Datasets:

farleyknight

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big_patent_10_percent

like 1

the present invention overcomes the disadvantages of the prior art problems by providing a hookfree fixture which can be easily mounted onto and detached from a rod without the necessity of threading the accessory onto and off the rod . as used herein , the terms “ rod ” or “ rod - like ” refers to an elongated object which can have a varying cross - section , but preferably a uniform cross - section and it can be solid or hollow . more preferably , the cross - section is circular . the rod can be made of wood , metal , plastic , a combination of any of the foregoing , or any other suitable material for supporting the inventive hookfree fixture . the hookfree fixture can be secured to a curtain , drape , portiere , or the like , or an intermediate segment between a rod and another portion , such as , a sheet of material or the like . accordingly , the sheet of material would be attached to the hookfree fixture either permanently or detachably and the hookfree fixture would be mounted onto the rod . as used herein , the term “ sheet of material ” broadly refers to a piece of material having relatively large dimensions in the directions of height , length and width as compared to its thickness . the sheet of material can be made of any substance consistent with the scope of the invention . the invention in a preferred embodiment relates to a hookfree fixture adapted for detachable mounting onto a rod - like member . the “ sheet of material ” could further include a relatively flexible sheet of material having an end portion and mounting means integral with the material near the end portion both for mounting onto and detaching from the rod - like member without the necessity of threading the hookfree fixture onto and off the rod - like member . the inventive hookfree fixture further provides reinforcing means integral with the material for each of the openings for inhibiting the tearing of the material and maintaining the integrity of the shape of the openings while engaged on the rod - like member . fig1 a is a first embodiment of the invention showing the front view of the male portion 10 , of the inventive hookfree fixture or module or ring 23 . the male portion 10 , has at least one offset protruding tab 11 a , and a plurality of paired protruding tabs 11 . the male portion 10 , has a tab portion 15 , to accommodate at least one offset protruding tab 11 a . the male portion 10 , has an opening or a hole 13 , and a channel openings 17 a and 17 b , that allows the tab 15 , to move up or down from the plane of the male portion 10 , thus providing a living hinge . the channel opening 17 a , preferably originates at the outer periphery of the male portion 10 , such as an edge 19 , and goes around a portion of the offset protruding tab 11 a . the channel opening 17 b , is preferably a straight channel opening , and it connects the opening 13 , to the channel opening 17 a . for some applications a portion of the channel opening 17 a would have a curvature or be substantially straight , while in other applications a portion of the channel opening 17 b would be substantially straight or have a curvature . it should be appreciated that in fig1 a , the protruding tab 11 a is shown on the surface of the tab 15 , while protruding tabs 11 are shown in an almost circular fashion around the periphery of the opening 13 , on the surface of the male portion 10 , but a person skilled in the art can easily adjust the location , protruding extension , diameter and similar other features of the protruding tabs 11 and 11 a . however , it is preferred that the protruding tab 11 a , is on the surface of the tab 15 , and is in an offsetting position from the other protruding tabs 11 . it is preferred that the tab area 15 , having the at least one protruding tab 11 a , is between an edge 12 , and an edge 19 , of the male portion 10 . the protruding tabs 11 and 11 a , have a cross - section that is selected from a group comprising substantially a triangular shape , a rectangular shape , a circular shape , a cylindrical shape , an hour - glass shape , a conical shape , a pyramidal shape , to name a few . fig1 b is a rear view of the inventive hookfree fixture or module 23 , of fig1 a . fig1 c is a side view of the inventive hookfree fixture or module 23 , of fig1 a , clearly showing the at least one protruding tab 11 a , and a plurality of protruding tabs 11 , in the male portion 10 . fig2 a is a first embodiment of the invention showing the front view of the female portion 30 , of the inventive hookfree fixture or module 23 . the female portion 30 , has at least one offset tab hole or blind hole or opening 31 a , to securely accommodate the at least one corresponding offset protruding tab 11 a , and a plurality of tab holes or blind holes or paired openings 31 , to securely accommodate the corresponding paired protruding tabs 11 . the female portion 30 , has a tab portion 35 , to accommodate at least one tab opening 31 a . the female portion 30 , has an opening or a hole 33 , and a channel openings 37 a and 37 b , that allows the tab 35 , to move up or down from the plane of the female portion 30 , thus providing a living hinge 36 . there are many ways of creating the optional living hinge 36 , one such way would be have a slight weakness along a portion of the tab portion 35 , thus allowing the tab 35 , to move up and down along a weak portion such as along an edge of the living hinge 36 . however , for some applications it is preferred that either the male portion 10 , or the female portion 30 , or both have a living hinge 36 . the channel opening 37 a originates at the outer periphery of the female portion 30 , and goes around a portion of the tab opening 31 a . the channel opening 37 b , is preferably a straight channel opening , and it connects the opening 33 , to the channel opening 37 a . for some applications a portion of the channel opening 37 a would have a curvature or be substantially straight , while in other applications a portion of the channel opening 37 b would be substantially straight or have a curvature . it should be appreciated that in fig2 a , the tabs opening 31 a is shown on the surface of the tab 35 , while the tab openings 31 are shown in an almost circular fashion around the periphery of the opening 33 , on the surface of the female portion 30 , but a person skilled in the art can easily adjust the location , opening diameter and similar other features of the tab openings 31 and 31 a . however , it is preferred that the tab opening 31 a , is on the surface of the tab 35 , and is in an offsetting position from the other tabs openings 31 . it is preferred that the tab area 35 , having the at least one tab opening 31 a , is between an edge 32 , and an edge 39 , of the female portion 30 . the cross - section for the tab openings 31 and 31 a , have a cross - section that is selected from a group comprising substantially a triangular shape , a rectangular shape , a circular shape , a cylindrical shape , a hour - glass shape , a conical shape , a pyramidal shape , to name a few . fig2 b is a rear view of the inventive hookfree fixture or module 23 , of fig2 a . fig2 c is a side view of the inventive hookfree fixture or module 23 , of fig2 a , clearly showing the at least one tab opening 31 a , and a plurality of tab openings 31 , in the female portion 30 . it should be appreciated that the channels or slits 17 a , 17 b , 37 a and 37 b , allow the selective opening and closing for the male member 10 and female member 30 , and the sealing of the same via the use of tab members 15 and 35 . in fact male member 10 and female member 30 , can be securely locked in place upon the insertion of the offset protruding member 11 a , into the offset hole 31 a , and the insertion of the paired protruding members 11 , into the corresponding paired openings 31 , and snapping each member in place . in a closed position the hookfree fixture or module 23 , securely and snugly holds its content in place while allowing a sliding movement of its secured content along the path of its opening 13 and 33 . in one sense the hookfree module provides a ring to its content , which ring can be opened and sealably closed using the male member 10 and the female member 30 , such as , the tab portions 15 and 35 . fig3 is second embodiment of the invention showing the inventive hookfree fixture 23 , secured to an upper edge 49 , of the inventive hookfree curtain 27 , and slideably secured to a rod 25 . the curtain 27 , has a big opening 21 , and a plurality of small openings ( not shown ) to allow the passage of the protruding tabs 11 and 11 a , of the male portion 10 . it is preferred that the opening 21 , in the hookfree curtain 27 , is similar in size to the openings 13 and 33 , in the male portion 10 , and the female portion 30 , respectively , so as to easily and slideably accommodate a rod 25 , such as , a curtain rod 25 , or a shower curtain rod 25 . once the protruding tabs 11 and 11 a , from the male portion 10 , are passed through the corresponding openings in the curtain 27 , the female portion 30 , is then securely attached to the male portion 10 , such that the protruding tabs 11 and 11 a , pass through the curtain 27 , and are securely held in place within the corresponding openings 31 and 31 a , in the female portion 30 . it should be appreciated that the tab 15 , on the male portion 10 , and the tab 35 , on the female portion 30 , are placed in such a way such that at least a portion of the tab 10 , overlaps at least a portion of the channel 37 a , while at least a portion of the tab 35 , overlaps at least a portion of the channel 17 a , so as to provide a continuous secured positioning to the curtain 27 , which is sandwiched between the male portion 10 and the female portion 30 , which is more clearly shown in fig4 . it should also be understood that the channel openings 17 b and 37 b may or may not overlap but that may not create a security problem as the overlapping of the tabs 15 and 35 , provide an excellent security to the inventive hookfree curtain 27 , once the protruding tab 11 a is securely snapped into the corresponding opening 31 a . fig4 is a third embodiment of the invention showing the inventive hookfree curtain 27 . the hookfree curtain 27 , has at least one large opening or hole 43 , to substantially correspond to the openings 13 , in the male portion 10 , and the opening 33 , in the female portion 30 . the opening 43 , is further surrounded by a plurality of holes or openings 41 , that substantially correspond to the protruding tabs 11 , in the male portion 10 , so as to allow the passage of the protruding tabs 11 , to pass there through and mate with corresponding holes or openings 31 , in the female portion 30 . at least one off - set hole or opening 41 a , in the hookfree curtain 27 , allows the passage of the corresponding tab 11 a , from the male portion 10 , to pass there through and connect with the corresponding hole or opening 31 a , in the female portion 30 . at least one channel 47 , provides an opening or channel or a slit or an edge gap in the curtain 27 , so as to provide a link between the hole or opening 43 , and the outer edge 49 , of the curtain 27 . at least a portion of the channel opening 17 b , is substantially parallel to the channel opening 47 . similarly , at least a portion of the channel opening 37 b , is substantially parallel to the channel opening 47 . it is preferred that at least a portion of the channel opening 17 b , 37 b and 47 , are at an angle of between about 30 degrees to about 60 degree to the edge of the hookfree curtain 27 . however , it is more preferred that at least a portion of the channel opening 17 b , 37 b and 47 , are at a 45 degree angle to the edge of the hookfree curtain 27 . an important feature of this invention is that the male portion 10 , has at least one protruding tab 11 a which is substantially and distinctly separate from the protruding tabs 11 . for example , if the protruding tabs 11 , share a common or substantially common distance or radius as taken from the center of the opening 13 , then the protruding tab 11 a will have a different distance or radius as taken from the center of the opening 13 . another important feature of this invention is that the female portion 30 , has at least one tab opening 31 a which is substantially and distinctly separate from the tab openings 31 . for example , if the tab openings 31 , share a common or substantially common distance or radius as taken from the center of the opening 33 , then the tab opening 31 a will have a different distance or radius as taken from the center of the opening 33 . similarly , another important feature of this invention is that the hookfree curtain 27 , has at least one opening 41 a which is substantially and distinctly separate from the openings 41 . for example , if the openings 41 , share a common or substantially common distance or radius as taken from the center of the opening 43 , then the opening 41 a will have a different distance or radius as taken from the center of the opening 43 . as a person skilled in the art can appreciate that this offsetting of the openings 31 a and 41 a , is to allow the penetration of the corresponding offsetting protruding tab 11 a , through these openings 31 a and 41 a , for a secure installation of the hookfree curtain 27 , on the rod 25 . similarly , a person skilled in the art can also appreciate that the openings 31 , in the female portion 30 , and the openings 41 , in the hookfree curtain 27 , allow the penetration of the corresponding protruding tabs 11 , from the male portion 10 , to pass through these openings 31 and 41 , for a secure installation of the male portion 10 , to the female portion 30 , through the curtain 27 . as a person skilled in the art can also appreciate that channels 17 a , 17 b , 47 , 37 a and 37 b , allow the sliding of a curtain rod 25 , therethrough , and then the hookfree fixture 23 , can be snapped into place for the secure hanging of the curtain 27 , onto a rod 25 . thus , with this invention there is no need to remove the rod 25 , in order to install a curtain 27 . there are many ways to install the hookfree curtain 27 , onto a rod 25 . for example , one way would be to pass the curtain 27 , through the channel 47 , and onto the rod 25 , such that the rod 25 , passes through the opening 43 . the next step would be to pass the protruding tabs 11 , 11 a , through the corresponding openings 41 , in the curtain 27 , such that the rod 25 , passes through the opening 13 , in the male portion 10 . the final step would be to snap and secure the female portion 30 , to the male portion 10 , by snapping the protruding tabs 11 and 11 a , inside the corresponding openings 31 and 31 a , in the female portion 30 . it should be appreciated that the living hinge portion or the tab portions 15 and 35 , having the offsetting protruding tab 11 a , and the corresponding offsetting opening 31 a , respectively , overlap the edge gap 47 , thus preventing the curtain 27 , or the hookfree fixture 23 , from sliding off from the rod 25 . it is preferred that the living hinge , such as , the living hinge 36 , is at an angle of between about 30 degrees to about 60 degree to an edge of either the male portion 10 , or the female portion 30 . however , it is more preferred that the living hinge , such as , the living hinge 36 , is at a 45 degree angle to the edge of either the male portion 10 , or the female portion 30 . it is also preferred that the living hinge , such as , the living hinge 36 , is between the protruding tabs 11 and 11 a , and thus allows the movement of the tab portion 15 , along the edge of the living hinge . similarly , it is preferred that the living hinge , such as , the living hinge 36 , is between the tabs openings 31 and 31 a , and thus allows the movement of the tab portion 35 , along the edge of the living hinge . fig5 is a fourth embodiment of the invention showing the male portion 10 , of the inventive hookfree fixture 23 , attached to the female portion 30 , of the inventive hookfree fixture 23 , along at least a portion of the edge via at least one connecting tab 40 . it should be appreciated that only one connecting tab 40 , is shown , however , it is within the realm of the invention to have a plurality of tabs 40 , along an edge or to have one large tab 40 , or to have a tab 40 , in such a way so as to have an edge - to - edge connection of the male portion 10 , and the female portion 30 , of the inventive hookfree fixture 23 . fig6 illustrates an embodiment of the invention showing the inventive living hinge 36 , for the inventive hookfree fixture 23 , as it appears in the female portion 30 . it is within the realm of a person in the art to know that the living hinge 36 , can have any shape , however , it is preferred that the shape of the living hinge 36 , is selected from a group comprising substantially of a triangular shape , a rectangular shape , a semicircular shape , a semi - cylindrical shape , a conical shape , a trough - type shape , a weak spot , a plurality of indentations , to name a few . the material of the inventive hookfree fixture 23 , is preferably selected from a group comprising a plastic material , a vinyl material , a metallic material , a rubber material , a composite material , a recycled material , a recyclable material , a hydrophobic material and a teflon - type or polytetrafluoroethylene - type material , to name a few . furthermore , the material for the inventive hookfree fixture 23 , could also be selected from a group comprising of opaque material , transparent material , translucent material , to name a few . similarly , the material for the inventive hookfree curtain 27 , could also be selected from a group comprising of opaque material , transparent material , translucent material , pleated material , to name a few . the curtain 27 , could be selected from a group comprising of a shower curtain , a privacy curtain , a window treatment , a blind , a shade , a drapery , a portiere , a room divider , a windscreen and a window curtain , to name a few . furthermore , the material for the hookfree curtain 27 , could be selected from a group comprising of a cloth material , plastic material , a vinyl material , a polyester material , a polyester - type material , a polypropylene material , a polypropylene - type material , a metallic material , a rubber material , a composite material , a recycled material , a recyclable material , a hydrophobic material , a teflon material , a paper material , a disposable - type material , a metallic foil - type material , to name a few . this is especially important when this inventive curtain 27 , is used in a field environment , such as , setting up a showering facilities in a remote area , or setting up a field operation during a natural catastrophe , such as , during an earthquake relief efforts , or in a war zone where field hospitals are being set - up quickly and there is a need to provide privacy to the injured people . the inventive hookfree sheet or curtain 27 , can also be made of a plastic or resin , such as commonly used for shower curtains , or a woven fabric or the like , or a non - woven fabric or the like , or a water resistant paper , or sheet metal , or woven metal strands or rods , or some other material suitable for the practice of the invention . an advantage of using a relatively inexpensive material , such as , a water resistant paper or the like is that the hookfree curtain 27 , can be manufactured at a price enabling it to be sold as a disposable curtain . for example , the hookfree curtain 27 , can be a disposable shower curtain . a disposable shower curtain could be used in many commercial situations , such as , hotels and motels , and could also be used in other institutional environments . it should be appreciated that a portion of the hookfree fixture 23 , may be visible after the curtain has been mounted . thus , for some applications the hookfree fixture 23 , may have to be provided with some aesthetic appeal to compensate for the necessity of having it exposed . it is within the realm of this invention to provide the inventive curtain 27 , with antibacterial treatment so as to kill most surface germs and to prevent the formation of mold or mildew . it should be appreciated that hookfree is a trademark of neilmax industries , inc . and is available on the internet from their website www . neilmax . com . while the present invention has been particularly described in conjunction with a specific preferred embodiment , it is evident that many alternatives , modifications and variations will be apparent to those skilled in the art in light of the foregoing description . it is therefore contemplated that the appended claims will embrace any such alternatives , modifications and variations as falling within the true scope and spirit of the present invention .

the present invention relates to a hookfree curtain and fixture thereof . more particularly , the invention encompasses a hookfree shower curtain that can be used in the motel / hotel industry . this invention further includes inventive features , such as , a snap - on or clip - on curtain fixture or module or ring which is either a single piece or a two piece module that is secure to a curtain and allows the curtain , such as , a shower curtain , to be slideably secured to a rod , such as , a shower rod , without having to disassemble the rod , such as the shower rod .

referring in detail to the drawings , there is shown in fig1 to 3 , 5 and 6 a preferred form of adaptor a which is specifically conformable for use with sleeping bags represented at 3 , the sleeping bag 3 being of a type conventionally referred to as a &# 34 ; mummy bag &# 34 ;. as a setting for the present invention , the standard sleeping bag has generally rectangular panel portions folded along a common longitudinal edge into superimposed relation to one another with removable fastener means extending at least along the opposite coextensive longitudinal edges and end edges for releasably securing said panel portions together . specifically in the case of mummy bags , as noted from fig2 and 3 , the panel portions are tapered toward the foot end and the removable fastener means or zipper 2 extend only along the coextensive longitudinal edges and terminate at the foot end of the bag . thus , when unzipped and unfolded as illustrated in fig3 the mummy bag has zipper portions extending along the separated longitudinal edges ; and of course when unfolded will greatly increase the effective size of the mummy bag for utilization in combination with the preferred form of adaptor a now to be described . the adaptor is preferably composed of a resilient or flexible cushion material and for example may be composed of a thin foam cushion pad encased in a fabric cover , as illustrated in fig5 and 6 . in configuration , the pad includes a relatively wide , generally rectangular portion extending from the head end of the pad for its greater length and terminating in a tapered portion toward the foot end so as to generally conform in configuration to that of a zipped mummy bag . a conventional type of drawstring 1 is affixed to the head end of the bag so as to extend completely around the head end surface and a portion of the sides whereby to permit tightening to draw the pad at its head end into the form of a hood very much in the manner that is done with a mummy bag . further , the adaptor pad is provided with a removable fastener on its undersurface preferably in the form of a zipper section 2 which is spaced inwardly of the side edges to extend from a common point at the foot end of the adaptor pad for substantially the entire length of the pad and terminating adjacent to the head end , as best seen from fig1 . the adaptor pad is preferably dimensioned to be of a width sufficient to accommodate two persons in side - by - side relation and specifically is of a configuration and width to permit its insertion into the opening created by unzipping the zipper portion of the mummy bag , spreading it open , and folding or wrapping the unzipped edges of the mummy bag over the side edges of the adaptor pad and folding thereunder until the zipper portions of the mummy bag are aligned with the zipper section ii of the adaptor pad , again as illustrated in fig3 . for the purpose of illustration and not limitation , the adaptor pad a may be approximately forty - five inches wide so as to allow two average - sized persons to lie comfortably side - by - side on the pad and the zipper section 2 may be set back from the longitudinal edges of the pad approximately four inches thereby creating a draft flap when joined with the side edges of the mummy bag to insure greater warmth between the bag and adaptor pad . in this manner , the mummy bag will completely cover the top surface and side edges of the adaptor pad so as to form a double bag construction . thus , when used in combination , the adaptor pad has longitudinal edges extending along opposite sides as well as opposite end edges , the pad being of a length slightly less than the length of the panel portion of the mummy bag and of a width greater than the folded width of the panel portion but less than the unfolded width of the panel portions . the generally u - shaped zipper section defines removable fastener means affixed to the undersurface of the adaptor pad and spaced inwardly of the opposite side longitudinal edges and end edges and extending continuously therealong ; and the zipper portions of the mummy bag along opposite longitudinal edges and end edges of the panel portions also form mating removable fastener means which can be folded over the side longitudinal edges and end edge of the adaptor pad with the removable fasteners on the panel portions secured to the fastener means on the pads and the panel portions extending across and above the surface of the adaptor pad a opposite to the undersurface . fig4 and 7 illustrate the conformability of the adaptor pad a for use with a special insert 4 to form a single bag . the insert 4 is nothing more than a sleeping bag of a reduced width in relation to that of the conventional bag but of a corresponding construction . a zipper extends around opposite coextensive longitudinal edges and at a tapered or rounded end which once again can be folded over the opposite side edges and foot end of the adaptor pad a . as best seen from fig7 by virtue of the reduced width of the insert 4 its joinder along the zipper section with the adaptor pad a will cause the adaptor pad to be drawn up along its side edges . similarly , the drawstring at the head end of the bag is drawn up so as to form a somewhat curved configuration of the adaptor pad at its head end . further , as noted from fig4 when the insert and pad are zipped together , the tapered end of the pad will lay somewhat flat but the head end be curled or rolled up slightly along its edges so as to more snugly fit around a single person lying on the pad and within the insert with the insert extending down over the foot end of the adaptor pad so as to completely surround and cover the feet . by virtue of utilization of the adaptor pad with a single panel portion or insert as described , such facilitates use of a pair of adaptor pads with a sleeping bag formed with two panel sections zipped together and separable into halves so that each half may be used independently with an adaptor pad as described and shown with respect to fig4 and 7 . fig8 illustrates a somewhat modified form of adaptor pad - sleeping bag construction in which a draft flap 5 is inserted between the side edges of the adaptor pad and longitudinal edges of the mummy bag to create further insulation at the juncture between the bag and the pad . in this form , the bag is illustrated as being removably fastened or zipped to the lower corner edge of the adaptor pad , and most desirably the draft flap is permanently secured to opposite edges of the pad directly adjacent to the zipper portion . as illustrated , the draft flap may be composed of a foam - filled , polyester or downfill encased within a cover having the thickness as indicated . still another modified form of adaptor pad a &# 39 ; is illustrated in fig9 wherein the pad 5 is composed of a synthetic fiber fill body in double layers separated by sheets of nylon 8 , and the zipper 2 sewn through one layer of the nylon 8 in order to stabilize its position and minimize any tendency to become separate from the pad or stretched by the sleeping bag unless sewn directly to the inner portion of the pad as illustrated in fig9 . another modified pad construction is shown in fig1 in which screen vents 10 are backed by one or more layers of a porous material 9 so as to permit water to pass through while preventing the down 12 from escaping . a cloth wind cover 11 is secured to the upper corner edge of the pad along opposite side edges to extend downwardly over the vents 10 so as to prevent loss of thermal efficiency which would otherwise occur during wind blowing through the vent . this modified form is of special value in the use of rip - stop nylon and other tight weaves which resist the passage of water when wet . utilization of the screened vents as described affords a means for venting the fiber and downfilled sleeping bags in order that wash water surging though the bag will not burst the seams . the vents also will permit air to escape when the bag is to be rolled or folded as well as to permit air to enter the pad when unfolded .

an adaptor pad is devised for use with sleeping bags , particularly those commonly referred to as mummy bags , in which the mummy bag can be unfolded and the zipper edges wrapped or folded over the opposite side edges of the adaptor pad and removably secured to zipper sections at or beneath the side edges of the adaptor pad . the pad is so constructed and arranged as to permit its use either with a single or double panel portion of a sleeping bag to provide sleeping accommodations for one or two persons , respectively .

fig1 shows a catheter head in accordance with one embodiment of the present invention , comprising a circular , flat cannula casing 1 and a circular , flat connecting element 2 fixed to said cannula casing 1 . a cannula 3 protrudes from the cannula casing 1 , and in the drawing is directed substantially downwards , perpendicularly from the cannula casing 1 . the cannula 3 can , however , protrude from the cannula casing 1 at any other angle and therefore penetrate organic tissue at any angle . in the example shown , a wall 4 which is arranged annularly about a central opening protrudes upwards from the cannula casing 1 . the cannula 3 is guided though the central opening and secured by an insertion part 5 , i . e . a septum , inserted within the circumference of the wall 4 . the septum 5 also comprises a central opening which forms the passage channel 6 . the connecting element 2 comprises a fluid supply 7 which feeds into a tube - like central continuation 8 arranged centrally in the middle of the connecting element 2 . the continuation 8 is guided along the central opening of the septum 5 until it feeds into the cannula 3 , whereby a liquid connection from a fluid container ( not shown , but typical ) via the fluid supply 7 and the cannula 3 into the organic tissue is established . if the connecting element 2 is only partially inserted into the central opening of the septum 5 , it can be rotated about the axis of the tube - like continuation 8 — which at the same time also represents the extension of the longitudinal axis of the cannula — relative to the cannula casing . in the example shown in fig1 , the guiding means is formed in accordance with the present invention by first protrusions 9 on the cannula casing 1 and by second protrusions 10 on the connecting element 2 . the protrusions 9 are arranged on an outer annular area of the cannula casing 1 which points upwards , wherein the first protrusions on said annular area extend or are aligned generally radially with respect to the center of the cannula casing . the second protrusions 10 of the connecting element 2 are arranged on the circumferential edge area of the connecting element 2 , wherein the edge of the connecting element 2 with the second protrusions 10 is curved towards the cannula casing 1 in such a way that the second protrusions 10 are arranged generally opposite the first protrusions 9 . the second protrusions 10 therefore also run , extend or are aligned generally radially towards the center of the cannula casing 1 or connecting element 2 , respectively . when placing the connecting element 2 onto the cannula casing 1 , i . e ., when inserting the continuation 8 into the central opening of the insertion part 5 , the connecting element 2 can be rotated relative to the cannula casing 1 , until the fluid supply 7 is led away from the catheter head in a desired direction . this selected position either directly corresponds to one of the discrete rotational positions of the guiding means or can be moved into a nearby position corresponding to a discrete rotational position by a slight , negligible angular movement . this discrete rotational position is determined by the second protrusions 10 on the connecting element 2 engaging with the intermediate space , opposite in this position , between the first protrusions 9 on the cannula casing 1 . when the connecting element 2 and the cannula casing 1 are further joined together , these two parts are guided by the protrusions 9 and 10 which slide into each other . in order to enable the discrete positions to be located and the continuation 8 to be gently inserted , the protruding sides of the protrusions are arranged obliquely with respect to their base area . the connecting element 2 is inserted into the cannula casing 1 until the second protrusions 10 rest on the base area of the intermediate spaces of the first protrusions 9 . in this state , the continuation 8 protrudes into the cannula 3 to a certain depth , in order to ensure the fluid connection . if a different rotational position of the connecting element 2 relative to the cannula casing 1 is desired , the connecting element 2 is raised slightly from the cannula casing 1 , until the engagement between the protrusions 9 and 10 is released . the connecting element 2 can then be rotated again relative to the cannula casing 1 , until a desired new rotational position has been reached . by pushing the connecting element 2 and the cannula casing 1 together , the second protrusions 10 of the connecting element 2 are then inserted into the intermediate space between the first protrusions 10 of the cannula casing 1 , now opposite them in accordance with the new discrete rotational position . when the connecting element 2 is raised from the cannula casing 1 in order to change a rotational position , the continuation 8 preferably remains in the central opening of the septum 5 , preferably in the cannula 3 , at least via its tip , in order to not interrupt the fluid connection despite the change in rotational position . in order to form the fixing means , two elongated opening slits 11 through the connecting element 2 are arranged in accordance with the invention in the example shown in fig1 . the slits begin from the edge of the connecting element 2 and initially run substantially towards the center of the connecting element 2 , then pass into a part running substantially in the circumferential direction , and terminate in a part running substantially radially outwards again before the edge of the connecting element 2 . accordingly , they are formed in generally curved or wave shape . two outer regions 12 of the connecting element 2 are defined by these opening slits 11 . the outer regions each form a sort of arm of the connecting element 2 , which can be moved towards the center of the connecting element 2 if a pressure is exerted on the outer regions from the edge . a first barb 13 is provided on the cannula casing 1 , as a first clamping element of the fixing means , and protrudes upwards from the cannula casing 1 towards the connecting element 2 . the first barb 13 is preferably formed by a projection protruding towards the center of the cannula casing 1 and is circumferentially arranged on the entire circumference of the cannula casing , annular about the center of the cannula casing 1 . it is , however , also possible to only arrange the barb on circumferential sectors . on the connecting element 2 , second barbs 14 protruding downwards towards the cannula casing 1 , complementary to the first barb 13 , are arranged on the outer regions 12 , as second clamping elements of the fixing means . the barbs 14 extend in the circumferential direction on the edge of the part of the opening slits 11 running in the circumferential direction . the second barbs 14 can run continuously along the part of the opening slit 11 running in the circumferential direction or can be interrupted . when placing the connecting element 2 onto the cannula casing 1 , the outer regions 12 of the connecting element 2 are pressed together , e . g ., by the thumb and forefinger , such that the second barbs 14 move towards the center of the connecting element 2 and , when the connecting element 2 is inserted into the cannula casing 1 , are guided past the first barb 13 of the cannula casing 1 . preferably , the outer regions 12 can be moved far enough inside that the second barbs 14 do not rub on the first barb 13 . if a rotational position has been selected and the cannula casing 1 and the connecting element 2 guided completely into each other in said rotational position , the pressure on the outer regions 12 is reduced and the barbs 13 and 14 interlock into each other in a clamping connection . if a new rotational position is to be selected , the outer regions 12 are pressed together again , in order to release the clamping connection of the barbs 13 and 14 , such that the connecting element 2 can be at least partially raised from the cannula casing 1 , at least until the locking connection of the guiding means is released . the connecting element 2 and the cannula casing 1 can then be rotated relative to each other , into a new desired rotational position . by pushing the cannula casing and the connecting element completely together when the outer regions 12 are pressed in , the second protrusions 10 can in turn engage with the intermediate spaces between the first protrusions 9 , corresponding to the new rotational position . by abating , reducing , or relieving the pressure on the outer regions 12 , the barbs 13 and 14 interlock into each other and the connecting element 2 is fixed on the cannula casing 1 in this new discrete rotational position . in the exemplary embodiments shown in fig1 , the first protrusions 9 are provided on the entire circumferential area of the cannula casing 1 , whereas the second protrusions 10 of the connecting element 2 are only provided on the edge of the regions between the movable outer regions , i . e ., second protrusions 10 are not provided on the edge of the outer regions in the example shown . this facilitates the engaging of the clamping elements 13 and 14 . it would , however , be equally possible to also attach second protrusions 10 to the edge of the outer regions 12 . these second protrusions 10 would then slide along the first protrusions 9 when the clamping elements 13 and 14 engage and the pressure on the outer regions 12 is abated . it is also conceivable to provide the first and second , mutually complementary locking elements of the guiding means on the mutually facing areas of the clamping elements 13 and 14 . to this end , corresponding cooperating protrusions could , for example , be provided on the projections of the barbs 13 and 14 . in this case , the guiding means and the fixing means would be combined into one means . fig2 shows a cannula casing 1 of another exemplary embodiment of a catheter head in accordance with the present invention , which is also formed circularly and from which a cannula protrudes downwards ( not visible in fig2 ). in this embodiment , the guiding means in accordance with the present invention is provided on the wall 4 arranged around the central opening . in order to form a locking connection between the cannula casing 1 and a connecting element , to provide the discrete rotational positions in accordance with the invention , protrusions 15 — preferably triangular — are provided on the wall 4 , generally in the circumferential direction around the wall . through these triangular protrusions 15 , the outer circumference of the wall 4 is formed in a sort of star shape . it is then possible for adjacent wall areas of adjacent triangles to be orientated in the same direction and therefore to form a joint area , or for a recess to be created between adjacent triangles when the adjacent areas of these triangles are at an angle with respect to each other . furthermore , the protrusions 15 provided on the wall 4 do not have to be formed triangularly , but can , for example , also be quadrangular , can be formed by curves or can have any other suitable configuration . the discrete rotational positions are provided by the protrusions 15 formed on the circumferential area of the wall 4 , by an intermediate space 16 between two protrusions 15 , which is formed , for example , by adjacent wall areas of adjacent triangular protrusions 15 , corresponding to a discrete rotational position . the number of discrete rotational positions of a catheter head in accordance with the present invention can be varied by varying the number of protrusions on the wall 4 . on the connecting element corresponding to the cannula casing 1 of an embodiment as set forth in fig2 , a wall can be provided around the continuation 8 , the wall protruding from the connecting element towards the cannula casing 1 . protrusions can be provided on an inner circumferential area of the wall which run complementarily to the protrusions 15 of the cannula casing 1 . in case intermediate spaces 16 are formed by the protrusions 15 on the outer circumferential area of the wall 4 of the cannula casing 1 , as shown in fig2 , the protrusions on the inner circumferential area of the wall of the connecting element are formed in such a way that they fit into said intermediate spaces 16 . to this end , triangular protrusions having an obtuse angle can , for example , be provided . if adjacent areas of adjacent protrusions 15 on the wall 4 of the cannula casing 1 form a joint area , the inner circumferential area of the wall of the connecting element is formed as a polygon having inner areas corresponding or complementary to the joint areas of the protrusions 15 . if the protrusions 15 on the outer circumferential area of the wall 4 are provided by curves , then curves can also be formed on the inner circumferential area of the wall of the connecting element , said curves fitting into the intermediate spaces 16 . in the embodiment depicted in fig2 , the fixing means for a releasable clamping connection comprises an annularly circumferential elevation 17 on an outer region of the cannula casing 1 . a number of elongated recesses 18 running in the circumferential direction are provided in the inner circumferential area of the elevation 17 . on a connecting element corresponding to this fixing means , clamping elements on the movable outer regions 12 can be provided with a protrusion which fits into the recesses 18 . a discrete rotational position is selected for the catheter head and the clamping connection between the cannula casing and the connecting element is established analogously to the embodiment described with reference to fig1 . in order to facilitate removing the connecting element 2 by pressing the outer regions 12 together and raising it off the cannula casing 1 , guiding blocks 19 for the clamping elements are provided in front of the recesses 18 on the base area of the cannula casing 1 . preferably , the recesses 18 and the intermediate spaces 16 are arranged opposite each other and the guiding blocks 19 are arranged between the recess 18 and the intermediate spaces 16 . the guiding blocks 19 are preferably formed as wedge - shaped ramps , such that they comprise a guiding area which rises in the radial direction from the edge of the cannula casing 1 . a clamping element of the connecting element , when raised by pressing the biased outer regions 12 together , is repelled upwards from the cannula casing , along said guiding area . on or adjacent to the edge of the cannula casing 1 , flaps 20 are provided on opposite sides and serve , for example , to hold the cannula casing 1 on the surface of the tissue when the connecting element is raised . the embodiments shown in the drawings are to be understood to be exemplary and are not intended to restrict the scope of the invention . in particular , the angular arrangement of the cannula 3 and the fluid supply 7 of the catheter head in accordance with the present invention can be altered . in the foregoing description , embodiments of the present invention , including preferred embodiments , have been presented for the purpose of illustration and description . they are not intended to be exhaustive or to limit the invention to the precise forms disclosed . obvious modifications or variations are possible in light of the above teachings . the embodiments were chosen and described to provide the best illustration of the principals of the invention , methods of making the invention , and the practical application and use of the invention , and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated . all such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly , legally , and equitably entitled .

a catheter head , for introduction of a fluid into an organic tissue , including a cannula housing with a cannula , a connector element with a fluid inlet , a guide and a fixing device . the guide device has several selectable discrete rotational positions for positioning the connector element relative to the cannula housing about a longitudinal axis of the cannula . the connector element , positioned in a rotational position , is detachably connected to the cannula housing in the selected position by means of the fixing device .

antimicrobial compositions that provide enhanced immediate and residual anti - viral and antibacterial efficacy against rhinovirus , rotavirus , gram - positive bacteria , gram - negative bacteria and combinations thereof are taught in u . s . patent publications 20030235550 a1 , 20040001797a1 , and in published pct application wo 2004 / 000016 the content of which are incorporated herein by reference . these compositions were stated to have efficacy against gram negative and gram positive bacteria and also against viruses . we believe that certain formulations of these short chain , big head surfactant based antimicrobial compositions will be effective against a wide variety of pathenogenic agricultural organisms including but not limited to citrus canker . these antimicrobial compositions comprise an organic acid or organic acid mixture , a specific short - chain anionic surfactant with branching or a large head group , and , optionally , a calcium ion scavenger and / or anti - foam agents . for therapeutic use the formulations require in addition to the surfactant , an organic acid acid and a nonionic agent . preferred is to use c8 - ags as the surfactant , pyrrolidone carboxyilic acid as the organic acid and ethylhexyl glycerol ether ( ehop ) as the non - ionic agent . one of skill in the art will recognize that other agents as disclosed in 20030235550 a1 , 20040001797a1 , or wo 2004 / 000016 may be substituted . preferred are compositions having greater than about 0 . 50 % c8ags with most preferred compositions containing at least 1 . 25 % c8ags and a pyrrolidone carboxyilic acid content of greater than or equal to 2 . 0 %. one of skill in the art will readily recognize that other active ingredients can be included to provide different properties or to improve the effectiveness of the present compositions against specific organisms . when adding other actives , the concentration of surfactants , acids and / or non - ionic agents would also be modified to provide the degree of activity desired . for example , parachlorometaxylenol ( pcmx ), a known antimicrobial may be added to provide another broad spectrum antimicrobial . for example when adding pcmx , it is possible to reduce the amount of c8ags below 1 % concentration by weight . the composition of the present invention may be formulated for use in any manner known to one of skill in the art . formulations for topical , mucosal and aerosol delivery of drugs are taught in modern pharmaceutics by gilbert s . banker ( editor ), christopher t . rhodes ( editor ) marcel dekker ; 4th edition ( jun . 15 , 2002 ) isbn : 0824706749 , all of which is incorporated herein by reference . reference is also made to the international journal of pharmaceutical compounding which can be accessed at www . ijpc . com , the content of which is incorporated herein by reference . these sources teach and describe the basics of pharmaceutical compounding . one of skill in the art will know how to take the active ingredients of the present invention and formulate them for delivery . such formulations may take the form of lotions , ointments , gels , creams , drops washes , pastes , suppositories , lozenges , mouthwashes , gargles , douches , foams , surface coatings , liposomes , microspheres and transdermal patches . one of skill in the art will appreciate that the activity of the present compositions can be affected through the selection of excipients to provide varying degree of skin penetration or to control release . activity of the present formulations can be increased by occlusion of the skin after application with a suitable bandage or wrap . one of skill in the art will also recognize that persistent action can be increased by use of controlled release technologies which delay release of active over time . the formulations contemplated herein can also be coated or otherwise incorporated into medical devices such as wipes , sponges , bandages , surgical drapes , hospital gowns , surgical gowns . formulations can be developed that are suitable for disinfecting medical devices . such formulations could be in the form of a liquid which could be used for spraying onto surfaces , soaking of devices , pumping through devices or incorporated into wipes for decontaminating a surface . the formulations described above were tested for minimum bactericidal dilution and residual efficacy against c . albicans , e . coli , s . marcesens , methicillin resistant staphylococcus aureus , and e . faecalis , the above compositions from table 1 were tested for minimum bactericidal dilution . organisms to be tested were grown on slants and transferred to an agar plate by streaking to form a lawn . colonies are scraped off the agar plates using a sterile innoculating loop and suspended in phosphate buffered solution ( pbs ) and diluted to 5 × 10 6 cfu / ml . candida albicans was cultured under appropriate conditions . ( current usp procedures for culturing organisms is appropriate .) incubation period varies ( typically 120 hours at 25 ° c .+/− 1 ° c .) to a density of between 1 . 0e + 06 − 1 . 0e + 07 cfus / ml . actual cfus / ml of starting cultures were determined by serially diluting and plating an aliquot ( typically plate 10 − 6 , 10 − 5 , 10 − 4 , 10 − 3 , 10 − 2 dilutions ). a 50 μl aliquot of the yeast culture was pipetted into 5 . 0 ml of the antimicrobial solution ( s ) in a sterile scintillation vial ( organisms : solution ratio = 1 : 100 ) and mixed thoroughly by vortexing . test inoculum level was ˜ 1 . 0e + 04 − 1 . 0e + 05 cfus / ml . at the predetermined time point ( s ), 1 min , 5 min , and 10 min , a 0 . 5 ml aliquot of the inoculated antimicrobial solution is pipetted into 4 . 5 ml of dey / engley ( d / e ) neutralizing broth ( ratio = 1 : 10 ) and mixed by vortexing . an aliquot of the neutralized sample including yeast was plated onto a sabouaud dextrose agar ( sda ) plate using standard pour plate techniques . the sda plates were incubated at 25 ° c .+/− 1 ° c . for 5 days (˜ 120 hours ) and cfu &# 39 ; s are counted . cfus / ml for organism cultures are calculated and compared to cfus / ml for antimicrobial solutions to determine the log reductions . residual efficacy testing was performed by evenly coating the surface of a skin patch with 20 μl of the active solution . skin samples were allowed to evaporate for 1 minute , 15 minutes , 60 minutes , 120 minutes , 240 minutes , 360 minutes , 480 minutes , and 14 hours with the lid off the petri plate . at the appropriate time point , skin samples were inoculated with 10 μl of a 1 : 10 dilution of the 18 - hour microbial suspension (˜ 1 . 0e + 08 cfus / ml ), evenly covering the entire area and the sample recovered and allowed to sit 5 minutes . at this time the skin was extracted using sterile forceps and placed in a steril centrifuge tube . containing 10 ml of a sampling solution and vortexed for 30 seconds . an aliquot of the extracted sample containing any microbials from the skin was plated onto a trypticase soy agar plate using a spiral plater ( typically 50 μl in exponential mode ). the agar plates were incubated at 37 ° c . overnight (˜ 18 hours ) and cfus are counted . cfus / ml established by baseline count are calculated and compared to cfus / ml for antimicrobial / bacterial solutions to determine the log reductions . the baseline count was achieved by evenly spreading 10 μl of the diluted bacterial suspension on a square of the skin and processed in accordance with the above procedure , except no active solution was added . one of skill in the art will appreciate that this test can be repeated with any substrate including but not limited to bark , leaves , flowers , fruit , roots , etc . formulas r , m , h , ks and ksm were tested against candida albicans and compared for activity with chloraprep . the antifungal properties of these formulations were previously untested and unknown . in vitro time kill testing was performed as described above . the result of the testing are set forth in table 2 . the above data show that medically acceptable strengths of rid kill candida . faster kill , but not more residual activity can be obtained by adding known broad spectrum antimicrobial ( pcmx ). formulas r , m , h , ks and ksm were tested against e . coli and compared with chloraprep . residual skin efficacy testing against e . coli was performed as set forth above . the data are set forth in table 4 below . formulas r , m , h , ks and ksm were tested against s . marcesens and compared with chloraprep . residual skin efficacy testing against s . marcesens was performed as set forth above . the data are set forth in table 5 below . formulas r , m , h , ks and ksm were tested against mrsa and compared with chloraprep . residual skin efficacy testing against mrsa was performed as set forth above . the data are set forth in table 6 below . formulas r , m , h , ks and ksm were tested against e . faecalis and compared with chloraprep . residual skin efficacy testing against e . faecalis was performed as set forth above . the data are set forth in table 7 below . the plant microbiocidal composition of the present invention is expected to be effective against all known plant pathogens including but not limited to the citrus canker bacterium xanthomonas campestris . pv citri . the plant microbiocidal compounds of the present invention would be applied to a plant in an aqueous mixture by any conventional means , such as by spraying . after the compound is applied to citrus trees , the trees are protected against infection by the x . campestris organism . the antimicrobial of the present invention is preferrably applied to plants as an aqueous solution . the plant microbiocidal compound of the present invention can be applied to a plant by conventional techniques , such as by spraying or by fogging . the plant microbiocidal compound of the present invention can also be painted on a plant . the following examples will serve to further illustrate the present invention without , at the same time , however , constituting any limitation thereof . solutions of the plant microbiocidal compound from table 1 would be sprayed on citrus tree seedlings with both juvenile and mature foliage and observed for phytotoxicity . observations would be made daily for changes to leaves , buds , branches , trunk or roots . to test for eradication of the citris canker bacterium ( xanthomonas campestris pv . citri ) from artificially inoculated test surfaces the antimicrobial compound from example i would be applied to several surfaces . proposed surfaces include kraft paper , which represents a porous inanimate surface , and unwashed citrus fruit to test sanitizing capability on a citrus fruit surface . inoculum concentration would be 106cells / ml in water , which is approximately the highest concentration of citrus canker organisms that can be expected to be found exuding from the natural lesions . after 10 minutes on paper or 2 minutes on fruit , the test surfaces would be swabbed with sterile cotton swabs and streaked out on nutrient agar . untreated controls would also be tested . in each test , the test surface would be replicated three times . a sterile water rinse would be applied to the surface of the fruits and checked for surviving x . campestris cells by transferring a small amount on a sterile cotton swab to nutrient agar . seeds of red winter wheat ( arrowhead mills , inc . hereford tex .) could be soaked in an aqueous solution of the plant microbiocidal compound of the present invention for 15 minutes or thirty minutes . the seeds would be air dried , planted in peat pots and exposed to 16 hours of artificial light daily . observations would be made each day to determine the percent of seeds that sprout , the average time to sprout , and the average growth rate . it should be understood , of course , that the foregoing relates only to a preferred embodiment of the present invention and that numerous modifications or alterations can be made therein without departing from the spirit and the scope of the invention as set forth in the appended claims . all documents cited in the detailed description of the invention are , in relevant part , incorporated herein by reference ; the citation of any document is not to be construed as an admission that it is prior art with respect to the present invention . to the extent that any meaning or definition of a term in this written document conflicts with any meaning or definition of the term in a document incorporated by reference , the meaning or definition assigned to the term in this written document shall govern . while particular embodiments of the present invention have been illustrated and described , it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention . it is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention .

microbiocidal method for treating and preventing infections in plants , said method employing antimicrobial compositions comprising an organic acid or organic acid mixture and a short - chain anionic surfactant having at least one of a large head group ; a branched alkyl chain and an unsaturated alkyl chain .

fig1 sets forth a perspective view of a multiple tier token balance game constructed in accordance with the present invention and generally referenced by numeral 10 . game 10 includes a vertically free - standing balance member 20 which rests upon a base 21 having a convex undersurface 22 . as a result , balance member 20 is tiltable in accordance with its weight distribution . as described below in greater detail and in accordance with an important aspect of the present invention , balance member 20 is rigid in its extension from base 21 and thus provides no weight distribution or weight compensation that is maximally sensitive to the distribution of weight upon the balance member . game 10 further includes a plurality of tokens 14 and 15 shown in fig1 distributed between two opposing players . however , it will be apparent that the present game is by no means limited to any particular number of players . the final elements of the present invention game is a chance device 12 which , in the embodiment shown in fig1 is represented by a spinner 17 . for purposes of convenience and in the preferred fabrication of the present invention game , a board 11 is provided to support chance device 12 and provide a play surface 13 upon which balance member 20 is received . it will be apparent , however , that the present invention game is not limited to the combination of a board 10 having a play surface and a support for the chance device . on the contrary , the present invention game may be played virtually any convenient surface such as a table top or the like and the chance device may be separated from the play surface . more specifically , balance member 20 includes a base 21 preferably formed of a molded plastic material and having a structure set forth below in greater detail in fig2 , and 5 . suffice it to note here that base 21 defines a convex preferably spherical undersurface 22 and a pair of upwardly extending substantially parallel flanges 23 and 24 . as is also better seen in fig2 and 3 , a channel 25 is formed between parallel flanges 23 and 24 and a rib 28 extends between flanges 23 and 24 at the approximate center point of base 21 . balance member 20 further includes a plurality of substantially planar , generally rigid trunk elements 30 , 40 , 50 , 60 , and 70 serially stacked upon base 21 in an alternating orthogonal pattern . thus base 30 is formed of a rigid planar material and defines a plurality of slots 31 , 32 , 33 , and 34 , examples of which are better seen in fig4 . the lower end of trunk element 30 defining slot 34 is inserted forcibly in a tight fit between flanges 23 and 24 and within channel 25 . as is better seen in fig2 a plurality of inwardly extending projections are formed on the interior surfaces of flanges 23 and 24 to tightly secure the inserted portion of trunk element 30 . in addition , slot 34 receives rib 28 as shown in fig3 to fully secure trunk element 30 to base 21 in a rigid attachment . similarly , trunk element 40 is formed of a substantially rigid planar material and defines a plurality of slots 41 , 42 , 43 , and 44 . trunk element 40 is rotated 90 degrees from trunk element 30 and is secured thereto by inserting the lower portion of trunk element 30 downwardly upon the upper portion of trunk element 30 having slots 44 and 32 of trunk elements 40 and 30 mutually aligned to provide a sliding engagement in which slot 32 of trunk element 30 extends beyond slot 44 of trunk element 40 and vice versa to secure the attachment of trunk elements 30 and 40 . this type of attachment between two planar objects is well known in the art and forms the type of attachment between the various trunk elements and tier elements forming balance member 20 . trunk element 50 is formed of a generally planar rigid material and defines a plurality of slots 51 , 52 , 53 , and 54 and is secured to trunk element 40 in a 90 degree rotation through the cooperation of slot 42 of trunk element 40 and slot 54 of trunk element 50 . thus trunk element 50 is substantially coplanar with trunk element 30 and is orthogonal to trunk element 40 . trunk element 60 is formed of a substantially planar rigid material and defines a plurality of slots 61 , 62 , 63 , and 64 therein . the lower portion of trunk element 60 is secured to the upper portion of trunk element 50 using the above - described orthogonal positioning and slot engagement in which slot 52 of trunk element 50 is received upon the lower portion of trunk element 60 while slot 64 thereof is received upon the upper portion of trunk element 50 . trunk element 70 forms the uppermost trunk element of balance member 20 and is also formed of a substantially planar rigid material defining slots 71 , 72 , and 73 . trunk element 70 is rotated 90 degrees to trunk element 60 and secured thereto by the engagement of slots 73 and 62 of trunk elements 70 and 60 , respectively . the resulting combination of trunk elements 30 , 40 , 50 , 60 , and 70 assembled in the engagement described above provides a center trunk portion for balance member 20 which is three dimensional in character and rigid in structure extending upwardly from base 21 to form a secure rigid and high strength member notwithstanding its fabrication from planar materials such as molded plastic , die cut cardboard , or other materials . in further accordance with the present invention , a plurality of outwardly extending substantially horizontal tiers are secured to opposed sides of each of trunk elements 30 , 40 , 50 , 60 , and 70 using a cooperating slot engagement of the type described for the trunk element couplings and shown in an exemplary fashion in fig4 . more specifically , balance member 20 includes a tier 35 having a generally circular shape and defining a slot 36 therein . tier 35 is secured to one side of trunk element 30 by the cooperation of slot 36 formed in tier 35 and slot 33 formed in trunk element 30 . as mentioned , this attachment is shown in greater detail in fig4 . as should be understood , the example of the attachment of tier 35 to trunk element 30 shown in greater detail in fig4 should be understood to be equally descriptive of the attachment of the remaining tiers of balance member 20 to their respective trunk elements . accordingly , balance member 20 further includes a tier 37 having a slot 38 formed therein which is secured to the opposite side of trunk element 30 by the cooperation of slots 31 and 38 . once again the details of this attachment are shown for illustration in fig4 and should be understood to be equally illustrative of the attachment of the remaining tier elements . thus in a similar attachment balance member 20 includes tiers 45 and 47 having slots 46 and 48 respectively formed therein which are secured to trunk element 40 using cooperating slots 41 and 43 . similarly , a pair of tier members 55 and 57 having slots 56 and 58 formed respectively therein are secured to opposed sides of trunk element 50 through the cooperative engagement of slots 56 and 58 of the tier elements with slots 51 and 53 of trunk element 50 . an additional pair of tier elements 65 and 67 having slots 66 and 68 respectively formed therein are secured to opposed sides of trunk element 60 using the cooperation of slots 66 and 68 of the tier elements with slots 61 and 63 of trunk element 60 . finally a pair of tier elements 75 and 77 having slots 76 and 78 respectively formed therein are secured to opposed sides of trunk element 70 through the cooperation of slots 76 and 78 with slots 71 and 72 , respectively , of trunk element 70 . as thus far described , balance member 20 is completely assembled and forms a center trunk member of interlocking trunk elements and a plurality of outwardly extending substantially horizontal tier elements which are positioned at a plurality of different levels of balance member 20 . it will be apparent that in the absence of tokens placed upon the tier elements , balance member 20 is substantially symmetrical in weight distribution about the center of convex surface 22 of base 21 . as a result balance member 20 if left undisturbed and unencumbered by token elements stands generally vertically . in further accordance with the present invention , a plurality of tokens 14 and 15 are distributed to each opposing player at the initiation of game play . it will ba apparent that tokens may be evenly distributed by various numbers of opposing players and that the present invention is not limited to any particular number of players . finally game 10 includes a chance device 12 which in the example shown includes a spinner 17 rotatably secured to board 11 by a pin 16 and having a plurality of indicia 18 encircling the path of rotation of the pointed end of spinner 17 . in accordance with conventional fabrication techniques , spinner 17 is spun by a player to provide a random chance number selection from indicia 18 at the point at which spinner 17 stops . it would be apparent to those skilled in the art , however , that an alternative chance device may be used without departing from the spirit and scope of the present invention so long as it provides a random or pseudo - random number selection to be usable in game play . thus chance devices which are the equivalent of chance device 12 for this function include one or more dice , numeric cards , or if desired , a random or pseudo - random number generator which operates in an electronic circuit and display . the essential function of chance device 12 however provided is the creation of a chance number for each player at the commencement of their respective turns . during game play , balance member 20 is initially empty and the tokens are distributed substantially evenly between opposing players . each player thereafter takes a turn initiated by spinning pointer 17 of chance device 12 and in response to the number indicated by the chance device , placing a token from their token quantity upon a tier of balance member 20 . in the anticipated play pattern of the present invention game , the plurality of locations or spaces of indicia 18 correspond numerically to the tier levels of balance member 20 . for example , the numeral 1 may correspond to the level occupied by tier members 35 and 37 while the numeral 2 may correspond to the level occupied by tier members 45 and 47 with numeral 3 corresponding to the level occupied by tier members 55 and 57 , and so on . the uppermost tier being the level occupied by tier members 75 and 77 . thus a player having spun pointer 17 may , for example , be presented with the numeral 4 . in such case , the objective of the player is to analyze the condition of balance of balance member 20 and decide whether to place the next token upon tier 65 or alternatively tier 67 to complete the appointed task . it will be apparent that once tokens begin accumulating upon the various tiers of balance member 20 considerable challenge is presented to the player in deciding which of the two tier elements to place a token upon and to decide the most optimum placement of the token upon the selected tier element . the overall objective of each player is to successfully place their tokens during each turn upon the assigned tiers of balance member 20 while avoiding the game losing consequence of tipping base member 20 and toppling the base member to cause the accumulated tokens thereon to fall from the supporting tiers . this consequence is , of course , a game loss for the player having such an unsuccessful turn and the other player becomes the winner . the game play continues as each player takes a turn operating chance device 12 and in response to the numeral provided thereby , placing tokens from their token supply upon the indicated tier level of balance member 20 . for purposes of illustration , fig1 shows balance member 20 having pluralities of tokens 80 through 89 accumulated upon the various tiers of balance member 20 . in further illustration , fig1 shows a player &# 39 ; s hand in the process of attempting to place a token 90 upon the assigned tier level of balance member 20 . game play may be varied somewhat utilizing the apparatus of game 10 in several ways . for example , if a number of players are playing , the game rules may include an alternative exercisable by a player to &# 34 ; pass &# 34 ; and choose not to take a token from the player &# 39 ; s token supply in view of the risk associated with the particular tier which chance device 12 has given that player . in such a game play variation , an additional aspect of game play rules is desirable in which the winner among a plurality of players becomes the player to first exhaust their supply of tokens . in this manner , the choice of assuming the risk of placing a token upon balance member 20 as dictated by chance device 12 and risking a tumble or game losing imbalance to balance member 20 is weighed against the inability to delete the player &# 39 ; s supply of tokens . other variations are possible and a number of creative game play patterns may be exercised using the apparatus of game 10 . in accordance with an important advantage of the present invention game , the apparatus is readily fabricated of planar material such as rigid cardboard or molded plastic and thus balance member 20 may be stored conveniently by disassembling trunk elements 30 , 40 , 50 , 60 , and 70 from each other and from base 21 during storage or transport and assembling the balance member when needed . it will be apparent to those skilled in the art that notwithstanding the three - dimensional character of balance member 20 provided by its novel structure , the entire assembly may be stored in an extremely limited space . this space may be further limited by disassembling balance member 20 completely by removing the respective tier member pairs from each trunk element . as a result , balance member in its entirety including trunk elements and supported tiers with the exception of base 21 may be fabricated of a die cut planar sheet of rigid cardboard or other suitable material . fig2 sets forth a top view of base 21 having trunk element 30 removed therefrom . as mentioned above , base 21 is preferably formed of a molded plastic material and as is seen in fig3 includes a center weight 102 which increases the stability of base 21 . base 21 is circular in shape and supports a pair of upwardly extending substantially planar parallel flanges 23 and 24 . the spacing of flanges 23 and 24 forms a channel 25 therebetween . a rib 28 sized to be receivable within slot 34 of trunk element 30 ( seen in fig3 ) extends between flanges 23 and 24 traversing channel 25 . in addition , a plurality of inwardly extending projections 29 are formed on the interior surfaces of flanges 23 and 24 . projections 29 provide engagement with the lower portion of trunk element 30 to rigidly and tightly secure the lower portion of trunk element 30 within channel 25 . rib 28 engages slot 34 ( seen in fig3 ) to further engage and secure trunk element 30 to base 21 . fig3 sets forth a section view of base 21 taken along section lines 3 -- 3 in fig2 . as described above , base 21 is generally circular in shape and supports trunk element 30 shown in dashed line representation . base 21 is preferably formed of a pair of mating portions formed by upper portion 100 and lower portion 110 . upper portion 100 supports flanges 23 and 24 ( the former seen in fig2 ). in addition upper portion 100 defines a plurality of interior bosses such as bosses 103 and 104 together with a center boss 101 . a center weight 102 preferably formed of a metal or other heavy material is received and supported within boss 101 in a simple press fit installation . the function of weight 102 is to increase the stability and resistance to tipping of balance member 20 in the above - described game play . lower portion 110 defines a convex surface 22 which is preferably spherical to provide even multi direction balancing of base 21 and which includes a plurality of upwardly extending posts such as posts 105 and 106 receivable within respective bosses such as bosses 103 and 104 of upper portion 100 to secure lower portion 110 to upper portion 100 . a simple snap fit between the pluralities of posts and their respective bosses will adequately secure lower portion 110 to upper portion 100 . however , additional attachments such adhesive or thermal or sonic welding may be utilized if desired . the resulting structure of base 21 is configured to receive trunk element 30 in the above - described attachment allowing base 21 to support balance member 20 in the above - described game play . fig4 sets forth a partial perspective assembly view of a portion of balance member 20 showing the attachment of trunk elements 30 and 40 together with the attachment of tier members 35 and 37 . as described above , the trunk elements such as trunk elements 30 and 40 of balance member 20 ( seen in fig1 ) are preferably formed of a rigid planar material such as rigid cardboard , molded plastic , or other suitable fabrications . as is also described above , a plurality of tier members such as tier members 35 and 37 are secured to the various trunk elements of balance member 20 in the manner shown in fig1 . more specifically , trunk element 30 includes a plurality of slots including slots 31 , 32 , and 33 while trunk element 40 defines a plurality of slots including downwardly facing slot 44 . in accordance with the invention , trunk element 30 and trunk element 40 are assembled by positioning trunk element 40 orthogonally with respect to trunk element 30 and aligning slots 44 and 32 . thereafter movement of trunk element 40 downwardly as indicated by arrow 91 assembles trunk element 40 to trunk element 30 in an overlapping engagement in which slot 44 extends beyond slot 32 upon trunk element 30 and slot 32 extends beyond slot 44 upon trunk element 40 . similarly , tier members 35 and 37 having slots 36 and 38 respectively formed therein are assembled opposed sides of trunk element 30 by a similar cooperating engagement of slots . thus , for example , tier member 37 is positioned in an orthogonal relationship with trunk element 30 and slot 38 is aligned with slot 31 therein . thereafter tier 37 is moved in the direction indicated by arrow 92 passing a portion of tier 37 through slot 31 and passing a portion of trunk element 30 through slot 38 . the resulting attachment is shown in the assembly of tier 35 to trunk element 30 . slot 36 of tier member 35 extends beyond slot 33 of trunk element 30 while slot 33 of trunk element 30 extends beyond slot 36 of tier member 35 . the resulting engagement horizontally positions tiers 35 and 37 upon opposed sides of trunk element 30 . as mentioned above , the assembly of tier members 35 and 37 and the assembly of trunk element 40 to trunk element 30 shown in fig4 is descriptive and illustrative of the corresponding assemblies of tier members and trunk elements described above in fig1 . fig5 sets forth a section view of an alternative embodiment of the present invention having a base member 120 . base member 120 is substantially the same as base member 21 and is secured to trunk element 30 in the same manner as described for base 21 . the difference between base 120 and base 21 is found in the elimination of boss 101 and center weight 102 ( seen in fig3 ). the elimination of a center weight from base 120 renders the resulting balance member formed by attaching trunk elements and tier members as shown in fig1 to be substantially less stable and therefore substantially more challenging than the apparatus provided with the use of a center weight . thus base 120 is circular in shape and virtually identical to the circular shape of base 21 shown in fig2 and is formed of an upper portion 121 matingly joined to a lower portion 122 . by further similarity , lower portion 122 defines a convex , preferably spherical surface 127 . lower portion 122 supports a plurality of upwardly extending posts such as posts 125 and 126 while upper portion 121 supports corresponding pluralities of attachment bosses such as bosses 123 and 124 . finally , upper portion 121 supports a pair of upwardly extending substantially parallel flanges 128 and 129 . flanges 128 and 129 receive the bottom portion of trunk element 30 in the manner shown in fig3 for base 21 and thus include a rib 131 and a plurality of inwardly extending projections 130 . what has been shown is a multiple tier token balance game which is conveniently fabricated of a plurality of planar members and elements to form a three - dimensional multi - tiered balance member which receives corresponding pluralities of tokens distributed by players in response to a chance device . the game shown is capable of play by a variety of player numbers and is challenging to play while relatively simple to learn . the entire game apparatus may be repeatedly assembled and disassembled for convenient storage and transport in a relatively small container due to the flat character of the elements used in fabricating the balance member of the game device . while particular embodiments of the invention have been shown and described , it will be obvious to those skilled in the art that changes and modifications may be made without departing from the invention in its broader aspects . therefore , the aim in the appended claims is to cover all such changes and modifications as fall within the true spirit and scope of the invention .

a balance member is formed of a plurality of substantially planar rigid trunk elements arranged in a vertical stack and alternately oriented orthogonally to each adjacent trunk element . each planar trunk element further supports a pair of oppositely positioned substantially horizontal tier members . a chance device and a plurality of tokens are provided to complete the game apparatus . the game is played by operating the chance device at the initiation of each player &# 39 ; s turn to designate a particular tier level upon the balance member which the player must place a token successfully without tipping the balance member during each turn . the balance member is supported by a base having a downwardly convex preferably spherical surface which allows the balance member to tip in response to imbalances of token distribution caused by player placement of tokens .

