away from cover 220 . as discussed briefly above , ring 310 retains base 210 in one or more rotated positions . in an implementation , ring 310 and in particular arms 312 - 318 and stops 372 - 374 , operate to hold base 210 in two positions referred to herein as an intermediate position and a locked position . fig7 - 9 omit cover 220 to clarify the cooperation of ring 310 with post 340 to hold base 210 at various orientations . while base 210 is positioned in the decoupled position , as shown in fig7 , arms 312 - 318 do not apply a force on post 340 . as discussed above , while base 210 is in the decoupled position , base 210 may be separated from cover 220 and ring 310 because no portion of ring 310 or cover 220 interfere with the movement of base 210 away from cover 220 and / or ring 310 . graft 1100 of fig1 represents the relative force to rotate base 210 from the decoupled position to the locked position . the decoupled position is represented by orientation 710 . from the decoupled position , base 210 may be rotated , counterclockwise from the perspective of fig5 and 7 - 9 . the orientation of the protrusions 342 - 348 with respect to ring 310 in the decoupled position is identified as orientation 710 . rotating base 210 angular distance 820 from orientation 720 to orientation 810 moves base 210 from the decoupled position to the intermediate position . further rotating base 210 angular distance 920 from orientation 810 to orientation 910 moves base 210 from the intermediate position to the locked position . under proper operating conditions , base 210 does not rotate further counterclockwise past the locked position . base 210 may be rotated , clockwise from the perspective of fig5 and 7 - 9 , from the locked position to the intermediate position . base 210 may be further rotated from the intermediate position to the decoupled position . although the above description uses the terms counterclockwise and clockwise with respect to coupling and decoupling respectively , any direction of rotation may be used for coupling and the opposite direction for decoupling so that coupling is not limited to counterclockwise rotation and decoupling is not limited to clockwise rotation . as base 210 rotates with respect to ring 310 and cover 220 , arms 312 - 318 cooperate with ( e . g ., interact with , operate on , interfere with ) protrusions 342 - 348 . as base 210 rotates from the decoupled position at orientation 710 toward intermediate position at orientation 810 , protrusions 342 and 344 push against ramps 612 and 632 respectively . ramps 612 , 622 , 632 , and 642 are positioned at an angled , as opposed to orthogonal , to with respect to faces 614 , 624 , 634 , and 644 respectively so that protrusions 342 and 344 may apply less on arms 312 - 318 to cause arms 312 - 318 to deflect ( e . g ., bend , flex ) away from the center of ring 310 which corresponds to axis 360 / 364 . as base 210 rotates from orientation 710 to orientation 810 , protrusions 342 and 344 push against ramps 612 and 632 respectively and cause arms 312 and 316 to move outward away from axis 360 / 364 . as base 210 continues to rotate counterclockwise , protrusion 342 and 344 move past ramps 612 and 632 respectively , and along face 614 and face 634 until protrusion 342 and 344 contact end portion 620 and end portion 640 respectively . the force required to rotate base 210 so that protrusions 342 and 344 pass ramps 612 and 632 respectively , shown as amount ( e . g ., level , magnitude ) of force 1116 in fig1 , is greater than the amount of force 1114 required to rotate ( e . g ., move ) protrusions 342 and 344 along faces 614 and 634 . the force required to rotate protrusions 342 and 344 past ramps 626 and 646 of end portions 620 and 640 respectively , amount of force 1118 , is greater than the force , amount of force 1114 , required to rotate protrusions 342 and 344 along faces 614 and 634 and greater than the force , amount of force 1116 , required to rotate protrusions 342 and 344 along ramps 612 and 632 , so when protrusions 342 and 344 contact end portions 620 and 640 respectively , the user turning base 210 , or the object coupled to base 210 , feels a definite stop ( e . g ., bump , pause ) in the movement of base 210 , or object coupled to base 210 , upon reaching orientation 810 . while base 210 is positioned at orientation 810 in the intermediate position , protrusions 342 and 344 push against end portions 610 and 630 so that arms 312 and 316 remain positioned away ( e . g ., distal , deflected ) from axis 360 / 364 . because arms 312 and 316 are formed of a resilient material , arms 312 and 316 apply a force on protrusions 342 and 344 respectively . the force applied by arms 312 and 316 on protrusions 342 and 344 operate to retain base 210 in the intermediate position . the interference of end portions 620 and 640 with protrusions 342 and 344 act to limit further counterclockwise rotation of base 210 without a further increase in the amount of force that operates on base 210 to cause it to rotate . ramps 626 and 646 of end portions 620 and 640 that are proximate to protrusions 342 and 344 while in the intermediate position are angled , as opposed to orthogonal , to faces 624 and 644 respectively to decrease the amount of force required to rotate base 210 over ramps 626 and 646 past the ends of arms 314 and 318 . however , the angle of ramps 626 and 646 with respect to faces 614 and 634 respectively is greater than the angle of ramps 612 and 632 with respect to faces 614 and 634 respectively , so the amount of force , amount of force 1118 , required to rotate protrusions 342 and 344 past ramps 626 and 646 is greater than the amount of force , amount of force 1116 , required to rotate protrusions 342 and 344 past ramps 612 and 632 . base 210 remains in the intermediate position as long as a force applied to base 210 in the clockwise direction is less than the force applied by arms 312 and 316 on protrusions 342 and 344 respectively and the force applied to base 210 in the counterclockwise direction is less than the force , amount of force 1118 , required to move protrusions 342 and 344 past ramps 626 and 646 of end portions 620 and 640 . when a user applies the force , amount of force 1118 , required to move protrusions 342 and 344 along ramps 626 and 646 past the ends of end portions 620 and 640 , base 210 begins to rotate from orientation 810 toward orientation 910 . protrusions 342 and 344 push arms 314 and 318 outward away from axis 360 / 364 as protrusions 432 and 344 move along ramps 626 and 646 respectively . as protrusions 342 and 344 move down ramps 616 and 636 and past end portions 610 and 630 , arms 312 and 316 move toward axis 360 / 364 until they return to their original positions . further , as protrusions 342 and 344 move past arms 312 and 316 , the force applied by arms 312 and 316 on protrusions 342 and 344 decreases . protrusions 342 and 344 push arms 314 and 318 outward as protrusions 342 and 344 move along ramps 626 and 646 until protrusions 342 and 344 reach faces 624 and 644 . as base 210 continues to rotate , protrusions 342 and 344 move along face 624 and 644 respectively . the force , amount of force 1114 , required to move protrusions 342 and 344 along face 624 and 644 respectively , is less than amount of force 1118 and amount of force 1116 . while arms 314 and 318 are pushed outward by protrusions 342 and 344 , arms 314 and 318 apply a force on protrusions 342 and 344 . base 210 continues to rotate counterclockwise until protrusions 342 and 344 reach ramps 622 and 642 respectively . as protrusions 342 and 344 reach ramps 622 and 642 respectively , the force required to rotate base 210 in a counterclockwise direction down ramps 622 and 642 decreases because of the orientation of ramps 622 and 642 with respect to faces 624 and 644 and because the force applied by arms 314 and 318 on protrusions 342 and 344 helps to move protrusions 342 and 344 down ramps 622 and 642 . the force , amount of force 1112 , required to move protrusions along ramps 622 and 642 is less than amount of force 1114 , 1116 , and 1118 . after protrusions 342 and 344 have cleared ( e . g ., moved past ) ramps 622 and 642 , protrusions 342 and 344 contact stops 372 and 374 respectively and base 210 is positioned at orientation 910 . while at orientation 910 , base 210 is in the locked position . amount of force 1118 required to rotate base 210 so that protrusions 342 and 344 move counterclockwise along ramps 626 and 646 past the ends of end portions 620 and 640 respectively is greater than the force , amount of force 1114 , required to rotate protrusions 342 and 344 along faces 624 and 644 respectively . amount of force 1112 required to rotate base 210 so that protrusions 342 and 344 pass along ramps 622 and 642 respectively is less than the force , amount of force 1114 , required to move protrusions 342 and 344 along faces 624 and 644 respectively . when protrusions 342 and 344 contact stops 372 and 374 respectively base 210 stops rotating and base 210 is at orientation 910 . stops 372 and 374 do not include angled surfaces . stops 372 and 374 contact a portion of protrusions 342 and 344 respectively that is closer to axis 360 / 364 , as opposed to a portion closer to an end portion of protrusions 342 and 344 , to increase the force required to move protrusions 342 and 344 past stops 372 and 374 . under proper operation , base 210 does not rotate counterclockwise past orientation 910 . rotating base 210 counterclockwise past orientation 910 would require breaking off stops 372 and 374 . amount of force 1120 required to rotate base 210 past stops 372 and 374 represents a force that is significantly greater than amount of force 1112 , 1114 , 1116 , and 1118 . while base 210 is positioned at orientation 910 in the locked position , stops 372 and 374 stop ( e . g ., limit , impair , halt ) further counterclockwise rotation while at the same time end portions 620 and 640 resist clockwise rotation . while base 210 is in the locked position , arms 314 and 316 may apply some pressure on protrusions 342 and 344 and end portions 620 and 640 may apply some pressure on protrusions 346 and 348 respectively to resist clockwise movement of base 210 out of orientation 910 . the forces show in fig1 are relative to each other and are not absolute representations of force . the levels of force in fig1 are not to scale and show only a relative increase or decrease of the amount of force . the positive or negative slope in the line of graph 1100 has no meaning . the change in force to rotate base 210 may occur with little change in the orientation of base 210 or base 210 may rotate slightly as the level of force increases or decreases between the levels of force ( e . g ., 1112 , 1114 , 1116 , 1118 ) shown in fig1 . at orientation 1130 , protrusions 342 and 344 start to move along ramps 612 and 632 respectively . at orientation 1132 , protrusions 342 and 344 start to move off of ramps 612 and 632 and along faces 614 and 624 respectively . at orientation 810 , base 210 is in the intermediate position . at orientation 1140 , protrusions 342 and 344 start to move along ramps 626 and 646 . the force required to for protrusions 342 and 344 to move down ramps 616 and 636 is not shown because movement down ramps 616 and 636 occurs after movement of protrusions 342 and 344 up ramps 626 and 646 . at orientation 1142 , protrusions 342 and 344 start to move off of ramps 626 and 646 respectively and along faces 624 and 644 respectively . at orientation 1144 , protrusions 342 and 344 start to move down ramps 622 and 642 . many factors affect the force required to rotate base 210 from one orientation to another orientation . factors include the resilient force applied by each arm 312 - 318 on protrusions 342 - 348 , the orientation ( e . g ., angles ) between surfaces on ring 310 , the shape of protrusions 342 - 348 , in particular the shape of protrusions 342 and 344 , and a coefficient of friction between protrusions 342 - 348 and the surfaces of ring 310 . protrusions 342 and 344 are diametrically ( e . g ., oppositely , 180 degree difference , mirrored ) positioned with respect to each other across axis 360 . protrusions 346 and 348 are also diametrically positioned with respect to each other across axis 360 . when protrusions 342 or 346 are positioned so that arms 312 or 314 applies a force to protrusion 342 or 346 , an opposite , and preferably equal , force is apply by arms 316 and 318 to protrusion 344 and protrusion 348 . arms 312 - 318 are positioned symmetrically ( e . g ., mirrored ) in ring 310 . arms 312 and 316 are positioned opposite each other across axis 364 . arms 314 and 318 are positioned opposite each other across axis 364 . because protrusions 342 and 344 are positioned opposite each other across axis 360 , when arm 312 applies a force to protrusion 342 , protrusions 344 is positioned so that arm 316 applies an opposing force ( e . g ., force in opposite direction to arm 312 ) to protrusion 344 at the same time . when arm 314 applies a force to protrusion 342 , protrusion 344 is positioned so that arm 318 applies an opposing force to protrusions 344 at the same time . when arm 314 applies a force to protrusion 346 , protrusion 348 is positioned so that arm 318 applies an opposing force to protrusion 348 . opposing arms interact with and operate on opposing protrusions at the same time . the simultaneous opposing ( e . g ., symmetrical ) forces that are applied to protrusions 342 - 348 , as discussed above , result from symmetry of arms 312 - 318 in ring 310 . the symmetrical application of force by arms 312 - 318 on protrusions 342 - 348 improves retention of base 210 at any particular rotated orientation . the symmetry of arms 312 - 318 and protrusions 342 - 348 causes arm pair 312 / 316 and arm pair 314 / 318 to operate against protrusions 342 / 344 and 346 / 348 to apply opposing forces to post 340 to retain base 210 at rotated positions . because arms 312 and 316 cooperate with each other and arms 314 and 318 cooperate with each other to respectively apply force on post 340 , arm pair 312 / 316 may operate distinctly from air pair 214 / 318 . for example , the resilient material that forms arm pair 312 / 316 may be different from the resilient material that forms arm pair 314 / 318 so that arms of a pair apply the same amount of force on post 340 while arm pairs apply a different amount of force on post 340 . for example , arm pair 314 / 318 may be formed of a more resilient ( e . g ., stiffer , springier ) material than used to form arm pair 312 / 316 so that rotating base 210 from decoupled position 710 to intermediate position 810 takes less force than rotating base 210 from intermediate position 810 to locked position 910 . the same may be done in reverse so that arm pair 314 / 318 is formed of a more resilient material than arm pair 312 / 316 so that more force is required to rotate base 210 from decoupled position 710 to intermediate position 810 than from intermediate position 810 to locked position 910 . preferably , each arm of arm pair 312 / 316 and arm pair 314 / 318 have the same resilient characteristics so that the force applied by the arms of an arm pair on post 340 is about equal in the amount of force and opposing in direction . the orientations where base 210 is retained ( e . g ., 810 , 910 ) may be at any position along an arc . the angular distances between orientations where base 210 is retained may be equal or different . an angular distance from one orientation to another orientation may be the same or different . for example , angular distance 820 and 920 may be the same or different . angular distance 820 may be greater than angular distance 920 or vice versa . to decoupled base 210 from cover 220 , base 210 is rotated from the locked position at orientation 910 , to the intermediate position at orientation 810 , and from the intermediate position to the decoupled position at orientation 710 . from the stopped position , rotating base 210 clockwise , with respect to fig7 - 9 , forces protrusions 342 and 344 against ramps 622 and 642 respectively . as protrusions 342 and 344 travel along ramps 622 and 642 , protrusions push arms 314 and 318 outward away from 360 / 364 . as arms 314 and 318 are pushed outwardly , arms 314 and 318 apply a force on protrusions 342 and 344 respectively . as base 210 continues to rotate clockwise , protrusions 342 and 344 move across faces 624 and 644 until a portion of ( e . g ., edge ) of protrusions 342 and 344 contact the ends of end portions 610 and 630 of arms 312 and 316 . contact with end portions 610 and 630 creates an greater resistance to rotation in the clockwise direction that requires additional force to overcome to continue clockwise rotation . this position , when protrusions 342 and 344 contact the ends of end portions 610 and 630 of arms 312 and 316 , may be referred to as the intermediate return position . the intermediate return position is not the same as the intermediate position . the orientation of the intermediate return position lies between orientation 810 and 910 . while base 210 is positioned in the intermediate return position , protrusions 342 and 344 push arms 314 and 318 respectively outward . because arms 314 and 318 are arm formed of a resilient ( e . g ., springy , elastic ) material , while arms 314 and 318 are pushed outward , they exert a force on protrusions 342 and 344 that acts to maintain base 210 in the intermediate return position . from the intermediate return position , applying additional force pushes protrusions 342 and 344 with greater force against end portions 610 and 630 . end portions 610 and 630 may include an angle so that the end of end portions 610 and 630 are not orthogonal to face 614 and 634 respectively . as protrusions 342 and 344 push on ( e . g ., cooperate with , interact with , operate on ) end portions 610 and 630 , arms 312 and 316 begin to move outwardly away from axis 360 / 364 . as protrusions 342 and 344 move along face 614 and 634 , protrusions 342 and 344 move past arms 314 and 318 so that arms 314 and 318 move inwardly toward axis 360 / 364 . when protrusions 342 and 344 clear end portions 620 and 640 of arms 314 and 318 , arms 314 and 318 move back to their original position . as base 210 continues to rotate clockwise , protrusions 342 and 344 move across faces 614 and 634 respectively , and across ramps 612 and 632 until protrusions 346 and 348 contact stops 374 and 372 respectively . clockwise rotation stops when protrusions 346 and 348 contact stops 374 and 372 and base 210 is in the decoupled position at orientation 710 . from the stopped position , the force required to move protrusions 342 and 344 clockwise along ramps 622 and 642 respectively is greater than the force required to move protrusions 342 and 344 clockwise along faces 624 and 644 . once protrusions 342 and 344 have contacted the end of end portions 610 and 630 , the force to continue clockwise rotation in greater than the force required to move protrusions 342 and 344 along faces 624 and 644 . the force required to move protrusions 342 and 344 along faces 614 and 634 respectively is less than the force required to move protrusions 342 and 344 past the end of end portions 610 and 630 . the force required to move protrusions 342 and 344 along ramps 612 and 632 is less than the force required to move protrusions 342 and 344 along faces 624 and 644 . once protrusions 346 and 348 contact stops 374 and 372 respectively , the force required for continued clockwise movement is very high . in normal operation , base 210 cannot rotate in a clockwise direction past orientation 710 . the force required to move past stops 372 and 374 would break stops 372 and 374 . once base 210 is back in the decoupled position at orientation 710 , base 210 may be separated from cover 220 and ring 310 . as discussed above , while base 210 is coupled to cover 220 , upper surface 384 of base 210 does not extend above ( e . g ., beyond ) surface 338 of cover 220 or surface 376 of ring 310 . so , the entire thickness ( e . g ., width ) of coupler 200 may be the same or slightly more than the width of base 210 . for example , in an implementation , base 210 has thickness 1022 . if upper surface 384 does not extend past surface 388 or surface 376 , coupler 200 may have a thickness that is about the same as thickness 1022 . if upper surface 384 does not quite reach the same level as surface 338 ( e . g ., it is below ), then the thickness of coupler 200 may be more than thickness 1022 by the amount of difference between upper surface 384 and surface 338 . in light of the construction and thickness 1022 of base 210 , coupler 200 may be relatively thin ( e . g ., low profile ) when compared to the objects to which base 210 may be attached . for example , for dvr that has a thickness of 0 . 8 inches ( i . e ., 20 . 32 mm ), connector 200 with a thickness of only 5 mm is only one quarter of the thickness of the dvr . in an implementation , coupler 200 may couple a dvr to a person . a dvr coupled to a person may be used to record an event ( e . g ., occurrence , incident ). in accordance with the above discussion , base 210 couples to dvr 120 , cover 220 couples to the uniform 130 of the officer 110 . ring 310 is positioned in recess 334 . officer 110 couples dvr 120 to uniform 130 by rotating camera so that base 210 is oriented at orientation 710 . while dvr 120 is rotated so that base 210 is oriented at orientation 710 , the lens of dvr is not oriented upright , so any video taken by dvr 120 while base 120 is in position 720 would be rotated about 90 degrees to the right so that the heads of people standing upright would be oriented to the right side of the picture . while dvr 120 is rotated so that base 210 is at orientation 710 , officer 110 aligns axis 360 of base 210 with axis 362 of cover 220 and 364 of ring 310 and inserts post 340 into opening 330 and aligned opening 320 until surface 380 touches cover 220 . base 210 is now in the decoupled position . officer 110 rotates dvr 120 counterclockwise , from the perspective of officer 110 , until officer feels increased resistance and possibly hears an audible clicking sound of protrusions 342 and 344 hitting the end of end portions 620 and 640 . at this orientation , base 210 is in the intermediate position . even though the force applied by arms 312 and 316 on protrusions 342 and 344 may hold base 210 and therefore dvr 120 in the intermediate position , dvr 120 is still oriented at an angle with respect to the officer so the video recorded by dvr 120 in the intermediate position would not show upright objects as being upright . officer 110 applies more force to rotate dvr 120 further counterclockwise past the intermediate position until officer 110 feels increase resistance and possible an audible click as protrusions 342 and 344 hit against stops 372 and 374 respectively . at this orientation , base 210 is in the locked position and oriented at orientation 910 . in the locked position , dvr 120 is properly oriented for recording video at an angle where the objects in the recorded video will be oriented at the same orientation as viewed by officer 110 . for example , the head of people who are standing or are upright will be oriented toward the top of the recorded video . to accomplish positioning dvr 120 at an orientation for proper operation while base 210 is in the locked position , dvr 120 must be oriented with respect to base 210 , base 210 must be oriented with respect to cover 220 and cover 220 must be oriented with respect to uniform 130 so that rotating base 210 to the lock position results in positioning dvr 120 at the desired orientation for proper operation . dvr 120 may be decoupled from uniform 130 by rotating dvr 120 clockwise from the perspective of officer 120 until base 210 is in the decoupled position then officer 120 may pull base 210 away from cover 220 to accomplish decoupling and complete separation of base 210 from cover 220 and ring 210 thereby decoupling dvr 120 from the uniform of officer 110 . in an implementation , the strength of coupling between base 210 and cover 220 ( e . g ., coupling of base 210 to cover 220 ) may be increase by using a magnetic force to attract base 210 to cover 220 and vice versa . a magnetic attraction between base 210 and cover 220 may be used in addition to the force applied by ring 310 to retain base 210 at an orientation . ring 210 may be formed of a non - magnetic material so that a magnetic force do not interfere with the operation of ring 310 to hold base 210 at an orientation as discussed above . a magnetic attraction between base 210 and cover 220 may be used to couple base 210 to cover 220 in addition to the interference between cover 220 and surface 1010 while portions of cover 220 are positioned in slot 410 . base 210 may be formed of a material or include material that provides a magnetic force and cover 220 may be formed , in whole or part , of a material that is attracted by the magnetic force provided by base 210 or visa versa . the magnetic force cannot be so strong that once base 210 and cover 220 contact each other that base 210 cannot be rotated , due to the magnitude of the magnetic force , to position the object coupled to base 210 . the magnetic force cannot be so strong that is it extremely difficult to separate base 210 from cover 220 while base 210 is in the decoupled position . the magnetic coupling is not likely to be used alone ( e . g ., user forgets to rotate base 210 ) to couple base 210 to cover 220 because rotation of the object coupled to base 210 orients the object , in this case a dvr , for proper operation such as capturing video at the proper orientation as discussed above . in an implementation , all or part of plate 392 is formed of a magnetic material ( e . g ., permanent magnet ) while all or part of cover 220 is formed of a material ( e . g ., ferromagnetic ) that is attracted to a magnetic field . in another implementation , all or part of cover 220 is formed of a magnetic material while all or part of plate 392 is formed of a ferromagnetic material . the foregoing description discusses preferred embodiments of the present invention , which may be changed or modified without departing from the scope of the present invention as defined in the claims . examples listed in parentheses may be used in the alternative or in any practical combination . as used in the specification and claims , the words ‘ comprising ’, ‘ including ’, and ‘ having ’ introduce an open ended statement of component structures and / or functions . in the specification and claims , the words ‘ a ’ and ‘ an ’ are used as indefinite articles meaning ‘ one or more ’. when a descriptive phrase includes a series of nouns and / or adjectives , each successive word is intended to modify the entire combination of words preceding it . for example , a black dog house is intended to mean a house for a black dog . while for the sake of clarity of description , several specific embodiments of the invention have been described , the scope of the invention is intended to be measured by the claims as set forth below . in the claims , the term “ provided ” is used to definitively identify an object that not a claimed element of the invention but an object that performs the function of a workpiece that cooperates with the claimed invention . for example , in the claim “ an apparatus for aiming a provided barrel , the apparatus comprising : a housing , the barrel positioned in the housing ”, the barrel is not a claimed element of the apparatus , but an object that cooperates with the “ housing ” of the “ apparatus ” by being positioned in the “ housing ”.

a coupler for removable coupling an object to a support . the coupler includes a cover , a ring , and a base . the cover couples to the support . the ring includes a first arm , a second arm , a third arm , a fourth arm , a first stop , and a second stop . each arm of the ring is formed of a resilient material . the ring is positioned in a cavity of the cover . the base couples to the accessory . the base cooperates with the cover and the ring to couple to the cover and to rotate from a decoupled position to an intermediate position and further to a clocked position .

the following discussion provides many example embodiments of the inventive subject matter . although each embodiment represents a single combination of inventive elements , the inventive subject matter is considered to include all possible combinations of the disclosed elements . thus if one embodiment comprises elements a , b , and c , and a second embodiment comprises elements b and d , then the inventive subject matter is also considered to include other remaining combinations of a , b , c , or d , even if not explicitly disclosed . one should appreciate that the disclosed techniques provide many advantageous technical effects including improved methods and devices for mounting components to walls . fig1 shows a perspective view of a wall mounting assembly 100 . assembly 100 includes a panel 110 and a plurality of brackets 120 , 130 , and 140 . brackets 120 , 130 , and 140 removably and repositionably engage slots on panel 110 . assembly 100 is useful for storing items on a wall . fig2 shows a perspective view of a bracket 200 . bracket 200 has a first frame member 210 and a second frame member 220 that are rotatably coupled via hinge 230 . first frame member 210 has an l - shaped hook 240 for engaging a recess or slot . bracket 200 also has an elongated member 260 extending therefrom , for hanging an item . fig3 shows a side view of the bracket 200 . this view reveals an l - shaped hook 250 on second frame member 220 . fig3 shows bracket 200 in a first position , also referred to as an engaging position . in the engaging position , hooks 240 and 250 are downward and upward facing , respectively , and can be used to grab two recesses ( e . g ., slots ) on a wall or panel . fig4 shows a side view of bracket 200 . fig4 is similar to fig3 except that second frame member 220 has been rotated with respect to first frame member 210 , about hinge 230 . fig4 shows bracket 200 in a second position , also referred to as a disengaging position . in the disengaging position , hook 250 is angled outward so that a recess can be disengaged . second frame member 220 has an angled handle portion 221 that allows a user to grip and rotate second frame member 220 . fig5 shows a perspective view of the back side of bracket 200 in the disengaging position . first frame member 210 has an opening 211 through which hook 250 is disposed . fig6 shows a perspective view of a plurality of disengaged panels 600 for a wall mounting assembly . panel 610 and panel 620 engage one another to form a wall mountable panel for attaching brackets . trim panels 630 , 640 , 650 , and 660 provide a border around panels 610 and 620 . fig7 a shows a side view of a plurality of panels 700 for a wall mounting assembly . panels 700 include a first panel 710 engaged with a second panel 720 . panel 710 and panel 720 are substantially identical . trim panels 740 and 760 engage panels 720 and 710 at their lower and upper edges , respectively . first panel 710 has first major surface ( i . e ., a front surface ) and a second major surface ( i . e ., a back surface ). on the first major surface is a first t - shaped slot 711 and a second t - shaped slot 712 running parallel to one another along the length of panel 710 . slots 711 and 712 are separated by distance 713 . panel 710 has a height 714 . the height of panel 710 is extended by a distance 715 when trim panel 760 is engaged with panel 710 . trim panel 760 has a height of 716 . the first and second major surfaces of panel 710 are joined by a first edge ( i . e ., a top edge ) and a second edge ( i . e ., a bottom edge ), each having an acute angle ( e . g ., acute angle 719 ). the first major surface of first panel 710 has a first angled slot 717 near the second edge of panel 710 . second major surface of panel 710 has a second angled slot 718 near the first edge of panel 710 . the top edge of panel 710 is sized and dimensioned to engage the lower angled slot on an adjacent panel , whereas the bottom edge is sized and dimensioned to engage the upper angled slot on an adjacent panel . fig7 b shows a close - up side view of the engagement of the lower edge of first panel 710 with the upper edge of second panel 720 . when the two edges are engaged , there is a hollow channel 721 disposed therebetween due to the angle of angled edge 719 and the shape of first angled slot 717 . fig7 c shows a close - up side view of first panel 710 disengaged with trim panel 760 . engagement is achieved by overlaping the edge of panel 710 with the edge of panel 760 , and pushing panel 710 forward and downward . panel 710 can remain substantially parallel with panel 760 during the engagement . the angled configurations of the slots and edges on the panels eliminates the need to tilt the panels to achieve an engagement . fig8 is a perspective view of a wall mounting assembly 800 being used to store items , such as container 810 . assembly 800 includes a plurality of panels and brackets ( e . g ., bracket 820 and panels 830 ). fig9 shows a perspective view of a bracket 900 and two bracket covers 910 and 920 . covers 910 and 920 can be sized , dimensioned , colored , and otherwise configured to resemble the back of a smart phone or some other consumer product . fig1 shows an exploded view of bracket 900 . covers 910 and 920 removably couple with bracket 900 by slidably engaging the edges of bracket 900 . bracket 900 has two holes 930 for removably receiving elongated member 940 . holes 930 can have threads , snap - fitting protrusions , or some other means for removably securing elongated member 940 in place . in this manner , bracket 900 can be exchangeably used with different configurations of elongated members , hangers , shelving , and the like . fig1 shows a perspective view of a bracket 1100 that has a rotatable hook 1110 . hook 1110 can rotate outward as shown by arrow 1120 . as used in the description herein and throughout the claims that follow , the meaning of “ a ,” “ an ,” and “ the ” includes plural reference unless the context clearly dictates otherwise . also , as used in the description herein , the meaning of “ in ” includes “ in ” and “ on ” unless the context clearly dictates otherwise . the recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range . unless otherwise indicated herein , each individual value is incorporated into the specification as if it were individually recited herein . unless the context dictates the contrary , all ranges set forth herein should be interpreted as being inclusive of their endpoints , and open - ended ranges should be interpreted to include commercially practical values . similarly , all lists of values should be considered as inclusive of intermediate values unless the context indicates the contrary . all methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context . the use of any and all examples , or exemplary language ( e . g . “ such as ”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed . no language in the specification should be construed as indicating any non - claimed element essential to the practice of the invention . groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations . each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein . one or more members of a group can be included in , or deleted from , a group for reasons of convenience and / or patentability . when any such inclusion or deletion occurs , the specification is herein deemed to contain the group as modified thus fulfilling the written description of all markush groups used in the appended claims . as used herein , and unless the context dictates otherwise , the term “ coupled to ” is intended to include both direct coupling ( in which two elements that are coupled to each other contact each other ) and indirect coupling ( in which at least one additional element is located between the two elements ). therefore , the terms “ coupled to ” and “ coupled with ” are used synonymously . it should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein . the inventive subject matter , therefore , is not to be restricted except in the scope of the appended claims . moreover , in interpreting both the specification and the claims , all terms should be interpreted in the broadest possible manner consistent with the context . in particular , the terms “ comprises ” and “ comprising ” should be interpreted as referring to elements , components , or steps in a non - exclusive manner , indicating that the referenced elements , components , or steps may be present , or utilized , or combined with other elements , components , or steps that are not expressly referenced . where the specification claims refers to at least one of something selected from the group consisting of a , b , c . . . and n , the text should be interpreted as requiring only one element from the group , not a plus n , or b plus n , etc .