exemplary embodiments may be better understood with reference to the drawings , but these embodiments are not intended to be of a limiting nature . like numbered elements in the same or different drawings perform similar functions . the combination of hardware and software to accomplish the tasks described herein may be termed a platform , treatment suite , or the like . the instructions for implementing processes of the platform may be provided on computer - readable storage media or memories , such as a cache , buffer , ram , removable media , hard drive or other computer readable storage media . computer readable storage media include various types of volatile and nonvolatile storage media . the functions , acts or tasks illustrated or described herein may be executed in response to one or more sets of instructions stored in or on computer readable storage media . the functions , acts or tasks may be independent of the particular type of instruction set , storage media , processor or processing strategy and may be performed by software , hardware , integrated circuits , firmware , micro code and the like , operating alone or in combination . some aspects of the functions , acts , or tasks may be performed by dedicated hardware , or manually by an operator . in an embodiment , the instructions may be stored on a removable media device for reading by local or remote systems . in other embodiments , the instructions may be stored in a remote location for transfer through a computer network , a local or wide area network , by wireless techniques , or over telephone lines . in yet other embodiments , the instructions are stored within a particular computer , system , or device . where the term “ data network ”, “ web ” or “ internet ”, or the like , is used , the intent is to describe an internetworking environment , which may include both local and wide area telecommunications networks , where defined transmission protocols are used to facilitate communications between diverse , possibly geographically dispersed , entities . an example of such an environment is the world - wide - web ( www ) and the use of the tcp / ip data packet protocol , and the use of ethernet or other known or later developed hardware and software protocols for some of the data paths . often , the internetworking environment is provided , in whole or in part , as an attribute of the facility in which the platform is located . communications between the devices , systems and applications may be by the use of either wired or wireless connections . wireless communication may include , audio , radio , lightwave or other technique not requiring a physical connection between a transmitting device and a corresponding receiving device . while the communication may be described as being from a transmitter to a receiver , this does not exclude the reverse path , and a wireless communications device may include both transmitting and receiving functions . such wireless communication may be performed by electronic devices capable of modulating data as a signal on a carrier wave for transmission , and receiving and demodulating such signals to recover the data . the devices may be compatible with an industry standard protocol such as ieee 802 . 11b / g , or other protocols that exist , or may be developed . the terminology associated with the use of a magnetic resonance imaging ( mri ) device is specialized to the apparatus and may differ from that used for other imaging modalities . the terms used herein are believed to be , and are meant to be interpreted as , understood by a person of skill in the art at the time of preparation of the specification , unless specifically differentiated herein . vessel size imaging ( vsi ) is a method of determining the mean blood vessel size for a tissue volume of interest ; for example , a tumor . vsi is based on measuring the magnetic susceptibility differences between blood vessels and surrounding tissues induced by the injection of a superparamagnetic blood pool ( intravascular ) contrast agent . contrast is the relative difference of signal intensities in two adjacent regions of an image . due to the t 1 and t 2 relaxation properties in magnetic ( mri ) resonance imaging , differentiation between various tissues in the body is possible . contrast is affected by not only the t 1 and t 2 values of specific tissues and contrast agents , but also the differences in the magnetic field strength , temperature changes , and many other factors . contrast relies on the selection of appropriate pulse sequences ( spin echo , inversion recovery , gradient echo , turbo sequences and slice profile ). t 2 weighted imaging using a spin echo type sequence is only sensitive to the signal arising from the microvascular network whereas t 2 * weighted imaging is sensitive to susceptibility perturbations arising from all sizes of blood vessels ranging from capillaries to major vessels . a vessel size index d may be calculated from measurements of the transversal relaxation rate changes δr 2 and δr 2 * pre - and post - contrast - agent administration . taking into account a diffusion coefficient d , the gyromagnetic ratio γ ( for water protons , γ = 42 . 576 mhz / t ), the susceptibility differences between blood vessel and surrounding tissue δχ , and the magnetic field strength b 0 , d is given by : d = 0 . 425 ⁢ ( d γδχ ⁢ ⁢ b 0 ) 1 / 2 ⁢ ( δ ⁢ ⁢ r 2 * δ ⁢ ⁢ r 2 ) 3 / 2 . ( 1 ) changes in the relaxation rate δr 2 can be calculated from t 2 weighted spin echo ( se ) measurements by taking the natural logarithm of the relative signal intensities from post - and pre - contrast images , divided by the echo time t e : δr 2 * maps may be calculated from the transversal relaxation time t 2 * before and after injection of the contrast agent : t 2 * can be measured by acquiring t 2 * weighted multi - echo gradient echo ( gre ) images with increasing t e . δr 2 * maps may be obtained by fitting an exponential decay function t e to each analyzed voxel in the pre - contrast post - contrast t 2 * weighted image series and subtracting the r 2 * fit parameter of the post - and pre - contrast data . for computational purposes , the diffusion constant d may either be assumed to be constant over the whole imaged volume , or taken from apparent diffusion coefficient ( adc ) maps obtained from diffusion weighted imaging . the susceptibility difference δχ between blood vessels and the surrounding tissue depends on the specific type contrast agent used and is determined for each specific type of contrast agent . instead of the susceptibility difference , δχ , the spread of the larmor frequency δω at the surface of vessels which are perpendicular to the magnetic field may be determined . using δω leads to a slightly different equation to determine the vessel size index d : both , δχ and δω can be determined by filling a hollow ball with blood and the specific contrast agent to be used . the concentration of contrast agent used is related to the concentration used in the vsi measurement . inside the ball , two water filled capillary tubes are disposed perpendicular to each other . the ball , including the capillaries , may be positioned in an mri system such that that one of the capillaries is aligned with the magnetic field b 0 , while the other is orthogonal to b 0 . by measuring the resonance frequencies inside the two capillaries , δω can be determined by : where ω ∥ is the resonance frequency of the water inside the parallel capillary and ω ⊥ is the resonance frequency of the water inside the perpendicular capillary to the magnetic field . δχ can be calculated from δω by : a method for calculation of vessel size index maps from se and gre images is described . additionally , blood volume ( bv ) maps can be calculated from the t 2 * weighted pre and post images by : vessel size imaging may be used to supplement dce - mri data . in this context , an increase of the vessel size index d after administering therapy may be interpreted as the destruction of small immature tumor vessels and be consistent the expected changes of tumor visualization after blocking the of vascular endothelial growth factor receptor vegfr2 . vsi may be combined with dce - mri measurements to increase the specificity or sensitivity of the investigation . dce - mri analysis software enables the quantitative analysis of the acquired data to obtain functional parameters such as vessel permeability , perfusion and relative blood volume . these parameters may change a relatively short time after beginning the anti - angiogenic therapy , but these parameter changes can also regress during treatment . this occurrence may be explainable by the shrinkage of tumors under therapy , leading to a compartmental shift . in contrast , the vsi changes relatively slowly after the beginning of the therapy and may not be substantially influenced by changes in tumor growth or size . thus , the parameters obtained by dce - mri and vsi may not be highly correlated . by evaluation of the data of dce - mri and vsi , control of the therapy can be improved as compared to evaluation of dce - mri or vsi data alone . in another aspect , vsi data based on mri studies with very small iron oxide particle ( e . g . vsop , from ferropharm , berlin , germany ) may evaluated using , for example , a software program product in a syngo ® task card for controlling anti - angiogenic tumor therapy , such as for avastin therapy . vsop are super - paramagnetic single - domain nanoparticles with increased r 1 relativity and surface - stabilizer substances . these nanoparticles may include iron hydroxide , ferric hydrate , iron oxide , iron mixed oxide or iron ; are between 1 and 10 nm in size , have a mean particle diameter of 2 - 4 nm ; and have increased r 1 relaxivity of between 2 and 50 , the ratio of the relaxivities r 2 / r 1 being less than 5 . typically , stabilizer substances such as carboxylic acids may be bound to the particle surfaces ; these stabilizers inhibit aggregation and sedimentation of the particles under gravity force or in a magnetic field . the particles can also contain further known stabilizer substances and other pharmacological substances . vsop in this use , when compared with to low molecular weight gadolinium chelates , is characterized by the substantial absence of extravasation of this blood - pool contrast medium into the extravasal tissue . the uptake of the vsop material is facilitated by its small size and a negative surface charge . other suitable contrast agents that may be used instead of vsop may be , for example , supravist , gadomer and vasovist ( all available from bayer schering , leverkusen , germany ). other appropriate blood - pool contrast agents may also be used . intravascular ( blood pool ) contrast agents normally remain substantially confined to the intravascular space , compared to gd - dtpa , for example , which distributes or diffuses throughout the extracellular fluid space . this is a result of intravascular agents , which may be macromolecules , having a substantially higher molecular weight , compared to a molecular weight of 590 for gd - dtpa . in a method of evaluating treatment , the patient may be investigated with t 1 weighted dce - mri and subsequently with vsi . also a combination of both applications using a slow - extravasating contrast agent can be considered . mri measurements may be performed using a clinical mri system . tumor morphology may be assessed using high resolution t 1 weighted gre and t 2 weighted se or turbo se sequences . dce - mri may be performed using a dynamic t 1 weighted saturation recovery turbo flash ( fast low angle shot ) sequence . a contrast agent , such as gadomer , may be injected during acquisition of , for example , the tenth dynamic image . post - processing may be performed by pharmacokinetic modeling of contrast - enhanced dynamic data . permeability - related constants can be quantified using a dce analysis software package . vessel size imaging may be based on the susceptibility differences between vessels and the surrounding tissue , which is assessed by measuring the relaxation rate changes δr 2 and δr 2 * induced by injection of an intravascular superparamagnetic contrast agent . the vessel size index d may then be calculated using ( 1 ) or ( 4 ). in an experiment , nude mice bearing squamous cell carcinoma xenografts were treated with an antiangiogenic therapy and investigated the therapy effects on dce - mri parameters and on vsi were investigated . seven nude mice bearing subcutaneous squamous cell carcinoma xenografts ( hacat - ras - a5rt3 ), of which 4 were treated for 1 week with the vegfr2 blocking antibody dc101 ( 800 μg / day ), were investigated with t 1 weighted dce - mri and 24 hours later with vsi . mri measurements were performed on a clinical 1 . 5 t whole - body mri system ( siemens magnetom vision , erlangen , germany ) using a custom - made active radiofrequency coil . animal and tumor morphology were assessed using high - resolved t 1 weighted gradient echo sequences ( flash ) and t 2 weighted turbo spin echo sequences . dce - mri was performed using a t 1 weighed turbo flash sequence ( tr 13 ms , te 5 . 3 ms , ti 300 ms , flip 12 , averages 4 , fov 60 × 22 . 5 , res . 0 . 5 × 0 . 5 × 2 mm 3 ). as a contrast agent , gadomer ( 0 . 05 mmol / kg diluted in 0 . 9 % nacl to a total volume of 100 μl ), was injected via the tail vein . post - processing was performed according to the two compartment model of brix using a software program from dynalab ( from mevis , bremen , germany ), with a diffusion coefficient d of 10 − 3 m 2 / s and a susceptibility difference δχ of 0 . 571 ppm . t 2 weighted images ( tse , tr 3930 ms , te 85 ms , averages 5 , fov 62 × 31 , res . 0 . 5 × 0 . 5 × 1 . 5 3 ) were recorded and t2 * determinations ( flash 2d , tr 200 , te 6 - 24 ms , flip 45 °, averages 5 , fov 62 × 50 , res . 0 . 5 × 0 . 5 × 1 . 5 mm 3 ) were performed before , and 3 min after , contrast agent ( vsop ) administration . the image data were analyzed using idl ( research systems inc ., boulder , colo .) and imagej . imagej is a public - domain java image processing program inspired by nih image for the macintosh computer . it runs , either as an online applet or as a downloadable application , on any computer with a java 1 . 4 or later virtual machine . the author , wayne rasband , is at the research services branch , national institute of mental health , bethesda , md ., usa . large liquid tumor areas , identified on t 2 weighted and t 2 * weighted images , were excluded from analysis of dce - mri and vsi scans . differences in vessel density between treated and untreated tumors were also confirmed by immunofluorescence microscopy measuring area fractions of cd 31 positive vessels . the amplitudes ( a ) of treated tumors ( 0 . 19 ± 0 . 06 ) were found to be lower than those of untreated ones ( 0 . 42 ± 0 . 16 ). the opposite results were obtained for k ep , which was elevated in treated ( 0 . 70 ± 0 . 31 / min ), as compared with untreated ( 0 . 36 ± 0 . 15 / min ) tumors . these results did not differ with a suitable statistical significance . in contrast , differences in the vsi data were highly significant ( p & lt ; 0 . 002 ) as between untreated and treated tumors . the vsi of untreated and treated tumors was 0 . 25 ± 0 . 01 mm and 0 . 35 ± 0 . 03 mm , respectively . histological analysis demonstrated the success of the antiangionic therapy and showed a reduction of vessel area fractions in treated tumors , which was particularly true for small vessels in the tumor centers ( p & lt ; 0 . 05 ) the vessel size imaging software program may execute as a stand - alone software package on a computer or on either the host of a mri scanner , a satellite console , or a dedicated workstation . fig1 illustrates a magnetic resonance imaging ( mri ) apparatus 1 which may be used to perform the therapy assessment in animals or humans . the apparatus 1 includes a magnet system 11 and gradient coils 12 . these components provide magnetic fields used for magnetic resonance imaging . for magnetic field shimming purposes , a shimming coil 13 may be present . an antenna unit 14 sends radio frequency ( rf ) signals to an examination object ( e . g ., a patient 19 or an experimental animal ), and for receiving a magnetic resonance signal emitted by the examination object . the examination object may be positioned in a field of view 18 of the apparatus 1 having a homogenous magnetic field by a movable patient bed 15 . for controlling the magnetic resonance apparatus , a control unit 16 is present , which is connected to a computer 17 for entering measurement parameters and evaluating image data acquired by the apparatus 1 . fig2 illustrates steps in an example of the method . in describing the method , quantitative values are given for many of the specific mri imaging functions . such values are intended to provide a person of skill in the art with suggestions for adapting the method to the same or similar studies when using the other than the mri device described herein . for the present mri device , the values are indicative of parametric settings which may be useful in initial experimentation . moreover , at the present time , acronyms are not fully standardized , and different manufacturers of mri devices may use varying acronyms to describe the same or similar functions . herein , where there is a conflict between the acronyms used , the acronym presently used by siemens ag , at the time that this specification was prepared , is intended . the volume of the contrast media to be administered is calculated with respect to the patient body weight ( step 21 ). standard values which may be used are 200 μmol fe / kg body weight for vsop or 50 μmol gd / kg body weight for gadomer . the concentration of the contrast agent may be changed without changing the dce - mri setup ; however , a corresponding determination of δχ for the vsi calculations may be needed . a first magnetic resonance data set of a patient is acquired using the mri device after placement of an intravenous catheter and positioning of the patient in the mri system ( step 22 ). the first imaging step may be high - resolved t 1 weighted gre , t 2 weighted se and turbo se sequences for tumor localization and assessment of tumor morphology . for example , a t 1 quantification using a series of t 1 weighted saturation recovery turbo flash ( fast low angle shot ) ( tr = 17 ms , te = 7 . 06 ms , flip = 12 °, matrix : 128 × 64 , res . : 0 . 4 × 0 . 4 × 2 mm 3 ) sequences with different inversion times from 100 to 5000 ms may be performed ( step 23 ). the t 1 quantification may be used for the dce analysis and may also be used to choose an appropriate tr for the t 2 weighted se sequences of the vsi experiment . to minimize t 1 effects in the t 2 weighted se sequences , tr may be set to about five times t 1 of the tissue of interest , e . g . the tumor , leading to tr values up to about several seconds . thus , quantification of t1 enables choosing the shortest tr that results in substantial exclusion of t 1 effects , and having optimal acquisition times . the dce - mri data may then be obtained ( step 24 ). for example , a dynamic series of t 1 weighted saturation recovery turbo flash sequences ( tr = 13 ms , te = 5 . 3 ms , ti = 300 ms , flip = 12 °, matrix : 128 × 48 , res . : 0 . 5 × 0 . 5 × 2 mm 3 , averages = 4 ) may be performed . two single slice stacks are obtained : one positioned over the tumor , while the other is positioned over an artery to determine the arterial input function . this may be used for dce - mri analyses and to verify the correct contrast agent injection . other t 1 weighted sequences may be used for acquisition of dce - mri data the contrast agent may be injected via the venous catheter during acquisition of , for example , the tenth dynamic image to obtain a correct baseline for the post - processing . post - processing of dce - mri data ( step 25 ) may be performed . pharmacokinetic models may be applied to the dynamic data , for example , by using non - linear fitting algorithms , and allow the calculation of parameter maps with physiological relevant information , such as vessel permeability ( k trans ), extra - vascular extra - cellular volume fraction ( v e ), or vascular volume fraction ( v p ). user - defined regions - of - interest ( roi ), may be employed to calculate and compare quantitative results for specific tissues - of - interest . post - processing of dce - mri data may be performed before the vsi studies in a clinical situation as the absence of enhancement in the dce - mri data may be taken to imply that the vessels , if present , are not perfused . in this case the therapy success may be presumed and the examination can be stopped , so as to minimize patient exposure to radiation and reagents . if enhancement is detected in step 26 , another mri sequence may be performed to measure the relaxation rate changes δr 2 * and δr 2 corresponding to the injection of the contrast agent . the measurement may consist of two imaging parts including , for example , t 2 weighted se images ( tr = 6000 ms , te = 100 ms , averages = 1 , fov : 60 × 50 . 4 mm 2 , voxel size : 0 . 5 × 0 . 5 × 1 . 5 mm 3 ) and t 2 * quantification before , and 3 min after administering the contrast agent . t 2 * may be quantified , for example , by acquiring a series of t 2 * weighted flash 2d images ( tr = 380 ms , te = 4 . 76 - 47 . 6 ms ( 10 in - phase echoes ), flip = 45 °, averages = 3 , fov : 62 × 50 . 4 mm 2 , res . : 0 . 5 × 0 . 5 × 1 . 5 mm 3 ) with different tes . optionally , in step 26 , the apparent diffusion coefficient ( adc ) may be determined for the vessel size index calculation ( step 27 ) by diffusion weighted imaging . an se echo planar imaging sequence may be performed ( tr = 3000 ms , te = 83 ms , averages = 4 , matrix : 64 × 64 , res . : 1 × 1 × 1 . 5 mm 3 ), in post - processing ( step 27 ) the mean vessel size index d may be calculated using the data from the second mri experiment using the vessel size imaging analysis program . after data import and fast data inspection the vessel size index d may be calculated by equation ( 1 ), where d is the diffusion coefficient , γ is the gyromagnetic ratio , δχ is the susceptibility difference between blood vessel and surrounding tissue , and b 0 is the magnetic field strength . if δω instead of δχ is known for the used contrast agent , the vessel size index d may be calculated by equation ( 4 ) the changes in relaxation rate δr 2 can be calculated from the se ( tr = 6000 ms , te = 100 ms , averages = 1 , fov : 60 × 50 . 4 mm 2 , voxel size : 0 . 5 × 0 . 5 × 1 . 5 mm 3 ) measurements by taking the natural logarithm of the relative signal intensities from post - and pre - contrast images divided by the echo time t e , using equation ( 2 ). δr 2 * maps may be calculated from t 2 * weighted gre ( tr = 380 ms , t e = 4 . 76 - 47 . 6 ms ( 10 in - phase echoes ), flip = 45 °, averages = 3 , fov : 62 × 50 . 4 mm 2 , res . : 0 . 5 × 0 . 5 × 1 . 5 mm 3 ) images acquired with increasing t e , using equation ( 3 ). δr 2 * maps may be obtained by fitting an exponential decay function vs . t e to voxel in the pre contrast response - post contrast t 2 * weighted image series and subtracting the r 2 * fit parameter post - and pre - contrast for each voxel being analyzed . the diffusion constant d may either be assumed to be constant over the whole imaged volume , or taken from the apparent diffusion coefficient ( adc ) maps obtained from diffusion weighted imaging in step 26 a . the results of the post - processing steps 23 and 27 may be presented to the user for assessing the therapy response ( step 28 ). in another aspect automatic evaluation of the therapy response is performed and the result is presented to the user . in either embodiment the visualization may include a display of parametric maps which overlay the calculated physiologic parameter and anatomical information pixel by pixel . while the methods disclosed herein have been described and shown with reference to particular steps performed in a particular order , it will be understood that these steps may be combined , sub - divided , or reordered to from an equivalent method without departing from the teachings of the present invention . accordingly , unless specifically claimed herein , the order and grouping of steps and the parametric values are not a limitation of the present invention . a computer program product is described for processing dicom ( digital communications in medicine ) images and extracts needed parametric information form the dicom header . the dicom data may be retrieved from a data base over a network . images may be displayed simultaneously , allowing quick navigation through images and fast inspection of data quality of measured images . the quality of fitting of the data can be assessed on maps or by displaying fitting curves with data curves for individual voxel assessment . the accuracy of parametric maps may be improved by using a filter algorithm to exclude voxels with low agreement between fit and data curves . segmentation of the images may allow the calculation of quantitative values for a specific tissue type of interest . a load - and - save function for region - of - interest ( roi ) information may facilitate repeated analyses for each data set . the parametric images may be exported to an image data base so that vessel size index or bv maps may be used for further processing or visualization steps , such as fusion with anatomical images : for example , using syngo ®, available from siemens , munich , germany . for visualizing data , setting mri parameters , and controlling aspects of the treatment and analysis a data interface , as is known in the art , may be provided . the interface may be a visual display , keyboard data entry device , computer mouse , touch screen , or the like . the apparatus and method can also be used in pharmaceutical research and the development of pharmaceuticals . in this case , the methods are typically applied to animals , e . g . mice , using small animal imaging . the apparatus and method can also be used for tissue differentiation , such as identification of cicatrizes or relapse after tumor resection , tumor staging and classification . the examples of diseases , syndromes , conditions , and the like , and the types of examination and treatment protocols described herein are by way of example , and are not meant to suggest that the method and apparatus is limited to those named , or the equivalents thereof . as the medical arts are continually advancing , the use of the methods and apparatus described herein may be expected to encompass a broader scope in the diagnosis and treatment of patients . it is intended that the foregoing description be regarded as illustrative rather than limiting , and that it be understood that it is the following claims , including all equivalents , that are intended to define the spirit and scope of this invention .

a system and method of evaluating the effectiveness of antiangionetic therapy is described . a patient or test animal is treated with an antiangionetic substance . magnetic resonance imaging data is obtained prior to and subsequent to the treatment . the parameters of the imaging process are configured so that , by administering a intravascular contrast agent , the relative size of the microvascular and the total vascular volumes in a region of interest may be obtained , so as to form a vascular size index . the value of the vascular size index and other pharmacokinetic data obtained by the administration of a diffusible contrast agent are used to assess the efficacy of the treatment or the antiangionetic substance being studied .

a laparoscopic surgical tool 10 ( fig1 ) embodying the invention comprises a proximal handle unit 11 hand engageable by a surgeon for laparoscopic surgery , a distal jaw unit 12 insertable into a surgical site ss for working of tissue of a patient undergoing laparoscopic surgery , and an intervening elongate extension unit for supporting and actuating the jaw unit upon manipulation of the handle unit . the jaw unit 12 and extension unit 13 are diametrally compactly sized to allow insertion into a conventional laparoscopic cannula , a fragment of which is indicated at 14 in fig1 by way of example . the cannula 14 guides entry of the jaw unit 12 into the surgical site ss , for surgical working of tissue therein . the extension unit 13 thus serves both to support and actuate the jaw unit 12 . the handle unit 11 ( fig2 ) comprises a body 20 , a trigger 21 and a cover 22 . the body 20 and cover 22 are opposed , shallow , generally cup - shaped elements which when fixed together , as generally indicated in fig1 form a chamber 23 ( fig2 ) for enclosing additional parts of the tool , including the top of the trigger 21 . integrally fixed to and angling rearward and downward from the body 20 is an extension bar 24 ( fig2 ) terminating in a thumb ring 25 engageable by the thumb of the user . such body , extension bar , thumb ring , trigger , and cover are preferably of suitable rigid molded plastic material . the body 20 and cover 22 have opposed parallel side walls 28 and 29 respectively , from the perimeters of which perimeter rims 30 and 31 respectively extend toward each other as generally indicated fig3 and 4 . the perimeter rims 30 and 31 on the body 20 and cover 22 abut , with the cover assembled on the body as shown in fig1 and 8 , to enclose the chamber 23 . the body 20 and cover 22 may be located in accurate registry and held together by any convenient means . in the embodiment shown in fig3 and 4 , for example , opposed , hollow , generally cylindrical bosses 32 extend laterally toward each other and may be fixed coaxially together , as by sizing coaxially aligned bosses 32 to telescope one into to the other , or as by sizing coaxially opposed hollow bosses 32 to receive a common coaxial connector pin , as at 33 in fig4 . it will be understood that the bosses 32 appearing in the present drawings are not to scale . the cover 22 is intended to be permanently affixed to the body 20 in a last stage of assembly of the tool 10 , as by the use of adhesive bonding , solvent bonding , localized heat ( e . g . laser ) bonding , or the like , around the perimeter of the rims 30 and 31 , or by friction fit of laterally opposed bosses 32 with respect to each other , or the like . the trigger 21 ( fig2 and 5 ) comprises a depending multiple finger loop 40 surmounted by an upstanding arm 41 . the arm 41 has a trigger pivot hole 42 intermediate its ends and a drive hole 43 adjacent the top of the arm 41 and spaced above the trigger pivot hole 42 . both holes extend through the arm in a direction perpendicular to the plane of the arm , and hence to the plane of the page in fig5 . the drive hole 43 is elongated vertically so as to be oval in shape . a central slot 44 ( fig2 ) in the top of the arm 41 extends forwardly / rearwardly therethrough and opens upward therefrom . the bottom of the slot is below the bottom of the hole 43 . the bottom portion of the rims 30 and 31 of the body 20 and cover 22 are notched in opposition to each other to thereby form a downward opening window 45 , upward through which the arm 41 of the trigger 21 is received into the chamber 23 enclosed by the body 20 and cover 22 , as seen in fig7 . there the trigger 21 is pivotally supported , for movement in the plane of the paper ( and hence parallel to the planes of the body 20 and cover 22 ) by pivotal insertion of the lower central boss 32 of the body 20 through the trigger pivot hole 42 , such that rearward displacement of the depending finger loop 40 of the trigger 21 pivots forward the upper end of the arm 41 , including the drive hole 43 therein , for purposes of appearing hereinafter . the elongate extension unit 13 comprises an elongate axially shiftable actuation rod 50 snugly but axially slidably housed in an elongate extension tube 51 ( fig1 ). it will be understood that the tool 10 is relatively small . for example in one unit constructed according to the invention , the outside diameter of the extension tube 51 is somewhat less than 0 . 190 inch . the elongate extension unit 13 rotatably mounts on front and rear bearings in the handle unit 11 . the perimeter rim 30 at the forward ( rightward in fig2 ) end of the body 20 protrudes laterally toward the cover 22 to form a lateral tab 52 ( fig6 ). the tab 52 fits snugly into a corresponding notch 53 ( fig4 ) in the forwardmost reach of the perimeter rim 31 of the cover 22 . a bearing hole 54 ( fig6 ) extends forward through the tab 52 and acts as a front bearing for snugly and rotatably supporting a portion of the extension tube 51 , as generally shown in fig7 and 8 . in the preferred embodiment shown , the plane of abutment of the perimeter rims 30 and 31 of the body 20 and cover 22 contains the center of the hole 54 and the central axis of the elongate extension unit 13 . the rear bearing for the extension tube is spaced rearward ( leftward in fig3 ) from , and is coaxially along with , the front bearing hole 54 in the tab 52 ( fig6 ). in the preferred embodiment shown , such rear bearing is formed by laterally opposing rear bearing parts 60 and 61 fixed to and extending laterally inboard from the inner surfaces of the side walls 28 and 29 , respectively , of the body 20 and cover 22 respectively . in the preferred embodiment shown , such bearing parts 60 and 61 are integrally molded into the body 20 and cover 22 respectively . the rear bearing 60 , 61 is here disposed approximately above the forward end of the downwardly opening trigger window 45 . the rear bearing part 60 on the body side wall 28 ( fig3 and 6 ) is , as seen from the front as in fig6 generally u - shaped , having top and bottom legs 62 and 63 protruding toward the cover 22 and flanking a hemi - circular ( here semi - circular ) bearing groove 64 . in the embodiment shown , the shaped rear bearing part 60 is relatively thick in the front / rear direction ( from left to right in fig6 ) and is divided into front and rear bearing webs 65 and 66 by top , middle and bottom relief slots 70 extending laterally from the side wall 28 of the housing 20 toward the opposing cover 22 . the top , middle and bottom relief slots 70 prevent distortion of the axially relatively thick rear bearing part 60 during molding , where the body 20 is of molded plastics material . the rear portion of the extension tube 51 ( fig2 and 7 ) has an annular groove 73 , preferably of rectangular cross section , which snugly but rotatably fits , both radially and axially , in the semi - circular bearing groove 64 in the rear bearing part 60 . the generally u - shaped rear bearing part 60 thus is the axial thrust bearing for the extension tube 51 . the rear bearing part 60 also constrains the rear portion of the extension tube against movement upward or downward and toward the housing side wall 28 . the rear bearing part 61 of the cover 22 , in the assembled apparatus , engages the annular groove 73 in the extension tube 51 and prevents it from moving sideways ( radially ) out of the annular groove 73 . thus , the rear bearing 60 , 61 acts as a radial thrust bearing to maintain coaxial location of the extension tube 51 while permitting its rotation about its own length axis . in the embodiment shown , the rear bearing part 61 , as seen in fig4 comprises a substantially t - shaped , pad - like protrusion ( hereafter t - shaped pad ) fixedly extending inward laterally from the side wall 29 of the cover 22 . the t - shaped pad has a forward extending leg 74 and a vertically extending crosshead 75 at the rear end of the leg . the crosshead 75 rearwardly opposes the rear bearing web 66 of the 20 and the leg 74 extends forward to substantially the front end of the front bearing web 65 , such that the leg 74 and the central portion of the crosshead 75 radially engage in the annular groove of the extension tube 51 in a radial thrust bearing manner , as well as assisting the rear bearing web 66 of the housing 20 in axially locating the extension tube 51 , while supporting same for rotation . the rear bearing part 61 of the cover 22 further includes a finger 76 ( fig4 ) integrally fixed thereon and aimed laterally away from the cover side wall 29 toward the top portion of the rear bearing web 66 of the body , to assist same in preventing upward displacement of the rear portion of the extension tube 51 , particularly as the upper part of the trigger arm 41 pivots upward into the central portion of its swing hereafter discussed . in this way , the proximal end portion of the extension tube 51 is held fixedly but rotatably about its own axis within the chamber 23 . spaced just forward of the rear bearing 60 , 61 and protruding laterally in from the side walls 28 and 29 of the housing 20 and cover 22 , are vertically extended , plate - like , laterally opposed , generally u - shaped saddles 90 and 91 ( fig3 and 6 ). the saddles 90 and 91 , like the rear bearing parts 60 and 61 are very closely laterally opposed to each other but need not meet when the cover 22 is assembled on the housing 20 . the laterally depressed central portions of the saddles 90 and 91 are sized to allow close passage therethrough of the rotatable extension tube 51 just forward of the annular locating groove 73 therein . the saddle 90 on the side wall 28 of the body 20 carries and locates a spring - like , electrically conductive metal contact 93 hereafter discussed in respect to fig6 and 11 . the u - shaped saddles 90 and 91 have a depressed central portion flanked by top and bottom horns 92 which protrude away from the respective side walls 28 and 29 of the body 20 and cover 22 respectively . the actuating rod 50 , which is axially slidable within the extension tube 51 has a rear end portion extending rearwardly from the extension tube 51 and into the upward opening central slot 44 ( fig8 ) in the arm 41 of the trigger 21 and across the drive hole 43 therein . a slotted drive pin 82 extends axially through the drive hole 43 and is rotatable therein . an annular groove 81 coaxial in the actuating rod 50 coacts with the slotted drive pin 82 ( fig2 and 8 ) for connecting the top portion of the arm 41 of the trigger 21 to the rear end portion of the actuating rod 50 for forwarding of the actuating rod 50 along the extension tube 51 in response to a rearward pull on the depending finger loop 40 of the trigger 21 by the user of the tool 10 . to this end , the drive pin 82 comprises a member , preferably of molded rigid plastics material , having a generally u - shaped diametrally extending notch 83 opening through one end thereof and sized to snugly but slidably receive diametrally therethrough the annularly grooved portion 81 of the actuating rod 50 ( fig8 ). the notch 83 is flanked at its diametrally opposite ends by diametrally opening generally u - shaped recesses 84 ( fig8 and 9a ) for receiving portions of the actuating rod 50 at the opposite ends of the annular recess 81 . the axial length of the annular recess 81 is equal to or slightly larger than the diametral extent of the notch 83 and the diameter of the pin 82 is equal to or only slightly less than the minimum diameter of the hole 43 , such that clockwise ( fig7 ) pivoting of the trigger 21 positively and axially shifts forward the actuating rod 50 . as the trigger 21 ( fig7 ) is pivoted about its boss 32 , its drive hole 43 moves through an arc whose major component of direction is parallel to the direction in which the actuating rod is constrained to move , i . e ., along the length axis of the extension tube 51 . however , the trigger and drive hole 43 are also a minor component of direction perpendicular to the length axis of the extension tube and hence to the direction of movement available to the actuating rod 50 . accordingly , the elongation of the drive hole 43 in the latter direction allows the drive pin 82 lost motion along the length of the oblong drive hole 43 in the upper end of the arm 41 , so that the drive pin 82 does not tend to bend the actuating rod 50 as the drive pin pushes forward or pulls rearward the actuating rod during pivoting at the trigger 40 . as seen in fig8 the drive pin 82 is snugly trapped between the side walls 28 and 29 of the body 20 and cover 22 in the assembled condition of the tool 10 . the drive pin 82 thereby cannot escape from the upstanding arm 41 of the trigger 21 and the rear end portion of the actuating rod 50 , and must thus accomplish forward and rearward movement of the actuating rod 50 in response to manual rearward and forward pivoting of the finger loop 40 of the trigger 21 . in this way the user of the tool can forwardly and rearwardly move the actuating rod 50 with respect to the extension tube 51 in which it is axially slidably guided . the front / rear movement of the actuating rod 50 with respect to the extension tube 51 accomplishes opening and closing movement of the jaw unit 12 ( fig1 ) at the front ( distal ) end of the tool 10 as hereafter discussed . to allow the jaw unit 12 to perform electrocauterization , an electrically conductive terminal pin 94 ( fig1 ) is provided on the handle unit 11 for connection to a conventional electric cauterizing current source schematically indicated at 95 . more particularly , the current source 95 is connected , as indicated schematically by the dotted lines 96 and 97 , respectively to the pin 94 and to the patient at the surgical site ss . as hereafter discussed , the terminal pin 94 is electrically connected to the extension tube 51 and the actuating rod 50 therein . the extension tube 51 and actuating rod 50 are of electrically conductive metal ( in the preferred embodiment shown of surgical grade stainless steel .) the extension tube 51 and actuating rod 50 both are physically and electrically connected to the jaw unit 12 as hereafter more fully discussed . the terminal pin 94 is of electrically conductive material , preferably surgical grade stainless steel . the exposed upper end of the terminal pin 94 is diametrally slotted at 100 ( fig2 ) to make it radially springy in a direction transverse to the slot 100 , to enable it better to be gripped by a conventional electrical connector , not shown , connected through the line 96 to the current source 95 . the inner end portion of the terminal pin 94 is provided with an annular groove 101 used to fix the pin 94 in the handle unit 11 . more particularly , the upper portion of the rims 30 and 31 of the body 20 and cover 22 include , preferably by integral molding therein , respective upward and rearward angled bosses 102 and 103 ( fig2 ). with the cover 22 installed along the body 20 as shown in fig1 the bosses 102 and 103 abut each other to form a rearward angled composite boss 102 , 103 . an outwardly and rearwardly angled hole penetrates through the composite boss 102 , 103 and comprises opposed grooves 104 and 105 ( fig3 and 4 ), which define a composite hole 104 , 105 communicating with the chamber 23 . the outer end of the composite hole 104 , 105 communicates with a radially enlarged , outwardly facing coaxial composite recess 106 , 107 defined by opposed recess portions 106 and 107 respectively ( fig3 and 4 ). in the assembled apparatus , the annular groove 101 of the pin 94 is trapped axially in the composite hole 104 , 105 , leaving a short inner end portion 110 of the terminal pin positively trapped inside the chamber 23 and a long outer end portion 111 of the terminal pin extending outboard of the composite recess 106 , 107 and carrying outer end slot 100 . in the preferred embodiment shown , the opposing recess portions 106 and 107 and the groove 104 are of circular cross section corresponding closely to that of the corresponding portions 101 and 111 of the contact pin 94 . the groove 105 may be of circular cross section if desired but it can also be , as illustrated in fig4 of the different cross section , here square , as desired . in any event , it is the boss portions 112 ( fig3 and 4 ) surrounding the composite hole 104 , 105 , which extends radially into the annular groove 101 of the terminal pin 94 to axially trap same between the body 20 and cover 22 . the contact spring 93 ( fig1 and 11 ) here comprises a spring tempered stainless steel sheet of uniform thickness , preferably of elongate generally rectangular shape , and having a substantially flat , elongate central portion 120 provided with an elongate rectangular central hole 121 . the lower end portion 122 of the contact 93 is bent in a u - shape . the upper end portion 123 of the contact 193 is bent substantially in an l - shape . the elongate central hole 121 extends substantially the full distance between the u - shaped and l - shaped end portions 122 and 123 . a tab 124 bends up from the upper left ( fig7 and 11 ) corner of the l - shaped end portion 123 . in its installed position of fig6 and 7 , the spring contact 93 abuts , with its u - shaped and l - shaped end portions 122 and 123 , the interior face of the side wall 28 of the body 20 immediately below and above the saddle 90 . the horns 92 of the saddle 90 protrude through the elongate hole 121 of the spring contact 93 , leaving the central portion of the saddle 90 laterally outward of the flat central portion 120 of the spring contact 93 . the flat central portion 120 of the spring contact 93 is spaced far enough from the body side wall 28 that the installed extension tube 51 bears forcibly against and bends slightly laterally outwardly , toward the body side wall 28 , the central portion 120 of the spring contact 93 , to assure firm and reliable electric current passing contact between the spring contact central portion 120 and rotatable extension tube 51 . indeed , the spring contact 93 is fixed in place on the horns 92 of the saddle 91 by the extension tube 51 pressing same laterally outward toward the side wall 28 of the body 20 . thus installed the spring contact 93 locates its tab 124 to face upward and rearward and extend laterally inboard away from the body side wall 28 . the free edge of the tab 124 resiliently presses against the interior end of the electrical terminal pin 94 , so as to make firm , reliable electrically conductive contact therewith . in this matter , electric current is passed through the pin 94 and contact 93 to the periphery of the extension tube 51 and to the actuating rod 50 therein . the outer periphery of the extension tube 51 is snugly and fixedly covered by an electrically insulated sheath 147 ( fig8 and 20 ) which extends from within the front end of the knob 130 almost to the front end of the extension tube 51 . in the preferred embodiment shown , the sheath is of conventional heat shrink tubing , for example of polytetrafluoroethylene ( ptfe or teflon brand ) heat shrink tubing . the extension tube 50 , immediately ahead of the body 20 and cover 22 , carries a rotator knob 130 in fixed relation thereon , so that the user , by rotating the rotator knob 130 , can thereby rotate the extension tube 51 and with it , the actuating rod 50 therein . in the embodiment shown in fig1 , the rotator knob 130 is a rigid molded plastics element having a flat rear face whose perimeter is substantially a five pointed star , providing circumferentially spaced flute - like finger grips 129 . the rotator knob 130 preferably tapers from rear to front , as shown in fig1 and a rear face is provided with material saving recesses 128 ( fig1 ). the knob 130 may be fixed to the extension tube 51 by any convenient means , but in the preferred embodiment shown such is done as follows . an axially extending keyway 131 ( fig8 ) in the rear portion of the extension tube 51 receives an axially extending key 132 fixed , preferably integrally radially , to the knob 130 and inwardly extending into the central bore 133 of the knob 130 . the key 132 thus compels rotation of the extension tube 51 with the knob 130 . the knob 130 is axially fixed on the extension tube 51 by any convenient means , here comprising knurling or grooving 134 on the periphery of the extension tube 51 , which frictionally and or mechanically grips firmly the interior surface of the central bore 133 of the knob 130 in at least the rear portion thereof . in the preferred embodiment shown , provision is made for transfer of liquid to or from the surgical site ss longitudinally along the annular interface between the extension tube 51 and actuating rod 50 . thus , for example , irrigation liquid may be passed to the surgical site ss or , alternatively , liquid may be suctioned from the surgical site ss . in more detail , the front portion of the central bore 133 of the knob 130 is radially enlarged , as indicated at 135 in fig8 at a location immediately ahead of the grooving 134 . spaced slightly forward of the grooving 134 , the exterior peripheral surface of the extension tube 51 is provided with an axially spaced pair of annular grooves to respectively receive and resilient seals , preferably o - rings , 136 and 137 . such o - rings 136 and 137 bear snugly and sealingly but rotativably on the inner surface of the enlarged front bore portion 135 of the knob 130 . a radial hole 140 penetrates the perforated extension tube 51 in axially spaced relation between the o - rings 136 and 137 . radially outboard of the hole 140 , the knob 130 includes a radially outwardly extending tubular stack 141 having a coaxial liquid passage 142 connectable through a liquid conduit 143 to an irrigation liquid source ls or , if desired a gravity or suction liquid drain ld as schematically indicated in fig8 . the radially outer end of the stack 141 is provided with a conventional end fitting , preferably molded therein , here for example a luer male fitting 144 suitable to fixedly and sealingly engage a conventional female luer fitting on liquid line 143 . a plug 145 may be inserted in the outer end of the stack 145 to close same when no liquid line 143 is connected thereto . to facilitate liquid flow between the liquid hole 140 and the jaw unit 12 , along the annular area between the extension tube 51 and the actuating rod 50 the corresponding length of the actuating rod 50 is provided with at least one longitudinally extending flat 146 which increases radial spacing from the interior surface of the extension tube 51 and thereby provides a longitudinal channel for liquid flow between the liquid stack 141 and the surgical site ss . in the preferred embodiment shown , the actuating rod 50 carries several ( here four ) evenly circumferentially spaced ones of the elongate flats 146 . it is contemplated that other forms of liquid channel may be provided between the extension tube 51 and actuating rod 50 , such as keyways , etc . but the flats 146 are preferred for ease in manufacture . attention is directed to the jaw unit 12 at the distal end of the tool 10 . the distal ( rightward in fig1 and 15 ) end of the actuating rod 50 includes an axially deep , diametrally and forwardly opening slot 150 ( fig1 ). a diametral hole 151 ( fig1 , 18 and 19 ) extends through the actuating rod 50 immediately adjacent the distal ( rightward in fig1 ) end thereof and perpendicularly crosses the width of the slot 150 . the slot 150 thus forms the distal end of the actuating rod 50 as a forward opening yoke whose arms 152 diametrally oppose each other across the forward opening slot 150 . in fig2 , the actuating rod 20 is shown in a position during assembly of the tool 10 , namely with its distal end portion extended forwardly from the extension tube 51 preparatory to its connection to the links 200 hereafter described . the distal end of the extension tube 51 comprises a forwardly opening substantially rectangular , diametral slot 160 ( fig1 and 23 ) of width slightly less than the inside diameter of the extension tube 51 . the blind end 161 of the slot 160 is slotted to form a narrower , shorter subslot 162 ( fig1 ) of rectangular cross section and which at its forward end thus opens into the slot 160 . the slot 160 and subslot 162 have the same central plane . the slot 160 and subslot 162 divide the forward end of the extension tube 51 into diametrally opposed arms 163 . a diametral through hole 164 ( fig1 and 20 ) extends through the arms 163 in a direction perpendicular to the central plane of the slot 160 and subslot 162 . the jaw unit 12 comprises a pair of preferably identical jaws 170 ( fig2 ). in the particular embodiment shown , the jaws 170 are dissector jaws having distal end portions 171 which can be brought together for gripping tissue of a patient and moved apart to release same . it is also contemplated that jaws of other types and / or purposes , for example , scissors jaws ( not shown ) may be substituted . the jaws 170 are preferably identical to each other , and are used with one rotated at an 180 ° angle about its longitudinal axis with respect to the other . the proximal end portions 172 of the jaws 170 are each of generally circular perimeter shape , as seen in fig2 . the mid - portion 173 of each jaw extends forward , generally tangentially , from the proximal portion 172 to the distal end portion 171 . the mid - portion 173 , as seen in fig2 , is semi - circular in cross - section . the mid - portion 173 generally tapers toward the distal end portion 171 , having either a semi - cylindrical rear part 174 and tapered front part 175 as in fig2 or merely tapering as in fig2 - 24 . the mid - portions 173 of the jaws 170 have opposed flat faces 176 . the distal end portions 171 of the jaws 170 are of semi - circular cross - section and forwardly extend the reduced diameter end of the mid - portion 173 and have rounded noses 177 . the distal end portions 171 also continue forward the flat face 176 of the mid - portion 173 , but add a forwardly extending series of transverse serrations , or teeth , 181 . the teeth 181 of the jaws 170 can closely oppose each other for gripping patient tissue as generally indicated in fig2 . the semi - circular rounded distal end portions 171 may be substantially cylindrical as in fig2 or may taper forwardly , as in fig2 . the proximal end portions 172 of each extend in an imaginary plane perpendicular to the plane of the flat face 176 of the corresponding jaw . the proximal portion 172 is of flat faced , hockey puck - like shape and is offset to one side of the longitudinal central axis j ( fig2 ) of the jaw 170 , and more particularly of the mid - portion 173 and distal end portion 171 of the jaw . each jaw proximal portion has a central pivot hole 182 which extends coaxially therethrough and has a central axis h which is substantially perpendicular to the longitudinal axis j of the jaw . the opposed faces 183 of the puck - like proximal end portions 172 are relieved at 184 . the relief 184 lies immediately behind the tangentially forwardly extending jaw mid - portion 173 , as seen in fig2 . in the orientation of the jaw in fig2 , the relief 184 opens upward away from the pivot hole 182 and opens rearward . the bottom of the relief 184 comprises front and rear ramps 185 and 186 that rise gradually ( the rear ramp 186 the more gradual of the two ) to a peak close above the hole 182 to form a kind of gable roof over the hole 182 . the front end of the front ramp 185 goes forward and upward to form a rear facing front wall 187 of the recess 184 . the proximal and mid - portions 172 and 173 share a continuous flattened tangential edge which in the jaw orientation of fig2 is substantially horizontal and at the top of the jaw . the jaws top ( in fig2 ) edge 190 , shared by the proximal and mid - portions 172 and 173 , is flattened and horizontal , substantially in parallel to the longitudinal extent of the jaw 170 . a pivot stub shaft 191 protrudes laterally fixedly into the recess 184 . a jaw pivot pin 192 ( fig2 ) extends through and beyond the diametral through hole 164 in the arms 163 . one end 193 of the pin 192 is enlarged . the other end 194 of the pin 192 is conveniently peened over to form a further enlarged head indicated at 194 in fig2 . the enlarged ends 193 and 194 axially trap the pivot pin 192 in transverse spanning relation across the diametral slot 160 of the extension tube 51 . the jaw pivot pin 192 extends through the pivot holes 182 in the puck - shaped proximal end portions 172 of the opposed jaws 170 , which jaw end portions thus lie in parallel between the arms 163 at the distal end of the extension tube 51 and are pivotally supported on the extension tube 51 by the pivot pin 192 . the jaws 170 are thus pivotable from their fully closed fig2 position , through their fig2 position , to their fig2 90 ° open position . more particularly , the puck - like proximal end portions 172 of the jaws 170 are spaced side - by - side from each other in the diametral slot 160 , leaving a space therebetween for links 200 discussed hereinafter . each jaw 170 is connected to the distal end of the actuating rod 50 ( fig2 ) by a generally p - shaped actuating link 200 . each link 200 is of flat rigid stock having a relatively large planar head 201 with a generally domed proximal end 202 and substantially parallel , forwardly extending edges 203 and 204 . each link 200 further includes a neck 205 extending forward from the head 201 . the neck 205 is substantially narrower than the head 201 as measured in a direction perpendicular to the edges 203 and 204 . the leg 205 continues forward the edge 203 . a hole 206 is provided in the domed proximal portion 202 of the head 201 . the head 201 and arm 205 form a generally l - shaped structure , leaving a relatively large notch facing forward , and in fig2 downward . such notch is defined by an interior edge 10 extending forward along the leg 205 opposite from the edge 203 , and further leaving a forward facing edge 11 which is the forward edge of the head 201 . the forward end portion of the leg 205 bulges slightly into the notch at 212 to leave room for a hole 213 in the distal end portion of the leg 205 for pivotally receiving therein the pivot stub shaft 191 of the corresponding jaw 170 , as seen in fig2 . in this way , the arm 205 of each link 201 connects pivotally to the proximal end portion 172 of the corresponding jaw in an eccentric manner , so that forward movement of the links 200 tends to close the distal portions of the jaws together , toward their fig2 position , and rearward pulling of the links pivots the jaws in the opposite direction , namely toward their open fig2 position . the link 200 ( fig2 ) with its head 201 and neck 205 has a perimeter profile which may be thought to caricature , or cartoon , the head and neck of a turkey , complete with caricature beak at the join of edges 211 and 204 and caricature eye at 206 . the rear ends of the links 200 are pivotally connected by a pivot pin 214 ( fig2 ) extending through their rear pivot holes 206 and through the diametral holes 151 in the arms 152 of the actuating rod 50 . in the assembled tool 10 , the proximal ends 202 and pivot holes 206 of the planar head 201 of the links 200 are thus relatively pivotally retained in the forward opening slot 150 of the actuating rod 50 for pivotal motion with respect thereto and for forward and rearward movement upon corresponding forward and rearward movement of the actuating rod 50 . successive front , mid and rear positions of the actuating rod 50 and far actuating link 200 are shown in fig2 in solid line , chain line and dotted line respectively and are referenced by characters 50f , 50m and 50r , respectively and 200f , 200m and 200r , respectively . as further seen in fig2 , these positions of the actuating rod 50 and link 200 correspond to the respective closed , mid and open positions of the corresponding jaw 170 indicated at 170f , 170m and 170r in solid , chain and dotted lines , respectively in fig2 . just as the assembled jaws 171 are rolled 180 ° about their length axis with respect to each other , so to are the links 200 , as generally indicated in exploded relation in fig2 . thus , in use , the two necks 205 are spaced close above and below the pivot pin 192 of the jaws 171 . the plate - line links 200 , need to be unbendable in use , but of sufficiently small thickness to fit side - by - side in the actuating rod forward slot 150 in a freely pivotable manner , as generally shown in fig2 - 24 . the location of the jaws 170 and links 200 with respect to the slot 160 of the extension tube 51 is seen from the top in fig2 , without minor visual distortions that may appear in the pictorial fig2 - 24 . the apparatus may be assembled as follows . with the links 200 assembled to the respective jaws 170 , the links 200 may be inserted rearward into the forward opening slot 150 ( in its exposed assembly position of fig2 ) and pivoted there by insertion of the pin 214 . the actuating rod 50 , and with it the links 200 and jaws 170 , may then be pulled rearward , so the links 200 and the rear portions of the jaws 170 enter the slot 160 in the front end of the extension tube 51 , sufficient to allow insertion of the jaw pivot pin 192 to pivotally mount the jaws on the forward end of the extension tube 51 . thereafter , the free protruding end 194 of the pin 192 can be peened to maintain the pin 192 axially trapped on the arms 163 of the extension tube 51 . the sheath 147 may be applied to the extension tube 51 either before or after installation of the jaws 170 and links 200 with respect thereto but is installed on the extension tube 51 preferably before installation of the knob 130 thereon . with the electrically insulating sheath 147 and o - rings 136 and 137 ( fig8 ) fixed on the extension tube 51 , the knob can be forced axially onto the rear end portion of the extension tube to its operative fig8 position . the extension tube 51 , containing the actuating rod 50 , can then be inserted rearwardly through the bearing hole 54 and past the spring contact plate 93 and rear bearing part 60 . with the actuating rod 50 thus pulled far enough rearward in the extension tube 51 , and the upper end of the trigger 21 inserted upward through the window 45 , the rear end portion of the actuating rod 50 enters the slot 44 in the top portion of the trigger and is pivotally secured in place therein by lateral insertion of the slotted drive pin 82 to operatively connect the actuating rod 50 to the trigger 21 . the electrode pin 94 can then be placed laterally into the boss 102 ( fig7 ) with its inner end 110 in electrical abutting contact with the edge of the tab 124 of the contact spring 93 . the cover 22 can then be fixed rim - to - rim on the body 20 . the tool 10 is operated as follows . the tool 10 is useable in laparoscopic surgery by insertion of the closed jaw unit 12 and elongate extension 13 ( fig1 ) through the usual laparoscopic cannula 14 , which has previously been inserted in a conventional manner into the surgical site ss . the tool is normally handled and actuated by one hand of the user , the thumb of such hand inserted in the thumb ring 25 and one or more fingers inserted in the depending loop of the trigger 21 . pulling the bottom of the trigger 21 rearward toward the thumb loop 25 forwards the top of the trigger 21 , by pivotal movement of the trigger 21 around the corresponding boss 32 ( fig7 ). the shallow arcuate movement of the top of the trigger 21 , generally indicated by the adjacent arrow in fig7 acts through the drive pin 82 to forward the actuating rod 50 . the minor vertical component of trigger pivoting motion is absorbed by the vertical lost motion of the drive pin 82 in the oblong hole 43 in the top of the trigger and does not tend to vertically bend the rear end of the actuating rod 50 , but instead applies purely axial urging thereto . such forward movement of the actuating rod 50 moves the opposed jaws 170 to their closed position 170f ( fig2 and 26 ). this closed position is a normal position of the jaws for insertion of the tool into the laparoscopic cannula since it minimizes the width ( or diameter ) of the distal portion of the tool and enables it easily to pass through the laparoscopic cannula . once the jaw unit 12 has been inserted through the laparoscopic cannula 14 into the surgical site ss , as shown in fig1 the jaws 170 ( fig2 - 24 ) can be moved from closed to open position by moving the lower part of the trigger 21 forwardly to rock the upper end of the trigger 21 rearwardly and thereby pull the actuating rod 50 rearwardly , as generally indicated in the sequence from 50f to 50r in fig2 . in opening the jaws 170 , the legs 205 of the links 200 move rearwardly in a shallow generally horizontal arc ( note the sequential positions of the pin 191 in fig2 ). accordingly , each rearward moving arm 205 moves radially outward slightly to clear the top of the hill formed by the saw ramps 185 and 186 ( fig2 ). as seen in fig2 , each arm 205 at most rises only to the outer edge of the extension tube front slot 160 , so that the electrical insulating sheath 147 does not interfere with actuating motion of the links 200 . the configuration of the jaw recess 187 ( fig2 ) and corresponding link 200 represents a best compromise between desirably minimizing the outside diameter of the extension tube 51 and forwardmost extension of its surrounding electrically insulating sheath 147 , with sufficient link stiffening and hence resistance to bending as to enable the link 200 to forcibly push , as well as pull , on the jaw stub shaft 191 during forcible pulling and pushing of the trigger 21 . to this end , the shape and depth of the jaw recess 184 is selected to allow maximum width of the link neck 205 , particularly to maximize the amount of link neck material surrounding the pivot pin 191 and to maximize the width of the link neck 205 where it merges into the link head 201 . the substantial width of the link head 201 at its forward end portion , from which the neck 205 forwardly extends , permits maximizing of spacing between the parallel , forward extending edges 203 and 204 of the head 201 to allow them to lie closely to the surrounding sheath . this configuration also allows the forward portion of the link head 201 adjacent the neck 205 to lie close behind the puck - shaped jaw portion 172 in the forward position of the link 200 . maximizing the width of the link head 201 roughly halfway between the pivot holes 206 and 205 thereof , by maximizing the widthwise spacing of the link head edges 203 and 204 , advantageously allows each link head 201 in this area between edges 203 and 204 to reinforce the other link 200 against any tendency to twist between its front and rear ends , particularly when the links 200 are pushing the jaws 170 closed , to grip forcibly - a portion of patient tissue . also , the configuration of the link 200 and the attached rear portion of the jaw 170 advantageously allows the user to open the dissector jaws very widely and yet be capable of easily and carefully controlling the relative position of the jaws . the plate - like links 200 ( fig2 - 24 and 26 ) must be very thin to pivotally fit side - by - side with each other between the puck - like proximal end portions 172 of the jaws 170 in the extension tube forward slot 160 , in view of the small outside diameter extension tube 51 required to slidably insert in a conventional laparoscopic surgical cannula 14 ( fig1 ). for example , in one unit constructed according to the invention , the height ( vertically in fig2 and 27 ) of the puck - like jaw proximal end portion 172 was about 0 . 186 inch , the outside diameter of the extension tube 51 was about 0 . 188 inch , and the width of its front slot 160 was about 0 . 095 inch ( less than 1 / 10 inch ). in the same unit , the thickness of each puck - like jaw proximal end portion 172 was about 0 . 45 inch and the thickness of the recess 184 therein was sufficient to accommodate a link 200 of about 0 . 018 inch thick . this left about 0 . 001 inch clearance at the sliding interfaces between the extension tube 51 ( at the forward slot 160 thereof ), the jaw proximal end portions 172 and the links 200 . though of relatively stiff material ( preferably surgical grade stainless steel ), nevertheless a link 200 , and particularly a link neck 205 , only 0 . 018 inch thick ( approximately the combined thickness of pages 1 - 5 of the present specification ) would be expected to bend responsive to a relatively small lengthwise compressive force thereto , with the link unsupported . in the same unit built according to the invention , the minimum width of the link neck 205 was about 0 . 047 inch ( approximately 3 / 64 inch , about the maximum allowed by the space between the pivot pin 192 and the sheath 147 ). on the other hand , the width between the flat edges 203 and 204 of the link head 201 , which head is spaced from and does not need to clear the pin 192 , was about 0 . 175 inch ( a bit over 11 / 64 inch ), to maximize the stiffness of the head 201 in response to axial compressive forces on the link 200 . with these very thin links 200 ( i . e ., 0 . 018 inch in such one unit constructed according to the invention ), sufficient link stiffness and resistance to bending ( as to enable the link 200 to forcibly push on the jaw stub shaft 191 sufficient to press the jaws 170 to forcibly grip a portion of patient tissue ) is here achieved by close lateral support of the link by laterally adjacent structure . more particularly , the narrow neck 205 of each link is closely laterally slidably backed on one side by the side of the recess 184 in the corresponding jaw 170 , which jaw 170 is in turn laterally backed by the extension tube 51 at the edge of the slot 160 . the link narrow neck 205 is laterally supported on the other side by the proximal portion 172 of the other jaw 170 , diametrally remote from the recess 184 therein , which other jaw rear end portion is in turn laterally backed by the material of extension tube 51 at the other side of the slot 160 therein . as seen in fig2 , most of the narrow link neck 205 is continuously closely sandwiched in slidable but laterally supported relation between the laterally imposed jaw rear end portions . further , the length portion of the neck 205 laterally supported between proximal end portions of adjacent jaws 170 is maximized with the jaws closed or almost closed , as in tissue grasping relation , and is only lessened with the jaws pulled apart . thus as maximum gripping force is applied to the jaws by forward pushing on the actuating rod 50 , the jaw necks 205 are in their range of maximum lateral support between the cheeks of the adjacent jaw rear end portions . also , the narrowed rear end portions 202 of the links 200 are closely laterally supported by the lateral edges of the reduced width subslot 162 of the extension tube 51 . the widest portion of the link 200 , between the parallel top and bottom edges 203 and 204 in fig2 , while not laterally supported by the jaws 170 or extension tube 51 , nevertheless resists bending upon axial compression of the link due to its short axial length , its maximized lateral ( vertically in fig2 ) width and the close side - by - side mutual support against bending one toward the other achievement of the cheek - to - cheek sliding abutment of these two portions of links 200 . the result is that the links 200 are capable of transmitting substantially higher axially compressive forces than would have otherwise been expected . the very small clearances laterally between the extension tube slot edges , jaw proximal end portions and link necks maximizes the lateral support and hence resistance to bending imparted to the link necks by the sandwiching jaw rear end portions and extension tube slot edges . slight interference to sliding between the parts is tolerable since it adds to the resistance to bending of the link necks . in a figurative sense , the link necks almost become an interior part of a solid block although one in which they are allowed to translate and pivot in their own plane . in some instances , it may be desirable during surgery to pass an electric cauterizing current through the jaws 170 to patient tissue , for cauterizing same . this may be true in the case of dissector type jaws as well as with jaws of other types , such as conventional jaws ( not shown ) capable of scissors - like cutting . to that end , the electric cauterizing current source 95 can in a conventional manner be connected by electric conductors 96 and 97 ( fig1 ) to the terminal pin 94 at the proximal portion of the tool 10 , as well as to the patient near the surgical site ss . cauterizing current is conducted by the spring - like contact 93 from the inner end 110 of the electric terminal pin 94 to the extension tube 51 . such electrical contact is particularly reliable due to bearing of the spring contact edge 124 forcibly and resiliently against the inner end portion 110 of the pin 94 and due to the resilient self - urging of the mid - portion of the springy contact member 93 radially against the periphery of the extension tube 51 , such contact being continuous despite possible rotation of the extension tube 51 by user rotation of the knob 130 . thus , electric current is supplied to the extension tube 51 as well as to the actuating rod 51 electrically contacting the interior thereof , through the pivot pins 192 and 214 ( fig2 ) of shafts 191 and links 200 to the jaws 170 , all of which are of electrically conductive material , preferably surgical grade stainless steel . as mentioned , liquid flow is permitted between the surgical site ss and the stack 141 on the rotate knob 130 . thus , for example , during a surgical procedure , irrigation liquid from a liquid source ls ( fig8 ) can be admitted to the stack 141 on the rotate knob 130 to thus feed through the hole 140 and along the flats 146 on the actuating rod 50 ( and thus within the extension tube 51 ) to enter the surgical site ss adjacent the jaws 170 . it will be noted that the tool 10 can be manufactured inexpensively , the parts being of molded plastics material in the handle unit 11 , and so can be sold and used as a disposable , for disposal after a surgical procedure on a single patient , thereby avoiding the expense of and risks associated with resterilization . the human hand is formed such that it can apply more force to the finger loop of the trigger 21 in pulling it rearwardly toward the thumb ring ( by clenching the hand into a fist ) than by pushing the finger loop of the trigger forwardly . in consequence , the closing force applied to the jaws and hence their gripping force on patient tissue is maximized at least in part due to the arrangement of the links 200 to close the jaws 170 in response to such a fist clenching , rearward pull on the lower portion of the trigger 21 . although a particular preferred embodiment of the invention has been disclosed in detail for illustrative purposes , it will be recognized that variations or modifications of the disclosed apparatus , including the rearrangement of parts , lie within the scope of the present invention .

a handpowered , low cost , disposable laparoscopic surgical tool has a proximal hand engageable unit , an elongate extension unit and a distal jaw unit . pulling a trigger of the hand engageable unit forwards an extension rod in the extension unit to pivot the jaws together . in one embodiment of the invention , the handle unit is primarily of molded plastic material for low cost and disposability . in an embodiment , electrocautery contact with the extension unit is through a bendable spring element . in an embodiment specially shaped links and connected jaw portions improve strength and control in opening and closing the jaws .

the entire system is described based on fig1 . a collar 107 is attached to a pet 104 ( a dog is shown ). a harness wound on and fixed to the body and the neck of a pet may be used in place of a collar . when the harness is used , though a problem such as collar pullout does not occur , it may be bothering to attach it to a pet , and the pet may dislike wearing it . a lead joint 113 for connecting a lead 101 for pulling a pet during walk is mounted on the collar 107 . also , an electronic device attached to pet 106 is fixed to the collar 107 by screwing for preventing it from being detached when the pet scratches the collar 107 with the foot or someone tries to pull it so as to detach it . the other end of the lead 101 is detachably connected to the lead joint 113 on the collar 107 . a portable electric power generator 204 is connected to the lead 101 through a pull wire for charging 200 . a power supply cable for charging 102 comes out from the portable electric power generator 204 , and is routed along the lead 101 . when the pull wire for charging 200 is pulled , a part wound inside the portable electric power generator 204 comes out while the portable electric power generator 204 is generating electricity . since the wire 200 extending outside from the portable electric power generator 204 becomes longer as a result , the power supply cable for charging 102 provided in parallel with the wire 200 has to have a slack with a predetermined length . the power supply cable for charging 102 branches from the lead 101 after routing along the outside or the inside of the lead 101 , and reaching a neighborhood of the lead joint 113 , and is connected with a dc jack for power supply cable 400 by way of an unillustrated dc plug or the like formed at the end of the power supply cable for charging 102 . a grip 108 in a loop shape for a convenience of human hand gripping is provided on the other end of the portable electric power generator 204 . when a person is walking with the pet 104 while gripping the grip 108 , since the pet starts and stops walking and changes the direction , a tensile force is applied to or disappears from the lead 101 . when the grip 108 is held by the human hand or bound on a certain place , the portable electric power generator 204 generates electricity each time when the tensile force is applied to or disappears from the lead 101 . the generated electrical energy is supplied for the electronic device attached to pet 106 through the power supply cable for charging 102 , the unillustrated dc plug disposed on the power supply cable 102 , and the dc jack for power supply cable 400 in this order , and then , through an unillustrated cable disposed inside the collar 107 . then , it charges the rechargeable battery in the electronic device attached to pet 106 . when the pet 104 gets lost while wearing the collar 107 with the electronic device attached to pet 106 , the electronic device attached to pet 106 conducts ( 1 ) detecting the occurrence of the stray pet , ( 2 ) wirelessly reporting information on the occurrence of the stray pet , ( 3 ) reacting so as to be searched , and ( 4 ) controlling the operation according to the remaining battery capacity according to operation control parameters shown in fig7 . the stray pet occurrence information may be wirelessly reported by transmitting a message addressed to a predetermined a terminal apparatus 112 through a cellular phone base station 109 and a public network 110 , by reporting the message to a center 111 offering stray pet search service again through the cellular phone base station 109 and the public network 110 , or by simultaneously conducting both of them . when the stray pet occurrence information is reported , persons concerned start searching for the stray pet . respective proper reactions are necessary for the search according to the situation . the electronic device attached to pet 106 controls the operation such as reacting to be searched and controlling the operation according to the remaining battery capacity based on the reaction of remotely setting the proper operation control parameters to the electronic device attached to pet 106 . referring to fig5 ( a ) and fig5 ( b ), the difference in the remaining energy amount of the battery contained in the electronic device attached to pet 106 between a case where the portable electric power generator 204 charges , and a non - rechargeable battery is incorporated . fig5 ( a ) is a conceptual drawing showing the transition of the remaining energy amount of the battery in the prior art disclosed in japanese patent registration no . 3289983 . in fig5 ( a ), the remaining energy amount of the battery is at the maximum ( q 1 level shown in the drawing ) immediately after the non - rechargeable battery is replaced , and the remaining energy amount simply decreases until the battery is replaced next time . it is necessary to always maintain the power of the electronic device attached to pet 106 to on if the electronic device attached to pet 106 is used to search for a pet when the pet gets lost . this is that the pet may always get lost , and the electronic device attached to pet 106 must stand by so as to automatically detect the stray state and to report it once the pet gets lost . thus , the electronic device attached to pet 106 always consumes standby electric power , and the remaining energy amount of the battery decreases as time elapses . in addition , for example , when the electronic device attached to pet 106 wirelessly transmits a certain message , the remaining energy amount decreases more than it does in the standby state . when the remaining energy amount of the battery decreases less than q 2 , it is probable that the remaining energy amount becomes almost zero before the pet search is successfully completed , even though using the electronic device attached to pet 106 is tried . thus , when the pet gets lost in a section a in fig5 ( a ), the search for the pet becomes difficult . fig5 ( b ) shows a case where the system of the present invention is used , and is a conceptual drawing of the transition of the battery remaining energy amount when the lead 101 with the portable electric power generator 204 is used to take the pet for a walk or leash the pet to a certain place . when the pet is stationary even if the pet is leashed to a certain place with the lead 101 , or when the pet is unleashed , and stays in a room , for example , the remaining energy amount decreases . this is that the electronic device attached to pet is in the standby state , and consumes the standby electric power in case that the pet gets lost . however , in an ordinary pet keeping , the pet is taken for walk while leashed to the lead everyday or every few days . during the walk , the lead is often pulled . also , the pet moves around and pulls the lead while it is leashed to a certain place . a section b in fig5 ( b ) shows that the pet goes for a walk while the lead 101 with the portable electric power generator 204 is used , and consequently , the remaining energy amount of the battery recovers rapidly . a section c shows a case where the electronic device attached to pet 106 consumes electric power by conducting wireless report or the like . as fig5 ( b ) shows , with the system of the present invention , since the remaining energy amount of the battery does not decrease below the level of q 2 , sufficient energy required by the electronic device attached to pet 106 for the search remains at any time when the pet gets lost and the search becomes necessary . fig2 shows the structure of the portable electric power generator 204 . a drum incorporating spiral spring 207 is installed rotatably about a shaft 208 fixed to an enclosure 202 . one end of an unillustrated spiral spring in the drum 207 is fixed to the shaft 208 , and the other end is fixed to the inner wall of the drum 207 . a strong string is wound around the drum 207 . one end of the string is fixed to the outer wall surface of the drum 207 , and the other end of the string is connected to the pull wire for charging 200 . when the pull wire for charging 200 is pulled , the string wound on the drum is pulled . consequently , the drum 207 rotates while it deforms the spiral spring in it such that the spring is squeezed toward the center . when the drum 207 rotates , a gear 206 attached to the drum 207 rotates , and a gear 209 meshed with this gear 206 rotates so as to rotate a rotation shaft of a rotor of a dc generator 205 , thereby generating electricity . when the tensile force applied to the pull wire for charging 200 disappears , the wound - out string is automatically wound on the drum by the restoring force of the spiral spring attached to the inside of the drum , and simultaneously , the pull wire for charging 200 is pulled inside the portable electric power generator 204 . the electricity from the dc generator 205 is supplied on a power supply cable for charging 201 connected to the outside through a stopper 203 . as a portable electric power generator 204 , one disclosed in japanese patent laid - open publication no . 2001 - 136707 may be used . based on fig3 , description is provided for the electronic device attached to pet 106 . the basic functions of the electronic device attached to pet 106 are realized by an antenna unit 300 , a wireless data communication unit 301 , a gps unit 302 , a memory 303 , a control unit 304 , a rechargeable battery 305 , an interface circuit for charging 306 , and a dc jack 307 . the basic functions include ( 1 ) using the interface circuit for charging 306 to regulate the electricity received by the dc jack 307 to a constant voltage , thereby charging the rechargeable battery 305 , and ( 2 ) using the electrical energy of the rechargeable battery 305 to drive the gps unit , measuring the current location of the electronic device attached to pet 106 , and making the wireless data communication unit use the antenna unit 300 to transmit information including the current location to a predetermined destination . it is desirable to include information corresponding to the remaining energy amount of the rechargeable battery into the information wirelessly transmitted . this is that the information from the electronic device attached to pet 106 is useful for the receiving party to prepare a plan for searching for the stray pet , and to determine what control to be performed in terms of the operation control items described later considering the remaining energy amount . for executing the basic functions , information processing conducted by the control unit 304 while it is using the memory 303 is indispensable . the control unit 304 is realized by a one - chip microcomputer , for example . since the most important information is the current location of the pet when the pet gets lost , the basic functions ( 1 ) and ( 2 ) described above are functions primarily required for the electronic device attached to pet 106 . if the wireless data communication unit 301 uses the antenna unit to wirelessly transmit sound and other sensing information obtained by a microphone unit 310 and an ambient environment sensor 311 to a predetermined destination , the information is useful to narrow down the location of the stray pet when the location measuring by the gps unit 302 is not available due to the ambient environment or the like . a speaker 308 and an led 309 are used to generate guide sound or guide light for guiding a person searching for a stray pet to the location of the stray pet when the searching person comes immediately close to the stray pet . also , the control unit 304 uses the antenna unit 300 and the wireless data communication unit 301 to receive the operation control parameters from the outside , memorizes them into the memory 303 , and uses them for the operation control of the electronic device attached to pet 106 . the operation control parameters include those shown in fig7 . in the system shown in fig1 , both the electronic device attached to pet 106 and the lead 101 are installed on the single collar 107 . therefore , when the lead 101 is fixed to something , if the pet 104 pulls the lead 101 while wearing the collar 107 on the neck , the collar 107 is pulled out from the neck , and the electronic device attached to pet 106 is left on the collar 107 not worn by the pet . if this is the case , using the electronic device attached to pet 106 for finding the location of a stray pet as a function of it is not attained at all . a structure shown in fig4 is used as a counter measure against the collar pullout which is a serious situation . as collars , two of a collar for pulling 107 a and a collar for information 107 b are prepared , and the two collars are attached to the neck of a pet such that the collar for pulling 107 a is above ( closer to the ears of the pet ) the collar for information 107 b . the collar for pulling 107 a is connected with the lead 101 , and is then used for pulling the pet . a device ( such as a metal plate , a name tag , and cloth ) on which information useful for reporting a pet to persons concerned with the pet ( such as the registration number of the pet , the contact of the pet owner , and the name of the pet ) when the pet gets lost is shown , engraved , printed , or embroidered , and / or a device for wirelessly transmitting the status information of the pet ( such as the location , the ambient environment , the health of the pet , and the sound generated by the pet ) is installed on the collar for information . when two of the collar for pulling 107 a , and the collar for information 107 b are prepared , and the two of the collars are attached on the neck of a pet such that the collar for pulling 107 a is above ( closer to the ears of the pet ) the collar for the information 107 b , even when the upper collar for pulling 107 a is pulled out , since the lower collar for information 107 b remains while it is attached on the neck of the pet , the collar for information 107 b is useful for the persons concerned with the pet ( such as the owner ) to obtain information on the pet , and it is expected that the probability of finding the pet increases if the pet gets lost . when existence detecting means for detecting the existence of the collar for pulling 107 a is provided in the electronic device attached to pet 106 installed on the collar for information 107 b , the pullout of the collar for pulling 107 a is detected when the existence detecting means detects the absence of the collar for pulling 107 a . the type of the existence detecting means may vary . for example , a thin metal wire may be embedded in the bottom surface of the collar for pulling 107 a , namely , the surface in contact with the collar for information 107 b , and the electronic device attached to pet 106 may have a function of a proximity sensor for detecting the existence of the metal wire . if the metal wire is not detected , it can be determined that the collar for pulling 107 a does not exist any more . as another method , a small pin protruding downward from the collar for pulling 107 a is provided , and the pin is inserted into a hole incorporating a switch of the electronic device attached to pet 106 . when the switch turns off , the electronic device attached to pet 106 can determines that the collar for pulling 107 a is lost . the structure shown in fig4 can use the electricity generated by using the energy obtained when a pet pulls the lead 101 to charge the rechargeable battery 305 integrated into the electronic device attached to pet 106 in addition to including the system for detecting the collar pullout described above . the lead 101 is detachably attached to the collar for pulling 107 a . the power supply cable for charging 102 is disposed along the lead 101 , and a dc plug is formed at the end of the power supply cable for charging on the side of the collar , and can be inserted into and pulled out from the dc jack for power supply cable 400 disposed on the surface of the collar for pulling 107 a . a mechanism for preventing the inserted dc plug from being pulled out with a force lower than a certain degree is provided inside the dc jack for power supply cable 400 . in the collar for pulling 107 a , a power supply cable 401 runs from the dc jack for power supply cable 400 to the dc plug 312 . the dc plug 312 is firmly attached to the collar for pulling 107 a . the electronic device attached to pet 106 is firmly installed on the collar for information 107 b . an opening of the dc jack 307 integrated into the electronic device attached to pet 106 faces upward , and is displaced at an exact position for inserting the dc plug 312 into the dc jack 307 . thus , the collar for pulling 107 a and the collar for information 107 b are connected electrically and mechanically with each other by inserting the dc plug of the collar for pulling 107 a downwardly into the dc jack of the electronic device attached to pet 106 . as a result , the rechargeable battery integrated into the electric device attached to pet 106 is charged by the electricity supplied through the lead 101 . also , the interface circuit for charging 306 of the electronic device attached to pet 106 detects whether the dc plug 312 is inserted into the dc jack 307 , reports the detection result to the control unit , and simultaneously , transmits a signal corresponding to the remaining energy amount of the rechargeable battery to the control unit . the dc plug 312 is pulled out from the dc jack 307 when it is pulled by a force more than a predetermined value . thus , when the collar for pulling 107 a on which the dc plug 312 is firmly installed is pulled out from the neck of a pet , the dc plug 312 is pulled out from the dc jack 307 , and the collar for information 107 b remains on the neck . the interface circuit for charging 306 of the electronic device attached to pet 106 installed on the collar for information 107 b detects that dc plug 312 is pulled out from the dc jack 307 , and then , transmits an interrupt signal indicating the collar pullout to the control unit 304 . as a result , the control unit 304 detects the collar pullout . the operation of searching for a stray pet starts from “ stray status occurrence detection ” by the electronic device attached to pet 106 . however , even when the electronic device attached to pet 106 does not detect the stray status occurrence , a concerned person who recognizes a stray status of a pet may wirelessly transmit a set of the operation control parameters shown in fig7 to the electronic device attached to pet 106 so as to react against the occurrence of stray status . when any one of the following cases is met , the electronic device attached to pet 106 detects the stray status occurrence . since the system shown in fig1 is not prepared for the collar pullout , it cannot detect a case 1 , and detects only a case 2 and a case 3 . however , if the part of the collar in the system in fig1 is changed to that in fig4 , the system can detects all of the case 1 to case 3 . case 2 : a locating apparatus ( such as a gps receiver ) integrated into the electronic device attached to pet detects a location separated from a registered location ( such as home or a kennel ) by a predetermined distance , and the rechargeable battery 305 has not been charged for more than a predetermined period case 3 : the pet has been staying still in a dangerous zone for more than a predetermined period fig6 shows two cases where the collar pullout occurs in the home garden and during walk away from the home as the case 1 . the collar pullout detection method for detecting that the collar of the pet is pulled out in the case 1 has already been described in [ measure against collar pullout and detecting collar pullout ]. thus , referring to fig6 , the cases 2 and 3 are described in more detail here . the case 2 is used to prevent recognizing a status where a lead is not attached to a pet and the pet is unleashed at home or in the home garden as a stray status occurrence , and to recognize a status where the lead 01 is not connected to the collar at a location away from home ( outside a stray determination zone 602 ) for more than predetermined period as a stray status . for that purpose , the location of home 606 and a radius of the stray determination zone are registered to the electronic device attached to pet 106 in advance . there are many ways for the registration , and the following method is one of them . a portable terminal 112 in fig1 is used to transmit information of the address or the latitude and longitude of the home , the radius of the stray determination zone , and the phone number assigned to the subject electronic device attached to pet to the center 111 . the center 111 uses wireless data transmission to call the electronic device attached to pet 106 through the public network 110 and the cellular phone base station 109 , and transmits the latitude and longitude of the home , and the radius of the stray determination zone . the electronic device attached to pet 106 memorizes the latitude and longitude of the home , and the radius of the stray determination zone received in this way . after the data required for determining the stray status are prepared in this way , the electronic device attached to pet 106 checks whether the current location obtained from the gps unit 302 is within the stray determination zone 602 with the registered home 606 at its center at a time interval indicated by a parameter p 1 shown in fig7 . if it is detected that the device is located outside the stray determination zone 602 , the device uses the interface circuit for charging 306 to monitor whether the remaining energy amount of the rechargeable battery 305 increases , and the distance between the current location and the registered home 606 after that time t 1 . if the remaining energy amount of the rechargeable battery 305 continuously decreases from t 1 to t 2 , which is the time after δt has elapsed , the stray status is determined . it can be determined that charging is not conducted for a long period indicates that the lead 101 is not connected with the collar of the pet . however , it is determined that the stray status is not present if the remaining energy amount increases , or the current location detected by the gps unit 302 enters within the stray determination zone 602 with the home 606 at its center even once from the time t 1 to the time t 2 . the case 3 assumes detecting a case where the pet involves in an accident in a dangerous zone 604 , is injured or dead , and cannot move . the dangerous zone 604 is registered as a combination of multiple circles in advance . the method for registering the individual circles is the same as the method for registering the stray determination zone 602 with the home as its center . the stray status is determined when the location detected by the gps unit 302 remains for more than a predetermined period , and stays in this dangerous zone . referring to fig1 and fig6 , description is provided . immediately after the electronic device attached to pet 106 detects the stray status , the electronic device attached to pet 106 uses the wireless data communication unit 301 to wirelessly transmit the location information detected by the gps unit 302 , the remaining energy amount detected by the interface circuit for charging 306 , identification information of the pet , and information on the current time along with a code or a message indicating that the stray status is present to a predetermined destination . then , the procedure moves to a phase 2 . the predetermined destination may be the terminal apparatus 112 in fig1 , the center 111 , or both of them . when the center 111 receives the abovementioned report indicating the stray status transmitted from the electronic device attached to pet 106 , it reads out image data recording the appearance of the pet , and the characteristics ( the type , the size , the color of the hair , and contact of the owner ) of the pet based on the identification information of the pet from a database . then , the center 111 automatically transmits an electronic mail with attached message indicating that the pet is searched for , and cooperation with the search is appreciated to a public health center , pet shops , and other owners of pets close to the location where the pet got lost . further , the center 111 automatically posts information the same as the content transmitted with this electronic mail to an electronic bulletin board related to pet search . as a result , the request for searching the pet is asked to a large number of people at an early stage of the stray status of the pet , and the possibility of finding the pet increases . further , when the center 111 transmits an appearance image of the pet as an image of a detection subject to a network system of surveillance cameras surveying outdoors , information on the location and the time of pets having an appearance similar to the appearance of the pet is automatically obtained . in addition , when the search for the pet is completed , the center 111 transmits the note of the completion of the search to the destinations to which information for the search was transmitted . then , the operation control parameters shown in fig7 are set to defaults . the defaults for p 3 , p 4 , p 7 , and p 8 are 0 . the electronic device attached to pet 106 wirelessly reports the location information detected by the gps unit 302 , the remaining energy amount detected by the interface circuit for charging 306 , the name of the pet , the information on the current time along with the code or the message indicating that the stray status is present to a predetermined destination at the interval of p 1 or each time after traveling a distance of p 2 according to the values of the operation control parameters while monitoring the incoming instruction of setting the operation control parameters through the wireless data communication unit 301 . when a searching person starts searching on the stage of the phase 1 or the phase 2 , the procedure moves to the phase 3 . the relationship between the stray pet and the searching person becomes the positional relationship between the searching person 601 and the pet in a case 4 , the searching person knows the location and the status of the pet , and wirelessly transmits the setting instruction of the operation control parameters for protecting the pet soon while keeping the operation control parameters p 3 and p 4 to zero so as to prevent the consumption of the battery . in this way , when the positional relationship between the searching person and the pet becomes that between the searching person 603 and the pet in the case 4 where the searching person enters in a near distance zone 600 , the procedure moves to a phase 4 . in the phase 4 , the searching person is so close to the pet that the searching person can see the pet with the naked eye , and can detect the guide sound and the guide light generated by the electronic device attached to pet 106 . thus , the searching person properly sets the operation control parameters p 3 , p 4 , p 5 , and p 6 , and also uses the guide sound and the guide light to search for the pet . when the pet is found , the search ends . the search also ends when the search is given up for some reason . when the search ends , the end of the search is reported through the terminal apparatus 112 to the destination to which the information on the stray status of the pet was transmitted , and the destination to which the search request was transmitted .

wearable devices that can be used to help track and prevent a stray or lost condition of a human or animal wearer . for example , when a lead used for taking a pet for a walk or leashing the pet to a place such as a kennel is pulled by the pet or a human during walk or while the pet is leashed , a portable electric power generator connected with the lead generates electricity using mechanical energy obtained by the pulling action . the electricity generated by the portable electric power generator is supplied for the electronic device attached to pet worn by the pet through a charging cable disposed along the lead inside or outside the lead , thereby charging a rechargeable battery inside the electronic device attached to pet . the electronic device attached to pet uses the electrical energy of the integrated battery to perform a predetermined operation . the electronic device attached to pet reports that the pet got away from a location where the owner exists and has gotten lost for a number of conditions .

referring to fig2 , a facemask 1 having an aromatic capsule provided by this invention comprises a mask body 10 having an outer cover layer 10 a and an inner cover layer 10 b , and a respective band 30 disposed at the two sides thereof for looping around the ears of the wearer . a bridge attachment piece 11 is disposed on the mask body 10 to enable the facemask 1 to be more closely fitted to the bridge of the nose of the wearer , such that the facemask is able to filtrate air efficiently . this invention is characterized by a plurality of aromatic capsules 20 provided with the mask body 10 , either within or outside the mask body 10 . most preferably , the plurality of aromatic capsules 20 is provided between the outer cover layer 10 a and the inner cover layer 10 b as shown in fig2 . alternatively , a fixer 22 in transverse bar shape for wrapping around and positioning the plurality of aromatic capsules 20 is placed between the outer cover layer 10 a and the inner cover layer 10 b through binding or stitching . the plurality of aromatic capsules 20 can be placed fixed at the two ends of the bridge attachment piece 11 or fixed adjacent to the nostrils . since the aromatic capsule 20 is small , the wearer &# 39 ; s breathing will not be affected . referring to fig3 and 4 , the aromatic capsule 20 is sealed ordinarily so as to prevent the aroma from dissipating . the material used for the capsules can be easily snapped open when pressed upon . each aromatic capsules 20 can further be filled with adsorbent 24 for adsorbing liquid fragrances . before wearing the facemask , the wearer presses the aromatic capsule 20 so that the fragrance contained in the aromatic capsule 20 starts its gradually release . since the material of the mask body 10 is also liquid absorbable , the closing part 26 of the aromatic capsule 20 , which is also the cracked part 26 when pressed , can be placed inside the facemask adjacent to the inner cover layer 10 b . when the aromatic capsule 20 is cracked , the fragrance is adsorbed by the inner cover layer 10 b of the mask body 10 as to be nearer to the wearer . the facemask having an aromatic capsule of this invention is not limited to the planar type facemasks . any type of facemask in which an aromatic capsule can be sandwiched between the layers of the facemask can use this invention . furthermore , the facemask having an aromatic capsule of this invention can contain a fragrance component able to adsorb and dissolve unfavorable odors . moreover , it can even contain sterilization components . when the conventional facemask collects sweat or other bodily fluids and is giving off unfavorable odors , the aromatic capsule 20 can be pressed to adsorb and dissolve the unfavorable odors to provide the wearer with a more pleasant smell , and thus making the wearer feel more comfortable and in better mood . moreover , because the fragrance is stored in the capsule to keep from dissipating , the storage life of this facemask is simultaneously prolonged . in addition , since breathing is somewhat affected when wearing the facemask , the aromatic capsule may contain revitalizing fragrance component such as mint , camphor or borneol to reinvigorate the wearer . for example , when operating surgeons have to wear facemasks for a long time and are unable to take them off , then they can press the aromatic capsule to reenergize themselves . alternatively , when riding a motorcycle , the wearer can press the aromatic capsule if they are feeling tired or unable to concentrate well . the invention may be embodied in other specific forms without departing from the sprit or essential characteristics thereof . the present embodiments are therefore to be considered in all respects as illustrative and not restrictive , with the scope of the invention being indicated by the appended claims rather than by the foregoing description and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein .

a facemask having an aromatic capsule has a mask body having an inner cover layer and an outer cover layer , at least one press - to - crack aromatic capsule held fixed within the inner cover layer and the outer cover layer , and is provided with fragrance therein , and two bands disposed at the two sides of the mask body .

preferred embodiments of the present invention will be described in detail with reference to the drawings . the present invention should not be construed as being limited by the following embodiments . fig1 shows a fluid container assembly using a plug holding extendable member of a pull type . in fig1 a fluid container ( 1 ) comprises a flexible vessel ( hereinafter referred to as a bag ) ( 3 ), a drug vial ( hereinafter referred to as a vial ) ( 5 ) as a drug container , and a connecting part ( 20 ). the bag ( 3 ) contains a liquid for dissolving or diluting a drug therein in a sterilizing condition and has a fluid communicating port ( 2 ) in an upper portion thereof . the vial ( 5 ) contains a solid drug therein in an aseptic condition and has a drug communicating port ( 4 ) in a lower portion thereof . the connecting part ( 20 ) connects the fluid communicating port ( 2 ) to the drug communicating port ( 4 ). the reference numeral ( 6 ) denotes a suspension member which is provided on the top of the vial ( 5 ) and is made of a soft polypropylene resin or the like . the reference numeral ( 7 ) denotes a fluid outlet which is provided in the lower portion of the bag ( 3 ). the bag ( 3 ) is made of a flexible material such as a soft vinyl chloride resin , a polyolefine resin , an ethylene vinyl acetate copolymer , or the like . it is preferred that the bag ( 3 ) is made of a polyolefine resin which has good chemical resistance and is eluted little . examples of the liquid for dissolving or diluting a drug contained in the bag ( 3 ) include a physiological saline solution , a 5 % glucose solution , distilled water for infusion , a solution containing various electrolytes , and the like . the vial ( 5 ) ( container body ) is made of a known glass or plastic , and contains a solid drug therein . examples of a drug contained in the vial ( 5 ) include an antibiotics , an antitumor agent , an antiulcer agent and the like . as an antibiotics , there can be used cephem antibiotics such as cefazolin sodium , ceftizoxime sodium , cefotiam dihydrochloride , cefmenoxime hemihydrochloride , cefacetrile sodium , cefamandole sodium , cefaloridine , cefotaxime sodium , cefotetan sodium , cefoperazone sodium , cefsulodin sodium , ceftezole sodium , cefpiramide sodium , cefmetazole sodium , or cefuroxime sodium ; or penicillin antibiotics such as ampicillin sodium , carbenicillin disodium , sulbenicillin disodium , or ticarcillin sodium . as an antitumor agent , mitomycin c , fluorouracil , tegafur , cytarabine , etc . can be used . as an antiulcer agent , famotidine , ranitidine hydrochloride , cimetidine , etc . can be used . the connecting part ( 20 ) includes an integral rubber plug ( 8 ) and a bellows tube ( 9 ). the rubber plug ( 8 ) is removably fitted into the fluid communicating port ( 2 ) and the drug communicating port ( 4 ). the bellows tube ( 9 ) is made of a soft plastic , and serves as a plug holding movable member for connecting the outer periphery of the fluid communicating port ( 2 ) to that of the drug communicating port ( 4 ) and for supporting the rubber plug ( 8 ) therein . as shown in fig3 the rubber plug ( 8 ) has lower and upper portions ( 10 ) and ( 11 ) integrally bonded back to back through an intersecting portion ( 12 ). the lower portion ( 10 ) is fitted into the fluid communicating port ( 2 ). the upper portion ( 11 ) is fitted into the drug communicating port ( 4 ). the intersecting portion ( 12 ) is made of a soft plastic . each tip end of the intersecting portion ( 12 ) is supported integrally with an inner wall on the center of the bellows tube ( 9 ) by bonding or fusion . a fluid communicating path ( 13 ) is provided between the bellows tube ( 9 ) and the rubber plug ( 8 ). there will be described a method for using the fluid container assembly ( 1 ) having the above - mentioned structure . in fig1 and 2 , when the bag ( 3 ) and the vial ( 5 ) are pulled in the opposite directions ( shown by arrows a and b ), the rubber plug ( 8 ) can be unplugged from the fluid communicating port ( 2 ) and drug communicating port ( 4 ). consequently , the bag ( 3 ) can be communicated to the vial ( 5 ) through the fluid communicating port ( 2 ), drug communicating port ( 4 ) and fluid communicating path ( 13 ). when the bag ( 3 ) is intermittently compressed or the fluid container ( 1 ) is turned upside down , the liquid for dissolving or diluting a drug in the bag ( 3 ) goes to and from the vial ( 5 ) to dissolve the drug contained in the vial ( 5 ). consequently , a drug solution can uniformly be prepared in the fluid container assembly ( 1 ). before use , the outside of the bellows tube ( 9 ) may be held by a clamp ( 14 ) as shown in fig4 such that the rubber plug ( 8 ) is not unplugged from the communicating ports ( 2 ) and ( 4 ). in fig4 and 5 , the clamp ( 14 ) has such a structure that upper and lower fragments ( 15 ) and ( 16 ) are urged by a shaft ( 17 ) and a spring ( not shown ) in the holding direction . by fitting u - shaped portions ( 20 ) and ( 21 ) of the upper and lower fragments ( 15 ) and ( 16 ) in the neck portions ( flange portions ) of the vial ( 5 ) and bag ( 3 ) as shown in fig4 the bellows tube ( 9 ) can be prevented from extending . the reference numerals ( 18 ) and ( 19 ) denote handle portions of the clamp ( 14 ). fig6 shows a connecting part of a fluid container assembly using a plug holding extendable member of a rotary type as another embodiment of the present invention . in fig6 a connecting part ( 50 ) includes a bag plug ( 58 ), a vial plug ( 59 ), a plug holding member ( 57 ), an inner cylinder ( 56 ), an outer cylinder ( 55 ) and a packing ( 60 ). the bag plug ( 58 ) and vial plug ( 59 ) are removably fitted into a fluid communicating port ( 51 ) of a bag ( 53 ) and a drug communicating port ( 52 ) of a vial ( 54 ), respectively . the plug holding member ( 57 ) integrally holds the bag plug ( 58 ) and the vial plug ( 59 ). the inner cylinder ( 56 ) is fixed to the outer periphery of the drug communicating port ( 52 ). the outer cylinder ( 55 ) is fixed to the outer periphery of the fluid communicating port ( 51 ). the packing ( 60 ) is fixed to the outer cylinder ( 55 ) for sealing the inside of the connecting part ( 50 ). four projections ( 56a ) are provided on the outer periphery of the inner cylinder ( 56 ) and are fitted into grooves ( 55b ). the grooves ( 55b ) are provided on the inner periphery of the outer cylinder ( 55 ). four projections ( 57a ) are provided on the outer periphery of the plug holding member ( 57 ) and are fitted into grooves ( 56b ). the grooves ( 56b ) are provided on the inner periphery of the inner cylinder ( 56 ). the reference numeral ( 55a ) denotes a stopper for preventing the plug holding member ( 57 ) from rotating . two stoppers ( 55a ) are provided . fig8 is a section view taken along the line a -- a in fig6 and shows the relationships between the groove ( 55b ) and the projection ( 56a ) and between the groove ( 56b ) and the projection ( 57a ). fig9 is a section view taken along the line b -- b in fig6 and shows the relationship between the stopper ( 55a ) and the projection ( 57b ). as apparent from fig9 the plug holding member ( 57 ) does not rotate counterclockwise because the projection ( 57b ) is in contact with the stopper ( 55a ). fig1 is a section view taken along the line c -- c in fig6 and shows the shape of the groove ( 56b ). fig1 is a section view taken along the line d -- d in fig6 and shows the shape of the groove ( 55b ). there will be described a method for using the fluid container assembly provided with the connecting part ( 50 ) having the above - mentioned structure . in fig6 the outer cylinder ( 55 ) is fixed and the vial ( 54 ) is rotated counterclockwise when seen from above . as apparent from fig1 , the projection ( 56a ) of the inner cylinder ( 56 ) ascends the groove ( 55b ) so that the vial ( 54 ) is raised . as shown in fig9 however , the stopper ( 55a ) prevents the plug holding member ( 57 ) from rotating . as apparent from fig1 , even if the inner cylinder ( 56 ) ascends while rotating , the projection ( 57a ) of the plug holding member ( 57 ) is not moved . consequently , the plug holding member ( 57 ), bag plug ( 58 ) and vial plug ( 59 ) remain stationary . accordingly , the vial ( 54 ) and the inner cylinder ( 56 ) are raised so that the vial plug ( 59 ) is unplugged from the drug communicating port ( 52 ) first . further , when the vial ( 54 ) is rotated counterclockwise , the projection ( 56a ) of the inner cylinder ( 56 ) further ascends the groove ( 55b ) as seen from fig1 . consequently , the inner cylinder ( 56 ) is raised together with the vial ( 54 ). as a result , a horizontal groove portion ( 56c ) is fitted into the stationary projection ( 57a ) shown in fig1 . the horizontal groove portion ( 56c ) is provided on the lower right of the groove ( 56b ). furthermore , since the inner cylinder ( 56 ) is raised , the horizontal groove portion ( 56c ) of the groove ( 56b ) lifts up the projection ( 57a ). consequently , the plug holding member ( 57 ) formed integrally with the projection ( 57a ) is raised together with the bag plug ( 58 ). thus , the bag plug ( 58 ) is unplugged from the fluid communicating port ( 51 ). more specifically , when the vial ( 54 ) is rotated counterclockwise , it can be communicated to the bag ( 53 ). this state is shown in fig7 . while four projections ( 56a ) and four projections ( 57a ) are provided in the above - mentioned embodiment , three projections ( 56a ) and three projections ( 57a ) may be used . according to the fluid container assembly ( 1 ) described above , the number of parts can be decreased , and a drug solution can easily be prepared by pulling or rotating the vial ( 5 ) or ( 54 ) and the bag ( 3 ) or ( 53 ). when the rubber plug ( 8 ) [ bag plug ( 58 ) and vial plug ( 59 )] is unplugged from the drug communicating port ( 4 ) or ( 52 ) and the fluid communicating port ( 2 ) or ( 51 ), a drug can come in contact with a liquid for dissolving or diluting a drug through a preformed fluid communicating path and a fluid communicating path which is newly formed by unplugging the plug . consequently , the drug solution can surely be prepared . according to the present invention , a flexible vessel can be communicated to a drug container very surely and easily . furthermore , the number of parts can be decreased so that costs can be reduced .

a fluid container assembly including a flexible vessel containing a solvent or diluent and having a fluid communicating port in an upper portion thereof , a drug container containing a drug and having a drug communicating port in a lower portion thereof , and a connecting part for connecting the fluid communicating port of the flexible vessel to the drug communicating port of the drug container , wherein the connecting part includes a plug removably fitted into both the fluid communicating port and the drug communicating port and a plug holding extendable member for holding the plug while unplugging the same when assuming its extended position , the member connecting the outer periphery of the fluid communicating port to the outer periphery of the drug communicating port and defining a fluid communicating path .

in order to properly deliver ventricular resynchronization therapy , it is important to pace the ventricles to as great an extent as possible . if the pacemaker is operating in a synchronous mode where paces are inhibited by intrinsic activity , this can be brought about by optimal adjustment of pacing parameters such as the length of escape intervals . a clinician may properly set the parameters initially , but changes in the patient &# 39 ; s condition over time may render those parameter values inappropriate for optimally delivering resynchronization therapy . pacemakers typically collect diagnostic data over time which can be downloaded by an external programmer using a data link . this data includes counts of senses received from sensing channels and counts of paces delivered . in order to optimally configure the pacemaker for delivering resynchronization therapy , however , more information than that is needed . specifically , information is needed that enables a clinician to determine the reasons why paces are or are not being delivered . the present invention provides this by separately counting pacing events using isolated pace counters . pacemakers are typically implanted subcutaneously and have leads threaded intravenously into the heart to connect the device to electrodes used for sensing and pacing . a programmable electronic controller causes the pacing pulses to be output in response to lapsed time intervals and sensed electrical activity ( i . e ., intrinsic heart beats not as a result of a pacing pulse ). pacemakers sense intrinsic cardiac electrical activity by means of internal electrodes disposed near the chamber to be sensed . a depolarization wave associated with an intrinsic contraction of the atria or ventricles that is detected by the pacemaker is referred to as an atrial sense or ventricular sense , respectively . in order to cause such a contraction in the absence of an intrinsic beat , a pacing pulse ( either an atrial pace or a ventricular pace ) with energy above a certain pacing threshold is delivered to the chamber . [ 0013 ] fig1 shows a system diagram of a microprocessor - based pacemaker physically configured with sensing and pacing channels for both atria and both ventricles . the controller 10 of the pacemaker is a microprocessor which communicates with a memory 12 via a bidirectional data bus . the memory 12 typically comprises a rom ( read - only memory ) for program storage and a ram ( random - access memory ) for data storage . the pacemaker has atrial sensing and pacing channels comprising electrode 34 a - b , leads 33 a - b , sensing amplifiers 31 a - b , pulse generators 32 a - b , and atrial channel interfaces 30 a - b which communicate bidirectionally with microprocessor 10 . the device also has ventricular sensing and pacing channels for both ventricles comprising electrodes 24 a - b , leads 23 a - b , sensing amplifiers 21 a - b , pulse generators 22 a - b , and ventricular channel interfaces 20 a - b . in the figure , “ a ” designates one ventricular or atrial channel and “ b ” designates the channel for the contralateral chamber . in this embodiment , a single electrode is used for sensing and pacing in each channel , known as a unipolar lead . other embodiments may employ bipolar leads which include two electrodes for outputting a pacing pulse and / or sensing intrinsic activity . the channel interfaces 20 a - b and 30 a - b include analog - to - digital converters for digitizing sensing signal inputs from the sensing amplifiers and registers which can be written to by the microprocessor in order to output pacing pulses , change the pacing pulse amplitude , and adjust the gain and threshold values for the sensing amplifiers . an exertion level sensor 330 ( e . g ., an accelerometer or a minute ventilation sensor ) enables the controller to adapt the pacing rate in accordance with changes in the patient &# 39 ; s physical activity . a telemetry interface 40 is also provided for communicating with an external programmer 500 which has an associated display 510 . a pacemaker incorporating the present invention may possess all of the components in fig1 and be programmable so as to operate in a number of different modes , or it may have only those components necessary to operate in a particular mode . the controller 10 controls the overall operation of the device in accordance with programmed instructions stored in memory . the controller 10 controls the delivery of paces via the pacing channels , interprets sense signals from the sensing channels , implements timers for defining escape intervals and sensory refractory periods , and performs the pace counting functions as described below . it should be appreciated , however , that these functions could also be performed by custom logic circuitry either in addition to or instead of a programmed microprocessor . bradycardia pacing modes refer to pacing algorithms used to pace the atria and / or ventricles when the intrinsic atrial and / or ventricular rate is inadequate due to , for example , av conduction blocks or sinus node dysfunction . such modes may either be single - chamber pacing , where either an atrium or a ventricle is paced , or dual - chamber pacing in which both an atrium and a ventricle are paced . the modes are generally designated by a letter code of three positions where each letter in the code refers to a specific function of the pacemaker . the first letter refers to which heart chambers are paced and which may be an a ( for atrium ), a v ( for ventricle ), d ( for both chambers ), or o ( for none ). the second letter refers to which chambers are sensed by the pacemaker &# 39 ; s sensing channels and uses the same letter designations as used for pacing . the third letter refers to the pacemaker &# 39 ; s response to a sensed p wave from the atrium or an r wave from the ventricle and may be an i ( for inhibited ), t ( for triggered ), d ( for dual in which both triggering and inhibition are used ), and o ( for no response ). modern pacemakers are typically programmable so that they can operate in any mode which the physical configuration of the device will allow . additional sensing of physiological data allows some pacemakers to change the rate at which they pace the heart in accordance with some parameter correlated to metabolic demand . such pacemakers are called rate - adaptive pacemakers and are designated by a fourth letter added to the three - letter code , r . pacemakers can enforce a minimum heart rate either asynchronously or synchronously . in asynchronous pacing , the heart is paced at a fixed rate irrespective of intrinsic cardiac activity . there is thus a risk with asynchronous pacing that a pacing pulse will be delivered coincident with an intrinsic beat and during the heart &# 39 ; s vulnerable period which may cause fibrillation . most pacemakers for treating bradycardia today are therefore programmed to operate synchronously in a so - called demand mode where sensed cardiac events occurring within a defined interval either trigger or inhibit a pacing pulse . inhibited demand pacing modes utilize escape intervals to control pacing in accordance with sensed intrinsic activity . in an inhibited demand mode , a pacing pulse is delivered to a heart chamber during a cardiac cycle only after expiration of a defined escape interval during which no intrinsic beat by the chamber is detected . if an intrinsic beat occurs during this interval , the heart is thus allowed to “ escape ” from pacing by the pacemaker . such an escape interval can be defined for each paced chamber . for example , a ventricular escape interval can be defined between ventricular events so as to be restarted with each ventricular sense or pace . the inverse of this escape interval is the minimum rate at which the pacemaker will allow the ventricles to beat , sometimes referred to as the lower rate limit ( lrl ). in atrial tracking pacemakers ( i . e ., vdd or ddd mode ), another ventricular escape interval is defined between atrial and ventricular events , referred to as the atrio - ventricular interval ( avi ). the atrio - ventricular interval is triggered by an atrial sense or pace and stopped by a ventricular sense or pace . a ventricular pace is delivered upon expiration of the atrio - ventricular interval if no ventricular sense occurs before . atrial - tracking ventricular pacing attempts to maintain the atrio - ventricular synchrony occurring with physiological beats whereby atrial contractions augment diastolic filling of the ventricles . if a patient has a physiologically normal atrial rhythm , atrial - tracking pacing also allows the ventricular pacing rate to be responsive to the metabolic needs of the body . a pacemaker can also be configured to pace the atria on an inhibited demand basis . an atrial escape interval is then defined as the maximum time interval in which an atrial sense must be detected after a ventricular sense or pace before an atrial pace will be delivered . when atrial inhibited demand pacing is combined with atrial - triggered ventricular demand pacing ( i . e ., ddd mode ), the lower rate limit interval is then the sum of the atrial escape interval and the atrio - ventricular interval . another type of synchronous pacing is atrial - triggered or ventricular - triggered pacing . in this mode , an atrium or ventricle is paced immediately after an intrinsic beat is detected in the respective chamber . triggered pacing of a heart chamber is normally combined with inhibited demand pacing so that a pace is also delivered upon expiration of an escape interval in which no intrinsic beat occurs . such triggered pacing may be employed as a safer alternative to asynchronous pacing when , due to far - field sensing of electromagnetic interference from external sources or skeletal muscle , false inhibition of pacing pulses is a problem . if a sense in the chamber &# 39 ; s sensing channel is an actual depolarization and not a far - field sense , the triggered pace is delivered during the chamber &# 39 ; s physiological refractory period and is of no consequence . finally , rate - adaptive algorithms may be used in conjunction with bradycardia pacing modes . rate - adaptive pacemakers modulate the ventricular and / or atrial escape intervals based upon measurements corresponding to physical activity . such pacemakers are applicable to situations in which atrial tracking modes cannot be used . in a rate - adaptive pacemaker , for example , the lrl is adjusted in accordance with exertion level measurements such as from an accelerometer or minute ventilation sensor in order for the heart rate to more nearly match metabolic demand . the adjusted lrl is then termed the sensor - indicated rate . cardiac resynchronization therapy is pacing stimulation applied to one or more heart chambers in a manner that restores or maintains synchronized bilateral contractions of the atria and / or ventricles and thereby improves pumping efficiency . certain patients with conduction abnormalities may experience improved cardiac synchronization with conventional single - chamber or dual - chamber pacing as described above . for example , a patient with left bundle branch block may have a more coordinated contraction of the ventricles with a pace than as a result of an intrinsic contraction . in that sense , conventional bradycardia pacing of an atrium and / or a ventricle may be considered as resynchronization therapy . resynchronization pacing , however , may also involve pacing both ventricles and / or both atria in accordance with a synchronized pacing mode as described below . a single chamber may also be resynchronized to compensate for intra - atrial or intra - ventricular conduction delays by delivering paces to multiple sites of the chamber . it is advantageous to deliver resynchronization therapy in conjunction with one or more synchronous bradycardia pacing modes , such as are described above . one atrial and / or one ventricular pacing sites are designated as rate sites , and paces are delivered to the rate sites based upon pacing and sensed intrinsic activity at the site in accordance with the bradycardia pacing mode . in a single - chamber bradycardia pacing mode , for example , one of the paired atria or one of the ventricles is designated as the rate chamber . in a dual - chamber bradycardia pacing mode , either the right or left atrium is selected as the atrial rate chamber and either the right or left ventricle is selected as the ventricular rate chamber . the heart rate and the escape intervals for the pacing mode are defined by intervals between sensed and paced events in the rate chambers only . resynchronization therapy may then be implemented by adding synchronized pacing to the bradycardia pacing mode where paces are delivered to one or more synchronized pacing sites in a defined time relation to one or more selected sensing and pacing events that either reset escape intervals or trigger paces in the bradycardia pacing mode . multiple synchronized sites may be paced through multiple synchronized sensing / pacing channels , and the multiple synchronized sites may be in the same or different chambers as the rate site . in bilateral synchronized pacing , which may be either biatrial or biventricular synchronized pacing , the heart chamber contralateral to the rate chamber is designated as a synchronized chamber . for example , the right ventricle may be designated as the rate ventricle and the left ventricle designated as the synchronized ventricle , and the paired atria may be similarly designated . each synchronized chamber is then paced in a timed relation to a pace or sense occurring in the contralateral rate chamber . one synchronized pacing mode may be termed offset synchronized pacing . in this mode , the synchronized chamber is paced with a positive , negative , or zero timing offset as measured from a pace delivered to its paired rate chamber , referred to as the synchronized chamber offset interval . the offset interval may be zero in order to pace both chambers simultaneously , positive in order to pace the synchronized chamber after the rate chamber , or negative to pace the synchronized chamber before the rate chamber . one example of such pacing is biventricular offset synchronized pacing where both ventricles are paced with a specified offset interval . the rate ventricle is paced in accordance with a synchronous bradycardia mode which may include atrial tracking , and the ventricular escape interval is reset with either a pace or a sense in the rate ventricle . ( resetting in this context refers to restarting the interval in the case of an lrl ventricular escape interval and to stopping the interval in the case of an avi .) thus , a pair of ventricular paces are delivered after expiration of the avi escape interval or expiration of the lrl escape interval , with ventricular pacing inhibited by a sense in the rate ventricle that restarts the lrl escape interval and stops the avi escape interval . in this mode , the pumping efficiency of the heart will be increased in some patients by simultaneous pacing of the ventricles with an offset of zero . however , it may be desirable in certain patients to pace one ventricle before the other in order to compensate for different conduction velocities in the two ventricles , and this may be accomplished by specifying a particular positive or negative ventricular offset interval . another synchronized mode is triggered synchronized pacing . in one type of triggered synchronized pacing , the synchronized chamber is paced after a specified trigger interval following a sense in the rate chamber , while in another type the rate chamber is paced after a specified trigger interval following a sense in the synchronized chamber . the two types may also be employed simultaneously . for example , with a trigger interval of zero , pacing of one chamber is triggered to occur in the shortest time possible after a sense in the other chamber in order to produce a coordinated contraction . ( the shortest possible time for the triggered pace is limited by a sense - to - pace latency period dictated by the hardware .) this mode of pacing may be desirable when the intra - chamber conduction time is long enough that the pacemaker is able to reliably insert a pace before depolarization from one chamber reaches the other . triggered synchronized pacing can also be combined with offset synchronized pacing such that both chambers are paced with the specified offset interval if no intrinsic activity is sensed in the rate chamber and a pace to the rate chamber is not otherwise delivered as a result of a triggering event . a specific example of this mode is ventricular triggered synchronized pacing where the rate and synchronized chambers are the right and left ventricles , respectively , and a sense in the right ventricle triggers a pace to the left ventricle and / or a sense in the left ventricle triggers a pace to the right ventricle . as with other synchronized pacing modes , the rate chamber in a triggered synchronized pacing mode can be paced with one or more synchronous bradycardia pacing modes . if the rate chamber is controlled by a triggered bradycardia mode , a sense in the rate chamber sensing channel , in addition to triggering a pace to the synchronized chamber , also triggers an immediate rate chamber pace and resets any rate chamber escape interval . the advantage of this modal combination is that the sensed event in the rate chamber sensing channel might actually be a far - field sense from the synchronized chamber , in which case the rate chamber pace should not be inhibited . in a specific example , the right and left ventricles are the rate and synchronized chambers , respectively , and a sense in the right ventricle triggers a pace to the left ventricle . if right ventricular triggered pacing is also employed as a bradycardia mode , both ventricles are paced after a right ventricular sense has been received to allow for the possibility that the right ventricular sense was actually a far - field sense of left ventricular depolarization in the right ventricular channel . if the right ventricular sense were actually from the right ventricle , the right ventricular pace would occur during the right ventricle &# 39 ; s physiological refractory period and cause no harm . as mentioned above , certain patients may experience some cardiac resynchronization from the pacing of only one ventricle and / or one atrium with a conventional bradycardia pacing mode . it may be desirable , however , to pace a single atrium or ventricle in accordance with a pacing mode based upon senses from the contralateral chamber . this mode , termed synchronized chamber - only pacing , involves pacing only the synchronized chamber based upon senses from the rate chamber . one way to implement synchronized chamber - only pacing is to pseudo - pace the rate chamber whenever the synchronized chamber is paced before the rate chamber is paced , such that the pseudo - pace inhibits a rate chamber pace and resets any rate chamber escape intervals . such pseudo - pacing can be combined with the offset synchronized pacing mode using a negative offset to pace the synchronized chamber before the rate chamber and thus pseudo - pace the rate chamber , which inhibits the real scheduled rate chamber pace and resets the rate chamber pacing escape intervals . one advantage of this combination is that sensed events in the rate chamber will inhibit the synchronized chamber - only pacing , which may benefit some patients by preventing pacing that competes with intrinsic activation ( i . e ., fusion beats ). another advantage of this combination is that rate chamber pacing can provide backup pacing when in a synchronized chamber - only pacing mode , such that when the synchronized chamber pace is prevented , for example to avoid pacing during the chamber vulnerable period following a prior contraction , the rate chamber will not be pseudo - paced and thus will be paced upon expiration of the rate chamber escape interval . synchronized chamber - only pacing can be combined also with a triggered synchronized pacing mode , in particular with the type in which the synchronized chamber is triggered by a sense in the rate chamber . one advantage of this combination is that sensed events in the rate chamber will trigger the synchronized chamber - only pacing , which may benefit some patients by synchronizing the paced chamber contractions with premature contralateral intrinsic contractions . an example of synchronized chamber - only pacing is left ventricle - only synchronized pacing where the rate and synchronized chambers are the right and left ventricles , respectively . left ventricle - only synchronized pacing may be advantageous where the conduction velocities within the ventricles are such that pacing only the left ventricle results in a more coordinated contraction by the ventricles than with conventional right ventricular pacing or biventricular pacing . left ventricle - only synchronized pacing may be implemented in inhibited demand modes with or without atrial tracking , similar to biventricular pacing . a left ventricular pace is then delivered upon expiration of the avi escape interval or expiration of the lrl escape interval , with left ventricular pacing inhibited by a right ventricular sense that restarts the lrl escape interval and stops the avi escape interval . in the synchronized modes described above , the rate chamber is synchronously paced with a mode based upon detected intrinsic activity in the rate chamber , thus protecting the rate chamber against paces being delivered during the vulnerable period . in order to provide similar protection to a synchronized chamber or synchronized pacing site , a synchronized chamber protection period ( scpp ) may be provided . ( in the case of multi - site synchronized pacing , a similar synchronized site protection period may be provided for each synchronized site .) the scpp is a programmed interval which is initiated by sense or pace occurring in the synchronized chamber during which paces to the synchronized chamber are inhibited . for example , if the right ventricle is the rate chamber and the left ventricle is the synchronized chamber , a left ventricular protection period lvpp is triggered by a left ventricular sense which inhibits a left ventricular pace which would otherwise occur before the escape interval expires . the scpp may be adjusted dynamically as a function of heart rate and may be different depending upon whether it was initiated by a sense or a pace . the scpp provides a means to inhibit pacing of the synchronized chamber when a pace might be delivered during the vulnerable period or when it might compromise pumping efficiency by pacing the chamber too close to an intrinsic beat . in the case of a triggered mode where a synchronized chamber sense triggers a pace to the synchronized chamber , the pacing mode may be programmed to ignore the scpp during the triggered pace . alternatively , the mode may be programmed such that the scpp starts only after a specified delay from the triggering event , which allows triggered pacing but prevents pacing during the vulnerable period . in the case of synchronized chamber - only synchronized pacing , a synchronized chamber pace may be inhibited if a synchronized chamber sense occurs within a protection period prior to expiration of the rate chamber escape interval . since the synchronized chamber pace is inhibited by the protection period , the rate chamber is not pseudo - paced and , if no intrinsic activity is sensed in the rate chamber , it will be paced upon expiration of the rate chamber escape intervals . the rate chamber pace in this situation may thus be termed a safety pace . for example , in left ventricle - only synchronized pacing , a right ventricular safety pace is delivered if the left ventricular pace is inhibited by the left ventricular protection period and no right ventricular sense has occurred . as noted above , synchronized pacing may be applied to multiple sites in the same or different chambers . the synchronized pacing modes described above may be implemented in a multi - site configuration by designating one sensing / pacing channel as the rate channel for sensing / pacing a rate site , and designating the other sensing / pacing channels in either the same or the contralateral chamber as synchronized channels for sensing / pacing one or more synchronized sites . pacing and sensing in the rate channel then follows rate chamber timing rules , while pacing and sensing in the synchronized channels follows synchronized chamber timing rules as described above . the same or different synchronized pacing modes may be used in each synchronized channel . ventricular rate regularization ( vrr ) is a ventricular pacing mode in which the lrl of the pacemaker is dynamically adjusted in accordance with a detected intrinsic ventricular rate . when a pacemaker is operating in a ventricular pacing mode ( e . g ., vvi or ddd ), intrinsic ventricular beats occur when the instantaneous intrinsic rate rises above the lrl of the pacemaker . thus , paces are interspersed with intrinsic beats , and the overall ventricular rhythm as a result of both paces and intrinsic beats is determined by the lrl and the mean value and variability of the intrinsic ventricular rate . vrr regularizes the overall ventricular rhythm by adjusting the lrl of the pacemaker in accordance with changes in the measured intrinsic rate . resynchronization therapy is only as effective as to the extent to which paces are delivered and not inhibited by intrinsic activity . in order to provide a clinician with diagnostic information enabling proper adjustment of pacing parameters to optimally deliver cardiac resynchronization therapy , data needs to be collected by the pacemaker which reflects the events responsible for causing paces to be delivered or inhibited over a period of time . in accordance with the present invention , isolated pace counters are provided for separately counting different pacing events in each pacing channel . depending upon the pacing mode which is being used , separate counters are provided for separately counting paces due to expiration of different escape intervals and triggering events . in a ventricular resynchronization pacing mode , for example , counters are provided for separately counting paces delivered to rate ventricular rate chamber due to expiration of a ventricular escape interval corresponding to the lower rate limit setting and due to expiration of the atrio - ventricular interval in an atrial tracking mode . separate counters are also provided to count paces delivered to the rate and / or synchronized ventricles that are triggered by ventricular senses in a ventricular triggered mode . separate counts of senses from each sensing channel may be also maintained . [ 0038 ] fig2 through 5 illustrate examples of how the separate pace counters can be used for diagnostic purposes in order to optimally deliver ventricular resynchronization therapy . each figure shows the sense and pace counts as they would be collected by non - separated counters , and the same data as reflected by isolated counters in accordance with the invention . the counts are shown for sensing and pacing events in each ventricular sensing / pacing channel . in all cases , the counts are presented as a percentage of total cardiac cycles . [ 0039 ] fig2 shows exemplary counts collected by a pacemaker operating in an atrial tracking mode with one ventricular sensing / pacing channel . it is desirable in such a situation that ventricular paces should track the atria as much as possible . the non - separated counter column shows that the ventricle is being 100 % paced . however , the isolated counters reveal that the reason for the ventricular pacing is all due to expiration of the lrl escape interval . this indicates that the lrl setting is inappropriately programmed in order for the pacing rate to be controlled by intrinsic atrial activity . [ 0040 ] fig3 shows another example of data collected by a pacemaker with one sensing / pacing channel operating in an atrial tracking mode . the non - separated counters indicate that the ventricles are being 100 % paced , which is what is desired in ventricular resynchronization pacing . however , the separated pace counters reveal that many of the ventricular paces are not occurring at the expiration of the atrio - ventricular interval indicating too high an atrial rate , the effect of vrr , or other condition interfering with proper av sequential pacing . [ 0041 ] fig4 shows data collected by a pacemaker with right and left ventricular sensing channels operating in a left ventricular - only pacing mode that includes ventricular rate regularization and biventricular triggering . fig5 shows the same data as in fig4 but presented to show the total pace counts due to all events for each ventricular channel and separate counts for each type of pacing event expressed as a percentage of the total paces in that channel . in this example , what is desired is left ventricular pacing due to expiration of the lrl ventricular escape interval . the non - separated counters show that the left ventricle is paced frequently , but not at the ideal of 100 %. also , the percentage of right ventricular paces is quite high , and it is clear that this is due to frequent left ventricular senses occurring ( i . e ., right ventricular safety paces are being delivered ). the separated counters help to diagnose the situation . the right ventricular counters reveal that there has been a right ventricular safety pace on 25 % of the cycles which indicated oversensing of the left ventricle . the right ventricular counters also show that 60 % of the cycles were triggered right ventricular paces , while the left ventricular counters show that only 45 % of the cycles had a triggered left ventricular pace . this further indicates a left ventricular oversensing situation . finally , it can be seen that only 15 % of the cycles were of the type desired , a left ventricular pace due to expiration of the lrl escape interval . the above - described embodiments dealt with ventricular resynchronization pacing modes in which the right and left ventricles were designated as the rate and synchronized chambers , respectively . embodiments may similarly be constructed in which contralateral heart chambers are designated as the rate and synchronized chambers or in which a plurality of synchronized channels are utilized to provide synchronized pacing to multiple sites of a single chamber . in each of these cases , separate counters may be maintained for each sensing / pacing channel . although the invention has been described in conjunction with the foregoing specific embodiment , many alternatives , variations , and modifications will be apparent to those of ordinary skill in the art . such alternatives , variations , and modifications are intended to fall within the scope of the following appended claims .

a system and method recording sensing and pacing events in a cardiac rhythm management device . the method may be particularly useful in assessment of pacing parameters for ventricular resynchronization therapy .

now , a height adjusting apparatus for a suction brush of an upright vacuum cleaner according to a preferred embodiment of the present invention will be described in detail with reference to the annexed drawings . [ 0038 ] fig5 is a perspective view of a vacuum cleaner with an inlet unit according to the present invention . as shown in fig5 a vacuum cleaner 100 is comprised of a cleaner body 101 in which a vacuum generating unit ( not shown ) is mounted , an inlet pipe assembly 102 coupled to the cleaner body 101 and an inlet unit 110 coupled to the inlet pipe assembly 102 so as to suck foreign substance from an outside . the inlet pipe assembly 102 comprises a flexible pipe 104 coupled to an inlet port 106 of the cleaner body 101 , an inlet pipe 105 coupled to a rear portion of the inlet unit 110 and an handle pipe 105 interposed between the flexible pipe 104 and the inlet pipe 105 . [ 0039 ] fig6 is an enlarged view of a main part of fig5 showing the inlet unit according to the present invention , and fig7 is an exploded perspective view of fig6 and fig8 is a lower perspective view of fig7 . the inlet unit 110 includes an inlet main body 120 coupled to the inlet pipe 105 of the vacuum cleaner 100 , and an auxiliary inlet body 150 which is expandable / contractible and simultaneously rotatable with respect to the inlet main body 120 . the inlet main body 120 is connected via a first connecting pipe 116 and a second connecting pipe 117 to the inlet pipe 105 . the first and second connecting pipes 116 and 117 are connected with each other so as to be relatively rotated . the inlet main body 120 is provided with a main casing 121 and a center body 141 disposed in the main casing 121 . as shown in fig9 and 10 , the center body 141 is provided with a hinge rib 143 forming a rotational shaft of the auxiliary inlet body 150 , and a dust outlet port 142 opened in a rear direction thereof . the hinge rib 143 is formed with a dust inlet port 146 opened downwardly . an air passing portion 145 is formed at an outer surface of the hinge rib 143 . the main casing 121 is comprised of a lower case 123 and an upper cover 122 . the lower case 123 is formed with a center portion 131 in which the center body 141 is disposed , and a pair of wing portions 124 and 124 ′ that are extended from both sides of the center portion 131 . in the center portion 131 , there is formed an air path 134 in a front - rear direction . at a front end of the air path 134 , there is formed a body mounting portion 132 in which the center body 141 is disposed , and at a rear end thereof , there is formed a pipe coupling portion 133 in which the second connecting pipe 117 is coupled . therefore , the foreign substance discharged to the dust outlet portion 142 of the center body 141 is flowed along the air path 134 , and then introduced through the second connecting pipe 117 into the inlet pipe 105 . inclined surfaces 126 , 126 ′ that are inclined at a desired angle in a rear direction are formed at the wing portion 124 , 124 ′ of the lower case 123 . at a center area of a bottom surface of the wing portion 124 , 124 ′, there are formed a guide groove 125 , 125 ′ forming an arc with the hinge rib 143 of the center body 141 in the center . guide protrusions 166 , 166 ′ protruded upward on a rotational brush 161 , 161 ′ of the auxiliary inlet body 150 are received in the guide groove 125 , 125 ′. the guide protrusions 166 , 166 ′ guide a rotation of the rotational brush 161 , 161 ′, while moving along the guide groove 125 , 125 ′. at this time , the inclined surfaces 126 , 126 ′ function to restrict an excessive rotation of the rotational brush 161 , 161 ′, when the rotational brushes 161 , 161 ′ are contacted with , for example , a wall of a room or furniture , etc . spring protrusions 127 , 127 ′ are formed on the bottom surface of the wing portion 124 , 124 ′ of the lower case 123 to be protruded upward . preferably , the spring protrusions 127 , 127 ′ are formed between the guide groove 125 , 125 ′ and the hinge rib 143 . torsion springs 135 , 135 ′ are inserted onto the spring protrusion 127 , 127 ′. each of the torsion springs 135 , 135 ′ is fixed to the wing portion 124 , 124 ′ at one end , while fixed by the other end to each guide protrusion 166 , 166 ′ formed on the rotational brushes 161 , 161 ′. therefore , the rotational brushes 161 , 161 ′ rotatably supported by the wing portion 124 , 124 ′ can be returned to an original position thereof by an elastic force of the torsion spring 135 , 135 ′, as described below . [ 0044 ] fig1 is an enlarged perspective view showing a coupled state of the auxiliary inlet body of fig7 and fig1 is a cross - sectional view taken along a line i - i of fig1 , and fig1 is a cross - sectional view taken along a line ii - ii of fig1 . the auxiliary inlet body 150 is provided with a pair of rotational brush 161 , 161 ′ and a pair of extension brush 171 , 171 ′ that is extendably and contractibly received in the rotational brush 161 , 161 ′. in the drawings , only the rotational brush 161 and the extension brush 171 are shown , and hereinafter , it will be described centering on them the rotational brush 161 is comprised of a hinge portion 163 coupled to the hinge rib 143 of the center body 141 , and a rotational body 162 extended from the hinge portion 163 in a radial direction . the rotational body 162 is in the form of a rectangular box , and has an opening 167 at an end opposite to the hinge portion 163 . in a bottom surface of the rotational body 162 , there is formed an auxiliary inlet port 168 that is protruded upward . the auxiliary inlet port 168 is extended along a length of the rotational body 162 , and one end of the auxiliary inlet port 168 is communicated with the dust inlet port 146 of the center body 141 . the guide protrusion 166 ( referring to fig7 ) is protruded upward on an upper surface of the rotational body 162 so as to be inserted into guide groove 125 formed in the wing portion 124 of the main casing 121 . meanwhile , the hinge portion 163 is in the form of a ring , and rotatably coupled to an outer surface of the hinge rib 143 . the hinge portion 163 is formed at an upper portion of an end of the rotational body 162 so as to have a thickness corresponding to the half of a height of the rotational body 162 . and the hinge portion 163 ′ of another rotational brush 161 ′ is formed at a lower portion of an end of the corresponding rotational body 162 ′. therefore , as shown in fig1 , the hinge portions 163 and 163 ′ are overlapped on the outer surface of the hinge rib 143 . in addition , the hinge portion 163 ′ of the rotational brush 161 ′, which is disposed at a lower side of the other hinge portion 163 , is formed with a dust passing portion 165 on an outer surface thereof . the dust passing portion 165 serves to communicate the auxiliary inlet port 168 of the rotational brush 161 with the dust inlet port 146 of the center body 141 . as shown in fig1 , the hinge portions 163 , 163 ′, which are overlapped with each other on the outer surface of the hinge rib 143 of the center body 141 , are supported by a hinge cover 181 coupled to the hinge rib 143 at a lower side thereof . a hook 182 is formed at an upper end of the hinge cover 181 , and a hook slot 144 in which the hook 182 is coupled is formed at the hinge rib 143 . and since an air passing portion 185 is also formed at an outer surface of the hinge cover 181 , the auxiliary inlet port 168 , 168 ′ and the dust inlet port 146 are communicated with each other . meanwhile , the extension brush 171 is also in the form of a rectangular box , and received in the opening 167 of the rotational brush 161 . in a bottom surface of the extension brush 171 , there is also an auxiliary inlet port 178 . the auxiliary inlet port 168 of the rotational brush 161 32 is engaged with the auxiliary inlet port 178 of the extension brush 171 . therefore , the extension brush 171 can be slid in the length direction of the rotational brush 161 to be extended or contracted . the auxiliary inlet port 178 of the extension brush 171 is directly communicated with the dust inlet port 146 of the center body 141 in a contracted state , and communicated through the auxiliary inlet port 168 of the rotational brush 161 with the dust inlet port 146 in an extended state . a latching rib 177 that is protruded to the outside is formed at an outer end of the extension brush 171 . the latching rib 177 is contacted with an open surface of the rotational brush 161 , when the extension brush 171 is contracted in the rotational brush 161 . therefore , it is prevented that the extension brush 171 is excessively contracted . as shown in fig1 , the extension brush 171 can be fixed to a desired position with respect to the rotational brush 161 by a leaf spring 191 and a plurality of latching jaws 192 . the leaf spring 191 is fixed to a spring groove 193 formed in an outer surface of the extension brush 171 . the plurality of latching jaws 192 are formed to be protruded inward along the length of the rotational brush 161 . the leaf spring 191 is engaged with the latching jaws 192 of the rotational brush 161 , when the extension brush 171 is extended or contracted . herein , the leaf spring 191 may be provided at the rotational brush 161 , and the latching jaws 192 may be provide at the extension brush 171 . on the upper surface of the extension brush 171 , there is formed a moving protrusion 196 , and on the upper surface of the rotational brush 161 , there is formed a moving guide 195 in the length direction of the rotational brush 161 . the moving protrusion 196 is received in the moving guide 195 and moved in the length direction of the rotational brush 161 . thus , the extension brush 171 can be smoothly slid to be extended or contracted with respect to the rotational brush 161 . herein , the moving protrusion 196 may be provided on the rotational brush 161 , and the moving guide 195 may be formed on the extension brush 171 . in order to assemble the inlet unit 110 as described above , firstly , the center body 141 is disposed at the lower case 123 of the main casing 121 . then , the hinge portions 163 and 163 ′ formed at the rotational brushes 161 and 161 ′ are coupled to the hinge rib 143 of the center body 141 in a status that the hinge portions 163 and 163 ′ are overlapped with each other . at this time , if an external force is applied upward from a lower side of the hinge portion 163 , 163 ′, the guide protrusion 166 , 166 ′ formed on the rotational brush 161 , 161 ′ can be received in the guide groove 125 , 125 ′ formed at the wing portion 124 , 124 ′ of the lower case 123 . in this situation , the hinge cover 181 is coupled to the hinge rib 143 of the center body 141 . then , the rotational brushes 161 , 161 ′ are supported by the hinge cover 181 and the wing portion 124 , 124 ′ of the lower case 123 so as to be rotatable in a left or right direction with the hinge rib 143 in the center . the torsion springs 135 , 135 ′ are coupled to the spring protrusion 127 , 127 ′ of the lower case 123 , and then , both ends of the torsion spring 135 , 135 ′ are respectively fixed to the bottom surface of the lower case 123 and the guide protrusion 166 , 166 ′ of the rotational brush 161 , 161 ′. at this time , both rotational brushes 161 and 161 ′ are disposed to be opposite to each other with the hinge rib 143 in the center by the elastic restoring force of the torsion spring 135 , 135 ′. then , the extension brushes 171 , 171 ′ are coupled to the rotational brush 161 , 161 ′. and at the same time or at another time , the second connecting pipe 117 connected with the first connecting pipe 116 is coupled to the pipe coupling portion 133 of the lower case 123 . if the upper cover 122 is coupled to an upper portion of the lower case 123 , the assembling process of the inlet unit 110 is completed . in this situation , the first connecting pipe 116 can be coupled to the inlet pipe 105 of the vacuum cleaner 100 . then , the vacuum cleaner is turned on , and as shown in fig1 , the corner of the room can be cleaned . that is , if the inlet unit 110 is pressed forward in a status that is disposed to be adjacent to both sidewalls 55 , the rotational brushes 161 , 161 ′ are rotated by the walls 55 . the extension brushes 171 , 171 ′ received in the rotational brushes 161 , 161 ′ can be properly extended so as to increase a cleaning area . meanwhile , the rotational brushes 161 , 161 ′ that are rotated with the hinge rib 143 of the center body 141 in the center are rotated no longer , when being contacted with a corner of both walls 55 . then , if the external force applied to the rotational brushes 161 , 161 ′, the rotational brushes 161 , 161 ′ are returned to the original position by the elastic force of the torsion spring . while the present invention has been described in detail , it should be understood that various changes , substitutions and alterations can be made hereto without departing from the spirit and scope of the invention as defined by the appended claims .

disclosed is an inlet unit of a vacuum cleaner . the inlet unit comprises an inlet body having a dust inlet port and removably coupled to an inlet pipe of the vacuum cleaner ; and an auxiliary inlet body coupled extendably and contractibly to the inlet body so as to variably cope with a corner having a desired angle , and having an auxiliary inlet port communicated with the dust inlet port in an extending and contracting direction . therefore , an suction area of the inlet unit can be properly increased or decreased so as to rapidly and simply perform a corner of a room . further , the sucked foreign substance is not held or fixed with the inlet portion .