wall mounting assemblies and methods are disclosed . the assembly includes a bracket that has two frame members coupled at a hinge . each frame member has a hook for engaging a recess or slot on a panel . the assembly further includes a panel that has edges that are configured to engage the edges of adjacent panels , without the need for tilting the panel to engage . each panel has two slots for receiving the bracket . bending the two frame members on the bracket causes the bracket &# 39 ; s hooks to lock into the slots on the panel .

the following specification taken in conjunction with the drawings set forth the preferred embodiments of the present invention . the embodiments of the invention disclosed herein are the best modes contemplated by the inventor for carrying out her invention in a commercial environment , although it should be understood that various modifications can be accomplished within the parameters of the present invention . referring now to fig1 through 6 of the appended drawings , a first preferred embodiment 20 of the blood specimen collector of the present invention is disclosed . it should be noted at the outset that the blood specimen collector of the present invention is designed and adapted to utilize standard disposable needle assemblies and standard blood collection tubes , both of which are ordinarily used in the art for the collection of blood specimens . although these standard items do not , in and of themselves , comprise the present invention , they are described here first , to the extent necessary to explain and illuminate the present invention . thus , a standard needle assembly 22 includes a first needle 24 which is normally used to penetrate a patient &# 39 ; s veins ( or other parts of the patient &# 39 ; s body ) to draw blood . an intermediate portion of the needle assembly 22 is a plastic body 26 of larger diameter than the first needle 24 . the plastic body 26 is substantially cylindrical , and has a threaded part 28 and a ribbed part 30 , with the two being separated from each other by a radially extending shoulder 32 . a second needle 34 extends from the plastic body 26 in a direction which is opposite to that of the first needle 24 . the two needles 24 and 34 are hollow and in fluid communication with one another . in fact , for practical construction of the needle assembly 22 , the two needles 24 and 34 comprise the same piece of metal to which the plastic body 26 is attached . still in accordance with standard practice in the art , the needle assembly 22 is usually packaged and stored in protective sheaths ( not shown ) which are separately removable from the first and second needles 24 and 34 , respectively . moreover , the second needle 34 usually carries a protective rubber or like sleeve 36 which may be retracted on the second needle 34 , as is shown on fig5 . the blood collection tubes 38 used in the present invention comprise tubular receptacles of glass or plastic , which have a resilient septum seal 40 penetrable by the second needle 34 . the interior of the blood collection tube 38 is usually evacuated so as to contain partial vacuum . as it will be readily understood by those skilled in the art , the vacuum in the blood collection tube 38 eliminates the need for an air vent or vented needle during the blood collection process . the appended drawing figures show a tubular , hollow cylinder 42 having a front wall 44 which includes a relatively short sleeve 46 . prior to taking of blood specimens the threaded portion 28 of the plastic body 26 is fitted into the sleeve 46 , whereby the needle assembly 22 is mounted to the hollow cylinder 42 . the blood collection tube 38 is placed and pushed into the cylinder 42 so that the second needle 34 penetrates the septum seal 40 , as is specifically shown on fig5 . as it will be readily understood by those skilled in the art , under the above - described circumstances blood can be drawn from a patient &# 39 ; s body into the blood collection tube 38 . after the first needle 24 is withdrawn from the patient &# 39 ; s body , and the blood collection tube 38 is removed from the cylinder 42 , the collected blood specimen can be stored in the collection tube 38 . the needle assembly 22 which has come into contact with the patient &# 39 ; s blood , must be discarded . the hereinafter - described novel features of the present invention facilitate the step of discarding the used needle assembly 22 , and render it much less likely that a doctor , nurse , or other health care worker accidentally should prick or injure himself or herself with the used needle . thus , in accordance with the present invention , and referring still primarily to fig1 through 6 , a plate 48 is pivotably mounted to the front wall 44 of the cylinder 42 . in the herein - described first preferred embodiment 20 , the front wall 44 includes a pivot pin 50 . an edge 52 of the plate 48 includes a somewhat resilient plastic female pin receiver 54 which is fitted on the pin 50 . the pin 50 and the pin receiver 54 jointly form a hinge which permits pivoting motion of the plate 48 relative to the front wall 44 of the cylinder 42 . the plate 48 includes an opening or hole 56 through which the needle assembly 22 is fitted when the needle assembly 22 is mounted into the cylinder 42 . as is shown on fig5 in the mounted position of the needle assembly 22 , the plate 48 lies flat or substantially flat against the front wall 44 of the cylinder 32 , and the plate 48 abuts the shoulder 32 of the needle assembly 22 . fig6 shows how the pivotably mounted plate 48 is used to dislodge and eject the used needle assembly 22 from the cylinder 42 . thus , one edge of the plate 48 is grasped and moved by the health care worker ( not shown ) whereby the plate 48 pushes against the shoulder 32 and removes the needle assembly 22 from the sleeve 46 . the needle assembly 22 is then allowed to fall out into a waste container ( not shown ), preferably into a type of waste container which is specifically designed for receipt and disposal of used hypodermic needles and the like . it is still noted in connection with the first preferred embodiment 20 of the present invention , that the interior bore of the sleeve 46 is not threaded , even though ordinarily used &# 34 ; standard &# 34 ; needle assemblies include the threaded intermediate plastic portion 28 . it should be apparent from the foregoing that to dislodge or eject the needle assembly 22 from the cylinder 42 , the health care worker &# 39 ; s hands do not need to touch the needle assembly 22 . for this reason , it is not necessary to replace the protective sheath ( not shown ) on the first needle 24 before the needle assembly 22 is ejected from the cylinder 42 and is discarded . it will be immediately appreciated by those skilled in the art that obviating the need to replace the sheath ( not shown ) on the first needle 24 before the needle assembly 22 is manipulated and discarded , is highly advantageous , because most accidental skin punctures with the used needle occur when the health care worker ( not shown ) attempts to fit a sheath ( not shown ) on the used needle . referring now to fig7 through 12 of the appended drawings , a second preferred embodiment 58 of the present invention is disclosed . the second preferred embodiment 58 is similar in many respects to the first preferred embodiment 20 , and is therefore described here only to the extent necessary to describe the differences between the two preferred embodiments . thus , the hollow cylinder 42 of the second preferred embodiment 58 includes a pair of pin receivers 60 mounted to spaced ribs 62 disposed on the front wall 44 of the cylinder 42 . the edge 52 of the pivotably mounted plate 48 has a pivot pin 64 which is mounted into the pin receivers 60 to form a hinge . the aperture provided in the sleeve 46 of the front wall 44 of the cylinder 42 has a short female thread 66 which is complementary to threads of the plastic body 26 . the thread 66 is approximately one turn or less . to permit ready demounting of the needle assembly 22 from the cylinder 42 by the pivoting motion of the plate 48 , the female thread 66 in the sleeve 46 must be short , and cannot hold the needle assembly 22 too firmly . operation of the second preferred embodiment 58 is substantially the same as of the first preferred embodiment 20 . the second preferred embodiment 58 also offers the same advantage over the prior art , that is , it minimizes exposure of health care workers to accidental needle pricks by used needles during blood specimen collecting procedures . referring now to fig1 through 23 of the appended drawings , a third preferred embodiment 70 of the blood specimen collector of the present invention is disclosed . like the previously described embodiments , the third preferred embodiment 70 is also used in conjunction with the standard disposable needle assembly 22 and with the standard blood collection tube 38 having the septum seal 40 . principal differences between the previously described embodiments and the third preferred embodiment 70 is in the construction of the portions of third embodiment 70 which retain the needle assembly 22 while a blood specimen is collected , and which eject the used needle assembly 22 after the collection is completed . referring still to fig1 - 23 , the third preferred embodiment 70 includes the tubular hollow cylinder 42 . the front wall 44 of the hollow cylinder 42 includes a sleeve 46 . the sleeve 46 of the third preferred embodiment 70 is , however , more forwardly disposed than the sleeves of the previously described embodiments , and comprises split segments or pieces 72 , as is shown on fig1 , 15 , 18 , and 22 . the interior of the sleeve 46 has female threads 66 which are complementary to the threads of the intermediate plastic body 26 of the needle assembly 22 . the entire front wall 44 of the cylinder 42 of the third preferred embodiment 70 is mounted through a narrow hinge - like piece to the rest of the plastic body of the cylinder 42 . the hinge - like piece 74 is perhaps best shown on fig2 , 21 and 23 . it should already be apparent from the foregoing description , that unless the segments 72 of the sleeve 46 are held together by an additional member , the sleeve 46 of the third preferred embodiment 70 is incapable of retaining the needle assembly 22 , or is able to retain the needle assembly 22 only very weakly . with reference to the foregoing , retention of the needle assembly 22 is provided in the third preferred embodiment 70 by a retainer plate 48 . the retainer plate 48 , similarly to the retainer plate of the second preferred embodiment 58 , is mounted through its pivot pin 64 into a pair of pin receivers 60 which are themselves mounted to spaced ribs 62 attached to the cylinder 42 . the retainer plate 48 of the third preferred embodiment 70 includes an l - shaped extension 76 which is designed to be manipulated by the thumb ( not shown ) of a health care worker ( not shown ). the l - shaped extension 76 also has a protrusion 78 which is capable of engaging a second protrusion 80 on the cylinder 42 , 50 as to reversibly lock the retainer plate 48 into a closed position relative to the cylinder 42 . the retainer plate 48 still further includes a forwardly extending forked plate 82 , the purpose of which is to eject the needle assembly 22 . this is described in more detail below . two parallel disposed side plates 83 of the retainer plate 48 , shown on fig1 , touch the front wall 44 of the cylinder 42 in the closed position of the retainer plate 48 . the retainer plate 48 also has an opening 84 of such dimensions that in the locked position of the plate 48 the interior wall of the opening 84 engages the exterior of the segments 72 of the sleeve 46 , so as to form a substantially firm threaded opening in the sleeve 46 . the threaded opening in the sleeve 46 , when engaged or held by the locked retainer plate 48 , is capable of firmly retaining the needle assembly 22 through its threaded plastic body 26 . this is well shown on fig1 ; the figure shows the retainer plate 48 in a locked position relative to the cylinder 42 . referring now primarily to fig2 , the process is illustrated wherein the needle assembly 22 is placed into the third preferred embodiment 70 . during this process , the retainer plate 48 is not locked , but is disposed in such position that the needle assembly 22 can be placed through the opening 84 . after the needle assembly 22 has been inserted into the sleeve 46 , the retainer plate 48 is locked , as is shown on fig1 , whereby the needle assembly 22 is firmly engaged . in the locked position of the retainer plate 48 the forked plate 82 is disposed below the radially extending shoulder 32 of the plastic body 26 , and is slightly compressed , so that it is resiliently biased by the shoulder 32 . ejection of the needle assembly 22 from the third preferred embodiment 70 , without exposure of human hands ( not shown ) to the proximity of contaminated and potentially highly infectious used needle , is shown on fig2 . in order to eject the needle assembly 22 a health care worker ( not shown ) simply unlocks the l - shaped extension of the retainer plate 48 . the slightly compressed but resilient plastic material of the forked plate extension 82 then ejects the needle assembly 22 from the sleeve 46 , the segments 72 of which are no longer held together by the opening 84 in the retainer plate 48 . a fourth preferred embodiment of the present invention is constructed substantially similar to the third preferred embodiment 70 , except that the retainer plate 48 is not a separately formed plastic piece , but rather it is molded or otherwise fabricated together with the plastic cylinder 42 , and is attached thereto by a living hinge . such living hinges are well known in the plastic manufacturing arts . the blood collecting system or apparatus of the present invention may be manufactured from such materials which are well known in the art . more particularly , the needle assembly 22 and the blood collection tubes 38 are state - of - the - art , and can be made from medical grade plastic , rubber , and stainless steel materials . the cylinder 42 and the needle assembly ejecting plate mounted to it is made from suitable plastic , such as polypropylene , polyethylene , polystyrene or polyvinyl chloride . several modifications of the above - described invention in terms of specific construction and materials may become readily apparent to those skilled in the art in light of the foregoing disclosure . therefore , the scope of the present invention should be interpreted solely from the following claims as such claims are read in light of the disclosure .

a blood collector system utilizes a standard disposable needle assembly and standard blood collecting and receiving tubes of the type sealed by a pierceable septum . the system has a hollow cylinder , including an internally apertured sleeve into which the needle assembly is mounted and into which the sealed blood collecting tubes are inserted to be pierced by a needle of the needle assembly . a member , such as a plate , is pivotably mounted to the cylinder . a hole in the plate accommodates the needle assembly while the needle assembly is retained in the cylinder . when the blood specimen collection is complete , the plate is moved in a pivoting motion whereby it catches the needle assembly and ejects it from the cylinder . the apparatus of the invention eliminates the need for a protective sheath to be replaced on the needle assembly before the needle assembly is discarded , and thereby minimizes the health care worker &# 39 ; s exposure to accidental needle pricks .

fig1 shows an absorbent article 10 according to the invention , seen from the wearer - facing side ( inside ) and with all elastic components of the absorbent structure 30 fully extended . the article comprises a belt 20 and an absorbent structure 30 . in fig1 , the belt 20 is open . in use , the belt 20 is fastened about the wearer &# 39 ; s waist , where it acts to hold the absorbent structure 30 in place . the belt 20 of fig1 comprises two belt halves , 21 , 22 , although it is conceivable that a single belt is present , which wraps completely around the waist of the wearer . the belt 20 of fig1 also comprises belt attachment means 23 which fastens to belt reception surface 25 , so that the belt can be fastened around the waist of the wearer . if the belt attachment means 23 comprises hook material of a hook - and - loop ( e . g . velcro ®) fastener , belt reception surface 25 suitably comprises loop material . likewise , if the belt attachment means 23 comprises adhesive material , the belt reception surface 25 suitably comprises a plastic film material to which the adhesive material can fasten , preferably in a releasable manner . the belt 20 may comprise a single length of belt material , to which the absorbent structure 30 is attached , or may comprise two separate lengths of belt material , each of which is attached to the absorbent structure 30 . the width of the belt 20 should be between circa 50 mm and 250 mm . the belt 20 may comprise nonwoven material or plastic film , or laminates thereof . in a preferred embodiment , the belt 20 comprises a laminate of at least one nonwoven material and at least one plastic film . the belt 20 may have elastic properties in at least one region thereof , and in at least one direction , preferably in the length direction of the belt . elastic properties may be provided by the use of one or more elastic components , such as e . g . elastic threads , elastic nonwoven materials or elastic films . belts 20 having elastic properties are particularly useful . the belt 20 is desirably breathable , and the material constituting the belt 20 may be perforated or porous or the belt 20 may be spaced from the skin of the wearer by spacer fabric or spacer elements . the belt 20 comprises an article reception surface 24 , which is preferably the same material as belt reception surface 25 . indeed , a single reception surface ( e . g . of nonwoven material ) may constitute both the article reception surface 24 and the belt reception surface 25 . the article reception surface 24 is located on the outside ( garment - facing ) surface of the belt 20 when worn . article reception surface 24 and belt reception surface 25 may each comprise separate pieces of material which are joined to the belt 20 during manufacture , or the wearer - facing surface of the belt 20 may itself consist of one or both of these reception surfaces 24 , 25 ( as shown in fig1 ). the absorbent structure 30 is the component of the absorbent article 10 which receives and stores exuded bodily fluids . it extends in the longitudinal ( l ) and transverse ( t ) directions as shown in fig1 , and may have any suitable shape , e . g . rectangular , hourglass or t - shaped . in use , the absorbent structure 30 is located between the legs of the wearer so as to cover the wearer &# 39 ; s genitals and anal region , and is held in place on the wearer by the belt 20 . the absorbent structure 30 has a longitudinal centre line ( l 1 ) about which it is symmetrical , and opposing first 31 and second 32 longitudinal end regions . each of said longitudinal end regions 31 , 32 has a perimeter constituted by a transversely extending end edge 33 , 34 and a pair of opposed longitudinal edges 35 , 36 . traditionally , belt diapers are applied to a wearer by fastening the belt 20 around the wearer &# 39 ; s waist , with the absorbent structure 30 hanging downwards at the wearer &# 39 ; s rear . the absorbent structure 30 is then brought between the wearer &# 39 ; s legs and fastened to the belt 20 at the wearer &# 39 ; s front . in this case , the first longitudinal end region 31 of the absorbent structure 30 will comprise the rear portion of the absorbent article 10 , while the second longitudinal end region 32 of the absorbent structure 30 will comprise the front portion of the absorbent article 10 . however , the reverse situation is also possible . in cross - section , the absorbent structure 30 usually comprises a liquid - permeable topsheet 38 , a liquid - impermeable backsheet 39 and an absorbent core 37 located between said topsheet 38 and said backsheet 39 . however , in certain absorbent structures 30 , it may be sufficient to include only an absorbent core 37 and a liquid - impermeable backsheet 39 . the topsheet 38 of the absorbent structure 30 is the layer which lies in contact with the wearer &# 39 ; s body when the absorbent article is in use . as such , it should be soft , non - irritating and comfortable against the skin , and bodily fluid should be able to pass through it without hindrance . the topsheet 38 can consist of a nonwoven material , e . g . spunbond , meltblown , carded , hydroentangled , wetlaid etc . suitable nonwoven materials can be composed of natural fibers , such as woodpulp or cotton fibres , manmade fibres , such as polyester , polyethylene , polypropylene , viscose etc . or from a mixture of natural and manmade fibres . the topsheet may further be composed of tow fibres , which may be bonded to each other in a bonding pattern , as e . g . disclosed in ep - a - 1 035 818 . further examples of materials suitable for topsheets are porous foams , apertured plastic films etc . the topsheet 38 may be different in different parts of the absorbent structure 30 . the backsheet 39 of the absorbent structure 30 is the layer which lies furthest from the wearer &# 39 ; s body when the article is in use . to protect the wearer &# 39 ; s garments from soiling , it should be liquid - impermeable , but is desirably gas - permeable to allow air and vapour to pass in and out of the article so that the warm , damp conditions which can arise in a diaper are reduced . typically , the backsheet 39 is of a liquid impervious material , such as a thin plastic film , e . g . a polyethylene or polypropylene film , a nonwoven material coated with a liquid impervious material , a hydrophobic nonwoven material , which resists liquid penetration or a laminate comprising plastic films and nonwoven materials . examples of breathable backsheet materials are porous polymeric films , nonwoven laminates of spunbond and meltblown layers and laminates of porous polymeric films and nonwoven materials . the backsheet 39 may be different in different parts of the absorbent structure 30 . the absorbent core 37 of the absorbent structure 30 acts to receive and contain liquid and other bodily exudates and can be of any conventional kind . as such , it typically comprises absorbent material . examples of commonly - occurring absorbent materials are cellulosic fluff pulp , tissue layers , highly - absorbent polymers ( so called superabsorbents ), absorbent foam materials , absorbent nonwoven materials or the like . it is common to combine cellulosic fluff pulp with superabsorbents in an absorbent body . it is also common to have absorbent cores comprising layers of different material with different properties with respect to liquid receiving capacity , liquid distribution capacity and storage capacity . the thin absorbent cores , which are common in for example baby diapers and incontinence guards , often comprise a compressed mixed or layered structure of cellulosic fluff pulp and superabsorbent material . the size and absorbent capacity of the absorbent core 16 may be varied to be suited for different uses such as for infants or for incontinent adults . the absorbent core 37 may comprise one or more layers which are designed to improve the handling of bodily waste . such layers are designed to receive a large amount of liquid in a short space of time and distribute it evenly across the absorbent structure 30 . they may include so - called transfer , distribution , surge or acquisition layers , and are usually located between the topsheet 38 and the absorbent core 37 . the topsheet 38 and backsheet 39 generally have a similar extension in the plane of the article , while the absorbent core 37 has an extension which is somewhat smaller . the topsheet 38 and backsheet 39 are joined to one another around the periphery of the absorbent core 37 , so that the core 37 is enclosed within the envelope formed by the topsheet 38 and the backsheet 39 . the absorbent core 37 is at least located in the crotch portion of the absorbent article 10 , and may also extend somewhat into the front and rear portions . the topsheet 38 , backsheet 39 and other components of the absorbent article 10 may be joined to one another by any means common in the art , e . g . ultrasonic welding , thermal welding or gluing . in addition , the absorbent structure 30 may comprise one or more elastic elements 70 . these help the article 10 fit tightly against the body of the wearer , and are usually present as leg or waist elastic elements ( shown as leg elastic elements 70 in fig1 ). the first longitudinal end region 31 of said absorbent structure 30 is attached to the belt 20 . attachment of the absorbent structure 30 to the belt 20 may occur substantially in the middle of the belt , as shown in fig1 , or towards one end of the belt 20 . the attachment may be permanent — i . e . it is not possible to separate the first longitudinal end region 31 of the belt 20 without tearing or otherwise damaging the article 10 . alternatively , the first longitudinal end region 31 of the absorbent structure 30 may be removably attached to the belt 20 via at least one article fastening means 40 ′ located at the first longitudinal end region 31 of the absorbent structure 30 , said article fastening means 40 ′ having the shape and alignment of the article fastening means 40 as described herein . the absorbent structure 30 comprises at least one ( e . g . two ) article fastening means 40 at the second longitudinal end region 32 thereof . preferably , the absorbent structure comprises two article fastening means 40 at the second longitudinal end region 32 , each of which is located towards the transverse edge thereof . the article fastening means 40 is adapted to fasten to the article reception surface 24 on the belt 20 such that the absorbent article 10 adopts a pant - like shape in use ( fig2 ). as such , it may comprise a hook portion of a hook - and - loop type fastener ( e . g . velcro ®), or an adhesive tab . the present invention is based on the discovery that the form and alignment of the article fastening means 40 are significant for obtaining a secure fit and for minimizing the risk of the fastening means being undesirably uncovered or turned up . as mentioned above , the primary forces in the waist and hip region of belted absorbent articles when being worn are directed from the hip region of the belt inwards and downwards towards the crotch of the wearer ( see arrow x in fig2 ). the angle α made between the longitudinal centre line of the article and the force arrow x typically lies between 5 ° and 85 °, preferably between 10 ° and 80 °, more preferably between 15 ° and 45 °. the article fastening means 40 of the invention has a shape such that it is accommodated within an imaginary rectangle 50 . the imaginary rectangle comprises a rectangular area located towards the transverse edge of the second longitudinal end region 32 ; i . e . in that region where the article fastening means 40 is located . the article fastening means 40 is totally enclosed within the imaginary rectangle . the maximum extension of the article fastening means 40 in the transverse and longitudinal directions corresponds to the maximum extension of the imaginary rectangle 50 in the transverse and longitudinal directions . as shown in fig3 , the rectangle 50 has opposed upper and lower first edges 51 , 52 extending parallel to said transversely extending end edge 34 of the second longitudinal end region 32 . it also has opposed distal and proximal second edges 53 , 54 extending parallel to said pair of opposed longitudinal edges 35 , 36 of said second longitudinal end region 32 . a rectangle 50 is thereby defined which has an upper distal corner 55 , an upper proximal corner 56 , a lower distal corner 57 and a lower proximal corner 58 , the edges of which are aligned with the longitudinal / transverse directions . as used herein , the terms “ upper ” and “ lower ” are used to refer to a component or an element ( such as the edge of the rectangle 50 ) which lies further away from (= upper ) or closer to (= lower ) the transversely - extending centre line t 1 of the absorbent structure 30 , relative to another component or element . similarly , the term “ distal ” and “ proximal ” are used to refer to a component or element which is further from (= distal ) or closer to (= proximal ) the longitudinal centre line than another component or element . the article fastening means 40 contacting said imaginary rectangle 50 at least two places . the article fastening means 40 may contact the imaginary rectangle 50 at two places if the article fastening means has a parallelogram or rhombus shape in the l - t plane . the article fastening means 40 may contact said imaginary rectangle 50 at three places if it has a triangle shape in the l - t plane . the article fastening means 40 may contact said imaginary rectangle 50 at four places if it has a square or rectangular shape in the l - t plane . a continuous region 60 is located adjacent the lower distal corner 57 of the imaginary rectangle 50 . the continuous region 60 is defined by a portion of the distal second edge 53 and a portion of the lower first edge 52 of the imaginary rectangle 50 , and the edge of the article fastening means 40 which lies closest to the lower distal corner 57 . by “ a portion of ” a given edge is meant that the continuous region 60 is not defined by the entire length of said edge . at least this continuous region 60 is free of article fastening means 40 . the article fastening means 40 of the invention maximises the extension of the article fastening means 40 which lies along the force line ( x ), while minimising the extension of the article fastening means 40 in the region outside this line , particularly in the lower distal corner 57 of the imaginary rectangle . in addition , the article fastening means 40 of the invention avoids the presence of sharp ( acute ) angles in the region outside the force line ( x ). these features reduce the tendency for the article fastening means 40 to turn up or become uncovered in use . preferably , one place at which the article fastening means 40 contacts the imaginary rectangle 50 is located on the lower first edge 52 . in this way , good alignment of the article fastening means 40 with the force arrow x can be obtained . an imaginary straight line drawn along at least one edge of the article fastening means 40 towards the first longitudinal end 31 of the absorbent structure 30 preferably meets the longitudinal centre line l 1 of the absorbent structure at an acute angle α which lies between 5 ° and 85 °, preferably between 10 ° and 80 °, more preferably between 15 ° and 45 ° ( see fig4 a , 4 b ). alternatively , an imaginary straight line drawn as a continuation of a diagonal of the article fastening means 40 towards the first longitudinal end 31 of the absorbent structure 30 preferably meets the longitudinal centre line l 1 of the absorbent structure at an acute angle α which lies between 5 ° and 85 °, preferably between 10 ° and 80 °, more preferably between 15 ° and 45 ° ( see e . g . fig4 c ). the article fastening means 40 of the invention may have a rectangular shape ( fig4 a ), a square shape ( fig4 b ), a parallelogram shape , a rhombus shape or a triangular shape ( fig4 d ) in the l - t plane . of these , rectangular , square , parallelogram and rhombus shapes are most preferred , as they can be easily produced from a strip of fastening means with little or no wasted material . fig4 e shows an article fastening means 40 which is based on a square , in which the material in the lower distal corner 57 is absent . suitably , the article fastening means 40 is not circular or ellipse - shaped . suitably , the maximum extension of the article fastening means 40 in a direction perpendicular to a force line ( x ) which passes through the centre of the article fastening means 40 and which makes an angle with the longitudinal centre line ( l 1 ) of the absorbent structure 30 of between 5 ° and 85 °, preferably between 10 ° and 80 °, more preferably between 15 ° and 45 °, is less than 3 cm , preferably less than 2 cm , more preferably less than 1 cm . fig5 is an illustration of an absorbent article 10 according to the invention in the fastened configuration , magnified in the region around the absorbent structure where it fastens to the belt . the article fastening means 40 in this case has a parallelogram shape . as can be seen in fig5 , the entire article fastening means 40 lies flat against the belt , without being undesirably turned up or exposed . fig6 is an illustration of a prior art absorbent article in the fastened configuration , magnified in the region around the absorbent structure where it fastens to the belt . the article fastening means is a simple rectangle , the edges of which are parallel to the edges of the absorbent structure . it is evident how the force line in the absorbent structure causes the article fastening means to turn up at its lower right - hand edge , thus exposing the article fastening means 40 . the invention has been described with reference to a number of embodiments and accompanying figures . however , the full scope of the invention is determined by the appended claims .

an absorbent article has a belt and an absorbent structure . the absorbent structure is fastened to the belt via an article fastener having a form such that the article fastening means does not fold or bend upwards under the forces present when the diaper is assembled .