it has now been found that acyclovir can be advantageously formulated in the form of a hydrophilic gel with ideal viscoelastic and mucoadhesive properties , using vehicles containing salts of hyaluronic acid and / or derivatives thereof , in combination with at least one polyacrylic polymer called carbopol ® or carbomer ®. the formulations of the invention are characterised by better release properties , better mucoadhesion properties , and lower leachability than known formulations available on the market . the viscosimetric properties of the gels according to the invention are also compatible with the manufacturing requirements ( workability , packaging ) and use requirements ( extrusion , spreadability ) of the product . the ha derivatives which can be used in the novel formulations of the invention are listed below : 2 . hyaff ®: esters of ha with alcohols in the aliphatic , arylaliphatic , cycloaliphatic , aromatic , cyclic and heterocyclic series , with a percentage of esterification which can vary , depending on the type and length of the alcohol used , from 0 . 1 to 100 % ( ep 216453 b1 ); 3 . hyadd ®: amides of ha with amines of the aliphatic , arylaliphatic , cycloaliphatic , aromatic , cyclic and heterocyclic series , with an amidation percentage of 1 to 10 %, preferably 4 % ( ep 1095064 b1 ); 4 . o - sulphated derivatives of ha up to the 4th degree of sulphation ( ep 0702699 b1 ); 5 . acp ®: inner esters of ha with an internal esterification percentage ranging between 0 . 5 and 10 %, and preferably 5 % ( ep 0341745 b1 ); 6 . ha deacetylates : they derive from deacetylation of the n - acetyl - glucosamine fraction with a deacetylation percentage preferably between 0 . 1 and 30 %, while all the carboxyl groups of ha can be salified with organic and / or inorganic bases ( ep1313772 b1 ); 7 . hyoxx ®: percarboxylated derivatives of ha obtained by oxidation of the primary hydroxyl of the n - acetyl - glucosamine fraction with a degree of percarboxylation of between 0 . 1 and 100 %. all the carboxyl groups of ha can be salified with organic and / or inorganic bases ( ep1339753 ). the ha used in this invention , as such or in the preparation of its derivatives , may derive from any source , e . g . extraction from cockscombs ( ep0138572 b1 ), fermentation ( ep0716688 b1 ), or a technological process . the salts of hyaluronic acid or derivatives thereof are preferably sodium salts of hyaluronic acid with a low molecular weight of between 80 , 000 and 300 , 000 da , depending on the source and manufacturing technique . hyaluronic acid with a molecular weight of between 90 , 000 and 230 , 000 da is preferably used . the salt of hyaluronic acid or derivatives thereof is present in the formulations according to the invention in the percentage by weight of between 0 . 1 and 1 %, preferably 0 . 2 %. the acrylic polymer is preferably carbopol ® 974p or carbopol ® 934p ( also called carbomer 974p and 934p respectively ), available on the market from bf goodrich , ohio usa , and is present in the formulations according to the invention in the percentage by weight of between 1 and 5 %, preferably 1 . 5 %. the percentage by weight of acyclovir can approx . range from 1 to 10 %, and is preferably 5 %. the formulations according to the invention contain conventional excipients compatible with the topical administration to the skin and mucous membranes . in addition to preservatives ( such as parabens ), the formulations can contain , for example , glycerol and propylene glycol as wetting agents , polyethylene glycol ( such as peg 400 ) as solubiliser of the active ingredient , and ph regulators such as triethanolamine . the applicant has surprisingly found that the therapeutic efficacy of the formulations of the invention is particularly advantageous due to the association between low molecular weight hyaluronic acid sodium salt and carbopol ® 974p or carbopol ® 934p , as it produces : 1 . a significant increase in the mucoadhesive properties of the formulations of the invention compared with the well - known commercial formulation of acyclovir cream ( zovirax ®); 2 . a significant increase in the cumulative amount of drug that permeates into the mucosa compared with acyclovir cream ; 3 . a significant increase in the release of the active ingredient compared with acyclovir cream ; 4 . a significant reduction in the percentage of drug removed from the skin / mucosa by means of physiological removal mechanisms compared with acyclovir cream (“ washability ” test ). the tests conducted to prove this finding were performed with formulations based on low molecular weight ha sodium salt ( mean molecular weight : 200 kd ) and high molecular weight ha sodium salt ( mean molecular weight : 1800 kd ), in association with carbopol for the release of the active ingredient acyclovir . hyaluronic acid sodium salt of fermentative origin with a low molecular weight ( lmw - ha ) of 90 - 230 kda ( mean molecular weight : 200 kda ), or ha sodium salt ( hmw - ha ) with a high molecular weight ( mean molecular weight : 1800 kda ), or the sulphated derivative of ha or the benzyl ester of ha used for the formulations reported below ( ha was not added for the control formulations ), was hydrated in bidistilled sterile water , after hot solubilisation of the preservatives methyl p - hydroxybenzoate and propyl p - hydroxybenzoate . peg 400 and carbopol ® 974p or 934p were added to the solution under magnetic stirring . after complete hydration of the carbopol ®, tea ( triethanolamine ) was added to buffer the polymer solution to ph 6 . 0 so that the carbopol ® gelled . glycerol , propylene glycol and finally acyclovir were then incorporated , still under stirring . the gel thus obtained was homogenised with an ultraturrax turbine stirrer ( t 25 janke & amp ; kunkel ika ®- labortechnick , g ) for 5 minutes at the speed of 13 , 500 rpm . two further controls were also prepared for formulation 4 by replacing : 1 . carbopol 974 p ( 1 . 5 % w / w ) with polycarbophil ( noveon ® aa - 1 ) ( 1 . 5 % w / w ), and lmw - ha ( 0 . 2 % w / w ) with hmw - ha with a molecular weight of 1 × 10 6 da ( 0 . 2 % w / w ), or 2 . replacing carbopol 974 p ( 1 . 5 % w / w ) with polycarbophil ( 1 % w / w ) and lmw - ha ( 0 . 2 % w / w ) with hmw - ha with a molecular weight of 1 × 10 6 da ( 0 . 15 % w / w ), and adding polyvinyl alcohol ( mw 30000 - 70000 ) ( sigma - aldrich ) ( 1 . 5 % w / w ). these two controls are designed to perform specific mucoadhesion tests by comparison with formulation 4 to demonstrate that the topical compositions according to the invention are more effective than those of the prior art . mucoadhesion was measured with a tensile stress tester ( ferrari m . c . et al ., 1996 , drug dev . ind . pharm . 22 : 1223 - 1230 ). the equipment , assembled on a support with a horizontal base , consisted of a load cell with a linearity interval of 0 - 20 n and sensitivity of ± 4 mn , integral with a mobile carriage and connected to a personal computer ( ibm at , ibm , i ) via an amplifier . a motor fitted with a speed transformer moves a screw which , as it advances , pushes the load cell forward : the movement imparted by the motor is thus transmitted to the mobile carriage through the load cell . 100 mg of each formulation was applied to a filter paper disc with a diameter of 16 mm ( in the case of fig2 ) or 30 mm ( in the case of fig5 ), which was glued to the mobile carriage . a second filter paper disc , of the same diameter , was fixed to the sample holder , and the porcine vaginal mucosa was glued to it with acrylic glue . the mobile carriage was placed in contact with the sample holder , and a pre - load of 2500 mn was applied to it . after 3 minutes the pre - load was removed and the carriage moved at a speed of 4 mm / min , until the interface between film and mucosa had completely separated . the movement values and adherence force values obtained from the load cell were acquired and recorded by the computer . a force / movement curve was then constructed , from which the mucoadhesion work parameter was obtained , calculated by the trapezoid rule , as the area underlying the force / movement curve . a franz diffusion cell with a 20 mm diameter opening was used for the permeation measurements . the permeation was measured with porcine vaginal mucosa preserved in isotonic phosphate buffer at ph 7 . 4 until the time of use . the whole mucosa was used , without thinning , so as not to damage the epithelium . 100 mg of each formulation was placed on a circular area of mucosa ( diameter 25 mm ), which was positioned on an absorbent paper disc to separate the donor compartment from the receptor compartment . an isotonic buffer at ph 7 . 4 was placed in the receptor compartment to thermostat the mucosa and keep it hydrated . the permeation test was conducted for 5 . 5 hours . at the end of the test , the tissue was frozen at − 20 ° c . the tissue was then cut into slices 40 μm thick with a cryostat ( leica cm 1510 , leica microsystems , i ). the drug which had permeated the various layers of tissue was extracted according to the method described in volpato n . m . et al ., 1997 , j pharm . biomed anal , 16 : 515 - 520 , and assayed by the hplc method . the amount of drug in relation to the depth of the tissue , and the total amount of drug recovered from the mucosa , were evaluated . six replications were performed for each sample . the franz diffusion cell had to be modified in order to perform the washability measurements . the donor compartment used for these measurements was equipped with two side arms to allow the entry and exit of the acetate buffer at ph 5 . 0 , thermostated at 37 ° c ., at a flow rate of 0 . 2 ml / min , to simulate the vaginal secretions . the donor compartment has an air vent at the tip , which is closed by a screw at the compartment - filling stage . porcine vaginal mucosa approx . 1 cm thick , stored at − 20 ° c ., was used as biological substrate . after thawing , the mucosa was laid on a dialysis membrane ( cut - off 12 - 14 kd ) and positioned in the donor compartment . 100 mg of each formulation was then placed on a 2 cm 2 area of mucosa . the receptor compartment containing isotonic phosphate buffer at ph 7 . 4 was used for the sole purpose of keeping the mucosa hydrated and thermostated at the temperature of 37 ° c . the backflow sample from the donor compartment was collected in a beaker fitted with a magnetic stirring system . 1 ml of backflow buffer was taken up from the beaker at pre - set times ( 30 minutes ) for a total of 5 . 5 hours , and replaced with 1 ml of fresh buffer . the total amount of drug “ washed away ” was measured by spectrophotometry , as described in the release test . the release test was performed with a franz diffusion cell with a 20 mm diameter opening . the system , consisting of an upper donor compartment and a lower “ receptor ” compartment with a volume of 10 ml , was thermostated with an external jacket at the temperature of 37 ° c . acetate buffer at ph 5 . 0 was used as receptor phase to imitate the vaginal environment . the buffer was degassed before use and stirred during the measurements at a constant speed with a magnetic anchor . the two compartments were separated by a dialysis membrane with a 12 - 14 kd cut - off . the dialysis membrane was boiled in distilled water for 10 minutes before use and then spread over the opening of the receptor compartment , taking care not to trap air during the operation . 100 mg of the formulations tested was applied to a filter paper disc with a constant area ( 2 cm 2 ), which was laid on the dialysis membrane wetted with the receptor phase to prevent air from being trapped between the two surfaces . the donor compartment was fixed to the receptor compartment with a clip . the upper opening of the donor compartment was closed by a waterproof membrane . at pre - set intervals , for a total of 5 . 5 hours , 500 μl of receptor phase was taken up with a microsyringe from the centre of the receptor compartment through the sampling arm . the volume taken up was replaced with fresh solvent each time . the drug was assayed spectrophotometrically , after suitable dilution of the samples , at the wavelength of 252 nm . fig1 shows the permeation profiles ( in the different layers of the porcine vaginal mucosa ) of the acyclovir contained in formulations 1 - 4 and in the commercial formulation zovirax ®, compared with the respective control formulations measured at the end of the test ( 5 . 5 hours ). the amount of acyclovir assayed in the first layers relates to a thickness of 0 - 600 μm . slices with a depth of up to 5 mm were analysed . the drug was found in the different layers examined in all cases . the amount of drug measured tends to decrease with distance from the surface of the mucosa . formulation 4 produces a higher drug content in the tissue analysed than formulations 1 and 2 , which present almost identical distributions . the commercial formulation , formulation 3 containing high molecular weight ha , and control formulation paa 1 . 5 , present almost identical profiles , much inferior to the other formulations 1 , 2 and 4 . control formulation paa 0 . 75 has the lowest distribution profile of all . fig2 shows the mucoadhesion work values of formulations 1 - 4 and the commercial formulation . as will be seen , all the formulations present significantly higher mucoadhesion values than the commercial formulation . in particular , formulation 4 presents a much higher value than all the others examined , indicating that the formulation containing low molecular weight ha at the concentration of 0 . 2 %, in combination with 1 . 5 % paa , presents the best mucoadhesive properties . as previously described , topical formulations based on ha and synthetic polymers ( including faa ) were already known as controlled drug delivery systems . patent it1273742 discloses the use of various kinds of synthetic polymers , polycarbophil and polyvinyl alcohol being selected as the preferred polymers , in combination with ha with a high molecular weight of 1 × 10 6 da . to demonstrate that the formulations of the invention are better than known compositions , direct comparisons were conducted between formulation 4 ( which presents the best performance in terms of mucoadhesion , washability , release and permeation ) and two control formulations similar to formulation 4 but with the replacements described above relating to polycarbophil , the molecular weight of ha , and polyvinyl alcohol . fig5 shows the results obtained by comparing the mucoadhesion work of composition 4 with control formulations 1 and 2 , demonstrating its clear superiority in terms of mucoadhesion to the skin / mucosa . fig3 shows the mean acyclovir release profiles , obtained in acetate buffer ph 5 . 0 , for formulation 4 and the commercial formulation . it is evident that formulation 4 presents a release profile over time far superior to that of commercial formulation zovirax ®. fig4 shows the mean profiles of the acyclovir “ washed away ” by the formulations tested . formulation 4 only reaches the value of 90 % of drug “ washed away ” after 5 . 5 hours , whereas the commercial formulation is totally removed from the mucosa in the first hour after application . the tests conducted clearly demonstrate that the association between low molecular weight hyaluronic acid and carbopol 974p leads to the formation of highly hydrophilic gels which present the best performances in both the mucoadhesion test and the test of washability , permeation and release of active ingredient , not only compared with the commercial cream formulation zovirax ®, but also compared with formulations containing high molecular weight ha and formulations based on paa without ha . these properties are considered an invaluable index of stability of the drug acyclovir suspended in said new formulations : in fact , only the strong inner structure of the gel of the invention prevents sedimentation of the active ingredient . formulation 4 presents the best performance in terms of mucoadhesion , washability , release and permeation , demonstrating that its ratio between ha concentration ( 0 . 2 %) and carbopol concentration ( 1 . 5 %) is the best among those chosen . the formulation , due to its composition , is consequently able to prolong the release of the drug to the damaged skin / mucosa and to ensure that a larger amount of active ingredient is absorbed . the improved mucoadhesion also allows a lower frequency of administration compared with the cream formulation , with evident advantages of practicality and economy of treatment . the therapeutic efficacy of the formulations described above proved particularly advantageous due to the action of hyaluronic acid , which also facilitates healing of the ulcers created locally by viruses by keeping the damaged skin and mucous membranes highly hydrated . the new formulations therefore provide both therapeutic efficacy and the best reconstruction properties for the altered dermis and / or mucosa .

the invention relates to topical formulations in the form of a bioadhesive hydrophilic gel comprising acyclovir as active ingredient , sodium hyaluronate and an acrylic polymer . said formulations improve the local administration of acyclovir in the treatment of herpes infections , because they possess good properties of adherence to the mucosa and high resistance to physiological removal mechanisms .

the feasibility of selectively cooling biological tissues has been explored experimentally . infrared radiometry can be used to measure the thermal response of in vivo human skin to cooling by a cryogen spurt . one model assumes a two - layered semi - infinite medium consisting of skin in contact with a cold film whose thickness may change with time . the term &# 34 ; boundary layer &# 34 ; refers to a film of cryogenic material in contact with both air and skin . when cryogen is spurted onto the skin surface , skin temperature is reduced as a result of supplying the latent heat of vaporization . as the skin surface temperature approaches the boiling point of the cryogen , the rate at which cryogen droplets evaporate becomes less than the accumulation rate or cryogen on the surface . fig1 is a representative section view of a preferred embodiment of a cooling handpiece with refillable coolant reservoir of the present invention . fig2 is a representative detail section view of the distal end of a preferred embodiment of a cooling handpiece with removable coolant reservoir of the present invention . the handpiece 100 has a housing 101 with a proximal end 100a and a distal end 100b . a laser or other functional or interventional energy source ( not shown ) is connected to an energy delivery means 102 . energy delivery means 102 typically comprises a single optical fiber , e . g . 400 micron diameter , a fiber optic cable , a fiber bundle or other fiber optic laser delivery device . while the present invention may be fully operable and efficacious utilizing a co2 laser , it will be understood that the present invention is especially suited for use with those energy sources capable of being transmitted conveniently via optical fibers . these include white light , infrared energy , q - switched ruby lasers , flashlamp - pumped type pulsed dye lasers , nd : yag , holmium - type and other solid - state lasers in use and known currently or in the future . moreover , the handpiece may optionally utilize any other operative energy source or functional device , including infrared or ultraviolet , x - ray or radio frequency delivery means , coherent or non - coherent energy , ultrasound delivery means , mechanical cutting tools , drilling apparatus , etc ., or combination of the above . applications which induce a thermal effect in the tissue can be controlled using the handpiece of the present invention , and applications which utilize tissue cooling in their performance are all included within the scope of this invention . a distal end 104 of the energy delivery device 102 is fixed within the distal end 100b of the handpiece by sma connector 98 . the sma connector is threaded onto a nipple 96 which itself is threaded into housing 101 . an optional lens or other energy focusing device 106 is disposed adjacent the distal end 104 of the energy delivery device 102 , and threaded nipple 96 allows for manual adjustment and precise orientation of distal end 104 of energy delivery device 102 and focusing means 106 . it will be understood that a great variety of design factors must be considered and will be included in the scope of the present invention . providing focusing means either integral with or separate from the laser or other energy delivery means allows flexibility in treatment or coverage , allows creation of different spot sizes and other parameter optimization depending upon the application , e . g . wrinkle removal , collagen shrinking , collagen stimulation or synthesis , blanching of port wine stains , photoablation in a cutting or tissue removal application , etc . it will be understood that in other preferred embodiments the focusing lens 106 is optionally located elsewhere within the apparatus 100 , and in other preferred embodiments a plurality of focusing means are located at different positions within the apparatus 100 . a transparent delivery tube 108 is mounted adjacent the distal end 100b of the handpiece 100 in operative relationship with the distal end 104 of the energy delivery device 102 and the optional lens or other focusing device 106 . thus , laser or other energy which enters the delivery tube 108 radiates therefrom at distal end 110 . the length of the delivery tube may vary depending upon the desired spot size , the need to provide an extending tip and the type of laser delivery means used . the focusing means is also adjustable in preferred embodiments . typical laser delivery device delivery tubes such as those known as handpiece extenders , part nos . rd - 1100 and rd - 1200 made by spectrum medical technologies , inc . in natick , mass . are commercially available . the delivery tube 108 is preferably transparent and tubular , but can have a plurality of different cross sectional geometries . a preferred embodiment is about 4 - 5 centimeters in length , but can be longer or shorter , depending upon desired spot size , etc . adjacent the distal end 110 of the delivery tube 108 there is a coolant port 112 which directs coolant toward the distal end 110 and target tissue , as desired . the design of delivery tube 108 will prevent possible &# 34 ; fly - away &# 34 ; of ablated tissue , cells or blood , providing protection from cross contamination for other inhabitants and equipment in the operating room . the tube will also direct the fluid cryogen to specific areas conveniently . waste of cryogen and loss of containment thereof as well as the risk for unintended contact with the cryogen is also minimized thereby . an additional advantage of the delivery tube 108 of the present invention is to provide a means for marking the surface of the tissue which has been treated or visualized , etc . small pressure marks , indentations , or other markings , dyes , etc . can be formed or released by the distal end 110 of the delivery tube 108 . thus , in the example of wrinkle removal using laser energy , the surface of skin which is irradiated and cooled using cryogen or other coolant bears no immediate visual indication of having just been treated , and the operator is thus aided by the visual indications made by the distal end 110 of the delivery tube 108 . adjacent the proximal end 112 of the delivery tube 108 , air vent 114 allows air or other fluid or gas to be flushed across outer surface 107 of lens means 106 . in the absence of the vent 114 and flowing gas , other means may be used to prevent accumulation and consequential fogging or other distortion of focusing means 106 by condensation of water or other vapor on the outer surface 107 of focusing means 106 . such means could include means for heating the lens and preventing condensation of vapor thereon . providing a transparent delivery tube 108 also provides the physician or technician with an unobstructed view of the treatment in progress . preferred embodiments have enhanced transmitting features , including anti - reflection coatings to protect the internal optical system and eliminate the potential for energy backlash , and perpendicular positioning means which reduce the risk of reflected light which could otherwise create a vision hazard in the operating room . a thermal feedback system comprises a lens 120 for focusing a detected infrared output from the treated and / or cooled target tissue onto a thermal sensor 122 . such thermal sensor 122 can be any operative thermal sensor such as a thermopile , etc . a typical sensed output from cooled target tissue is radiation at about 10 microns , or more or less , and will be a function of the type of thermal sensor 122 selected . a feedback signal is transmitted via sensor output 124 to the central processing unit of the energy delivery device , such as an on - board controller for a laser system . as mentioned above , various control schemes , protocols and other methods are known to those skilled in the art and will additional and new ones will be apparent . the present invention is intended to provide a novel apparatus for effecting these protocols . such protocol might call for initial steps including laser operation and controller tests , delivery means integrity and connection tests , and thermally sensing the status of the target tissue . during operation , the temperature of the target tissue can be sensed continuously or at discrete time points . excessive precooling , simultaneous cooling and post - cooling of the target tissue can be avoided , thereby preventing tissue damage due to excessive cooling , and other thermal mediation of surface strata of the target tissue during thermal treatment of sub - surface strata , etc . fig3 is a representative section view of a preferred embodiment of a coolant reservoir 200 of the present invention . reservoir 200 consists of a cylindrical tubular outer wall 202 , an integrally formed sealed portion 204 at a proximal end 206 and a valve assembly 208 at a distal end 210 . the proximal end 206 can also be capped or closed with a removable portion so as to allow filling from either end . the valve assembly 208 comprises a valve actuator 212 and male threaded portion 214 , and is coupled to a plug portion 216 mounted within the distal end 210 of the reservoir 200 . sealing o - rings 218 are used between the tube 202 and the plug 216 , between the plug 216 and the valve assembly 208 , and adjacent the valve actuator 212 . reservoir chamber 220 contains a certain volume of cryogenic fluid or other coolant . in a preferred embodiment , the reservoir 200 consists of a tube 202 between about 0 . 25 and 1 . 0 inches in diameter , or narrower or wider , and between about 4 . 0 and 8 . 0 inches long , or shorter or longer , manufactured out of plastic , glass or other suitable material . in preferred embodiments , the reservoir 200 can be either refillable or replaceable . in the refillable embodiment , suitable nozzle cap or other fill means is provided on the reservoir 200 . in the replaceable embodiment , the reservoir is a disposable canister which can be purchased in advance and stocked at the hospital or clinic . a suitable attachment or mounting means is provided to conveniently , efficiently and safely remove an empty reservoir when empty and replace it with a full canister . the reservoirs have either threaded end fittings or bayonet - type locking means for providing a leak - proof , secure attachment between the reservoir 200 and rest of the handpiece 100 . it will be apparent to those skilled in the art that the disposable and replaceable coolant reservoirs 200 can be manufactured with a wide range of variation in attachment means , volume , shape and materials , all of which are included in the scope of this invention . in a preferred embodiment , the reservoir chamber 220 has a volume of between about 10 and 500 milliters , or more or less as may be desired or necessary for particular applications . freon and liquid co2 have been widely used cryogens and are well known in the field of cryosurgery . another appropriate cryogen spray would be 1 , 1 , 1 , 2 - tetrafluoroethane , c 2 h 2 f 4 , an environmentally compatible , non - toxic , non - flammable freon substitute . other cryogens , such as 134r ( also a freon substitute ), may also be used , and based upon this description will be apparent to those skilled in the art . fig4 is a representative section view of a preferred embodiment of a fluid level indicator adapter 250 of the present invention . as shown , reservoir 200 threads into female threaded portion which results in valve assembly 208 opening and allowing coolant to flow from reservoir chamber 220 through valve assembly 208 and through coolant channel 254 in body 256 of adapter 250 . channel 254 empties into sight glass chamber 260 which is visible through window 262 in body 256 of the adapter 250 and through window 117 of handpiece housing 102 . additional sealing o - rings 264 are shown . at the distal end 280 of the adapter 250 , optional valve assembly 270 comprising insert portion 272 and valve actuator 274 serves to seal the adapter at that end in the situation where the adapter 250 is removed from the handpiece 100 while a reservoir 200 &# 39 ; containing coolant is coupled thereto . at the proximal end 282 of the adapter 250 , adapter vent holes 222 allows venting of any coolant remaining in the sight glass chamber 260 during disassembly of the apparatus . a safe , redundant , security locking system between the coolant reservoir 200 and adapter 250 comprises a threaded portion 252 and corresponding threaded portion on reservoir 200 &# 39 ; and set screw 292 . it will be understood that the reservoir 200 can be mounted onto the adapter 250 either before or after the adapter 250 is coupled to the handpiece 100 . in either case , the adapter 250 slides into recess 103 in handpiece 100 such that insert portion 272 is disposed within receiving base 105 , and bayonet pin 290 engages pin slot 207 at the proximal end 100a of the handpiece 100 . it will be understood that the receiving recess 103 can be any operative mounting opening , slot , flange , area , pad , surface etc . additionally , set screw 292 can be threaded through the proximal end 282 of the adapter 250 so as to prevent release of the reservoir 200 from the bayonet mount of the adapter 250 . coolant is delivered from the reservoir 200 through controllable cryogen valve 307 . valve 307 can be a low - temperature solenoid - type valve which delivers spurts of cryogen as desired . common automotive or other industrial liquid fuel injectors can also be used . delivery of spurts between about 10 milliseconds and about 500 milliseconds in length are possible with various types of valves . typically , the solenoid - type valve 307 is able to withstand pressures of up to about 80 to 100 psi and temperatures as low as about - 30 to - 40 degrees celsius . after passing through the valve 307 , the cryogen is directed through channel 109 and into the delivery tube 108 at channel port 112 . controller wires 116 will actuate the valve means , as desired , allowing cryogen to flow into the delivery tube 108 . in a preferred embodiment , a spraying nozzle means is employed such that the cryogen is sprayed onto a preselected surface area in a predetermined pattern or at a predetermined flowrate , velocity , etc . as described above , various dynamic cooling protocols , methods and systems are well known for use with thermally mediated treatment of biological tissue and other materials . simultaneously or alternatingly , predetermined amounts of laser energy as well as cryogenic coolant can be delivered to the operating site precisely according to temperature and position sensors and on - board computing means associated with the laser source . controllers based upon theoretically - derived or actually measured operating parameter data will allow the physician or technician to maintain a predetermined thermal gradient or temperature profile throughout certain preselected tissue . these control schemes will be possible with the apparatus of the present invention and particular or individual control schemes for specific applications will be apparent to those skilled in the art . a preferred embodiment of the present invention includes a timing circuit to control according to predetermined operating parameters time and rate of laser energy delivery , time and rate of cryogen delivery , sequencing and overlap of those events with ablation , cooling periods , etc . other preferred embodiments of the present invention comprise temperature sensors located at various positions , such as at a distal end of the delivery tube . the temperature sensor will sense the temperature of either the tip of the delivery tube , the skin upon which the laser energy and the coolant are directed , or both . temperature probes and methods are well known in the art . such temperature sensors operate in a variety of different ways , including black - body type radiation sensors , thermocouples , thermometers , etc . the temperature sensor provides information to a controller with feedback control of the laser , coolant delivery switch , etc . a preferred embodiment of the present invention comprises a laser and / or cryogen interlock system . in the event the handpiece is held such that vapors in the reservoir are delivered before liquid , a substantial decrease in cooling effect is observable . venting of cryogen fumes is very inefficient relative to the degree of cooling which can be achieved using liquid cryogen . unless the surgeon is careful , during operation the handpiece can be manipulated in such a way as to tilt or turn the handpiece so that the liquid cryogen flows away from the solenoid or other flow valve . to prevent discharge of vapors , and sometimes more importantly , to prevent delivery of laser energy in the absence of sufficient coolant an interlock system is used . this system can be configured in a number of different ways , as will be apparent to those skilled in the art . mercury switches to prevent switch actuation at certain orientations are widely used . integrated circuits and other types of microprocessors or micro - devices are also available for such level control . such a device ensures adequate orientation , such as a vertical position , of the handpiece prior to delivery of laser energy . additionally , the interlock can be tied into a temperature sensor / control circuit . such a circuit ensures a suitably low temperature at the skin surface or at a distal point on the valve or delivery tube prior to permitting delivery of laser energy . another embodiment of the preferred embodiment measures fluid flow through the valve . such apparatus prevents delivery of laser energy until and unless fluid cryogen is flowing at a predetermined minimum rate . fig5 is a representative perspective view of a preferred embodiment of a cooling handpiece with refillable coolant reservoir of the present invention . at the proximal end 100a of the handpiece 100 there is a strain relief assembly 115 which encloses any or all of the following : the energy delivery means 102 , the output 124 from thermal sensor 122 , and controller lines 116 for actuating coolant flow . fig6 is a representative section view of another preferred embodiment of a coolant reservoir 200 &# 39 ; of the present invention . this reservoir 200 &# 39 ; has a built - in sight glass 262 &# 39 ; for determining remaining coolant volume . reservoir 200 &# 39 ; consists of a cylindrical tubular outer wall 202 &# 39 ;, an sealed portion 204 &# 39 ; at a proximal end 206 &# 39 ; and a valve assembly 208 &# 39 ; at a distal end 210 &# 39 ;. the proximal end 206 &# 39 ; can also be capped or closed with a removable portion so as to allow filling from either end . the valve assembly 208 &# 39 ; comprises a valve actuator 212 &# 39 ; and is coupled to a plug portion 216 &# 39 ; mounted within the distal end 210 &# 39 ; of the reservoir 200 &# 39 ;. sealing o - rings 218 &# 39 ; are used between the tube 202 &# 39 ; and the plug 216 &# 39 ;, between the plug 216 &# 39 ; and the valve assembly 208 &# 39 ;, and adjacent the valve actuator 212 &# 39 ;. remaining fluid volume can be determined by the operator or technician by looking through the sight glass window 262 &# 39 ; and through window 117 of handpiece body 102 . fig7 is a graph demonstrating the experimentally obtained temperature gradient through a portion of the skin without precooling as a function of both the wavelength of incident laser energy and the depth of laser radiation penetration . the graph demonstrates a change in temperature ( δt ) of about 60 degrees celsius and all curves are shown for the time point 1 millisecond following exposure to the laser energy . the graph shows three lines corresponding to laser wavelengths of 10 . 6 microns , 1 . 3 - 1 . 4 microns and 1 . 06 microns . fig8 is a graph demonstrating the temperature gradient through a portion of the skin with precooling as a function of both the wavelength of incident laser energy and the depth of laser radiation penetration . the graph demonstrates a change in temperature ( δt ) of about 60 degrees celsius . in these experiments , precooling of the skin surface tissue for a period of 20 milliseconds was conducted immediately prior to exposure to laser energy . all curves are shown for a time point 1 millisecond following exposure to the laser energy . the graph shows three lines corresponding to laser wavelengths of 10 . 6 microns , 1 . 3 - 1 . 4 microns and 1 . 06 microns . it will be understood that the parameters of time , cooling and exposure to laser energy may be varied manually or automatically , as desired . studies have shown that irradiating tissue with a midinfrared laser source through a surface thermal absorption element or heat sink permits an optimum thermal profile within the target tissue with near physiologic temperature at the surface of the irradiated surface thus minimizing surface thermal damage . in the case of desired thermal collagen shrinkage , this is clearly the desired condition . others have shown that attenuating the surface temperature before laser irradiation and therefore creating a boundary layer on the skin surface can result in selective cooling of the target tissue thus preserving the normal overlying epidermis . during a typical dynamic cooling process , the surface of the skin is pre - cooled to as low as 0 degrees celsius or lower , at a rate fast enough to cool the surface only but not dissipate heat from below about 400 - 500 microns below the surface . in a preferred embodiment , during the cooling step the target tissue remains at body temperature and is not cooled at all . for example , in laser - induced shrinkage of collagen tissue , by applying cooling to the surface of the skin for a short period of time , typically between about 5 and 100 milliseconds , and then delivering laser energy , the surface is initially cooled but the target tissue never is . generally , the surface layer of skin is rapidly cooled . a high rate of cooling will prevent proximal hypothermia and will also tend to have a numbing , anesthetic or analgesic effect . therefore , upon delivery of laser energy onto the surface and therethrough , the target tissue will be raised to the optimal thermal shrinkage temperature and generally not any higher , in an adequately rapid process . in a preferred embodiment of the method of the present invention , cooling and heating are performed in a predetermined timing sequence , optionally with the use of timer circuits and / or other controller means . with respect to studies performed removing sub - dermal skin lesions , such as port wine stains and other red or brown marks , an optimum cooling strategy might be one that uses a short spurt of cryogen ( e . g ., 5 - 20 ms ) to reduce the local temperature in the pigmented epidermis , while minimizing attenuation of the laser light by the boundary layer , followed by post - irradiation cooling spurt that provides a heat sink for dissipation of the epidermal heat generated by melanin absorption . the present invention includes and encompasses all of the above . 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 invention belongs . although any methods and materials similar or equivalent to those described can be used in the practice or testing of the present invention , the preferred methods and materials are now described . all publications and patent documents referenced in this application are incorporated herein by reference . the nd : yag , nd : yap and nd : yalo - type lasers are such sources of coherent energy . this wavelength of 1 . 3 - 1 . 4 microns is absorbed relatively well by water , and as a result is attractive for tissue interaction . it is also easily transmitted through a fiber optic delivery system as opposed to the rigid articulated arm required for the co 2 laser . very precise methods of controlling laser systems and optically filtering produced light currently exist . by selecting the appropriate combination of resonance optics and / or anti - reflection coatings , wavelengths in the range of 1 . 3 - 1 . 4 microns and even 1 . 32 - 1 . 34 microns can be produced . light transport in skin and other tissues is dominated by primary and secondary scattering events , rather than by optical absorption alone . lask g , et al . nonablative laser treatment of facial rhytides ; spie proc . 1997 ; 2970 : xxx . the concept of an &# 34 ; effective attenuation coefficient &# 34 ; μ eff ( in an exponential attenuation relation similar to beer &# 39 ; s law for absorption alone ) has been used traditionally to approximate the light fluence φ ( units : j / cm 2 ) within a tissue in which scattering is important : μ a is the absorption coefficient ( units : cm - 1 ), μ s is the scattering coefficient ( units : cm - 1 ), and g is the scattering anisotropy ( units : dimensionless ). welch a . j ., van gemert m . j . c . ( editors ), introduction to medical applications : optical - thermal response of laser - irradiated tissue . ( plenum press , new york , 1995 ), pp . 609 - 618 . light fluence φ is the energy ( units : j ) passing through a cross - sectional area ( units : cm 2 ) from all directions . it differs from the radiant exposure f ( units : j / cm 2 ) which we use in describing treatment parameters since f is the energy density directed onto the tissue surface from the light source . the fluence φ can be much larger than the radiant exposure f due to multiple scattering events -- see fig1 of welch et al . when the tissue is highly scattering , on the average many photon scattering events occur before the photon is ultimately absorbed . if the real light fluence distribution were represented by equation [ 1 ], the &# 34 ; effective optical absorption &# 34 ; as a function of depth z would mimic this exponential function and the &# 34 ; effective optical absorption coefficient &# 34 ; would be given by equation [ 2 ]. however , the real light fluence distribution is more complicated than equation [ 1 ] indicates and is best represented by a monte carlo modeling calculation which includes the effects of initial light distribution striking the tissue ( e . g ., collimated light at normal incidence , diffuse light at non - normal incidence , etc . ), the changes of index of refraction at the air / tissue interface ( and at any other interfaces within the tissue ), absorption and scattering events within the tissue , and remittance from the tissue ( by reflection at the air / tissue interface and by backscattering from within the tissue ). jacques s l , wang l . monte carlo modeling of light transport in tissues : optical - thermal response of laser - irradiated tissue . ( plenum press , new york , 1995 ), pp . 73 - 100 . for the purposes of the present invention , it will be understood that the term &# 34 ; non - homogeneous collagen &# 34 ; will refer to that collagen typically found in human or other animal skin , as described in the preceding paragraph . non - homogeneous collagen is also anisotropic by nature , in that it does not exhibit identical properties ( such as light transmission , birefringence , conductivity of heat or electricity ) when measured along axes in different directions . it is well known that skin tissue is composed of such non - homogeneous collagen , as compared to other transparent , isotropic and homogeneous collagen - containing tissue , such as that of the cornea . while the principles of the invention have been made clear in illustrative embodiments , there will be immediately obvious to those skilled in the art many modifications of structure , arrangement , proportions , the elements , materials , and components used in the practice of the invention , and otherwise , which are particularly adapted to specific environments and operative requirements without departing from those principles . the appended claims are intended to cover and embrace any and all such modifications , with the limits only of the true purview , spirit and scope of the invention .

a cooling handpiece and method for use in therapeutic , cosmetic or aesthetic , diagnostic , exploratory , interventional or other medical procedures , the handpiece for use in conjunction with a controllable energy source such as coherent light , non - coherent light or laser light , ultrasound energy , radio frequency energy and other types of electromagnetic and mechanical energy , the handpiece comprising a main body portion adapted for directing the energy to target tissue , the main body portion further adapted for receiving a removable reservoir containing coolant fluid , the reservoir having an attachment means for releasable attachment of the reservoir to the handpiece , and the handpiece having a controllable valve for delivery of a portion of the coolant fluid to the target tissue .

embodiments of the present invention and the advantages thereof are best understood by referring to the following descriptions and drawings , wherein like numerals are used for like and corresponding parts of the drawings . according to the present invention and referring now to fig1 , assembly tool 10 according to the present invention is shown . the assembly tool 10 is used for assembly of a first component 12 of a prosthesis 14 to a second component 16 of the prosthesis 14 for use in joint arthroplasty . the tool 10 includes a housing 18 operably associated with the second component 16 . the housing 18 defines a housing longitudinal axis 20 of the housing 18 . the tool 10 also includes an internal component 22 operably associated with the second component 16 . the internal component 22 defines an internal component longitudinal axis 24 of the internal component 22 . the internal component 22 includes an actuating device 26 and an actuator rod 28 connected to the actuating device . the actuator rod defines a transverse axis 30 that is perpendicular to the internal component longitudinal axis 24 . the internal component 22 is adapted to provide relative motion of the internal component 22 with respect to the housing 18 when the actuator rod 28 is rotated relative to the housing 18 about the transverse axis 30 . the assembly tool 10 is suited for use with the prosthesis 14 when , for example , the prosthesis 14 includes the first component 12 and the second component 16 which are engaged and disengaged by relative motions along an axis . for example , the assembly tool 10 is suitable when the prosthesis 14 includes components , which are connected by a tapered connection . for example , as shown in fig1 , the first component 12 includes an internal taper 32 that mates with an external taper 34 located on the second component 16 . as shown in fig1 , the first component 12 is engaged with the second component 16 when the first component 12 moves in the direction of arrow 36 and / or when the second component 16 moves in the direction of arrow 38 . as shown in fig1 , the housing 18 is operably associated with the first component 12 while the internal component 22 is operably associated with the second component 16 . to provide for the operable association of the components , it should be appreciated that the housing 18 includes a housing operating feature 40 , which is operably associated with a first component operating feature 42 of the first component 12 . similarly , the internal component 22 includes an internal component operating feature 44 , which cooperates with a second component operating feature 46 of the second component 16 . for simplicity , since the housing 18 and the first component 12 are merely required to prevent motion of the two components toward each other , the housing 18 and the first component 12 may be designed such that the housing operating feature 40 may be in the form of a bottom and / or surface 41 ( fig3 ). similarly , the first component operating feature 42 may be in the form of a top surface 43 ( fig3 ) of the first component 12 . the internal component operating feature 44 and the second component operating feature 46 may be any features capable of urging the second component 16 upwardly in the direction of arrow 38 . for example , for simplicity , the internal component operating feature 44 may be in the form of internal threads 47 ( fig3 ) formed on the second component operating feature 46 , which may mate with external threads 45 ( fig3 ) formed on the second component 16 . the housing 18 and the internal component 22 may have any shape or configuration capable of providing relative motion along housing longitudinal axis 20 and internal component longitudinal axis 24 . for example , and as shown in fig1 , the housing 18 may be in the form of a hollow component or tube . similarly , the internal component 22 may be in the form of a rod or cylinder , which may slideably fit within the housing 18 . turning now to fig2 , in which a plan view of the instrument 10 is shown , the parts of the instrument 10 and their operation will be described in more detail . as shown , the housing 18 includes an outer housing 48 and the housing operating feature 40 . the outer housing 48 also includes apertures 49 for coupling the outer housing 48 to the internal component 22 . the internal component 22 includes an actuating device 50 and an actuator rod 52 . the actuating device 50 includes a screw 53 and four scissor members 54 a , 54 b , 54 c , 54 d . the scissor members 54 a , 54 b , 54 c , 54 d each include two legs 56 a , 56 b . the legs 56 a , 56 b are connected via a pin 58 . one pair of scissor members 54 a , 54 b are also connected via the pin 58 . the other pair of scissor members 54 c , 54 d are connected via the corresponding pin 58 . the two pins 58 also connect the screw 53 to the scissor members 54 a , 54 b , 54 c , 54 d . thus , when the screw 53 is rotated about the transverse axis 30 , the four scissor members 54 a , 54 b , 54 c , 54 d expand and contract ( like a car jack ). the scissor members 54 a , 54 b , 54 c , 54 d are connected to the outer housing 48 via pins 59 . the pins 59 extend through the apertures 49 in the outer housing 48 . the bottom portion of all four legs 56 b are connected with a connecting member 62 that includes an aperture 64 for receiving a rod 66 that is a part of the actuator rod 52 . the rod 66 extends longitudinally through the outer housing 48 of the housing 18 . the bottom of the rod 66 includes the internal component operating feature 44 , which in the illustrated embodiment is a threaded aperture 68 . surrounding and connected to the rod 68 is a cylinder 70 . when a user turns the cylinder 70 , the rod 66 also rotates . this can be used to connect the internal component operating feature 44 to the second component operating feature 46 ( as shown in fig1 ). the use of the scissor members 54 a , 54 b , 54 c , 54 d provide a greater mechanical advantage to the tool . by increasing the mechanical advantage through the use of the screw 53 and the scissor arms 54 a , 54 b , 54 c , 54 d , the amount of force that the user has to apply to the screw is greatly decreased from prior art designs . referring now to fig3 , the engagement of the assembly tool 10 with the prosthesis 14 is shown in greater detail . as shown in fig3 , the second component 16 includes a second component operating feature in the form of external threads 45 . the external threads 45 are matingly fitted to , for example , internal threads 47 formed on internal component 22 . the first component 12 includes an operating feature in the form of , for example , a top surface 43 which mates with bottom surface 41 of the housing 18 of the tool 10 . in some embodiments , the threads may be acme threads . since the housing 18 is in contact with the first component 12 , when the first component is moved in the direction of arrow 80 relative to the first component 12 , the internal component 22 is moved in the direction of arrow 82 relative to the housing 18 . thus , the relative motion of the internal component 22 with respect to the housing 18 in the direction of arrow 82 corresponds to the relative motion of the second component 16 with respect to the first component 12 in the direction of arrow 80 . referring now to fig4 , the prosthesis 14 is shown in greater detail . the prosthesis 14 as shown in fig4 includes a taper connection 31 . as shown in fig4 , the taper connection consists of the external taper 34 formed on the distal stem 16 that engages with internal taper 32 formed on the first component in the form of the proximal body 12 . it should be appreciated that the prosthesis for use with the assembly tool 10 of fig1 and 2 , respectively , may include the first component 12 ( in this case a proximal body ) and the second component 16 ( here a distal stem ) which have an interference connection that is , for example , an interference connection of a cylindrical bore to a cylindrical stem , as well as , a splined non - uniform cross - section stem to a splined or non - uniform cross - section opening . it should further be appreciated that proximal body and distal stem of the prosthesis 14 for use with the assembly tool of the present invention may include a taper connection in which the distal stem has an internal taper and the proximal body has an external taper . again referring to fig4 , the prosthesis 14 as shown may include external threads 45 formed on the distal stem 16 . the proximal body 12 may include a neck 84 to which a head 86 may matingly be fitted . as an additional precaution in assuring that the proximal body 12 remains secured to the distal stem 16 , the prosthesis 14 may further include a nut 88 that threadably engages the external threads 45 of the distal stem 16 . referring now to fig5 , the prosthesis 14 is shown with the proximal body 12 disassembled from the distal stem 16 . the external taper 34 of the distal stem 16 is defined by an included angle β 1 . in order that the proximal body 12 fits securely to the distal stem 16 , the proximal body 12 includes the internal taper 32 defined by included angle β 2 . the angles β 1 and β 2 may be generally the same . alternatively the taper angle may be divergent . the angles β 1 and β 2 should be chosen , such that the fit of the proximal body 12 to the distal stem 16 is secure . in one embodiment , the instrument is made of stainless steel , however it is contemplated that other sterilizable metals may also be used . turning now to fig6 , a flow chart describing the operation of the assembly tool 10 according to one embodiment will be described . at step s 100 , a first component and a second component are provided . the second component is removably attachable to the first component . an assembly tool or instrument is also provided , the assembly tool including a housing and an internal component . the internal component includes an actuating device and an actuator rod ( step s 101 ). the first component is assembled to the second component at step s 102 . at step s 104 , the user connects the housing of the tool to the first component . the user also connects the internal component of the tool to the second component ( step s 106 ). at step s 108 , the user moves the actuating device of the internal component in a direction transverse to a longitudinal axis relative to the housing . the actuator rod of the internal component is then moved along the longitudinal axis relative to the housing to secure the first component to the second component ( step 110 ). although the present invention and its advantages have been described in detail , it should be understood that various changes , substitutions , and alterations can be made therein without departing from the spirit and scope of the present invention as defined by the appended claims .

a kit for use in joint arthroplasty that includes a first component of a prosthesis , a second component of the prosthesis , and an assembly tool for assembling the first component to the second component . the tool includes a housing for contact with the first component and an internal component connected to the second component . the internal component includes an actuating device and an actuator rod . the actuating device has at least one scissor arm . the housing and the internal component are adapted to provide for the assembly of the first component of the prosthesis to the second component of the prosthesis . the internal component is adapted to provide relative motion of the internal component with respect to the housing when the at least one scissor arm is moved relative to the housing , the relative motion of the internal component with respect to the housing being utilized to effect the relative motion of the first component with respect to the second component to urge the second component into engagement with the first component .

although specific forms of apparatus embodying the invention have been selected for illustration in the drawings , and although specific terminology will be referred to in describing those forms in the description which follows , such use is not intended to limit the scope of the invention , which is defined in the appended claims . referring generally to the drawings , and especially referring to fig1 there is shown a game 10 which comprises a board 12 and a composite 14 embodying aspects of the invention . board 12 contains spinner 46 and accompanying spinning arrow 44 . composite 14 is mounted to board 12 by way of rigid retainer rails 15 . fluid containers 18 formed in upper layer 16 are the facing layer of composite 14 . fig2 and 3 show an enlarged sectional view of composite 14 having a deformable upper layer 16 with a multiplicity of upwardly projecting fluid containers 18 having upper flat surfaces 48 . a fluid retaining layer 20 lying against layer 16 retains fluid 22 within containers 18 . raised separator 24 lies between retaining layer 20 and design sheet 26 and forms spaces 28 . in fig3 portions of upper layer 16 are depressed in containers 18 as indicated at points a and b by finger or a mechanical instrument . retaining layer 20 has been severed at points c and d and fluid 22 now occupies corresponding spaces 28 . fig4 and 5 show retaining layer 20 separated from composite 14 . retaining layer 20 has weakened portions 30 , some of which have been broken at point e in fig5 . it is within the scope of the invention that weakened portions 30 be shaped in any suitable manner . a second embodiment of the invention is disclosed in fig6 wherein an upper layer 16 &# 39 ; forms containers 18 &# 39 ;. retaining layer 20 &# 39 ; retains fluid 22 &# 39 ; within containers 18 &# 39 ;. a distinct separator 32 lies between retaining layer 20 and a design sheet 34 and forms spaces 28 &# 39 ;. in fig7 another embodiment without a separator 34 is shown . upper layer 16 &# 39 ;&# 34 ; forms containers 18 &# 34 ; which contain fluid 22 &# 34 ;. retaining layer 20 &# 34 ; retains fluid 22 &# 34 ; within containers 18 &# 34 ;. design sheet 34 &# 39 ; lies directly against retaining layer 20 &# 34 ;. a fourth embodiment of the invention is shown in fig8 wherein upper layer 16 &# 39 ;&# 34 ; forms containers 18 &# 39 ;&# 34 ; which contain fluid 22 &# 39 ;&# 34 ;. retaining layer 20 &# 39 ;&# 34 ; retains fluid 22 &# 39 ;&# 34 ; within containers 18 &# 39 ;&# 34 ;. design sheet 36 has upwardly projecting separator 38 which contacts retaining layer 20 &# 39 ;&# 34 ; and forms spaces 28 &# 39 ;&# 34 ;. layer breaking tips 40 are positioned on design sheet 36 with one tip 40 being supplied underneath each container 18 &# 39 ;&# 34 ;. in fig9 a composite 14 as shown in fig2 is mounted on board 12 . board 12 has layer breaking tips 42 . referring to fig1 to 5 , game 10 has a board 12 onto which a visual design and character formation composite is mounted for playing an educational game wherein opposing players attempt to complete a phrase . it is to be understood that the particular game illustrated in fig1 and described below is chosen to illustrate one example in which composite 14 may be utilized . a first player spins spinner arrow 44 to determine the number of attempts from spinner 46 that the player will receive . an attempt consists of depressing the upper flat portion 48 of a fluid container 18 to cause fluid 22 to activate invisible designs and / or characters for formation of visible designs and characters on design sheet 26 . the player chooses whichever containers 18 desired to be activated , and then activates the designs in the portion of design sheet 26 corresponding to the underlying container 18 . designs are activated when fluid 22 contacts design sheet 26 . application of downward pressure on upper flat surfaces 48 causes fluid 22 to exert pressure on fluid retaining layer 20 . weakened portions 30 in retaining layer 20 give away to such pressure , thereby opening a small hole in retaining layer 20 as shown at point e in fig5 . the hole permits fluid 22 to pass therethrough from containers 18 into spaces 28 . as soon as fluid 22 contacts design sheet 26 , activation of the invisible design begins . separator 24 prevents fluid 22 from flowing underneath an adjacent container 18 . in this manner , the game player activates only small portions of design sheet 26 at a time . separator 24 may be formed in a number of shapes . for example , in fig6 the separator is formed in a triangular shape , whereas in fig2 it is formed as a square . either form , as well as others , may be equally effective . separator 24 may also be formed from a variety of differing materials such as rubbers , plastics , metals or the like . it can be rubber - like and act as a gasket or it can be porous or sponge - like so as to assist in absorbing excess activating fluid . in fig7 separator 24 has been eliminated . spaces 28 are not required , but are only preferred . weakened portions 30 continue to break upon application of fluid pressure thereon . fluid 22 traverses the breaks ( at point e ) in weakened portions 30 and travels by way of capillary action along the surface of design sheet 34 . it is also possible for separator 32 to be separate entities apart from its respective design sheet as shown in fig6 . however , in the preferred form , separators 24 are integrated with design sheet 26 . in fig8 the composite is provided with layer breaking tips 40 to assist in severing retaining layer 20 . preferably , tips 40 are aligned to fall along a line of weakened portions 30 . upon application of downward pressure on upper flat surfaces 48 , retaining layer 20 sags downwardly and contacts tip 40 to facilitate formation of a hole therein . fig9 shows another embodiment of the invention employing layer breaking tips 42 attached to board 12 . tips 42 provide sufficient force against design sheet 26 to transfer through to retaining layer 20 . retaining layer 20 may be selected from a variety of materials , although any fluid resistant material may be used . preferably a saran - type sheet is employed . in any event , the material may not be dissolvable by the activator fluid . similarly , upper layer 16 may be formed from a wide variety of materials . it should be transparent in order that designs may be viewed therethrough , and should be semi - rigid so as to be strong enough to reliably contain fluids , yet be capable of being deformed when subjected to force on upper surface 48 . upper sheet 16 and retaining layer 20 are preferably welded together at their contact points by a heat seal to insure that fluids 22 remain contained within containers 18 . it is , however , possible to employ other seal means such as adhesives or the like . fig1 shows a word game as an illustrative manner in which the invention may be employed . it is within the scope of the invention that composite 14 may be employed in any number of entertainment or educational uses . for example , containers 18 may be closely spaced in a honeycomb configuration to achieve near complete coverage of composite 14 . design sheet 24 may also then have a continuous design such as a likeness of a famous person . by activating all of the honeycomb cells , the user &# 34 ; paints &# 34 ; a picture . preferably , the design sheet 34 , 34 &# 39 ; is formed in the manner as shown in fig6 and 7 . in that configuration the design sheet is completely flat , and subsequent to complete activation of design sheet 34 , upper layer 16 and 20 and containers 18 may be peeled from the remaining portion of the composite to reveal a picture suitable for framing . fluids 22 may be of any type suitable to activate design sheet 26 . for example , invisible designs on sheet 26 may be formed from chemicals or printing inks known in the art . such chemicals and printing inks are invisible until contacted with an activating liquid . in the case of printing inks , such an activating fluid is preferably water . any number of liquid chemical fluid activators may also be employed . when chemical fluids are employed , it is possible that different chemicals be used in each container 18 . by using the composite sheet in its preferred form , with invisible printer &# 39 ; s ink employed on the design sheet , it is possible to use water as an activation fluid . this provides an inexpensive , non - messy and safe educational and / or entertainment means . although this invention has been described in connection with specific forms thereof , it will be appreciated that a wide array of equivalents may be substituted for the specific elements shown and described herein without departing from the spirit and scope of this invention as described in the appended claims .

a composite sheet for forming visually observable designs comprising a transparent deformable upper layer having a plurality of pockets formed therein ; a transparent intermediate layer sealed to the upper layer along edges of the pockets to form a plurality of containers ; a lower layer connected to the intermediate layer , with the lower layer having a plurality of fluid activatable invisible designs formed thereon ; and invisible design activation fluid contained within the containers to transform the invisible designs into visually observable designs upon breaking of the intermediate layer adjacent the containers by pressure exerted against the upper layer and subsequent contact of the fluid with the lower layer .

in fig1 and 2 , the preferred embodiment of the air freshener / deodorizer dispensing system 20 of the present invention is clearly depicted . as shown therein , air freshener / deodorizer dispensing system 20 comprises a small , compact , flexible housing or container 21 which is formed by securely affixing side walls or panels 22 and 23 to each other . in the preferred embodiment , as fully detailed below , side walls or panels 22 and 23 each comprise a plurality of integrally bonded layers to form a high strength , non - permeable and completely flexible panel or side wall member . in order to form container or housing 21 , side walls or panels 22 and 23 are placed in overlying contacting engagement with each other and intimately bonded together about their outer peripheral edges . in this way , a completely scaled , impervious container or housing 21 is formed which is sealed about all four sides thereof and incorporates an interior holding zone or pouch 24 . in the preferred construction , in order to attain access to interior holding zone or pouch 24 of container or housing 21 , a notch or slit 25 is formed along one edge of container 21 . in this regard , care must be exercised to prevent notch 25 from extending inwardly from the side edge so as to extend into holding zone or pouch 24 . in this way , holding zone or pouch 24 is completely sealed from the ambient surrounding . however , any individual , wishing to open holding zone or pouch 24 , is capable of doing so , whenever desired , by merely applying a tearing force to notch 25 , causing notch 25 to extend into holding zone or pouch 24 . in this way , zone 24 is maintained completely sealed from the ambient surroundings until access to zone 24 is sought by the user . in the preferred embodiment , prior to sealing side walls or panels 22 or 23 to each other to form container or housing 21 , super absorbent , cotton - based wicking means 30 is positioned within holding zone or pouch 24 . in addition , the air freshening / deodorizing composition is also placed in holding zone or pouch 24 , typically in fully absorbed , dispersed , cooperating interengagement with super absorbent cotton wicking means 30 . however , if wicking means 30 is fully absorbed with the air freshening / deodorizing composition and excess composition remains , the excess composition merely pools within holding zone 24 , remaining in direct contact with wicking means 30 . consequently , whenever container or housing 21 is open , as detailed above , and the air freshening / deodorizing composition is dispensed , wicking means 30 is maintained fully saturated by absorbing the excess air freshening / deodorizing composition until all of the excess formulation has been fully absorbed and all of the absorbed composition has been completely dispensed . as is apparent from fig1 and 2 , as well as the foregoing detailed disclosure , air freshening / deodorizing container and dispensing system 20 of the present invention may comprise any size or shape with interior , sealed holding zone 24 also comprising any desired size , shape or configuration . however , in order to employ the teaching of the present invention , cotton wicking means 30 must be mounted within , holding zone 24 substantially filling the entire holding zone . in this way , complete absorption and distribution of all air freshening / deodorizing composition contained therein is assured . furthermore , wicking means 30 must also be positioned in holding zone 24 in an area which will be directly adjacent notch 25 or any other opening means incorporated with container 21 . as is apparent from this disclosure , in order to attain the desired air freshening / deodorizing effect , with the composition absorbed within wicking means 30 being dispensed through the open zone , when formed , wicking means 30 must be positioned in cooperating association with the exit portal in order to assure that the desired dispensing of the air freshening / deodorizing composition to the surrounding ambient air is achieved . in the preferred embodiment of the present invention , as discussed above , notch 25 is employed in order to open container 21 through the sealed zone thereof , to obtain access to holding zone 24 and wicking means 30 . in this way , a safe , easy , and convenient opening of container and dispensing system 20 is attained . by employing notch 25 , the user is capable of controlling the size of the opening being made , thereby enabling the user to form a portal through which the air freshening / deodorizing composition can exit which is directly dependant upon the amount of air freshening or deodorizing desired . by virtually removing the entire top half of container or housing 21 , maximum dispensing of the air freshener / deodorizing composition is attained . however , if the user desires a slower rate of dispensing , only a portion of the top part of container 21 would be opened , so as to prevent excessive dispersion of the air freshening / deodorizing composition from wicking means 30 through the portal formed by the user . in fig4 an alternate controlled opening system is disclosed wherein a plurality of holes or portals 33 , 34 , 35 and 36 are formed in side wall 22 of container 21 . since holes 33 , 34 , 35 and 36 are formed through side wall 22 , these holes provide dispensing portals for enabling the air freshening / deodorizing composition to exit from holding zone 24 to the ambient surrounding . in order to prevent unwanted , early dispersion of the air freshening / deodorizing composition , prior to the user &# 39 ; s desire , an elongated sealing strip 38 is mounted in overlying sealing interengagement with portals 33 , 34 , 35 and 36 . in this way , holding zone 24 is completely sealed from the ambient surroundings and the desired , long - term retention of air freshening / deodorizing composition within holding zone 24 is provided . whenever the user is ready to employ air freshening / deodorizing container and dispensing system 20 , scaling strip 38 is employed by pulling sealing strip 38 away from one or more of the portals otherwise maintained closed by sealing strip 38 . as depicted in fig4 sealing strip 38 is removed from portals 35 and 36 , while maintaining portals 33 and 34 completely sealed . in this way , an average rate of dispersion of the air freshening / deodorizing composition is attained . as is apparent from the foregoing disclosure , by removing sealing strip 38 from the desired number of portals , the precisely desired rate of dispersion of the air freshening / deodorizing composition is realized . if maximum distribution is desired , sealing strip 38 is completely removed . however , any other rate of dispersion can be easily attained by uncovering the desired number of portals otherwise scaled by strip 38 . in this way , the consumer maintains complete control over the rate of dispersion of the air freshening / deodorizing composition while also assuring that prior to use , the air freshening / deodorizing composition is securely retained in sealed interengagement within container 21 , with the composition being incapable of being dispersed or permeated through side walls or panels 22 or 23 . in the preferred embodiment , the air freshening / deodorizing composition employed in the dispensing system of the present invention comprises the uniquely constructed formulation designed specifically for providing a concentrated , potent , long - lasting air freshening and / or deodorizing effect . in accordance with the present invention , the air freshening / deodorizing composition comprises between about 90 % and 99 % of one or more oil - based fragrances and between about 1 % and 10 % by weight of a fixative for the oil - based fragrance . in the preferred embodiment , the fixative employed in the composition of the present invention comprises methyl hydrogenated rosinate . methyl hydrogenated rosinate is the ester of methyl alcohol and the hydrogenated mixed long chain acids derived from rosin . it has been found that this particular composition works most effectively as a fixative in providing a superior air freshening / deodorizing composition , with the preferred amount being 5 % by weight . in addition to the methyl hydrogenated rosinate , the composition of the present invention incorporates , in the preferred embodiment , a plurality of oil - based fragrances to provide the desired air freshening and / or deodorizing effect . although a wide variety of oil - based fragrances can be employed in carrying out the present invention , without departing from the scope of the present invention , it has been found that the preferred oil - based fragrances are selected from the group consisting of fruity notes , spices , cloves , eucalyptus , floral notes , jasmine , lavenders , wintergreen , spearmint , and wood notes . by employing one or a combination of these oil - based fragrances in the preferred quantity of 95 % by weight of the entire composition , the desired air freshening and / or deodorizing fragrance is attained and the desired long - lasting , air freshening / deodorizing effect is realized . in fig3 the preferred embodiment of each of the side walls or panels 22 and 23 is depicted . preferably , side walls or panels 22 and 23 comprise identical constructions , with both panels incorporating the identical integrally bonded multi - layered configuration . in fig3 for exemplary purposes only , a portion of side wall panel 22 is shown in a greatly enlarged cross section in order to depict each of the plurality of integrally affixed layers forming side wall 22 . as is apparent from the disclosure , panel 23 comprises an identical construction . in the preferred embodiment , side wall or panel 22 and 23 comprises five separate and distinct independent layers , each of which are integrally bonded in secure , affixed interengagement to each other . the first or outer surface layer 41 comprises a polyester film , preferably having a thickness of about 48 gauge . although other materials and thicknesses may be used for layer 41 , polyester film is preferred in order to enable the surface of the layer to be printed upon . the middle layer of side wall 22 is layer 43 which comprises a thin metal foil material . preferably , metal foil layer 43 comprises a thickness ranging between 0 . 0001 and 0 . 0005 inches , with a thickness of 0 . 0003 inches being preferred . in order to securely bond metal foil layer 43 to polyester film layer 41 , layer 42 is employed . preferably layer 42 comprises a low density polyethylene film having a thickness of about 0 . 00075 inches . although other bonding films and other thicknesses may be employed , low density polyethylene is preferred and has proven to provide the desired intimate affixation of foil layer 43 to polyester layer 41 . the final two layers are layers 44 and 45 . layer 44 is similar in function to layer 42 and provides the desired secure bonding of foil layer 43 to layer 45 . although any suitable bonding film and thickness may be employed , layer 44 preferably comprises ethylene acrylic acid copolymer with a thickness of about 0 . 0015 inches . inside layer 45 of side wall 22 preferably comprises a film of linear law density polyethylene . preferably , the thickness of layer 45 is about 0 . 00125 inches . the composition of layer 45 is particularly important , since the secure affixation of side wall 22 with side wall 23 is achieved by heat - sealing the outer peripheral edges of side walls 22 and 23 to each other . in the preferred embodiment , side walls 22 and 23 are placed in overlying relationship with each other and , at the appropriate process time , the contacting surfaces of layer 45 of side walls 22 and 23 are intimately affixed together to form the desired , completely sealed container 20 . by employing linear low density polyethylene film as layer 45 , the desired complete sealed , bond affixation of side walls 22 and 23 is assured . in fig5 a further embodiment of the present invention is depicted . in this embodiment , as with the embodiments detailed above , air freshener / deodorizer dispensing system 20 comprises housing or container 21 , which is formed from integrally bonded , multi - layered side walls or panels 22 and 23 . in addition , this embodiment comprises wicking means 30 preferably formed from cotton material within which the desired air freshening / deodorizing composition is retained for distribution to the ambient surroundings . in order to provide enhanced control over the rate of dispersion of the air freshening / deodorizing composition contained within wicking means 30 , this embodiment of air freshener / deodorizing dispensing system 20 also incorporates a separate and independent permeable membrane layer 50 positioned between side wall 22 and wicking means 30 . preferably , permeable membrane layer 50 comprises an overall size and shape substantially equivalent to the size and shape employed tier side walls or panels 22 and 23 and is securely affixed as part of dispensing system 20 by intimately bonding the outside peripheral edge of permeable membrane layer 50 between side walls or panels 22 and 23 . in this way , the desired , completely sealed container 21 is easily attained with permeable membrane layer 50 controllably positioned between side wall 22 and wicking means 30 . as with the previous embodiments , whenever the dispensing of the air freshening / deodorizing composition is desired , dispensing system 20 is opened , using any desired access means incorporated into dispensing system 20 . in particular , any of the access systems detailed above can be employed , with equivalent efficacy , with the embodiment of dispensing system 20 depicted in fig5 . if desired , an alternate access system can be employed as shown in fig5 . in this access system , a flap member 51 is formed in side wall or panel 22 by incorporating a plurality of flap - defining notches 52 in the top surface of side wall or panel 22 . in the preferred construction , flap - forming notches 52 extend from the outside surface of side wall or panel 22 to metal layer 43 of side wall or panel 22 , in order to assure that the interior of dispensing system 20 is scaled and the air freshening / deodorizing composition is not dispensed prematurely . whenever a consumer is ready to employ dispensing system 20 , flap 51 is held by suitable means , such as an access tab , which enables flap 51 to separate from side wall or panel 22 , revealing permeable membrane 50 . once flap 51 has been opened to the desired extent , the air freshening / deodorizing composition contained in wicking means 30 is capable of passing through the pores of permeable membrane 50 and into the surrounding ambient air . by constructing permeable membrane 50 in the manner consistent with the molecular structure of the air freshening / deodorizing composition being employed , the rate of dispersion of the air freshening / deodorizing composition into the ambient air is precisely controlled automatically . furthermore , the use of permeable membrane 50 assures a continuous , dependable and completely repeatable rate of dispersion of the air freshening / deodorizing composition into the ambient surroundings . as is evident from this disclosure , flap 51 may be constructed in any desired size and shape . as a result , if desired , flap 51 may be constructed with flap forming notches 52 formed in side wall or panel 22 in a manner which would substantially encompass a major portion of side wall or panel 22 , as shown in fig6 . this enables virtually all of permeable membrane 50 to be exposed once flap 51 was opened . although this would enable a greater quantity of the air freshening / deodorizing composition to be dispersed into the ambient surroundings , the rate of dispersion of the air freshening / deodorizing composition is still controlled by the pore size of permeable membrane 50 . in this way , a continuous , substantially constant rate of dispersion is assured . by specifically formulating permeable membrane layer 50 with a precisely desired pore size and employing particularly selected fragrances having desired molecular characteristics , the overall effectiveness and longevity of dispensing system 20 of the present invention is substantially enhanced and controlled . furthermore , by employing permeable membrane layer 50 as part of dispensing system 20 , substantially stronger concentrations of the air freshening / deodorizing composition may be employed without fear that the potency of the air freshener / deodorizer composition will be overpowering in its initial stages . by controlling the rate of dispersion of the fragrance from the wicking means to the ambient surroundings , higher concentrated solutions of the air freshener / deodorizing composition can be employed and are efficiently and automatically dispensed , producing a continuous level of air freshening for the entire useful life of the air freshening / deodorizing composition . as a result , a highly effective and desirable dispensing system is realized . in fig6 a further alternate embodiment of the air freshening / deodorizing dispensing system 20 of the present invention is depicted . in this embodiment , dispensing system 20 incorporates a housing or container 21 formed from side walls of panels 22 and 23 in the manner detailed above . however , in order to provide a further enhanced construction , this embodiment employs permeable membrane layer 50 along with a second permeable membrane layer 55 . in the construction of this embodiment , membrane layers 50 and 55 comprise a size and shape substantially equivalent to or less than the size and shape of side walls or panels 22 and 23 . if desired , membrane layers 50 and 55 are integrally affixed and secured between side walls or panels 22 and 23 as detailed above . in addition , if desired , permeable membrane layers 50 and 55 are intimately bonded to each other to form a separate and independent dispersion controlling member which comprises an internal retaining zone 56 . retaining zone 56 is employed to hold and securely retain wicking means 30 . by forming a completely enclosed , independent dispersion controlling member within which wicking means 30 is securely retained , an easily assembled , dispensing system 20 is obtained which is easily employed to provide continuous dispersion of the fragrance at a fixed rate . in accordance with the present invention , permeable membrane layers 50 and 55 may comprise any desired size and shape , provided the membrane layers are easily retained within housing or container 21 formed by side walls or panels 22 and 23 . clearly , regardless of the overall size of permeable membrane layers 50 and 55 , the securement of wicking means 30 within permeable membrane layers 50 and 55 assures that all of the air freshening / deodorizing composition housed therein will be dispensed in a completely controlled manner , based upon the diffusion rate of the air freshening / deodorizing composition through the pores of permeable membrane layers 50 and 55 . in this embodiment , both side walls or panels 22 and 23 incorporate opening means formed therein to enable both sides of housing or container 21 to be opened . as depicted , enlarged flaps 51 are formed in both side walls or panels 22 and 23 , to enable both side walls 22 and 23 to be opened , allowing access to both permeable membrane layers 50 and 55 . as a result , greater surface area of the permeable membrane is exposed and a greater quantity of the air freshening / deodorizing composition is more readily dispensed into the ambient surroundings . by employing this embodiment of the present invention , dispensing system 20 can be effectively employed in locations where forced air flow occurs , such as on air delivery registers or conduits . using this embodiment , air is able to flow through dispensing system 20 , continuously driving the dispersion of the desired air freshening / deodorizing composition through permeable membrane layers 50 and 55 , carrying the fragrance in the air flow . as a result , the dispensing of the desired fragrance into the ambient surroundings is further enhanced and efficiently achieved . furthermore , in accordance with the present invention , any desired opening means can be employed in order to gain access to the permeable membrane . although several alternate embodiments have been shown in the drawings , other constructions such as tear strips and integrally formed tear - filaments can be employed with equal efficacy . consequently , all alternate constructions which achieve substantially the same results are encompassed within the scope of this invention . in fig7 a further alternate embodiment of the present invention is depicted . in this embodiment , dispensing system 20 incorporates a container or housing 21 formed from side walls or panels 22 and 23 , as detailed above . in addition , two permeable membrane layers 50 and 55 are also employed in this embodiment . as clearly depicted in fig7 in this embodiment of the present invention , permeable membrane layers 50 and 55 are constructed with an overall size and shape substantially equivalent to the size and shape of side walls or panels 22 and 23 , and are mounted in juxtaposed spaced relationship to each other with fragrance bearing means 58 sandwiched therebetween . when fully assembled , membrane layers 50 and 55 are integrally bonded to each other and to side walls or panels 22 and 23 about their respective outer peripheral edges , to form an integrally sealed container or housing 21 which defines dispensing system 20 . in addition , any desired access means can be employed to enable the user to open dispensing system 20 and allow the fragrance retained therein to be dispensed through permeable membrane layers 50 and 55 . in addition , since two membrane layers are employed , with fragrance bearing means 58 positioned between permeable membrane layers 50 and 55 , both side walls or panels 22 and 23 can both incorporate access means to enable either side or , if desired , sides of container or housing 21 to be opened for fragrance dispensing therethrough . in this embodiment , as with the previous embodiments detailed above , any desired fragrance dispensing system can be employed . although wicking means incorporating the desired fragrance composition , as fully detailed above , may be positioned between permeable membrane layers 50 and 55 of this embodiment , fig7 depicts an alternate construction wherein a unitary fragrance holding or bearing member 58 is depicted . as shown , fragrance bearing member 58 comprises a solid construction or a gel construction securely retained between permeable membrane layers 50 and 55 . if desired , any type of fragrance bearing member may be employed in this embodiment or in any other embodiments detailed above . regardless of the type of fragrance bearing member used , the dispersion of the desired fragrance through the side walls or panels 22 and 23 is attained . by employing any of the embodiments shown in fig5 - 7 , the membrane layer provides a controlled dispersion rate for the fragrance . in this way , assurance is provided that a continuous , precisely controlled level of fragrance is dispensed into the ambient surroundings , based upon the desired parameters sought by the manufacturer or the consumer . furthermore , permeable membrane layers 50 and 55 may be formed from any suitable material capable of providing a layer compatible with side walls or panels 22 and 23 , as well as incorporating a pore size consistent with the molecular structure of the fragrance to be dispersed therethrough . preferably , permeable membrane layers 50 and 55 are formed from polymeric plastic films or sheets which are impermeable to liquids but allow vapors to pass therethrough . generally , any suitable polymeric film or sheet can be employed , such as sheets or films formed from polyurethane , polyethers , polyesters , polypropylenes , polystyrene , and combinations thereof . it will thus be seen that the objects set forth above , among those made apparent from the preceding description , are efficiently attained and , since certain changes may be made in the above constructions without departing from the scope of the present invention , it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense . it is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described and all statements of the scope of the invention which , as a matter of language , might be said to fall therebetween . particularly , it is to be understood that in said claims , ingredients or compounds recited in the singular are intended to include compatible mixtures of such ingredients wherever the sense permits .