referring to fig1 the invention shown has a rigid central shaft 1 , having a top end 1a and a lower end 1b , and having top end cap 2 and lower end cap 17 affixed thereon at either end . the end caps 2 and 17 are pointed at their outer ends 4 and 18 to provide the balancing point for that end of the invention and can be glued or otherwise securely affixed to the shaft 1 , or either may be molded with the shaft . the primary flywheel 3 is of an approximate cylindrical shape and symmetrical about its central axis 3a in fig2 . although it may be solid , it is shown having an indented cup - shaped opening 5 on its lower inside . its diameter 11 is the widest diameter of the primary flywheel perpendicular to the shaft . the primary flywheel 3 is affixed to the shaft 1 adjacent to the top end cap 2 at a relatively small distance . the primary flywheel is shown in fig1 having a central shaft 6 which is also the central axis , radially centered thereon through which the shaft 1 extends and is glued or otherwise affixed allowing the primary flywheel to spin with the shaft . the handle 8 is positioned adjacent to , and a relatively small distance from , the primary flywheel 3 , at point 13 . the handle is longitudinally centered on the shaft 1 to allow it to spin symmetrically about the shaft . this is further illustrated in fig2 where the handle is shown as symmetrically shaped about its imaginary central axis 8a . the handle is shown as a heart shape in fig1 having two symmetrical halves or sides , but other similar shapes are envisioned . it is important that the shape and size of the handle relative to itself and the other parts be such that its diameter 10 , the widest diameter of the handle , be approximately equal to the diameter 11 of the primary flywheel and the longitudinal length of the handle 8e , within approximately 20 % of each other , however it is preferred that the handle have a slightly wider diameter than that of the primary flywheel . the diameter 10 is perpendicular to the shaft , and also perpendicular to the longitudinal length . moreover , the widest - most portion of the handle 8 as at 10 along aa &# 39 ;, is located at or between the center 8c and the upper and 8b of the handles &# 39 ; central axis . the lower end 8d of the handle is located near the lower end of the shaft ; the upper end 8b is located near the upper end . the preferred shape of the handle is further defined by its approximately straight contour in the proximity of points 9 and 20 on either side of the handle near the midpoint between the two ends . the preferred contour and position is shown as having protruding flat surfaces 19 and 21 extending the width of the handle . these flat surfaces are located on both sides of the handle , but their preferred location is such that they create the tangential points 19 and 21 . they provide stability in the handle when it sets on its side when the primary flywheel is spinning . the contour of the handle from near point 8b to the opposite end near 8d is shown rounded to allow for ease of handling . the shape of the handle is such that the angle of the imaginary straight line 25 , a tangential line of the handle at the outer surface , extending through the lower end point 18 to one of the tangential points of the handle at 19 or 21 creates an angle 26 between it and the straight line of the shaft 1 of at least 15 °. the tangential line 25 represents the surface upon which the top , if placed with the lower tip and handle touching the surface , would rest at the angle 26 of no less than 15 ° with the surface . the handle is shaped such that the tangential point is located approximately midway between the upper end and lower end of the handle or within 20 % thereof . a secondary flywheel 14 is positioned near the lower end of the handle , preferably affixed to the inside portion of the handle and adjacent thereto at the handle &# 39 ; s narrowest end , opposite that end near the flywheel , although it can also be positioned between the handle and the lower end cap . the secondary flywheel is shown as preferred , essentially cone shaped , with its edges 22 having either a straight edge or slight curvature to resemble the inside surface of the handle . the secondary flywheel may also be affixed to the shaft , rather than affixed to the handle . the invention works best if the secondary flywheel is of a size , weight , and shape ( and located on the shaft , at a position ) such that the invention , when spinning on the tip 4 , stabilizes in that position while spinning , thus allowing the invention to spin on either end . the handle is maintained on the shaft in its position by the lower end tip 17 , affixed to the shaft 1 . the device spins on the tip point 18 in the upright position ; in the upside down position , the device spins on tip point 4 . holes 15 and 16 are placed in the handle to allow the string 28 tied at one end to the shaft 1 to pass through for pulling to impart the spinning motion . by placing the hole 15 and 16 a substantial distance from either end 12 and 13 of the handle , preferably midway between or within 20 % thereof , the string is guided for rewind and not caught or tangled between the handle 8 and the shaft when rewound during spinning . the slit 27 in fig4 allows for quick threading of the string in the hole . the end caps 2 and 17 are of a size and shape and location such that the tips 4 and 18 extend a relatively small distance beyond the primary flywheel 3 and handle 8 , respectively , and such that the edges 23 and 24 near the tips 18 and 4 are essentially cone shaped . the invention is used by holding the handle in one hand and turning the primary flywheel to easily wind the string ; once wound , the string can be threaded through the hole and then either pulled back and forth while holding the handle , for a reversible spin or , with one firm pull and release of the string , the invention , once spinning , can be placed on either end to balance and spin , or it can be tossed on a hard surface or placed on either side ( preferably the flat portions ) on a hard surface , where , with sufficient spin , the tip 18 will , if not already touching , slowly draw towards the surface , and the invention will right itself , i . e . self balance , on tip 18 . the overall device as described provides an extremely versatile and enjoyable toy that allows it to spin on either end , self balance , provide for quick and easy rewinding and lack of tangling of the cord during spinning , is comfortable to hold and can also be spun back and forth while held in the hand .

an improved spinning toy comprised of a primary flywheel affixed near one end of a shaft penetrating the central axis , a symmetrical handle having a specific size , shape , and relational location rotatably connected about the shaft penetrating it ; a smaller secondary flywheel near the lower end of the handle through which the shaft penetrates , two end caps having conical terminations , flat protruding surfaces on the sides of the handle , a tangential line of the handle having the lower end tip in the line , and a hole in the handle through which a string passes .

the invention will hereafter be described with reference to the exemplary apparatus shown in fig1 and 2 , and as the description of the apparatus proceeds the description of the method will be integrated therewith . it should be noted , incidentally , that in the drawings the air supply which supplies air at super - atmospheric pressure to the apparatus has not been illustrated because this is known per se and does not form a part of the present invention . with this in mind it will be seen that reference numeral 1 identifies an inlet tube or hose through which air at super - atmospheric pressure from the not - illustrated air supply is furnished to the apparatus , and more particularly , to the pressure - controlled demand valve 2 of the apparatus . the pressure at which such air is supplied via the tube 1 is usually between 3 and 10 bar . of course , the hose or tube 1 can be connected with the pressure reducing device of a compressed - air bottle or container , or with any other type of compressed - air supplying device known in this art . installed in a housing 2a of the demand valve 2 is a diaphragm 3 ( known per se ) the outer circumferential edge of which is secured to the housing so as to subdivide the interior thereof into two compartments 7 and 7a . the compartment 7a communicates in the usual manner ( not illustrated ) with the ambient atmosphere and contains a biasing spring 4 which reacts against a portion of the wall 2a and the diaphragm 3 , respectively . also installed in the housing 2a , so as to communicate with the compartment 7 of the same , is the actual air - admitting valve 6 of the demand valve 2 , i . e . the valve to which compressed air is supplied by the tube 1 . a control arm 5 is connected with the valve member of the valve 6 and rests with its free end against the inner side of the diaphragm 3 so that , when the diaphragm 3 is deflected in direction inwardly of the compartment 7 , such motion is transmitted to the arm 5 which causes the valve 6 to open in response thereto , whereupon air flows from the tube 1 into the compartment 7 . the demand valve 2 is connected to the outer mask 8 of the device , i . e . the mask which surrounds the entire face of the user and engages the face along a circumferentially extending sealing edge 17 . the space within the mask 8 is , however , subdivided into two chambers 9 and 13 , respectively , by an inner mask 10 which is so dimensioned that it surrounds and communicates with only the external respiratory organs of a user , i . e . it surrounds the nose and the mouth of the user . the outer chamber 9 is in open communication with the compartment 7 so that the pressure prevailing in the compartment 7 is also the pressure which will prevail in the compartment 9 . the inner compartment 13 can communicate with the outer compartment 9 via two control valves 11 ( only one shown ) which are installed in the wall forming the mask 10 . as in fig2 the valves 11 have a valve member 12 which is pressed against its seat by a biasing spring 12a and their air passage communicate with the chamber 13 within the mask 10 via openings 12b . also installed in the device , and more particularly connected both with the mask 10 and the outer mask 8 is a venting valve 14 which communicates with the chamber 13 and , via passages 14a with the ambient atmosphere . the mask 10 has a circumferentially extending edge portion 16 which tapers to edge 16 of the edge portion , being so shaped that it can tightly engage the face of the user so the super - atmospheric pressure present in the chamber 9 -- as will be subsequently described -- aids in pressing the edge 16 against the face of the user to provide even further security against the undesired entry of ambient air and access to the respiratory passages of the user . the material for the masks 8 and 10 may be one of the synthetic plastic materials used in the prior art , for example pvc , pet or put . such materials are already widely used for this type of equipment and therefore require no more detailed discussion . the mask 8 is provided with a viewing port closed by a transparent plate 8a , of e . g . glass or a synthetic plastic material have the requisite characteristics and also known per se in this art . when air passes via tube 1 and valve 6 into the compartment 7 , the compartment 7 and hence the chamber 9 are at super - atmospheric pressure . the desired degree of super - atmospheric pressure , e . g . 4 mbar is a function of the operation of the valves 11 . in other words , the level of super - atmospheric pressure which develops in the compartment 7 and hence in the chamber 9 is a function of the biasing force exerted by the spring 4 . this super - atmospheric pressure of course is present throughout the chamber 9 , including the area where the sealing lip 17 of the mask 8 engages the face of the user . this super - atmospheric pressure of e . g . 4 mbar thus is the overpressure which prevents the entry of atmospheric air into the system . if there are any leaks along the seal established by the sealing lip 17 or elsewhere in the masks , air can flow out of the system to the ambient atmosphere , but it cannot enter from the ambient atmosphere into the system . this is the opposite of what would happen in a conventional respiratory apparatus in which sub - atmospheric pressure is present throughout the entire mask during inhalation . to prevent the valves 11 from opening at this stage and permitting the development of the same super - atmospheric pressure in the chamber 13 which is present in the chamber 9 at this time , the valves 11 have biasing springs 12a which urge the valve members 12 against their valve seats with a force which is at least equal to the force of the super - atmospheric pressure of e . g . 4 mbar times the surface area 15 of the valve members 12 and which tends to lift the valve members 12 off their valve seats . it is , however , currently preferred that the biasing force exerted by the springs 12a be somewhat greater than the equilibrium force required to maintain the valve members 12 in engagement with their valve seats . the vent valve 14 is of the type which is conventionally used in such breathing apparatus and which has very little resistance to opening , i . e . opens even when a very slight super - atmospheric pressure develops in the chamber 13 as a result of the exhalation of air by the user . the operation of the apparatus and method according to the present invention will be understood from what has been stated herebefore . it is clear that when the user inhales the development of even a very slight sub - atmospheric pressure in the chamber 13 causes the valves 11 to open so that air flows from the chamber 9 through the valves 11 into the chamber 13 and hence to the respiratory passages of the user . this results in a pressure drop in the chamber 9 and consequently in the compartment 7 which communicates with the chamber 9 ; since this pressure drop reduces the pressure in the compartment 7 , the spring 4 can now flex the diaphragm 3 in direction inwardly of the compartment 7 , displacing the arm 5 to the right ( in fig1 ) and thereby causing the valve 6 to open so that additional air at super - atmospheric pressure is admitted into the compartment 7 . the valve 6 remains in open condition until the air required for the inhalation phase has been supplied , i . e . until inhalation stops and thus the equilibrium condition is re - established . during all this time , the super - atmospheric pressure is maintained in the compartment 7 as well as in the chamber 9 which freely and openly communicates therewith , so that there is no danger that ambient air can enter the system . the only area in which sub - atmospheric pressure temporarily develops during inhalation is in the chamber 13 within the mask 10 . when the exhalation phase begins , positive pressure develops in the chamber 13 , causing immediate closing of the valves 11 , so that the compartments 9 and 13 are now again cut off from one another . the valve 14 responds to the developing over pressure by opening so that the exhaled air can be vented directly to the atmosphere without the user having to breathe out against the super - atmospheric pressure which exists in the chamber 9 . it is clear , therefore , that the invention achieves its intended purposes , in that it maintains the advantage of sealing the system against the entry of ambient air by providing super - atmospheric pressure in the chamber 9 , but completely eliminates any additional strain on the physiological breathing apparatus of the user due to the fact that the user does not have to exhale against the existing super - atmospheric pressure in the chamber 9 , but only exhales into the chamber 13 which is directly and immediately vented to the ambient atmosphere . although the invention has been described hereinbefore with reference to an exemplary embodiment as shown in the drawings , it is to be understood that this embodiment is in no way limiting and that various modifications will offer themselves readily to those skilled in the art , such modifications being intended to be included in the scope of the appended claims which is to be considered the sole measure of the protection sought for the invention .

a method of supplying respiratory air to a user , and a breathing apparatus for this purpose . an inner and an outer mask are provided , the inner mask communicating only with the respiratory passages of the user and the outer mask covering the face of the user . super - atmospheric pressure is maintained in the outer mask and the outer mask is communicated with the interior of the inner mask during suction created in the inner mask as a result of inhalation . air flowing from the outer mask into the inner mask is replenished from an extraneous air supply . when the exhalation cycle begins , the communication between the inner and outer mask is interrupted and exhaled air is vented from the inner mask directly to the ambient atmosphere .

the present invention provides for de - pigmenting compositions containing an effective amount of one or more depigmenting agents which , when applied to human skin , prevent , treat and / or ameliorate pigmentation at the area or portion of skin to which they are applied . the compositions are effective at reducing or diminishing pigmented areas or portions of the skin such as age spots , freckles , melasma , chloasma , and pigmented keratoses . the compositions are topically applied to the skin . the present invention also provides for anti - aging compositions containing an effective amount of one or more ingredients which , when applied to human skin , prevent , treat and / or ameliorate the various signs of aging at the area or portion of skin to which they are applied . the present invention provides anti - aging benefits to and improves the aesthetic appearance of the skin . in particular , the present invention provides compositions and methods for treating skin to prevent , inhibit , reduce and / or ameliorate the signs of dermatological aging due to , for example , chronological aging , hormonal aging , and / or photoaging . such signs of aging include , but are not limited to skin fragility ; loss of collagen and / or elastin ; estrogen imbalance in skin ; skin atrophy ; appearance and / or depth of lines and / or wrinkles , including fine lines ; skin discoloration , including dark eye circles ; skin sagging ; skin fatigue and / or stress , e . g . skin breakout due to environmental stress , such as pollution and / or temperature changes ; skin dryness ; skin flakiness ; cellular aging ; loss of skin tone , elasticity and / or luster ; loss of skin firmness ; poor skin texture ; loss of skin elasticity and / or resiliency ; and thin skin . the benefits and improvements to the aesthetic appearance of skin can be manifested in any of the following : reduction in pore size ; improvement in skin tone , radiance , clarity and / or tautness ; promotion of anti - oxidant activity ; improvement in skin firmness , plumpness , suppleness , and / or softness ; improvement in procollagen and / or collagen production ; improvement in skin texture and / or promotion of retexturization ; improvement in skin barrier repair and / or function ; improvement in appearance of skin contours ; restoration of skin luster and / or brightness ; replenishment of essential nutrients and / or constituents in the skin decreased by aging and / or menopause ; improvement in communication among skin cells ; increase in cell proliferation and / or multiplication ; increase in skin cell metabolism decreased by aging and / or menopause ; improvement in skin moisturization ; promotion and / or acceleration of cell turnover ; enhancement of skin thickness ; increase in skin elasticity and / or resiliency ; and enhancement of exfoliation , with or without the use of alpha or beta hydroxy acids , keto acids or other exfoliants . a first embodiment of the present composition has a compound corresponding to the following formula ( i ): wherein r 1 and r 2 are independently selected from the group of substituents consisting of hydrogen ; alkyls , substituted or unsubstituted , branched or linear ; alkenyls , substituted or unsubstituted , branched or linear , and having up to 5 double bonds ; alkynyls , substituted or unsubstituted , branched or linear and having up to 5 triple bonds ; aryls , substituted or unsubstituted ; cycloalkyls , substituted and unsubstituted ; and cycloalkenyls , substituted and unsubstituted . formula i compounds shall be referred to herein as either “ de - pigmenting agents ” or “ anti - aging agents ”. preferably , the formula i compound is 3 , 3 ′- thiodipropionic acid , wherein r 1 and r 2 are hydrogen . a second embodiment of the present composition has a de - pigmenting agent corresponding to formula ii : wherein r 3 and r 4 are defined the same as r 1 and r 2 in formula ( i ) above ; in addition , r 3 can be an acyl group ; wherein “ n ” is an integer from 1 to 4 , preferably 1 to 3 , and most preferably 1 to 2 . preferably , the de - pigmenting composition of formula ii is thiazolidine - 2 - carboxylic acid , wherein r 3 and r 4 are hydrogen and n = 1 . in a third embodiment of the present composition , the de - pigmenting agent is perilla oil . perilla oil is derived from the seeds of the mint of the genus perilla . in a fourth embodiment of the present composition , the de - pigmenting agent is clofibrate or a clofibrate analog or derivative . clofibrate is ethyl 2 -( p - chlorophenoxy ) isobutyrate , which corresponds to the following formula ( iv ): a fifth embodiment of the present composition has a de - pigmenting agent corresponding to the following formula ( iii ): wherein r 5 , r 6 , and r 7 are as defined as for r 1 and r 2 in formula ( i ) above . preferably , the de - pigmenting agent of formula iii is kaempferol - 7 - glycoside wherein r 5 , r 6 and r 7 are hydrogen . kaempferol - 7 - glycoside is believed to reduce pigmentation by inhibiting tyrosinase but may also reduce pigmentation by alternate pathways . in a sixth embodiment of the present invention , the de - pigmenting agent is a combination of one or more of the above de - pigmenting agents . preferably , the combination includes de - pigmenting agents that utilize different mechanisms of action . a preferred combination includes kaempferol - 7 - glucoside and perilla oil or clofibrate ( or a clofibrate analog or derivative ). the de - pigmenting agent is present in the composition at an amount effect to prevent , treat , or ameliorate pigmentation at the area or portion of skin to which it is applied . the de - pigmenting agent is preferably present at about 0 . 0001 percentage by weight ( wt %) to about 98 wt %, more preferably at about 0 . 001 wt % to about 30 wt %, and most preferably at about 0 . 05 wt % to about 10 wt % based on the total weight of the composition . the composition is preferably applied to an affective area of skin for a period of time prevent , treat , or ameliorate pigmentation of the area of skin to which the composition is applied . as can be understood by those in the art , the amount of times per day and the period of time that the composition is to be applied to be effective will vary according to the percentage of active used in the composition , the additional ingredients in the composition ( e . g ., whether or not there is a penetration enhancer or additional depigmenting agents ), as well as other factors known by those skilled in the art . the anti - aging agent is present in the composition at an amount effect to prevent , treat , or ameliorate the various signs of aging in the area or portion of skin to which it is applied . the anti - aging agent is preferably present at about 0 . 0001 percentage by weight ( wt %) to about 98 wt %, more preferably at about 0 . 001 wt % to about 30 wt %, and most preferably at about 0 . 05 wt % to about 10 wt % based on the total weight of the composition . the composition is preferably applied to an affective area of skin for a period of time to improve the aesthetic appearance of the area of skin to which the composition is applied . as can be understood by those in the art , the amount of times per day and the period of time that the composition is to be applied to be effective will vary according to the percentage of active used in the composition , the additional ingredients in the composition ( e . g ., whether or not there is a penetration enhancer or additional anti - agents ), the targeted improvement as well as other factors known by those skilled in the art . in particular , the present invention provides compositions and methods for treating skin to prevent , inhibit , reduce and / or ameliorate the signs of dermatological aging due to , for example , chronological aging , hormonal aging , and / or photoaging . such signs of aging include , but are not limited to skin fragility ; loss of collagen and / or elastin ; estrogen imbalance in skin ; skin atrophy ; appearance and / or depth of lines and / or wrinkles , including fine lines ; skin discoloration , including dark eye circles ; skin sagging ; skin fatigue and / or stress , e . g . skin breakout due to environmental stress , such as pollution and / or temperature changes ; skin dryness ; skin flakiness ; cellular aging ; loss of skin tone , elasticity and / or luster ; loss of skin firmness ; poor skin texture ; loss of skin elasticity and / or resiliency ; and thin skin . the benefits and improvements to the aesthetic appearance of skin can be manifested in any of the following : reduction in pore size ; improvement in skin tone , radiance , clarity and / or tautness ; promotion of anti - oxidant activity ; improvement in skin firmness , plumpness , suppleness , and / or softness ; improvement in procollagen and / or collagen production ; improvement in skin texture and / or promotion of retexturization ; improvement in skin barrier repair and / or function ; improvement in appearance of skin contours ; restoration of skin luster and / or brightness ; replenishment of essential nutrients and / or constituents in the skin decreased by aging and / or menopause ; improvement in communication among skin cells ; increase in cell proliferation and / or multiplication ; increase in skin cell metabolism decreased by aging and / or menopause ; improvement in skin moisturization ; promotion and / or acceleration of cell turnover ; enhancement of skin thickness ; increase in skin elasticity and / or resiliency ; and enhancement of exfoliation , with or without the use of alpha or beta hydroxy acids , keto acids or other exfoliants . when a composition according to the present invention includes a formula i compound , the compositions on are preferably used in methods of improving , ameliorating or treating the following signs of aging skin : texture , clarity , pigmentation ( mottled and / or discrete ), fine wrinkles , coarse wrinkles , sallowness , laxness , sagging , turgor , undereye puffiness , and / or overall photodamage . preferably , the formula i compound is 3 , 3 ′- thiodipropionic acid and / or a derivative thereof . most preferably , the formula i compound is 3 , 3 ′- thiodipropionic acid . the compositions of the present invention comprise a pharmaceutically and / or cosmetically acceptable vehicle to provide bulk and physical form . preferably , the vehicle is hypoallergenic , as allergens and other irritating agents exacerbate pigmentation . suitable vehicles include , but are not limited to , cetyl alcohol , ethanol , glycerin , myristyl palmitate , polyvinyl alcohol , propylene glycol , propanol , and water , and mixtures thereof . the depigmenting / anti - aging agent is admixed with the vehicle ( s ) along with any other adjuvants or ingredients to form the topical composition . the compositions of the present invention may also include actives in the form of liposomes . the present composition may take any suitable form such as a solution , cream , serum , stick , patch , mask , towelette , lotion , emulsion , ointment or gel . the present composition may optionally have one or more of the following ingredients : anesthetics , antiallergenics , antimicrobial agents , antiseptics , chelating agents , colorants , demulcents , emollients , emulsifiers , exfolients , fragrances , humectants , lubricants , moisturizers , preservatives , skin penetration enhancers , stabilizers , surfactants , thickeners , viscosity modifiers , vitamins , and mixtures thereof . the present invention may also include conventional cosmetic acitive agents , such as other conventional hypopigmenting agents , such as hydroquinone , ascorbic acid ( vitamin c ) and / or licorice extract ; retinoids , such as retinol or retinoic acid ; antiinflammatory agents , such as bisabolol , anti - acne agents , such as salicylic acid ; exfoliants , such as alpha - hydroxy acids , beta - hydroxy acids , keto acids , oxa acids or oxa diacids ( disclosed in u . s . pat . nos . 5 , 847 , 003 and 5 , 834 , 513 ); ascorbyl - phosphoryl - cholesterol ( disclosed in u . s . pat . no . 5 , 866 , 147 ); sunscreens , such as oxybenzone , octyl methoxycinnamate , octyl salicylate , octocrylene , titanium dioxide , zinc oxide , butyl methoxydibenzoylmethane , methylene bis - benzotriazoylteramehtylbuthylphenol ( mbbt ), bis - ethylhexyl oxyphenol methoxyphenol triazine ( bemt ); or anti - aging agents ; or any combination thereof . when conventional hypopigmenting agents are included in a composition of the present invention , it is preferred that the hypopigmenting agent has a mechanism of action that complements the mechanism of action of the depigmenting agent of the present invention . preferred alpha - hydroxy acids include lactic acid , glycolic acid , or a mixture thereof . the preferred oxa diacid is 3 , 6 , 9 - trioxaundecanedioic acid . formula i compounds , preferably 3 , 3 ′- thiodipropionic acid , may be used to enhance the effectiveness of other skin care actives , such as those disclosed above and those skin care actives disclosed in u . s . pat . no . 6 , 492 , 326 at col . 5 , lines 9 through col . 20 , line 50 , which is incorporated herein by reference . [ 0042 ] ingredient wt % de - pigmenting agent or anti - aging agent 0 . 001 to 98 e . g . ( 3 , 3 ′- thiodipropionic acid ) ph adjusting agent ( e . g . ammonium 0 . 001 to 4 humectants ( e . g . glycols , glycerols ) 0 . 5 to 15 thickeners ( e . g . gums , starches polymers ) 0 . 1 to 4 chelating agents ( e . g . edta ) 0 . 001 to 0 . 5 emollients ( e . g . isopropyl myristate , fatty esters ) 1 to 10 silicones ( cyclomethicone - pentamer ) 0 . 1 to 15 preservative ( e . g . parabens ) 0 . 01 to 2 alcohols ( e . g . ethanol ) 0 to 10 antioxidants ( e . g . vitamin e acetate ) 0 . 01 to 5 anti - inflammatory ( e . g . bisabolol ) 0 . 01 to 10 sunscreen ( e . g . titanium dioxide / benzophenone - 3 , 0 . 01 to 15 butyl methoxydibenzoylmethane ) water q . s . when the compositions of the present invention are used to improve the aesthetic appearance of skin or to improve , ameliorate and / or treat the signs of aging skin , the preferred anti - aging agent is 3 , 3 ′- thiodipropionic acid . it is more preferred that in addition to 3 , 3 ′- thiodipropionic acid , the cosmetic composition includes at least one ingredient selected from the group consisting of : palmatoyl tetrapeptide - 3 ( available under the trade name rigin from sederma , france ), gymnostemma pentaphyllum and / or an extract therefrom , stenolama chusana and / or an extract therefrom , morinda citrifolia and / or an extract therefrom , butea frondosa and / or an extract therefrom , luteoline 7 - beta - glucoside , chlorosalicylic acid , naringi crenulata and / or an extract therefrom , methylthioadenosine , ferutinin , ilex purpurea and / or an extract therefrom , asmunda japonica and / or an extract therefrom , rhapontin , uncaria gambir and / or an extract therefrom , lopanic acid , ellagic acid , 2 , 4 , 6 , 3 , 4 - pentahydroxychalcone , ligusticum chianxiong or an extract therefrom , azadirachta indica ( neem ) and / or an extract therefrom , aframomum melegueata and / or an extract therefrom , 2 ′ amino 4 , 5 - methyl thiazole , or any combination thereof . more preferably , the cosmetic composition contains at least two ingredients selected from the foregoing group . the present invention having been described with particular reference to the preferred forms thereof , it will be obvious that various changes and modifications may be made herein without departing from the spirit and scope of the invention as defined in the appended claims . as used herein , singular can mean plural .

the present invention relates to compositions useful in treating hyperpigmentation and the various signs of dermatological aging in human skin . the present invention also relates to cosmetic compositions and methods of using such compositions that improve the aesthetic appearance of skin . further , the present invention relates to methods of applying the compositions to the skin to effect treatment and to improve the aesthetic appearance of skin , particularly , by providing anti - aging benefits to the skin . these and other objects of the present invention are achieved by a method and composition that comprises a de - pigmenting agent or anti - aging agent in an amount effective to prevent , treat and / or ameliorate pigmentation or the various signs of aging at an area of skin to which it is applied , and a cosmetically or pharmaceutically acceptable vehicle . suitable de - pigmenting agents include 3 , 3 ′- thiodipropionic acid , thiazolidine - 2 - carboxylic acid , kaempferol - 7 - glucoside , perilla oil , and clofibrate and clofibrate analogs and / or derivatives , as well as those set forth below . suitable anti - aging agents include 3 , 3 ′- thiodipropionic acid and / or its derivatives .

it is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention , while eliminating , for purposes of clarity , many other elements found in a typical patient - safety or lifting device and stretcher supporter . those of ordinary skill in the art will recognize that other elements are desirable and / or required in order to implement the present invention . however , because such elements are well known in the art , and because they do not facilitate a better understanding of the present invention , a discussion of such elements is not provided herein . the disclosure hereinbelow is directed to all such variations and modifications to lifting and / or control devices for motor positioning as known , and as will be apparent , to those skilled in the art . referring now to fig1 , shown is an embodiment of a lifting device 110 , including a support base 112 having two locking rotatable casters 114 secured to the bottom of base 112 . foot operated levers 116 may provide simplified engagement of wheel locks . an example of such an embodiment can be found in u . s . pat . no . 6 , 665 , 894 to moffa , et al ., the entire disclosure of which is incorporated in its entirety by reference herein . rotatable column 120 extends vertically from , and is mechanically linked to , support base 112 via column mount 314 ( see fig3 ). lift arm assembly 122 , shown in a horizontal orientation , may be pivotally attached to column 120 at first pivot point 124 and second pivot point 126 . extension of the lift arm from about 29 degrees above , to about 45 degrees below , the horizontal reference position shown may be accomplished by , for example , electric motor driven linear actuator 128 . the actuator 128 acts as a lifter , providing power to extend or retract actuator rod 130 , thereby pivoting and raising or lowering lift arm assembly 122 and actuator rod 130 . referring now to fig2 , pivotally mounted to the support base 112 may be extensible legs 118 and 118 a having a rotatable caster 220 mounted at a distal end 222 thereof . each of the legs 118 and 118 a may be formed of a leg weldment 224 and a leg extension 226 that together define a telescoping leg assembly 234 capable of reversible extension from the support base . the leg extension 226 may be in a nesting relation with the leg weldment 224 , and may include a leg cylinder bracket 228 that is operatively associated with the distal end portion 236 of telescoping actuator rod 230 . the proximal end 238 of the telescoping actuator rod is operatively associated with a linear actuator 232 for reversible extension of the leg assembly 234 . referring now to fig3 , a top cross - sectional view of support base 112 shows actuator motors 232 that may each operate independently or together for extension of legs 118 and 118 a as desired . an additional motor 310 may be mechanically linked to each of legs 118 and 118 a . activation of motor 310 causes actuator rod 312 to pivot the legs outwardly from the initial parallel orientation to a point where the legs circumscribe about a 40 degree to a 90 degree angle . the operator is thus able to reversibly extend each of legs 118 , 118 a independently , while causing the legs to reversibly diverge from one another . this allows the device to set a safe footprint for patient transfer and to provide a compact system for easy transport from one patient area to another when in the compact retracted configuration . once in position at the patient &# 39 ; s bedside , the legs may then be extended and diverged so as to define a longer and wider footprint , thereby providing enhanced stability during the patient lifting process . column mount 314 retains the column in a vertical orientation with respect to the support base 112 , while allowing the column to rotate about its axis . electrically driven linear actuator 316 may act as a column 120 rotator that reversibly extends an actuator rod 318 that is pivotally attached to column 120 via an attachment arm 320 . the column may , for example , have a total angular sweep of about +/− 30 degrees to about +/− 90 degrees to either side of a reference position wherein it is perpendicular to a plane defined by the handle 410 ( see fig4 ). referring now to fig4 , a back view of the device 110 shows u - shaped handle 410 that may be attached to support base 112 and / or attached to column 120 via a handle strap 412 . the handle may also be of any shape . the handle may or may not enclose a basket area 410 that may contain a controller 412 for transmitting signals to the various actuator motors , and a battery 414 for powering the various electrically controlled devices . the basket may also be a post or column . a remote controller 416 may be provided in electrical communication with the control panel . the remote controller may contain the necessary switching devices to control up and down movement of the lifting arm , clockwise and counterclockwise rotation of the column , extension and retraction of each of the legs individually or simultaneously , and divergence and convergence of both legs simultaneously , for example . referring now to fig5 , the extendable legs 118 and 118 a are shown in phantom in the stowed position , such as before deployment . using actuator 310 of fig3 , the extendable legs 118 , 118 a , may be extended until each leg reaches a fully diverged and deployed state . for example , legs 118 and 118 a may extend together linearly , such that an angle a covers , for example , the range of 0 degrees to 45 degrees . in an embodiment , both legs 118 and 118 a may be extended simultaneously , such that angle a is roughly equal to angle b . the total divergence of the legs 118 , 118 a may be represented as angle c , and as an exemplary embodiment , angle c may have a range of , for example , between 0 degrees and 90 degrees . further , using actuators 232 , 232 a , both legs 118 , 118 a may be extended from length l 1 to length l 2 . the activation of all , or a portion of , the actuators may be monitored by a programmable controller 412 , such as a memory device activated switch , a programmable logic controller , or other microcontrollers apparent to those skilled in the art . using actuator 316 of fig3 , the lift arm assembly 122 may be rotated . referring also to fig6 , lift arm assembly 122 may be moved from its center position to a position indicated in phantom in fig6 as 122 a . this rotation is represented as angle d . similarly , the lift arm assembly 122 may be rotated to a position represented in phantom in fig6 as 122 b , thus moving through angle e . the full angle of motion of lift arm assembly 122 is thus represented as angle f . in an exemplary embodiment , angle f may be , for example , a maximum of +/− 60 degrees . safety considerations may be imposed , such that the rotation of lift arm assembly 122 through angle f may be limited so as not to allow the lifting device to tip over under load . this limiting may be performed , for example , by a limiting of actuators , dependent on predetermined criteria , such as a limiting by controller 412 . for example , angle f may be so limited at a point when angle c of fig5 is a predetermined minimum value , as determined by a sensing of angle c by controller 412 , such as wherein the controller 416 monitors the activation of an actuator . as an additional constraint , angle f of fig6 may be restricted to some minimum value if the combination of angle c of fig5 is below some minimum value , and the length of extendable legs 228 is below some minimum value of l 2 . in an exemplary embodiment , the rotation of lift arm assembly 122 of fig6 may be limited such that a maximum value of angle f is 10 degrees (+/− 5 degrees from center axis ) for a divergence angle c of less than about 66 degrees , and / or for an extension length l 2 of fig5 of less than , for example , 95 % of the full extended length l 2 . these restrictions may be imposed on the operation of the lifting device so as to prevent tipping . it should be noted that lift arm assembly 122 may be lowered and elevated by use of actuator 128 at any time without restriction . in this exemplary embodiment , angle f may be controlled by an actuator having a stroke of 3 . 94 ″, and this stroke may be limited to 1 . 91 ″ for proper operation . thus , full retraction of the actuator may cause an angle f of − 30 degrees from center axis , and a full stroke of actuator to 1 . 91 ″ may cause an angle f of + 30 degrees from center axis . other stroke values may also be used depending on the geometry of the device . however , in accordance with the status of length l 2 , and / or the openness of the angle c , the controller 412 may limit the actuator to function , for example , over a stroke of 1 . 08 ″+ 0 . 166 ″ right and 0 . 157 ″ left , thereby limiting angle f to +/− 5 degrees from center axis , wherein the controller assesses length l 2 to be less than 95 % of full length l 2 , and / or wherein the controller 412 assesses the legs to be less than 95 % open . for example , in this exemplary embodiment , the actuator that opens and closes the leg angle c may be , for example , an actuator having a total stroke of 5 . 91 ″, and an install length of 12 . 21 ″. such an actuator may be fully extended when the legs are closed , and fully retracted when angle c approaches , for example , 70 degrees . thus , the legs may be 95 % open when the stroke is down from 12 . 21 ″ to 0 . 295 ″. the actuators that extend the legs outwardly may have a stroke of , for example , 20 . 67 ″, and may be at full stroke upon full leg extension . thus , at 19 . 36 ″ stroke , the controller 412 may assess the respective leg controlled by the respective actuator as being 95 % extended . thereby , when at least one , or , for example , both , of these two 95 % minimum conditions are met , angle f may be allowed , by the controller 412 , to exceed +/− 5 degrees from center . in this exemplary embodiment , the patient lift device may lift up to , for example , seven hundred pounds . again , alternative stroke values may be used , in accordance with the geometry of the present device . an additional restriction on operation to maintain operation of the lift device within safe parameters may include inhibition of the retraction of the extendable legs , and / or inhibition of the closing of the angular divergence of the extendable legs , while performing a lift of a patient . specifically , one embodiment may include the operational restriction , by the controller 412 , of inhibiting and / or preventing movement of the actuators that control leg extension and / or retraction , or of the actuators that control leg divergence and / or closure when the lift arm is rotated more than 5 degrees left or right of the center location . equivalently , this occurs when the entirety of angle d or e of the lift arm assembly exceeds 5 degrees . correspondingly , leg extension and leg divergence actuators may be re - enabled if the lift arm assembly is rotated to be within 5 degrees left or right of the center axis . the degree of rotation may vary according to the geometry of the present invention . the handheld controller 416 of fig1 may be employed to provide an operational safety interlock to prevent patient lift and transfer outside of limit condition , such as the limit conditions on divergence angle and leg extension length discussed hereinabove . user control of all actuators in the lifting device may be provided by control pad 416 . the safety interlock within the controller 416 may operate by tracking the operation and position of actuators , and by allowing operation of particular ones of the actuators only upon proper actuation of other actuators , for example , in accordance with information from controller 412 . the control device may include therein the digital controller 412 running software that provides the limitations of movement stated hereinabove . software resident in the controller 412 may track performance of all actuators in the lifting device , or only actuators of interest and the respective position indicators thereof , in order to ensure safe operation of the lifting device . the software , and / or the controller 412 , and / or the handheld controller 416 , may track proper and safe operation , such as by monitoring the output of at least one reed switch engaged and aligned to monitor the position or performance of certain ones of the actuators , as discussed hereinabove . the handheld controller 416 may incorporate a keypad and may incorporate a display indicating some indicia of operation of the lifting device , such as , for example , the rotational position of the lift arm assembly , the angular displacement of the extendable legs , and the linear displacement of leg extension . in one embodiment of the present invention , the handheld controller 416 and / or the controller 412 monitors position sensors located in the lifting device to ensure that the hereinabove safety limits are met . for example , reed , limit , magnetic , hall effect or other proximity switches may be used to sense when the extendable legs are sufficiently diverged enough to allow safe operation . in addition to these sensors , sensors may be used to sense when the extendable legs are sufficiently deployed linearly to allow safe operation of the lifting device . once again , sensors may be used to sense the rotational location of the lifting arm so as to prevent rotation of the lifting arm when the extendable legs are not fully deployed in at least one of either length or angular displacement . in one embodiment , a digital position indicator may be used for the leg angular divergence , extension , and lifting arm rotation position . for example , a digital encoder may be used to indicate the actual position of the legs or lift arm assembly and make the information available to the digital controller . in one embodiment , rotary digital encoders may be used on all rotary type actuators . in this embodiment , the digital encoders indicate the number of revolutions , for example , in degrees or binary number count , to indicate the position of screw - type rotary actuators in order to limit the overall operation of the lifting device to be within the hereinabove safety limits . in this embodiment , the controller 412 would receive digitized position information from all actuators in the lifting device and translate that information to relevant positional information to ensure operation within safe operating limits . it is well understood by those of skill in the art that the actuators may be of the rotary or linear type , and that digitized position information may be obtained via any of the commercially available digital position sensing devices , including linear and rotary encoders . in an additional embodiment of the present invention , the handheld controller 416 and / or the controller 412 may monitor variables , such as sensors , such as weight transducers , and / or such as current drawn by an actuator , in order to monitor weight present on the hook device of the lift arm . movement , such as retraction of legs , closure of leg divergence , or the like , may thereby be limited , as set forth hereinabove , when a patient weight is sensed on the lift arm . the weight sensing may be calibrated , such as to account for the weight present on the lift arm when no patient is on the lift arm , such as , for example , the 20 - 30 lbs . that may be present due to certain embodiments of the hook device . a bypass mode of operation may be implemented in the controller 416 to facilitate breakdown and setup of the lifting device . the use of the bypass mode for actuating movement beyond the hereinabove ranges constitutes a safety hazard should an operator be using the device to lift a patient . therefore , a safety interlock may be implemented in the controller 416 to prevent inadvertent operation in the bypass mode . in one embodiment , a lockout keypad code may be entered in order to operate the unit in bypass mode . once in bypass mode , an audible alarm may be sounded to alert or remind the operator that the unit is in bypass mode , and is to be used only for breakdown and setup of the lifting device . in this embodiment , an additional keypad input may be required to exit the bypass mode . in one embodiment , a physical lockout key may be used to temporarily place the unit in bypass mode . once again , upon placement into bypass mode , an audible alarm may be sounded to alert or remind the operator that the unit is in bypass mode to be used only for breakdown and setup of the lifting device . exit from the bypass mode may be obtained by removal or reset of the physical key or key position . those of skill in the art will realize that any form of safety interlock mechanism may be used . for example , a physical key and key position , physical or magnetic , a digital key code , or a key switch of limited access on the controller device are exemplary of such mechanisms . as can be seen in fig7 and 8 , an adjustable locator of an open stretcher frame 700 may attach to the lifting arm at the lifting point of the assembly of fig1 . additionally , the open stretcher frame 700 may attach at the support point of a rail suspended above the bed , wherein the support point is mobile within or withon the rail , as will be known to those skilled in the art . in one embodiment of the invention , the open stretcher frame 700 may consist of two parallel and essentially identical arches , with a center rail connected to the apex of each arch . the arches and center rail are preferably rigid and may provide structural support to the stretcher supporter . the open framework of the stretcher supporter may be of alternate design shapes , such that it is engineered to attach to a stretcher and is sufficiently open and sturdy to be capable of supporting the weight of a broad range of persons . for example , the open frame may be square , hemispherical , elliptical , or triangular . alternatively , the open frame may be formed from semi - rigid or non - rigid materials , such as chains or cables . the open frame may also be constructed from a variety of materials , such as metal , plastic , fiberglass , or any other material or combination of materials that provide structural support to the open frame in a rigid , semi - rigid , or non - rigid embodiment . located near the bottom of the stretcher supporter may be one or more attachment points for attachment of a stretcher 710 . in an exemplary embodiment , the end points of the two arches of the open frame 700 effectively create four points of a rectangle in a horizontal plane formed tangent to the four end points . the number of attachment points may typically be at least two , but may consist of any number of attachment points depending on the design of the stretcher being attached to the stretcher supporter . if a standard stretcher is used , the distance between the four points in the exemplary embodiment may be such that the stretcher can be attached at the four points of the open frame . attached to the four end points may be one or more hooks , which are capable of holding a stretcher that has a loop , or eye , on each corner . thus , the stretcher may be securely attached to the stretcher supporter frame by placing the four loops of the stretcher over the four hooks of the assembly frame . of course , the manner of attachment can be any mechanism known in the art , so long as the attachment is secured such as , but not limited to , velcro , knots , or the like . the adjustable locator 740 of the stretcher frame 700 assembly may attach to the lifting arm or rail via a u bracket 730 . in such an embodiment , a central bolt 720 may extend through a hole in the bottom of the u bracket 730 and be tack welded to a sleeve portion , which sleeve may slide freely along the center rail . thereby , free radial rotation at the lifting point for the stretcher frame 700 assembly may be provided . the adjustable locator 740 may additionally provide for repositioning of the lifting point according to the location of the stretcher 710 when attached to the frame assembly , and according to the weight distribution across the stretcher 710 . in an exemplary embodiment , in the center of one side of the sleeve may be a plunger system utilizing a spring loaded pin 750 . when the pin is engaged , the sleeve may be locked into a fixed position by insertion of the pin through a hole in center rail 760 . when the plunger system is disengaged , the pin may be removed from a hole in the center rail , allowing the sleeve to slide freely along center rail 760 . this repositioning may be accomplished by the plunger mechanism , wherein the spring loaded pin may be engaged and disengaged through a series of holes along the length of the center rail of the stretcher frame 700 . the adjustable locator may thus include a mechanism capable of locking the lifting point within a range of locations . such a mechanism may include a pressurized constriction about the center rail such as the aforementioned plunger mechanism , that can be loosened and tightened until a suitable location is obtained . in one embodiment of the present invention , the series of holes into which the pressurized construction may occur may be in increments of an inch , with five holes to the left of center , and five holes to the right of center . of course , the number of holes from either side of the center pin hole location may be any number and any incremental distance , such that center rail 760 of the stretcher frame 700 maintains sufficient strength and rigidity . the adjustable locator is thus repositioned by disengaging the pin of the plunger system and shifting the adjustable locator over an adjacent pin hole , and subsequently pressurizing to re - engage the pin securely into the new pin hole . thus , if a tilt or unevenness is detected when the stretcher is minimally lifted from its resting position , the stretcher may be lowered back to a resting position , and the adjustable locator may be repositioned toward the tilt sufficiently to remove the tilt or unevenness . this process may be repeated as many times as necessary to allow for secure maneuvering . in certain embodiments , the adjustable locator and lifting point may be moved by an electrical motor , and controlled manually or by a computing device . for example , an operator may heuristically determine , by repeated lowering and raising of the stretcher , the proper pin location to maintain balance of the stretcher during lifting . alternatively , one or more sensors may determine the weight distribution on the stretcher , and / or a degree of tilt of the stretcher , and may thereby calculate the proper pin position to maintain balance . the proper pin position may then be provided to an operator to allow for manual repositioning , or may be employed to automatically control an electric motor or other similar device to disengage the pressure holding the pin in place , to relocate the pin at the proper position , and to re - engage the pressure to engage the pin to the proper pin location to maintain balance . a frictional system , or any other suitable system for positional adjustment , may also be automated as described . in operation , a patient may be placed upon a stretcher supporter as previously described . the lift arm or rail may be positioned above the patient , and the stretcher supporter may be properly positioned over the stretcher . this configuration minimizes swinging tendency , as the stretcher supporter and patient are pulled upward only after attachment of the stretcher to the assembly . while positioning the device , the lifting apparatus may be left free to roll so as to more easily align the end of the lift arm assembly above the patient . once the device is properly located , locking casters may be engaged so as to prevent any undesirable movement during the lifting process . it will be apparent to those skilled in the art that various modifications and variations may be made in the apparatus and method of the present invention without departing from the spirit or scope of the invention . thus , it is intended that the present invention cover the modification and variations of this invention provided they come within the scope of the appended claims and the equivalents thereof .

a stretcher supporter , and a method of balancing a stretcher supporter for a patient lifting device , are disclosed . the stretcher supporter includes an open frame , wherein said open frame provides for secure attachment of a stretcher to said open frame and an adjustable lifting point connected to said open frame , wherein said adjustable lifting point suspends said open frame and rotatably shifts to substantially balance said stretcher respective to said open frame . the method of balancing a stretcher supporter for a patient lifting device , includes the steps of securely attaching a stretcher to an open frame of said stretcher supporter and adjusting a lifting point connected to said open frame , wherein said adjusting a lifting point suspends said open frame and linearly and rotatably shifts to substantially balance said stretcher respective to said open frame .

with regard to the accompanying figs , there is shown one preferred embodiment of fast - baking pizza stove according to this invention . as the taste and sensation of a wood - fired food product has become a recent popular phenomenon , this invention attempts to bring end product ( closer ) to the end consumer . whether at a campground , backyard deck or rear porch , this easy - to - transport and assemble stove unit can be used for rapidly making and then baking one pizza pie at a time , up to 12 - 14 ″ in diameter , or several loaves of bread / buns raising in a pan or two . this invention enables one individual , alone , to make and bake customized pizza pies right at the point of “ sale ”/ consumption . with modification , it may be possible to cook two smaller pies together but considering how short baking time is with this device ( i . e . about 2 minutes per pie ), a “ one - size ” approach is preferred and , admittedly , more intimate . these units can be sold , leased or rented , a unit may be franchised by a pizza maker / provider to do as part of a bigger restaurant - style service providing “ package ”, or possibly even affixed to a small pull - behind trailer for transporting to and from an end user , pie - baking location like a backyard party , street fair or the like . as for the respective component parts , they are shown ( less the flue pipe ) in fig1 as they would appear when broken down ( or dis - assembled ) for transport to a remote assembly location . more specifically , a single pizza stove unit 10 would include : a cooking chamber 20 ( as better seen on its front end / edge in accompanying fig3 ), a fire grate 30 ( fig1 and 2 , purposefully removed from view in fig4 ), a multi - section , chimney stack 40 ( fig4 through 6 ), firebox 50 and stove stand 60 ( both in fig1 - 2 , 4 - 6 ). in fig1 , the aforementioned components ( less the flue or stack 40 ) are shown in an exploded view , from top to bottom . these main components stack together to form : ( i ) a portable ; ( ii ) easily transportable ; and ( iii ) assembl - able at the site of use , ( iv ) fast - baking pizza oven . this invention requires no electric hookups to assemble and / or operate . when supplied with a fuel of choice , it can fully bake a pizza pie every 2 - 3 minutes . . . during which time a single oven operator has sufficient time to “ dress ” the next pizza pie shell ( pre - made , or hand - tossed ) with sauce and customized topping combinations requested by the subsequent consumer standing / partying nearby . pizza stove 10 comprises a cooking chamber 20 with its own top exit port 21 , front access door 22 , with hinges 23 and door handle 24 , a pair of carrying handles 25 , an internal cooking surface 26 with a central pizza stone 27 surrounded by a plurality of apertures 28 through which heat may enter from below and circulate about said chamber 20 . stove 10 further includes a fire grate 30 with a top surface 32 for holding a fuel source ( preferably wood ; alternately , coal ) and plurality of grate legs 34 . connecting to the top exit port 21 of cooking chamber 20 will be a multi - sectioned chimney stack 40 with its optional rain cap 42 . all of the foregoing rests on a firebox 50 ( with its own front access door 52 , hinges 53 and handle 54 ) with its own set of venting holes or apertures 58 . firebox 50 sits directly on its own stove stand 60 with four corner legs 62 . on a preferred basis , at least two and preferably all four of said legs include an adjustable height leveler 64 . in the model depicted in fig3 , a flagpole holder - looking adapter a extends from a back end of cooking chamber 20 . that adapter a holds angled piping that can used for bending at a first ninety degree angle before bending back at a second right angle for preventing any ( rain ) water from reaching pizzas baking in the cooking chamber or otherwise dousing the heat emanating from the wood ( or other fuel ) in the firebox beneath said cooking chamber . alternately , if a heavy storm was forecast before the party was scheduled to start , the whole unit 10 could be set up under a porch , tent or temporary canopy of some sort . on average , it should take about 10 - 15 minutes to stack the components and connect them together . once arranged and stacked , the assembled unit need not be mechanically joined any further as the assembly is not meant to be permanent . rather , the “ stand ” will be held together by its own weight . fully stacked , the entire unit will weigh roughly 250 to 300 pounds , extend about 4 to 5 feet high and have a baking firebox that is about 24 × 24 inches in diameter . unlike some of the small campfire ( heating ) stoves of the prior art , this invention can accommodate full size logs in its “ firepit ”— and typically heat a fully prepared pizza shell to a serving temperature of about 450 or 500 ° f ., up to about 850 ° f . in less than 5 minutes , actually more like about one and a half to three minutes per pizza pie . for some breads , baking time in a properly pre - heated oven can take a bit longer ; they will usually have to sit under a 3 ″ tall loaf or less . during the whole time of “ use ”, outdoors immediately adjacent a campground , deck or outside party , neighbors will all reap the benefits of these freshly made pizza / bread smells ! in the model depicted in fig6 , there is shown a flagpole holder - looking adapter a that extends from a rear end r of the cooking chamber . that adapter serves as a supplemental stand / holder support for a pair of right angled flue pipes , should the assembled unit need to angle about a deck roof or other “ permanent ” outside structure . in most instances , however , it is recommended that a standard , straight flue configuration be employed . height restrictions usually are not a problem for most outdoor baking setups . still other options would include : separately adjustable leg height levelers l should the assembling surface be the least bit uneven . a built in , temperature resistant level ( not shown ) may be added optionally , as well as a high temperature thermometer that can magnetically attach to a side of the firebox and / or cooking chamber . the baking chamber can be fitted with a solid 15 ″ pizza stone ( baking surface ). while removal for cleaning , more deluxe versions may include an optional , rotatable stone , one that can be manually spun , or possibly mechanically rotating within the cooking chamber for better , all around rapid baking of each pie placed thereon . when baking is complete , the whole assembly could be kept intact for a bit longer to warm the party attendees as a pseudo - chiminea . alternately , it could be allowed to completely cool down , taking no more than about 45 - 60 minutes to sufficiently cool for disassembly and transfer to the back of an suv or pickup flatbed . total cooling time depends on how fast the fuel source ( coals / firewood ) can be removed from the unit , transported in a metal bucket and safely doused out so as to not create any risk of re - ignition later . this “ in situ ” wood fire pizza baker permits an acceptable degree of control over temperatures within and above its combustion chamber . it is contemplated that this stove can be made in several varieties of sizes and dimensions . its outer box could also other than square - shaped , such as a fancier - looking octagonal or semi - rounded variation . if intended for other than outdoor use , a longer set of flue connections must be arranged for proper smoke venting and temperature dissemination . before assembly and after cooling and disassembly , it is meant for the various component parts to be carried to a set up site . in other words , the sub - elements can be brought by one or two folks , perhaps in just a few trips , for assembling at the ultimate pie - baking destination for the evening . main components of this stove can be manufactured from readily available materials , preferably metal , and more particularly steel or cast iron . to a lesser degree , other fancier looking alternatives may be substituted for one or more elements or used to embellish / adorn one or more sections — for aesthetic purposes . for instance , copper , aluminum , ceramic materials , and a host of man - made materials can be used . thus the scope of the invention should be determined by the appended claims and their legal equivalents , rather than by the examples given .

portable stove in which wood can be burned for rapidly baking a plurality of pizzas on a small lot basis in five minutes or less . the stove can be broken into sections / segments for transporting to a given site for assembly and use at that site before being disassembled for another use elsewhere . preferred embodiments include individually leveling legs .

for obvious reasons of simplifying the description , only one sole according to the invention will be described , corresponding to the left foot for example , the right sole being deduced by symmetry . with reference to fig1 and 2 , the sole according to the invention has on its lower face a semi - rigid corrective element capable of providing a so - called inner retrocapital support 1 , on the back part of the first metatarsal head , and / or a so - called median retrocapital support 2 , on the back part of the second and / or third and / or fourth metatarsal head , and / or a so - called outer retrocapital support 3 , on the back part of the fifth metatarsal head . said inner 1 , median 2 and outer 3 retrocapital corrective elements are advantageously connected to the sole in a removable manner . on its lower face , the sole has at least one recess 4 extending from the inner edge to the outer edge of the sole , opposite the metatarsal heads , and in which the inner 1 , median 2 and outer 3 retrocapital corrective element or elements are capable of being positioned . the walls of the recess 4 are inclined towards the inside of said recess 4 from its bottom to the edge of the said recess , i . e . to the lower face of the sole , in order to form a lip 5 at the edge of the recess 4 . this recess 4 is capable of accommodating at least one of the inner 1 , median 2 or outer 3 retrocapital corrective elements represented in fig4 a to 6b . each retrocapital corrective element 1 to 3 is substantially triangular in shape and has at its periphery a chamfer 6 so that the lip 5 at the periphery of the recess 4 holds said retrocapital corrective elements 1 to 3 in place in said recess 4 . clearly , the edge of the inner retrocapital corrective element 1 and of the outer retrocapital corrective element 3 which is adjacent to the inner and outer edge of the sole respectively when the said elements 1 and 3 are inserted into the recess 4 does not have a chamfer 6 . furthermore , the inner 1 , median 2 and outer 3 retrocapital corrective elements are made of a more rigid and denser material than the material of the sole and are inserted into the recess 4 by elastic deformation of the lip 5 thereof . it will be noted that the particular shape of the recess 4 and the retrocapital corrective elements 1 to 3 prevent any inadvertent movement , as well as any escape , of said corrective elements during walking or running moreover , it will be observed that the retrocapital corrective elements are not in contact with the foot , thus avoiding any injury to the plantar skin such as cuts , blisters , clefts or suchlike . nevertheless , it is very clear that the inner 1 , median 2 and outer 3 retrocapital corrective elements can be positioned on the upper face of the sole without departing from the scope of the invention . advantageously , with reference to fig1 and 2 , the sole has on its lower face a recess 7 positioned in front of the metatarsal heads , at the plantar cushion , said recess 7 extending from the inner to the outer edge of the sole , and capable of receiving a so - called lower anterocapital element 8 having pre - cut lines 9 in order to enable the creation of a hollow beneath the callus or calluses and / or skin disorder . these pre - cut lines 9 delimit removable elements . these removable elements extending opposite the calluses are removed in order to create a hollow on the lower face of the sole . moreover , in the same way as before , the walls of the recess 7 are inclined towards the interior of the said recess 7 from their bottom up to their respective edge in order to form a lip 5 round the edge of the said recess 7 . the said lower anterocapital element is flat and has round its periphery , along its proximal and distal edges , a chamfer 6 in order to ensure that it locks into the recess 7 . in this particular embodiment , the anterocapital element 8 has 4 pre - cut lines 9 extending from the proximal edge to the distal edge respectively of the said anterocapital element 8 . thus , with reference to fig3 , the retrocapital corrective elements 1 to 3 exert an upward pressure p 1 onto the back part of the corresponding metatarsal head ( s ) enabling the excessive pressures that cause the formation of the callus or calluses to be corrected . and the hollow or hollows 7 formed by removing the movable parts of the anterocapital element 8 between the pre - cut lines 9 allow the sole to be compressed into the hollow when a pressure p 2 ( fig3 ) is exerted during walking limiting rubbing against the callus d on the upper face of the sole simultaneously making walking much more comfortable . as the appearance of calluses is often due to a problem of posture causing excessive pressure on the metatarsal heads , the sole according to the invention advantageously has posture - correction means . thus the sole , with reference to fig1 and 2 , also has a second so - called anti - varus or anti - supination recess 10 , generally rectangular in shape , located along the outer edge of the sole and extending from the cuboid to the first recess 4 of the retrocapital corrective elements and a final so - called hemi - dome shaped anti - valgus or anti - pronation recess 11 located along the inner edge of the sole under the plantar vault . in the same way as described above , the wall of the anti - varus 10 and anti - valgus 11 recesses is inclined towards the inside of the said recesses 10 and 11 from their bottom to their respective edge in order to form a lip 5 bordering the said recesses 10 and 11 . each of the anti - varus 10 and anti - valgus 11 recesses is capable of accommodating an anti - varus 12 and anti - valgus 13 corrective element respectively , represented successively in fig7 a , 7 b and 8 a , 8 b ; the anti - varus corrective element 12 is generally rectangular in shape and the anti - valgus corrective element 13 is the shape of a hemi - dome . each of these corrective elements is flat and made from a more rigid and denser material that the material of the sole ; these elements also have round their periphery a chamfer 6 in order to ensure that they lock into their respective recess . according to a variation of the sole , the said retrocapital corrective elements 1 , 2 and 3 , the anterocapital element 8 and the anti - varus 12 and anti - valgus 13 corrective elements have fixing means capable of cooperating with additional fixing means connected to the lower face of the sole . these means can consist for example in lugs projecting from the upper face of the corrective elements 1 , 2 , 3 , 8 , 12 and 13 and capable of cooperating with corresponding holes located at the bottom of corresponding recesses 4 , 8 , 10 and 11 , corrective elements 1 , 2 , 3 , 8 , 12 and 13 therefore not having a chamfer and the recesses 4 , 8 , 10 and 11 not having a lip 5 . alternatively , these means can consist in loops and / or hooks capable of cooperating with hooks and / or loops in order to form velcro - type fixing means . moreover , it is very clear that the corrective means 1 , 2 , 3 , 8 , 12 and 13 can be fixed removably onto the lower or upper face of the sole by any appropriate means well known to a person skilled in the art or permanently on the lower and / or upper face of the sole by means of glue , double - sided adhesive or any other means well known to a person skilled in the art without departing from the scope of the invention . according to a particularly advantageous variation , with reference to fig9 and 10 , the sole has on its upper face , means to stress , from the strike of the step usually performed by the heel , the articular receptors located between the talus and the calcaneus and means guiding the progression of the foot along the physiological axis of the gait as described in french patent application 2 676 918 , filed by the applicant . these means basically consist in a profiled channel , called a console 14 , and a set of profiled elements 16 , 17 , 18 distributed along the entire length of the sole to create a rail around which the foot is guided . the console 14 extends longitudinally from the heel to the front end of the calcaneus , just vertically below the neck of the talus . the said console 14 has a thickness that increases from the heel to its front end 15 . by way of a particular example , the height of the console 14 increases gradually from 1 mm to 2 mm from the heel to its front end 15 . the set of profiled elements 16 , 17 , 18 , from the back forwards , i . e . from the heel towards the tip of the foot , consists of a subscaphoidian profiled element 16 , a subcuboidian profiled element 17 and a media - tarsian axial means 18 . the subscaphoidian profiled element 16 extends along the console 14 towards the interior of the foot in the manner of a hemi - dome . this subscaphoidian profiled element 16 has in this example a height of about 2 mm and thus extends the front end 15 of the console 14 . the profiled subcuboidian element 17 , in the top view , according to fig9 , has the shape of a bean corresponding generally to the projection of the shape of the cuboid on the sole . this element 17 is located on the outer side of the subscaphoidian element 16 , its convexity turned backwards , at about 45 ° from the median longitudinal axis of the sole . the thickness of the said element 17 increases from the side towards the centre and from the back forwards gradually to reach a height of about 4 mm . the media - tarsian means 18 is oval in shape , i . e . roughly the shape of a drop of water , widening towards the front and ending just before the metatarsal heads of the foot . this media - tarsian element is domed ; its height varies longitudinally from a height of 2 . 5 mm to reach a maximum height in the order of 3 . 5 mm , at about two thirds of its length . it will be observed that , during the progression of the step , the console 14 stresses the calcaneus of the foot , whether a flat foot or a high - arch foot , in order to prepare the continuation of the step under good conditions ; then the subscaphoidian 16 and / or subcuboidian 17 profiled elements which act as lateral stabilisers for the foot , encourage the foot to stay within the physiological rail of the gait and the media - tarsian element 18 prepares the terminal digitigrade phase of the step by distributing the support of the foot under the metatarsal palettes so that this support remains channeled along the axis of the second metatarsal head through which the physiological axis of the gait passes . advantageously , the sole has on its upper face an upper anterocapital element called the upper plantar pad 19 extending from the inner edge to the outer edge of the sole in front of the media - tarsian element , having a general bean shape , and made of a flexible material so as to provide cushioning when walking this upper plantar pad 19 is between 2 and 4 mm in height and is made of any flexible material well known to a person skilled in the art . according to a final particularly advantageous variation , with reference to fig1 and 12 , the sole has means to stress , from the strike of the step usually performed by the heel , the articular receptors located between the talus and the calcaneus and means guiding the progression of the foot along the physiological axis of the gait . these means basically consist in a profiled channel , called a console 14 , and a set of subscaphoidian 16 , subcuboidian 17 and medio - tarsian 18 profiled elements distributed along the entire length of the sole to create a rail around which the foot is guided . moreover , the sole has , in the same way as before , an upper plantar pad 19 . this variation differs from the previous one by the fact that the console 14 is located on the lower face . in this way , apart from its function of stressing the articular receptors during the strike of the step , the console 14 has a straightening function . in order to enable the rapid supply of soles to patients , the invention also includes a conventional foot cast taking device 100 , with reference to fig1 and 14 , enabling a foot cast to be taken by the transfer of ink or by the deformation of foam for example , well known to a person skilled in the art , and a transparent or translucent template 110 having pre - defined lines 120 corresponding to the position of the metatarsal heads for different sizes . thus , all that is required is to take the patient &# 39 ; s foot cast then match the rear part of the template to the rear part of the heel of the cast thus taken and read the corresponding size . as the rear part of the foot cast is 6 mm further forward than the rear part of the heel , the template has been designed with this difference in mind . all that is then required is to insert the retrocapital corrective elements 1 and / or 2 and 3 into the recess 4 of the sole corresponding to the size measured and cut the lower anterocapital element 8 of the sole at the cutting lines 9 , if necessary , in order to create a corrective sole to eliminate the patient &# 39 ; s callus or calluses . said callus or calluses disappear in about a month and the correction made prevents any appearance of new calluses . lastly , it is very clear that the examples just given are merely particular illustrations and are in no way limiting as regards the fields of application of the invention .