by providing a unique fragrance composition which incorporates a fixative for controlling the rate of dispersion of the fragrance and associating the fragrance composition with cotton - based wicking member which is securely sealed in a flexible container formed from a multi - layered sheet material , a unique and highly advantageous air freshener and / or deodorizer dispensing system is attained . in the preferred embodiment , the multi - layered flexible container is constructed for cooperating association with all conventional heating systems which enables the temperature of the fragrance composition to be raised , causing its dispersion throughout the desired area to be substantially enhanced . in addition , in the preferred embodiment , the dispensing system of this invention employs a small , compact and flexibly moldable container or housing which enables the dispensing system to be easily positioned in any desired location , regardless of the size constraints imposed thereon .

the method according to the invention is described in more detail hereinafter with reference to fig1 . in a first step 10 filter rods are removed from the production process manually or automatically through a filter rod hopper . the filter rod hopper supplies the removed filter rods for measuring to a filter rod measuring station . in one method step 12 in the filter rod measuring station , the mass m of the filter rod is provided . in a subsequent step 14 the filter rod is supplied to a microwave sensor . the microwave measuring device has a microwave resonator into which the filter rod to be measured is introduced . in the microwave resonator a stationary wave is formed with the resonance frequency , with which a filter rod to be measured interacts . the filter rod with its spatial expansion and its electrical properties alters the resonator so that the resonance curve occurring in the resonator is altered . two alterations in the resonance curve are important for the measurements . on the one hand , a shift of the resonance frequency occurs . this variable is denoted by a . the second characteristic variable is the shift b of the resonance curve . the alteration a may be primarily due to the real part of the dielectric constant of the inserted filter rod , whilst the alteration b is primarily based on the imaginary part of the dielectric constant . generally , the parameter a is used for determining the mass of the product . the ratio of the variables b / a is independent of the mass and provides an indication of the moisture content . in step 14 the microwave sensor detects , in a manner known per se , the measured variables a and b . in a subsequent step 16 , the measurement of the draw resistance ( pd ) is carried out which is also denoted as “ pressure drop ”. the draw resistance specifies the pressure drop through the filter rod which is present with a defined air flow . it is important here that measurements are carried out with stationary air flow and transient effects are not considered , as occur when increasing or reducing the air flow . in a final method step 18 the diameter of the filter rod is measured . the data obtained in the filter measuring station are processed in an evaluation unit in the measuring station . particularly advantageous for the measurement of the triacetin mass is the following formula : mtriacetin = a 0 + a 1 * a + a 2 * b + a 3 * m + a 4 * pd . this formula is important in that the variables pd for determining the triacetin mass enter into the equation . even a term b 4 ? m / b being able to be considered additionally to or instead of the b 3 term . fig2 shows for different titres ( 1 . 6 y 30 , 2 . 5 y 36 , 3 . 0 y 35 and 5 . 0 y 40 ) the comparison between measured moisture content values on the ordinate with predetermined reference values on the abscissa . it is clearly visible that a reliable detection of the moisture is carried out with the method according to the invention . it is a distinctive feature in the determination of the moisture content in the filter rod that this is able to be carried out independently of the titre . in other words , a set of parameters ( b 0 , b 1 , b 2 , b 3 ) which , independently of the titre of the material , discloses the moisture content . shown in fig3 is the measurement of the triacetin content . in this connection , again the measured variables are applied to the ordinate , whilst predetermined reference values are applied to the abscissa . also in this case the above formula is a reliable measurement for determining the triacetin mass in the filter rod . in contrast to the determination of moisture , with the determination of triacetin , the coefficient set ( a 0 , a 1 , a 2 , a 3 , a 4 ) is not independent of the titre of the material . this means that for evaluating the measured data , the titre of the material additionally has to be known in order to select the correct set of parameters . in addition to the aforementioned formula in which the triacetin mass is detected directly dependent on the measured variables a , b , m and pd , there is also the possibility of determining the dry masses in an approximate manner via other combinations ( tabular values ). thus it is known , for example , to determine the approximate dry mass from the value of the draw resistance and the diameter of the filter rod . from the dry mass , the triacetin amount may then again be determined in combination with the measured mass m and the characteristics of the microwave measuring device . combining these tabular values for the dry mass with the microwave measured values has , therefore , the object of improving the insufficient accuracy of these tabular values and compensating for the variation in moisture effect . in contrast to the predetermined formula , consideration is additionally given in this case to the measured variables a , b , m and the draw resistance pd , as well as the diameter ( d ) of the filter rod . as , however , the approximate dry mass is only determined by two measured variables , this method is on the whole less accurate than that first described . fig4 shows a microwave measuring device which is suitable for measuring a triacetin profile in a filter rod . the microwave measuring device corresponds in its construction substantially to the microwave measuring device known from ep 0 889 321 a1 . the microwave measuring device according to fig4 has a resonator cavity 20 through which a filter rod 22 is transported in the direction 24 . the filter rod 22 is supplied to the resonator cavity via a guide tube 26 . due to the selected geometry for the resonator cavity , the characteristic variables a and b are measured in a region 28 . the guide tube 26 has a diameter 28 which is slightly larger than the diameter of the filter rod 22 . in the region 30 the guide tube 26 is placed on the resonator body . the microwaves are fed into the resonator cavity 20 via a microwave transmitting aerial 32 , where they are measured and / or again decoupled via a microwave receiving aerial 34 . the resonator cavity is defined by an upper part 36 and a lower part 38 . the geometry is selected in this case such that the height d is markedly smaller than the extension of the resonator cavity in its expansion transversely to the direction of transport 24 . the measured values a and b provide information about the triacetin concentration in the portion 28 and thus allow by transport of the filter rod 22 a plurality of portions on a filter rod to be measured . each individual portion may be evaluated according to the method disclosed above . tests have shown that when measuring , the time passed since the production of the filter rod also has an important effect . it has been shown that it is possible to operate within the first ten minutes , with a coefficient set which is time - independent . if the time duration of 10 minutes from the application of the triacetin is exceeded and thus hardening has started , it has been proved that the coefficient sets for determining the triacetin mass are altered . a determination of the triacetin mass is , however , also possible with the altered coefficient set . in a particularly preferred embodiment , the detected measured data are processed by a control unit and compared with predetermined reference values . if the comparison shows that the triacetin value or the dry value of the processing material which is actually present deviates too sharply from the corresponding reference value , a warning signal may be triggered . the accuracy of the measurements has also shown that the measured values are , in principle , suitable for adjusting both the mass flow and the triacetin flow in the process of manufacturing the filter rod .

a filter rod measuring station is equipped with measuring devices which measure at least the mass of a filter rod and the draw resistance of the filter rod , and a microwave measuring device is provided for measuring the mass of the softener and / or the moisture content and / or the dry mass of the filter rod .

fig1 is a partial sectional side view of height adjustment assembly 10 of the preferred embodiment of the invention installed within changing table 12 shown atop play yard 14 , and fig2 is a perspective view of height adjustment fixture 11 of the preferred embodiment of the invention . the view of height adjustment fixture 11 in fig2 is from the opposite side of the view shown in fig1 in order to better show the structure of height adjustment fixture 11 . height adjustment fixture 11 of fig1 and 2 includes a series of at least two slots 16 alternating with lands 18 which , when installed within changing table 12 , are aligned in a vertical orientation . slots 16 and lands 18 are formed on support structure 20 , and tube 22 is attached to support structure 20 on surface 24 opposite lands 18 . height adjustment fixture 11 also includes coupling ring 26 which is attached to support structure 20 at the end of support structure 20 remote from opening 21 of tube 22 . coupling ring 26 is attached to support structure 20 at surface 28 which is the surface most remote from lands 18 , so that axis 27 of coupling ring 26 is parallel to axis 23 of tube 22 and to axis 31 of changing table support 30 , and coupling ring 26 has no interfering structures on either side of it along its axis 27 . as shown in fig1 , the clearance on both sides of coupling ring 26 permits height adjustment fixture 11 to be installed within changing table 12 and perform its function although it need not be permanently attached to changing table 12 . for changing table 12 to accommodate height adjustment fixture 11 , changing table 12 itself needs three structures . one is changing table support 30 which can be a basic tube structure that is used to attach most accessories to supporting structures such as play yard 14 . changing table support 30 is attached to changing table 12 by any conventional means such as hole 32 and fasteners 34 . the attachment of changing table 12 to play yard 14 is also conventional in that holding fixture 36 with socket 38 is attached to play yard 14 at an upper location , such as adjacent to a corner where horizontal rail 40 is attached to vertical support 42 . socket 38 in holding fixture 36 can then accept any simple rod or tube , such as changing table support 30 , as long as the tube is of smaller diameter than socket 38 . however , such simple holders for accessory structures provide no height adjustment since the lower part of the accessory structure would merely sit upon holding fixture 36 . the simple structure of height adjustment fixture 11 furnishes a vital part of the height adjustment with no modification of either support 30 or holding fixture 36 . in the preferred embodiment shown in fig1 , height adjustment fixture 11 is shown installed in changing table 12 . this is accomplished by slipping coupling ring 26 over changing table support 30 so that the bottom surface 29 of coupling ring 26 rests upon holding fixture 36 . tube 22 of height adjustment fixture 11 then fits into a socket concentric with tube 22 within changing table 12 and aids in aligning height adjustment fixture 11 with changing table 12 . tube 22 also holds spring 44 . spring 44 is a compression spring , which is shown with dashed lines in fig1 and inserted within tube 22 in fig2 , has its upper end against an inner surface of changing table 12 , and serves to overcome any friction between tube 22 and its socket . spring 44 thus assures that height adjustment fixture 11 continues to rest on holding fixture 36 of play yard 14 as changing table 12 is raised . in regard to stability and alignment , it is worthwhile to note that the most typical installation of height adjustment assembly 10 of the present invention is in pairs with one on each of two supports 30 located at opposite ends of changing table 12 . the two supports are installed into holding fixtures 36 located near adjacent corners of play yard 40 . such an arrangement provides an appropriate length for the changing table and does not require any locking apparatus to prevent supports 30 from rotating within fixture 36 . height adjustment assembly 10 requires one more device attached to changing table 12 . that is lever 46 which holds changing table 12 in one of the height positions provided by slots 16 . lever 46 rotates around pivot point 48 when lever handle 50 is pushed toward lands 18 , and as lever 46 rotates , latch 52 moves out of the slot 16 in which it is lodged . this permits changing table 12 to be manually raised or lowered . when lever handle 50 is released , spring 54 forces lever handle away from slots 16 , thus moving latch 52 into an available slot 16 . since height adjustment assemblies are typically installed near the ends of changing table 12 , and when pushing lever handle 50 the user &# 39 ; s hands are in contact with the underside of changing table 12 , it is not at all difficult to operate two lever handles simultaneously and also raise or lower changing table 12 . fig3 is a side view of alternate embodiment 60 of the height adjustment assembly of the invention . support structure 20 , tube 22 , and coupling ring 26 of height adjustment assembly 60 are identical to and serve the same function as the same parts of height adjustment fixture 11 in fig1 and 2 so they are identified by the same numbers . the difference in height adjustment assembly 60 is in the recess and land structure . alternating slots 62 and lands 64 of height adjustment assembly 60 are constructed to operate as rack 61 in conjunction with gear 66 so the spacing of lands 64 must match the spacing of teeth 68 on gear 66 . the height adjustment is then accomplished by rotating gear 66 in the appropriate direction . gear 66 is mounted upon and attached to the changing table ( not shown in fig3 ) in a manner similar to lever 46 of fig1 , so that as gear 66 literally climbs up rack 61 , the changing table is raised . this eliminates the requirement to manually lift the changing table to adjust the height . gear 66 can be rotated by any conventional means . one rotating device is shown in fig3 . knob 70 is mounted on surface 72 of the changing table ( not shown ) and drives gear 66 by conventional linking means 74 either directly or through a reduction drive . one requirement for any height adjustment assembly is that it have some sort of latching device to prevent the changing table from moving down with increased weight . the latching device is provided for height adjustment assembly 60 at knob 70 . knob 70 includes latch 76 that is pushed outward by spring 78 and moves into slots 80 to prevent both knob 70 and gear 66 from turning unless latch 76 is pulled into knob 70 by moving tab 79 against spring 78 . latch 76 is only one of many conventional devices to permit locking knob 70 . another such device is a tab on a spring loaded shaft that mates with slots around the shaft unless moved axially to disengage the tab from the slots for turning the shaft . fig4 is a perspective view of another alternate embodiment of a height adjustment assembly 84 of the invention with only partial structure 86 of the changing table shown . similar to the changing table 12 of fig1 , changing table structure 86 has changing table support 88 attached so that support 88 can be installed into a holding fixture ( not shown ) on the supporting structure upon which it will be supported . the essential difference between height adjustment assembly 84 and height adjustment assembly 10 of fig1 is that latches 90 are integrated with coupling 92 into coupling and latch assembly 94 . coupling and latch assembly 94 thus minimizes the number of parts and simplifies the design of changing table structure 86 . all that is required within changing table structure 86 are socket 96 ( shown with invisible lines ) within which coupling and latch assembly 94 fits and holes 98 to mate with latches 90 . as with height adjustment assembly 10 of fig1 , height adjustment assembly 84 permits changing table support 88 to slide within coupling 92 when latches 90 are depressed , and changing table structure 86 and the entire changing table are raised as coupling and latch assembly 94 slides within socket 96 . releasing latches 90 then permits them to mate with other holes 98 and hold the changing table at a different height . fig5 is a perspective view of coupling and latch assembly 94 of height adjustment assembly 84 of fig4 . latches 90 are mounted upon spring 100 so that simply pressing latches 90 in toward the center of support structure 102 flexes spring 100 and releases the latches from holes 98 in changing table structure 86 ( fig4 ). this simple mechanism on support structure 102 eliminates the need for an external latching mechanism on the changing table . it should be understood that the rectangular configuration of support 102 and the use of pairs of latches 90 and twin holes 98 ( fig4 ) are not vital to the function of height adjustment assembly 84 , and many other configurations of these structures can be used . the invention thus provides a convenient and easily manufactured height adjustment for a changing table used in conjunction with a play yard or any other supporting structure , and it requires no complex modification of the supporting structure or the changing table supports because the height adjustment assembly is external to those supports . it is to be understood that the form of this invention as shown is merely a preferred embodiment . various changes may be made in the function and arrangement of parts ; equivalent means may be substituted for those illustrated and described ; and certain features may be used independently from others without departing from the spirit and scope of the invention as defined in the following claims . for example , springs other than leaf spring 54 as shown can be used , or height adjustment fixture 11 can use holes or any other type of recesses within support structure 20 instead of slots 16 , and the latch can be a spring loaded retractable pin instead of pivoting latch 52 . furthermore , neither the changing table support nor the coupling of the height adjustment assembly need to have cylindrical cross sections , nor the coupling even be a ring , as long as they mate , can be assembled together , and the support can move within the coupling .

the apparatus is a height adjustment assembly for a child &# 39 ; s changing table with support tubes inserted into sockets at the top of a supporting structure such as a play yard . a height adjustment fixture external to the support tubes rests on top of the supporting structure and has a vertical series of recesses such as slots or holes and a ring through which the changing table &# 39 ; s support tube slides . the changing table has an attached latching device that locks into the recesses to hold the table at several heights above the supporting structure . alternate embodiments include a structure in which the height adjustment fixture contains the latching device and the recesses are in the changing table .

as seen in fig1 device 10 has a main body portion 11 comprised of corrugated plastic in which the corrugations are vertically oriented for ease of fitting to patient which includes a generally longitudinal elongated center reinforcement portion 12 which is comprised of preferably a single thickness solid vacuum molded plastic which is then permanently mounted thereon as by stapling to the central section 11 &# 39 ; of main body 11 with 1 &# 34 ; metal staples . preferably reinforcement 12 has rounded top and bottom edges 12b . depending outwardly at the top of main body 11 are head flanges 13 and 15 . these are generally rectangular of optionally double thickness with preferably round upper corners 14 and lower corners 16 . disposed intermediate the head flanges at the top and the body members 25 , 27 at the bottom of the device 10 , are the neck collars 17 , and 19 which are the next element to described . disposed just below said head flanges and also extending outwardly on either side of said center portion 12 are the neck collar members 17 and 19 . fold lines 33 and 35 which commence external to 12b , for the interior edge of both head flanges while the hard neck collar members 17 and 19 have fold lines designated 33 &# 39 ; and 35 &# 39 ;, which are in fact segments of fold lines 33 and 35 , as their interior edges . while designated fold lines , the folds will most likely transpire at time of usage . returning now to the discussion of the flanges , it is seen that the intermediate vertical fold lines 81 and 82 are spaced substantially equidistant from each other , and though by a greater distance from the outer vertical edge of each head flange to the outermost of said fold lines 81 , 82 , as well as equidistant from the respective interior fold lines 33 and 35 . optionally a throughbore 83 , 84 may be made in the head flange of about 1 &# 34 ; diameter , spaced up about 4 &# 34 ; on the first inwardly intermediate fold line 81 and 82 . these throughbores serve as a guide means for sound directed to the ears of the patient such that when the head flange is positioned as shown in fig8 the patient can still hear , since sound will not easily penetrate the closed cell foam stabilizer which is designated 90 and is described below . slots 18 and 20 , usually about 1 / 2 &# 34 ; in elevation , are situated between the bottom edge of each head flange and its adjacent collar member , to permit each to be used independently . the neck collar members 17 and 19 comprise generally outwardly extending , mirror image , 90 degree downwardly depending , boot - like portions secured to or integrally formed with central member 11 &# 39 ;. these include vertical fold lines 71 and 72 . portions 17 and 19 each include a built in triangular chin tab 51 and 52 within the upper distal corner relative to the central reinforcement portion 12 . these chin tabs may be separately padded on the front surface , e . g . with a urethane foam layer or preferably as seen in fig1 the pads extend full width across the upper edge thereof and are designated 251 , 252 . diagonal score lines 55 and 56 are used to fold back these built in chin tabs 51 and 52 to conform to the bone structure of the patient . note the angularity elsewhere in the figures of the chin tab . the boot - like portions 17 &# 39 ; and 19 &# 39 ; also have rounded edges at the lower end thereof , again to avoid injury to the patient . lower score lines 23 and 24 , are used in the positioning of the collar members 17 and 19 relative to the patient as seen in fig6 - 8 . in use , the lower score lines 23 , 24 are bent outward to allow a flat surface to press against the patient &# 39 ; s chest in order to complete the support of the collar members 17 , 19 . score lines are to be differentiated from fold lines in that score lines are diagonal , while fold lines are vertical as used herein . an optional , but preferred hemispherical cutout 29 may be made on the edge of the members 17 and 19 to permit an easy wide access to the throat should a tracheotomy be necessary . as will be understood on reading the area below pertaining to use of this invention , the disposition of the collar is key , since it serves to center the board 10 on the patient in contrast to virtually every other vest type spinal immobilization device wherein the patient is centered by the body flanges . the discussion now turns to the body members 25 and 27 , per fig1 . these single thickness body members 25 and 27 are each disposed on opposite sides of the central section 11 &# 39 ; and are preferably integrally formed therewith since they too are made of double walled corrugated plastic , preferably the same plastic material as to the head flanges and collar members preferably with the corrugations vertically oriented . body members 25 and 27 each include several segments . the first of these are l - shaped , outwardly extending mirror image segments 25a and 27a which are disposed adjacent to the central section 11 &# 39 ; as reinforced by elongated member 12 . each of these segments extends outwardly to a vertical fold line 61b and 62b respectively . the intermediate fold lines 61c and 62c respectively are vertically aligned with a pair of the exterior intermediate fold lines 81 and 82 on head flanges 15 and 13 respectively . the wing segments 25b and 27b commence along the fold lines 61b and 62b and comprise two parts . the first parts are each quadrilaterals , 125b and 127b and each extends from along fold line 61b and 62b respectively , generally outward and then upward and convexly arcuate from the bottom edge 37 , 36 of the shorter in elevation part of the l - shaped segments to fold lines 61a and 62a respectively , as well as outwardly and then concavely arcuate upward from the top edge 39 , 38 of the shorter in elevation part of the l - shaped segments to fold lines 61a and 62a ; to their terminal also at fold line 61a and 62a , which fold lines constitute the intersections of the second part of the wing segments , 225b and 227b . these wing segment second parts 225b and 227b are each generally rectangular with each of the three corners being preferably rounded for the comfort of the patient . vertical fold line 61a &# 39 ; and 62a &# 39 ; are spaced inwardly from the outer edge of the second segments , i . e . fold lines 61a and 62a . having described the structure in general , the discussion now turns to the elements used to secure the patient within the device . the actual mode to do so will be discussed infra . reference is now made to fig4 as well as to fig1 . since fig1 is the larger figure , the plurality of elongated slots for the threading of the single layer webbing belts is shown with their appropriate numerical designator . to keep the 4th figure from being cluttered , only the straps and belts have been numbered , and not the slots . it is to be seen however that the strapping used for the velcro connections , as around the head , constitutes two layered strapping . as is known , velcro is a registered trademark of velcro usa for its patented engageable and releasable multihook cloth closure . the closure employs a male hooking section and a female hook receiving section . the head flanges 13 , 15 are secured by two vertically spaced velcro straps 40 and 41 each of which is two layered . the first layer is a nylon or polyolefin on the rear , i . e . the surface designated 43 , while the front face has a co - extensive pile type layer thereupon designated 42 . each of these straps 40 , 41 , is engageable with its respective vertically spaced rock type tab 45 and 44 , which tabs are horizontally axially aligned with their respective straps . the neck collar members are secured by a single simlar velcro pile type strap 46 which engages a single velcro hook type tab 47 , after the members have been bent from a first extended position , through a second parallel position , to a third position facing each other over the upper chest of the victim ( wearer ), with the area beneath the score lines 23 and 24 bent outwardly . it is to be seen that a male velcro section can be substituted for the female on the strap and that the tab can be female , since the same closure interlock will transpire . also , there is no criticality as to left or right for the disposition of the tabs and straps . any and all of the straps may be on the left side of the rear of the device 10 or on the right rear thereof , so long as the tab is placed in the counterpart location . caution should be exercised because velcro hooks stick to anything and are abrasive on the skin . sets of two pairs of vertically elongated horizontally and vertically aligned slots designated 95au , 95bu , 95al , 95bl , 96au , 96bu , 96al , and 96bl respectively are provided in the second segments 27b and 25b . a second set of pairs of vertically and horizontally similarly sized vertically elongated slots 97au , 97bu , 97al , 97bl , 98au , 98bu , 98al & amp ; 98bl are provided in the l - shaped segments between fold lines 61c and 33 ; and between fold lines 62c and 35 respectively laterally . the second two pair of slots should be horizontally aligned with the respective upper and lower first two pair of slots , in order to receive webbing belts , to be described else where herein . in the nomenclature pertaining to elongated slots 95 through 98 inclusive , &# 34 ; a &# 34 ; designates the outer of the two slots , and &# 34 ; b &# 34 ; the inner ; while &# 34 ; u &# 34 ; and &# 34 ; l &# 34 ; designate upper or lower position . the belts are made of nylon or polyolefin webbing and are similar to those used for automobile or airplane seat belts . thus belts 48u and 48l ( upper and lower ) are threaded through the pairs of aligned elongated slots as described previously for proper disposition . the height of the slots 95au , 95bu , 95al , 95bl are large enough such that the belts 48 can be disposed in place with the tongue 49 and receptor 50 in place at opposite ends of each belt . any type of conventional tongue and appropriate receptor available in the marketplace may be employed . complete belts 48 including the tongue and receptor are readily available from several manufacturers . also seen in fig4 are a pair of vertically aligned slots which are both wider and longer than the slots discussed above . these slots 37 , 38 are designed as hand holds and are sized to receive an average human hand . a hand of an ambulance team member is placed in each hand hold 37 , 38 , during the positioning of the patient onto a stretcher , to avoid slippage due to the inherent slippery nature of the plastic material employed in the construction of device 10 . the tabs and straps may be secured in place by any conventional means , e . g . glue , staples , stitching or a combination thereof . returning now to the reinforcement member 12 , as seen in fig1 which is held in place by staples , and / or adhesive , there is superposed thereon a closed cell foam head stabilizer 90 . this head stabilizer is a u - shaped member having a central portion 91 secured as by a suitable adhesive to reinforcement member 12 adjacent rounded upper edge 12b and between 12b and the bottom of the recess 12c on 12 . extending outwardly therefrom on opposite sides are a pair 92 , 93 of extension sections that are integrally formed with central portion 91 and extend generally forward . the extension sections serve both to cushion and to better hold the head of the user in position when the head flaps are folded up around the head as shown in the drawings . the head stabilizer provides both comfort to the face and retention within the head flaps 15 , 14 . upper surface 12c is an optional recess that receives and comforts the back of the head . see fig1 . while the device can be positioned on a patient by a single rescuer , the use of two persons who are adequately trained in c - spine immobilization techniques is recommended . first , position the collar as shown in fig6 . this is achieved by bending the chin tabs 51 and 52 back at the pre - scored cuts 56 and 55 per fig1 and fig4 - 6 . the small rubber pads 252 and 251 seen in fig1 are to be placed just under the outer edges of the jaw per fig6 . if necessary bend the lower portion of the collar outward as needed to keep the neck of the patient in a neutral position . the pair of head straps 40 , 41 , which have pile type velcro thereon are brought over into engagement with the hook type velcro tabs 45 and 44 neither of these last mentioned tabs being visible in fig8 but which are seen in fig4 . next , bring the pile type strap 46 into engagement with the hook tab 45 adjusting for patients size . thirdly , the straps 48u and 48l are adjusted to accommodate the girth of the patient , by moving the tongue ends 49 along their respective belts such that the tongues can engage the receivers 50 to thereby retain the patient within the confines of the body member segments . reference is made to fig8 . as a caution , the rescuers are advised to make sure that there is no pressure being applied against the trachea or the carotid arteries or throat . one reason for elements 251 and 252 is to help avoid such pressure . the instant device is intended for either a one time usage , after which it can be discarded , due to its relatively low cost or if desired it can be used a multiplicity of times , since it is strong enough to permit same . in view of the materials employed herein , while the device is not primarily intended to be used for the vertical lifting of a sitting patient , nor for the dragging of an injured party from the scene of an incident as by pulling on the device , it may be used for such purposes on a limited basis if necessary . the corrugated double walled plastic board recommended for this device need not be dipped sprayed or otherwise coated with a waterproofing agent such as a wax or plastic coating , since the plastic layers used herein is itself is waterproof , as is the webbing used for the strapping . printed indicia such as instructions , product safety information and the like can be printed at various locations such as those marked 58 . the device of this invention , which is preferably made , except as noted , primarily from high density polyethylene corrugated plastic sheeting overlaid on each side with high density non - corrugated reinforcing panels is seen to provide the dual benefit of both c - spine immobilization , as well as providing a built in hard cervical collar to rigidity the head of an injured patient , when secured to the body using the straps as disclosed herein . since certain changes may be made in the above article without departing from the scope of the invention herein involved , it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense .

an optionally disposable lightweight , readily stored , low cost cervical spine board made of plastic corrugated board . the device has pre - cut score lines therein for folding the device around the sides of the head and around the sides of the body . head and neck tabs , and body wings are secured by straps which straps are pre - attached to the device , and which are secured by conventional lock closures similar to those used in car seat belts and other restraining devices .

fig1 illustrates a disposable active pulse sensor 100 having a body 110 , a cable 120 and a connector 130 . in an embodiment , the body 110 is configured to wrap around a fingertip . the body incorporates an emitter 210 ( fig2 ) and a detector 220 ( fig2 ) that generates a sensor signal responsive to blood oxygen saturation , as described above . advantageously , the body 110 also incorporates an active pulse element , such as an unbalanced electric motor 300 ( fig3 ) adapted to induce pulsatile blood flow in a tissue site so as to provide a sufficiently strong sensor signal for meaningful physiological measurements . as shown in fig1 , an emitter marking 140 may designate the location of the emitter 210 ( fig2 ) within the body 110 allowing easy placement of the emitter 210 ( fig2 ) over a fingernail , for example , so as to transmit optical radiation into the blood perfused fingernail bed tissue underneath . likewise , a detector marking 150 may designate the location of the detector 220 ( fig2 ) within the body 110 allowing easy placement of the detector 220 ( fig2 ) on the fingertip opposite the fingernail and the emitter 210 ( fig2 ). a housing 250 described in further detail below covers an unbalanced electric motor , which is located so as to mechanically vibrate the fingertip proximate the detector at a predetermined frequency so as to induce pulsatile blood flow at that frequency . in the illustrated embodiment , the electric motor is located behind the detector 220 ( fig2 ), i . e . such that the detector is between the electric motor and the end of the finger tip . the electric motor may also be placed at other locations relative to the detector 220 ( fig2 ). in an embodiment , the electric motor is located in front of the detector 220 ( fig2 ), i . e . such that the motor is between the detector and the end of the fingertip . in an embodiment , the electric motor is located on or near the very end of the fingertip . in an embodiment , the electric motor is located on either side of the detector 220 ( fig2 ) along the fingertip . in the illustrated embodiment , the electric motor is located immediately behind the detector 220 ( fig2 ), sharing the fingertip with the detector . in other embodiments , the electric motor is located at any of various other distances from the detector , such as between the first and second finger joints for example . in yet other embodiments , the electric motor is placed at any of various distances behind the emitter along the top of the finger . also shown in fig1 , the cable 120 provides electrical communication between the emitter 210 ( fig2 ), the detector 220 ( fig2 ), the motor 300 ( fig3 ) and the connector 130 . the connector 130 is adapted to electrically and mechanically connect the sensor 100 to a monitor 500 ( fig5 ) either directly or via a patient cable . the monitor 500 ( fig5 ) drives the emitters 210 ( fig2 ), receives the detector signal , provides physiological measurements and controls the electric motor 300 ( fig3 ), as described in further detail with respect to fig5 , below . fig2 further illustrates a disposable active pulse sensor 100 having a cable assembly 400 , a motor housing 250 and a tape assembly 203 . the cable assembly 400 has an emitter 210 , a detector 220 and an unbalanced electric motor 300 , which are interconnected to the cable 120 opposite the monitor connector 130 . the emitter 210 is configured with at least red and infrared leds that , for finger attachment , project light through the fingernail and into the blood vessels and capillaries underneath . the detector 220 is positioned at the fingertip opposite the fingernail so as to detect the led emitted light as it emerges from the finger tissues . in an embodiment , the unbalanced motor 300 is also positioned at the fingertip opposite the fingernail and configured to vibrate the fingertip while the motor 300 is activated so as to induce blood flow in the finger tissues . the motor housing 250 accommodates the motor 300 and facilitates securing the motor 300 within the tape assembly 203 . an electromagnetic interference ( emi ) shield 230 is attached to the detector 220 so as to reduce detector noise . electrically insulating tapes 240 are attached to the emitter 210 and the shielded detector 220 . the cable assembly 400 is terminated at the monitor connector 130 . a monitor 500 ( fig5 ) activates the emitter 210 and motor 300 and receives a corresponding sensor signal from the detector 220 all via the monitor connector 130 , as described in detail with respect to fig5 . as shown in fig2 , the tape assembly 203 is adapted to attach the emitter 210 , the detector 220 and the electric motor 300 to a tissue site , such as a fingertip . the tape assembly 203 has a face tape 260 , a trifold wrap 270 and a release liner 280 . the trifold wrap 270 has a center portion 271 disposed between foldable side portions 275 , which are symmetrical about the center portion 271 . the center portion 271 is attached to the emitter 210 , the detector 220 and the electric motor 300 with an emitter aperture 272 aligned so as to pass light from the emitter 210 and a detector aperture 274 aligned so as to pass light to the detector 220 . the trifold wrap 270 has a pressure sensitive adhesive ( psa ) on the component side and a patient adhesive , such as med 3044 , on the center portion 271 of the patient side . the release liner 280 is removably attached to the patient side of the trifold wrap 270 . the face tape 260 has a housing aperture 262 allowing the motor housing 250 to protrude through the aperture 262 . the face tape 260 is fixedly attached to the trifold wrap 270 and removably attached to the release liner 280 . in one embodiment , the trifold wrap 270 is polypropylene and the face tape 260 is a laminate . in other embodiments , not shown , a disposable active pulse sensor utilizes a flexible circuit for physical and electrical attachment and interconnection of the emitter , detector and unbalanced electric motor components . the flexible circuit may have an integrated connector for attachment to a sensor cable or patient cable , which communicates with a monitor or the flexible circuit may be soldered to or otherwise permanently attached to an integrated sensor cable . further , in other embodiments , the tape assembly may be layered without a tri - fold wrap , or the sensor assembly may have a tissue attachment mechanism in lieu of or in addition to adhesive tape . in other embodiments , the disposable active pulse sensor may include multiple emitters , multiple detectors or multiple unbalanced motors or combinations of such multiple components . the emitter ( s ) may incorporate light sources other than or in addition to leos , such as laser diodes or fiber optics transmitting light from an external source . the leos or other light sources may emit light having multiple wavelengths in addition to or instead of pulse oximetry - related red and infrared wavelengths . for example , multiple wavelengths emitters may be utilized with a disposable active pulse sensor for the detection of blood constituents other than oxyhemoglobin and reduced hemoglobin and for the measurement of blood parameters other than oxygen saturation , such as carboxyhemoglobin ( hbco ), methemoglobin ( hbmet ) and other abnormal hemoglobin constituents . other blood parameters that may be measured to provide important clinical information are fractional oxygen saturation , total hemaglobin ( hbt ), bilirubin and blood glucose , to name a few . in other embodiments , a disposable active pulse sensor is configured as a reflectance or transflectance sensor . other embodiments may be configured to attach to other tissue sites rather than a fingertip , such as ear , nose , forehead , foot , cheek and lip sites , to name a few . further , other embodiments of a disposable active pulse sensor may have additional components to those described above , such as an information element ( ie ) as described in u . s . patent application ser . no . 11 / 367 , 036 , filed mar . 1 , 2006 and entitled configurable physiological measurement system , or a sensor life indicator ( sli ), as described in u . s . pat . no . 7 , 186 , 966 entitled amount of use tracking device and method for medical product , both incorporated by reference herein . fig3 illustrates an unbalanced electric motor 300 having a motor body 320 , a rotary shaft 340 and an unbalanced flywheel 360 . the motor body 320 is generally cylindrical and accommodates the shaft 340 , which extends along a center axis of the body 320 . electrical leads 380 extend from the body 320 opposite the shaft 340 so as to electrically connect the motor 300 to the cable 120 ( fig1 ). when the motor 300 is activated by a monitor 500 ( fig5 ) via the cable 120 ( fig1 ), the shaft 340 rotates the flywheel 360 . in an embodiment , the flywheel 360 is a generally semi - circular disc centrally mounted to the shaft 340 . when the shaft 340 rotates , the flywheel &# 39 ; s eccentric imbalance causes the motor as a whole to vibrate at a predetermined frequency according to the motor rotational speed . this vibration “ pulses ” a tissue site , which creates a pulsatile blood flow . in other embodiments , the unbalanced motor 300 is configured with rotational elements other than the semi - circular flywheel , such as a circular flywheel composed of two or more materials of differing weights or densities , or an otherwise unsymmetrical flywheel . in other embodiments , the unbalanced motor is replaced with an alternative , electrically - activated vibrating component such as a piezo - electric element . fig4 illustrates a cable assembly 400 having an emitter 210 , a detector 220 , an unbalanced electric motor 300 and a cable 120 . the cable 120 has an emitter portion 122 , a detector portion 124 and a motor portion 126 . a pair of emitter wires 123 extend from the emitter portion 122 and are soldered to corresponding emitter leads 212 . a pair of detector wires 125 extend from the detector portion 124 and are soldered to corresponding detector leads 222 . a pair of motor wires 127 extend from the motor portion 126 and are soldered to corresponding motor leads 380 . the cable wires 123 , 125 , 127 terminate at the monitor connector 130 ( fig2 ). fig5 illustrates a patient monitoring system 500 that generates one or more blood parameter measurements , such as sp02 , perfusion index ( pi ), hbco , hbmet , and hbt , to name a few . the patient monitoring system 500 is adapted to trigger an active pulse sensor as needed . in one embodiment , an active pulse is advantageously triggered when the monitor measures poor perfusion at the tissue site . in a particular embodiment , the active pulse is activated by a pi measurement below a predetermined threshold and deactivated between successful measurements . in an embodiment , an active pulse is triggered upon any measure indicating poor signal strength or signal quality . signal quality and data confidence measures are described in u . s . pat . no . 6 , 996 , 427 entitled pulse oximetry data confidence indicator , assigned to masimo and incorporated by reference herein . in an embodiment , an active pulse is triggered to induce a venous blood pulse so as to measure venous oxygen saturation or related venous blood parameters . also shown in fig5 , the patient monitor 502 communicates with the sensor 100 to receive one or more intensity signals indicative of one or more physiological parameters . drivers 510 convert dig ital control signals into analog drive signals 512 capable of driving the emitter 210 . a front - end 520 converts composite analog intensity signal ( s ) 522 from the detector ( s ) 220 into digital data input to the dsp 540 . the dsp 540 comprises any of a wide variety of data and signal processors capable of executing programs for determining physiological parameters from input data . the dsp 540 generates an activation signal 532 from a motor driver 530 to the electric motor 300 when an active pulse is needed or desired . in an embodiment , the patient monitoring system 500 controls the active pulse so as to accentuate a natural , heart - induced pulse . in particular , the patient monitor 502 generates an activation signal 532 so that an active pulse frequency and phase matches the frequency and phase of the natural pulse . in an embodiment , the dsp 540 executes a phase - locked - loop algorithm that has as inputs the natural pulse and the induced active pulse as derived from the detector signal 522 and an output that controls the activation signal 532 accordingly . the instrument manager 560 may comprise one or more microcontrollers providing system management , such as monitoring the activity of the dsp 540 . the instrument manager 560 also has an input / output ( i / o ) port 568 that provides a user and / or device interface for communicating with the monitor 502 . in an embodiment , the i / o port 568 provides threshold settings via a user keypad , network , computer or similar device , as described below . further shown in fig5 are one or more user i / o devices 580 including displays 582 , audible indicators 584 and user inputs 588 . the displays 582 are capable of displaying indicia representative of calculated physiological parameters such as one or more of a pulse rate ( pr ), plethysmograph , perfusion index ( pi ), signal quality and values of blood constituents in body tissue , including for example , oxygen saturation ( sp02 ), carboxyhemoglobin ( hbco ) and methemoglobin ( hbmet ). the monitor 502 may also be capable of storing or displaying historical or trending data related to one or more of the measured parameters or combinations of the measured parameters . the monitor 502 may also provide a trigger for the audible indictors 584 , which operate beeps , tones and alarms , for example . displays 582 include for example readouts , colored lights or graphics generated by leds , lcds or crts to name a few . audible indicators 584 include speakers or other audio transducers . user input devices 588 may include , for example , keypads , touch screens , pointing devices , voice recognition devices , or the like . a disposable active pulse sensor has been disclosed in detail in connection with various embodiments . these embodiments are disclosed by way of examples only and are not to limit the scope of the claims that follow . one of ordinary skill in art will appreciate many variations and modifications .

a disposable active pulse sensor has an emitter that generates optical radiation having a plurality of wavelengths , a detector that is responsive to the optical radiation and an unbalanced electrical motor that vibrates when energized . a tape assembly removably attaches the emitter , the detector and the unbalanced electrical motor to a tissue site . the tape assembly also physically mounts the emitter , the detector and the unbalanced electrical motor in a spatial arrangement so that vibration from the unbalanced electrical motor induces pulsatile blood flow within the tissue site , the emitter transmits the optical radiation into the tissue site and the detector generates a sensor signal responsive to the intensity of the optical radiation after attenuation by the pulsatile blood flow within the tissue site .

in accordance with the present invention , there is provided a solid pesticidal composition which contains a microbial propagule and an agriculturally - acceptable carrier and is obtained by a dry compaction process . the present invention also provides sprayable liquid containing the dispersed pesticidal composition , methods of using the solid pesticidal composition as well a process for making the solid pesticidal composition . the solid pesticidal composition described herein is advantageous because it is safe to use on plants ( e . g ., in some embodiments , it is not phytotoxic ), it limits particle exposure to the end - user during pre - application steps ( e . g ., mixing ), it can include a surfactant or a disintegrant , it can be designed for organic crop production and it can be stored without substantially altering its pesticidial activity . throughout this application , various terms are used according to their plain meaning in the art . however , for purposes of clarity , some of terms are more precisely defined herein . granulation . as used herein , the term “ granulation ” refers to the act or process of forming grains from a mixture of at least two components . granulation can be achieved through wet granulation , extrusion or spheronisation as well as dry granulation . the expression “ wet granulation ” refers to a granulation process which is performed in the presence of a granulating fluid ( usually an aqueous liquid or water ). the components are usually dry mixed first and than put into contact with the granulating fluid ( through direct addition or spray ). afterwards , the granules are formed either by low - shear granulation , high - shear granulation and fluid bed granulation . the granules are then preferably dried and optionally submitted to further processing such as compaction . alternatively , the expression “ dry granulation ” ( also referred to as “ dry compaction ”) refers to a granule - making process which is performed in the absence of a granulating fluid . dry granulation involves the aggregation of particles by high press to form bonds between particles by virtue of their close proximity . forming granules without moisture requires the compacting / densifying elements . dry granulation can be achieved by the use of an hydraulic press ( to form directly a solid shape composition ) or by roller compaction ( to form a sheet of material which can be further processed into a solid shape composition ). compaction . as used herein , the term “ compaction ” refers to a process for formulating a pesticidal composition in which all the components of the composition are mixed and submitted to a compaction force . in a preferable embodiment , the compaction process is a dry compaction process ( either through hydraulic press or roll compaction ) where solid pesticidal compositions are obtained through a dry granulation process . compaction force . a force ( in kg ) applied during the compaction process to make a solid form from the powder . granule . as used herein , the term “ granule ” is intended to refer to a formulation consisting of an active ingredient ( e . g ., a pesticide ) combined with a carrier and which has not been submitted to a dry compaction process . hardness level . a mass ( in kg ) used to measure the crush resistance of end product solid formulation . propagate . as used herein , the term “ propagule ” is intended to refer to a material that can used for the purpose of propagating an organism to the next stage in their life cycle via dispersal . the propagule is usually distinct in form from the parent organism . microbial propagules can be produced by fungi , protozoa and bacteria . bacterial and fungal propagules produce microbial spores . as it is known in the art , “ spores ” are reproductive structures , usually adapted for dispersal and surviving for extended periods of time in unfavorable conditions . fungal propagule also include conidia ( also termed conidiospores or mitospores ) which are asexual non - mobile spores . surfactant . as used herein , this term refers to agents capable of reducing surface tension between the pesticide and the liquid phase to which it is being admixed or between the pesticide solution and the plant surface . surfactants may act as detergents , wetting agents , emulsifiers , foaming agents and / or disintegrants . surfactants are usually amphophilic organic compounds . wettable powder : as used herein , the term “ wettable powder ” or wp is intended to refer to a formulation consisting of an active ingredient ( e . g . a pesticide ) in a finely ground state combined with different adjuvants ( e . g ., wetting agents , stabilizing agents ) and bulking agents . the surfactants or disintegrants used facilitate the dispersion of wettable powders into water . wettable powers are designed to be applied as a dilute ( usually aqueous ) suspension through liquid spraying equipment . as wettable powders are not mixed with water until immediately before use , storing and transporting the products is simplified as the weight and volume of the water is avoided . wettable powders may be supplied in bulk or in measured sachets made from water soluble film to simplify premixing and reduce operator exposure to the product . traditionally , pesticides such as insecticides are formulated as either wettable powders or granules . the pesticidal composition described herein is a solid compacted formulation for pesticides , such as insecticides , it distinguishes from existing wettable powders and granules because it provides little to no dust ( during storage , handling or dispersion in water ). this reduction / elimination of dust increases the safety of the composition because it reduces the risk of inhalation of the insecticide by the end users . in some embodiments , the pesticidal composition is less bulky ( in some embodiments three times less bulky ) then comparable wettable powder formulations and is therefore more suited for packaging and transportation . further , because the pesticidal composition of the invention is compressed / compacted during its manufacture , it can be designed in any shape or form . for example , it can be compacted into a tablet ( also referred to as a bar or a briquette ) which can facilitate dispensing . in addition , because the pesticidal composition uses a water - dispersible agricultural carrier , in some embodiment , it can be easily dispersed in cold water without the use of surfactants . in some embodiments , the pesticidal composition can be stored for several months ( in some embodiments up to 12 months ) at room temperature without lost or reduction of pest - control efficacy . in other embodiment , suspendibility ( e . g ., percentage of sediment weight to total weight ) of the pesticidal composition can be 88 - 77 % w / w . in another embodiment , the suspendibility is 72 . 3 ± 11 . 2 % ( mean ± 95 % cl ). in embodiments , wetting time ( e . g ., time required for completing wetting of the composition ) is 22 - 28 sec . in an alternative embodiment , the wetting time is 25 . 7 ± 8 . 0 sec ( mean ± 95 % cl ). further , as it will be shown below , the pesticidal composition can also be used in organic crop production . it can be designed to use only organic - acceptable components which will be specific for some target pests , will not harm beneficial insects ( parasites and predators ) of those targets pests , will not be phytotoxic and / or will not be harmful towards bees . the solid pesticidal composition of the invention is obtained by submitting a mixture of dry components to a compaction process ( hydraulic press or roll compaction , for example ). the mixture comprises ( or consists of ) a microbial propagule and a water - dispersible agriculturally acceptable carrier and can include a surfactant and / or a disintegrant . the mixture optionally further comprises ( or includes ) a water dispersant , and / or a binder . the process for obtaining the solid pesticidal composition does not include ( or lacks ) the use of a granulating fluid to the dry mixture and / or a drying step of the granules prior to compaction . the process does not include ( or lacks ) a heating step for preparing the granules as currently required in a wet granulation process . in a further embodiment the solid pesticidal composition of the invention is an effervescent solid formulation which can be produced the same way as the conventional solid formulation requiring humidity control to control the effervescent reaction and packaging restrictions . the first component of the pesticidal composition is a pesticide , and in some embodiment , the pesticide is an insectide . as used herein , the term “ pesticidal agent ” refers to an agent capable of deterring , incapacitating , killing or otherwise discouraging plant pest , such as , for example , insects . the pesticidal composition described herein are especially advantageous for deterring , incapacitating , killing or otherwise discouraging phytophagous insects . examples phytophageous insects include , but are not limited to , insects of the isopoda order ( e . g . oniscus asellus , armadium vulgare , porcellio scaber ), from the diplopoda order ( e . g . blaniulus guttulatus ), from the chilopoda order ( e . g . geophilus carpophagus , scutigera spp . ), from the symphyla order ( e . g . scutigerella immaculate ), from the thysanura order ( e . g . lepisma saccharina ), from the collembola order ( e . g . onychiurus armatus ), from the orthoptera order ( e . g . latta orientalis , periplaneta americana , leucophaea maderae , blattella germanica , acheta damomesticus , gryllotalpa spp ., locusta migratoria migratorioides , melanoplus differentialis , schisterocerca gregaria ), from the dermaptera order ( e . g . forficula auricularia ), from the isoptera order ( e . g . reculitermes spp ), from the anoplura order ( e . g . phylloxera vastatrix , pemphigus spp ., pediculus humanus corporis , haematopinus spp ., linognathus spp . ), from the mallophaga order ( e . g . trichodectes spp ., damalinea spp . ), from the thysanoptera order ( e . g ., hercinothrips femoralis , thrips tabaci ), from the heteroptera order ( e . g . eurygaster spp ., dysdercus intermedius , piesma quadrata , cimex lectularius , rhodnius prolixus , triatoma spp . ), from the homoptera order ( e . g . aleurodes brassicae , bernisia tabaci , trialeurodes vaporariorum , aphis gossypii , brevicoryne brassicae , cryptomyzus ribis , doralis fabae , doralis pomi , erisoma lanigerum , hyalopterus aruadinis , macrosiphum avenae , myzus spp ., phorodon humuli , rhopalosiphum padi , empoasca spp ., scotinophora coarctata , drasicha mangiferae , euscelis bilobatus , nephotettix cincticeps , lecanium corni , saissetia oleae , laodelphax striatellus , nilaparvata lugens , aonidiella aurantii , aspidiotus hederae , pseudococcus spp ., psylla spp . ), from the heteroptera order ( e . g . lygus spp ., nezara viridula , drasicha mangiferae , euschistus spp . ), from the lepidoptera order ( e . g . pectinophora gossypiella , bupalus piniarius , chemimatobia brumata , lithocolletis blancardella , hyponomeuta padella , plutella maculipennis , malacosoma neustria , euproctis chrysorrhoea , lymantria spp ., diathrea sacharalis , bucculactrix thurberiella , phyllocnistis citrella , agrotis spp ., euxoa spp ., feltia spp ., earias insulana , heliothis spp ., laphygma exigua , mamestra brassicae , panolis flammea , prodenia litura , spodoptera spp ., trichoplusia ni , carpocapsa pomonella , ostrinia spp ., perileucoptera coffeella , pieris spp ., chilo spp ., pyrausta nubilalis , ephestia kuehniella , galleria mellonella , tineola bisselliella , tinea pellionella , hofmannophila pseudospretella , cacoecia podana , capua reticulana , choristoneura fumiferana , clysia ambiguella , homona magnanima , tortrix viridana , dendrolimus spp ., laspeyresia pomonella ), from the coleoptera order ( e . g ., anobium punctatum , hypothemenus hampei , pityogenes chalcographus , cyrlomon luridus , xyleoterus lineatus , ips typographus , rhizopertha dominica , bruchidius obtectus , acenthoscelides obtectus , hylotrupes bajulus , agelastic alni , leptinotarsa decemlineata , phaeddn cochleariae , diabrotica spp ., psylliodes chrysocephala , epilachna varivestis , atomaria spp ., oryzaephillus surinamensis , anthonomus spp ., sitophilus spp ., otiorrhynchus sulcatus , sitona lineatus , cosmopolites sordidus , ceuthorrhynchus assimilis , hypera postica , dermestes spp ., trogoderma spp ., anthrenus spp ., attagenus spp ., lyctus spp ., meligethes aeneus , ptinus spp ., niptus hololecus , gibbium psylliodes , tribolium spp ., brontispa longissima , tenebrio molitor , agriotes spp ., conoderus spp ., melolontha melolontha , sphenophorus - levis , amphimallon solstitialis and costelytra zealandica ), from the hymenoptera order ( e . g . diprion spp ., hoplocampa spp ., lasius spp ., monomorium pharaonis , vespa spp .) from the diptera order ( e . g . aedes spp ., anopheles spp ., culex spp ., drosophila spp ., musca spp ., fannia spp ., calliphora erythrocephala , lucilla spp ., chrysomyia spp ., cuterebra spp ., gastrophilus spp ., hypobosca spp ., glossina moritans , stomoxys spp ., oestrus spp ., hypoderma spp ., tabanus spp ., tannia spp ., bibio hortulanus , oscinella frit , phorbia spp ., pegomyia hyoscyami , ceratitis capitata , dacus oleae , tipula paludosa ), from the siphonaptera order ( xenopsylla cheopis , ceratophyllus spp ), from the arachnida order ( e . g . scorpio maurus , latrodectus mactans ), from the acarina order ( e . g . acarus siro , argas spp ., ornithodoros spp ., dermanyssus gallinae , eriophyes ribis , phyllocoptruta oleivora , boophilus spp ., rhipicephalus spp ., amblyomma spp ., hyalomma spp ., ixodes spp ., psoroptes spp ., chorioptes spp ., sarcoptes spp ., tarsonemus spp ., bryobia praetiosa , panonychus spp ., tetranychus spp .). in an embodiment , the pesticide is specific for a single order , a single species or a single genus of insects . alternatively the insecticide can have a broader toxicity spectrum and be entomopathogenic towards more than one order , more than one species or more than one genus of insects . in an embodiment , the insecticide of the pesticidal composition is specific for phytophageous insects and is harmless ( e . g ., fails to show toxicity ) against predators or parasites of phytophageous insects and / or bees . in another embodiment , the pesticide of the pesticidal composition preferably does not induce cytotoxic effects in the plant to which it is feeing applied . for example , in some embodiments , the pesticidal composition is not considered phytotoxic to plants of different families such as solanaceae , brassicaceae , asteraceae , poaceae and / or fabaceae . the pesticidal agent is provided in an agriculturally effective amount ( dose ) effective in mediating the reduction of pest density below a crop injury level and , in some embodiments , can lead to the eradication of the presence of a pest in a plant or crop . it is also to be understood herein that a “ agriculturally effective amount ” may be interpreted as an amount giving a desired agricultural effect , either applied in one dose or in any dosage , applied alone or in combination with other agents . the pesticide of the pesticidal composition must be amenable to compression and retain its pesticidal activity once compressed into a solid form . further , since the composition are obtained through a process performed in the absence of a granulating liquid or the application of heat , the pesticide of the composition can be heat and / or moisture sensitive . one of the pesticides that can be advantageously used in the pesticidal composition is a microbial propagule . microbial propagules ( such as bacterial and / or fungal propagules ) have been shown to be efficient to control pest without exhibiting cytotoxic or phytotoxic effects against the plants to which they are being applied . in one embodiment , the microbial propagule is a fungal propagule , for example , a propagule from an entomopathogenic fungus . one of the entomopathogenic fungus propagule that can be advantageously used in the pesticidal composition is the conidia of beauveria bassiana ( balsamo ) vuillemin ( hypocreales ). an advantage of using b . bassiana &# 39 ; s over other entomopathogenic microorganisms is its ability to infect the insect through both ingestion and contact , thus making the eggs , larvae , pupae and adults as well as diapausing stages sensitive to b . bessiana - based fungal preparations . upon contact with the insect &# 39 ; s cuticle , the fungal infectious unit , the conidiospore , germinates and penetrates the tegument combining mechanical pressure and enzyme action on the cuticle . in the insect &# 39 ; s tissues and hemolymph , the fungus produces hyphae , which invade the insect and provoke its death . one strains of b . bassiana ( strain ant - 03 or isolate ccfc 242052 of the canadian collection of fungal cultures ) is highly pathogenous for its target pests . such target pests include , but are not limited to , tarnished plant bugs ( l . lineolaris ), whiteflies ( aleyrodoidea ), aphids ( homoptera : aphididae ), thrips ( thysanoptera ), strawberry bud weevils ( anthonomus signatus ( say ) ( coleoptera : curculionidae )), and stripped cucumber beetles ( acalymma vittatum ( coleoptera : chrysomelidae )). this b . bassiana strain is also considered non toxic to most predatory insects in the ecosystem ( for example , coleoptera : coccinellida ( coleomegilla maculata lengi timb . ), neuroptera : chrysopidae ( chrysoperla rufilabris ), hemiptera : pentatomidae ( perillus bioculatus ( f . )), green lacewing , the twospotted stink bug ). this b . bassiana strain is also considered non - toxic towards bees . in an embodiment , if is possible to use a fungal propagule from a single species , a single genus or a single strain of entomopathogenic fungus . alternatively , it is also possible to use a propagule from a combination of more than one species , more than one genus or more than one strain of entomopathogenic fungus . exemplary entomopathogenic fungus include , but are not limited those from the hypocreales of the ascomycota order ( e . g ., beauveria spp ., metarhizium spp ., nomuraea spp ., paecilomyces spp ., hirsutella spp ., cordyceps sp .) as well as entomophthorales of the zygomycota order ( e . g ., entomophthora spp ., zoophthora spp ., pandora spp ., entomophaga spp .). additional species from which a fungal propagule can be included in the pesticidial composition include , but are not limited to , beauveria brongniartii , metarhizium anisopliae ( metschn . ), metarhizium anisopliae var . acridium , aschersonia aleyrodis , sporothrix insectorum , isaria fumosorosea , lecanicillium spp ., verticillium spp ., tolypocladium spp ., paecilomyces spp ., nomuraea spp ., hisutella spp ., culcinomyces spp ., sorosporella spp ., fusarium spp ., trichoderma spp . and / or exserohilum spp . in one embodiment , the fungal propagule comprises ( or consists of ) a conidia from a beauvaria sp . in an alternative embodiment , the fungal progagule comprises ( or consists of ) a plurality of conidiae from different entomopathogenic fungi . in still another embodiment , the microbial propagule is considered hydrophobic . as is known in the art , the hydrophobicity of a microbial propagule can vary from strain to strain and also depends from abiotic factors ( such as ph , temperature , etc .). in some embodiment , the hydrophobicity of b . bassiana propagules can have an hydrophobicity ranging between about 60 to 80 percent based on the salt - mediated aggregation and sedimentation test ( sas ). in some embodiment , the weight percentage of the microbial propagule ( with respect to the total weight of the pesticidal composition ) is between 15 to 25 %, 16 to 24 %, 17 to 23 %, 18 to 22 % or 19 to 21 %. in optional embodiments , the weight percentage of the microbial propagule ( with respect to the total weight of the pesticidal composition ) is about 20 %. the second component of the pesticidal composition also comprises an agriculturally acceptable carrier . as used herein , the term “ agriculturally acceptable ” carrier refers to an acceptable carrier that may be applied to a crop without inducing toxicity to the crop . the term also refers to its ability not to interfere ( e . g ., destroy ), the biocidal activity of the pesticide . in the context of the present invention , the agriculturally acceptable carrier retains its agriculturally acceptable properties even when it is submitted to compaction and / or compression to form the solid pesticidal composition . still in the context of this invention , the agriculturally acceptable carrier in its compressed / compacted form is dispersible in water ( e . g . distribute into finer particles in water ). in some embodiments , the agriculturally acceptable carrier can be used to facilitate the dispersion of the pesticide in a sprayable liquid . in some embodiments of the pesticidal composition described herein , the agriculturally acceptable carrier is used not only to provide a pesticidal composition in a solid compacted form , but can also be used as an insect repeller . in this embodiment the resulting pesticidal composition provides a dual - mode of action where the microbial propagule limits the viability of the target pests ( by , for example , colonizing and killing the target pests ) and the agriculturally acceptable carrier repels targets pests from the crop . in other ( complementary or alternative ) embodiments , the agriculturally acceptable carrier can protect the microbial propagule from harsh environmental conditions once it has been applied on crops . in some embodiment , the weight percentage of the agriculturally acceptable carrier ( with respect to the total weight of the pesticidal composition ) is between 50 to 70 %, 55 to 70 %, 60 to 70 %, 62 to 70 % or 50 to 62 %, 56 to 62 %, 60 to 62 %. in optional embodiments , the weight percentage of the carrier ( with respect to the total weight of the pesticidal composition ) is about 52 %. in one embodiment , the agriculturally acceptable carrier is cellulose that acts as an inert material and a binder facilitating dry compaction . binders are normally necessary in effervescent solid formulations to bring their hardness to a point where handling is possible . the ideal amount of binder is one that makes the formulation herd enough to handle , but soft enough to disintegrate . the weight percentage of cellulose may be between 5 % to 15 %. in an advantageous embodiment , a clay can be used as the agriculturally acceptable carrier . clays are amenable of being mixed with the microbial propagule and submitted to dry compaction to form the solid pesticidal composition . in addition , some clays are also known to have insect - repelling properties . further , some clays are also recognized as useful for protecting microbial propagules from harmful ultra - violet rays . the use of clays into organic crop production has also been recognized . exemplary clays include , but are not limited to the kaolin clay , kaolinite , bentonite , montmorillonite and / or attapulgite . in the pesticidial composition . in an embodiment , a single clay is used . in an alternative embodiment , a combination of more than one clay is used . the pesticidal composition can optionally comprise an additional water dispersant . such dispersant can be used to facilitate the water dispersion of the pesticidal composition . as indicated above , the pesticidal compositions described herein are free of surfactants and / or disintegrate and as such , the additional water dispersant is not a surfactant or a disintegrate . similar to the carrier , the water dispersant must also be agriculturally acceptable and amenable to compression / como paction . in some embodiment , the additional water dispersant can play a dual role of protecting the pesticide from harsh environmental conditions and thereby increase of prolong its biocidal activity as well as facilitating its dispersion in a sprayable liquid . in some embodiments , the weight percentage of the additional water dispersant ( with respect to the total weight of the pesticidal composition ) is between 10 to 25 %, 12 to 23 %, 14 to 21 %, 15 to 20 % or 16 to 19 %. in optional embodiments , the weight percentage of the additional water ( with respect to the total weight of the pesticidal composition ) is about 17 %. exemplary water dispersant includes , but are not limited to starch such as a water - soluble starch . some water soluble starch are known to facilitate water dispersion of hydrophobic components ( such as for example hydrophobic microbial propagule ) as well as to protect microbial propagule from harmful ultra - violet rays . some water soluble starches are also used in organic crop production . water - soluble starches include , but are not limited to , corn starch , rice starch , barley starch , wheat starch and / or potato starch . in an embodiment , a single starch ( e . g ., corn starch , rice starch , barley starch , wheat starch or potato starch ) is used . in an alternative embodiment , a combination of more than one starch ( e . g ., corn starch , rice starch , barley starch , wheat starch and / or potato starch ) is used . in the effervescent embodiment of the present invention the water dispersant may include calcium carbonate ( gaco 3 ), in either a granulated or powder form , in combination with citric acid . citric acid acts as a disintegration agent in combination with caco 3 by producing the effervescent effect . effervescence is the reaction ( in water ) of acids and bases producing carbon dioxide . in the embodiment caco 3 releases the carbon dioxide producing effervescence or bubbling effect when the formulation comes in contact with water with the citric acid . the carbon dioxide causes the formulate disintegrations . concentrations of the citric acid are preferrably greater than caco 3 in order to provide proper effervescence . caco 3 may also provide sun screening properties . the weight percentage of calcium carbonate may be between 5 % to 15 % and the weight percent of citric acid may be between 10 % to 30 % so that the ratio of citric acid to calcium carbonate is 2 : 1 . the weight percent of starch may be between 3 % to 10 %. the effervescent solid pesticidal composition allows for safer handling of the composition in comparison with a powder form and does not require bulky transportation . furthermore it is easy to disperse in cold water due to the effervescence effect and is not phytotoxic . it has improved active ingredient efficacy due to sun screening effect from clay , calcium carbonate and starch , and has an improved shelf life of the active ingredient due to presence of kaolin clay as spore protectant and calcium carbonate as a desiccant . the pesticidal composition can optionally comprise a binder or a sticking agent . such binder or sticking agent can be used to increase the cohesion of the components of the pesticidal composition . similar to the carrier , the binder or sticking agent must also be agriculturally acceptable and amenable to compression / compaction . even though the use of a binder can delay the water dispersion of the carrier , it must not prevent the carrier from being dispersed in water ( and optionally in cold water ). the binder can also be selected to further protect or stabilize the insecticide by , for example . increasing its rain fastness . some binders used in organic crop production can also be incorporated in the pesticidal composition described herein . in some embodiment , the weight percentage of the binder ( with respect to the total weight of the pesticidal composition ) is between 0 . 5 to 5 %, 0 . 5 to 4 %, 0 . 5 to 3 %, 0 . 5 to 2 %, 0 . 5 to 1 % or between 1 to 5 %, 1 to 4 %, 1 to 3 %, 1 to 2 %. in optional embodiments , the weight percentage of the binder ( with respect to the total weight of the pesticidal composition ) is about 1 %. in one embodiment , the binder is a gum . gums are known to be amenable to compaction , can provide binding in a dry composition , can be selected for organic crop production and some have been shown to increase the rain fastness of microbial propagule ( such as fungal propagule ). exemplary gums include , but are not limited to xanthan gum . emultex ™ ( a low viscosity natural gum ), acacia gum , and / or sodium alginate and carrageenan . in an embodiment , a single binder or gum is used in the preparation of the pesticidal composition . in an alternative embodiment a combination of more than binder or gum is used in the preparation of the pesticidal composition . the pesticidal composition can optionally comprise a surfactant . such a surfactant can be used to decrease surface tension between the solid components of the pesticidal composition and aqueous solution . the surfactant must also be agriculturally acceptable and amenable to compression / compaction . tween ™ is a detergent that provides surfactant properties to the composition , lowering surface tension between solids and liquid when the formulation is dispersed into a liquid solution . another aspect of the surfactant is that it acts as a stabiliser of fungal conidia during storage . the weight percent of tween ™ may be between from 0 . 3 % and 1 %. polyethylene glycol ( peg ) is a water - soluble molecule , which can be coupled to hydrophobic molecules to produce a non - ionic surfactant . peg acts as a surfactant , reducing surface tension between solid components of the mixture and liquid when dispersed in aqueous solution . peg can act not only a surfactant , but also as a water - soluble lubricant for the effervescent solid formulations , especially important during dry compaction process . polyethylene glycol has a low toxicity and is used as a lubricating coating for various surfaces in aqueous and non - aqueous environments . the weight percent of polyethylene glycol maybe between from 3 % and 10 %. depending on the intended , uses of the solid pesticidal composition , additional components can be added , such as , for example , a fertilizer , etc . these additional components are preferably amenable to compaction , agriculturally acceptable and can be used in organic crop production . the solid pesticidal composition of the invention is not to be applied to a plant or a crop as a solid , it is preferably dispersed within a sprayable liquid which can be applied to the aerial parts of the plant and / or the roots . it is understood that the pesticidal composition cannot be solubilised into the sprayable liquid due to the hydrophobic nature of its main components . however , in the presence of a sprayable liquid , the components of the solid pesticidal composition are dispersed within the liquid . in an embodiment , the solid pesticidal composition is optionally provided as a tablet or briquette with marks associated to a specific weight of the pesticidal composition . as such , the user can easily determined ( without weighing the pesticidial composition ) the amount of the pesticidal composition that should be dispersed into the sprayable liquid . in one embodiment , the sprayable liquid is aqueous and the solid composition is mixed with the sprayable liquid to form an aqueous sprayable liquid . in some embodiments , the concentration of the pesticidal composition in the sprayable liquid is between about 1 to 6 g per l . in alternative or complementary embodiments , the concentration of the microbial propagules in the sprayable liquid is between about 1 × 10 7 to 1 × 10 9 propagules / ml or between about 1 × 10 10 to 1 × 10 12 propagules / ml . the aqueous sprayable liquid can be water and even cold wafer ( e . g ., at a temperature between about 15 ° c . to about 24 ° c . or between about 15 ° c . to about 18 ° c .). this aqueous sprayable liquid can be advantageously applied to plants / crops growing in an environment having an ambient temperature of less than about 30 ° c . and a relative humidity higher than about 40 %. in an alternative embodiment , the sprayable liquid is an oil - in - water emulsion of the solid pesticidal composition . the oil - in - wafer emulsion is obtained by combining a mixture of an oil and a surfactant to an aqueous sprayable liquid having dispersed components of the pesticidal composition . the weight / weight concentration of the oil / surfactant mixture in the oil - in - water emulsion is between about 0 . 5 to 2 %, and preferably 1 %. the oil in the oil / surfactant mixture can be a mineral oil or vegetable oils ( such as for example , a rapeseed oil , a corn oil , a sunflower oil ) or a mixture of a vegetable and / or mineral oils . the weight concentration of the oil in the oil / surfactant mixture is between about 95 to 88 %, and preferably 96 %. the surfactant of the oil / surfactant mixture is a non - ionic surfactant and preferably results in an hydrophile - lipophile balance ( hlb ) of the resulting oil - in - water emulsion between 8 to 16 , and even more preferably of 12 . the surfactant of the oil / surfactant mixture can be a single surfactant ( such as , for example , twen - 40 ™, tween 60 ™, tween 65 ™, tween 80 ™, span 20 , span 80 or myrj 49 , brij 97 , merpol , igepal , hydroponix ™ and peg ) or a combination of surfactants ( such as , for example , a combination of twen 40 ™, tween 60 ™, tween 65 ™, tween 80 ™, span 20 , span 80 or myrj 49 , brij 97 , merpol , igepal , hydroponix ™ and / or peg ). an advantageous combination of surfactants is a mixture of tween 80 ( at a weight concentration of between about 78 to 82 %, preferably 80 % of the total combination of surfactants ) and span 80 ( at a weight concentration of between about 18 to 22 %, preferably 20 % of the total combination of surfactants ). in combination or alternatively , the surfactant can be a lecithin , such as , for example , a soy lecithin . alternatively , the surfactant can be hydroponix ™. once the solid pesticidal composition has been admixed with the sprayable liquid , it is applied to the aerial part ( s ) of the plant and / or roots for preventing / limiting pest . because the solid pesticidial composition comprises a microbial propagule ( and in a preferred embodiment , a fungal propagule ), the sprayable liquid is preferably not applied simultaneously with fungicides . as indicated herein , the solid pesticidal composition is obtained through dry granulation or dry compaction . the solid pesticidal composition will disperse faster in water than other formulations ( such as wettable powders or granules produced by wet compaction ) due , in part , to the low - binding properties of the components used and inter - particle air removal during compaction . the any granulation or dry compaction process also limits viability diminishing of the microbial propagules by significantly reducing the manipulation of the components and avoiding the use of a granulating liquid and drying of the product . the dry granulation or dry compaction process is particularly advantageous with respect to the wet granulation process for formulating microbial propagules - containing pesticidal composition : it is more efficient ( reduction in time , labor , material and equipment use ), it is less detrimental to the viability of the microbial propagules and it is less costly . the dry granulation or dry compaction of components as proposed herein is advantageous because the components need not to be soluble in water to be admixed and the dry compaction process provides formulations which are more easily dispersed in water and more efficiently applied to plants . in the process for producing the solid pesticidal composition , a substantially homogenous mixture of a microbial propagule and a water - dispersible agriculturally acceptable carrier is provided . as used herein , the term “ substantially homogenous ” refer to the property of the mixture of dispersing the microbial propagule within the water - dispersible agriculturally acceptable carrier , so that once it is compacted , the microbial propagule is present throughout the composition ( and not concentrated in one section of the composition such as the surface or the core ). the mixture can optionally comprise an additional wafer dispersant and / or a binder ( also substantially homogenously dispersed within the carrier ). the components of the mixture can be provided in a solid form ( such as a powder ) for facilitation the substantial homogeneity of the mixture . in some embodiment to limit the degradation of the microbial propagule , the microbial propagules are first admixed with a binder . the microbial propagules / binder mixture is then admixed with a water dispersant . further , the microbial propagules / binder / water dispersant mixture is admixed with the agriculturally acceptable carrier . the microbial propagules / binder / water dispersant / agriculturally acceptable carrier mixture is the submitted to dry compaction . once the initial mixture is provided , it is submitted to compaction . the compaction is provided in the absence of a granulating fluid . the compaction can be achieved through the use of a hydraulic press ( compaction force between about 250 to about 500 kg ) to remove the air from the composition and provide the solid formulation ( such as a tablet ). the compaction can also be achieved through the use of a roll compactor . in this embodiment , the initial mixture is passed through the transporter ( roll compactor ) to produce a solid formulation such as a tablet , briquette or individual granules depending on the intended use . care should be taken during the compaction process to preserve the viability of the microbial propagules , for example , by providing a compaction force which does not substantially reduce the viability of the microbial propagules . as shown below , the use of an excessive compaction force can decrease the viability of the microbial propagules . care can also be taken during the storage of the compacted formulations to preserve the viability of the microbial propagules . for example , the solid formulation can also be packaged in water - impermeable packaging to prevent or limit loss in viability of the microbial granules . the process for producing the solid pesticidal composition that is effervescent is similar to solid pesticidal composition in that it is a dry compaction using the stokes d3 16 station tablet press or similar . specifically the effervescent composition requires microbial propagules , clay , cellulose , starch , calcium carbonate , citric acid , surfactant and lubricant in the weight percentages previously set out . due to the effervescent nature of the composition , the production requires strict control of the humidity levels so as not to initiate the effervescent reaction and reduce effectiveness of production bathes . furthermore all the ingredients must be anhydrous and be packages in high moisture barrier containers such as foil bags or high density polyethylene bags . the hardness levels tested ( table 7 ); 4 . 3 kg , 6 kg , 15 kg and 16 kg all tested hardness levels except 4 . 3 kg reduced conidia germination up to 10 - 15 % ( table 1a ). the hardness level is a minimal force or mass ( in kg ) that applied to the compacted product and make it crush . the present invention will be more readily understood by referring to the following examples which are given to illustrate the invention rather than to limit its scope . methodology . 20 % ( w / w ) of dried b . bassiana spores were mixed by vortex with 82 % ( w / w ) kaolin clay ( sigma aldrich , canada ), 17 % ( w / w ) of water soluble corn starch ( sigma aldrich , canada ) and 1 % ( w / w ) of xanthan gum ( sigma aldrich , canada ). the components were compressed using a manual hydraulic press ( carver , usa ) to produce individual briquettes . the following compression levels have been applied to the mixture of dry components : 0 ( control ). 250 , 500 , 750 and 1000 kg for 15 sec in a 9 . 5 mm matrix ( generating a 1 or 2 g briquette ). resulted briquettes ( 5 briquettes for each compaction level ) were used to test b . bassiana spore viability ( 48 h germination test ). for the germination test , b . bassiana spores mixed with all mentioned above ingredients and not subjected to compaction were used as a control . as shown in fig1 , dry compacted b . bassiana spores remain viable in briquettes which have been submitted to a compaction force of up to 500 kg . further , no statistically significant difference between briquettes which have been submitted to a compaction force of between 250 to 500 kg has been observed . a significant reduction in b . bassiana viability has been observed in briquettes submitted to a compaction force of 750 or 1000 kg . however , the minimal compaction force required to produce a briquette was 250 kg ( table 1a ). three protocols were conducted in greenhouse - grown tomatoes . a two - block design , with randomly selected and marked plants ( six per replication ) per treatment , was used in all greenhouse experiments . bio - ceres - wb ( water dispersible briquettes ) formulations of b . bassiana ( strain ant - 03 ) were produced as indicated in example i using xx compaction force . experiments were conducted in the mcgill university horticultural research center ( ste - anne - de - bellevue , quebec , canada ). the positive control ( botanigard 22wp ) was applied at the recommended rate as indicated below . various treatments were applied to greenhouse - grown tomatoes ( cultivar : trust ). the presence of whiteflies larvae ( trialeurodes vaporariorum ) in the treated plants was then assessed . the plant stage was also determined using the following classification : 16 106 , 6 leaf on main shoot unfolded . 61 601 , first inflorescence : first flower open . 71 701 , first fruit cluster : first fruit has reached typical size . 73 703 , 3 rd fruit cluster : first and second fruits have reached typical size . 84 804 , 40 % of fruits show typical fully ripe color . in experiment 1 , the following treatments were applied : 1 / control ( water ); 2 / botanigard 22 ™ wp diluted 1 . 25 g / l in wafer ( 4 × 10 10 spores / l ); 3 / bioceres - wb diluted 1 g / l in water ( 1 × 10 10 spores / l ; 4 / bioceres - wb diluted 2 g / l in water ( 2 × 10 10 spores / l ) or 5 / bioceres - wb diluted 4 g / l in water ( 4 × 10 10 spores / l ). the results of experiment 1 are shown in table 1 as well as on fig2 . in experiment 2 , the following treatments were applied : 1 / control ( water ); 2 / botanigard 22 ™ wp diluted 1 . 25 g / l in wafer ( 4 × 10 10 spores / l ); 3 / bioceres - wb diluted 4 g / l in water ( 4 × 10 10 spores / l ); 4 / bioceres - wb diluted 6 g / l in water ( 6 × 10 10 spores / l ) or 5 / bioceres - wb diluted 8 g / l in wafer ( 3 × 10 10 spores / l ). the results of experiment 2 are shown in table 2 as well as in fig3 . in experiment 3 , the following treatments were applied : 1 / control ( water ); 2 / botanigard 22 ™ wp diluted 1 . 25 g / l in water ( 4 × 10 10 spores / l ); 3 / bioceres - wb diluted 2 g / l in water ( 2 × 10 10 spores / l ); 4 / bioceres - wb diluted 4 g / l in wafer ( 4 × 10 10 spores / l ) or 5 / bioceres - wb diluted 6 g / l in water ( 6 × 10 10 spores / l ). the results of experiment 3 are shown in table 3 as well as in fig4 . the results provided in experiment 1 indicate that bioceres - wb applications at 4 × 10 10 spores / l significantly decreased whitefly larva density , since it decreased the whitefly population by more than 90 % when compared to the negative control ( table 1 ). such treatment was also superior to botanigard ™ treatment ( table 1 ). as shown in fig2 , the box plot analysis also showed that that all bioceres - wb treatment caused a significant whitefly reduction in comparison with untreated control . in experiment 2 , bioceres - wb treatment caused a significant reduction in whitefly density ( middle plant section ) and was comparable or superior to botanigard ™ treatment ( table 2 ). as shown in fig3 , in bioceres - wb treated - plats , more than 50 % of observed tomato plants had less than 5 whitefly larva per plant while in negative control treatment , more than 50 % of plants has 10 - 15 larva per plant ( low section ) and up to 20 - 25 larvae / plant ( middle section ). in experiment 3 , bioceres - wb treatments reduced whitefly density in comparison with untreated control ( fig4 ). however , statistically significant reduction of white fly density by all bioceres - wb treatments was shown after a 5 th application ( table 3 ). further biocereswb applied at different concentrations ( 1 , 2 , 4 , 6 and 8 g / l ) did not cause any phytotoxcity to tomato plants during different phenological stages : flowering , development and ripening of fruit ( visual observations ). three protocols were conducted in greenhouse - grown cucumbers . a two - block design , with randomly selected and marked plants ( six per replication ) per treatment , was used in all greenhouse experiments . bioceres - wb ( wafer dispersible briquettes ) formulations of b . bassiana ( strain ant - 03 ) were produced as indicated in example i using 300 kg compaction force . experiments were conducted in the mcgill university horticultural research center ( ste - anne - de - bellevue , quebec , canada ). the positive control ( botanigard ™ 22wp ) was applied at the recommended rate as indicated below . various treatments were applied to greenhouse - grown cucumbers ( cultivar : dishon ) in which side shoots were removed during the vegetative period . the presence of thrips ( frankliniella spp .) on the leaves of the treated plants was then assessed . the plant stage was also determined according to the following classification : 16 106 , six true leaf on main stem unfolded , 51 . 501 , first flower initial with elongated ovary visible on main stem . 63 . 603 , 3 rd flower open on main stem . 72 702 . 2 nd fruit has reached typical size and form . 73 703 , 3 rd fruit has reached typical size and form , 75 70 5 , 5 th fruit has reaped typical size and form . in experiment 1 , the following treatments were applied : 1 / control ( water ); 2 / botanigard 22 ™ wp diluted 1 . 25 g / l in water ( 4 × 10 10 spores / l ); 3 / bioceres - wb diluted 1 g / l in water ( 1 × 10 10 spores / l ; 4 / bioceres - wb diluted 2 g / l in water ( 2 × 10 10 spores / l ) or 5 / bioceres - wb diluted 4 g / l in water ( 4 × 10 10 spores / l ). the results of experiment 1 are shown in table 4 as well as in fig5 . in experiment 2 , the following treatments were applied : 1 / control ( water ); 2 / botanigard 22 ™ wp diluted 1 . 25 g / l in water ( 4 × 10 10 spores / l ); 3 / bioceres - wb diluted 4 g / l in water ( 4 × 10 10 spores / l ); 4 / bioceres - wb diluted 6 g / l in water ( 6 × 10 10 spores / l ) or 5 / bioceres - wb diluted 8 g / l in water ( 8 × 10 10 spores / l ). the results of experiment 2 are shown in table 5 as well as on fig6 . in experiment 3 , the following treatments were applied : 1 / control ( water ); 2 / botanigard 22 ™ wp diluted 125 g / l in water ( 4 × 10 10 spores / l ); 3 / bioceres - wb diluted 2 g / l in water ( 2 × 10 10 spores / l ); 4 / bioceres - wb diluted 4 g / l in water ( 4 × 10 10 spores / l ) or 5 / bioceres - wb diluted 6 g / l in water ( 6 × 10 10 spores / l ). the results of experiment 3 are shown in table 6 as well as on fig7 . in experiment 1 , after second application with biocereswb , the number of thrips on cucumber plants was reduced ( leaf 4 , leaf 6 and leaf 8 results in table 4 ). a similar effect was observed at a later time ( table 4 ). as seen in fig6 , in average 4 thrips were observed on plants treated with bioceres - wb while more than 12 thrips per leaf were observed on plants treated with water . in experiment 2 . if is shown that bioceres - wb treatment significantly reduced thrips density on cucumber plants in comparison with control treatment ( table 6 ). as shown on fig6 , thrips density on plants treated with bioceres - wb was less than 5 thrips per leaf while more than 10 thrips per leaf were observed on plants treated with water . in experiment 3 , after a 5th application , the number of thrips on bioceres - wb treated plants was significantly lower than in control ( table 6 ). as shown on fig7 , in average 5 thrips per leaf were found on the plants treated with bioceres - wb while more than 20 thrips per leaf ware observed on plants treated with water . bioceres - wb ( water dispersible briquettes ) formulations of b . bassiana ( strain ant - 03 ) were produced as indicated in example i using 300 kg compaction force . experiments were conducted in quebec in 2010 against the tarnished plant bug ( tpb ) on field strawberry and lettuce and in british columbia in 2011 against the strawberry aphid ( sa ). fields crops were treated with bioceres - wb or with an alternative chemical pesticide ( assail 70 ™ according to the label recommendations ). selected results are provided in table 6 . a single tablet was placed in a 1 . 5 l beaker containing 1 l of water at 20 - 22 ° c . disintegration of the tablet occurres resulting in numerous bubbles of co 2 gas . when the evolution of gas around the tablet or its fragments ceases , the tablet have disintegrated , being either dissolved or dispersed in the water so that no agglomerates remain . table 7 disclose the viability of conidia in pellet formulation . while the invention has been described in connection with specific embodiments thereof , it will be understood that the scope of the claims should not be limited by the preferred embodiments set forth in the examples , but should be given the broadest interpretation consistent with the description as a whole .

it is herewith provided a pesticidal composition composing a microbial propaguse and an agriculturally - acceptable carrier provided in a solid formulation obtained by dry compaction . the pesticidal composition can optionally contain a water dispersant as well as a binder . the pesticidal composition doss not contain a surfactant but is nevertheless dispersible in water .

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 structures . 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 , an embodiment of an improved emesis container 100 is shown . the container 100 includes a receptacle 102 , a chute 104 , and a retainer 106 . with reference also to fig2 the receptacle 102 is preferably in the form of a bag 108 having a back portion 108 a and two side portions 108 b extending between an open end 108 c and a closed end 108 d . the open end 108 c of the bag 108 has a perimeter 110 . the bag 108 is preferably formed from a flexible , liquid impervious material , such as polyethylene . while it should be understood that the receptacle 102 may be of any desirable size , a preferred bag has a capacity of at least 1200 milliliters of liquid . furthermore , to aid in monitoring a patient &# 39 ; s condition , the receptacle 102 may be provided with volume demarcations 112 , which indicate the amount of liquid contained in the receptacle 102 . in addition , the receptacle 102 may be formed of a material that is transparent or translucent to allow quick visual inspection of the container contents . coupled to the receptacle 102 is the chute 104 . referring more specifically to fig3 a - c , in addition to fig1 and 2 , the chute 104 preferably comprises an entrance end 104 a and an exit end 104 b , with a back panel 114 and side panels 116 extending therebetween . the back panel 114 has a front surface 114 a and a back surface 114 b . the back panel front surface 114 a is generally the receiving surface for emesis and , therefore , preferably has sufficient surface area to help collect the emesis . the preferred surface area comprises at least forty square inches . the side panels 116 preferably extend away from the back panel front surface 114 a , perpendicularly or obliquely , along a panel junction 120 , which may be provided as a score or crease 146 . the side panels 116 may be formed integrally with the back panel 114 or attached thereto . to enable one method of assembly , the exit end 104 b of the chute 104 is preferably formed with notches 122 proximate the panel junction 120 . the chute 104 preferably includes an attachment margin 124 including and extending from the exit end 104 b towards the entrance end 104 a . the chute 104 preferably extends around less than the entire bag open end perimeter 110 . the open end perimeter 110 preferably encompasses an area of at least thirty square inches . the chute 104 may be comprised of a material that is more rigid than the material comprising the receptacle 102 . the added rigidity helps to maintain the receptacle 102 in a wide open configuration when the device 100 is in use . to provide reinforcement that helps to maintain the receptacle 102 in an open configuration when the container 100 is in use , support tabs 118 are coupled to or formed integrally with the chute 104 . while it is preferred that the chute 104 not extend around the entire bag open end perimeter 110 ( see fig1 ), the support tabs 118 may do so ( not shown ). to add further support to a coupling of the receptacle 102 and the chute 104 , a reinforcement member 126 may be used . while various reinforcement members 126 will occur to those having skill in the art , the preferred reinforcement member 126 is a plastically deformable member such as a metal wire 128 or flat metal strip ( not shown ). the plastic deformability of the wire 128 aids in positioning and maintaining the open end 108 a of the receptacle 102 in a desirable wide open configuration . furthermore , the chute 104 may be provided with score lines 146 , including the panel junctions 120 , to aid in manufacturing , folding and packaging the container 100 . a plurality of reinforcement members could also be used , such as foldable l - or u - shaped channel reinforcement structures ( not shown ) arranged over and supporting predetermined score lines 146 . to provide hands - free emesis collection by the container 100 , a retainer 106 is provided , which is coupled to the chute 104 at retainer sites 130 . while the retainer 106 may take many forms , the retainer 106 preferably comprises a flat strap 132 . as seen in fig3 a and 3b , a first preferred retainer site 130 comprises an aperture 134 having a hole 136 and a slot 138 , and notches 140 cooperating with the aperture 134 to create a stress riser 142 . the shape of the hole 136 is not specific or limiting . rather , the hole 136 provides an area of less frictional resistance — than the slot 138 — between the chute 104 and the retainer 106 . a second preferred retainer site 130 is provided in fig3 c . in this embodiment , the retainer 106 is a flat strap 132 held in slidable , frictional contact with the chute 104 by a staple 144 . in this embodiment , the frictional resistance between the chute 104 and the retainer 106 is kept relatively constant . with an appropriate choice of retainer 106 , however , such as a strap 132 having elastic properties , when the retainer 106 is stretched , the friction lessens , enabling adjustment of the retainer 106 in the direction of the application of the stretching force . about the staple 144 , perforations 148 may be provided , thereby creating at least one stress riser to enable tearing or removal of a portion the chute material for a quick disconnect of the device 100 from a patient or other support . further , if a staple 144 is used to maintain the strap 132 in contact with the chute 104 , the ends of the strap 132 may be provided with an inelastic portion or obstruction , such as a knot or aglet ( not shown ), that would prevent slippage through the staple 144 , thereby preventing accidental removal of the strap 132 from the retainer site 122 . in addition , an additional friction fit slot 149 may be provided in addition to the staple 144 to further reinforce the coupling of the retainer 106 to the chute 104 . turning now to fig4 a - d , a preferred method of assembling an embodiment of an emesis container according to the present invention includes forming the receptacle 102 , the chute 104 and the retainer 106 , and then coupling the components together . the receptacle 102 is formed from raw materials . for instance , where the receptacle 102 is a bag 108 , polyethylene sheet material may be used . the chute 104 may be formed from a material suitable for liquid exposure over a determinable time . for example , the chute 104 may comprise a paperboard material having at least one side coated with a liquid impervious wax or plastic coating . the retainer 106 may be a simple flat strap portion cut from a spool of material . after the receptacle raw material is selected and the chute 104 is formed , the coupling of the bag 108 to the chute 104 is achieved preferably through the use of a thermal bonding process including a thermal press or crimp . while the bag material could simply be thermally pressed to the chute attachment margin 124 or other attachment points , it is preferred that the attachment margin 124 be folded towards the chute back panel back surface 114 b ( as shown ) or folded towards the chute back panel front surface 114 a ( not shown ). into the fold , the material to comprise the bag 108 may be inserted and then heat bonded to both the chute attachment margin 124 and the chute back surface 104 b . the sheet material is then folded over the attachment margin 124 , as is shown in fig4 a . after the bag material has been heat sealed to the chute 104 , the chute 104 may be folded along a medial score 146 , thereby causing the sheet material to fold too , as seen in fig4 b . a formed joint can be seen in fig5 . a desired shape of the bag 108 may be obtained by using a heat sealer , such as an l - bar heat sealer or heated wire in a desired shape , to seal and trim the bag 108 , as seen in fig4 c , along a front seam 108 e and the closed end 108 d , and excess material may be trimmed from the open end 108 c of the bag 108 . an emesis container according to the present invention is preferably packaged in a compact way that allows easy deployment by users in emergency medical situations , among others . the ease in deployment is facilitated by convenient packaging 150 . as seen in fig6 , an emesis container 100 is folded in such a way to allow compact packaging . the folding may be aided by the scoring or creases 146 provided in the chute 104 . the package 150 is preferably formed from a plastic sheet material as is well known . an emesis container 100 in a packaged configuration is preferably no larger than four inches long by four inches wide by one - half of an inch thick . such a size enables convenient , easy storage of the devices . while the emesis container was designed to be rather self - explanatory to use , the packaging 150 may further contain instructions ( not shown ) directed to proper use of the container 100 , adjustment of the retainer 106 , and proper disposal methods . with reference to fig7 and 8 , to use an emesis container according to the present invention , a user removes a container 100 from its package 150 , unfolds the container 100 , and places the retainer 106 about a support structure , such as the neck of the patient 1 , to allow positioning of the chute 104 under the chin of the patient 1 . the retainer 106 maintains proximity between the emesis container 100 and the mouth of the patient 1 . preferably , the patient 1 may be positioned in various poses and the retainer 106 will maintain such proximity , such as when the patient 1 is walking , standing , or sitting , or when the patient 1 is in a semi - fowler &# 39 ; s , a high - fowler &# 39 ; s , a left - lateral , or a right - lateral position . indeed , the container 100 may even be used when the patient 1 is fitted with a cervical brace . the retainer 106 is adjusted to provide proper positioning . where the retainer 106 is a flat strap 132 , the strap 132 may be adjusted a number of ways . while the strap 132 could be provided with an adjustment buckle , preferred adjustment is achieved by using the retainer site 130 . if the strap 132 is kept in frictional contact with the chute 104 by a staple 144 , the strap 132 may be pulled through the staple 144 to adjust positioning of the container 100 . a staple 144 may not work for some situations , however . for example , the retainer 106 may not be long enough to easily slip over a desired support structure . in such circumstances , the retainer 106 is preferably a flat strap 132 in cooperation with the chute 104 at a retainer site 130 having an aperture 134 . the strap 132 can be removed from the site 130 , threaded about a support member such as the neck of the patient 1 , and threaded back through a hole 136 of the aperture 134 from which it was removed . while the strap 132 is in the hole 136 , the strap 132 can move relatively freely through the aperture 134 , thereby allowing easy adjustment . when desired positioning is achieved , the strap 132 can be forced into the slot 138 of the aperture 134 . while the strap 132 is in the slot 138 , a friction fit is provided , thereby maintaining the desired positioning . to remove the container 100 from the patient 1 , one method involves lifting or supporting the container 100 while removing the retainer 106 from the support structure . for instance , if the retainer 106 is a strap 132 , the strap 132 may be lifted up and over the patient &# 39 ; s head . alternatively , the retainer 106 may be disconnected from one or both retainer sites 130 . if the retainer 106 is a strap 132 coupled to the chute 104 by a staple 144 , the strap 132 may be pulled out of the friction fit and the container 100 removed from the patient 1 . alternatively , if a staple 144 is used , the retainer site 130 may be provided with the perforated section 148 to enable tearing or removal of a portion the chute material for a quick disconnect of the device 100 from a patient or other support upon the exertion of a determinable force . this method is preferred if the strap 132 includes an anti - slip mechanism , such as an aglet . in a similar fashion to using a strap 132 in combination with a staple 144 , if the retainer 106 is a strap 132 in frictional cooperation with an aperture 134 at a retainer site 130 , the strap 132 could be removed from the aperture 134 ; or the chute 104 , itself , may be caused to fail at a stress riser 142 formed by the aperture 134 and cooperating notches 140 . once the container 100 is removed from the patient 1 , the container 100 is simply disposed of , preferably by being thrown into a biohazard receptacle . 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 collapsible , hands - free emesis container is provided with improved portability , deployment and emesis reception characteristics . the container includes a receptacle for receiving emesis , a chute for directing emesis and a retainer to maintain desired positioning of the container about a support structure , which may be the neck of an impaired patient . the container may be provided in a package having size characteristics for easy storage and access by emergency medical service personnel .

turning now to the figures , fig2 depicts a medical device 30 having a pair of magnet assemblies 32 , 34 . the first magnet assembly 32 includes a first magnetic core 36 and a first jacket 40 connected to the outer periphery of the first magnetic core 36 . the first jacket 40 projects axially , ( i . e ., relative to the longitudinal axis la ), beyond the first magnetic core 36 to define a rim sized to receive the second magnet assembly 34 . the second magnetic assembly 34 includes a second magnetic core 38 having a second jacket 42 connected to the outer periphery thereof . preferably the first and second magnetic assemblies 32 and 34 are disc shaped , although any annular configuration may be employed . the second jacket 42 is sized smaller ( i . e ., has a smaller outer diameter ) than the first jacket 40 such that the pair of magnet assemblies 32 , 34 are capable of nesting . specifically , the first and second magnet cores 36 , 38 have their respective poles oriented such that they are magnetically attracted to one another ( when in proximity to one another ) to form the nested configuration of the medical device 30 depicted in fig2 . in this configuration , the tissue 24 , 26 from the two viscera are compressed between the first and second magnet assemblies 32 , 34 , thereby approximating the tissues 24 , 26 so that formation of an anastomosis may be accomplished . the jackets 40 , 42 define engagement surfaces 43 , and in this embodiment the engagement surface 43 of the jacket 42 presses the tissue 24 , 26 against the first magnetic core 36 . as such , the engagement surfaces 43 are atraumatically designed . the surfaces 43 are depicted as flat in the figures , although numerous atraumatic shapes may be employed as will be recognized by those skilled in the art , such as rounded edges or the like . turning now to fig3 , the first and second magnetic cores 36 , 38 define large axial openings 44 , 46 , respectively . these large openings 44 , 46 provide access to the tissue portions 28 held between the first and second magnet assemblies 32 , 34 , for the introduction of a cutting device 52 . the axial openings are thus sized to correspond with the desired size of the anastomosis and are preferably at least 10 mm for gastrointestinal anastomoses . each of the magnet assemblies 32 , 34 includes a smaller transverse passageway 48 , 50 ( respectively ) extending generally orthogonal to the longitudinal axis la . the transverse passageways 48 , 50 are much smaller in size than the axial openings 44 , 46 , and are generally sized to receive a wire guide therethrough for introduction of the magnet assemblies 32 , 34 into the desired viscera over the wire guide , as will be discussed below . a method of forming an anastomosis employing the magnetic assemblies 32 , 34 of the medical device 30 will now be described with reference to fig3 - 5 . placement of the magnet assemblies 32 , 34 may be accomplished in many ways , such as by use of a wire guide over which the assemblies are traversed by way of the transverse passageways 48 , 50 in combination with a pushing catheter , or by swallowing the magnet assembly 32 , 34 and employing massage under fluoroscopy , or through the use of endoscopic procedures using implements such as grasping forceps , by way of laparoscopic or open surgery , or other controlled insertion through natural orifices . as one example , gastrojejunostomy is typically performed by delivery of a first ( jejunal ) magnet assembly ( e . g . magnet assembly 34 ) over a wire guide and through the oral cavity . a pushing catheter ( not shown ) is used to push the jejunal magnet assembly along the wire guide to a point within the jejunum 16 that is adjacent to the stomach wall 14 . this is usually accomplished with the aid of dynamic radiographic imaging ( fluoroscopy ). a second ( gastric ) magnet assembly ( e . g . magnet assembly 32 ) is then introduced into the stomach using an endoscope and grasping forceps . when the gastric magnet is manipulated into a position that is near the jejunal magnet , the force of attraction between the magnets increases to a level that is sufficient to approximate the jejunal and stomach walls , thereby compressing these tissues together between the two magnet assemblies , as shown in fig3 . as shown in fig4 , a portion of the compressed tissue 28 is then excised using the cutting device 52 ( fig3 ) which is manipulated around the large axial opening ( 44 or 46 ). this leaves an excised edge 28 a . preferably , the cutting device 52 is an electrosurgical instrument which is employed through a working channel of an endoscope , although it will be recognized by those skilled in the art that numerous types of cutting devices may be employed with or without the aid of an endoscope , such as puncturing and dilating devices . upon removal of the excused portion of the tissues portion , the remaining portion 28 b of the tissues 24 , 26 are affixed together as shown in fig5 and 5 a . as with the excision , the affixing of the tissues 24 , 26 is preferably accomplished endoscopically by using , for example , an affixation device such as a suturing instrument to place one or more sutures 54 , although it will be recognized by those skilled in the art that numerous types of affixing devices may be used with or without the aid of an endoscope , such as clips , staples , adhesives , or mechanical closure devices . upon completion of the affixation , a secure anastomosis 56 is formed in the tissues 24 , 26 between the two viscera . removal of the magnet assemblies 32 , 34 may be accomplished by traditional methods used with mads . for example , grasping forceps can be used to take a hold of one of the magnet assemblies 32 , 34 and withdraw the magnet assembly from the site . the second magnet may then pass naturally through the body , or may also be removed endoscopically using grasping forces . the second grasping forceps may be used to engage the other magnet assembly to provide sufficient traction to overcome the magnetic force . finally , it will be recognized that the magnet assemblies 32 , 34 could be left in place to cause necrosis of the remaining portion 28 b of the tissues 24 , 26 , thereby forming an even larger anastomosis than the initial anastomosis 56 . in this case , the jackets 40 , 42 may be provided with sharp engagement surfaces 43 to facilitate the necrosis of tissues 24 , 26 , although this is not necessary . after formation of the larger anastomosis , the magnet assemblies 32 , 34 may be removed manually or naturally or a combination thereof . it will be recognized by those skilled in the art that during these anastomosis formation procedures , the ring of compression of the tissues 24 , 26 provides an additional barrier that guards against leakage of the gi contents or other bodily fluids depending on the viscera involved . likewise , the anastomosis is formed with surety before the patient leaves the medical facility , eliminating the need for a follow - up procedure . fig6 - 8 illustrate several variations of the medical device 30 and method for forming an anastomosis . in fig6 , a medical device 130 includes a pair of magnet assemblies 132 , 134 having magnetic cores 136 , 138 and jackets 140 , 142 connected to the outer periphery of the magnetic cores 136 , 138 . the magnetic cores 136 , 138 define first and second axial openings 144 , 146 which have a substantially similar size , ( i . e ., diameter ). it will be noted that in the prior embodiment of fig2 - 5 , the first and second axial openings 44 , 46 were generally of a different size and diameter . the similar size of the openings 144 , 146 allows the user to determine the maximum area of tissue that can be removed from either side of the device 130 . in the embodiment of fig7 , the magnetic device 230 includes a pair of magnet assemblies 232 , 234 having magnetic cores 236 , 238 and jackets 240 , 242 . in the prior embodiment of fig2 - 5 , the jackets 40 , 42 were connected to the outer periphery of the magnetic cores 36 , 38 . however , in this embodiment , the jackets 240 , 242 are connected to the inner periphery of the magnetic cores 236 , 238 . as such , the jackets 240 , 242 define the large axial openings 244 , 246 . it will be recognized that in this embodiment , the engagement surface 243 of jacket 242 is positioned closer to the tissue portion 28 to be excised and affixed . it will also be recognized that the embodiment in fig2 - 5 can also be modified to locate the axially projecting rims defined by the flanges 40 , 42 at a position closer to the axial openings 44 , 46 , thereby moving the area of approximated tissue closer to the area of excises tissue . in fig8 , the medical device 330 includes a pair of magnet assemblies 332 , 334 having magnetic cores 336 , 338 defining large axial openings 344 , 346 . the first magnet assembly 332 includes a jacket 340 attached to the outer periphery of the magnetic core 336 as in the embodiments of fig2 - 6 . unlike the prior embodiments , the second magnet assembly 334 does not include a jacket . as such , the axially - facing surfaces 341 , 343 of the magnetic cores 336 , 338 form the engagement area of the medical device 330 . this provides a large surface area over which the tissues 24 , 26 of the two viscera may be compressed , thereby providing secure approximation of the tissues 24 , 26 for performing the excision and affixation . the foregoing description of various embodiments of the invention has been presented for purposes of illustration and description . it is not intended to be exhaustive or to limit the invention to the precise embodiments disclosed . for example , the medical can be applied in many different situations other than gi surgery , for example in forming anastamoses between vascular structures , or any body structures . numerous modifications or variations are possible in light of the above teachings . the embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated . all such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly , legally , and equitably entitled .

a medical device and procedure is provided for rapidly forming an anastomosis between two viscera , while minimizing the potential of breaching the mural boundary . the medical device generally includes a first magnet assembly and a second magnet assembly . each of the magnet assemblies includes a magnetic core defining an axial opening and at leas one includes a transverse passageway . the axial openings are sized to correspond with the size of the desired anastomosis . the transverse passageway is size to permit passage of a wire guide therethrough for placement of the first and second magnet assemblies . the medical device approximates the tissues of the two viscera , such that endoscopic excision and affixation of the tissues may be performed to create the anastomosis .

referring now to fig1 - 8 , there is shown a golf cart 10 ( fig6 ) which is equipped with an interactive media system 12 ( fig7 ), configured in accordance with the principles of the present invention . the golf cart 10 comprises a body 14 of conventional construction and a top 16 which is disposed above the body 14 on four conventional posts 18 . the golf cart top 16 may be of generally conventional construction , typically of molded plastic , such as rotationally molded high - density polyethylene with ultra - violet ( uv ) resistant properties , except for some unique features which will be described below . it is designed to be utilized in combination with known golf carts , including , for example , those manufactured by ez go , yamaha , and club car . the golf cart top 16 comprises a monitor cavity 20 ( fig5 ) preferably molded into a lower surface 22 of the top 16 at a forward end thereof , within which is disposed a video monitor unit 24 . advantageously , the disposition of the monitor 24 up within the cavity 20 minimizes any obstruction of the view ahead of the cart 10 from within the cart . the monitor 24 is disposed with its video screen 26 facing rearwardly , so that occupants of the cart may readily view the screen 26 . the top 16 is designed to be adaptable for use with any commonly available golf cart . the video screen 26 , in a preferred embodiment , has a screen size of 10 . 4 inches , although any suitable screen size may be employed . also , the preferred monitor is a color lcd ( liquid crystal display ) model , although , again , any suitable monitor may be employed . relative to a vertical axis 27 ( fig3 ), the monitor 24 is preferably tilted at an angle α of greater than 10 degrees and preferably about 55 degrees , in order to reduce its profile . the combination of the monitor &# 39 ; s recessed position in the cavity , and the screen tilt functions to advantageously minimize screen glare , by minimizing incident light on the screen 26 . the golf cart top 16 also preferably comprises a raised forward portion 28 ( fig3 ) which slopes downwardly through a sloped portion 30 toward a lower rearward portion 32 . wireless transmitting and receiving apparatus , such as one or more antennas 34 , extends rearwardly from the sloped portion 30 . advantageously , the raised forward portion 28 protects the antenna from damage due to overhead trees , low overpasses , and the like . the purpose of the antennas 34 , which may alternatively be internally mounted , in any suitable manner , will be discussed in greater detail hereinbelow . now with particular reference to fig7 , there is shown a schematic representation of the interactive media system 12 of the present invention . typically , a plurality of golf carts 10 are parked in a golf cart barn or garage overnight or otherwise when the golf course is closed . a computer 36 or other suitable device is disposed therein as well , for downloading executable content from a remote server or source 38 over the internet or via satellite , and then transferring that content to each of the golf carts 10 . in fig8 , the video monitor unit 24 is illustrated schematically . this unit includes a microprocessor and memory unit 40 which also includes a global positioning system ( gps ) transmitter / receiver . the microprocessor 40 is programmed to receive an executable media file from the computer 36 , which is displayable on the video screen 26 . additionally , the microprocessor utilizes the gps transmitter / receiver to calculate and display on the video screen 26 the yardages from the cart &# 39 ; s location at any given point in time to the green of the current hole . in particular , the coordinates of the front , middle , and back of each green are pre - programmed into a look - up table stored in the memory 40 . then , as the golfer drives the cart about the golf course , he or she may at any time view the gps feature , which is conventional except as described herein , to determine the location from the cart &# 39 ; s position at that instant to the front , middle , and back of a selected green . the gps yardages are set - up to automatically display on a continuous basis . this unique approach , whereby yardages are available to each of the front , middle , and back of the green , is more useful than known prior art systems , wherein yardage to the pin is generally available . the reason for this is , first , that non - expert golfers often prefer to know the distance to safely place the ball in the middle of the green , rather than the distance to the pin , particularly if the hole placement is near a hazard or the edge of the green . second , since golf courses frequently move the holes on each green , the gps systems in conventional systems must be re - programmed to include the coordinates for the new pin placement each time such changes are made . however , with the present inventive system , such re - programming is avoided . another particularly advantageous feature of the present invention is a unique advertising approach which lends itself to easy operation , while effectively reaching the golfing community . as mentioned above , an executable loop of advertising spots is downloaded periodically , preferably nightly , from the remote server 38 to the computer 36 ( fig4 ). in one preferred embodiment , the loop comprises approximately 55 separate advertising spots , each of which is nine ( 9 ) seconds in length . of course , it is within the scope of the invention to change both the length of each spot and the total number of spots to any desired value , although the foregoing specifications have been found to be particularly effective , since 9 second spots are about the right length for obtaining maximum attention from golfers , and the number of spots described above permits a golfer to view each spot as many as twenty four or so times during an eighteen hole round . golf courses which agree to host the inventive system may be allocated a certain number of advertising spots for their own advertisements , such as for upcoming tournaments , greens fee specials , or merchandise specials in the pro shop . an additional feature of the preferred embodiment is the interspersing of 50 or so partitioned “ entertainment ” spots among the 55 or so advertising spots . the purpose of these “ entertainment ” spots , which may also each comprise about 9 seconds in length , is to maintain the golfers &# 39 ; attention to the monitor by breaking up the advertising spots with interesting facts , trivia , golf instruction tips , and the like . the executable files may comprise still ( jpg ) images , animation , mpeg images , or any other known media . the monitor 24 can be turned off by the golfer and by golf course personnel , if desired . for example , such systems are often not permitted during tournament play , and are turned off during such events . additionally , if a particular cart is to be stored for a considerable period of time , the system should be turned off . the source of power for the system is the golf cart battery , and a disable switch is wired directly to the battery to permit the system to be shut off . the display is preferably in 32 bit color or higher , with high resolution . as explained above , the executable files are transferred from the computer 36 to the memory 40 in each golf cart 10 periodically . typically , this transfer occurs weekly , during the night , while the carts are all parked in close proximity to the computer 36 in the cart barn , and are being electrically recharged . the preferred mode of transfer , at present , is via wireless technology ( such as wi - fi ), transmitting the data to the memory 40 on the cart 10 via the antennas 34 disposed on each cart . then , when the carts are started in the morning , and the onboard computer or memory 40 is turned on , the new executable file is installed from the memory . it should be noted that the present invention is not technology - based , meaning that all of the technology is well known to those skilled in the art , and readily available . any suitable known technology which is capable of performing the above described functions is fine . what is important , and unique , about the present invention is the manner , as described herein , in which the conventional technology has been assembled and utilized to perform the unique described functions . the actual advertising content is designed by each client , in accordance with parameters supplied by the system manager , and is uploaded to the remote server 38 by the client . the system permits clients to update their ads weekly , and more often , for an additional fee , if desired . a preferred business method is to charge each client a fixed price per month , per advertising spot , per golf course . included in this price might be a predetermined number of free advertising updates ( i . e . weekly ), with additional fees being charged for updates beyond this predetermined number in a given month . another advantageous feature of the present business method is to provide to each advertiser , either as an included feature for the fixed monthly fee or as an option for an additional fee , a golfer database for the golf course at issue , which can be utilized by the advertiser for follow - up direct marketing activities . this database is emailed to the advertiser so that the advertiser can , for example , generate a follow - up mailing or e - mailing which might reference a spot the golfer saw or potentially saw during a recent round , and offer an additional incentive ( i . e . a free gift for an automobile test drive ) if the golfer visits the advertiser &# 39 ; s place of business . the golfer can be asked to volunteer to release his / her address or email address for this service , in order to avoid potential legal concerns , in exchange for a reduced greens fee or other suitable incentive . additionally , the home page of the golf course preferably includes links to the advertisers which are participating in the described program , to further coordinate the advertiser &# 39 ; s marketing efforts . the present inventive system also is configured to incorporate , if a golf course desires , a clubhouse restaurant interface module for permitting golfers to pre - order food and drinks prior to reaching the clubhouse at the turn between the 9 th and 10 th holes . this interactive feature comprises an interactive menu screen which pops up when a golf cart reaches a predetermined location , such as the 9 th hole tee box , triggered by a wireless transmitter located near this predetermined location . point - of - sale software completes the order , the order is sent to the restaurant via antenna , and the transaction is processed through the pos software . thus , by the time the golfer reaches the restaurant , the food is ready for pick - up . the system also includes a capability for the golf course to track precisely the location of all equipped golf carts . referring now to fig5 , in particular , an advantageous feature of the present invention is the unique video screen layout , which enhances the golfer &# 39 ; s attention to the video advertising spots . more particularly , the monitor 24 includes a predetermined number of control knobs 42 , for various monitor control functions , such as power , brightness , contrast , auxiliary functions ( such as ordering food ), golf hole selection , and the like . the video screen 26 is arranged so that an upper banner 44 and a lower banner 46 each display information of interest to the golfer , such as the above described yardage information generated by the onboard gps system . in a preferred embodiment , these banners 44 , 46 are displayed in eye - catching colors , such as red , white , and blue , to attract the golfers &# 39 ; attention . for example , yardage to the front of the green may be displayed in red , to the middle of the green in white , and to the back of the green in blue . above the lower banner 46 is the main display portion 48 , on which the above described advertising and “ entertainment ” spots are continuously displayed in a loop format . advantageously , the golfers &# 39 ; eyes are drawn toward the main display portion 48 , thus viewing the advertising content . this interactive approach maximizes the golfers &# 39 ; exposure to the advertising content . the upper banner 44 may display additional information of interest to the golfer . for example , this banner might comprise a scroll , providing updated sports scores or the stock market transmitted by satellite , since such services are now readily available , and might also display the current time and date , or the like . of course , alternatively , only one banner might be utilized , and any type of content may be displayed on either banner , as desired . preferably , the monitor 24 descends beneath the top 16 by a distance just sufficient to permit a golfer to view the lower banner 44 , which displays the above described gps data , from a location outside of the cart 10 . the method for operating the business of providing the inventive system 12 to golf courses is unique and advantageous as well . in a preferred approach , the media system owner / operator approaches a golf course with an offer to install the system , including new golf cart tops , wireless equipment , microprocessors , video equipment , computer , and other necessary components , at no charge to the golf course . in addition , the golf course is offered a percentage of all generated advertising revenue , on a monthly basis . in a preferred method , that percentage is 10 %. of course , the percentage , and the base cost to the golf course can vary , although the basic concept is to provide the system to the course on a basis that it is difficult to refuse , because it is a net revenue generator for the course . then , as mentioned above , advertisers are charged a flat monthly cost for each spot they purchase . in one preferred embodiment , that cost is $ 1 , 200 , although , of course , that fee can vary according to market conditions , and the type of media ( i . e . jpg , animation , mpeg ). the apparatus and method of the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics . the described embodiments are to be considered in all respects only as illustrative and not restrictive . the scope of the invention is , therefore , indicated by the appended claims rather than by the foregoing description . all changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope .

a global positioning system is provided for use by golfers in their golf carts , which supplies useful yardage information to the golfer without the need for frequent manual maintenance by the golf course . furthermore , the inventive system also comprises a highly effective advertising medium for reaching golfers at the golf course , without being unduly obtrusive . a business method related to providing the gps system to golf courses benefits those courses by permitting them to obtain the system at no cost , and , in fact , typically at a substantial financial gain , and also permits them to obtain updated and improved golf carts at a substantial discount . golf courses also benefit because of faster resultant play by golfers on the course , thus permitting them to consider offering more tee times .

the following abbreviations may be used herein : pma , phorbol myristate acetate : mim - 1 , myb induced myeloid protein - 1 ; pbs , phosphate buffered saline ; trap , tartrate resistant acid phosphatase ; egta , ethylene glycol - bis ( β - aminoethylether ) n , n ′, n ′- tetraacetic acid ; edta , ethylenedinitrilo tetraacetic acid ; naf , sodium fluoride ; pmsf , phenylmethylsulfonylfluoride ; sds - page , sodium dodecylsulfate - polyacrylamide gel electrophoresis ; pvdf , polyvinylidine difluoride ; bsa , bovine serum albumin . osteoclasts are terminally differentiated cells of hematopoietic origin . pma stimulates bone resorption 4 - fold with a simultaneous dose dependent increase in calmodulin protein levels . pma treatment of osteoclasts also results in a dramatic decrease in a 35 kd protein in osteoclast lysates detected by coomassie staining . the decrease in 35 kd protein correlates with increases in bone resorption . peptide digests of the protein were analyzed by hplc / ms / ms and provided sequence data for 7 peptides . sequence analysis indicates that the protein is myb induced myeloid protein - 1 precursor ( mim - 1 protein ) based on sequencing 104 of 326 amino acids . mim - 1 is expressed specifically by cells of hematopoietic origin , has an internal repeat sequence of 136 amino acids , has no known function and is reported to be a secreted protein . mim - 1 is homologous with lect2 , a neutrophil chemokine , which also stimulates proliferation of osteoblasts . western analysis demonstrated that the pma dependent decrease in mim - 1 in osteoclasts is due to the protein being secreted into culture media . immunofluorescence studies demonstrate that mim - 1 is localized with a cytoplasmic and perinuclear distribution , in both avian osteoclasts and human osteoclast - like cells . expression and secretion of a chemokine - like protein suggests a possible , osteoclast derived , signaling pathway that may be involved in coordinating bone remodeling . the present invention is drawn to methods of inducing bone resorption activity of osteoclasts , and inducing recruitment and differentiation of osteoblasts by mim - 1 protein . generally , the mim - 1 protein has the sequence of seq id no . 8 or a fragment thereof . in another aspect of the present invention , there is provided methods of inducing recruitment and differentiation of osteoblasts and increased bone resorption by osteoclasts following secretion of mim - 1 . generally , the mim - 1 protein has the sequence of seq id no . 8 or a fragment thereof . the following examples are given for the purpose of illustrating various embodiments of the invention and are not meant to limit the present invention in any fashion : avian osteoclasts ( from egg - laying white leghorn hens ) were utilized because gram quantities of pure osteoclasts are readily obtained . avian osteoclasts (& gt ; 10 7 cells ) were isolated as previously described ( 16 ). laying hens on a limited calcium diet produce massive numbers of osteoclasts to meet the calcium requirement for eggshell production . the endosteum of such birds is & gt ; 50 % osteoclasts by mass . medullary bone was scraped from the endosteum into calcium - and magnesium - free phosphate buffered saline ( pbs ) at 4 ° c . cells were separated from matrix by washing through 100 μm nylon filters and sedimented through 70 % newborn calf serum . osteoclasts purified by density gradient sedimentation were ˜ 75 - 90 % viable . following sedimentation , macrophages represent & lt ; 2 % of the cell mass . for experiments requiring homogeneous osteoclasts , the cells purified by serum sedimentation were then affinity purified by attachment to bone fragments and then resedimented 24 hrs later , eliminating essentially all but viable , bone - attached osteoclasts ( 17 ). human blood monocytes were isolated by plasma pheresis from healthy volunteers . human blood monocytes ( 1 × 10 5 cells / well ) were cultured in the presence of 90 % confluent mg63 cells in minimal essential media α containing 10 % fetal bovine serum , 10 − 7 m dexamethasone , and 10 − 8 m 1 , 25 dihydroxy vitamin d 3 . differentiation to trap positive cells was used as a marker for the osteoclast phenotype . in parallel experiments cells were plated at a similar density on 18 × 18 mm cover slips and immunostained for mim - 1 . l -[ 3 h ]- proline - labeled devitalized bone was used as substrate in the avian osteoclast resorption assay . this substrate has the advantages of reflecting removal of both the mineral and organic phases of bone , and is resistant to artifacts due to physicochemical exchange ( e . g ., media acidification ( 16 )). weanling rats ( 40 - 60 g ) were injected with 1 mci of l -[ 2 , 3 , 4 , 5 - 3 h ]- proline , & gt ; 100 ci / mmol , on alternate days for 10 days . rats were sacrificed on day 12 and the bone was recovered by dissection . after washing , the bone was dried in a desiccator at 42 ° c . for 7 days . labeled 20 - 40 μm bone fragments were obtained by grinding the bone in a ball bearing mill and sieving to size . osteoclasts were plated at 2 - 3 × 10 3 cells / well on 24 well plates with 100 μg of labeled 20 - 40 μm 3 h labeled bone fragments . to avoid possible contamination due to fusing macrophages or growth of fibroblast / osteoblast cells , bone resorption was measured after 4 days . osteoclasts rapidly (˜ 4 hrs ) attach to and begin to degrade the bone fragments , releasing label into the media . bone degradation was determined by measuring label released to the media . comparison of the 3 h proline release and pit assays give comparable results ( 17 , 18 ). the 3 h proline assay is also resistant to ph - dependent artifacts and has less inter - assay variability than pit assays ( 17 - 19 ). activity with 100 μg bone fragments is linear over 5 - 7 days ( 16 ). avian osteoclasts were washed with phosphate buffered saline ( pbs ) and lysed as previously described ( 20 ). the lysis buffer ( buffer a ) is 50 mm tris , ph 7 . 0 , 250 mm sucrose , 1 mm egta , 1 mm edta , 1 mm ammonium molybdate , 50 mm naf , 1 mm orthovanadate , 0 . 5 μm okadaic acid , 5 mm benzamidine , 0 . 1 mm pmsf , 0 . 05 mg / ml pepstatin , 0 . 06 mg / ml leupeptin , 0 . 018 trypsin inhibitor units of aprotinin / ml , 10 % glycerol and 1 % triton x100 . cells were solubilized 1 hr with rotation and the triton insoluble material removed by centrifugation at 15 , 000 × g for 5 min at 4 ° c . lysates ( 25 μg protein ) were resolved on 10 % sds - page . protein was transferred under standard conditions ( 21 ) to pvdf membranes . mim - 1 was detected on western analysis using a polyclonal antibody generated against a trpe - mim - 1 fusion protein ( 15 ) ( generously provided by scott ness , university of new mexico ) by enhanced chemiluminescence . protein concentrations were determined by the bio rad dc assay ( bio rad , richmond , calif .). high quality water was prepared using a millipore ( bedford , mass .) milli - q reagent grade water system . hplc grade acetonitrile was purchased from burdick and jackson ( muskegon , wis .). sequencing grade trifluoroacetic acid ( tfa ) was purchased from pierce ( rockford , ill .). reagent grade ammonium bicarbonate was purchased from mallinckrodt ( st . louis , mo .). iodoacetic acid was purchased from sigma ( st . louis , mo . ), and dithiothreitol was purchased from aldrich ( milwaukee , wis .). sequencing grade modified trypsin was purchased from promega ( madison , wis .). separated proteins were reduced , alkylated , and digested in - gel using a procedure based on published methods ( 22 , 23 ). gel pieces were finely diced and de - stained by multiple 40 minute extractions with 200 mm nh 4 hco 3 in 50 % acetonitrile at 30 ° c . destained gel pieces were dried in a vacuum centrifuge , then rehydrated with 10 mm dithiothreitol and reduced for 1 hour at 56 ° c . after reduction , the proteins were alkylated with 100 mm iodoacetic acid for 30 minutes in the dark at room temperature . reaction products were removed by rinsing twice with 200 mm nh 4 hco 3 , followed by twice shrinking the gel with acetonitrile and re - swelling it with 200 mm nh 4 hco 3 . the gel pieces were dried in a vacuum centrifuge and re - swelled with 50 μg / ml trypsin in 100 mm nh 4 hco 3 ( prepared by mixing equal volumes of a stock solution of 100 μg / ml trypsin in 1 mm hcl with 200 mm nh 4 hco 3 ). the gel pieces were covered with 200 mm nh 4 hco 3 and incubated overnight at 30 ° c . the reaction was quenched with 2 μl of 10 % tfa followed by removal of the supernatant . the gel pieces were twice extracted with 100 μl 0 . 1 % tfa in 60 % acetonitrile . the combined extracts and supernatant were taken to near dryness in a vacuum centrifuge and stored frozen until analyzed . protein digests were analyzed using a custom built microcapillary hplc coupled to a finnigan mat lcq quadrupole ion trap mass spectrometer ( 24 ). separations were carried out using 150 μm ( inner diameter ) porous polymer monolithic columns ( 25 ). data were generated using the finnigan triple play data - dependent analysis , in which an ion identified in a full mass range scan is scanned at high resolution to determine its appearance mass and charge state and then fragmented to give a tandem ( ms / ms ) mass spectrum . instrument parameters were : 210 ° c . heated metal capillary temperature , 1 . 10 kv spray voltage , and 35 % relative collision energy . spectra were collected with 2 microscans and a 5 × 10 7 automatic gain control target for full scans , 5 microscans and 1 . 5 × 10 6 automatic gain control target for zoom ( high resolution ) scans , and 8 microscans and 1 × 10 7 automatic gain control target for ms / ms scans . ms / ms spectra were searched against the owl non - redundant database using the sequest ( 26 ) program . sequest results were confirmed by manually comparing observed and predicted fragmentation patterns for the identified peptides . osteoclasts were cultured on 18 × 18 glass cover slips with or without 20 - 40 μm bone fragments . cells were washed with ice cold phosphate buffered saline ( pbs ), fixed in 3 % formaldehyde and permeabilized with 100 % methanol for 30 min at − 20 ° c . nonspecific binding was blocked with 1 % bsa in pbs at 23 ° c . for 15 minutes . mim - 1 polyclonal antibody ( rabbit serum ) or nonimmune serum was diluted 1 : 1000 in blocking buffer and incubated on cover slips for 1 hour at 23 ° c . cover slips were washed 4 times for 15 minutes each with pbs and blocked again with blocking buffer . secondary antibody ( fitc conjugated ) was diluted 1 : 1000 and incubated on the cover slips for an hour at 23 ° c . in the dark . cover slips were hoescht stained ( 20 μg / ml ) for 1 hour for nuclear localization . cover slips were mounted in 0 . 1 % phenylenediamine in 90 % glycerol / pbs . fluorescence microscopy was performed on a leica wetzler microscope attached to a power macintosh computer running ip lab 3 . 2 software . the phorbol ester , pma , stimulated bone resorption by isolated osteoclasts 4 - fold with a k 0 . 5 between 0 . 1 and 0 . 3 μm ( fig1 ). the pma - concentration dependent increase in bone resorption was paralleled by a decrease in a 35 kd protein in osteoclast cell lysates as visualized on coomassie stained gels ( fig2 ). this protein was the lowest molecular weight of three abundant proteins migrating between 35 and 40 kd on sds - page . the concentration of the 35 kd protein decreased dramatically in response to pma while the relative abundance of the other two proteins in this region did not change with respect to coomassie staining . this protein , being one of the most abundant proteins in solubilized osteoclast lysates , was alkylated , reduced , tryptically digested and sequenced from excised gel slices and unambiguously identified as chicken myeloid protein 1 ( 15 , ncbi identifier p08940 ) or mim - 1 ( myb induced myeloid protein - 1 ) as described above . briefly , coomassie stained bands were excised from gels post - transfer ( reducing the number of potential background proteins ) and tryptically digested ( fig3 ). tryptic peptides were resolved by hplc ( fig3 a ). seven distinct peptides comprising 31 . 9 % of the complete sequence were identified by tandem mass spectrometry ( seq id no : 1 - 7 ). one of the peptides identified included the amino acid at position 297 , which is the site of a sequence conflict , and was found to be isoleucine rather than tyrosine . no other proteins were identified in the gel band containing the myeloid protein , with the exception of the regularly observed minor contaminant human keratin . sequence obtained includes 104 amino acids ( fig3 b ) of the 326 amino acids in the full length sequence reported in original cloning and sequence paper ( 15 ). the sequenced peptides were illustrated in fig3 b in bold in the full - length sequence of mim - 1 ( seq id no : 8 ). examination of the sequence demonstrates that there is a repeat sequence of approximately 136 amino acids in each half of the protein joined by a 14 amino acid “ linker ”. there is high sequence homology between the repeat sequences of mim - 1 and the neutrophil chemokine protein , lect2 ( also known as chondromodulin ii ). the repeat sequences of mim - 1 and lect2 are aligned and illustrated in bold print in fig3 c ( seq id no : 9 - 11 ). in this repeat structure there are 99 amino acids that are identical and most of the non - identical sites are conservative substitutions . this protein has no known function but was reported to be a secreted protein ( 15 ). to determine the effects of pma on osteoclast secretion of mim - 1 and its relation to bone resorption , osteoclasts were cultured as described above in the absence of pma and aliquots of media removed at the indicated times ( fig4 ) and the level of mim - 1 determined by western analysis . levels of mim - 1 increase throughout the 4 day time course . osteoclasts were then treated with increasing concentrations of pma , and bone resorption was measured ( 17 , 27 , 28 ). as bone resorption was stimulated ( see fig1 ), mim - 1 decreased in the cell lysate ( fig5 left side , lysates ), and increased in the culture media ( fig5 right side , media ). it is also evident from these data that osteoclasts have a basal rate of secretion of mim - 1 that is independent of pma treatment . the decrease in mim - 1 in osteoclast lysates in response to pma treatment was rapid . mim - 1 was substantially reduced in cell lysates by 48 hours treatment with pma ( fig6 ). the amount of mim - 1 in cell lysates decreased by 25 % after 24 hrs and 75 % at 48 hrs of pma treatment ( fig6 a ). interestingly , this decrease in mim - 1 preceded by a day the largest change in the time dependent increase in pma stimulated bone resorption ( fig6 b ). mim - 1 is expressed in bone marrow promyelocytes ( 18 ), and is secreted by osteoclasts ( fig2 - 6 ) and has been previously been reported to be localized within granules in granulocytes . immunohistochemistry showed that mim - 1 was present in both avian osteoclasts ( data not shown ) and human osteoclast - like cells derived from human blood monocytes ( fig7 ). osteoclasts were hoechst stained to show nuclei and mim - 1 was localized by immunofluorescence microscopy with fitc labeled secondary antibody . in avian osteoclasts mim - 1 fluorescence was localized in the cytosol and had a perinuclear pattern in osteoclasts . the fluorescence intensity decreased dramatically in response to pma treatment , consistent with the observation that osteoclasts secrete mim - 1 to the media . mim - 1 in pma treated osteoclasts appeared to be within granules , similar to the distribution reported in promyelocytes ( 15 ). mim - 1 staining was specific since in both control and pma treated osteoclasts fluorescence background with the nonimmune antibody was substantially lower than that with mim - 1 antibody . mim - 1 was present in the human osteoclast precursor cells ( fig7 a ) while cells treated with non - immune serum were negative ( fig7 b ). in these experiments the plane of focus was at the level of the blood monocytes which were above the mg63 cells . consequently , the nuclei of the mg63 cells were out of the plane of focus and appeared dark blue rather than bright blue as in the monocytes . numerous monocytes had begun to fuse as can be seen by the presence of bi - nucleated cells . mim - 1 is also present in the mouse marrow macrophage differentiation model . in fact , mim - 1 dramatically inhibited trap staining of osteoclast - like cells suggesting that mim - 1 inhibits differentiation of these cells in the presence of m - csf and soluble rankl . in order to examine whether mim - 1 may regulate recruitment of osteoblast precursor cells , migration assays were performed on mesenchymal stem cells . as shown in fig8 the stem cells migrated to mim - 1 in a concentration dependent manner , suggesting that mim - 1 may serve to attract osteoblast precursor cells to an area that is newly resorbed , thereby providing a mechanism for coordinating bone remodeling . the role of mim - 1 in modulating signal transduction in osteoblast precursor cells was examined as follows . mim - 1 stimulated increased tyrosine phosphorylation of proteins ranging in molecular weight from 40 to 80 kda ( fig9 ), including activation of map kinase . furthermore , mim - 1 stimulated a five - fold increase in binding of the osteoblast specific transcription factor , cbfal , to the osteocalcin promoter in electrophoretic mobility shift assays ( fig1 ). osteocalcin is a marker of late osteoblast differentiation , and the data strongly suggest that mim - 1 stimulates differentiation of osteoblastic precursor cells . regulation of bone mass is a complex process requiring tight regulation of the cellular activity of both osteoclasts and osteoblasts . this tight regulation necessitates an intricate and dynamic coordination of cellular signals . it has long been speculated that a wide variety of molecules including neuropeptides ( 29 ), il - 6 ( 30 ), osteoprotegrin ( 7 , 31 ), parathyroid hormone ( 32 ), tgfβ ( 33 ), prostaglandins ( 34 ) and osteopontin ( 35 ), to name a few , are important mediators of cellular signaling between osteoclasts and osteoblasts . much attention has also been focused on signaling between osteoblasts and osteoclasts ( 13 , 36 , 37 ). many factors are involved in recruiting precursor cells of osteoblast or osteoclast lineage . it would seem especially important for osteoclasts to have a mechanism to stimulate recruitment of osteoblastic precursors . such a pathway would allow for coordinated remodeling of bone . secretion of an abundant cellular protein which is important in maintaining the balance between bone degradation and bone synthesis has not been reported in either osteoblasts or osteoclasts . secretion of an abundant osteoclastic protein may be necessary to attain physiologically relevant concentrations of a 35 kda protein in the bone microenvironment . a 35 kda osteoclast protein , mim - 1 , was unambiguously identified that was secreted in a time dependent manner . mim - 1 secretion was correlated with increased osteoclast activity when stimulated by pma ( fig3 ). mim - 1 was originally cloned from chicken marrow promyelocytes ( 15 ). in these cells mim - 1 was very abundant , consistent with the observation in osteoclasts . there is no known function described for mim - 1 ( 15 ) and thus its potential role in osteoclast or osteoblast biology is not readily apparent . however , mim - 1 and a 16 kd protein ( lect2 ) that has sequence homology with mim - 1 are both reported to be secreted proteins ( 15 , 38 , 39 ). interestingly , lect2 ( also known as chondromodulin ii ( 40 )) has chemokine activity in attracting neutrophils ( 38 , 39 ) and stimulates osteoblast proliferation ( 41 ). mim - 1 was speculated to have some function in the milieu of bone marrow , or to possibly serve as a structural protein in granules where it is localized ( 15 ). the present data indicates that mim - 1 was secreted by isolated osteoclasts under basal conditions since mim - 1 accumulated in media over a four day incubation in culture ( fig4 ). however , mim - 1 secretion was rapidly increased in response to pma treatment of osteoclasts ( fig5 ). the pma concentration dependent increase in bone resorption is paralleled by an increase in calmodulin protein levels , and calmodulin antagonists inhibit both the pma dependent increase in bone resorption and calmodulin levels . in contrast , the calmodulin antagonists did not inhibit the secretion of mim - 1 . analysis of mim - 1 sequence demonstrates two imperfect direct repeat sequences of 136 amino acids linked together by a 14 amino acid tether . in the 136 amino acid repeat sequences only 30 amino acids are non - identical ( 77 % identity ) and most of the 30 non - identical sites have conservative substitutions . lect2 / chondromodulin ii ( 38 , 39 ) has high sequence homology with the repeat structure in mim - 1 but is a 16 kd protein isolated from human t - cells . lect2 is expressed primarily in liver and is a distinct gene product from mim - 1 ( 40 ). the majority of previous investigations of the mim - 1 protein involved transcriptional regulation of mim - 1 gene expression ( 15 ). northern blot analysis indicated that bone marrow was the tissue with the only detectable expression of mim - 1 and that mim - 1 was localized in promyelocytes but was not expressed in brain , heart , lung , kidney , liver , muscle , thymus , bursa or spleen ( 15 ). transcriptional regulation of mim - 1 expression is governed by the transcription factor myb . myb activity in regulating mim - 1 expression is reported to undergo synergistic activation with c / ebp ( 42 , 43 ). interestingly , transcriptional regulation of mim - 1 expression is negatively regulated by pu . 1 which has been previously been reported to be necessary for osteoclast differentiation ( 44 ). in fact pu . 1 knockouts are osteopetrotic ( 43 ), while neutrophils deficient in pu . 1 fail to differentiate ( 45 ). in addition , myb knockouts are embryonic lethals due to a failure of hepatic hematopoiesis ( 46 ). furthermore , there is a negative correlation between expression of mim - 1 and cell differentiation ( 15 ). mim - 1 was first identified in promyelocytes and is abundant in freshly isolated osteoclasts ( fig2 , and 7 ), which were reported to be derived from promyelocytes in the presence of stromal cells ( 47 , 48 ). together with the fact that mim - 1 is secreted preceding a 4 - fold stimulation of osteoclastic bone resorption by pma , these data suggest that mim - 1 may have paracrine effects on osteoclast differentiation . in addition , due to the high sequence homology with the neutrophil chemokine lect2 , mim - 1 may have a dual purpose in bone . mim - 1 may is also serve to attract osteoblast precursor cells to areas of recent bone resorption , thereby participates in a mechanism of coordinating bone remodeling ( fig1 ). 3 . udagawa et al . ( 1990 ) proc . natl . acad . sci . usa 87 : 7260 - 7264 . 5 . yasuda et al . ( 1998 ) proc . natl . acad . sci . usa . 95 : 3597 - 3602 . 13 . manolagas and weinstein . ( 1999 ) j . bone miner . res . 14 : 1061 - 1066 . 21 . towbin et al . ( 1979 ) proc . natl . acad . sci . usa 76 : 4350 - 4354 . 24 . davis and lee . ( 1998 ) j . am . soc . mass spectrometry 9 : 194 - 201 . 26 . eng et al . ( 1995 ) j . am . soc . mass spectrom . 5 : 976 - 989 . 28 . williams et al . ( 1997 ) biochem . biophys . res . commun . 235 : 646 - 671 . 30 . manolagas . ( 1998 ) annals of the new york academy of sciences 840 : 194 - 204 . 33 . duivenvoorden et al . ( 1999 ) clinical & amp ; experimental metastasis 17 : 27 - 34 . 34 . kawaguchi et al . ( 1995 ) clinical orthopaedic & amp ; related res . 313 : 36 - 46 . 37 . aurbach et al . ( 1985 ) in williams &# 39 ; textbook of endocrinology ( wilson j d and foster d w eds .) 7 th ed ., pp . 1173 - 1174 , wb saunders co ., philadelphia . 38 . yamagoe et al . ( 1997 ) biochem . biophys . res . commun . 237 : 116 - 120 . any patents or publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains . further , these patents and publications are incorporated by reference herein to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference . one skilled in the art will appreciate readily that the present invention is well adapted to carry out the objects and obtain the ends and advantages mentioned , as well as those objects , ends and advantages inherent herein . the present examples , along with the methods , procedures , treatments , molecules , and specific compounds described herein are presently representative of preferred embodiments , are exemplary , and are not intended as limitations on the scope of the invention . changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention as defined by the scope of the claims .