an orthopedic insole capable of being inserted into a shoe or the like for relieving and / or treating skin disorders and / or calluses and / or metatarsal pain comprises at least one semi - rigid corrective element capable of producing an inner metatarsal support , over the rear portion of the head of the first metatarsal , and / or a median metatarsal support , over the rear portion of the second and / or third and / or fourth metatarsal head , and / or an external metatarsal support , over the rear portion of the fifth metatarsal head .

referring to fig1 , the anatomy of an infrarenal abdominal aortic aneurysm comprises the thoracic aorta ( ta ) having renal arteries ( ra ) at its distal end above the iliac arteries ( ia ). the abdominal aortic aneurysm ( aaa ) typically forms between the renal arteries ( ra ) and the iliac arteries ( ia ) and may have regions of mural thrombus ( t ) over portions of its inner surface ( s ). fig2 illustrates a filling structure 201 embodying aspects of the invention . filling structure 201 comprises central lumen 204 defined by luminal wall 202 , outer wall 209 , and reinforcing sleeve 203 . fill tube 208 is attached to a cannula during placement of the device , and allows hardenable filling material to enter the interior volume of the filling structure , then seals itself to prevent backflow of filling material when the cannula is removed . fill tube 208 may comprise a tear line 210 created by a partial perforation or notched edges . the tear line allows part or the entire exterior portion of the fill tube to be removed when the fill cannula is removed so that none of the fill tube protrudes beyond the filling structure once the filling structure is placed . this prevents contact between the fill tube and the artery wall , reducing the risk of thrombosis . still referring to fig2 , reinforcing sleeve 203 may be laminated , welded , sewn , or adhesively attached to central lumen 204 , or may be a separate sleeve that is placed over central lumen 204 during the assembly process . both reinforcing sleeve 203 and central lumen 204 may vary in diameter in order to conform more closely to the natural diameter of the target artery , particularly at the ends . this may afford superior sealing by matching the diameter of the filling structure more closely to the diameter of the neck of the aneurysm . as shown in fig3 , a filling structure 301 may be constructed such that inner lumen 303 varies in diameter over the length of the filling structure in order to increase filled volume 305 and improve sealing against one or more necks of the aneurysm . in one aspect , the filling structure 301 has an exterior wall 302 and a lumen 303 . the lumen 303 has a larger diameter 304 at each end than at a point therebetween , and may comprise a cylindrical middle portion 303 a with one or more conical end portions 303 b . the slope of the shoulder of conical end portions 303 b may be chosen to control the shape of filling structure 301 after it is filled . choosing a maximum diameter of conical section 303 b that is close to the outside diameter of the filling structure results in a more circular cross - section , while a smaller maximum diameter relative to the outside diameter of filling structure 301 results in an oval or eye - shaped cross - section . other taper profiles for the inner lumen may be selected ; for example it is possible to use a parabolic or hyperbolic profile to provide a continuous transition from one inner diameter to another , which may reduce turbulent flow in the lumen . note that the foregoing description is for exemplary purposes and is not meant to exclude other diameter profiles . fig4 illustrates a filling structure 401 comprising at least two filling compartments . endoframe 402 may be used to support the filling structure while it is being filled , maintaining a diameter of interior lumen 403 inner compartment 404 may be connected directly to a fill valve 407 such that filling material enters compartment 404 forming an inner polymer jacket 405 before flowing to outer compartment 406 . in this aspect the two compartments may be in fluid communication with each other , optionally with a restriction between the two compartments such that the viscosity of the filling medium inflates the inner compartment fully before filling the outer compartment . u . s . patent application ser . no . 12 / 429 , 474 ( attorney docket no . 025925 - 002610us ) discloses various delivery system configurations and methods for delivering and deploying a filling structure that may be used for any of the filling structures disclosed herein , the entire contents of which are incorporated herein by reference . in an alternate aspect , inner compartment 404 may be separated from outer compartment 406 and each compartment may have a separate fill valve similar to fill valve 407 . in this case valve 407 communicates with the inner compartment and another fill valve ( not shown ) communicates with the outer compartment . this permits the use of two different filling media , each with potentially different material properties . for example , the inner compartment - filling medium may be selected for a fast cure time to allow rapid removal of the endoframe 402 , or for a larger bulk modulus to provide enhanced resistance to pulsatile pressure . the outer compartment - filling medium may for example be selected for enhanced adhesion to an inner wall of filling structure 401 . separate fill valves also allow the compartments to be filled in a controlled order . in one aspect , the inner compartment is filled before the outer compartment to allow the inner compartment to be fully filled , providing a solid structure for resisting pulsatile pressure . the outer compartment is then filled sufficiently to fill the aneurysm sac without overloading the artery wall . referring now to fig5 a , we describe an exemplary method of placing and filling a multi - partition filling structure in an aneurysm 500 . furled filling structure 501 is introduced to the aneurysm on guidewire 503 and cannula 502 . sheath 504 is withdrawn to release filling structure 501 . cannula 502 contains guidewire 503 as well as one or more optional lumens ( not illustrated ) for filling the filling structure compartments , and possibly for introducing an endoframe and expansion balloon , as well as lines permitting detachment of the filling structure and other components from the cannula for deployment . continuing to fig5 b , the unfurled filling structure may be unfurled completely by filling with a solution containing contrast agent , saline , combinations thereof , as well as other fluids . this is advantageous since the walls of the filling structure may stick against adjacent walls , especially after terminal sterilization and storage . once unfurled , the volume of solution required to unfurl may be used as an estimate of the volume of hydrogel mix to introduce in order to fill the aneurysm sac completely without overpressure on the wall . continuing to fig5 c , endoframe 505 may be introduced into the inner lumen of filling structure 501 to support the inner lumen during the hydrogel filling step . endoframe 505 may be self - expanding , or may be expanded by an expandable member such as a balloon ( not illustrated ) introduced via cannula 502 . endoframe 505 may be withdrawn after the filling step , or may be left in place indefinitely . continuing to fig5 d , uncured liquid hydrogel is introduced through cannula 502 into inner partition 506 of filling structure 501 . in one aspect , inner partition 506 may be in restricted fluid communication with outer partition 507 of filling structure 501 . in this case , once inner partition 506 is filled , hydrogel flows to outer partition 507 via a passageway . the hydrogel &# 39 ; s viscosity in combination with the cross - section area of the passageway causes inner partition 506 to stay inflated while outer partition 507 fills with the remaining volume of hydrogel until filling structure 501 completely fills the aneurysm sac . in another aspect , inner partition 506 and outer partition 507 may be filled by independent filling tubes ( not illustrated ) in cannula 502 . in this aspect , inner partition 506 is filled until a measured pressure of the hydrogel reaches a threshold pressure , or until a dispensed volume of hydrogel reaches a threshold volume indicating complete filling of inner partition 506 . then outer partition 507 is filled with the remaining volume of hydrogel as estimated in the pre - fill step described previously . note that the filling structure may comprise more than two compartments , in which case the filling process continues until all compartments are properly and completely filled . once the hydrogel cures — preferably in less than ten minutes , and more preferably in less than five minutes , and even more preferably in less than about 4 minutes , the filling tubes may be detached from the filling structure and the cannula and guidewire may be withdrawn . note that this process may be conducted on two filling structures simultaneously , with one filling structure inserted through each iliac artery . filling of the filling structure may be performed with the endoframe expanded fully or partially , or the endoframe may be unexpanded . additionally , the expandable member may be partially or fully expanded , or unexpanded during the filling procedure . filling may also be visualized using fluoroscopy , ultrasound , or other methods in order to ensure that the filling structure properly expands and fills the aneurismal space . while the above is a complete description of the preferred embodiments of the invention , various alternatives , modifications , and equivalents may be used . therefore , the above description should not be taken as limiting in scope of the invention which is defined by the appended claims .

a system for treating an aneurysm includes a first double - walled filling structure having an outer wall and an inner wall . the filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a generally tubular lumen to permit blood flow therethrough . the inner wall comprises a blood contacting layer and a reinforcing layer . the reinforcing layer prevents circumferential creep or elastic expansion of the lumen .

this treatment is for diseases with or without chronic pain . in this invention , patients are diagnosed with an ailment and then treated in accordance with this invention . treatments are repeated periodically until symptoms of the ailment diminish or ameliorate . the treatment of this invention is designed to normalize various bodily functions including normalizing abnormal circulation , normalizing abnormal carbohydrate metabolism , decreasing inflammation and / or normalizing decreased immune system function . without being bound by any particular theory , the current working hypothesis is that the treatment of this invention is effective due to a combination of the following aspects of the treatment : low frequency electrical current passing through long sections of nerves ; electrode pad placement ; production of cyclic adenosine monophosphate ; the choice of the peripheral nerves being stimulated so there is a cross - over effect in the central nervous system ; leakage of action potentials from the nerves being stimulated into nerves entering the sympathetic ganglia ; the quadrilateral location of stimulation ; creation of action potentials in peripheral nerves being stimulated ; activation of the sodium pump in the nerves being stimulated ; production of acth ; production of dynorphins , enkephalins or beta - endorphins ; creation of action potentials in sympathetic fibers within the peripheral nerves being stimulated , which enter the sympathetic ganglia directly ; analgesia causing a reduction in the production of substance p ; production of melatonin ; and / or the production of circulation altering neuropeptides such as vasoactive intestinal polypeptide ( vip ) and calcitonin gene - related peptide ( cgrp ). by applying electrical currents in accordance with this invention , the treatment of this invention is effective for chronic pain but also many diseases and ailments which may or may not be painful and which heretofore have been thought to be unrelated . ailments treatable by this invention fall into several categories : ( 1 ) situations where the predominate mechanism is abnormal carbohydrate metabolism ; ( 2 ) situations where the predominate mechanism is poor to mediocre circulation ; ( 3 ) situations where the predominate mechanism is abnormal inflammation and ( 4 ) situations where the predominate mechanism is a poorly functioning immune system . while most diseases and ailments treatable by this invention involve all or most of these abnormalities , most diseases are primarily caused by one or two of these abnormalities . this is not to say that the ultimate cause of the ailments treatable by this invention are those abnormalities listed above . typically , the ultimate cause is some other factor , often genetics , that creates the abnormalities which this invention can ameliorate . abnormal carbohydrate metabolism is believed responsible , or at least substantially responsible , for alzheimer &# 39 ; s disease , cancer , diabetes type 1 and type 2 , narcotic withdrawal , fibromyalgia , gulf war syndrome , hypoglycemia , insomnia , irregular heart beat , irritable bowel syndrome , depression , bipolar disorder , low testosterone levels , panic attacks , parkinson &# 39 ; s disease , sleep apnea , and skin ulcerations . abnormal circulation is believed responsible , or at least substantially responsible , for brittle bone disease , crohn &# 39 ; s disease , cystic fibrosis , diabetes type 1 and type 2 , diabetic retinopathy , endometriosis , erectile dysfunction or impotence , fibromyalgia , gastroesophageal reflux disease commonly known as gerd &# 39 ; s , glaucoma , gulf war syndrome , hypercholesterolemia , hypertension , hypertriglyceridemia , hypoglycemia , insomnia , irregular heart beat , irritable bowel syndrome , depression , bipolar disorder , low testosterone levels , osteoporosis , panic attacks , parkinson &# 39 ; s disease , peripheral vascular disease , psoriasis , sickle cell anemia , sleep apnea , skin ulcerations , tmj disease , trigeminal neuralgia and ulcerative colitis . abnormal inflammation is believed responsible , or at least substantially responsible , for aids , als , alzheimer &# 39 ; s disease , cancer , congestive heart failure , gulf war syndrome , hypercholesterolemia , hypertension , hypertriglyceridemia , irregular heart beat , irritable bowel syndrome , parkinson &# 39 ; s disease , psoriasis , sickle cell anemia , skin ulcerations , tmj disease and ulcerative colitis . abnormal immune function is believed , responsible , or at least substantially responsible , for aids , cancer , crohn &# 39 ; s disease , cystic fibrosis , diabetes type 1 and type 2 , endometriosis , fibromyalgia , gulf war syndrome , irritable bowel syndrome , skin ulcerations and ulcerative colitis . in this invention , an electric circuit is established in the patient &# 39 ; s body . the circuit includes at least two , often four and ideally eight segments . each segment includes the nerve fibers having one terminus on an extremity , i . e . on the foot or hand of the patient , and one terminus adjacent a sympathetic nerve ganglia near a nerve ganglia adjacent a particular vertebra on the spinal column . some type of electrical connection , the exact details of which are as yet unknown , is made between the nerve ganglia adjacent the spinal column . it is clear that the circuit includes the nerve fibers which extend from the more distal aspect of a first peripheral nerve to its root adjacent the spinal column . it is believed the circuit continues through the root of the first nerve into the spinal column , through the spinal column and exits from the spinal column through the root of a second nerve . the circuit continues through the fibers of the second peripheral nerve to a more distal aspect of that nerve . the energy delivered through the circuit may be selected from a variety of electromagnetic types . although interferential electrical energy has so far been shown to be the most desirable , h - wave stimulation with a physical therapy device such as made by electronic waveform lab , huntington beach , calif ., galvanic stimulation with a physical therapy device such as a model sw made by rehabilicare corporation , st . paul , minn ., smp stimulation with a physical therapy device which creates constantly changing tens frequency such as made by rehabilicare corporation , st . paul , minn ., or matrix electrostimulation with a physical therapy device such as made by rehabilicare corporation , st . paul , minn ., have shown desirable effects . referring to fig1 and 6 , a patient 10 is illustrated as being treated in accordance with this invention by a conventional electrical interferential therapy device 12 such as available commercially from rehabilicare corporation of st . paul , minn . the device 12 includes a control panel 14 with output jacks 16 , 18 capable of accepting a jack 20 of an insulated wire pair 22 leading to electrode pairs 24 , 24 ′ and 26 , 26 ′. the dial 28 of the device 12 controls the amperage delivered to the electrodes and is set to deliver maximum amperage consistent with patient comfort . the electrode switch 30 is set to either two or four depending on whether one or two pair of electrodes are being used . the setting of the frequency switch 32 is subject to some adjustment . the frequency switch 32 controls the “ beat ” frequency . for example , if the setting is at ten , the patient receives ten beats per second . in fact , the frequency of the alternating current delivered by the device of rehabilicare is nominally 4000 hz and the frequency switch 32 acts to vary the frequency , at a setting of ten , to 4010 hz . in the event a more complete understanding of the device 12 is necessary , reference is made to appropriate publications of rehabilicare corporation . in this invention , the settings of the frequency switch 32 is normally below ten , and preferably below five and is optimally at four . the electrodes 24 , 26 are attached to the patient &# 39 ; s skin in a conventional manner , i . e . they are self adherent . the location of the electrodes 24 , 26 on the patient establish the electrical circuit in the patient &# 39 ; s body . as shown in fig1 , in one technique , one electrode 24 is placed adjacent the end or terminus of the right medial plantar nerve l 5 and its matching electrode or mate 24 ′ is placed adjacent the end or terminus of the left sural nerve s 1 , inferior to the left ankle bone ( lateral malleolus ) thereby establishing or creating a first circuit 34 in the patient &# 39 ; s body . as used herein , the reference characters l 5 , s 1 and the like are standard medical terminology for the nerve . those skilled in the art will recognize l 5 as being the nerve which extends away from the fifth lumbar vertebra and s 1 as being the nerve which extends away from the first sacral vertebra . those skilled in the art will recognize that the terminus of the right medial plantar nerve l 5 is located on the bottom of the right foot , approximately on the ball of the foot . the terminus of the left sural nerve s 1 is located below the left ankle bone ( lateral malleolus ). another electrode 26 is placed adjacent the terminus of the right sural nerve s 1 and its matching electrode or mate 26 ′ is placed adjacent the terminus of the left medial plantar nerve l 5 thereby establishing a second circuit 36 in the patient &# 39 ; s body . turning the device 12 on delivers electrical energy through the circuits 34 , 36 . experience has shown a decrease in pain in patients complaining of pain and a decrease in symptoms consistent with an imbalanced sympathetic nervous system . those skilled in the art will recognize that the medial plantar nerves l 5 and the sural nerves s 1 terminate adjacent the spinal column near adjacent spinal vertebra , in the area of the connection to the lumbar sympathetic ganglia . preferably , a second electrical interferential therapy device 12 ′ is used simultaneously with the first device 12 and another set of circuits is simultaneously established as suggested in fig2 . the electrical interferential therapy device 12 ′ is either a separate unit from the device 12 or they may be incorporated together in a single housing . in any event , an electrode 38 is attached to the patient &# 39 ; s skin adjacent the terminus of the right lateral plantar nerve l 5 and its matching electrode or mate 38 ′ is placed adjacent the terminus of the left saphenous nerve l 4 , at the ankle , thereby establishing a circuit 40 . those skilled in the art will recognize that the terminus of the right lateral plantar nerve l 5 is on the bottom of the right foot below the little toe and the fourth toe on the pad of the foot near the fifth metatarsal head . the terminus of the left saphenous nerve l 4 is on the top inside ( medial - anterior aspect ) of the left ankle . an electrode 42 is attached to the patient &# 39 ; s skin adjacent the terminus of the right saphenous nerve l 4 and its matching electrode or mate 42 ′ is placed adjacent the terminus of the left lateral plantar nerve l 5 thereby establishing a circuit 44 . those skilled in the art will recognize that the terminus of the right saphenous nerve l 4 is on the top inside of the right foot , forward of the right ankle . the terminus of the left lateral plantar nerve is on the bottom of the left foot below the little toe and the fourth toe on the pad of the foot . turning the device 12 on delivers electrical energy through the circuits 40 , 44 . the techniques of fig1 and 2 are preferably run simultaneously with similar or identical settings on the devices 12 , 12 ′. those skilled in the art will recognize that the lateral plantar nerves l 5 and the saphenous nerves l 4 terminate adjacent the spinal column near adjacent spinal vertebrae . another technique is shown in fig3 . an electrode 46 is placed adjacent the end or terminus of the nerve l 5 of the left forefoot plantar aspect . its matching electrode or mate 46 ′ is placed adjacent the end or terminus of the right cranial nerve c 8 where the fifth finger joins the right hand thereby establishing or creating a first circuit 48 in the patient &# 39 ; s body . another electrode 50 is placed adjacent the terminus of the left sural nerve s 1 on the lateral aspect of the left ankle and its matching electrode or mate 50 ′ is placed adjacent the terminus of the right cranial nerve c 6 where the thumb joins the hand thereby establishing a second circuit 52 in the patient &# 39 ; s body . turning the device 12 on delivers electrical energy through the circuits 48 , 52 . those skilled in the art will recognize that the nerves l 5 and the sural nerves s 1 terminate adjacent the spinal column near adjacent spinal vertebra , in the area of the connection to the lumbar sympathetic ganglia while the nerves c 6 , c 8 terminate adjacent the spinal column near spinal vertebrae that are far above the termini of the nerves l 5 , s 1 . a second electrical interferential therapy device 12 ′ may be used simultaneously with the first device 12 and another set of circuits may simultaneously established as suggested in fig4 so the circuits of fig3 and 4 are normally used together . an electrode 54 is attached to the patient &# 39 ; s skin adjacent the terminus of the nerve l 5 on the right forefoot planar aspect and its matching electrode or mate 54 ′ is placed adjacent the terminus of the cranial nerve c 8 on the left palmer surface where the fifth finger joins the hand thereby establishing a circuit 56 in the patient &# 39 ; s body . an electrode 58 is attached to the patient &# 39 ; s skin adjacent the terminus of the right sural nerve s 1 and its matching electrode or mate 58 ′ is placed on the left palmer surface adjacent the terminus of the left cranial nerve c 6 thereby establishing a circuit 60 . turning the device 12 ′ on delivers electrical energy through the circuits 56 , 60 . the techniques of fig1 and 2 are preferably run simultaneously with similar or identical settings on the devices 12 , 12 ′. those skilled in the art will recognize that the nerves l 5 and the sural nerves s 1 terminate adjacent the spinal column near adjacent spinal vertebra , in the area of the connection to the lumbar sympathetic ganglia while the nerves c 6 , c 8 terminate adjacent the spinal column near spinal vertebrae that are far above the termini of the nerves l 5 , s 1 . referring to fig5 , another set of circuits 62 , 64 is established . an electrode 66 is adhesively placed at the terminus of the cranial nerve c 8 on the left palmer surface where the fifth finger joins the hand and its matching electrode 66 ′ is placed at the terminus of the cranial nerve c 6 on the right palmer surface where the thumb joins the hand thereby establishing the circuit 62 . an electrode 68 is attached adjacent the terminus of the cranial nerve c 6 on the left palmar surface where the thumb joins the hand and its matching electrode or mate 68 ′ is placed adjacent the terminus of the cranial nerve c 8 on the right palmer surface where the fifth finger joins the hand thereby establishing the circuit 64 . a 47 year old caucasian male had been diagnosed as having diabetes type 2 for eight years . the patient developed erectile dysfunction / impotence three years after the diagnosis of diabetes . after 10 days of treatments , this problem disappeared . a 69 year old caucasian woman was diagnosed as having cataracts . the woman received the treatments twice a day for two months . she had been scheduled for cataract surgery . however , when her opthamologist examined her , she was advised that she no longer had cataracts and , therefore , the surgery was cancelled . a 45 year old caucasian woman had been advised years previously that she had glaucoma . she had tried a variety of prescription medications , without improvement . within 30 days of treatment the patient &# 39 ; s ophthalmologist retested the patient &# 39 ; s intraocular pressure and found that the pressure had normalized . a 24 year old caucasian woman had been diagnosed as having diabetes type 1 when she was 14 years old . following 30 days of treatments , the patient reported that she was using less than one half the amount of insulin that she had used prior to the treatments . a 29 year old veteran of the gulf war had all of the symptoms of gulf war syndrome . however , after 30 days of treatment , the patient no longer had any symptoms of gulf war syndrome . a 14 year old caucasian girl had been diagnosed as having bipolar disorder . numerous medications had been utilized without success . she was given the treatments twice per day and after 14 days of treatment , she no longer exhibited the behaviors which resulted in her diagnosis of bipolar disorder . a 60 year old caucasian man had been diagnosed as having diabetes type 2 for many years was advised by an ophthalmologist that he had significant diabetic retinopathy . however , after three months of treatments , he was advised that he no longer had the diabetic retinopathy . a 44 year old caucasian woman was diagnosed as having severe hypercholesterolemia . however , after receiving 90 days of treatments follow - up blood tests showed that her cholesterol level was nearly normal . a 50 year old caucasian an was diagnosed as having severe hypertriglyceridemia . however , after receiving 90 days of treatments follow - up blood tests showed that his triglyceride level was nearly normal . a 62 year old caucasian man was diagnosed as having alzheimer &# 39 ; s disease . he received twice a day treatments for 30 days . at the end of that time his daughter said her father was able to read the newspaper and carry on a normal conversation and that he was unable to do either of these before beginning treatments . a sixty five year old caucasian woman was diagnosed as having ovarian cancer . the patient received once per day treatments for two months . after one month , she was able to discontinue her wheelchair . after two months of treatment , a ct scan was no longer able to identify a malignant lesion . a 48 year old hispanic man was diagnosed as having sleep apnea , on the basis of sleep studies . the patient began twice per day treatments for one month and , thereafter , once per day treatments for four months . at the end of this time the patient had sleep studies , which showed that he no longer had sleep apnea . a six year old caucasian boy was diagnosed as having autism at age 5 . he received nightly treatments for 20 minutes through his feet and hands . normally , his parent would have to drag him up the sidewalk to the special school he attended . however , the day following his first treatments he walked into the autism school without objection . in addition , within two weeks , he was trying to verbalize much more than he was prior to beginning treatments . a 44 year old hispanic woman had suffered from insomnia for more than 20 years and only slept fitfully for three to four hours per night . the patient received twice per day treatments for one month . by the end of the month of treatment , the patient was sleeping six to eight hours per night and reported sleeping very soundly . a 66 year old caucasian man had a two centimeter ulceration , on the dorsum of this right foot . the patient began twice per day treatments for one month . at the end of this time the ulceration was completely healed . a cardiologist diagnosed a 66 year old caucasian man as having an irregular heart beat and placed upon appropriate medication . in spite of this medication , he continued to exhibit irregular heat beating . the patent began twice per day treatments . within two weeks , his heart rate became regular . after another month , he was able to stop taking the medication , without resumption of his irregular heartbeat . a 64 year old caucasian man had been diagnosed as having diabetes type 2 more that 25 years before . prior to beginning treatments , his blood sugar was very high , in spite of , taking insulin . after six months of treatments , his blood sugar was low , in spite of , taking no insulin . a 45 year old hispanic man had a chief complaint of grinding his teeth , while sleeping , which was verified by his wife . the patient began twice per day treatments for one month . at the end of this time the patient &# 39 ; s wife stated that he no longer ground his teeth while sleeping . a 38 year old caucasian woman was diagnosed as having irritable bowel syndrome . the patent suffered from diarrhea and constipation . the patient began twice per day treatments . within one month , the diarrhea and constipation stopped . a 24 year old caucasian woman was diagnosed as having tmj disease . the patient began twice per day treatments for one month and , thereafter , one treatment per day for two months . at the end of this time the patient had no symptoms of tmj . a 64 year old caucasian man was being treated for kidney failure due to hypertension and diabetes . he had been advised that this kidneys were failing and that he only had approximately 50 % or normal kidney function . a nephrologist advised the patient that the patient should expect that he would be on renal dialysis within 2 years . the patient began twice per day treatments for one month followed by once per day treatment thereafter . after nine months of treatments his nephrologist advised the patient that his kidney function was now normal . a 60 year old hispanic man was being treated for low testosterone blood levels . the patient began twice per day treatment for one month followed by once per day treatment thereafter . following four months of treatment the patient had normal blood levels of testosterone , even though his supplemental medications had been discontinued . an obese 38 year old caucasian woman began twice per day treatments for one month and , thereafter , once per day treatments for four months . at the end of the first month , the patient noticed that she was losing weight even though she had not changed her diet . the patient continued to lose weight throughout her treatment period , even though she never altered her diet . a 60 year old hispanic man was diagnosed as having osteoporosis , with a bone mineral density of 70 % of normal for his age and sex . the patient began twice per day treatments for the first month followed by once per day treatments thereafter . after six months of treatment , the bone mineral density was 98 % of normal for his age and sex . a 45 year old caucasian woman had been diagnosed , 7 years previously , as having depression . the patient reported that , within 30 days of receiving twice a day treatments , she felt much less depressed and had a much more positive outlook on life . a 25 yard old caucasian woman was diagnosed as having panic attacks . the patient began twice per day treatments for one month . at the end of one month , the patient was able to be in crowds and in elevators , without experiencing panic attacks . a 58 year old caucasian man was diagnosed as having parkinson &# 39 ; s disease by his neurologist . the patient began twice per day treatments for one month and , thereafter , once per day treatments for six months . during this time the patient &# 39 ; s tremors stopped , his memory markedly improved , and he was able to walk much more normally . a 47 year old caucasian woman had taken oral medication for hypertension , since she was 17 years old , however , after 4 months of treatment , she was able to stop taking the medication for hypertension and still had normal blood pressure , a 14 year old caucasian girl was diagnosed with hypoglycemia . however , after 30 days of treatment , the girl stated that she no longer was shaky before meals , nor did she have a headache if she did not eat on schedule . the girl &# 39 ; s glucose tolerance test showed that she no longer had hypoglycemia . a 45 year old caucasian man was diagnosed as having psoriasis . the patient began twice per day treatments for one month and , thereafter , once per day treatments for three months . at the end of this time , the patient &# 39 ; s psoriatic lesions had virtually disappeared . a 3 year old caucasian boy was diagnosed as having influenza with early pneumonia , with audible lung involvement . after three days of twice a day treatments , the influenza symptoms resolved and the lungs were clear . a 3 year old caucasian boy , the twin of the subject of case study 32 , was diagnosed as having influenza . after two days of twice a day treatments the influenza symptoms resolved . it would seem unlikely that the same , or substantially the same , treatment would have a beneficial effect on such a large number of diverse ailments . even though these ailments seem unrelated , there are , in fact , root causes which are ameliorated by the treatments of this invention . by passing impulses from the periphery to the central nervous system , this invention appears to help the body manufacture various neuropeptides and other chemicals , which control the essential basics of the body &# 39 ; s health and well being . although this invention has been disclosed and described in its preferred forms with a certain degree of particularity , it is understood that the present disclosure of the preferred forms is only by way of example and that numerous changes in the details of operation and in the combination and arrangement of parts may be resorted to without departing from the spirit and scope of the invention as hereinafter claimed .