the present invention demonstrates the biological function of a newly identified osteoclast - secreted protein . this protein , mim - 1 , has sequence homology with but is distinct from a previously identified neutrophil chemokine protein . mim - 1 may be a key signaling protein secreted by osteoclasts that regulates recruitment and / or differentiation of osteoblast and osteoclast precursor cells . this protein may also serve to maintain osteoclasts in a relatively inactive state prior to secretion . this mechanism is essential for regulating the mass and structural integrity of bone . this protein or an analog and / or antagonists of this protein will have potential therapeutic potential in the treatment of a variety of pathological bone diseases including osteoporosis and metastatic bone diseases .

the present invention provides minimally invasive , flexible fixation of the ankle syndesmosis whilst resisting tibio - fibular diastasis . it allows physiological micromotion at the ankle syndesmosis . there is no need for routine removal of the implant and its use should enable patients to weight - bear at an earlier stage . the present invention is indicated for use in the fixation of ankle syndesmosis tibio - fibular diastasis ( splaying apart ). these are typically seen in weber c - type ankle injuries , caused by severe pronation - external rotation forces . the fibula is fractured above the level of the syndesmosis . a medial ankle injury ( malleolar fracture or deltoid ligament rupture ) is also usually present . reduction and fixation of the ankle syndesmosis is necessary to prevent lateral talar shift , which can lead to premature ankle osteo - arthritis . thus , referring to the accompanying drawings , the apparatus of the present invention comprises a pair of buttons 10 , which , in the preferred embodiment illustrated are 9 mm by 3 . 5 mm in dimension , more particularly in length and width respectively . the buttons 10 are preferably formed from titanium or stainless steel , although it will of course be appreciated that any other suitable material could be used , in particular any suitable bioabsorbable material . the pair of buttons 10 each have a first aperture 12 and a second aperture 14 which , in the preferred embodiment illustrated , are triangular in shape , each of the first and second apertures 12 , 14 having an apex 16 , the respective apices 16 preferably being directed away from one another and being located substantially about a longitudinal mid - line of the button 10 . referring in particular to fig2 , the pair of buttons 10 are secured or pre - threaded together by means of a flexible coupling in the form of first suture 18 , preferably of no . 5 braided polyester , which is double looped through the first and second apertures 12 , 14 of the pair of buttons 10 , as will be described in greater detail hereunder . it will be readily understood however that any suitable material could be used for the first suture 18 . a straight needle 22 with a second ( pull - through ) suture 20 , again of any suitable material , is also looped through either the first or second aperture 12 , 14 of one of the pair of buttons 10 , hereinafter referred to as the leading ( or first ) button 10 . the needle 22 is preferably 100 mm in length . in the embodiment illustrated in fig2 , the second suture 20 is looped through the first aperture 12 of the first button 10 . in the present embodiment , leading and trailing edges of the button 10 of the present invention are substantially symmetrical , although it will be appreciated that this is not a requirement of the present invention . specifically , the leading edge 24 of the button 10 of the present invention should be blunt and should have a width sufficient to reduce the possibility that the leading edge 24 of the first button 10 follows the second or pull through suture 20 through the intact medial skin or to catch or skewer any soft tissue structures between the bone and the medial skin , as will be described in detail hereinafter . the button 10 of the third aspect of the present invention may be provided with apertures 12 , 14 which are countersunk ( not illustrated ) so as to allow easier threading passage of the first and second sutures 18 , 20 . care needs to be taken in such countersinking , to avoid compromising the mechanical strength of the first and second apertures 12 , 14 of the button 10 of the present invention . the first suture 18 used in the apparatus of the present invention can be of any material , which is suitable for this purpose , whether absorbable or non - absorbable , provided it is sufficiently strong . a number 5 - strength braided polyester ( ethibond — trade mark ) suture is preferred . this is a non - absorbable suture which knots easily without slipping . the second suture 20 used in the present invention can be of any material which is suitable for this purpose , provided it is of at least 0 - strength . the pull through needle 22 can be of any dimensions , provided it is long enough to span the ankle . its tip can be either “ taper cut ” or “ cutting ”. the patient is positioned supine on a radiolucent operating table ( not shown ). intra - operative fluoroscopy is necessary during the procedure . the patient and all theatre personnel should be adequately protected for x - ray radiation . a sandbag ( not shown ) is placed under the ipsilateral buttock to facilitate internal rotation of the leg . antibiotic prophylaxis and the use of a tourniquet are recommended . an a . o . small fragment set ( or equivalent ) should be used for fracture osteosynthesis . the 3 . 5 mm drill bit is required for drilling the hole 30 through both the fibula 26 and tibia 28 , for the first button 10 and first and second sutures 18 , 20 to pass through , as illustrated in fig3 to 7 . this corresponds to the 3 . 5 mm drill bit which is part of the small fragment set routinely used to internally fix ankle fractures . it will , of course , be appreciated that the diameter of the hole 30 must be sufficient to permit the first button 10 to be pulled , lengthways , therethrough . osteosynthesis should be undertaken according to a . o . principles of internal fixation . it is recommended that fractures ( not shown ) in the lower half of the fibula 26 should be fixed . high fibular fractures ( maisonneuve injury ) can be managed by addressing the syndesmosis diastasis only . care should be taken not to injure the superficial peroneal nerve during the lateral approach to the fibula 26 ; the nerve passes posteriorly to anteriorly as it pierces the deep fascia . a one - third tubular plate usually provides sufficient stability and can be contoured easily to sit on the bone . the use of a lag screw for fracture compression is rarely required , once fibular length and rotation have been corrected . the syndesmosis is reduced by internal rotation of the ankle , at around 30 ° of plantar flexion . this does not result in an over - tightening of the syndesmosis . reduction should be confirmed using the image intensifier . all four cortices are drilled from the open lateral side using the 3 . 5 mm drill bit . the drill ( not shown ) should be angled at 30 ° upwards from the horizontal , at a distance of 2 - 3 cm above the ankle joint . placing a finger on the medial aspect of the leg can help with aiming and feel when the drill has passed through . the drill hole 30 may go through one of the holes of a one - third tubular plate ( not shown ), if needed . to ensure accurate placement , drilling should be performed under image intensifier control . the long straight needle 22 with pull - through , second suture 20 is passed through the drill - hole 30 and out the intact medial skin ( see fig3 ). the pull - through suture 20 , which engages the apex 16 of the first aperture 12 of the first button 10 , can now advance the first or leading button 10 , substantially horizontally through the drill hole 30 ( fig4 & amp ; 5 ). engagement of the second suture 20 in the apex 16 ensures that the second suture 20 is located adjacent the longitudinal mid - line of the first button 10 so that the second suture 20 stays central in the first aperture 12 . once this first button 10 has exited the medial tibia 28 , the angle of traction on the pull - through , or second suture 20 is changed and counter - traction is exerted on the first suture 18 , in order to flip ( pivot ) and engage the first button 10 against the medial tibial cortex ( fig6 ). once the first button 10 is anchored , the pull - through ( second ) suture 20 can be cut and removed . the trailing or second button 10 is tightened down on the lateral side by further traction on the free ends of the first suture 18 and should be tied hand tight ( fig7 ). this will further squeeze the syndesmosis but will not over - tighten it . following wound closure , the ankle should be placed in either a well - padded below - knee cast or backslab , ensuring the ankle is kept in a neutral position . the patient should be kept non - weight bearing for the first two weeks , and then allowed to partial weight - bear ( 50 %) from two to six weeks in cast , depending on fracture stability . full weight bearing can be allowed out of cast at six weeks . routine removal of the suture - button construct is not required . if , for any reason , it needs to be removed , this can be performed simply by small incisions over the medial and lateral buttons 10 , cutting the first suture 18 as it loops through the button 10 and removing the pair of buttons 10 and the first suture 18 . phase one aims to reproduce a cadaver model of a syndesmosis injury , with a medial deltoid ligament rupture . an intact fibula simulates an anatomically fixed fracture . phase two compares the suture - button versus conventional a . o . screw fixation following total intraosseous membrane ( iom ) division , in a model resembling a maisonneuve injury . sixteen embalmed cadaver legs ( eight pairs ) were used . for each leg ( not shown ), the tibia and foot were fixed to a customised jig using steinman pins . the foot was fixed to a mobile footplate so that the centre of rotation was directly under the centre of the ankle joint . external rotation moment was applied tangential to the centre of rotation at a radius of 25 cm . 1 kg of weight used therefore corresponds to approximately 2 . 5 newton - meters of torque . the syndesmosis was exposed via an antero - lateral approach . marker pins were placed in the tibia and fibula at the level of the syndesmosis to aid clinical and radiographic measurements . clinical measurements were made using vernier calipers . in order to reduce bias , x - rays received a coded label to help blind subsequent review . the distance between the tips of the marker pins was measured on the mortise view x - ray . the stress lateral view was found to be less reliable , due to lack of reproducibility . a 5 kg ( 12 . 5 nm ) load was used for all phase one measurements . following baseline readings , the medial deltoid and syndesmotic ligaments were divided . measurements of diastasis were taken following 5 cm , 10 cm and total intraosseous membrane division . in phase two , left and right ankles were randomised to receive a suture - button 10 ( 4 mm × 11 mm ; the button being a conventional button marketed by smith & amp ; nephew inc . under endo - button ®) or a . o . standard ( 4 . 5 mm ) screw fixation ( not shown ). in both groups , the syndesmosis was first reduced by internal rotation of the footplate . a hole was then drilled from lateral to medial , at 30 ° anterior to the horizontal , 2 cm superior to the ankle joint . in the suture - button group of the present invention , a 4 mm drill hole 30 was drilled through all four cortices . the no . 5 braided polyester first suture 18 was looped twice through first and second apertures 12 , 14 of the first and second buttons 10 . the second suture 20 was threaded through the first aperture 12 of the first button 10 and also through the needle 22 . this needle 22 was passed into the drill hole 30 from the lateral side and out through the intact medial skin . using the leading pull - through suture 20 , the first button 10 was advanced horizontally along the drill hole 30 until it has exited the medial tibial cortex . using the leading pull - through second suture 20 , whilst maintaining traction on the braided polyester first suture 18 , the first button 10 was flipped to engage and anchor against the medial tibial cortex . the second suture 20 was then pulled out . the second button 10 was tightened against the lateral fibular cortex by further manual traction on the braided polyester first suture 18 . the first suture 18 was securely tied over the second button 10 when flush with the lateral fibular cortex . the progress of the first button 10 may be followed intra - operatively using an x - ray image intensifier ( not shown ), if available . in the comparative group ( a . o . screw ), a 3 . 2 mm drill hole was drilled through all four cortices . the hole was measured , tapped and an a . o . 4 . 5 mm cortical screw inserted to engage all four cortices , maintaining the reduction of the syndesmosis , without compression . measurements of syndesmosis diastasis were taken both under direct vision and radiographically at increasing external rotation torques . torque loads were increased in increments of 1 kg , to a maximum of 8 kg or until fracture or implant failure . in four ankles ( two per group ), fixations were also tested at 5 cm above the ankle joint , having removed the fixations at 2 cm , in order to determine the optimum level of fixation placement . in phase one , the mean values of the measured diastasis above the baseline value at 5 cm , 10 cm and total intraosseous ( iom ) division under 5 kg ( 12 . 5 nm ) load were 3 . 7 mm , 5 . 5 mm and 7 . 2 mm , respectively ( see fig8 ). each value showed significant increase in diastasis compared to the previous measurement , ( p & lt ; 0 . 001 , unpaired t - test ). radiographic measurements were less reliable than direct clinical measurements , but gave a similar picture . in phase two , there was a gradual diastasis with increasing torque load in both groups , which was probably due to the quality of the bone . the mean diastasis from baseline for the suture - endo - button ® and the a . o . screw groups for torque loads increasing at 1 kg intervals , up to 8 kg , are shown in table 2 . these differences were not statistically significant ( p = 0 . 7 , unpaired t - test , fig9 ). the apparatus and method of the present invention did give a more consistent performance , though . the distribution of standard deviations for a . o . screw fixation was 0 . 64 mm higher than that for the apparatus and method of the present invention ( 95 % c . i . 0 . 46 to 0 . 84 , hodges - lehmann estimation of shift ). there were no implant failures in either group . there were two fibular fractures in the a . o . screw group , prior to reaching the 8 kg load ( 5 kg , 8 kg ). only measurements prior to fracture were used for analysis . by comparison , there was one fibular fracture in the group of the present invention ( 8 kg ). comparing fixation placement at 2 cm versus 5 cm showed no significant difference ( table 2 ). the cadaver model in this study was tested using a jig ( not shown ) generating external rotation torque , which reproduces the mechanism of syndesmosis injury and , therefore , reflects the clinical situation . syndesmosis diastasis is seen with increasing intraosseous membrane division , under an external rotation torque load . this corroborates the findings of previous studies , showing a significantly larger diastasis with greater intraosseous membrane division . regarding the level of placement of the fixation , there was a trend towards better fixation at 2 cm , although only a small sample size was tested ( table 2 ). flexible fixation gives a more physiological end - result , allowing for micromotion at the distal tibio - fibular joint . implant fatigue or breakage is less likely and routine removal is not essential . this avoids the complication of loss of reduction following removal of fixation . earlier weight - bearing may be allowed , depending on the overall fracture configuration . the advantages of the suture - button technique are that it is simple , flexible , minimally invasive as the medial side does not need to be opened , and has given a consistent performance on biomechanical testing . clinical testing of the suture - button in ankle injuries that require reduction and fixation of a syndesmosis diastasis is recommended . 8 patients had suture - button fixation . the buttons used in example 2 were conventional buttons supplied by smith & amp ; nephew inc . and marketed under endo - button ®. a retrospective cohort of 8 patients with similar weber c fractures , treated using syndesmosis screw fixation , were recalled for clinical and radiological evaluation . outcome was assessed using the american orthopaedic foot and ankle surgeons ( aofas ) score on a 100 - point scale . patients with screw fixation had a mean aofas score of 79 ( range : 61 - 100 ) at an average follow - up of four months ( range : 3 - 6 months ). the suture - button group had a mean score of 92 ( range : 76 - 100 ) at three - month review ( p = 0 . 02 , unpaired t - test ). six of the screw group required further surgery for implant removal , compared to none of the suture - button group ( p = 0 . 007 , fisher &# 39 ; s exact test ). patients treated using the suture - button 10 regained a better functional outcome , within a shorter time frame . the technique is minimally invasive , as the medial side is not opened , and allows tibio - fibular micromotion whilst resisting diastasis . the need for secondary surgery for implant removal is significantly lessened . the suture - button technique may become the gold standard for syndesmosis diastasis injuries . the present invention also provides minimally invasive , flexible fixation of the ac joint dislocation by resisting superior migration of the clavicle with respect to the coracoid process . it allows physiological micromotion at the ac joint . there should be no need for routine removal of the implant . the present invention is indicated for use in the fixation of ac joint dislocation . these are typically seen in rockwood type iii ac joint dislocations , usually caused by severe downward blunt trauma to the point of the shoulder , or acromium . typically , the clavicle is upwardly displaced as a result of the injury because of disruption to the ac and coracoclavicular ligaments . reduction and fixation of displaced ac joint dislocations are necessary to prevent painful deformity and loss of function . fig1 and 10 a show anterior and schematic views of a normal shoulder 10 . fig1 and 11 a show anterior and schematic views of a shoulder 10 that has suffered a rockwood type iii ac joint dislocation injury . referring to fig1 and 11 , the structure of a shoulder 10 relevant to a rockwood type iii dislocation injury includes the clavicle 12 , the coracoid process 14 and the acromium 16 . the acromium 16 and the clavicle 12 are connected by the acromioclavicular ligament 18 . the acromioclavicular ligament 18 extends from the lateral end 20 of the clavicle 12 to the medial surface 22 of the acromium 16 . the coracoid process 14 is connected to the clavicle 12 by the coracoclavicular ligaments 24 , which comprise the trapezoid ligament 26 and the conoid ligament 28 . the coracoclavicular ligaments 24 extend from the inferior surface 30 of the clavicle 12 to the superior surface 32 of the coracoid process 14 . a rockwood type iii ac joint dislocation is characterized by the disruption of the ac and the coracoclavicular ligaments 18 , 24 , respectively . as shown in fig1 and 11 a , the clavicle 12 separates from , and moves away from , the coracoid process 14 and the acromium 16 , accompanied by disruption of the coracoclavicular and the ac ligaments 18 , 24 , respectively . the acromioclavicular joint 34 ( fig1 ) is dislocated and the clavicle 12 is relatively displaced upwardly . the coraco - acromial ligament 36 ( fig1 ) is not impacted in the type iii shoulder dislocation . repair of the type iii shoulder dislocation according to the present invention is an out - patient procedure performed with a general anesthetic . the procedure is done with the patient lying supine on the operating table , preferably in the “ deck - chair ” position to allow the surgeon full access to the affected shoulder . referring to fig1 , the apparatus of the present invention comprises a first or second suture anchor in the form of a button 50 , which , in the embodiment illustrated , is about 10 . 0 mm in length by about 3 . 5 mm in width . the button 50 is preferably formed from titanium or stainless steel , although it will be appreciated that any other suitable material could be used , in particular any suitable bioabsorbable material . the button 50 has a first aperture 52 and a second aperture 54 which , in the embodiment illustrated , are oblong in shape , the longitudinal mid - line of each of the first and second apertures 52 , 54 being located substantially about a longitudinal mid - line of the button 50 . referring to fig1 , there is illustrated an alternative first or second suture anchor , generally indicated as 150 . in the illustrated alternative embodiment , the button 150 is about 9 . 0 mm in length by about 3 . 5 mm in width , with a thickness of about 1 . 5 mm . the button 150 has first and second apertures 152 and 154 , respectively . in the illustrated alternative embodiment , each of the apertures 152 , 154 are triangular in shape , the respective apices 155 being directed away from each other and being located substantially about a longitudinal mid - line of the button 150 . reference is now made to fig1 and 14 a which illustrate a first or second suture anchor in the form of a washer 60 . in the illustrated embodiment , the washer 60 has an external diameter of about 10 . 0 mm . while the illustrated washer is disc - shaped , the washer is not so limited . the washer 60 is preferably formed from titanium or stainless steel although , as will be appreciated by those skilled in the art , any other suitable material , in particular any suitable bioabsorbable materials , may be used . the washer 62 also has at least two flexible coupling - locating apertures 64 . in the illustrated embodiment , there are four apertures 64 circumferentially arranged about the aperture 62 . in the illustrated embodiment , each of the apertures 64 has a diameter of about 1 . 0 mm . each of the apertures 64 have beveled edges , above and below , while the aperture 62 has beveled edges above . the washer 60 also has a substantially centrally located bone screw - retaining aperture 62 . in the illustrated embodiment , the aperture 62 has a diameter of about 4 . 6 mm and the washer 60 is adapted to allow mobile positioning against an arcuate undersurface 69 of the head of the bone screw 68 ( illustrated in fig1 b ). referring to fig1 and 14 a , the washer 60 of the fourth aspect of the present invention is provided with a screw - retaining aperture 62 and at least two flexible coupling - locating apertures 64 which are preferably countersunk so as to allow easier threading passage of the flexible coupling 70 ( not shown in fig1 - 14 b ). care needs to be taken in such countersinking , to avoid compromising the mechanical strength of the apertures 62 , 64 of the washer 60 . fig1 illustrates the implant apparatus used for fixation of the ac joint dislocation . the button 50 and the washer 60 are secured or pre - threaded together by means of a flexible coupling in the form of first suture 70 , preferably of number 5 - strength braided polyester , which is double looped through the first and second apertures 52 , 54 of the button 50 and the peripheral apertures 64 of the washer 60 , as will now be described in greater detail . specifically , the first suture 70 is fed through to aperture 64 a of the washer 60 ; through the second and first apertures 54 , 52 of the button 50 ; through the aperture 64 b , under the washer 60 and back out the aperture 64 c ; through the second and first apertures 54 , 52 of the button 50 again ; and finally through the aperture 64 d of the washer 60 . a needle 72 , which may be straight or curved , with a second , pull - through suture 74 is also looped through either the first or second apertures 52 , 54 of the button 50 . the second suture 74 is looped through the first aperture 52 of the button 50 . the first suture 70 used in the apparatus can be made from any material which is suitable for this purpose , whether absorbable or non - absorbable , provided it is sufficiently strong . a number 5 - strength braided polyester ( fiberwire ®) suture is preferred . this is a non - absorbable suture which knots easily without slipping . the second suture 74 can be made from any material which is suitable for this purpose , and preferably should be at least 0 - strength . the pull through needle 72 can be of any dimensions , provided it is long enough to span the clavicle 12 or the coracoid process 14 of the shoulder 10 . the needle 72 is preferably about 100 mm in length . the needle &# 39 ; s body can either be straight or curved . the needle &# 39 ; s tip can be either “ taper cut ” or “ cutting .” in the present embodiment , leading and trailing edges of the button 50 are substantially symmetrical , although it will be appreciated that this is not a requirement of the present invention . specifically , the leading edge 56 ( illustrated in fig1 ) of the button 50 should be blunt and should have a width sufficient to reduce the possibility that the leading edge 56 of the button 50 follows the second or pull - through suture 74 through the intact skin or to catch or skewer any soft tissue structures between the bone and the skin , as will be described in detail hereinafter . fig1 also illustrates a bone screw 68 as part of the implant apparatus . the bone screw 68 is used for engaging the washer 60 with the coracoid process 14 ( fig1 f ). as discussed below in detail and with reference to fig1 b , the bone screw 68 has an arcuate undersurface 69 for defining the movement of the washer 60 between the coracoid process 14 and the arcuate undersurface 69 . the following sets out the procedure , as shown in fig1 a - 16 f , to be followed for rockwood type iii dislocations . surgeons skilled in the art will appreciate the modifications that might be needed in addressing rockwood type ii and iv - vi dislocations . the patient is positioned in a “ deck - chair ” position on the operating table ( not shown ). a sandbag ( not shown ) can be placed under the scapula to ease access to the shoulder region . a longitudinal or horizontal incision of about 5 cm is made on the skin , at the front of the shoulder , overlying the coracoid process 14 and the clavicle 12 . the clavicle 12 and the superior surface of the coracoid process 14 are exposed by blunt dissection . as explained in detail below , if the clavicle hole 80 is to be drilled ( fig1 a ) from above and substantially downwardly through the clavicle 12 , it will also be necessary to retract the skin about the clavicle 12 , in order to expose the superior surface 33 of the clavicle 12 . a 3 . 5 mm drill bit is required for drilling a hole 80 through the clavicle 12 . a 2 . 5 mm drill bit is required for drilling a hole 82 into the base of the coracoid process 14 of the scapula ( fig1 a ). it is not necessary that the drill holes 80 , 82 be aligned with each other . in addition , it is not necessary , when the coracoclavicular interspace is reduced to normal , that the longitudinal axes of the respective drill holes 80 , 82 be co - linear or even substantially parallel with each other . as illustrated in fig1 b , the long straight needle 72 with pull - through , second suture 74 is passed upwards through the 3 . 5 mm drill hole 80 in the clavicle 12 and can be passed through the intact skin on the superior aspect of the clavicle 12 or through the open surgical wound . in fig1 c , the pull - through suture 74 , which engages the first aperture 52 ( not shown ) of the button 50 , can now advance the button 50 , substantially longitudinally through the drill hole 80 . engagement of the second suture 74 in the aperture 52 ( not shown ) ensures that the second suture 74 is located adjacent the longitudinal mid - line of the button 50 so that the second suture 74 stays central in the first aperture 52 . in fig1 d , once the button 50 has exited the superior surface 33 of the clavicle 12 , the angle of traction on the pull - through , or second , suture 74 is changed and counter - traction is exerted on the first suture 70 , in order to flip ( pivot ) the button 50 and engage the button 50 against the superior surface 33 of the clavicle 12 . once the button 50 is anchored , the pull - through , or second , suture 74 can be cut and removed ( fig1 d and 16 e ). in fig1 f , the screw 68 containing the washer 60 is inserted into the 2 . 5 mm drill hole 82 ( fig1 e ) in the base of the coracoid process 14 of the scapula . before the washer 60 / bone screw 68 is fully seated into the drill hole 82 , the acromioclavicular joint 34 is reduced by downward manual pressure on the lateral end 20 of the clavicle 12 ( fig1 e and 16 f ). the two trailing ends of the first suture 70 ( fig1 e ) are pulled to approximate the desired distance between the button 50 and the washer 60 , and hence reduce the interval between the clavicle 12 and the coracoid process 14 . the first suture 70 is then secured to itself with a knot , tied tight by hand . the free ends of the first suture 70 can then be cut approximately lcm long , to avoid knot slippage . the screw 68 can then be fully seated into the drill hole 82 in the coracoid process 14 to maximize suture tension , or may be advanced or retracted accordingly to fine tune the suture tension , according to the surgeon &# 39 ; s preference . the volume between the arcuate undersurface 69 of the bone screw 68 and the coracoid process 14 defines the maximum flexibility of the washer 60 therebetween . the designed flexibility is helpful in increasing the tolerance for non - aligned drill holes and the like . following wound closure , the shoulder should be placed in a shoulder immobilizer for three weeks . gentle range of motion exercises can begin after three weeks . full range exercises can be allowed after six weeks . routine removal of the first suture anchor - suture - second suture anchor construct is not required . if , for any reason , it needs to be removed , this can be performed simply by re - opening the surgical incision , cutting the first suture 70 as it loops through the button 50 and removing the button 50 . the screw 68 and washer 60 can be removed easily using the screwdriver . it is noted that the above description and drawings are exemplary and illustrate preferred embodiments that achieve the objects , features and advantages of the present invention . it is not intended that the present invention be limited to the illustrated embodiments . any modification of the present invention which comes within the spirit and scope of the following claims should be considered part of the present invention .

an apparatus for performing ankle syndesmosis repairs includes , inter alia , a first button , a second button , and a suture connecting the first button and the second button . the first button and the second button are stainless steel buttons . at least one of the first button and the second button is oblong . the suture includes multiple strands that extend between the first button and the second button . a first free end of the suture is tensionable to shorten a length of the suture between the first button and the second button and thereby move the first button and the second button closer together .

as used in the specification and claims , the singular forms “ a ”, “ an ” and “ the ” include plural references unless the context clearly dictates otherwise . for example , the term “ an article ” may include a plurality of articles unless the context clearly dictates otherwise . those with ordinary skill in the art will appreciate that the elements in the figures are illustrated for simplicity and clarity and are not necessarily drawn to scale . for example , the dimensions of some of the elements in the figures may be exaggerated , relative to other elements , in order to improve the understanding of the present invention . there may be additional components described in the foregoing application that are not depicted on one of the described drawings . in the event such a component is described , but not depicted in a drawing , the absence of such a drawing should not be considered as an omission of such design from the specification . before describing the present invention in detail , it should be observed that the present invention utilizes a combination of system components which constitutes a pillow cover used for achieving comfortable sleeping conditions in presence of hair devices on one &# 39 ; s hair and providing a separation between the face and pillow . accordingly , the components and the method steps have been represented , showing only specific details that are pertinent for an understanding of the present invention so as not to obscure the disclosure with details that will be readily apparent to those with ordinary skill in the art having the benefit of the description herein . as required , detailed embodiments of the present invention are disclosed herein ; however , it is to be understood that the disclosed embodiments are merely exemplary of the invention , which can be embodied in various forms . therefore , specific structural and functional details disclosed herein are not to be interpreted as limiting , but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure . further , the terms and phrases used herein are not intended to be limiting but rather to provide an understandable description of the invention . disclosed herein is a pillow cover for accommodating a pillow and forming an indention comprising a generally rectangular shaped pillow case smaller than a pillow to be inserted therein , having at least one opening but alternatively a first and second opening on each end thereof and means to close the opening , wherein the opening is sufficiently large for insertion and removal of at least one pillow ; a front side and a rear side of the case , wherein the front side contains a panel comprising about one third to about one quarter ( ⅓ to ¼ ) of the total space of the pillow cover , such that when the pillow is inserted into the cover , at least one edge along the panel buttresses an edge of the pillow panel causing the pillow to curl and form an indentation , the depth of which is at least about ⅓ the size of the pillow . the pillow cover and panel can be made of a variety of fabrics such as satin , cotton , flannel , winceyette , nylon , velvet , polyester and linen and the like . the resulting rolled pillow having a defined indentation can be used by a person wearing hair curlers or other appliances while they sleep or used by those needing additional support during rest . a pillow cover 100 designed to be used by a user for sleeping with a set of hair devices ( not shown ) attached to his hair is shown in fig1 according to an embodiment of the present invention and is also designed to produce a cavity between the user and pillow to protect the face from pillow marks . the pillow cover 100 not only provides neck support to the user but also provides comfort when the hair devices are attached on the user &# 39 ; s head . the pillow cover 100 minimizes discomfort caused while sleeping with a set of hair or head devices and creates a comfortable sleeping condition for the user . the set of head devices may include hair rollers , hair curlers , hair clippers , and hair crimpers or medical head gear or ear gear or the like . the pillow and pillow cover 100 of the present invention are intended to be used with such hair devices ; however , they can be used without the hair devices , wherein the user seeks a comfortable sleeping posture , or when a traditional pillow is required to be used as an orthopedic pillow . the indented pillow can also be used as a leg or arm rest ( i . e ., body rest ) or a back support while sitting up on a chair or bed mattress . the pillow cover 100 includes an opening 102 for inserting and removing a pillow , such as a traditional pillow . alternatively , other insertions for the pillow may be used ; such as side seams along the edge of a panel . to close the seam , i . e . zippers , buttons , velcro , etc . can be used in the body of the invention . the point being is to have an opening to insert a rolled pillow , and form a dent . in a preferred embodiment of the present invention , the opening 102 is on both ends present along the width of the pillow cover 100 . in an alternative embodiment , the opening 102 may be provided on one end only . the pillow cover 100 is intended to be used with a traditional standard sized pillow . however , it should be appreciated that the pillow of any dimension can be accommodated inside the pillow cover 100 by appropriately designing the pillow cover 100 . the pillow cover 100 has a front side 104 and a rear side ( not shown ). the user attempts to sleep with his head always occupying the front side 104 of the pillow cover 100 . edges 106 are formed between the front side 104 and the rear side ( not shown ) of the pillow cover 100 . the edges 106 define an area therebetween on the front side 104 , onto which indentations 108 are formed . the edges 102 are made of an elastomeric material , such as rubber . it should be appreciated that any polymeric material that exhibits good stretch ability and elastic properties can be used as the elastomeric material . the pillow cover 100 is designed in such a way that total surface area of the pillow is always greater than total surface area occupied by the pillow cover 100 . as a result , when the pillow is placed inside the pillow cover 100 , the front side 104 forms a concave surface in the form of an indentation 108 as shown in fig2 . as the total surface area of the pillow is more than the total surface area of the pillow cover 100 , the plurality of edges 106 bends outwardly to form the indentation 108 . in other words , the pillow is curled inside the pillow cover 100 , when viewed from a side position , as shown in fig2 . the size of the pillow cover 100 plays a significant role in the formation of the indentation 108 . if the size of the pillow cover 100 is greater than desired , the pillow will be folded in half inside the pillow cover 100 failing to form an appropriate indentation 108 . similarly , a considerably smaller size of the pillow cover 100 will force the pillow to form a roll and not the indentation 108 . hence , the pillow cover 100 of appropriate dimension should be used that will enable the formation of the indentation 108 . the pillow cover 100 should be of sufficient size that the rolled up pillow forms a dent and not a roll , or alternatively folds in effect to half its size and does not form a defined dent . neither of the later two options are the intent of the subject invention . a panel 110 is present on the indentation 108 such that the area covered by the indentation 108 coincides with the area covered by the panel 110 . in an embodiment of the present invention , the panel 110 occupies about one - fourth to one - third of the total area that is covered by the front side 104 of a standard size pillow , having either one of soft , medium and / or firm foam . while foam is a preferred pillow interior , feathers or other pillow internal material can be used . the panel 110 covers a central area of the front side 104 of the pillow cover 100 . as the openings as shown in the figures are of an elastomeric material , they shrink , thereby making the panel 110 appear tapered towards the openings 102 . the panel 110 provides a visual indication , or a marker , to the user for appropriately placing the pillow inside the pillow cover 100 such that a front face of the pillow lies below the panel 110 at all times thereby facilitating the formation of the indentation 108 . the panel 110 also contributes to the formation of the indentation through use of the elasticized ends , and the edges or seams thereof . according to an embodiment of the present invention , when using a standard size us ( united states ) pillow inserted in the case , the width of the panel 110 is about 9 inches , tapering at the gathered ends . at the elastomeric openings 102 , the width of the panel 110 is about 5 inches with the pillow inserted in the case . the following dimensions are considered for pillows and pillow cases for forming ideal indentations : the ideal length for a pillow case was found to be about 25 inches long for a standard jumbo ( us term ) pillow or about 22 inches long for a super standard ( us term ) pillow . in another embodiment , the panel 110 can range from about 9 . 5 to 13 . 5 inches , however this range will vary based on the size of the pillow to be used . in an example , the dimensions of the sleeping pillow can range from about 27 to 44 inches long while the dimensions of the panel 110 can range from about 9 . 5 to 13 . 5 inches wide . in an embodiment the maximum width of the pillow cover 100 without a pillow inside , i . e ., including the edges and the panel ( or when the pillow cover is completely stretched ) at the center of the front side is at least about 18 inches . the distance measured between the opening 102 present at both ends of the pillow cover 100 ( i . e ., the overall length of the pillow cover 100 ) is about 20 - 22 inches ; however , it may be longer . hence , to form the indentation 108 , the dimensions of the pillow need to be greater than the dimensions of the pillow case cover 100 . it should be appreciated that any standard us pillow can be used with the pillow cover 100 to form the indentation 108 . the dimensions are provided for a standard us pillow , but these can be altered proportionally to a different size pillow . to use the cover , the pillow is rolled along its length and inserted into the pillow cover 100 through the openings 102 or a side seam and zipper , such that the roll enters with the pillow edges first . after inserting , the pillow is unrolled inside the pillow cover 100 so that it forms the desired indentation 108 on the pillow which is reflected on the panel 110 . fig4 and 6 show a user rolling a pillow lengthwise and inserting the pillow in the pillow cover 100 through the opening 102 . the user adjusts the pillow inside the pillow cover 100 having the edges of the pillow along or near the edges of the panel , thereby positioning the pillow at the center of the pillow cover 100 , and forming a dent . a soft or medium padding on the pillow forms a softer indentation 108 whereas a firm padding on the pillow forms a harder indentation 108 . however , the type and size of the pillow can vary depending on the user &# 39 ; s desired comfort . the formation of an indentation 108 is affected by the cushioning or thickness of the pillow . if the panel 110 is narrow , the indentation 108 formed is small . however , the small indentation 108 an still provide desired comfort to a person . moreover , a bigger indentation 108 is likely preferred on the pillow when a user wears large curlers on their hair . if they just want to keep their face off the pillow , a smaller indentation 108 is likely suitable . when the pillow cover 100 with the pillow is used as a back rest or leg rest / holder , a smaller indentation 108 is suitable . the design of the pillow cover 100 helps to manipulate a pillow for various uses in an inexpensive manner . in an example , a pillow is folded , inserted , and accommodated in the pillow cover 100 through the opening 102 to form a dent . the formed indentation 108 on the top surface 104 allows a person with hair accessories such as rollers or curlers to comfortably place the head in the indentation 108 . the design of the pillow cover 110 does not disturb the hair or head pieces , or the hairstyle of the person and moreover allows the person to rest or sleep without damage to their hairstyles . it has been found that the indentation 108 is formed when the pillow is positioned within the pillow cover 100 such that the edges of the pillow are abutting the edges of the panel 110 . in an embodiment of the present invention , the panel includes a seam 112 on an inner side 114 of the pillow cover 100 . the seam 112 on the inner side 114 of the pillow cover 100 can be seen when the pillow cover 100 is folded inside - out as shown in fig3 . the seam 112 defines a region of adherence of the panel 110 to the pillow cover 100 . on this seam maybe closure means such as zipper , buttons , or velco . the pillow cover 100 can be made of a variety of soft fabrics including satin , cotton , flannel , winceyette , nylon , velvet , polyester and linen . alternatively , the fabric can also be of a disposable type material particularly useful in germ - centered or germ - concerned areas such as a hospital setting , or the like . it should be appreciated that any other material used for manufacturing the pillow cover 100 is well within the scope of the invention . the panel 110 can be made from the same fabric as the remainder of the pillow or it can be made from any other suitable material . the panel 110 and the pillow cover 100 can both be made of elastomeric ( or stretch ) fabric , or of a non - stretch fabric , or a mixture of either . the choice of fabric is per the user &# 39 ; s discretion , but the chosen fabric should be easy to maintain , clean , and use . the present invention has been described herein with reference to a particular embodiment for a particular application . although selected embodiments have been illustrated and described in detail , it may be understood that various substitutions and alterations are possible . those having ordinary skill in the art and access to the present teachings may recognize additional various substitutions and alterations are also possible without departing from the spirit and scope of the present invention , and as defined by the following claim .

disclosed herein , is a pillow curler case , also called a pillow cover having a specialty panel that is used in conjunction with a traditional pillow . when the pillow is placed in the cover , an indentation is formed allowing the user to place their head in the indented region of the pillow while having their neck and shoulders supported by the edges of the pillow . this indentation provides for greater comfort when lying on the pillow , in particular when wearing hair or head devices or where there is a desire for separation between a user &# 39 ; s face and their pillow . other applications will be apparent to those of skill in the art for uses of the final rolled pillow which is formed .

the bone anchoring device 1 according to a first embodiment shown in fig4 to 12 includes a bone anchoring element , in this case a screw member 2 having a threaded shaft 3 having a bone thread and a head 4 . the head 4 is shaped , for example , as a spherical segment . it has a recess 4 ′ at its free end for engagement with a screwing - in tool . the bone anchoring device further includes a receiver member 5 for connecting the screw member 2 to a rod 20 . the receiver member 5 includes two portions in the form of separated chambers , a head receiving chamber 6 and a rod receiving chamber 7 . the head receiving chamber 6 and the rod receiving chamber 7 are connected by means of an intermediate portion 8 , which is in the embodiment shown a rod portion or a bar . the head receiving chamber 6 is , as shown in fig4 to 6 and fig8 , a body with a substantially cuboid shape having a first end 6 a and an opposite second end 6 b . a through - hole 9 extends from the first end to the second end . in a region adjacent to the second end , the diameter of the through - hole is smaller than that adjacent to the first end . thus , a seat 9 a is provided for the screw head 4 , preventing escaping of the screw head and enabling the screw head 4 to pivot within the head receiving chamber 6 . the seat can have a spherical or a tapered portion or a portion with any other shape . adjacent to or near the first end 6 a , an internal thread 10 is provided . the internal thread can be a metric thread or can have any other thread shape . since the thread is provided in the through - hole , the thread is closed in a circumferential direction . this allows use of a metric thread since a splaying of a u - shaped receiver , as it is known to be a problem in conventional polyaxial bone screws , does not occur . the diameter of the opening at the second end 6 b , which is defined by the through - hole , is such that the shank 3 of the screw member can be passed therethrough . when the head 4 of the screw member 2 is in the head receiving portion , the screw member can pivot so that the shank axis can assume different angles with respect to the axis of the through - hole . to fix the angular position of the screw member 2 in the head receiving chamber 6 , a first locking element 11 is provided , which can be seen in detail in fig9 to 11 . the first locking element 11 has a threaded portion 11 a with an external thread cooperating with the internal thread 10 of the through - hole , and a cylindrical portion 11 b , which extends in the direction of the head 4 when the screw member and the first locking element are inserted into the head receiving chamber . the threaded portion 11 a and the cylindrical portion 11 b form a one - part first locking element 11 . at the free end of the cylindrical portion 11 b , a spherical recess 11 c is formed , the radius of which is adapted to the radius of the head 4 . the recess 11 c serves to distribute the load exerted by the first locking element 11 onto the head 4 . the outer diameter of the cylindrical portion 11 b is slightly smaller than the inner diameter of the through - hole 9 and also of the threaded portion 11 a so that the first locking element can be easily introduced into the through - hole . the first locking element 11 further comprises a coaxial bore 12 that allows access to the screw head 4 by a tool . at the free end of the threaded portion 11 a , the first locking element 11 has a structure , such as a hexagonal structure 13 for engagement with a tool . referring to fig4 and 8 , the second end 6 b of the head receiving chamber 6 has an inclined surface that extends at an angle to the surface defined by the first end 6 a . by means of this , the pivot angle of the screw member can be enlarged to one side . as can be seen in fig4 to 7 , the rod receiving chamber 7 has also a cuboid shape with a first end 7 a and an opposite second end 7 b . a u - shaped recess 14 extends from the first end 7 a in the direction of the second end 7 b to form a channel for the rod 20 to be received therein . by means of the u - shaped recess 14 , two free legs are formed . an internal thread 15 extends from the first end or near the first end 7 a in the direction of the second end 7 b for screwing in a second locking element 16 . the second locking element 16 is in this embodiment a set screw . the internal thread 15 can be a flat thread with horizontal flanks to eliminate a splaying of the legs when the second locking element 16 is screwed in . in the embodiment shown in fig4 to 12 , the head receiving chamber 6 and the rod receiving chamber 7 are connected by the intermediate portion 8 and arranged in such a way that the central axis a 1 of the through - hole of the head receiving chamber 6 is inclined by an angle of 45 ° with respect to the central axis a 2 of the rod receiving chamber 7 , as can be seen in particular in fig8 . the arrangement of the chambers 6 , 7 with respect to each other is such that the internal threads of the through - hole and the u - shaped recess , respectively , are oriented towards the same side . by means of this arrangement , as can be seen in fig8 , it is possible to align the screw axis s nearly parallel to the longitudinal axis l of the rod . by means of the length of the intermediate portion 8 , the lateral offset between the screw and the rod can be defined . the shape of the head receiving chamber 6 and the rod receiving chamber 7 is not limited to the cuboid shape shown , it is also possible to use a cube shape , a cylindrical shape or any other symmetric or asymmetric shape . although the head receiving chamber 6 is shown to be a top loading chamber , where the screw is inserted with its tip portion first through the first end 6 a , it can also be designed as a bottom loading chamber where the head is introduced from the bottom , i . e . the second end 6 b . the material of the elements of the bone anchoring device is a body - compatible material , such as stainless steel , titanium , and body - compatible alloys such as nickel - titanium alloys , for example nitinol . it is also possible to construct the bone anchoring device or parts thereof from a body - compatible plastic material , such as , for example medical - grade peek . in modifications of this embodiment , the receiver member can be constructed such that the head receiving chamber 6 and the rod receiving chamber 7 have another orientation with respect to each other . any orientation is possible , for example , an orientation where the central axes a 1 and a 2 are parallel to each other . a specific modification of the bone anchoring device according to the first embodiment is shown in fig1 a and 12 b . like parts are indicated with the same reference numerals as in the first embodiment and the descriptions thereof are not repeated . the bone anchoring device 1 ′ of this modified embodiment has an identical rod receiving chamber 7 and a modified head receiving chamber 6 ′. the head receiving chamber 6 ′ has a through - hole 9 in which the first locking element 11 is screwed in and a seat 91 a for the head 4 provided at the second end , which is sized such that the head is pivotably held therein . it further includes a recess 91 , which extends in the region near the second end 6 b ′ perpendicular to the through - hole 9 and is open to the second end 6 b ′ and to the through - hole 9 . when the screw member is inserted into the through - hole 9 it can be pivoted once the head 4 is in the seat 91 a such that the threaded shank extends at an angle of around 90 ° to the through - hole 9 . in addition , as shown in fig1 a , the central axes a 1 and a 2 of the head receiving chamber and the rod receiving chamber are parallel in this case and the chambers are arranged such that the locking elements are accessible from the same side . fig1 shows a sectional view of the first locking element 11 and a partial sectional view of the head receiving chamber 6 showing the through - hole 9 together with different screw elements . the screw element 2 as shown in the left part of fig1 can have different shanks 3 with different lengths and diameters . the screw element 2 ′ shown in the middle portion has a coaxial bore 21 extending therethrough from the first end to the tip , providing a channel for the introduction of bone cement or other substances . in another example , the bore 21 is closed at the tip of the shank and can have lateral openings 22 extending from the coaxial bore 21 . in a further modification the screw element 2 ″ can be a screw element for non - spine applications . the screw element 2 ″ has a threaded portion 23 and a thread - free portion 24 . different screw members 2 ″ with different threads can be provided . the features of the screw elements can be combined among each other . the head 4 of the different screw members 2 , 2 ′, 2 ″ are all the same with respect to their outer shape and diameter so that they can be assembled with the receiver member described before and clamped with the same locking element 11 . in use , first the appropriate screw member and receiver member are selected . thereafter , the screw member is inserted into the head receiving chamber of the receiver member . thereafter the screw member is screwed into the bone . typically , several screw members with receiver members are screwed one after the other into portions of adjacent vertebrae . then , the angular position of the receiver member with respect to the screw member is adjusted and the first locking element 11 is inserted and tightened to clamp the head . thus , the head is locked by a downward movement of the first locking element in the direction of the shank . thereafter , the rod is inserted and is adjusted to the screw position . thereafter , the rod is fixed by the second locking element . during adjustment of the positions of the rod and the head , it can be necessary to open the head and / or rod fixation again to further adjust the positions . since the head fixation and the rod fixation are completely independent from each other , a convenient and precise adjustment is possible . a second embodiment of the bone anchoring device will now be described with reference to fig1 to 24 . the second embodiment differs from the first embodiment in the design of the receiver member 50 . the screw member 2 is identical or similar to that of the first embodiment . also , different screw members can be used as for the first embodiment . the receiver member 50 has a body having a substantially cuboid shape and the head receiving chamber and the rod receiving chamber are formed by portions of the cuboid body . the body has a first end 50 a and a second end 50 b , which can be defined as the short sides 51 of the cuboid . between the first end 50 a and the second end 50 b , walls are defined between the long sides 52 of the cuboid . a central axis c extends through the center of the cuboid body and is parallel to the long sides 52 . approximately one half of the body , adjacent to the second end 50 b , forms a head receiving chamber 60 that is constructed by means of a through - hole 90 , the longitudinal axis 90 a of which extends perpendicular to the central axis c of the cuboid body . the through - hole 90 is shaped similarly to the through - hole 9 of the first embodiment . it comprises an internal thread 100 at one end and a seat 91 a for receiving the head 4 of the screw member 2 in a pivotable manner at the opposite end . at the first end 50 a , a u - shaped recess 74 is provided , which forms a channel for receiving the rod 20 . adjacent to or near the first end 50 a , an internal thread 150 is provided at the legs formed by the u - shaped recess . the central axis a 2 of the internal thread 150 is coaxial with the central axis c of the body 50 and is perpendicular to the bore axis 90 a of the through - hole 90 . by means of this arrangement , the rod axis l and the screw axis s include an angle of approximately 90 °± α , wherein a is the pivot angle that the screw can assume in the seat . further , the screw axis s projects out of a plane that contains the rod axis l and the central axis c of the receiver member . this arrangement is particularly suitable for application in the lumbosacral region of the spine as shown in fig2 and 3 . the first locking element 11 and the second locking element 16 are the same as in the first embodiment . the bone anchoring device of the second embodiment can also be used in other regions of the spinal column . if the screw member 2 is screwed into the pedicles , the bone anchoring device is a bone anchoring device with a lateral rod arrangement . since the body 50 can be a compact design , a low - profile and low - cost bone anchoring device is provided . fig2 to 24 show further modifications of the second embodiment . all modifications have in common a compact body 50 ′, 50 ″, 50 ′″, which has a head receiving chamber 60 ′, 60 ″, 60 ′″ and a rod receiving chamber 70 ′, 70 ″, 70 ′″, which are laterally separated from each other and can be accessed with two separate locking elements 11 and 16 ′, 16 ″, 16 ′″. in fig2 , the rod receiving chamber 70 ′ is laterally arranged and has an inclined u - shaped recess 74 ′ for introducing the rod 20 from the side and a locking element 16 ′ in form of a set screw to be screwed in a threaded bore 72 extending from the top into the inclined u - shaped recess . this is a side - loading arrangement in which the locking elements 11 and 16 ′ are accessible from the same side . in fig2 , the u - shaped recess 74 ″ for the rod 20 extends from the same side as the threaded portion 100 ′ of the through - hole 90 ′ for the head 4 . this embodiment is a top - loading embodiment , where the rod has a lateral arrangement and the locking elements for the head and the rod are accessible from the same side . fig2 shows a further modification , where instead of a u - shaped recess , a through - hole 76 for the rod 20 is provided and the rod is secured by a set screw 16 ′″ extending through a threaded bore 78 . the shape of the receiver member of the second embodiment is not limited to the shapes depicted in fig1 - 24 . common to all modifications is that the receiver member has a body with a compact shape . the head need not be spherically shaped , but can also have a tapered portion or another shape .

a bone anchoring device includes a bone anchoring element having a shank and a head , a continuous one - piece receiver member , a continuous one - piece first locking element and a second locking element . the receiver member has a first chamber for receiving the head , the head being pivotable in the first chamber , and a second chamber with a channel for receiving the rod . a first locking element fixes the head in the first chamber at an angle , and a second locking element fixes the rod in the second chamber . the receiver member includes a body including both the first chamber and the second chamber . the head and the rod can be inserted and locked independently from each other . the head is fixed by exerting pressure onto it . the bone anchoring device is particularly applicable to the stabilization of the spine in the sacro - iliac and the cervical region .

fig1 shows the suppository 10 of the present invention suitable for use in hemorrhoid treatment . the suppository 10 of the present invention has a shaft 2 with a first end 7 and a second end 8 , and a retaining ring 3 attached between the ends 7 and 8 of the shaft 2 . the shaft 2 has a generally cylindrical shape . the best maximum diameter of the shaft to movably hold the shaft against the peristaltic movement is less than 6 mm , this size being approximately 15 % of the length of the average length of an anal canal . the maximum diameter of the shaft 2 to stay within the anal canal , avoiding the involuntary evacuative reaction of the rectal and the anal canal , is 8 mm , approximately 20 % of the length of the anal canal . as the diameter of the shaft increases , the ratio between the surface area to capacity decreases , such that the device loses the ability to be retained within the anal canal . the best ratio between the surface area and the volume of the shaft is between 1 : 2 and 2 : 1 , with diameters being between 2 mm and 8 mm . the best maximum diameter of the shaft is 20 % of the occupied length of the shaft within the anal canal . the ring 3 has a maximum diameter of 14 millimeters because an increase in the size of the ring requires the size of the shaft to increases , causing undesirable involuntary evacuation of the entire device . the best maximum diameter is 12 millimeters . since the size of the human body parts have a great variety , all figures are approximate . fig2 is a bottom view of the present invention . fig3 illustrates the suppository 10 of the present invention inserted in the anal canal . the broken line 80 illustrates the entrance of the anus . area 81 is the external sphincter that contains the external hemorrhoids . broken line 82 is illustrative of the intermuscular groove . area 83 illustrates the pecten . this pecten is a narrow passage section of the anal canal . the pecten has a two - way valve function at its inner portion . any small sized lump - like mass entering the upper portion of the pecten will be pushed up to the internal hemorrhoid area , and any small lump in the lower half of the pecten will be pushed out from the anus . broken line 84 illustrates the dentate line . this dentate line is a slightly indented portion in the anal canal . area 85 illustrates the internal hemorrhoid area . the broken line 86 indicates the upper edge of the internal hemorrhoid area . area 87 is the ampulla of rectum . the anal canal is between the intermuscular groove 83 and the upper edge 86 of the internal hemorrhoid area 85 . in a typical human body , the internal hemorrhoidal area 85 will have a length of between 15 and 20 millimeters . the pecten area 83 will have a length of between 15 and 20 millimeters . the subcutaneous external sphincter area 81 will have a length of between 5 and 10 millimeters . the length of the anal canal is typically between 3 cm and 4 cm inclusive . as can be seen in fig3 , the suppository 10 is inserted into the anal canal such that the wide section 4 of the ring 3 passes the dentate line 84 . the suppository 10 will stay around in this position a period of time . then , the down ward peristaltic movement of the anal canal applies to the shaft to bring down . fig4 shows the peristaltic movement bringing the ring 4 to enter the pecten . the pecten detects the ring 3 from the sudden change in diameter as a lump - like mass , then the pecten reacts to the ring by push the ring up from the pecten . thus , the device 10 can be moved up and down within the anal canal , until the device 10 is removed from the anal canal manually . as can be seen , the device 10 contacts the entire anal canal wall , including an upper edge of the internal hemorrhoid area , without striding the anal canal . again , choosing the proper size of the shaft and the combination of the shaft and the ring , the upward force and the downward force to the suppository will be balanced , and the suppository will stay by itself slightly moving up and down within the anal canal . the foregoing disclosure and description of the invention is illustrative and explanatory thereof . various changes in the details of the illustrated construction can be made within the scope of the appended claims without departing from the true spirit of the invention . the present invention should only be limited by the following claims and their legal equivalents .

a suppository for use in an anal canal includes a shaft having a first end and a second end . the shaft has a size to provide sufficient friction against the evacuative pressure of the anal canal . a retaining ring is attached on the shaft between the first end and the second end .

referring to the drawings in describing the invention 15 , which contains a long main body section 12 , which is essentially interrupted at both ends by angled sections 20a and 20b , which each contain angles of varying degree , height , and depth , and are mirror images of one another . in the drawing contained of the preferred embodiment of the invention ( fig1 ), referring to the first angled section 20a . starting from the end section 11 , of the main body 12 , both of which exist on a straight plane 17 , along with the last portion 13 of the main body 12 ; the first angled section 21 , turns at approximately a 50 degree angle 19 , and extends approximately one inch along section 21 , whereupon turning at an approximately 80 degree angle 22 , in the opposite direction of the first angle 19 , and extending approximately two inches along the second section 23 , whereupon turning at another approximately 80 degree angle 24 , in the opposite direction as the last angle 22 , and extending approximately one inch along the third section 25 , whereupon turning at an approximately 50 degree angle 26 , and returning to the original plane 17 , whereupon extending along the main body section 12 for approximately 11 inches , whereupon turning at approximately a 50 degree angle 27 , and extending approximately one inch along section 28 , whereupon turning at approximately an 80 degree angle 29 in the opposite direction as the previous angle 27 , and extending in such a direction for approximately two inches along section 30 , whereupon turning at approximately an 80 degree angle 31 , and extending along a plane for approximately one inch along section 32 , whereupon turning at approximately a 50 degree angle 33 , so as to return to the original plane 17 , in line with the main body 12 , and the opposite end section 11 . all angles 19 , 22 , 24 , 26 , 27 , 29 , 31 , and 33 contained within the structure 15 may vary in degree , so as to maximize efficiency . accordingly , all angled sections 21 , 23 , 25 , 28 , 30 , and 32 contained in the sections 20a and 20b , as described in the illustration fig1 can be of varying length , so as to maximize efficiency . further , the angles and angled sections can vary in number , length and degree , so as to maximize efficiency . angled sections 20a . and 20b ., being mirror images of each other , and lying equidistant from the center of the main body 12 , wherein the angle 26 within angled section 20a that lies closest to the center of the main body 12 would be of equal degree and would be positioned in equal distance from the center of the main body 12 , as the angle 27 , within the angled section 20b . all succeeding angles and wing sections leading out from the center of the main body 12 , would also be the same in mirror image . the first section 21 of angled section 20a being the same length as the first section 31 of angled section 20b ; the second section 23 , of angled section 20a being the same length as the second section 30 , of the angled section 20b ; the third section 25 , of angled section 20a , being the same length as the third section 28 , of the angled section 20b . further , angle 19 would be the same as angle 33 , angle 22 would be the same as angle 31 , and angle 24 would be the same as angle 29 . referring to the end sections 11 and 13 , as shown in fig2 these sections would preferably be constructed so as to taper to rounded edges , which would decrease wind resistance and maximize flight time . the angle at which these sections 11 and 13 taper can vary but would be essentially identical and would be constructed to specifications to which the optimal flight time would be achieved . the invention 15 , would preferably be constructed of lightweight material , so as to minimize drag on the invention 15 , and maximize flight time . the length of the main body 12 and the end sections 11 and 13 , would vary in length and would adhere to specifications that would maximize efficiency in flight time and ease of throwing and catching the toy , in accordance to the invention 15 . referring to the recommended embodiment of the invention , the width 35 , of the main body 12 as illustrated in fig2 would vary , depending on constructional design , but would most likely be between three and four inches wide , depending on what width would provide the most ease for throwing and catching . referring to the recommended use of the invention 15 , as illustrated in fig9 the main body 12 , is gripped in one hand 41 , and thrown so as to cause the invention 15 to travel forward in a direction away from the thrower 40 , and travel on a upward path , while rotating on a reverse rotation along a horizontal plane 17 . as understood from the descriptions contained herein , the reader will see that the angled section single wing throwing toy of this invention can be used to throw and catch in a successful manner , and can be greatly controlled by use of the balance provided by the symmetrically mirrored angled sections . in addition , the toy &# 39 ; s angled sections also provide air lift and stability during flight . the size and weight of the toy also aid in flight time , providing thrust and momentum . although the description above contains several specifications , these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention . for example , the toy can have varied numbers of angles contained within the angled sections . further , the end sections could have varied shapes other than rounded , such as oval , squared , or decorative , provided the design does not greatly decrease the efficiency of the toy . thus the scope of the invention should be determined by the appended claims and their legal equivalents , rather than by the examples given .

a light - weight yet sufficiently dense object made of reasonably rigid material for throwing and catching , having an elongated main body section dividing congruent angled sections on either side . each angled section containing a plurality of angles , and both section being mirror images of each other . the object being of suitable size so as to be thrown and caught easily by an average human .