a method of treating a wide variety of heretofore considered unrelated ailments comprises delivering electricity through a circuit in the body . the circuit includes at least four nerves leading from at least two of the patient &# 39 ; s extremities to various nerve roots adjacent the spinal column . electrical energy from an electrical interferential therapy device is delivered through electrodes on the extremities adjacent the nerve endings until symptoms of the diagnosed ailment ameliorates . sending impulses from the periphery to the central nervous system appears to the help the body manufacture various neuropeptides and other chemicals which control the essential basics of the body &# 39 ; s health and well being .

this invention relates generally to garments , and more specifically , to a lower body garment with a two slider invisible zipper . specific details of certain embodiments of the invention are set forth in the following description , fig1 - 5 and in the appendix to provide a thorough understanding of such embodiments . the present invention may have additional embodiments , may be practiced without one or more of the details described for any particular described embodiment , or may have any detail described for one particular embodiment practiced with any other detail described for another embodiment . fig1 a and 1 b are front views of a lower body garment with a two slider invisible zipper 1 , in accordance with an embodiment of the invention . fig1 a depicts the garment with an open invisible zipper , and fig1 b depicts the garment with a closed invisible zipper . in some embodiments , a lower body garment with a two slider invisible zipper may be a pair of pants . in different embodiments , a lower body garment with a two slider invisible zipper may be another type of garment . for example , in some embodiments , a garment with compartments may be shorts , or any other garment worn on the lower body . in the exemplary embodiment , a lower body garment with a two slider invisible zipper 1 may include an invisible zipper 2 , the invisible zipper having a first slider 3 and a second slider 4 , the first and second sliders operable to open and shut the chain 23 of the invisible zipper . the exemplary embodiment may further include a waistband 10 , a left leg portion 11 and a right leg portion 12 . the waistband surrounds the waist of the wearer , encircling the wearer from front to rear , with the left leg and right leg portions joined to the waistband . in some embodiments , the left and right leg portions 11 and 12 are divided in between the legs of the wearer by a seam 16 . the seam is defined at least in part by the invisible zipper 2 . the invisible zipper couples the left and right leg portions beginning at a front portion 14 of the waistband and extending downwards along the seam between the left and right leg portions , through at least the crotch portion 13 , the crotch portion dividing the left and right leg portions , and to at least a perineum portion 17 , the perineum portion being the portion of the seam in the vicinity ( vicinity meaning from zero to four inches in either direction along the seam ) of the perineum of the wearer . in some embodiments the invisible zipper may end at the perineum portion , with the seam 16 continuing upward to a point just below the rear portion 15 of the waistband . in a preferred embodiment the invisible zipper continues past the perineum portion upwards all the way to the point just below the rear of the waistband , the invisible zipper defining the seam between the left and right leg portions all the way from the waistband at its front to the waistband at its rear . while the closed position of the first slider , and thus the first end of the invisible zipper , will usually be at the front of the waistband , in some embodiments the end of the invisible zipper opposite the first end may be at any point in between the perineum portion and the rear of the waistband . in some embodiments , the invisible zipper 2 is not visible from the exterior of the garment when the invisible zipper is closed . the construction of the left and right leg portions 11 and 12 of the garment in the vicinity of the seam 16 is such that the invisible zipper is hidden from view when the invisible zipper is closed . the invisible zipper is hidden by left and right interior flaps 33 and 34 of the garment , the flaps being defined by folds 31 and 32 in the left and right leg portions of the garment . the aforementioned construction will be discussed further relative to fig3 a and 3 b . in some embodiments , the invisible zipper further comprises left and right zipper tapes 21 and 22 , a zipper chain 23 which is coupled to the left and right zipper tapes 21 and 22 , and the first and second sliders 3 and 4 . the left zipper tape is coupled with the left leg portion of the garment at the seam , and the right zipper tape is coupled with the right leg portion of the garment at the seam . in some embodiments , the first and second sliders 3 and 4 of the invisible zipper 2 may slide along the entire length of the zipper chain 23 . in some embodiments , when the first and second sliders are at first and second slider closed positions 18 and 19 , the invisible zipper is closed and the left leg and right leg portions 11 and 12 are coupled at the seam 16 . in some embodiments , the first slider closed position 18 is at the front of the waistband . in some embodiments , the second slider closed position 19 is at the end of the zipper opposite the front of the waistband . in some embodiments , the second slider closed position 19 is just below the rear of the waistband 15 . in some embodiments , the first slider 3 may have a first zipper pull 24 coupled to the first slider . in some embodiments , the second slider 4 may have a second zipper pull 25 ( not depicted in fig1 a and 1 b but visible in , for example , fig2 a ) coupled to the second slider . the first and second zipper pulls will generally be accessible from the exterior of the garment . in some embodiments , the garment may have an elastic or other expandable strap sewn into the waistband , the strap having a fastex or other snap - lock buckle providing an additional closure of the garment around the waist . in some embodiments , the buckle additionally conceals the first zipper pull between the buckle and the garment . in some embodiments , the invisible zipper 2 is a waterproof zipper . in some embodiments , the first slider and second slider have zipper pulls configured for enabling a wearer to open or close the invisible zipper , the zipper pulls being sized such that they may be pulled by a wearer wearing one of mittens or gloves . fig2 a , 2 b and 2 c are rear views of a lower body garment with a two slider invisible zipper , in accordance with an embodiment of the invention . in some embodiments , the lower body garment with a two slider invisible zipper 1 may have a compartment 5 , the compartment operable to conceal a rear zipper pull 25 ( the rear zipper pull coupled to the second slider 4 of the invisible zipper 2 ), the compartment being located directly below a rear portion 15 of the waistband 10 , at a closed position for the second slider 19 . it will be understood that the second slider may slide along the length of the invisible zipper , from the rear portion of the waistband in some embodiments beyond the perineum portion 17 and all the way to the front portion 14 of the waistband . in some embodiments , the compartment 5 is disposed directly below the bottom portion 15 of the waistband 10 . at least a portion of the left and right portions 11 and 12 of the garment , including the folds in the left and right portions 31 and 32 of the garment , are stitched together at the seam 16 to define the compartment . when the second slider 4 is at the closed position 19 for the second slider , the left and right portions of the garment that are stitched together cover the second slider . below the compartment , the folds in the left and right portions 31 and 32 of the garment are not stitched together , allowing the left and right portions to separate when the invisible zipper 2 is opened . fig3 a and 3 b are an interior view and a top cross - sectional view of a lower body garment with a two slider invisible zipper , in accordance with an embodiment of the invention . fig3 a is a view of the interior of the garment , looking at the rear of the garment near its top . in some embodiments , the invisible zipper 2 is constructed by coupling the left and right portions 11 and 12 of the garment with the left and right zipper tapes 21 and 22 of the invisible zipper . particularly , the left and right portions of the garment are folded over at 31 and 32 , creating a left interior flap 33 and right interior flap 34 . the left and right zipper tapes 21 and 22 are stitched along lines a - a to the left and right interior flaps 33 and 34 . this construction defines the invisible zipper 2 , in which the left and right interior flaps lay on the exterior of the invisible zipper , making the line along which the invisible zipper runs appear to be a fixed seam and concealing the invisible zipper from exterior view . the sliders ( second slider 4 being depicted in fig3 a and 3 b , although this describes how the first slider is concealed as well ) slide along the zipper tapes and behind the interior flaps . the zipper pulls ( second zipper pull 25 depicted in fig3 a and 3 b , although this describes how the first zipper pull is concealed as well ) sit in between the zipper tapes and the interior flaps . in some embodiments , the compartment 5 is formed just below the rear portion 15 of the waistband 10 . the compartment is disposed at the closed position for the second slider 19 , and is sized to hide at least the second zipper pull 25 of the second slider 4 when the second slider is at the closed position for the second slider . the compartment is formed by a stitch 51 ( stitch 51 being the zig - zag line in between the sides of the chain of the invisible zipper 2 in fig3 a ) that couples the left and right interior flaps 33 and 34 for a length at least as long as the second zipper pull 25 . stitch 51 joins the left and right interior flaps at the folds in the left and right leg portions 31 and 32 , along a line b - b . fig4 is a front view of an alternate embodiment of a lower body garment with a two slider invisible zipper , in accordance with an embodiment of the invention . in some embodiments , an invisible zipper 2 having a chain may chafe if worn directly against the skin of the wearer . accordingly , a flap 6 may be disposed along the entire length of the invisible zipper 2 , from the front 14 of the waistband 10 all the way to the point below the rear 15 of the waistband . the flap 6 may be coupled to either the left leg portion 11 or the right leg portion 12 of the garment 1 . in different embodiments without a flap , the wearer may wear an undergarment such as underwear ( underwear not pictured ) in between the body and the garment 1 . in some embodiments , the underwear has an aperture disposed between the legs of the underwear from the front of a waistband of the underwear to the rear of a waistband of the underwear . in some embodiments , the underwear comprises at least a section of the left leg portion and a section of the right leg portion wherein the sections overlap one another , such that the sections can be pulled apart defining the aperture . in some embodiments , the invention comprises a system including the aforementioned underwear and the garment 1 , in which a slider of the invisible zipper 2 can be opened and the sections of the underwear are pulled apart , defining an aperture in both the garment 1 and the underwear . fig5 is a perspective view of a lower body garment with a two slider invisible zipper in accordance with an embodiment of the invention . the function and structure of the elements in fig5 are consistent with the descriptions related with respect to fig1 - 3 . while preferred and alternative embodiments of the invention have been illustrated and described , as noted above , many changes can be made without departing from the spirit and scope of the invention . accordingly , the scope of the invention is not limited by the disclosure of these preferred and alternate embodiments . instead , the invention should be determined entirely by reference to the claims that follow .

a lower body garment with an extended invisible zipper that extends past the perineum . the zipper may extend further upwards along the posterior of the wearer , perhaps to the waistline . the zipper is an invisible zipper having two sliders , a first slider which may unzip from the front to the back , and a second slider which may unzip from the back to the front . one or both sliders may tuck into a compartment , which in conjunction with the invisible zipper construction prevent others from knowing the wearer &# 39 ; s pants may be unzipped from the rear . a flap may cover the chain of the zipper on the inside of the pants . a system may include pants or shorts with a two slider invisible zipper , and underwear including a flap from front to back forming an aperture sized the same as the aperture in the pants at the zipper .

fig1 , 3 a and 3 b show a hairdryer 10 with a handle 20 and a body 30 . the handle has a first end 22 which is connected to the body 30 and a second end 24 distal from the body 30 and which includes a primary inlet 40 . power is supplied to the hairdryer 10 via a cable 50 . referring now to fig2 and 3 a in particular which show a simplified version of the internal components of the hairdryer , the handle 20 has an outer wall 200 which extends from the body 30 to a distal end 24 of the handle . at the distal end 24 of the handle an end wall 210 extends across the outer wall 200 . the cable 50 enters the hairdryer through this end wall 210 . the primary inlet 40 in the handle 20 includes first apertures that extend around and along 42 the outer wall 200 of the handle and second apertures that extend across 46 and through the end wall 210 of the handle 20 . the cable 50 is located approximately in the middle of the end wall 210 so extends from the centre of the handle 20 . it is preferred that the cable 50 extends centrally from the handle 20 as this means the hairdryer is balanced regardless of the orientation of the handle 20 in a users &# 39 ; hand . also , if the user moves the position of their hand on the handle 20 there will be no tugging from the cable 50 as it does not change position with respect to the hand when the hand is moved . if the cable were offset and nearer one side of the handle then the weight distribution of the hairdryer would change with orientation which is distracting for the user . upstream of the primary inlet 40 , a fan unit 70 is provided . the fan unit 70 includes a fan and a motor . the fan unit 70 draws fluid through the primary inlet 40 towards the body 30 through a fluid flow path 400 that extends from the primary inlet 40 and into the body 30 where the handle 20 and the body 30 are joined 90 . the fluid flow path 400 continues through the body 30 , around a heater 80 and to a primary fluid outlet 440 where fluid that is drawn in by the fan unit exits the primary fluid flow path 400 . the primary fluid flow path 400 is non linear and flows through the handle 20 in a first direction and through the body 30 in a second direction which is orthogonal to the first direction . the body 30 has a first end 32 and a second end 34 and includes an outer wall 360 and an inner duct 310 . the primary fluid flow path 400 extends along the body from the junction 90 of the handle 20 and the body 30 between the outer wall 360 and the inner duct 310 towards the primary fluid outlet 440 at the second end of the body 30 . another fluid flow path is provided within the body ; this flow is not directly processed by the fan unit or the heater but is drawn into the hairdryer by the action of the fan unit producing the primary flow through the hairdryer . this fluid flow is entrained into the hairdryer by the fluid flowing through the primary fluid flow path 400 . the first end 32 of the body includes a fluid inlet 320 and the second end 34 of the body includes a fluid outlet 340 . both the fluid inlet 320 and the fluid outlet 340 are at least partially defined by the inner duct 310 which is an inner wall of the body 30 and extends within and along the body . a fluid flow path 300 extends within the inner duct from the fluid inlet 320 to the fluid outlet 340 . at the first end 32 of the body 30 , a side wall 350 extends between the outer wall 360 and the inner duct 310 . this side wall 350 at least partially defines the fluid inlet 320 . at the second end 34 of the body a gap 370 is provided between the outer wall 360 and the inner duct 310 , this gap 370 defines the primary fluid outlet 440 . the primary fluid outlet 440 is annular and surrounds the fluid flow path . the primary fluid outlet 440 may be internal so the primary fluid flow path 400 merges with the fluid flow path 300 within the body 30 . alternatively , the primary fluid outlet 440 is external and exits from the body 30 separately to the fluid from the fluid flow path 300 at the fluid outlet 340 . a printed circuit board ( pcb ) 75 including the control electronics for the hairdryer is located in the body 30 near the side wall 350 and fluid inlet 320 . the pcb 75 is ring shaped and extends round the inner duct 310 between the inner duct 310 and the outer wall 360 . the pcb 75 is in fluid communication with the primary fluid flow path 400 . the pcb 75 extends about the fluid flow path 300 and is isolated from the fluid flow path 300 by the inner duct 310 . the pcb 75 controls such parameters as the temperature of the heater 80 and the speed of rotation of the fan unit 70 . internal wiring ( not shown ) electrically connects the pcb 75 to the heater 80 and the fan unit 70 and the cable 50 . control buttons 62 , 64 are provided and connected to the pcb 75 to enable a user to select from a range of temperature settings and flow rates for example . in use , fluid is drawn into the primary fluid flow path 400 by the action of the fan unit 70 , is optionally heated by the heater 80 and exits from the primary fluid outlet 440 . this processed flow causes fluid to be entrained into the fluid flow path 300 at the fluid inlet 320 . the fluid combines with the processed flow at the second end 34 of the body . in the example shown in fig2 , the processed flow exits the primary fluid outlet 440 and the hairdryer as an annular flow which surrounds the entrained flow that exits from the hairdryer via the fluid outlet 340 . thus fluid that is processed by the fan unit and heater is augmented by the entrained flow . referring now to fig3 a , 3 b and 4 which shows the primary inlet area in more detail , a device 100 for distributing wires 102 , 104 has a central hub 110 which houses the cable 50 and a pair of arms 120 , 122 which house the wires 102 , 104 as they are routed from the central hub 110 towards an inner wall 220 of the handle 20 of hairdryer 10 . the inner wall 220 has a greater diameter than the central hub 110 so the wires 102 , 104 with the arms 120 , 122 extend from the central hub 110 radially outwards towards the inner wall 220 forming a generally “ y ” shaped device 100 . referring to fig4 in particular , the inner wall 220 is formed from two parts 220 a , 220 b ; this simplifies assembly of the parts that are housed within the inner wall 220 . for example parts such as the fan unit 70 and wires 102 , 104 may be placed within one of the two parts of the inner wall 220 then when all the parts are aligned correctly , the two parts of the inner wall 200 may be joined together to form an inner handle of the hairdryer 10 . the wires 102 , 104 are housed within the arms 120 , 122 which can be hollow shells but are alternatively solid with recesses adapted to accommodate a wire passing through the arm . referring to fig5 in particular , the inner wall 220 includes a pair of recesses 224 , 226 which in this example are partly formed in each of the two parts of the inner wall 220 a , 220 b and when the two parts of the inner wall 220 a , 220 b are assembled the pair of recesses 224 , 226 are created to house the wires 102 , 104 . thus , the wires 102 , 104 are protected from being snagged or caught and are safely out of the fluid flow path 400 where they would cause some disruption to the flow of fluid . the cable 50 includes a live wire 104 and a neutral wire 102 . the neutral wire 102 passes from the device for distributing wires 100 and into one of the recesses 226 and live wire 104 also passes from the device for distributing wires 100 and into a second recess 224 . referring to fig2 a and 5 to 7 in particular , the fan unit 70 is supported within the inner wall 220 by two annular seats which retain the motor longitudinally within the inner wall 220 and thus the handle 20 . the recesses 224 , 226 could continue passed the fan unit 70 , however in this embodiment , the recesses 224 , 226 are discontinued where they meet the first annular seat 242 . both the neutral wire 102 and the live wire 104 are routed from their respective recesses 224 , 226 radially around the inner wall 220 a and then longitudinally along a pair of channels 240 formed within the inner wall 220 a . the pair of channels 240 is designed to receive the live wire 104 and the neutral wire 102 and hold those wires in place around the fan unit 70 . in order to fit the wires 102 , 104 within the inner wall 220 , the inner wall 220 is has a greater thickness t 1 in the vicinity of the wires 102 , 104 compared to the thickness t 2 of the inner wall 220 diametrically opposite the wires 102 , 104 . the thickness of the inner wall 220 may also vary along the length of the fan unit 70 . the inner wall 220 has an outer surface 230 having a central axis e and an inner surface 232 having a central axis f . axes e and f are different thus the fluid flow path 400 does not flow centrally through the inner wall 220 or the handle 20 of the hairdryer . the fan unit 70 is disposed approximately centrally of the inner surface 242 of the inner wall 220 within motor mount 72 . the central axis m of the fan unit 70 is substantially the same as the central axis f of the inner surface 232 of the inner wall 200 . the central axis m of the fan unit is offset with respect to the central axis f of the outer surface 230 of the inner wall 200 and the central axis w of the outer wall 200 . having a variable thickness in the inner wall 220 along with a fan unit 70 and fluid flow path 400 which are off - centre within the outer wall 200 of the handle 20 means that the diameter of the outer wall 200 of the handle 20 can be reduced compared to the diameter that would be required if all those components were axially aligned , for example by having a constant thickness around the circumference of the inner wall 220 . upstream of the fan unit 70 is a control switch 62 . in order to simplify the wiring within the hairdryer , the control switch 64 is approximately radially disposed in line with the pair of channels 240 . the invention has been described in detail with respect to a hairdryer however , it is applicable to any appliance that draws in a fluid and directs the outflow of that fluid from the appliance . the appliance can be used with or without a heater ; the action of the outflow of fluid at high velocity has a drying effect . the fluid that flows through the appliance is generally air , but may be a different combination of gases or gas and can include additives to improve performance of the appliance or the impact the appliance has on an object the output is directed at for example , hair and the styling of that hair . the invention is not limited to the detailed description given above . variations will be apparent to the person skilled in the art .

a hand held appliance including a wall , a fluid flow path extending within the wall from a fluid inlet into the appliance to a fluid outlet from the appliance , a fan unit extending longitudinally within the wall for drawing fluid into the fluid inlet wherein the fan unit is non - concentric with respect to the wall . the fan unit may be positioned coaxially within the fluid flow path . the wall has a thickness and the thickness of the wall may varies . the wall may be generally tubular and the thickness of the wall varies around a circumference of the wall . the wall may be generally tubular and has an inner surface and an outer surface . a central axis of the inner surface may be different to a central axis of the outer surface .

referring to fig1 and 2 , a catheter that is an embodiment of the present invention is shown . it is to be understood that embodiments of the invention may take the form of a typical catheter , a guide catheter , an introducer sheath or the like . catheter cylindrical body 9 features luer lock hub 10 mounted on its proximal end 11 and a central lumen 12 through which a guide wire and other devices may be passed . the proximal portion 21 of catheter body 9 is fixed so as to provide rigidity . catheter body 9 is preferably constructed of either a plastic polymer or a metallic substance . at junction point 22 , the catheter body 9 divides into flexible members 23 that , in their unexpanded state , as shown in fig1 a , maintain the same cylindrical shape as proximal portion 21 over the remaining length of the catheter body 9 . the distal portion of catheter body 9 may involve as few as two and as many as eight flexible members 23 . the flexible members 23 provide a measure of rigidity to the distal portion of the catheter body while at the same time allowing radial expansion . distal tip 25 features an inflatable cuff 26 attached about the circumference of the interior surface of members 23 . cuff 26 may be attached by bonding using biologically inert adhesives or a loop formed in the material of the flexible members 23 . cuff 26 is preferably composed of a slightly elastic plastic polymer which is biologically inert and expands to a predictable degree under inflation pressure . plastics such as polyurethane may be used for this purpose . the walls of inflatable cuff 26 are thin , so as to minimize added thickness to the profile of lumen 12 . a cuff inflation tube 28 provides a dedicated inflation lumen 29 that is in fluid communication with cuff 26 . cuff inflation tube 28 is connected to the interior surface of one of the members 23 so as to run longitudinally through lumen 12 . a side port 30 is connected to the proximal portion 21 of catheter body 9 and communicates with the proximal end of cuff inflation tube 28 . a syringe 32 connects to side port 30 via a luer lock hub 34 . inflation of cuff 26 is accomplished by the injection of fluid , most appropriately one containing a radiopaque contrast , through cuff inflation tube 28 via syringe 23 . the inflation of cuff 26 with liquid containing radiopaque contrast allows for easier positioning of the catheter during an interventional radiological procedure . in fig1 b and 2b , catheter body 9 is shown with the distal end of the lumen opening 35 in an expanded state . the diameter of expanded opening 35 is chosen depending upon the size of the tubular structure of the human body within which the catheter is placed . opening 35 maybe expanded with the intent of engaging the interior of the wall of the tubular structure so as to create a circumferential occlusive seal therein . however , in situations in which flow through the tubular structure cannot be completely interrupted , as , for example , in a main artery , the expanded diameter may be chosen so as to create an enlarged orifice , but without circumferential contact with the interior of the wall of the tubular structure . flow may then continue around opening 35 . as shown in fig2 a and 2b , encircling the entirety of catheter body 9 is an elastomeric membrane sleeve 40 ( omitted for clarity in fig1 a and 1b ), affixed to the outer surface of the catheter body members 23 . the elastomeric membrane sleeve 40 serves two main purposes . first , the membrane , by its elastic nature , contracts the members 23 so that the distal portion of catheter body 9 resumes its original shape after cuff 26 has been deflated . secondly , since inflation of cuff 26 forces the flexible members 23 away from one another , thus creating substantial space between them , the ability of the catheter to accept and trap material is compromised in the absence of a membrane which spans these members . elastic membrane sleeve 40 thus maintains a continuous wall about lumen 12 through which material drawn thereinto may pass to the exit port 42 . fig3 a through 3e show the catheter being used in accordance with the method of the invention to remove a blood clot from a vessel . it is to be understood that use of the device in a blood vessel to remove a blood clot is presented as an example only and that the catheter and method of the present invention may be used to remove a variety of undesirable materials from a number of different tubular structures in the human body . the latter includes , but is not limited to , tubular structures of the biliary , excretory and vascular systems . as shown in fig3 a , a guide wire 44 has been inserted into the blood vessel 46 . next , catheter body 9 is introduced into blood vessel 46 with a central dilator 50 disposed ahead of the catheter . this is done so that the blunt end 25 of the catheter body 9 does not damage the walls of vessel 46 as it is advanced . during this stage , cuff 26 is deflated . catheter body 9 is guided to the location of a blood clot 52 via travel along guide wire 44 ( which , it is noted , passes through the clot ). once the catheter body 9 is in the proper position , as shown in fig3 b , central dilator 50 is removed . at this point , catheter body 9 may be partially withdrawn if desired . however , it should never be advanced without central dilator 50 in place for the reason mentioned above . next , as shown in fig3 c , cuff 26 is inflated so that the distal end 25 of catheter body 9 is able to accommodate clot 52 . a balloon catheter 60 is then passed , in a deflated condition , along guide wire 44 , through lumen 12 and through clot 52 . such balloon catheters are well known in the art . referring to fig3 d , once the balloon portion 62 of balloon catheter 60 has passed through clot 52 , it is inflated via methods well known in the art . after the balloon portion 62 is inflated , as shown in fig3 e , the clot is pulled into catheter body 9 with expanded distal end 25 providing proper clearance . with clot 52 captured within catheter body 9 , cuff 26 is deflated so that the distal end 25 contracts back towards its original size and shape . this results in clot 52 being compacted by the interior surfaces of members 23 as they are pulled radially inwards by elastomeric membrane sleeve 40 . during this stage , the balloon portion 62 of balloon catheter 60 is also permitted to deflate . with distal tip 25 contracted back to approximately its original size and shape , and clot 52 compacted within the catheter body 9 , the unit may be easily removed from the vessel of the patient . alternatively , the balloon catheter 60 may be used to pull clot 52 through the remaining portion of catheter body 9 , including proximal end 21 , through lumen 12 and out exit port 42 ( see fig1 a and 1b ). in this manner , clots are removed from the vessel and body without necessitating reinsertion of catheter body 9 should retrieval of additional clots be desirable . while a balloon catheter 60 has been used in the example presented in fig3 a through 3e , a snare or other retrieving device may be used as an alternative . this would be necessary , for example , in situations wherein the undesirable material to be removed is not penetrable . while the preferred embodiments of the invention have been shown and described , it will be apparent to those skilled in the art that changes and modifications may be made therein without departing from the spirit of the invention , the scope of which is defined by the appended claims .

a device for removing undesirable material from a tubular structure within the human body features a cylindrical body with a lumen therethrough . the distal portion of the body is divided into a number of flexible members . an inflatable cuff is attached to the flexible members . when the cuff is inflated , the members flex radially outwardly so that the distal opening of the lumen is expanded . an inflation tube is used to inflate and deflate the cuff by means of a syringe . an elastomeric membrane sleeve surrounds the flexible members so that the latter are contracted towards their original position when the cuff is deflated . the sleeve also prevents material from escaping between the flexible members when the cuff is inflated .

in describing the exemplary embodiments of the present disclosure , as illustrated in fig1 - 7 , specific terminology is employed for the sake of clarity . the present disclosure , however , is not intended to be limited to the specific terminology so selected , and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner to accomplish similar functions . embodiments of the claims may , however , be embodied in many different forms and should not be construed to be limited to the embodiments set forth herein . the examples set forth herein are non - limiting examples , and are merely examples among other possible examples . referring now to the fig1 , and 3 there is illustrated wildlife reed call assembly 10 preferably configured as a multi - piece assembled wildlife or game call , device or the like having a collapsible flexible bag or other air capture mechanism , such as diaphragm bag 12 having first end 12 . 1 and a second end 12 . 2 with an open end or hole , such as aperture 14 and an inside of space within diaphragm bag 12 , such as interior 17 . it is contemplated herein that diaphragm bag 12 may be flexible and collapsible to pull air in and push air out of diaphragm bag 12 . moreover , interior 17 of diaphragm bag 12 may be filled with recoil filler material or fiber , such as recoil material 13 , which may be nylon stuffing , to enable compression during exhale of air from interior 17 via aperture 14 and expansion force against diaphragm bag 12 during inhale of air from interior 17 via aperture 14 . it is further contemplated herein that diaphragm bag 12 may have approximate dimensions of five and a half ( 5½ ) inches wide by five and a half ( 5½ ) inches in height ; however , other dimensions are contemplated herein . it is contemplated herein that collapsible bag , such as diaphragm bag 12 may preferably be constructed of plastic , rubber , or flexible composite materials that are available in a variety of natural and synthetic fiber , composites , laminated composite material , cast materials , polymers as these materials offers a variety of forms , shapes , strengths , and weights . it is contemplated herein that other suitable materials may be utilized or the like , whether formed of multiple layers with different materials , or the like , may be utilized , provided such material has sufficient strength , flexibility , collapsibility , bendable , formable , durability , chemical resistance , offers long service life , ph tolerance , small footprint , light weight , and / or durable as would meet the purpose described herein . it is further contemplated herein that interior 17 of diaphragm bag 12 may be filled with fibrous material , such as recoil material 13 , which may be nylon , styrofoam or other like material or recoil stuffing materials may be utilized or the like , whether formed of strands , three dimensional curved forms to create air pockets , or the like , may be utilized , provided such material has sufficient recoil strength , air holding capacity , durability , offers long service life , ph tolerance , light weight , and / or durable as would meet the purpose described herein . furthermore , wildlife reed call assembly 10 preferably configured as a multi - piece assembled wildlife or game call , device or the like further includes a vibrational sound generator , such as audible reed assembly 16 having reed 16 . 1 , a reed mount , such as first reed mount 16 . 2 , second reed mount 16 . 3 , and reed collar 16 . 4 . preferably , reed 16 . 1 may be positioned between first reed mount 16 . 2 and second reed mount 16 . 3 and positioned or friction fit therein reed collar 16 . 4 or otherwise configured to hold reed 16 . 1 between first reed mount 16 . 2 and second reed mount 16 . 3 . it is contemplated herein that audible reed assembly 16 may be configured in a number of sizes and lengths and configurations to generate life like animal sounds or grunts . in use , audible reed assembly 16 may be positioned through or partially positioned therethrough aperture 14 of diaphragm bag 12 to a position interior 17 thereof diaphragm bag 12 , where air or compressible air ca from within interior 17 of diaphragm bag 12 may be pushed ( exhale ) therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 . moreover , recoil material 13 includes expansion properties thereon interior 17 of diaphragm bag 12 where air or compressible air ca from outside of diaphragm bag 12 may be pulled ( inhale ) therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 . alternatively , air or compressible air ca from outside of diaphragm bag 12 may be pulled therein interior 17 of diaphragm bag 12 passing therethrough audible reed assembly 16 to expand of diaphragm bag 12 . it is contemplated herein that pitch of the audible vibration noise may be altered by changing reed 16 . 1 length , first reed mount 16 . 2 and second reed mount 16 . 3 length or position relative to reed 16 . 1 and the like and by manual modifications of the effective length of the vibrating column of air . still furthermore , wildlife reed call assembly 10 may include a tie seal or cinch , such as zip tie 18 utilized to seal or cinch second bag end , having lip 12 . 2 of aperture 14 thereto or therearound audible reed assembly 16 or more specifically thereto reed collar 16 . 4 to seal the junction between aperture 14 and audible reed assembly 16 . moreover , wildlife reed call assembly 10 may include a sound conduit , such as elongated tube 15 having first tube end 15 . 1 and second tube end 15 . 2 . preferably , second tube end 15 . 2 may be releasably affixed , connects or connected thereto audible reed assembly 16 or more specifically thereto reed collar 16 . 4 whether second tube end 15 . 2 may be positioned within interior 17 of diaphragm bag 12 or whether second tube end 15 . 2 extends therefrom lip 12 . 2 of aperture 14 . it is contemplated herein that elongated tube 15 may be flexible and / or corrugated to enable directional output of direct exhaust air ea and audible vibration noise , such as sound waves sw emanating therefrom wildlife reed call assembly 10 and / or muffle or sound modification of audible vibration noise or exhaust air ea and audible vibration noise , such as sound waves sw emanating therefrom wildlife reed call assembly 10 . it is further contemplated herein that audible reed assembly 16 connected thereto second tube end 15 . 2 may be positioned therethrough aperture 14 and into interior 17 of diaphragm bag 12 with first tube end 15 . 1 extended therefrom diaphragm bag 12 to direct exhaust air ea and audible vibration noise , such as sound waves sw emanating therefrom wildlife reed call assembly 10 . furthermore , a tie to seal or cinch , such as zip tie 18 may be utilized to seal or cinch second bag end , having lip 12 . 2 of aperture 14 thereto audible reed assembly 16 or more specifically thereto second tube end 15 . 2 to seal the junction between aperture 14 and second tube end 15 . 2 , and a tie to releasably seal the opening of the diaphragm bag thereto second tube end 15 . 2 . it is still further contemplated herein that as elongated tube 15 may have approximate dimensions of eight ( 8 ) inches in length and five - eighths ( ⅝ ) inches in diameter ; however , other dimensions are included herein . referring now to the fig4 there is illustrated wildlife reed call assembly 10 shown in use to provide hands free operation of wildlife reed call assembly 10 to generate life like animal sounds , mimic animal noises or grunts to attract or drive animals to a hunter . in use , an operator or hunter h may be positioned or tuck diaphragm bag 12 between torso t and arm a , whereby movement or pivot of arm a collapses interior 17 of diaphragm bag 12 to push air or compressible air ca from within interior 17 of diaphragm bag 12 therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 . moreover , release of arm a enables recoil material 13 expansion properties thereon interior 17 of diaphragm bag 12 where air or compressible air ca from outside of diaphragm bag 12 may be pulled therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 ; thus providing hands free operation of wildlife reed call assembly 10 . alternatively , air or compressible air ca from outside of diaphragm bag 12 may be pulled therein interior 17 of diaphragm bag 12 passing therethrough audible reed assembly 16 . fig5 there is illustrated wildlife reed call assembly 10 shown in use to provide hands free operation of wildlife reed call assembly 10 to generate life like animal sounds , mimic animal noises or grunts to attract or drive animals to a hunter . in use , an operator or hunter h may position or tuck diaphragm bag 12 under their foot f between any surface , such as ground g and foot f , whereby movement or pivot of foot f collapses interior 17 of diaphragm bag 12 to push air or compressible air ca from within interior 17 of diaphragm bag 12 therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 . moreover , release of foot f enables recoil material 13 expansion properties thereon interior 17 of diaphragm bag 12 where air or compressible air ca from outside of diaphragm bag 12 may be pulled therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 ; thus providing hands free operation of wildlife reed call assembly 10 . alternatively , air or compressible air ca from outside of diaphragm bag 12 may be pulled therein interior 17 of diaphragm bag 12 passing therethrough audible reed assembly 16 . it is contemplated herein that diaphragm bag 12 may be placed against other surfaces and a body part may be utilized to push and pull air or compressible air ca therethrough audible reed assembly 16 resulting in an audible vibration noise ( mimic animal noises or grunts to attract or drive animals to a hunter ) emanating therefrom audible reed assembly 16 . referring now to the fig6 there is illustrated wildlife reed call assembly 10 shown in use to provide hands free operation of wildlife reed call assembly 10 to generate life like animal sounds , mimic animal noises or grunts to attract or drive animals to a hunter . in use , an operator or hunter h may position or tuck diaphragm bag 12 between abdomen ab and operator &# 39 ; s waistline w of pant p , whereby movement or pivot of abdomen ab collapses interior 17 of diaphragm bag 12 to push air or compressible air ca from within interior 17 of diaphragm bag 12 therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 . moreover , release of abdomen ab enables recoil material 13 expansion properties thereon interior 17 of diaphragm bag 12 where air or compressible air ca from outside of diaphragm bag 12 may be pulled therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 ; thus providing hands free operation of wildlife reed call assembly 10 . alternatively , air or compressible air ca from outside of diaphragm bag 12 may be pulled therein interior 17 of diaphragm bag 12 passing therethrough audible reed assembly 16 . referring now to fig7 , there is illustrated a flow diagram 700 of a method of generating animal noises utilizing wildlife reed call assembly 10 . in block or step 710 , providing wildlife reed call assembly 10 as set forth in fig1 - 6 . in block or step 715 selecting or tuning audible reed assembly 16 of wildlife reed call assembly 10 to mimic or generate animal noises to 2 5 attract or drive animals to a hunter . in block or step 720 locating a wildlife area to attract or drive animals to an operator , such as a hunter . in block or step 725 , positioning wildlife reed call assembly 10 for use in an operators hands or in a hands free position , such as operator or hunter h may position or tuck diaphragm bag 12 between torso t and arm a , operator or hunter h may position or tuck diaphragm bag 12 under their foot f between any surface , such as ground g and foot f , or operator or hunter h may position or tuck diaphragm bag 12 between abdomen ab and operator &# 39 ; s waistline w of pant p . it is contemplated herein that diaphragm bag 12 may be positioned between a firm or stationary surface , such as torso t , ground g , operator &# 39 ; s waistline w of pant p or like stationary surface and an operator &# 39 ; s moveable surface or pivoting body part , such as arm a , foot f , and abdomen ab or like moveable operator surface . in block or step 730 , movement or pivoting of arm a , foot f , or abdomen ab through diaphragm bag 12 collapses interior 17 of diaphragm bag 12 to push air or compressible air ca from within interior 17 of diaphragm bag 12 therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 . in block or step 735 , releasing of arm a , foot f , or abdomen ab from diaphragm bag 12 enables recoil material 13 expansion properties thereon interior 17 of diaphragm bag 12 where air or compressible air ca from outside of diaphragm bag 12 may be pulled therethrough audible reed assembly 16 resulting in an audible vibration noise emanating therefrom audible reed assembly 16 or alternatively , pulling air or compressible air ca from outside of diaphragm bag 12 therein interior 17 of diaphragm bag 12 . in block or step 740 , mimicking or generating animal noises or grunts to attract or drive animals to a hunter . the foregoing description and drawings comprise illustrative embodiments of the present disclosure . having thus described exemplary embodiments , it should be noted by those ordinarily skilled in the art that the within disclosures are exemplary only , and that various other alternatives , adaptations , and modifications may be made within the scope of the present disclosure . merely listing or numbering the steps of a method in a certain order does not constitute any limitation on the order of the steps of that method . many modifications and other embodiments of the disclosure will come to mind to one ordinarily skilled in the art to which this disclosure pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings . although specific terms may be employed herein , they are used in a generic and descriptive sense only and not for purposes of limitation . moreover , the present disclosure has been described in detail , it should be understood that various changes , substitutions and alterations can be made thereto without departing from the spirit and scope of the disclosure as defined by the appended claims . accordingly , the present disclosure is not limited to the specific embodiments illustrated herein , but is limited only by the following claims .

an audible reed assembly and an elongated tube having a first tube end and a second tube end , the first tube end connected thereto the audible reed assembly , a diaphragm bag having an opening , wherein the bag is filled with a recoil stuffing fiber , the audible reed assembly is positioned therethrough the opening with the second tube end extended therefrom , and a tie to releasably seal the opening of the diaphragm bag thereto the first tube end or the audible reed assembly , and thus functions to functions to provide a hands free and moisture free call device , sound reproduction consistency , utilization of ambient temperature air to be propelled through the reed , enabling the hunter to keep focus on the landscape , maintain one &# 39 ; s grip on the fire arm or other hunting weaponry making it easier to spot incoming animals and maintain hands on the weapon ready to get the shot off .

referring to fig1 and 2 , there is shown a garment or baby carrier 10 being worn by a woman 12 . the garment has openings 14 and 16 for the arms 18 and 20 of the woman . the front of the garment 10 represents a pouch 22 in which a baby 24 can rest . the bottom of the garment can be drawn in by a bottom drawstring 26 which is preferably pulled tight to secure the garment firmly to the body of the woman . the upper opening 28 of the garment 10 is secured by an upper drawstring 30 which surrounds the entire opening from around the back of the neck of the woman to the front portion thereof . when the baby 24 is residing in the pouch 22 , the upper drawstring 30 can be adjusted for comfort and safety of the baby . fig1 emphasizes the hands - free feature of the garment . referring now to fig2 which shows the rear of the garment 10 , the rear portion has been drawn in by folding and stitching ( in a manner later to be described ) and is provided with an upper pocket 32 in which a suitable container 34 can be placed and another lower pocket 36 which extends from the central opening shown in the rear panel to the bottom of the garment and also , upwardly underneath the first pocket so as to accommodate a bottle 38 , if desired . turning now to fig8 . the garment 10 is shown as consisting of three pieces laid flat and viewing them from the inside surfaces . the three pieces are an upper drawstring assembly 40 , a lower drawstring assembly 42 and a central rectangular panel 44 which includes the two armholes 14 and 16 . the two drawstring assemblies will be sewn to the upper and lower edges , respectively , of the rectangular piece 44 prior to folding . turning now to fig3 , 5 and 6 . the manner of making either drawstring assembly 40 or 42 will be described . reference will be made in these figures solely to drawstring assembly 40 but it should be understood that the other drawstring assembly 42 will be made in the same way . the drawstring assembly 40 consists of a fleece cover 46 made of the same material that the garment 10 is made out of . a layer of batting 48 overlies the fleece cover 46 except for a portion to the right which will be an unpadded portion . a drawstring 50 is secured to opposite ends of the batting and a button hole 52 is provided in the batting so that the ends of the drawstring can be pulled through as shown in fig4 . a similar button holes is provided in the fleece cover . after the drawstring is pulled through the button holes , the longitudinal side edges of the batting 48 are folded over as shown in fig4 and stitched together longitudinally as shown in fig5 . next , as shown fig6 the longitudinal side edges of the fleece cover 46 are folded over and stitched together as shown in fig7 so as to provide an enclosure around the batting 48 . a transverse stitching 52 is provided across the folded and stitched fleece cover 46 where the batting ends so that there will be an unpadded portion 54 at the end of the assembly 40 . the drawstring 50 shown in fig3 through 7 will become drawstrings 30 and 26 in the upper and lower drawstring assemblies 40 and 42 , respectively . referring now to fig9 . the drawstring assemblies 40 and 42 have been stitched to the upper and lower longitudinal edges of the rectangular piece 44 . as shown in dotted lines in fig9 the right - hand end of the rectangular portion 44 together with the attached drawstring assemblies is folded into a coiled or tubular form by connecting ( sewing ) the right hand vertical edge of the rectangular piece 44 to the left hand vertical edge thereof . fig1 , 11 and 12 are diagrammatic representations of the composite garment shown in fig9 and being provided with letters along vertical side edges and along a line to the left of the right - hand edge for the purpose of describing the manner in which the garment laid flat is folded to produce the garment shown in fig1 and 2 . y and z represent the location of the upper and lower drawstrings 30 and 26 respectively . the distance between y and z will remain constant despite the folding which occurs in the rear , as will hereinafter be explained . it has been found that a convenient size for the rectangular portion 44 is approximately two feet by four feet . when the drawstring assemblies 40 and 42 have been added to the rectangular piece , the vertical dimension increases to approximately 28 or 29 inches . referring now to fig1 , the letters a through g along the right edge and letters a through g along the left edge represent locations where folding occurs in the rear , as will be explained below . given the preferred dimension of the rectangular piece as set forth above , the letters a through g will be approximately four and a half inches apart . another series of letters h through n , located along a vertical line approximately eight to ten inches to the left of the line a - g , is provided for the purposes of describing the folding operation . actually , the location of the line h - n relative to the line a - g represents the width of the back portion and the location of vertical stitching of the back panel . referring now to fig1 , when the right - hand edge of the flat piece shown in fig1 is folded over so that the letters a through g inclusive overlie the letters a through g , respectively , the garment is then stitched along a single vertical line , so as to produce a coiled or tubular formation as shown in fig1 . referring again fig1 , the garment is grasped from the rear by pulling up on the lower most edge 42 until the garment folds along the line e - l at which time the points f and m overlie d and k . the lower flap is folded back down until the lower most edge g - n now overlies e - l . at the same time , the upper edge 40 is folded along line c - j until points b and i overlie d and k . the upper portion is folded back up until the upper edge a - h overlies c - j . it is generally desired that the pieces be pinned in this condition before their final stitching . as shown in fig1 , a vertical stitch line is then provided from a to g and h to n and a horizontal stitching is provided from e to n to close off the lower end of the lower pocket 56 . fig1 shows what has just been described in relation to fig1 and 12 ; that is , the lower edge of the form 44 is folded along line e - l until the upper edge of this fold f abuts d and the lower edge g comes back down and overlies e . with respect to the upper edge of the garment , the rear portion is pulled down along fold line c until b overlies d and the remaining portion is folded back up until a overlies c . fig1 is a perspective view of garment itself without being placed upon a person and viewing the same from the rear . a simple inspection of fig1 will show that this garment or carrier , when placed upon a person , can scarcely fall off as in the case of carriers that are attached by straps . whereas the present invention has been described in particular relation to the drawings attached hereto , it should be understood that other and further modifications of the invention , apart from those shown or suggested herein , may be made within the spirit and scope of this invention . although the garment has been shown in relation to a person wearing the garment with both arms through both of the armholes , it is possible to wear this baby carrier over one shoulder by putting the head and one arm though the upper opening and then letting it drape over one shoulder . under such circumstances , both arms are still free as in the case where the arms are through the two armholes . the inventor does not particularly recommend this as a preferred method of wearing the baby carrier . however , it is mentioned that this can be done if one so desires . as compared to other carriers , the present invention provides two armholes that allow unrestricted movement of the wearers arms . the garment has two independent drawstrings for the upper and lower parts of the carrier . the back portion is provided with two pockets for the storage of items . because the garment completely encircles the body of the wearer , preferably , above the shoulders with the arms through the armholes , it is virtually impossible for the baby carrier of the present invention to fall of the wearer as might be the case if a strap became loose . reference has been made to the present invention in terms of a “ one piece baby carrier ”. when the original pattern is cut out from a cloth the central panel 44 is a one piece item . the armholes 14 and 16 are then cut into the fabric . suitable reinforcements , such as flannel piping can be stitched around the insides of the holes 14 and 16 . thereafter , when the two drawstring assemblies 40 and 42 are stitched to the upper and lower horizontal edges of the rectangular piece 44 the device is still a one piece item . after the folding and stitching shown in fig1 through 12 , the device is still a one piece device .

a garment to be worn by an adult for carrying an infant comprising a tubular carrier portion adapted to encircle the adult wearer from the shoulders to the waist with armholes being provided along sides of the garment to create a hands - free feature of the garment , a drawstring connected along the bottom of the garment to permit the garment to be pulled tight against the waist of the wearer , a second drawstring connected along the top edge of the garment , the rear portion of the garment being gathered , folded and vertically stitched to create a shorter vertical dimension of the garment in the rear as compared with the front , the front portion of the garment constituting a pouch in which a baby can rest , the top drawstring being adjustable for the comfort and safety of the baby .

generally stated , the non - limitative illustrative embodiment of the present disclosure provides a method and system for the evaluation , planning and modification of the dentition of an individual , such as , for example , a patient , by the application of generally vertical lines , hereby referred to as “ positioning lines ” ( y axis ), following the herein disclosed m proportion , which may be determined either explicitly or implicitly from measurements such as , for example , central incisor width and inter - molar distance , onto the dentition of the patient in order to determine “ ideal ” positioning of the patient &# 39 ; s teeth , and by the application of an horizontal line ( x axis ) apposed on the incisal edges of the upper centrals . in one embodiment , the resulting positioning lines may be applied to 2d or 3d digital images , x - rays , computed tomography ( ct ) scans , etc ., of the patient &# 39 ; s dentition or may be included as part of a modeling or re - modeling software to dispose the teeth when creating , for example , ceramic teeth , orthodontic molds , dentures , etc . in a further embodiment , the positioning lines may be angled at a specific angle in order to address an occlusion condition or for aesthetical considerations . the golden proportion , or divine proportion , represents a ratio of 1 : 1 . 618 . it has been used in a multitude of applications and is well known in the art . briefly speaking , referring to fig1 the golden proportion may be expressed as : for example , if the distance ab is 10 mm , then the distance ac will be 3 . 82 mm and cb will be 6 . 16 mm . referring to fig2 , the dentition ( 10 ) generally comprises the central incisor ( 11 ), the lateral incisor ( 12 ), the canine ( 13 ), the first premolar ( 14 ), the second premolar ( 15 ) and the first molar ( 16 ). the second ( 17 ) and third ( 18 ) molars are usually not visible in the smile . it is to be understood that for the purpose of clarity fig2 only shows the left side of the dentition ( 10 ), the right side being symmetrical . for the sake of clarity , from thereon reference will be made to the positioning lines on either the left side or the right side of the dentition ( 10 ) but it is to be understood that by virtue of symmetry , the same comments apply to the positioning lines on other side of the dentition ( 10 ). referring to fig3 , there is shown a front view image of a patient &# 39 ; s dentition ( 10 ) on which is applied the golden proportion ( ratio of 1 : 1 . 618 ) with seven positioning lines , resulting in a center positioning line ( 26 ) and six side positioning lines ( 25 , 24 , 23 , 22 , 21 , 20 ) on one side of the dentition ( 10 ). the center positioning line ( 26 ) is positioned at the center of the dentition ( 10 ) and the last side positioning line ( 20 ) is positioned by the user such that the second positioning line ( 25 ) is positioned between the central incisor ( 11 ) and the lateral incisor ( 12 ). once the first ( 26 ) and last positioning lines ( 20 ) are positioned , the remaining side positioning lines ( 25 , 24 , 23 , 22 , 21 ) are computed using the golden proportion with a ratio of 1 : 1 . 618 . as may be seen in fig3 , the position of the central incisor ( 11 ) and the lateral incisor ( 12 ) generally correspond to side positioning lines ( 25 ) and ( 24 ), respectively , but the position of the canine ( 13 ) does not fit with side positioning line ( 23 ), the side positioning line ( 23 ) actually passing in the middle of the canine ( 13 ). referring now to fig4 , there is shown an image of the patient &# 39 ; s smile on which is applied the m proportion ( ratio of 1 : 1 . 367 ) with seven positioning lines , resulting in a center positioning line ( 6 ) and six side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ) on one side of the dentition ( 10 ). the center positioning line ( 6 ) is fixed at the center of the dentition ( 10 ) and the last side positioning line ( 0 ) is positioned by the user , advantageously on the buccal face of the first molar ( 16 ), the remaining side positioning lines ( 5 , 4 , 3 , 2 , 1 ) being computed using the m proportion with a ratio of 1 : 1 . 367 . as may be seen in fig4 , the position of the central incisor ( 11 ), the lateral incisor ( 12 ), the canine ( 13 ) and the first premolar ( 14 ) generally correspond to side positioning lines ( 5 ), ( 4 ), ( 3 ) and ( 2 ), respectively . in an idealized view , shown in fig9 , it may be seen that the m proportion may be used to position the central incisor ( 11 ), the lateral incisor ( 12 ), the canine ( 13 ), the first premolar ( 14 ), the second premolar ( 15 ) and the first molar ( 16 ) on a virtual wax - up of a patient using side positioning lines ( 5 ), ( 4 ), ( 3 ), ( 2 ), ( 1 ) and ( 0 ), respectively . furthermore , referring to fig1 , the m proportion may be used with a real wax - up of the patient , which in turn is used to create , for example , crowns for the patient . thus , in this illustrative embodiment , using the m proportion , 12 front teeth ( six on each side ) of the dentition ( 10 ) were positioned instead of only four , as seen in fig3 . it is to be understood that the same technique described above using seven positioning lines for the positioning of 12 front teeth may also be extended to , for example , nine positioning lines permitting the positioning of 16 teeth . the number of teeth visible in the smile may vary from patient to patient depending on the physiognomy of the patient . although in m proportion with a ratio of 1 : 1 . 367 was used in fig4 , it is to be understood that it may vary depending on the physiognomy of the patient or the desired aesthetical effect . common ratio values may be , for example , from 1 : 1 . 250 to 1 : 1 . 500 , though more commonly from 1 : 1 . 360 and 1 : 1 . 500 , and with rare occurrences from 1 : 1 . 500 and 1 : 1 . 618 . it should also be understood that when using software tools , such as the m proportion calculator which will be introduced further on , the m proportion ratio is not limited to three decimals and may vary in precision depending on the application . for example , fig1 shows an interface ( 200 ) for m proportion calculator in which the m proportion ratio ( 208 ) is precise up to 13 decimals , i . e . 1 . 3676540544138 . as mentioned above , the central positioning line ( 6 ) is placed in the center of the smile and dentition ( 10 ) and the last side positioning line ( 0 ) is positioned by the user , advantageously on the buccal face of the first molar ( 16 ), the remaining side positioning lines ( 5 , 4 , 3 , 2 , 1 ) being computed using the m proportion for a given ratio . the side positioning lines ( 5 , 4 , 3 , 2 , 1 ) may be computed as follows : p ( i )= p ( i − 1 )− d / f 1 , i = 1 to n − 2 ; equation 2 d is the distance between positioning lines ( 0 ) and ( n − 1 ), i . e . [ p ( 0 )− p ( n − 1 )]; f 1 = r 0 + r 1 + r 2 + r 3 + r 4 + r 5 . it is to be understood that , as a result of symmetry , equations 2 to 4 may be adapted for computing the position of positioning lines on the other side of the smile or dentition ( 10 ). furthermore , it is also to be understood that the positioning of side positioning line ( 0 ) may be either dependent or independent of the positioning of its corresponding positioning line ( 00 ) ( see fig4 ) on the other side of the smile or dentition ( 10 ). this is to account for the fact that smiles may not always be perfectly symmetrical or that an image of the patient may not always be perfectly centered . in an alternative embodiments , shown in fig5 a and 5b , the positioning lines ( 6 !, 5 ′, 4 ′, 3 ′, 2 ′, 1 ′, 0 ′) may have corresponding angles ( 0 6 , 0 5 , 0 4 , 0 3 , θ 2 , θ 1 , θ 0 ) while positioning lines ( 6 ″, 5 ″, 4 ″, 3 ″, 2 ″, 1 ″, 0 ″) may have corresponding angles ( τ 6 , τ 5 , τ 4 , τ 3 , τ 2 , τ 1 , τ 0 ) in order to better conform to the natural positioning of the teeth , to address a certain condition such as , for example , occlusion , or for aesthetical reasons . for example , angles of 0 , 1 . 00 , 2 . 00 , 2 . 50 , 3 . 75 , 4 . 40 and 4 . 50 degrees may be used for angles ( θ 6 , θ 5 , 0 4 , 0 3 , 0 2 , 0 1 , θ 0 ), respectively . it is to be understood that other angles and that a combination of angles θ and τ may also be used . in order to facilitate the work of the practitioner , reference points ( 51 , 52 ) on the image of the patient may be identified , as shown in fig6 , and the distance ( 53 ) separating them inputted into the system , as shown in fig7 . in the example of fig6 and 7 , the reference points ( 51 , 52 ) are positioned at the center of the left and right pupils , respectively , and their distance ( 53 ) of 61 mm inputted as a reference . therefore , using this reference , the measurement of various features on the image of the patient may be computed by relating the inputted distance ( 53 ) to the number of pixels between the two reference points ( 51 , 52 ). for example , as shown in fig8 , the patient &# 39 ; s inter - molar distance ( 54 ) may be computed using the system , in this example the inter - molar distance ( 54 ) being 52 mm . in this example , the inter - molar distance is the distance between the buccal faces of the left and right first upper molars ( see fig1 a for the identification of the first upper molars ( 116 , 16 )). referring to fig9 , the practitioner may use the measurement of the inter - molar distance ( 54 ) or the measurement of the central width to create a virtual diagnostic wax - up ( 100 ) using the positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) as guidelines as to the size and positioning of the teeth ( 11 , 12 , 13 , 14 , 15 , 16 ). in an alternative embodiment , shown in fig1 , angled positioning lines ( 6 ′, 5 ′, 4 ′, 3 ′, 2 ′, 1 ′, 0 ′) may also be used . it is to be understood that although not shown , angled positioning lines ( 6 ″, 5 ″, 4 ″, 3 ″, 2 ″, 1 ″, 0 ″), as illustrated in fig5 b , may also be used . the image of the virtual diagnostic wax - up ( 100 ) may then be superimposed on the image of the patient and properly scaled so as to be able to view its appearance as a replacement to the patient &# 39 ; s dentition ( 10 ). if the practitioner wishes to make changes to the virtual diagnostic wax - up ( 100 ) he may make measurements directly on the image . once the practitioner is satisfied with the aesthetics of the virtual diagnostic wax - up ( 100 ), he may then use the measurements thus obtained to create a real diagnostic wax - up . it is to be understood that the virtual diagnostic wax - up ( 100 ) and the m proportion may be included as part of a cad cam , modeling or re - modeling software using , for example , 2d or 3d models , x - rays or ct scans of a patient &# 39 ; s mouth to dispose the teeth when creating , for example , ceramic teeth , orthodontic molds , dentures , etc . the practitioner may use an image of the real diagnostic wax - up , such as the one shown in fig1 , and superimpose it on the image of the patient , properly scaled according to the inter - molar distance ( 54 ) or the central width measured on the image of the patient , in order to view the real wax - up in the patient mouth . it is to be understood that real diagnostic wax - up created by other processes such as , for example , laboratory work , may be so viewed , not only those created from the virtual diagnostic wax - up . referring to fig1 , there is shown a plan view of a diagnostic grid ( 110 ) on which is applied the m proportion ( ratio of 1 : 1 . 38 ) with seven positioning lines , resulting in a center positioning line ( 6 ) and six side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ). the diagnostic grid ( 110 ) may be made of a material such as , for example , plastic , paper , cardboard , plasticized paper , metal , etc . referring now to fig1 , a diagnostic wax - up ( 120 ) may be positioned on top of the diagnostic grid ( 110 ) and the positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) may be used as guidelines as to the size and positioning of the teeth ( 11 , 12 , 13 , 14 , 15 , 16 ) of the diagnostic wax - up ( 120 ). the diagnostic grid ( 110 ) may also be used , for quality control , to diagnose a case , to treatment plans , to verify a diagnostic wax - up ( 120 ) created from measurements obtained from the virtual diagnostic wax - up ( 100 ), from measurements obtained from the image of the patient such as shown in fig8 , measurements obtained directly on the patient or from model casts of his teeth . referring to fig1 , there is shown , for comparison purposes , the wax - up ( 120 ) and diagnostic grid ( 110 ) of fig1 , the diagnostic grid ( 110 ) following m proportion ratio of 1 : 1 . 38 , under which is placed a conventional diagnostic grid ( 130 ) following a standard golden proportion ratio of 1 : 1 . 618 . as it may be observed , the first three positioning lines ( 6 , 5 , 4 ) of diagnostic grid ( 110 ) and the first three positioning lines ( 36 , 35 , 34 ) of conventional diagnostic grid ( 130 ) generally correspond to the positioning of the central incisor ( 11 ) and the lateral incisor ( 12 ). however , it may also be observed that the remaining positioning lines ( 3 , 2 , 1 , 0 ) of diagnostic grid ( 110 ) generally correspond to the positioning of the canine ( 13 ), the first premolar ( 14 ), the second premolar ( 15 ) and the first molar ( 16 ) while the remaining positioning lines ( 33 , 32 , 31 , 30 ) of conventional diagnostic grid ( 130 ) do not at all . it is apparent that in order to follow the golden proportion , the maxillary arch would need to be very narrow . in an alternative embodiment shown in fig1 , a diagnostic grid ( 140 ), following m proportion ratio of 1 : 1 . 38 , may have a configuration and dimensions suited for insertion in the mouth of a patient . referring now to fig1 , the practitioner may position the diagnostic grid ( 140 ) between the upper ( 142 ) and lower ( 144 ) teeth of a patient and use positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) as guidelines as to the positioning of the teeth ( 11 , 12 , 13 , 14 , 15 , 16 ). the practitioner may then establish a diagnostic regarding the dentition ( 10 ) of the patient . in a further alternative embodiment , the diagnostic grid ( 140 ) may have some sort of handle or protuberance at the front ( not shown ) so as to permit easy insertion and removal of the diagnostic grid ( 140 ) from the patient &# 39 ; s mouth . in typical applications the diagnostic grids ( 110 , 140 ) may be created with a specific central incisor ( 11 ) width , i . e . distance between positioning lines ( 6 ) and ( 5 ), and a specific m proportion ratio , the placement of the other positioning lines ( 4 , 3 , 2 , 1 , 0 ) being set using the selected m proportion ratio and central incisor ( 11 ) width . for example , the width of the central incisor ( 11 ) may typically vary from 7 . 5 mm to 10 mm in increments of 0 . 5 mm and the m proportion ratio may vary from 1 : 1 . 36 to 1 : 1 . 44 in increments of 0 . 01 , it is understood that more precise in paper . it is to be understood , however , that other values may be used for the central incisor ( 11 ) as well as other m proportion ratios as previously disclosed . it is to be understood that the above described diagnostic grids are based on the width of the central incisor ( 11 ) and a given ratio and that more precise diagnostic grids may be created by using m proportion calculator , which will be described further below . these more precise diagnostic grids may also be printed directly on paper , as will be seen below . as previously mentioned , the m proportion may be included as part of a modeling and / or re - modeling software or system using , for example , 2d or 3d models , images , x - rays or ct scans of a patient &# 39 ; s mouth to dispose the teeth when creating , for example , ceramic teeth , orthodontic molds , dentures , etc . ( 00751 to this end , with reference to fig4 , equations 2 , 3 and 4 may be adapted and incorporated into a modeling and / or re - modeling software or system to calculate the position of y axis side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ) from information inputted by the user of the software or system and position them onto a 2d or 3d model , image , x - ray or ct scan of a patient &# 39 ; s mouth , or even print them on some supporting media . in particular , the position of the side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ) may be computed from inputting at least two quantities such as , for example , a ratio , i . e . m proportion ratio , an inter - molar distance and a central incisor width . the various quantities may be inputted either from a user interface , such as , for example , a keyboard , a configuration file , by dragging and positioning the positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) or by using some software tool or interface . the molars used for the measurement of the inter - molar distance may vary depending on the number of positioning lines used , i . e . depending on the number of teeth that may be seen in the smile of the patient . for example , referring to fig1 a , 16 b and 16 c , in the case where six positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ) are used ( fig1 a ) the inter - molar distance ( 95 ) is taken between the two second premolars ( 15 , 115 ), in the case where seven positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) are used ( fig1 b ), the inter - molar distance ( 96 ) is taken between the two first molars ( 16 , 116 ) and in the case where eight positioning lines ( 7 , 6 , 5 , 4 , 3 , 2 , 1 , 0 ) are used ( fig1 c ), the inter - molar distance ( 97 ) is taken between the two second molars ( 17 , 117 ). in another example ( not shown ), four or five positioning lines may be used , in which case the inter - molar distance would be taken between the canine and first premolars , respectively . it is to be noted , however , that although reference will be made to fig1 b , in which there are seven positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ), this is for illustrative purpose only and the following discussion may similarly apply to other numbers of positioning lines . accordingly , for the sake of clarity , the discussion will focus on the use of seven positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) while the procedures will be presented such as to be applicable to varying numbers of positioning lines . in a first non - restrictive embodiment , the position of the side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ), referred to as lineposition ( i ) where i is the numeral identifying the positioning line , may be calculated from inputting m proportion ratio , referred to as ratio , and an inter - molar distance ( 96 ), referred to as intermolardistance and applying the procedure “ centralincisorwidth ”. it is to be understood that in the example of fig1 b with seven positioning lines , the variable # oflines , which represents the number of positioning lines , will be equal to seven . as for the inter - molar distance ( 96 ), it will be measured between the two first molars ( 16 , 116 ). it should be noted that in addition to calculating the position of the side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ), the procedure also provides the central incisor width . in a second non - restrictive embodiment , the position of the side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ), referred to as lineposition ( i ) where i is the numeral of the positioning line , may be calculated from inputting m proportion ratio , referred to as ratio , and a central incisor ( 11 ) width , referred to as centralincisorwidth , and applying the procedure “ intermolardistance ”. it is to be understood that in the example of fig1 b with seven positioning lines , the variable # oflines , which represents the number of positioning lines , will be equal to seven . it should be noted that in addition to calculating the position of the side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ), the procedure also provides the inter - molar distance ( 96 ), which is the distance between the two first molars ( 16 , 116 ), in a third non - restrictive embodiment , the position of the side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ), referred to as lineposition ( i ) where i is the numeral of the positioning line , may be calculated from inputting a central incisor ( 11 ) width , referred to as centralincisorwidth , and an inter - molar distance ( 97 ), referred to as intermolardistance , and applying the procedure “ ratio ”. it is to be understood that in the example of fig1 with seven positioning lines , the variable # oflines , which represents the number of positioning lines , will be equal to seven . it should be noted that in addition to calculating the position of the side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ), the procedure also provides the corresponding m proportion ratio . it is to be understood that in the loop “ for n = 1 to 100 ”, during the calculation of the m proportion ratio , the number of times the loop is executed , namely 100 , may vary depending on the desired precision of the result and as such , the number of times the loop is executed may be more or less than 100 . referring now to fig1 , there is shown a flow diagram of the m proportion calculator process . the steps composing the process are indicated by blocks 302 to 310 . the process starts at block 302 , where a visual representation of the dentition is provided . then , at block 304 , a value representative of the number of teeth on a side of the dentition is inputted , this value will be used to determine the number of positioning lines , i . e . number of teeth plus one , and between which teeth the inter - molar distance is to be measured . at block 306 , at least two quantities taken from a group consisting of a ratio , an inter molar distance ( also referred to as inter - teeth distance because , depending on the value inputted at block 304 , the measurement may not necessarily be taken between molars as explained previously ) and a central incisor width are inputted . at block 308 , the process computes the position of the positioning lines , which are used to determine the position of the teeth within the dentition , by applying a mathematical function to the value representative of the number of teeth inputted at block 304 and the quantities inputted at block 306 . the mathematical function will be further detailed below . finally , at block 310 , the positioning lines computed at block 308 are juxtaposed over the visual representation of the dentition . referring to fig1 , there is shown flow diagram depicting teeth position computing of block 308 of the m proportion calculator process described above , the steps composing the process are indicated by blocks 402 to 410 . at block 402 , the process verifies if a central incisor width was inputted . if a central incisor width was not inputted , the process executes , at block 404 , the centralincisorwidth procedure and then proceeds to block 310 of fig1 . if a central incisor width was inputted , the process proceeds to block 406 . at block 406 , the process verifies if an inter - molar distance was inputted . if an inter - molar distance was not inputted , the process executes , at block 408 , the intermolardistance procedure and then proceeds to block 310 of fig1 . if an inter - molar distance was inputted , the process proceeds to block 410 . at block 410 , the process executes the ratio procedure and then proceeds to block 310 of fig1 . referring to fig1 , there is shown an example of an interface ( 500 ) that may be used with the m proportion calculator . a first ( 502 ), second ( 504 ), third ( 506 ) and fourth ( 508 ) input boxes may be used to enter the number of lines to be displayed (# oflines ), the central incisor width ( centralincisorwidth ), the inter - molar distance ( intermolardistance ) and the m proportion ratio ( ratio ), respectively . as discussed previously , after the number of lines has been entered in input box ( 502 ), which may also be in the form of a scroll down menu , at least two of input boxes ( 504 ), ( 506 ) and ( 508 ) must be filled , i . e . two out of the central incisor width , inter - molar distance and m proportion ratio must be entered . to activate the m proportion calculator , the activation buttons ( 505 ), ( 507 ) and ( 509 ) corresponding the missing quantity is selected . for example , if the central incisor width ( 504 ) and inter - molar distance ( 506 ) are entered , then activation button ( 509 ) is selected . the m proportion calculator will then use the ratio procedure to calculate the position of the side positioning lines ( 5 , 4 , 3 , 2 , 1 , 0 ) as well as the m proportion ratio , which is then displayed in input box ( 208 ). it is to be understood that procedures centralincisorwidth and intermolardistance are similarly used when activation buttons ( 505 ) and ( 507 ) are selected , respectively . the positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) may then be displayed ( 510 ) on the m proportion calculator interface ( 500 ) and / or on an image of the patient &# 39 ; s dentition ( 10 ), as shown in fig2 . furthermore , the interface ( 500 ) may have various options such as , for example , the ability to print the positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) on a sheet of paper or to create , for example , diagnostic grids such as shown in fig1 and 14 , by selecting the print button ( 512 ). referring back to fig1 , there is shown an example of possible values obtained from the m proportion calculator with seven lines ( input box 502 ), a central incisor width of 8 . 25 mm ( input box 504 ), an inter - molar distance of 52 mm ( input box 506 ) and m proportion ratio of 1 . 3676540544138 ( input box 508 ). the resulting positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) are displayed ( 510 ) on the m proportion calculator interface ( 500 ). referring now to fig2 , there is shown representation of an image of the dentition ( 10 ) of a patient having received corrective crowns following the m proportion calculator values displayed in the interface ( 500 ) of fig1 . it may be observed that the corrected positions of the central incisor ( 11 ), lateral incisor ( 12 ), canine ( 13 ), first premolar ( 14 ), second premolar ( 15 ) and first molar ( 16 ) are now generally in accordance with the corresponding center positioning line ( 6 ) and six side positioning fines ( 5 , 4 , 3 , 2 , 1 , 0 ). referring to fig3 , the lines of the m proportion ruler ( 98 ) are attached to the each tooth in the teeth library . when clicking on a smile ( 202 ) in the library , the m proportion ruler ( 98 ) vertical lines ( 98 a ) and the horizontal line ( 98 b ) are fused over the patient mouth to the distal part of each tooth and the incisal edge of the centrals , respectively . this results in an immediate virtual wax - up . referring to fig3 and 34 , the adjustable , m proportion ruler ( 99 ) superimposed over the m proportion ruler ( 98 ) enables the displacement of each tooth individually to adapt the virtual wax - up ( 100 ) to the pre - op teeth and gum to execute a more accurate virtual wax - up ( 100 ). referring back to fig3 , the red lines ( 98 a ) between the center and the last lines moves along with the m proportion calculator values based on the central width , the inter molar width and the m proportion ratio of the patients mouth . the red lines ( 98 a ) cannot be moved individually , they are locked with the values of the m proportions calculator . referring to fig3 and 34 , the center blue line ( 99 e ) can move left or right to change the position of the adjustable m proportion ruler to be able to put the maximum of red lines at the distal part of the maxillary teeth . the last green lines can be moved through or against the center blue line to bring the green lines of the m proportion ruler on to the buccal crest of the first molar . each horizontal blue line ( 99 b , 99 c , 99 d ) can be moved up or down : the upper horizontal line ( 99 c ) moves the ginvigal height ; the middle horizontal line ( 99 b ) moves the incisal edge of all teeth ; and the lower horizontal line ( 99 d ) moves the lower teeth in height by moving both upper and middle horizontal ( 99 c , 99 b ) lines , this increases or decreases the length of the teeth . each vertical blue line ( 99 a ), except the centered line , can be moved to the right or to the left to accommodate the pre - op teeth and gum . the centered line is able to move by 1 mm through the facial to correct midline deviation , fig4 to 47 show the adjustment of the center line ( 99 e ) with respect to the midline ( 117 ). the blue square ( 104 ) attached to the lower blue horizontal line is a pitch adjustor that moves the posterior teeth in the library on a parabolic curvature when the blue square ( 104 ) is moved up or down , thus changing the pitch . this changes the angulation of the occlusal plane in accordance with the smile line . the m proportion ruler ( 98 ) is used to diagnose , and to dispose teeth in their best position in orthodontic treatment , prosthodontic treatment ( crowns , bridges , veneers ) or for dentures . the adjustable m proportion ruler ( 99 ) in the virtual wax - up ( 100 ) is automatically adapted to the horizontal line and the center vertical line of the m proportion ruler ( 98 ) to achieve the best disposition of teeth in the dental arch , taking in consideration the periodontal tissues of the underneath tooth contour and gum , the virtual wax - up ( 100 ) is customized to each mouth ( best seen in fig3 at the distal of the left lateral ), referring to fig4 to 43 , the system allows very accurate gingivectomies . the library smiles ( 202 ) slide between the teeth and gum ( 101 ) in the patient &# 39 ; s mouth on the facial picture . the upper horizontal blue line ( 99 c ) of the adjustable m proportion is pulled up to bring the teeth of the library ( 202 ) under the patient &# 39 ; s gum ( 101 ). a round size adjustable tool ( 103 ) allows the gingivectomy by cutting the gum ( 101 ) of the patient and showing the underneath tooth or teeth of the library ( 202 ). referring to fig4 , a part of the digital facebow is in the rotation application that positions the long axis of the face perpendicular to the floor . this application set up the position of the patient face ( 40 ) on the articulator . the long axis is usually used as the standard position but the upper lip line or inter papillary line can be used . when aligning the vertical line ( 110 ) to the long axis of the face the intersection of both horizontal ( 111 ) and vertical ( 110 ) lines are brought at the intersection of the incisal edges of the upper centrals and the dental midline of the upper centrals on the image ( 40 ). the horizontal line ( 111 ) is apposed at the incisal edges of the upper centrals and is perpendicular to the vertical line ( 110 ) passing through the dental midline . the intersection of the vertical and horizontal line is pivot of the digital facebow . referring to fig2 , the m proportion with the positioning lines ( 6 , 5 , 4 , 3 , 2 , 1 , 0 ) in conjunction with the horizontal line ( 41 ) passing at the incisal edges of the centrals ( 11 ) is used in order to implement a digital facebow from a 2d facial photograph or a 3d facial photograph or 2d and 3d video to transfer the 3d position of the maxillary on an articulator or any 3d software . the digital facebow replaces existing facebows or fox plates that are not accurate to wax up cases by using a simple facial photograph ( 40 ) of the patient in a frontal view . accurate correlation between a 2d or 3d image or video and 3d model or cast is impossible using mechanical facebows . in the illustrative embodiment , the facial photograph ( 40 ) of the patient is taken while the patient looks to the horizon while having its head parallel to the floor so as to have the articulator parallel to the floor . the frankfurt plane can be used as a reference position to position the head of the patient parallel to the floor . referring to fig2 , the frankfurt plane is a line ( 42 ) passing through two radiological points ; the porion ( 43 ) and the orbitalis ( 44 ). it is to be understood that a certain variance in the parallelism of the 2d photograph ( 40 ) or 3d photograph or video of the face of the patient to the floor is acceptable and does not compromise the transfer of the maxillary 3d position on the platform of the articulator or any 3d software for the functional or aesthetic side . it is to be understood the digital facebow will position the model or cast of the teeth on the articulator in correlation with the teeth position on the image . for example the pre - op teeth on the image ( 40 ) will serve to mount the pre - op model or cast on the articulator . the provisional teeth on the image will serve to mount the provisional teeth on the model or cast . if the post - op model is mounted on the articulator : the post op teeth on the image will serve to mount the post op model or cast . each patient facial photograph ( 40 ) and each positioning of the vertical ( 110 ) and horizontal ( 111 ) lines on the facial photograph ( 40 ) will give different position of the model on the articulator and are treated as different digital facebow positions . facebows are used to transfer the maxillary position on an articulator with the upper maxillary centrals at an approximated distance of 110 mm from the hinge axis of the articulator , to mimic the anatomy of the masticatory system . referring to fig2 , it is possible to transfer , the position of the maxillary model or cast in 3d aero special position on an articulator ( 60 ) using the digital facebow , with a distance of 110 mm from the centrals to the hinge axis of the articulator by transferring the teeth positions in the x , y and z axis of the existing model on the installed platform ( 62 ) on the articulator ( 60 ). referring to fig4 and 49 , the x axis is positioning the pitch and roll and the y axis is positioning the yaw of the model or cast on the platform of the articulator . platforms exist in many manufacturing companies . the z axis ( 61 ) is given by the teeth on the maxillary model or cast of the patient . the platform ( 62 ) on the articulator ( 60 ) has two lines , z axis ( 61 ) and y axis ( 63 ), crossing each other at approximately 110 mm from the hinge axis ; depending of the brand of articulator ( 60 ) and platform ( 82 ). the adjustable and / or the m proportion ruler is apposed against the z axis line on the platform ( 62 ). the x and y axis coordinates of the 2d pre op virtual wax up on the picture will be transpose in 3d on the pre - op model . the adjustable and / or the m proportion ruler provide the y axis of the ideal position for each tooth in the maxillary . referring to fig2 , a printed template ( 70 ) is positioned on the platform ( 62 ) against the z axis line ( 61 ). the template ( 70 ) lines ( 71 , 72 , 73 , 74 , 75 , 76 ) are positioned parallel to the center y axis line ( 63 ) on the platform ( 62 ). referring to fig2 , the maxillary model or cast ( 80 ) is then positioned on the template ( 70 ); the buccal edges of the centrals ( 81 ) of the maxillary model ( 80 ) are applied on the platform ( 70 ) against the z axis line ( 61 ) and the midline of the centrals ( 81 ) is positioned on the midline of the template ( 70 ). in some cases were the dental midline needs to be moved on one side in the patient &# 39 ; s mouth , the dental midline of the model or cast will not be positioned on the midline of the template . the midline of the model will be positioned on the original vertical centered line of the digital facebow passing through the midline of the pre - op centrals on the facial photograph . referring now to fig2 , two pieces of wax ( 82 ) ( or other adhesive or supporting material ) are placed in the molar regions on each side and then , referring to fig2 a , 26 b and 26 c , the model ( 80 ) is positioned on the template ( 70 ) relatively to the midline ( 76 ) and one of the last side lines on the left ( 71 ′, 72 ′) and right ( 71 , 72 ) in correlation with the lines on the image showing the same teeth to secure de yaw position . to achieve the correlation in the yaw position between the image and the 3d model , the midline of the central on the model must be locked with the central line on the template of the platform ( or locked on the original dental midline on the pre - op facial photograph if the midline is changed ). the model is turned slightly on the left and / or the right to correlate the landmark position on each side of the model and the image . it is to be understood that the digital facebow can be done with or without the template or m proportions , as long as it meet the following requirements : 1 — the image needs to be calibrated with the real measurements of the patient . 2 — combine with the rotation application using the intersection of the vertical and horizontal line at the junction of the dental midline and incisal edge of the upper centrals on an image with placement the same intersection of the vertical and horizontal line at the junction of the dental midline and incisal edge of the upper centrals of the correspondent model or cast of the teeth ( shown on the image ) on the platform of the articulator . for example any landmark on the model , at least one landmark on the right and one landmark on the left are needed to correlate with the image as long as it can be measured from the center line to the landmark on a side tooth ( in the premolar or molar area ) or the gum junction on the image and correlate those measurements from the center line to the landmark on the same side tooth or the gum junction on the platform . it is to be understood that each rotated image used to mount the model on the articulator as a specific position . with the same image , the model or cast can be mounted in as many positions as the intersection of the vertical and horizontal lines is applied on different position of the incisal edges and dental midline on the image . those different positions of the model on the platform of the articulator and are treated as different digital facebow positions . referring to fig2 , the 0 starting point on the x axis ( 65 ) is the top of the platform ( 62 ) from a frontal view . the x axis will determine the pitch and the roll of the model in 3d aero special position on the platform in correlation with the same measurements on the chosen teeth on the image . referring now to fig2 , both central widths from distal to distal is calibrated according to the first red lines of the m proportion lines at the distal of the centrals ( 75 , 75 ′). in the present example , both centrals ( 11 ) width is 17 . 75 mm , the m proportion ruler central width is automatically calibrated at 8 . 8750 mm . the central width can be recalibrated at any time to insure an exact calibration of the measuring tool . the measuring tool is used to take the measurements of x and y axis on the screen on the 2d photograph . referring to fig2 and 30 , the incorporation of a horizontal line ( 41 ) to the m proportion ruler passing at the incisal edges of the centrals ( 11 ) on the facial photograph ( 40 ) provides the x axis ( 65 ) representing the 0 starting point of the model ( 80 ) centrals ( 81 ), which is equal to the top of the platform ( 62 ) ( see fig2 ). two measurements from the horizontal line ( 41 ) to the incisal ( 91 ) or gingival ( 92 ) edges are taken on the facial photograph ( 40 ); one on the left and the other on the right in the premolar or molar regions ( 14 , 15 ) ( best seen in fig3 ). it is to be understood that any reference point on any part of a tooth or gum junction on each side of the maxillary can be taken to correlate the image and the model on the platform . referring back to fig2 , those two measurements ( 91 , 92 ) are used on the platform ( 62 ) representing the 0 starting point to position the maxillary model ( 80 ) with the right pitch and roll . referring to fig3 , both adjustable and / or m proportion rulers can be printed on a template ( 70 ′) and apposed on the platform ( 62 ) the virtual diagnostic wax - up for veneers , bridges and crowns will be achieved with the adjustable m proportion , the best position for orthodontic treatment and dentures will be done with the m proportion , i . e . model ( 80 ). referring now to fig3 , both m ( 98 ) and adjustable m ( 99 ) proportion rulers bring soft tissues and lips of the patient on the articulator by working in correlation with the position of the maxilla from the 2d image and the maxillary 3d model position on the articulator given by the digital facebow . the digital facebow function with both m and adjustable m proportion rulers . the diagnostic wax - up ( 100 ) is done on the picture ( 40 ) with the adjustable m proportion ruler respecting the smile line , the position of the lips , gingival architecture , axial inclinations , and emergence profile of each teeth , ect . the resulting virtual wax - up ( 100 ) is then transferred with the x and y axis on the mounted model or cast to do the wax - up , i . e . ( 80 ) or the final restoration ( 102 ) manually by a dental technician or transferred to 3d software that will print or mill a cast of the 2d virtual wax - up . the 3d wax - up done manually or printed or milled or saved as a 3d file by 3d software wig be used as the architectural plan to produce the final restorations . when the wax up is done manually by a lab technician , he will take the measurement in height from the x axis on the screen ( the line passing through the incisal edge of the upper centrals ) to the tip of each tooth in the virtual wax up in the image on the screen . the technician will also localize the position of the tip of the cusp between the medial and distal lines to localize the tip of each cusp on the wax up ( 102 ) ( see fig5 ). the lab technician will also mimic the morphology of the virtual wax up on the image to the wax up or the final restorations on the model or the cast . once the maxillary pre - op model is transferred on the articulator ( 60 ), the platform ( 62 ) is taken out of the articulator ( 60 ) to permit the mounting of the lower model in occlusion with the maxillary pre - op , wax - up , or final restorations model to verify the functional side of the wax up . to match the pre - op facial photograph of the patient , the actual upper denture is duplicated in wax and is mounted on the platform of the articulator with the same technique describe for a patient with natural teeth . before mounting the duplicated denture an accurate impression of the edentulous maxillary tissues have been taken with the duplication process or after and is mounted with the duplicated denture on the platform of the articulator . the same process can be done on the lower denture when both dentures are done at the same time by articulating the lower duplicated denture in occlusion with the upper duplicated denture . in this method the denture pictures are in the 2d libraries . a variety of different dentures teeth in shape , size , and colors are stored in the 2d libraries from different suppliers . the correspondent 3d dentures have been scanned and placed in the 3d software . the denture libraries in the 2d software are calibrated with the central width and height of each for each set of dentures teeth . those measurements are locked in the denture image with tracking lines that will stick to the adjustable or m proportion lines on the teeth of the facial photograph . the m proportion ruler is placed and calibrated on the teeth of the patient actual denture or the trial denture over the patient facial photograph . for each denture in the denture libraries placed in the patient mouth , the green lines in the picture of the library are fused to the red lines of the m proportion on the patient &# 39 ; s 2d photograph . the denture is adjusted automatically to the real size of the patient &# 39 ; s mouth for the patient to visualize a realistic view of is future smile . the denture teeth are adapted to the lip and mouth of the patient with the movement of the adjustable m proportion . the blue vertical lines are restricted to some minor adjustment of 0 . 5 mm on each side of the m proportion ( red line ) to make minor rotations . the upper horizontal line for the adjustment of the lip line ( level of the upper gum ), the middle horizontal line for the position of the incisal edges of the upper centrals , the length of the centrals is locked to , the size of the denture teeth insert over the patient &# 39 ; s actual denture . the parabolic curvature blue box attached to the lower horizontal line adapts the occlusal plane to the smile line by draging the blue square up or down . from the choosen denture library on the screen , the new set of teeth of that library are placed directly on the upper duplicated denture in wax . the technician will used the same technic as previously . all the teeth will be positionned in the wax of the upper duplicated denture with the template ( of adjustable m proportion or m proportion ruler used for the set up on the screen .) on the platform of the articulator . this technic saves multiple appointments for the practionner and the patient . transferring the 2d virtual wax up to a 3d software manufacturing a computerized wax up using 3d modeling the 2d libraries are in the 2d software for consultation , diagnosis and treatment planning with the patient . the 3d correspondent libraries of the 2d images are in the 3d software . in this method the 2d virtual wax up placed over the patient pre op teeth in the 2d software is reproduced on the 3d pre op model of the patient inside the 3d software by overlaying the correspondent 3d library of the 2d library used in the 2d virtual wax up . in the present method the 2d libraries used for virtual wax up come from real patient &# 39 ; s mouth with natural teeth or restored teeth or it can come from other sources . all the smile and teeth pictures in the 2d libraries have their correspondent 3d model or cast stored and scanned in 3d the 2d smile project file interfaces is proceeding by automatic mesh alteration and the used same algorithm ratio , central width and inter molar width used in the 2d software . once the 3d virtual wax up is overlaying the 3d pre - op model in the teeth data the lab technician will manually do alteration and adjustments on the teeth data model . 1 — for dentures ; 3d modeling of the smile under constraint ( red lines ). in this solution , the 3d model can admit small adjustments for each teeth 2 — for crowns , veneers , bridges : 3d modeling of the smile that can be modified ( blue lines ). in this solution , the 3d model will adjust itself to the smile as a whole . the 3d model will have to respect the data from the patient ( i . e . 2d coordinated ( x , y ). anatomic reference points of the smile ) as well as measurements from the wax model or scan of the mouth of the patient ( i . e . depth in the z axis ). referring to this fig5 a model of the 3d wax - up in the 3d software is printed by a stereolithographic printer . from that model a clear thin plastic shell ( 106 ) is done to guide the practitioner for the depth of cut for the placement of ceramic or other material as final restorations on the prepped teeth . a second clear plastic shell is done to produce the provisional &# 39 ; s in the patient &# 39 ; s mouth with a temporary composite material after prepping the teeth or putting abutment on implants to duplicate the virtual wax up in the patient &# 39 ; s mouth . although the present disclosure has been described by way of an illustrative embodiment and example thereof , it should be noted that it will be apparent to persons skilled in the art that modifications may be applied to the present particular embodiment without departing from the scope of the present disclosure . it is to be understood that the disclosed non - limitative illustrative embodiments may be used for assisting in various dental works such as , for example , surgery , fabrication and positioning of implants , fabrication of ceramic veneers and crowns , fabrication of dentures , orthodontic molds , partial and complete prostheses , etc .

a system for designing the dentition of a patient , comprising a first input for providing an image of the smile of the patient to the system , an output , a processor for computing and applying a first set of visual indicators onto the image of the smile of the patient through the output , the first set of visual indicators indicating ideal positioning of the teeth of the patient , and for computing and applying a second set of visual indicators onto the image of the smile of the patient through the output , the second set of visual indicators providing adjustment of positioning of the teeth of the patient , a memory having stored therein a library of 2d digital images of smiles and associated 3d dentition models , a user interface for selecting a desired 2d digital image to be applied to the image of the smile of the patient and adjusting the second set of visual indicators , the adjustment of the second set of visual indicators modifying the 2d digital image , wherein the processor modifies the 3d dentition model associated with the 2d digital image and provides a virtual wax - up of a dental restoration of the dentition of the patient .