turning now to the drawings , and particularly fig1 , an exercise recliner ( 10 ) constructed in accordance with the preferred embodiment is illustrated . the exercise recliner ( 10 ) broadly includes a recliner chair ( 12 ) and an exercise device ( 50 ). the person skilled in the art will understand that “ recliner chair ” ( 12 ) is used in the broadest sense and is meant to include recliner loveseats and recliner sofas . as shown in fig1 , a recliner type chair ( 12 ) is illustrated as having a frame ( 9 ), a back panel ( 11 ), a seat ( not shown ), arms ( 14 ) and ( 15 ), front legs ( 16 ) and back legs ( 17 ), a footrest ( 18 ) having a top surface ( 19 ), an under surface ( 20 ), a top edge ( 21 ), a lower edge ( 22 ) and two side edges ( 23 ). the recliner chair ( 12 ) also has a pair of side panels ( 24 ). a recliner handle ( not shown ) is located on one side panel ( 24 ) of the recliner chair ( 12 ). an extendable footrest support structure ( 26 ) connects the recliner chair ( 12 ) to the footrest ( 18 ). as seen in fig3 , the footrest support structure ( 26 ) may be selectively extended to a forward position through conventional means by pulling on the recliner handle ( not shown ) as provided in a conventional recliner chair ( 12 ). the footrest support structure ( 26 ) may be selectively retracted to a non - extended position by pulling on the recliner handle ( not shown ) in the opposite direction as provided in a conventional recliner chair ( 12 ). in another embodiment , the footrest ( 18 ) may be detached from the recliner chair ( 12 ) and moved out of the way by the user when the footrest is in the non - extended position . alternatively , the footrest ( 18 ) may have hinges at one of its side edges ( 23 ) so that it pivot outwardly to the right or left when the footrest ( 18 ) is in a non - extended position . also , the footrest ( 18 ) may have hinges located at the center of the top surface ( 19 ) such that it opens like a double door when the footrest ( 18 ) is in a non - extendable position . beneath the seat ( not shown ), the recliner chair ( 12 ) has an open space ( 8 ), which receives the exercise device ( 50 ) when the recliner chair ( 12 ) is in the retracted position as shown in fig1 . in the retracted position , the back panel ( 11 ), footrest ( 18 ) and side panels ( 21 ) of the recliner chair ( 12 ) completely conceal the exercise device ( 50 ). the footrest support structure ( 26 ) is also attached to a securing mechanism ( 7 ) at its lower edge ( 22 ) at the under surface ( 20 ) of the footrest ( 18 ), which allows the footrest ( 18 ) to pivot downwards as the exercise device ( 50 ) is moved out from the open space ( 8 ) beneath seat ( not shown ) as shown in fig2 . the securing mechanism ( 7 ) can be for example , hinges , latches , screws or rivets or any other suitable fastener . in one embodiment , the securing mechanism is a pair of hinged lids located at the lower edge ( 22 ) of the under surface ( 20 ) of the footrest ( 18 ), which permits the footrest ( 18 ) to pivot downwards as the exercise device ( 50 ) is moved out from the open space ( 8 ) beneath the seat ( not shown ) of the recliner chair ( 12 ). attached to the hinged lids is a spring that ensures the footrest ( 18 ) can return to its original position as shown in fig1 . referring to fig6 , the exercise device ( 50 ) is mounted on a movable extendable frame ( 30 ). the movable extendable frame ( 30 ) consists of a pair of track assemblies ( 31 ) that extend along the sides ( 6 ) of the recliner chair ( 12 ) between the back legs ( 17 ) and the front legs ( 16 ) of the recliner chair ( 12 ) to allow the exercise device ( 50 ) to be moved rectilinearly between an extended position and a retracted position . these track assemblies ( 31 ) are of the same type as commonly used for full - suspension filing cabinet drawers . in one embodiment , the track assemblies may consists of a telescoping frame , telescoping into a frame . in another embodiment , the track assemblies may be a chain mechanism or belt mechanism . the frame ( 30 ) has a first end ( 32 ) and a second end ( 33 ). the frame ( 30 ) is fastened at its first end ( 32 ) to a support ( 34 ) located at the rear of the recliner chair ( 12 ). the support ( 34 ) is attached to the underneath of the recliner chair ( 12 ) between the two back legs ( 17 ) by hinges , screws , latches , rivets or other suitable fasteners . attached to the support ( 34 ) is a power mechanism ( 25 ) comprising a motor ( 35 ), which in turn is connected to a gear and pulley system ( 36 ). the person skilled in the art will understand that the power mechanism may be mechanical or powered by an electrical power source , a battery power source or controlled by any other type of propulsion mechanism . in one embodiment , the motor ( 35 ) and gear and pulley system ( 36 ) are powered either by a battery or connected by a suitable cable ( not shown ) having a plug ( not shown ) at its free end to a power outlet ( not shown ). in one embodiment , cross - member bars ( 60 ) are attached to the underneath of the recliner chair ( 12 ) extending from one side ( 6 ) to the other side ( 6 ) of the recliner chair ( 12 ). the support ( 34 ) and the cross - member bars ( 60 ) form the non - moving foundation of the exercise recliner ( 10 ). attached to the gear and pulley system ( 36 ) is an actuating mechanism ( 39 ) that moves the frame ( 30 ) forward or backward from an extended position to a retracted position . in one embodiment , the actuating mechanism ( 39 ) is a threaded rod ( 40 ). the threaded rod has a first end ( 41 ) and a second end ( 42 ). the first end ( 41 ) of the threaded rod ( 40 ) is coupled to the gear and pulley system ( 36 ). the second end ( 42 ) of the threaded rod ( 40 ) is inserted into a locking mechanism ( 44 ) and into a threaded rod guide ( 43 ) located at the second end ( 33 ) of the frame ( 30 ). in one embodiment , the locking mechanism ( 44 ) is a nut . when the motor ( 35 ) and the gear and pulley system ( 36 ) are engaged , the threaded rod ( 40 ) turns and moves the frame ( 30 ) in or out from beneath the seat of the recliner chair . in one embodiment , a control unit ( 70 ) is connected to the motor ( 35 ) through a suitable cable ( 71 ) and an output cable ( 72 ) having a conventional plug ( 73 ) at its end is connected to the motor ( 35 ), which in turn is connected to an electrical power source ( not shown ). in another embodiment , the control unit may be wireless . the control unit ( 70 ) may be sized for hand - held use , or alternatively , it may be attached to one of the arms ( 14 ) ( 15 ) of the recliner chair ( 12 ). in any event , the control unit ( 70 ) will provide the circuitry and components necessary to take advantage of the operational control capabilities of the exercise recliner ( 10 ). in one embodiment , the control unit ( 70 ) has a button or switch that a user presses which in turn engages the actuating mechanism ( 39 ) to move the frame ( 30 ) in or out from beneath the exercise recliner ( 10 ). as the frame ( 30 ) moves forward from beneath the seat ( not shown ) of the recliner chair ( 12 ), the footrest ( 18 ) pivots downwards so that the frame ( 30 ) and exercise device ( 50 ) can extend over the under surface ( 20 ) of the footrest ( 18 ). in this position the under surface ( 20 ) of the footrest ( 18 ) acts as a stabilizing platform for the exercise device ( 50 ). in one embodiment , also located at the second end ( 33 ) of extendable frame ( 30 ) and proximal to the exercise device is a pair of floor supports ( 61 ). the floor support ( 61 ) has a first end ( 62 ) that is pivotally attached to the second end ( 33 ) of the frame ( 30 ) by a hinge ( 64 ). the floor support ( 61 ) has a second end ( 63 ) adapted to touch the floor or surface on which the recliner chair ( 12 ) rests and thereby acts to assist in supporting and stabilizing the weight of the exercise device ( 50 ) on the floor . the second end ( 63 ) of the floor support ( 61 ) is preferably shaped in a manner that widely and evenly distributes any pressure transferred through the floor supports to the floor . as shown in fig6 , the first pivot point ( 62 ) of the floor support ( 61 ) is connected to the second end ( 33 ) of the frame ( 30 ) and the two are aligned and cooperate such that the floor support ( 61 ) unfold and extends to the floor when the extendable frame ( 30 ) is extended and the floor supports ( 61 ) folds and retracts back underneath the seat ( not shown ) of the recliner chair ( 12 ) when the frame ( 30 ) is retracted . the location of the floor supports ( 61 ) on the floor will vary depending on such factors as the length of the user &# 39 ; s legs and desired position of the frame ( 30 ) when it is extended . in one embodiment , the exercise device ( 50 ) mounted to the frame ( 30 ) is a pedaling system including pedals ( 51 ) that are configured for rotational movement about an axis . the pedaling system ( 50 ) preferably includes a dampening mechanism ( 52 ) for adjusting the rotational movement of the pedals ( 51 ). the dampening mechanism ( 52 ) may be for example , a conventional mechanical brake including a friction pad , band or other suitable resistance mechanism . the dampening mechanism ( 52 ) can be adjusted by the user to set the desired level of resistance and thereby vary the desired level of difficulty of exercise . the pedaling system ( 50 ) preferably also includes a display unit ( 53 ) that displays information of interest to the user , such as the energy burned ( calories ), the distance traveled and the user &# 39 ; s heart rate . in use , the exercise recliner ( 10 ) allows the user to exercise his or her legs . the user merely positions himself in the recliner chair ( 12 ), engages the control unit ( 70 ) button , which causes the power mechanism to engage the actuating mechanism ( 39 ), which causes the frame ( 30 ) to begin moving forward out from the underneath the seat ( not shown ) causing the footrest ( 18 ) to pivot downwards . when the desired position of the frame ( 30 ) is reached , the user releases the control unit ( 70 ) button and the locking mechanism ( 44 ) locks the frame ( 30 ) in position . the exercise device ( 50 ) is ready to be used . to return to a recliner position , the user once again engages the control unit ( 70 ) button , which cause the motor ( 35 ) and gear pulley system ( 36 ) to engage the actuating mechanism ( 39 ), which causes in the frame ( 30 ) to move in the reverse direction until the exercise device ( 50 ) is back underneath the seat ( not shown ) of the recliner chair ( 12 ). when the exercise device ( 50 ) is back underneath the seat ( not shown ) of the recliner chair ( 12 ), the footrest ( 18 ) pivots back to its original position and the exercise device ( 50 ) is concealed from view .

the present invention is directed to an exercise recliner and in particular a recliner chair that conceals an exercise device . an exercise recliner is provided which includes a recliner chair and an exercise device . the exercise device is mounted to a movable and extendable frame that is associated with a power mechanism , an actuating mechanism and a locking mechanism allowing the exercise device to be moved rectilinearly between an extended position and a retracted position .

a first embodiment of a holder for inverted bottles is broadly indicated at 20 in fig1 - 11 . the holder 20 comprises a circular base 21 , a mid - section 22 , and an upper portion 23 . when nested for shipping and storage , as shown in fig1 the upper portion 23 is positioned within the base 21 and the mid - section 22 is seated on an annular ledge 24 within the base 21 , enclosing the upper portion 23 for compact storage . when assembled for use , the mid - section 22 and upper portion 23 are removed from the base 21 and the mid - section 22 is again seated on the annular flange 24 within the base , as shown in fig4 . the upper portion 23 is then seated in the mid - section 22 . the base 21 includes a circular sidewall 21 a rising from a bottom wall 21b . the sidewall 21a terminates at the ledge 24 which is defined by an annular flange 21c radially spaced and projecting upwardly from the sidewall 21a . the mid - section 22 is shown in the drawings as including an upwardly and inwardly tapered circular sidewall 22a , whose lower edge is supported on the ledge 24 in the base 21 . an annular top wall 22b extends inwardly from the upper edge of the sidewall 22a . the mid - section 22 has a circular opening 22c in the top wall 22b , defined by an annular rim 22d that extends downwardly in the drawings from the inner edge of the annular top wall 22b . the upper portion 23 is formed with a circular sidewall 23a that tapers downwardly and inwardly in use like a funnel , as shown in fig4 , 7 , 8 and 11 , terminating at its lower end in an annular spout 23b . diametrically opposed flanged portions 23c and 23d extend outwardly from the sidewall 23a and serve as auxiliary receptacles for the shoulders of bottles with generally rectangular body portions . in use , as shown in fig4 - 8 , the lower edge of the mid - section 22 is seated on the ledge 24 . the spout 23b of the upper portion 23 is then seated in the opening 22c in the top of the mid - section 22 with the spout in snug engagement with the annular rim 22d that extends around the opening 22c , as best seen in fig5 to provide stable support for a selected bottle , generally indicated at b . fig5 and 6 illustrate use of the holder 20 for supporting an opened bottle b with a generally rectangular body portion , indicated at b - 1 . as seen in fig5 the inverted bottle b is placed in the upper portion 23 of the holder 20 with the shoulders b - 2 and b - 3 of the bottle aligned with respective flange portions 23c and 23d in the upper portion 23 , and the neck b - 4 of the bottle extending through the spout 23b and opening 22c in the mid - section 22 . as best seen in fig6 the flanged portions 23c and 23d are complementary to the shape of the shoulders b - 2 and b - 3 and the snug fit restricts lateral motion of the bottle b . the neck of the bottle shown in fig5 is short enough so that the open end b - 5 of the bottle is spaced above the bottom 21b of the base 21 when the inverted bottle is fully supported by the upper portion 23 . so positioned , the contents of the bottle will freely drain into the base 21 . bottles with longer necks will extend all the way to the bottom 21 and engagement of a bottle &# 39 ; s open end b - 5 with the bottom wall 21b may restrict drainage of the bottle , except for the provision of an abutment 21e rising from the bottom wall 21b directly beneath the opening 22c . as best seen in fig8 the abutment 21e is placed directly in the path of any inverted bottle that is placed in the holder 20 . one embodiment of the abutment 21e ( fig9 ) is a thin strip of plastic extending from the bottom wall 21b a sufficient distance to provide space for adequate drainage from the bottle when the open end b - 5 of the bottle engages the abutment 21e . fig1 illustrates a modified abutment comprising perpendicularly arranged strips 21f and 21g . the function of the x - shaped cluster of strips 21f and 21g is to engage relatively thin bottle necks b - 6 ( fig1 ) which might slip off an abutment formed from the single strip 21e . fig7 shows an inverted round bottle b with a short neck b - 4 supported in the holder 20 . the annular shoulder b - 2 of the round bottle b is firmly seated against the tapered side wall 23a of the upper portion 23 and the round bottle does not engage the flanged portions 23c and 23d . the flanged portions are not used to support round bottles . fig1 shows the holder 20 supporting an inverted bottle b on a shelf s in the door d of a refrigerator . the holder 20 is also useful for supporting inverted bottles on tables , in pantries , and elsewhere as desired . a second embodiment 30 of the holder is seen in fig1 and 13 . as seen in fig1 , the second embodiment 30 includes an open ended base 31 with a circular wall 32 of sufficient diameter to provide stability to an inverted large bottle of catsup , for example . the upper portion 33 of the base 31 tapers inwardly to its juncture with a flat top wall 34 having a centrally located opening 35 defined by an annular rim 36 extending downwardly from the top wall 34 in fig1 . an upper portion 40 of the second embodiment 30 is structurally the same as the upper portion 23 of the holder 20 . specifically , the upper portion 40 of the second embodiment 30 includes a circular sidewall 40a that tapers downwardly and inwardly in use like a funnel , as shown in fig1 and 13 , terminating at its lower end in an annular spout 40b that fits snugly in the opening 35 against the annular rim 36 . diametrically opposed flanged portions 40c and 40d extend outwardly from the sidewall 40a and serve as auxiliary receptacles for the shoulders of bottles with generally rectangular body portions . in use with a closed bottle b that has been inverted to collect part of its contents in the neck of the bottle , as seen in fig1 , the inverted bottle b is placed in the upper portion 40 of the holder 30 with the shoulders b - 2 and b - 3 of the bottle aligned with respective flange portions 40c and 40d in the upper portion 40 , and the neck b - 4 of the bottle extending through the spout 40b and the opening 35 in the base 31 . the neck of the bottle b in fig1 is closed by a cap 41 so there is no need for a bottom wall in the base 31 . there is thus provided two embodiments of a novel holder for inverted bottles which are capable of supporting an infinite variety of inverted bottles , whether opened or closed , and which may be compactly nested for storage and shipment . although specific terms have been used in describing the invention , they have been used in a generic and descriptive sense only and not for the purpose of limitation . the scope of the invention is found in the following claims .

this invention is a holder for inverted bottles of different sizes and shapes . two embodiments are provided . one embodiment is intended to support opened bottles for drainage of the contents from the bottle . the other embodiment is intended to support closed or capped bottles that are inverted to collect a portion of the contents in the neck of the bottle for easy access when the bottle is opened by removing the cap .

the drawings illustrate an osmotically driven fluid dispenser , generally designated 11 . as shown in fig1 the basic components of dispenser 11 are an outer , shape - retaining semipermeable membrane 12 , an intermediate thermoformed sleeve 13 made from a dispersion of an osmotically effective solute in a water soluble , thermoplastic polymer vehicle ( matrix ), an inner flexible bag 14 , a plug 15 , a flow moderator 16 , and a flow moderator cap 17 . bag 14 is adapted to contain a fluid composition , such as an active agent composition 18 ( fig2 ) in fluid form . the term &# 34 ; active agent &# 34 ; as used herein means any compound or mixture of compounds that can be dispensed to produce a predetermined beneficial and useful result . active agents include pesticides , germicides , biocides , algicides , rodenticides , fungicides , insecticides , antioxidants , plant growth promoters , plant growth inhibitors , preservatives , surfactants , disinfectants , sterilization agents , catalysts , chemical reactants , fermentation agents , cosmetics , foods , nutrients , food supplements , drugs , vitamins , sex sterilants , fertility inhibitors , fertility promoters , air purifiers , microorganism attenuators , and other compositions that benefit the environment , surroundings , and habitat , including animals and humans . in the preferred embodiment the active agent is a drug that produces a local or systemic physiologic or pharmacologic response when administered to animals or humans . in order to be a suitable container for the fluid , bag 14 should be substantially impermeable to the fluid composition and be compatible with the composition . by &# 34 ; compatible &# 34 ;, it is meant that the bag should not be corroded , solubilized , or otherwise affected deleteriously by the composition . additionally , when the composition is a drug , the composition should not be significantly contaminated by the bag , such as by the extraction of leachables from the material forming the bag . bag 14 may be made from elastomeric compositions that may be formed into thin sheets . the elastomeric properties of the elastomeric composition and the thickness of the bag wall should be such as to cause the bag to readily collapse inwardly when a force is applied to the bag exterior . such elastomeric compositions are disclosed in commonly owned u . s . pat . no . 3 , 760 , 984 at col . 5 , line 40 to col . 7 , line 37 and in commonly owned u . s . pat . no . 3 , 995 , 631 at col . 8 , lines 14 - 32 which disclosures are incorporated herein by reference . bag 14 is elongated and generally cylindrical and is closed at its end 19 and open at its opposite end 22 . its wall is thickened outwardly at 23 to form a shoulder 24 . as seen in fig2 the portion of the exterior of bag 14 below shoulder 24 is encapuslated by sleeve 13 whose wall is approximately as thick as shoulder 24 is wide . sleeve 13 is made from a thermoformable osmotically effective solute composition . the components of the composition are an osmotically effective solute and a water soluble , thermoplastic polymer vehicle . the purpose of the solute is to imbibe water from the environment across membrane 12 into the space between the exterior of bag 14 and the inner surface of membrane 12 , that is , the space occupied by sleeve 13 . the osmotic pressure of the solute when in solution should be significantly greater than the osmotic pressure of the liquid of the environment . in dispensers that are to be ingested by or placed within an animal , the osmotic pressure of the solute solution must exceed the osmotic pressure of body fluids ( about 750 kpa ). osmotically effective solutes that may be used in sleeve 13 are disclosed in u . s . pat . no . 3 , 760 , 984 at col . 7 , line 38 to col . 8 , line 2 and in u . s . pat . no . 3 , 995 , 631 at p . 11 , line 65 to col . 12 , line 3 and col . 14 , lines 20 - 28 , which disclosures are incorporated herein by reference . sodium chloride is an especially effective osmotic solute in that the osmotic pressure of sodium chloride is sufficiently high to remove the dependence of pumping rate on the osmotic pressure of the surrounding environment . sodium chloride is efficient in salting out the polymer vehicle so that the influence of binder does not enter into the performance of the dispenser , and the dispenser is less imposing than those containing other salts on the surrounding biological environment . the polymer vehicle serves to make the osmotically effective composition thermoformable . depending upon its osmotic pressure in solution it may also contribute to the osmotic effectiveness of the composition . the vehicle functions as a matrix in which the osmotically effective solute is dispersed , and renders the composition flowable upon application of heat and pressure . a preferred vehicle is a mixture of about 40 % to about 70 % by weight poly ( ethylene oxide ) having a molecular weight in the range of about 100 , 000 to about 4 , 000 , 000 and about 30 % to about 60 % by weight poly ( ethylene glycol ) having a molecular weight in the range of about 1 , 000 and about 30 , 000 . the cellulose 2 - hydroxypropyl ethers sold by hercules , inc . under the mark klucel may also be used as the polymer vehicle . the thermoformability of the composition permits sleeve 13 to be produced by conventional thermoforming techniques such as compression molding , injection molding , or extrusion . because of this , sleeve 13 may be made as a module in large quantities with a high degree of thickness reproducibility . with sleeve 13 in modular form the assembly of dispenser 11 is simplified . furthermore , the subassembly composed of bag 14 and sleeve 13 is not as fragile as the solute coated bags of prior versions of the minipump . thus the subassemblies are less likely to be damaged in the coating process by which membrane 12 is applied to the subassembly . in addition to the solute and vehicle the osmotically effective solute composition may contain minor amounts of other materials such as fillers , pigments , lubricants , and other conventional additives that facilitate thermoforming . sleeve 13 is encapsulated by outer membrane 12 . membrane 12 also covers the exterior of the portion of bag 14 above shoulder 24 and forms a fluid tight seal therewith . at least a part of membrane 12 is permeable to water . membrane 12 is impermeable to the osmotically effective solute composition . membrane 12 is also shape - retaining , that is , it is sufficiently rigid to be substantially undeformed by the hydrostatic pressure that is generated in the space between its inner surface and the exterior of bag 14 by the water imbibed by the solute of sleeve 13 . the thickness and composition of membrane 12 affects the rate at which water will be imbibed through it by the solute in sleeve 13 . such membranes and compositions that may be used to form them include cellulose acetates , cellulose acetate butyrates , and other shape - retaining semi - permeable membranes including those disclosed in said u . s . pat . no . 3 , 760 , 984 at col . 4 , line 53 to col . 5 , line 39 and in said u . s . pat . no . 3 , 995 , 631 at col . 7 , line 40 to col . 8 , line 15 , which disclosures are incorporated herein by reference . plug 15 fits into the open end 22 of bag 14 . plug 15 is generally cylindrical and is approximately as long as the thickened portion of bag 14 above shoulder 24 . the exterior of plug 15 forms a fluid tight seal with the portion of the interior surface of bag 14 with which it is in contact . plug 15 has an axial , central bore 25 extending completely through it . bore 25 provides access to the interior of bag 14 for filling bag 14 with active agent composition 18 . bore 25 is also adapted to receive flow moderator 16 . plug 15 has a hemispherically shaped recess 26 in its inner ( bottom ) end 27 . the presence of such a recess or concavity in end 27 reduces the likelihood of entrapping air in bag 14 when filling bag 14 with composition 18 . in prior versions of the minipump this plug has been generally cylindrical in shape , its inner end joining the wall of the bag at a 90 ° angle . during the filling of the bag , the fluid has a natural tendency , due to its high surface tension , to form a curved surface beginning near the top of the wall of the bag and continuing up to the filling / discharge port . this curvature causes an air pocket at the intersection of the wall of the bag and the plug . the improved plug has a hemispherically recessed lower surface , curved to substantially match the arc created by the surface tension of the drug solution during the filling process . this improvement reduces the volume of the dispenser which cannot be filled due to air entrapment from approximately 15 % to less than 2 % to 3 %. plug 15 may be made from the same materials as are used to make flexible bag 14 ; however , the dimensions of plug 15 should be such that it is substantially inflexible . flow moderator 16 provides the passageway from the interior of bag 14 to the exterior of dispenser 11 by which composition 18 is discharged from dispenser 11 . flow moderator 16 comprises a conduit , in the form of a rigid cylindrical tube 28 , and a dome - shaped head 29 . tube 24 and head 29 may be made from suitable plastics or metals . head 29 has an axial , threaded bore 32 that receives threaded end 33 of tube 28 . as shown in fig1 and 2 , end 33 extends outwardly from the spherical surface of head 29 to provide a site for attaching an external catheter tube ( not shown ) in the event dispenser 11 is to be used to administer composition 18 to a remote location . the outer diameter of tube 28 is approximately the same as the diameter of bore 25 such that tube 28 may be inserted through bore 25 into bag 14 with tube 28 fitting snugly within bore 25 so as to form an essentially fluid tight seal with plug 15 . the length of tube 28 is such that it extends into bag 14 to at least about 50 % of the elongated dimension of the interior of bag 14 , i . e ., the distance from the inner side of end 19 to end 27 of plug 15 . preferably tube 28 extends into bag 14 over substantially the entire , but not all of ( say 85 % to 95 %), of said elongated dimension . the inner diameter of tube 28 is correlated to the length of tube 28 such that substantial diffusional flow of composition 18 through tube 28 will not occur . tube 28 is , in effect , a capillary that provides resistance to the flow of composition 18 , thereby reducing or eliminating bulk loss of composition 18 , from the outlet port of dispenser 11 . head 29 has a diameter slightly less than the outer diameter of plug 15 . as seen in fig2 the flat side of head 29 fits against the top of plug 15 . dispenser 11 may be filled with fluid 18 via bore 25 of plug 15 . for instance , the needle of a fluid loaded syringe may be inserted through bore 25 and the syringe &# 39 ; s contents discharged into bag 14 . to insure that a predetermined fluid pumping rate is achieved , it is desirable to completely fill bag 14 with fluid 18 . after the bag is filled , tube 28 of flow moderator 16 is inserted through bore 25 to the position shown in fig2 . as described above , tube 28 functions as a capillary and inhibits loss of fluid 18 from the dispenser even though it is subjected to substantial movement or tipped upside down . dispenser 11 operates in the following manner . once placed in aqueous enviroment , such as within a body cavity or within body tissue , water from the enviroment is imbibed by the solute of sleeve 13 through membrane 12 at a rate determined by the osmotic activity of the solute , and the osmotic reflection coefficient , composition , thickness , and area of membrane 12 . the imbibed water causes the volume of the space between the inner surface of membrane 12 and the exterior of bag 14 ( the space initially occupied by sleeve 13 ) to increase . and since membrane 12 is shape - retaining , the imbibed water generates hydraulic pressure on the exterior of bag 14 causing bag 14 to be squeezed inwardly . this squeezing forces fluid 18 through tube 28 and out of the dispenser . as indicated , fluid 18 may be an active agent composition . in such instances the dispenser 11 will , of course , discharge active agent directly . alternatively , fluid 18 may be inert and the dispenser may be used simply as a displacement pump . in this alternative the dispenser will , of course , have to be suitably interconnected by well known means to a reseroir of the fluid ( active agent ) to be discharged , such that the inert fluid displaces the fluid from the reservoir in a predetermined regimen to the desired administration site . such alternatives are particularly attractive in instances in which the fluid to be discharged is incompatible with bag 14 . flow moderator cap 17 may be used to cover protruding end 33 of tube 29 when dispenser 11 is used without an external catheter tube connection . cap 17 is crescent - shaped and has an axial threaded bore 34 that receives end 33 of tube 29 . the curvature of its concave underside 35 matches the convexity of the top surface of head 29 so that the former fits tightly against the latter ( fig2 ). the outer diameter of cap 17 is the same as the outer diameter of membrane 12 . thus the hemispherical exterior of cap 17 provides a smooth blunt surface that aligns with the exterior surface of membrane 12 . the components of dispenser 11 may be made and assembled as follows . bag 14 and sleeve 13 are thermoformed , such as by injection molding , by known techniques . the bag - sleeve subassembly may be made using solvent or adhesive bonding , depending on the material involved . if bag 14 and sleeve 13 are capable of being solvent bonded , bag 14 is dipped in the mutual solvent and inserted into sleeve 13 . when the subassembly is put together by adhesive bonding , bag 14 is dipped into an appropriate adhesive and then inserted into sleeve 13 . membrane 12 may be applied to the bag - sleeve subassembly by dipping it in a solution of membrane material as taught in u . s . pat . no . 3 , 987 , 790 at col . 4 , line 63 or membrane 12 may be coated onto the subassembly using conventional coating equipment and techniques such as pan coating and fluidized spray coating . the following example is intended to further illustrate the above described dispenser and its manufacture . this example is not intended to limit the invention in any way . cylindrical flexible bags ( 2 . 50 cm long , 4 . 01 mm i . d . and 4 . 62 mm o . d .) were injection molded at 176 ° c ., 3 . 5 × 10 3 kpa , from an elastomeric styrene - butadiene copolymer ( sold under the trade designation , kraton 2104 ). osmotic sleeves were prepared for each dispenser as follows . the components ( 64 . 5 wt % nacl , 20 w % poly [ ethylene oxide ], molecular wt 600 , 000 , 15 wt % poly [ ethylene glycol ] of molecular weight 20 , 000 and 0 . 5 wt % colloidal sio 2 , sold under the trade name [ cabosil ] were bulk blended in a hobart mixer for 20 minutes at low speed . the homogenous powder blend was pressed into 0 . 6 cm tablets capable of being gravity fed into arborg injection molding equipment . the osmotic sleeves ( 2 . 21 cm long , 4 . 87 mm i . d ., and 5 . 89 mm o . d .) were formed from the tablets by injection molding at 149 ° c . 6 . 5 × 10 3 kpa . cylindrical plugs of the above described styrene - butadiene copolymer were injection molded . the plugs were 0 . 5 cm long , had a 4 . 1 mm o . d ., their lower surfaces were recessed hemispherically to a depth of 1 . 37 mm , and had a central axial bore 0 . 76 mm in diameter through the length of the plug . the cylindrical flexible bags were dipped into a 15 wt % cyclohexane solution of the styrene - butadiene copolymer mentioned above and were inserted into the osmotic sleeve . the arcuate surfaces of the plugs were coated with a glue bead of 15 wt % cyclohexane solution of the copolymer and a plug was inserted into the open end of each of the bags . a 22 gauge needle was inserted through the bore of each plug and the plugged bags were placed in an oven at 40 ° c . for 2 hours . an outer semipermeable membrane was applied to the dispensers by coating with a wurster coater . the membrane was a 4 wt % methylene chloride solution of cellulose acetate butyrate ( sold under the designation eastman kodak 381 - 2 ). the coating was applied to a thickness of 0 . 38 mm . the dispensers were then oven - dried at 55 ° c . for about 5 - 10 days . flow moderators were prepared for each dispenser as follows . twenty - one gauge needle stock was cut into 2 . 36 cm lengths . each length of tubing was circumferentially grooved with 15 grooves , equally spaced 0 . 3 mm apart along one end of the tube , such that a 4 . 3 mm distance beginning at one end of the tube is grooved . caps were insert molded around the grooved portion of the tube 3 mm from the grooved end , from styreneacrylonitrile copolymer . the caps were hemispherical , 5 . 6 mm in diameter , with a 0 . 8 mm diameter diametrical bore . hemispherical overcaps had a 6 . 5 mm o . d ., were 4 . 3 mm in length with the bottom hemispherically recessed to a depth of 1 . 3 mm , had a 0 . 8 mm diameter diametrical bore through the length of the overcap , and were injection molded from ethylenevinyl - acetate copolymer . the overcaps were pressed onto the 3 mm grooved extension of the tube . modifications of the above described dispensers that are obvious to those of skill in the mechanical , chemical , and other related arts are intended to be within the scope of the following claims .

an improved version of an osmotically driven mini - osmotic pump that is used to administer drug solutions . the basic components of the improved pump are : an inner flexible bag that holds the drug solution ; a plug having a recessed inner end that seals the bag opening ; a solution filling / discharge port through the plug ; a cup - shaped , thermo - formed sleeve that fits partly about the bag and is made from a dispersion of an osmotically effective solute in a water soluble , theroplastic polymer vehicle ; a shape - retaining , semipermeable membrane that encapulates the bag - sleeve subassembly ; and a flow moderator that is received through the filling / discharge port in the plug .

fig1 a - 1c and 4a - 4c are graphical presentations of data comparing ctl induction by various ovalbumin formulations ; e : t represents effector to target ratio in all figures . fig2 a and 2b are graphical presentations of data comparing ctl induction by various β - galactosidase formulations ; fig3 is a graphical presentation of data comparing ctl induction by ovalbumin in a liposome and in an antigen formulation ; fig5 and 6 are graphical presentations of data showing the effect of cd4 and cd8 cell depletion on ctl induction ; fig7 is a graphical representation of data showing ctl induction by gp120 ; fig8 is a graphical representation of data showing ctl induction by a mixture of pluronic and tween and an antigen ; fig9 is a graphical representation of data showing ctl induction with a mixture of squalane and pluronic and an antigen ; fig1 is a graphical representation of data showing ctl induction by a mixture of squalane and pluronic and an antigen ; fig1 is a graphical representation of the effect of ova with various antigen formulations on ctl response ; fig1 is a graphical representation of the induction of anti - gp120iiib antibodies in monkeys with various antigen formulations ; fig1 depicts antitumor activity of hope2 cells ten days after a single immunization of soluble e7 protein in adjuvant ; and fig1 depicts antitumor activity of hope2 cells at days 10 , 19 after two immunizations with soluble e7 protein in adjuvant . antigen formulations useful in this invention are generally described above . those of ordinary skill in this art will recognize that equivalent formulations are readily prepared and can be expected to have equivalent properties in induction of a ctl response . such formulations are readily tested for their properties using techniques equivalent to those described in the examples below . there follow examples of the invention with the use of an antigen formulation ( af ) composed of about 2 . 5 % squalane , 5 % pluronic acid , and tween 80 in a phosphate buffered saline . specifically , an emulsion of the af included : 15 mg squalane , 37 . 5 mg poloxamer 401 ( pluronic l121 ), 6 mg polysorbate 80 ( tween 80 ), 0 . 184 mg potassium chloride , 0 . 552 mg potassium phosphate monobasic , 7 . 36 mg . sodium chloride , 3 . 3 mg sodium phosphate dibasic ( anhydrous ), per 1 ml water , ph 7 . 4 . this emulsion was microfluidized using standard technique ( microfluidics model m110f ) with a back - pressure module at 11 - 14 , 000 psi with gradual return to atmosphere pressure , cooling and packing in wet ice . in other examples , antigen was mixed with the microfluidized squalane ( s ), pluronic ( p ) and tween 80 ( t ) mixture to achieve a final concentration of 0 . 2 % tween 80 , 1 . 25 % pluronic and 5 % squalane respectively . to determine the sub - components necessary for an antigen specific immune response induction , squalane - tween 80 , pluronic - tween 80 or squalane - pluronic were prepared at the same concentration as for the three components mixture . pluronic , squalane or tween 80 was also prepared individually to determine the effect of individual component on the ctl induction . substitutions of tween 20 , tween 40 or zwittergent for tween 80 were also made to determine the effect of various tween derivative on the ctl induction in the ova system . substitutions of squalane in the three component formulation were made with eicosone or triacontone and substitution for the co - polymer pluronic in the same three components formulation were made by peg 1000 , pleuronic l62lf , and the tetronics 1501 and 150r1 . as two component formulations , various analogs in various combinations were mixed and tested for ova specific ctl induction . they are a mixture of cholesterol -- tween 80 , squalane -- tween 20 , pristane -- tween 80 or olive oil -- tween 80 . for a stabilization study , the microfluidized mixture of squalane - tween 80 was mixed with dextrose to a final concentration of 5 %. in all cases the combinations of excipients were mixed in a microfluidizer to made a stable emulsion . in some experiments , two components formulations were mixed with various concentration of mdp for ctl and humoral response inductions . table 1 describes a comprehensive list of various formulations used in this study . table 1______________________________________effect of various substitution in three or two component systems percent kill at e : t 100 : 1______________________________________substitution in three component formulationsstp 84tween 40 ( t ) 66tween 20 ( t ) 48t1501 ( p ) 0ti50r1 ( p ) 0pluronic l62lf ( p ) 47eicosane ( s ) * peg1000 ( p ) * triacontane ( s ) * zwittergent ( t ) * substitution in two component formulationsst 76pt 45sp 26cholesterol ( s ) + tween 80 0squalane + tween 29 ( t ) 65pristane ( s ) + tween 80 42olive oil ( s ) + tween 80 691 component formulationpluronic l121 0squalane 0tween 80 0squalane + tween 80 + 5 % dextrose 86______________________________________ * ctl assay is being repeated syntex adjuvant formulation ( microfluidized ; safm ) was used as an adjuvant control and consists of two parts . part i consists of phosphate buffered saline containing a final concentration of 5 % squalane , 1 . 25 % pluronic and 0 . 2 % tween 80 ( vehicle or i - saf ). part ii consists of n - acetylmuramyl - l - threonyl - d - isoglutamine ( thr - mdp ), a derivative of mycobacterium cell wall component . for immunization purposes , antigen is mixed with microfluidized vehicle ( part i ) to obtain a homogeneous emulsion . mdp is added to made safm , and vortexed briefly . the mdp concentration in the mixture was varied to determine if there was an optimum concentration for ctl induction . as an adjuvant control , mice were also immunized with soluble antigens mixed with alum according to the manufacturer &# 39 ; s manual ( pierce chemical , rockford , ill .) or with complete freund &# 39 ; s adjuvant ( cfa ). this antigen formulation is used for induction of cytotoxic t - lymphocyte responses in mice . those of ordinary skill in the art will recognize that such a mouse model is indicative that equivalent experiments or treatments will similarly induce cytotoxic t - lymphocyte responses in humans , domesticated , or agricultural animals . the amount of antigen formulation and antigen useful to produce the desired cellular response may be determined empirically by standard procedures , well known to those of ordinary skill in the art , without undue experimentation . thus , if desired to minimize the side effects of treatment with such a mixture those of ordinary skill in the art may determine a minimum level of such a mixture for administration to a human , domesticated , or agricultural animal in order to elicit a ctl response , and thereby induce immunity to a desired antigen . in normal use , such a mixture will be injected by any one of a number of standard procedures , but particularly preferred is an intramuscular injection at a location which will allow the emulsion to remain in a stable form for a period of several days or several weeks . the following materials and methods were used in the examples provided below unless otherwise noted : female c57bl / 6 ( h - 2 b ) and balb / c ( h - 2 d ) mice were purchased from harlen sprague ( san diego , calif .). ovalbumin ( ova , grade vii ; sigma chemical co ., st . louis , mo .) was used in the native form . β - galactosidase , ( β - gal , grade viii ; brl ) was used in the native form and after boiling in 1 m naoh for 2 min to give an alkali digest . recombinant gp120 was purchased from american biotechnology . the tumor cells used were the ia lines el4 ( c57bl / 6 , h - 2 b thymoma ) and p815 ( dba / 2 , h - 2 d mastocytoma ). derivation of the ova - producing el4 transfectant , eg7 - ova , is described previously by moore et al ., 54 cell 777 , 1988 . the β - gal - producing transfectant , p13 . 1 , was derived by electroporation of 10 7 p815 cells in 1 ml of phosphate buffered saline ( pbs ) with 10 mg of psti linearized pch110 ( pharmacia lkb biotechnology inc ., piscataway , n . j .) and 1 mg of pvui linearized psv2 neo ( southern et al ., 1 j . mol . appl . genet . 327 , 1982 ) followed by selection in 400 μg / ml of the antibiotic g418 . the c3 - 4 transfectant was derived from the balb / c hybridoma igm 662 by transfecting with a plasmid encoding the β - gal gene fused to the third and fourth exon of igm heavy chain ( rammensee et al ., 30 immunogenetics 296 , 1989 ). the gp160iiib expressing 3t3 fibroblast , 15 - 12 , was provided by dr . germain of nih ( bethesda , md .). the k b transfected l cell line was provided by dr . carbone , monash university , australia . the d d and l d transfected l cell lines were provided by dr . ted hensen , washington university , st . louis . mice were immunized intravenously with a 200 μl suspension of 25 × 10 6 splenocytes , after a cytoplasmic loading as described by moore et . al . supra , and carbone et al ., j . exp . med . 169 : 603 , 1989 ). for ova - antigen formulation or β - gal - antigen formulation immunization , 30 μg of each protein antigen was injected per mouse in the footpad and the tailbase subcutaneously . each injection consists of 67 μl of microfluidized antigen formulation ( made following standard procedures ) and 30 μg of protein antigen in a final volume of 200 μl . the final volume was made up with hbss , see , whittaker manual ( welkersville , md .). mdp was provided in concentrations between 0 and 300 μg . where stated , mice were immunized with soluble antigens in cfa , or in alum in a total volume of 200 μl . spleen cells ( 30 × 10 6 ) from normal or immunized mice which had been primed at least 14 days earlier were incubated with 1 . 5 × 10 6 eg7 - ova ( irradiated with 20 , 000 rad ) for ova responses or 1 . 5 × 10 6 c3 - 4 cells ( irradiated with 20 , 000 rad ) for β - gal response in 24 well plates at 37 ° c . in 7 % co 2 / air . all the tissue cultures were performed in a complete medium consisting of imdm medium , see , whittaker manual ( welkersville , md .) supplemented with 10 % fetal calf serum ( fcs ), 2mm glutamine , gentamycin and 2 × 10 - 5 m 2 - mercaptoethanol . for the in vitro depletion experiments , in vivo primed or in vitro stimulated spleen cells were treated with monoclonal antibodies ( mabs ) rl . 172 ( anti - cd4 ) or mabs 3 . 168 ( anti - cds ) for removal of cd4 + or cd8 + t cells ( sarmiento et al ., 125 j . immunol . 2665 , 1980 , and ceredig et al ., 314 nature 98 , 1985 ). the mab rl . 172 and mab 3 . 168 were obtained from dr . jonathan sprent at scripps clinic and research foundation , la jolla , calif . spleen cells ( 30 × 10 6 ) from normal or immunized mice which had been primed at least 21 days earlier were incubated with 1 . 5 × 10 6 15 - 12 cells ( treated with 200 ug of mitomycin c for 45 minutes per 10 8 cells ), or with 500 μg of 18iiib peptide containing the dominant ctl epitope in balb / c mice in complete imdm media ( irvine scientific , santa ana , calif .) containing 10 % pre - screened fcs ( icn flow ; icn biochemicals , inc ., costa mesa , calif . ), 2 mm glutamine , gentamycin and 2 × 10 - 5 m 2 - mercaptoethanol . for in vitro stimulation with peptides , spleen cells were cultured in complete imdm containing 5 % cona supernatant . for depletion experiments , in vivo primed or in vitro stimulated spleen cells were treated with mabs rl . 172 ( anti - cd4 ) or mabs 3 . 168 ( anti - cds ) in presence of low tox . rabbit complement ( cederlane laboratories , ltd ., hornby ontario , canada ) for removal of cd4 + or cd8 + t cells ( 22 , 23 ). the mab rl . 172 and mab 3 . 168 were a gift from dr . jonathan sprent at scripps clinic and research foundation , la jolla , calif . target cells ( 1 × 10 6 ) were labeled with 100 μci 51 cr ! sodium chromate for 60 min . for peptide pulsed targets , 50 μl of a 1 mg / ml peptide solution in hbss was added during the targets labeling with 51 cr . after washing , 104 labeled targets and serial dilutions of effector cells were incubated in 200 μl of rp10 for 4 h at 37 ° c . 100 μl of supernatant was collected and the specific lysis was determined as : percent specific lysis = 100 ×{( release by ctl - spontaneous release )/( maximal release - spontaneous release )}. spontaneous release in the absence of cytotoxic t - lymphocyte ( ctl ) was & lt ; 25 % of maximal release by detergent in all experiments . each well of 96 - well , u bottomed plates ( costar , cambridge , mass .) were coated with 150 ng of ova or gp120 in 50 ul of hbss and incubated overnight at 4 ° c . for the determination of anti - gp120 and anti - ova antibody responses in mice , plates were blocked with 1 % bsa for 1 hr . serially diluted sera were added in 25 μl volume per well and incubated for 2 hrs . plates were washed and 50 μl of 1 : 1000 dilution of goat anti - mouse igg conjugated to hrpo ( sbt , alabama ) in 1 % bsa were added per well . after 1 hr of incubation , plates were washed and 100 μl of substrate was added per well . the od405 was taken after 10 to 15 minutes . for the determination of monkey anti - gp120 antibody response , all the steps were the same except both the blocking of plates and the dilution of sera were done in 5 % normal goat serum in hank &# 39 ; s balanced salt solution . synthetic peptides corresponding to amino acid sequences 253 - 276 ( sequence listing no . 1 : eqlesiinfekltewtssnvmeer ; where the standard one letter code is used to represent each amino acid ) of ovalbumin ( ova 253 - 276 ), amino acid sequences 84 - 102 of myelin basic protein ( mbp 84 - 102 ) ( sequence listing no . 2 : denpvvhffknivtprtpp ), and synthetic peptides corresponding to amino acid sequences 308 - 322 ( 18iiib sequence ) of gp120iiib , were assembled by solid phase peptide synthesis using an applied biosystems 430a synthesizer . amino acids were coupled via pre - formed symmetric anhydrides with the exception of asparagine , glutamine and arginine which were coupled as hydroxybenzotriazole esters . coupling efficiency was monitored by ninhydrin reaction following the method of kaiser et al . 34 anal . biochem . 595 , 1970 . the peptides were released from the support with hf following the &# 34 ; low - high &# 34 ; procedure described by tam , et al . 21 j . am . chem . soc . 6442 , 1983 , and the peptides extracted from the resin with 10 % acetic acid . after lyophilization , peptides were desalted on a sephadex g - 25 column , and samples of the peptides then hplc purified by reverse phase chromatography on a vydac preparative c - 18 column . purified peptides ( 98 %) were solubilized in hbss at a final concentration of 10 mg / ml and diluted to the desired concentration in the complete media . samples of protein ( e . g ., β - galactosidase ) were treated with 100 fold molar excess of cyanogen bromide in a solution of 100 mm trifluoroacetic acid . the reaction was allowed to proceed for 18 hours at room temperature ( about 20 ° c .) with rotation . following the prescribed reaction time , the peptide fragments were separated from the reactant using a sep - pak c - 18 apparatus ( waters ), eluted with 95 % acetonitrile , and lyophilized . protein samples ( e . g ., β - galactosidase ) were treated with 1 n naoh and boiled for 2 minutes , and the resulting peptide fragments were separated from the reactants using a c - 18 sep - pak apparatus ( waters ), and eluted with 95 % acetonitrile and lyophilized . moore et al ., 113 ucla symp . mol . cell . biol . 1989 and carbone and beyan , 171 j . exp . medicine 377 , 1990 , demonstrate that mice immunized with spleen cells loaded cytoplasmically with soluble ova , were primed for ova specific , class i restricted ctl response . the ova - expressing el4 transfectant eg7 - ova was employed for in vitro stimulation of in vivo primed splenic lymphocytes and also used as target for ova specific ctl mediated killing . this study also demonstrated that cd8 + effectors induced by eg7 - ova transfectant or by spleen cells cytoplasmically loaded with ova , recognize a determinant mapped by the peptide ova 258 - 276 in the context of h - 2k b , lyse eg7 - ova , and also kill el4 cells coated with ova 258 - 276 . thus , in order to assess whether an endogenous class i restricted cd8 + t cell pathway can be induced by a soluble antigen , the above system was used to determine whether certain antigen formulations can be used to drive soluble antigen into a class i restricted pathway . c57bl / 6 mice were immunized once with various amounts of ova ( 30 μg -- 1 mg per mouse ) with or without an antigen formulation . mice were injected subcutaneously and in the tailbase . spleen cells were taken from the immunized mice at least two weeks after the immunizations and in vitro stimulated with the eg7 - ova transfectants . an ova concentration as low as 30 μg was as effective as a 1 mg dose . therefore , the ctl studies were routinely performed with spleen cells from 30 μg ova - primed mice . after five days of in vitro culture with eg7 - ova , priming was assessed by the presence of ova specific effectors capable of lysing eg7 - ova . mice injected with soluble ova in hbss as high as 1 mg , showed no evidence of ctl priming ( fig1 a ). however mice immunized with 30 μg ova in the antigen formulation described above ( shown as af in the figures ) showed a significant transfectant specific ctl response ( fig1 c ). furthermore , the extent of eg7 - ova killing by the ova - af immunized spleen cells was comparable to that of ova - loaded spleen cells immunized mice ( fig1 b ). that the specificity of ctl priming in vivo was antigen specific was shown by the lack of spleen cells from β - galactosidase immunized mice to manifest secondary ctl response in vitro when stimulated with eg7 - ova . no ova specific ctl induction was observed . similar results were obtained using another soluble protein antigen , β - gal . for assaying β - gal - specific ctl response , the target used was balb / c derived β - gal - expressing c3 - 4 transfectant . immunization of balb / c mice with soluble β - gal gave background ctl response . therefore , for the determination of specific ctl response , harvesting was postponed for at least eight weeks before spleen lymphocytes were harvested , and cultured for five days in the presence of irradiated c3 - 4 transfectants . fig2 b demonstrates that 30 μg of β - galactosidase in af induced strong specific ctl response against transfectant . at an effector - to - target ( e : t ) ratio of 3 : 1 , β - gal - af immunized mice showed about 80 % of specific c3 - 4 killing . however , only 20 % killing of the same target was achieved with effectors isolated from β - gal in hbss immunized mice at the same e : t ratio ( fig2 a ). since neither el4 nor p815 expresses class ii mhc gene products and the lysis shows syngeneic restriction , these ova and β - gal specific effectors are class i mhc restricted . to demonstrate the usefulness of the antigen formulation , mice were immunized with soluble ova encapsuled in two types of liposomes , one of which was a ph sensitive liposome . one week later , spleen cells were stimulated in vitro , as described above , and tested against 51 cr - labeled eg7 - ova or el4 . fig3 shows a representative result demonstrating that ova in liposome could not prime mice for substantial ctl induction . similar results were observed when ova was immunized in alum . carbone and bevan , supra , demonstrated that ctl induced in c57bl / 6 mice by eg7 - ova transfectant , and by cytoplasmically ova - loaded splenocytes recognize el4 cells coated with the peptide ova 258 - 276 . to determine whether soluble ovalbumin in af induces similar ctl responses , spleen cells were prepared from immunized mice and stimulated in vitro with eg7 - ova . the effectors were tested against el4 cells coated with the peptide ova 253 - 276 , or with a control peptide derived from myelin basic protein ( mbp 84 - 102 ). the results demonstrate that ova - af primed ctl with a similar specificity to those primed by transfectants , or by cytoplasmically loaded ova ( fig1 a , 1b and 1c ). ova - af primed effector cells effectively lysed eg7 - ova , and an untransfected el4 cells coated with 50 μg / 10 8 cells of ova peptide , but did not lyse el4 cells coated with 50 μg / 10 8 cells of mbp peptide . in the β - galactosidase system , carbone and bevan , supra , indicated that β - gal expressing transfectant and splenocytes cytoplasmically loaded with soluble β - galactosidase , induced ctl which lysed β - gal expressing transfectant and nontransfectant p815 cells coated with alkali digested β - galactosidase . soluble β - galactosidase induces ctl having similar specificity when immunized in af ( fig2 ). that soluble protein antigens in af induce cd8 + effector t cells was shown as follows . splenocytes from immunized mice were cultured for five days with irradiated transfectants in vitro . thereafter , cells were harvested and depleted of cd4 + or cd8 + t cells by using monoclonal anti - cd4 or anti - cd8 antibodies plus complement . depleted populations were then tested against 51 cr - eg7 - ova in the ova system or 51 cr - p13 . 1 in the β - gal system . the data shown in fig4 indicates that , in the ova system , depletion of cd8 + t cells abrogated cytolytic activity conferred by the whole effector cell population . however , depletion of cd4 + t cell population did not have any effect on the lysis of eg7 - ova . similarly , in the β - gal system , depletion of cd8 + t cells abrogated the cytolytic activity of β - gal - antigen formulation immunized spleen cells . to demonstrate that ova - af primes cd8 + t cell populations in vivo , and is critical for in vitro secondary response , cd4 + or cd8 + populations were depleted from spleens of ova - af immunized mice and from naive mice . these treated populations were then stimulated in vitro with eg7 - ova alone , or in a combination of cd4 + and cd8 + t cells from ova - af immunized mice , or in various combination of cd4 + or cd8 + t cells from ova - af immunized mice with the cd4 + or cd8 + cells from naive mice . fig5 shows that primed cd8 + cells are essential for the manifestation of a secondary ctl response in vitro . these data also indicate that for the effective secondary ctl response in vitro , cd4 + t cells are required . cd4 + cells are not needed for priming . similarly , cd8 + t cells were required for the manifestation of b - gal specific secondary ctl response in vitro . the above examples demonstrate the effect of the antigen formulation on the induction of class i restricted ctl responses against soluble protein antigens . the antigen formulation mediated soluble antigen induced ctl priming , and is similar in activity to that induced by transfectants and by splenocytes cytoplasmically loaded with soluble ova or β - gal . in the ovalbumin system , eg7 - ova , cytoplasmically loaded ova splenocytes , and ova - af induced : ( a ) class i restricted cd8 + ctl ; ( b ) ctl that recognize target sensitized with ova 253 - 276 synthetic peptide ; and ( c ) long lived ctl after only one immunization . in the β - galactosidase system , the β - gal - af induced ctl that recognize β - gal expressing transfectant c3 - 4 , and also the untransfected p815 cells sensitized with alkali digested β - gal . this is analogous to what was observed with ctl induced by immunization with spleen cells cytoplasmically loaded with β - galactosidase . the induction of ova - specific ctl by antigen formulation is unique because neither ova encapsulated in a ph sensitive liposome , nor in alum , could induce ctl priming in vivo . these examples indicate that the antigen formulation used above , and its equivalents , are useful in human therapy and in vaccine development for the induction of ctl in various cancers and viral diseases . this is a specific example to show the use of the above af on producing class i restricted ctl priming by soluble gp120 from hiv . the gp160 iiib expressing cell line ( 15 - 12 ) was produced in the balb / c fibroblast - derived 3t3 cell line . it was obtained from drs . ron germain and jay berzofsky , national institute of health , bethesda , md . the gp160 expressing cell line was employed for in vitro stimulation of in vivo primed splenic lymphocytes , and also used as target for gp160 specific ctl induction . balb / c mice were immunized once with 10 μg of gp160 per mouse with or without af . mice were injected at footpads and tailbase subcutaneously . spleen cells were taken from the immunized mice after two weeks of immunizations and in vitro stimulated with irradiated gp160 transfectants . after five days of culture in vitro , priming was assessed by the presence of specific effectors capable of lysing gp160 transfectants , and not the untransfected cell lines . the results are shown in fig7 where ctl response is potentiated with af and gp120 . the following example demonstrates the use of antigen formulations of this invention with use of only one or two components . these examples demonstrate that ctl - responses can be induced with only two of the above three components . to determine whether all the above - noted components are necessary for antigen specific ctl induction , mice were immunized with ovalbumin in a microfluidized formulation of various combinations of two of the three components presented in the af above . two component combinations used were as follows ; squalane / tween in pbs , squalane / pluronic in pbs or pluronic / tween in pbs . another set of groups were included where mice were immunized with ova formulated in a one component system i . e ., squalane in pbs , pluronic in pbs or tween in pbs only . the above three component antigen formulation was modified to exclude one component at a time , constituting pbs in its place . the above antigen formulations consist of : 0 . 300 g tween 80 ( aldrich , wis . ), 1 . 875 g pluronic l121 ( basf , nj ), and 7 . 5 g squalane ( aldrich , wis . ), brought to 50 ml with pbs . squalane / tween : 0 . 300 g tween 80 , and 7 . 5 g squalane , brought to 50 ml with pbs . pluronic / tween : 1 . 875 g pluronic l121 , and 0 . 300 g tween 80 , brought to 50 ml with pbs . pluronic / squalane : 1 . 875 g pluronic l121 , and 7 . 5 g squalane , brought to 50 ml with pbs . the samples were then processed through a microfluidizer , model 110t , microfluidics corp , and bottled and stored at 4 ° c . until use . ovalbumin ( sigma , mo .) was weighted and brought to a 0 . 3 mg / ml solution in hbss ( whittaker , supra ). the stock 0 . 3 mg / ml solution was combined with the two component formulation in the following amounts : 5 parts ovalbumin 0 . 3 mg / ml solution , 3 . 3 parts 2 component formulation , and 1 . 7 parts hbss . the formulation was vortexed and kept on ice until injected . all solutions were combined just prior to injection . each mouse received 200 μl of one formulation containing 30 μl of ova by injection in both hind footpads and any remaining solution was injected subcutaneously at the tail base . mice were allowed to rest for two to four weeks prior to spleen harvest . two weeks after immunizations , spleen cells were prepared and in vitro stimulated with irradiated eg7 - ova . after five days of culture , the presence of ova specific ctl was measured by testing against 51 cr - eg7 - ova or 51 cr - el4 in a 4 hour 51 cr release assay . the data shown in fig8 - 10 demonstrate that ovalbumin formulated in microfluidized two component system can prime ova specific ctls in vivo . we further evaluated the relative contribution of the individual components for their ability to induce ctl when combined with protein antigens . for immunization purposes soluble antigen was mixed with microfluidized excipients to obtain a stable homogeneous emulsion with particle sizes ranging from 250 - 300 nm . to further define the components of squalane - tween 80 - pluronic ( stp ) formulation responsible for ctl induction , we immunized mice with ova in squalane - tween 80 ( st ) mixture , pluronic - tween 80 ( pt ) mixture or squalane - pluronic ( sp ) mixture and as a control , in squalane ( s ), tween 80 ( t ) or pluronic ( p ). mice were also immunized with ova - safm ( containing 70 μg of mdp ) or ova - alum as adjuvant controls . for a positive control , mice were immunized with spleen cells cytoplasmically loaded with soluble ova . other combinations and substitutes were also used , and the results are presented in table 1 . for the detection of ctl priming studies , mice were immunized once . two weeks after the immunization , spleen cells were mixed with irradiated eg7 - ova ( the ova expressing el4 cells ) for five days and tested against 51 cr - eg7 - ova or 51 cr - el4 cells . the results ( fig1 ) demonstrate that 30 μg of ova in combination with stp or st primes class i restricted ctl response in mice . the priming of ova specific ctl by ova in stp or by ova in st appears to be better than that induced by spleen cells cytoplasmically loaded with soluble ova . ova in pt or in sp could induce ova specific ctl responses in mice but inconsistently and poorly . unlike safm , the addition of mdp to st formulation did not compromise the ova specific ctl induction in mice ( table 2 ). no ova specific ctl induction occurred when mice were immunized with ova mixed with the individual components , s , p or t nor when mice were immunized with ova - safm or ova - alum . mice immunized with as much as 1 mg ova in ( a ) hbss , in ( b ) safm or ( c ) absorbed to alum did not prime ova specific ctl . table 2__________________________________________________________________________induction of ova specific ctl response is not blocked by st + mdp % cytotoxicity in mice immunized with * ova - st - mdp ova - st - mdpstimulatortarget ** e - t ova - st ova - st 300 μg mouse 72 μg mouse__________________________________________________________________________eg7 - ovaeg7 - ova 100 : 1 0 100 82 76 33 : 1 0 86 67 62 11 : 1 0 33 39 25 3 : 1 0 6 13 3 1 : 1 0 0 0 0 3 : 1 0 0 0 0__________________________________________________________________________ * mice were immunized with 30 μg ova in various formulations **% cytoxicity was calculated by subtracting the percent kill against antigen nonexpressing cells lines mice were immunized three times at 2 week intervals with 30 μg of ova in hbss , stp , st , pt or sp . as a positive control , mice were also immunized with ova - safm , as safm is known to induce a strong antibody response . seven days after the second and third immunizations , mice were bled and the sera tested for ova specific antibody response . the results are shown in table 3 . they indicate that mice immunized with ova in stp , st or in safm display similar anti - ova responses after two immunizations . table 3______________________________________induction of anti - ova antibody response30 μg ova / animal # mice responded / formulation # mice injected 1 / dilution sera titer______________________________________hbss 0 / 3 & lt ; 1 / 20 , & lt ; 1 / 20 , & lt ; 1 / 20stp 3 / 3 & lt ; 1 / 4860 , & gt ; 1 / 4860 , & lt ; 1 / 4860st 3 / 3 & gt ; 1 / 4860 , & gt ; 1 / 4860 , & gt ; 1 / 4860pt na na , na , nasp na na , na , nasaf - m 3 / 3 1 / 4860 , 1 / 4860 , 1 / 4860______________________________________ * n / a ; not available hiv gp120 iiib was used as a second antigen system to determine ctl induction in stp , st or in mp - t . mice were immunized with 1 μg of gp120 iiib in hbss , stp , pt or in st . as a control , mice were immunized with 1 μg of gp120iiib in safm or cfa ( complete freund &# 39 ; s adjuvant ) or in ribi adjuvant system containing mpl ( monophoshoryl lipid a ) and tdm ( trehalose dimycolite ). three weeks after the immunization , spleen cells were prepared and stimulated in vitro with mitomycin treated transfectant cells 15 - 12 or with the 18iiib peptide . after five days of culture , the resultant effector cells were tested against vaccinia : gp160 iiib , or parental vaccinia infected p815 cells as targets . the results demonstrate that the gp120 - squalane - tween 80formulation and not gp120 - squalane - tween 80 pluronic formulation or gp120 - hbss induced gp120 specific ctl response in mice ( table 4 ). table 4__________________________________________________________________________induction of gp120 specific ctl response in mice % cytotoxicity in mice immunized with * stimulator target ** e - t gp120 - hbss gp120 - st gp120 - stp__________________________________________________________________________18iiib / il2 vac : gp120 100 : 1 23 42 na *** 33 : 1 23 38 na 11 : 1 0 0 na 3 : 1 0 35 na18iiib / il2 15 - 12 100 : 1 0 50 0 33 : 1 0 35 0 11 : 1 0 27 0 3 . 1 0 18 018iiib / il2 3t3 + 18iiib 100 : 1 0 59 13 33 : 1 0 59 2 11 : 1 0 57 0 3 : 1 0 29 015 - 12 vac : gp120 100 : 1 35 84 na 33 : 1 19 65 na 11 : 1 12 37 na 3 : 1 0 22 na 1 : 1 0 0 na__________________________________________________________________________ * mice were immunized with 1 μg of gp120iii in various formulations **% cytotoxicity was calculated by subtracting the percent kill against antigen nonexpressing cell lines *** na ; not available for the induction of gp120 specific humoral responses , mice were immunized with 1 μg of gp120iiib three times at two - week intervals . the animals were bled and tested for the presence of igg antibodies detecting gp120iiib in a solid phase elisa assay . the results demonstrate that gp120 - st is a better immunogen than gp120 - hbss , gp120safm ( table 5 ), or gp120 - stp . table 5______________________________________induction of anti - gp120 antibody response1 μg gp120 / animal # mice responded / formulation # mice injected 1 / dilution sera titer______________________________________hbss 0 / 3 & lt ; 1 / 20 , & lt ; 1 / 20 , & lt ; 1 / 20stp 1 / 3 & lt ; 1 / 20 , & gt ; 1 / 4860 , & lt ; 1 / 20st 3 / 3 & gt ; 1 / 4860 , & gt ; 1 / 4860 , & gt ; 1 / 4860pt 3 / 3 & gt ; 1 / 4860 , & gt ; 1 / 4860 , & gt ; 1 / 4860sp 2 / 3 & lt ; 1 / 20 , 1 / 540 , 1 / 540saf - m 2 / 3 1 / 180 , & gt ; 1 / 4860 , 1 / 540______________________________________ monkeys ( two per group ) were immunized with gp120 - safm , gp120 - spt , gp120 - st , or gp120 - hbss . as a control , a group of monkeys were immunized with recombinant vaccinia containing gp160 iiib . monkeys were immunized at two week intervals and bled two weeks and three weeks after the second immunization . pre - and immune sera from each monkey was serially diluted and assayed for anti - gp120 activity in an elisa as described in the materials and methods . the data ( fig1 ) indicate that monkeys immunized with gp120 - stp or gp120 - safm induced similar responses in monkeys . one monkey immunized with gp120 - st , induced anti - gp120 response similar to the gp120 - safm or gp120 - spt immunized group . one monkey immunized with gp120 - st did not induce a strong anti - gp120 response after two immunizations . in vivo activity of af in combination with hpv 16 e7 the hpv 16 e7 gene was cloned from a plasmid obtained from dr . karen vousden ( ludwig institute ) encoding the e7 gene derived from the carcinoma cell line caski . the coding regions were amplified by pcr using primers that encode the 5 &# 39 ; and 3 &# 39 ; ends of the genes flanked by bam hi and sal i cloning sites . the e7 pcr product was ligated into the pgex - 4t - 1 expression vector ( pharmacia biotech ) resulting in the pgex . e7 expression plasmid . e . coli strain xl1 - blue ( stratagene ) was transfected with the pgex . e7 expression plasmid . the sequence of the e7 was obtained from the plasmids of the resulting colonies and was identical to the e7 sequence obtained from caski cells . the pgex . e7 bacterial expression plasmid encodes a glutathione - s - transferase ( gst ) fusion protein consisting of the gst at the amino - terminus , a thrombin protease cleavage site and the e7 protein at the carboxy - terminus . e7 protein was produced and purified as described in the product information literature from the manufacturer of the pgex - 4t - 1 vector ( pharmacia biotech ). briefly , bacteria containing the pgex . e7 expression plasmid was induced to express the fusion protein by the addition of isopropyl b - d - thiogalactosidase to the culture medium . the cells were harvested and lysed by mild sonication . the lysate was applied to glutathione sepharose 4b ( pharmacia biotech ). after the fusion protein bound to the matrix , the resin was washed to remove non - specifically bound proteins . the bound fusion protein was digested with thrombin to release the e7 protein from the gst fusion partner . the e7 protein preparation was analyzed by sds - page and the e7 protein concentration was determined by bradford analysis ( biorad ). 9 mg soluble e7 protein was obtained per liter of bacterial culture . coding sequences for the hpv16 e7 protein ( see above ) have been inserted into the idec proprietary eukaryotic expression plasmid inpep4 . within this vector , e7 expression is controlled by the cytomegalovirus promoter / enhancer transcriptional elements . in addition , the first three nucleotides of the e7 coding sequence have been removed and replaced with an immunoglobulin light chain leader sequence placed immediately upstream and in frame with the e7 coding region . following transfection into the mouse cell line x21 individual g418 resistant clones were examined by northern blot analyses for e7 message production . every clone displayed detectable e7 message . western blot analysis of cell lysates from the two of those clones , 4e7 and 1c7 , ( hope1 and hope2 respectively ) were then performed and demonstrated e7 protein production . female mice of c3h background ( h2 k / k , harlan sprague dawley ) were used in these studies . animals were maintained according to &# 34 ; guide for the care and use of laboratory animals &# 34 ; ( dhhs publication no . nih 86 - 23 , bethesda , md . : nih , 1985 ), and received food and water ad libitum . the e7 transfectant cell line hope2 h2 k / k ) was used in these studies . the tumor cell line was maintained by serial passage in vitro . this cell line has been shown to maintain e7 cytoplasmic antigen expression , as detected by western blot analysis , following repeated in vitro passages . tumors were initiated in syngeneic c3h mice by subcutaneous injection of 150 , 000 in vitro passaged cells . tumors were measured in 2 perpendicular directions at biweekly intervals . tumor volume ( v ) was calculated according to the following formula : data in table 6 are presented as tumor mice ( number of tumor bearing animals over the total number of animals injected ). data in fig1 and 14 are presented as median tumor size ( mm 3 ) of each treatment or control group . each treatment group was compared to a control group that did not receive therapy . therapy began 10 days after incoculation of hope2 cells , when a majority of the tumors were palpable ( approx . 50 - 75 mm 3 ). therapy was initiated by immunization of mice with soluble e7 protein in af or alum adjuvants ( subcutaneously in a total volume of 0 . 2 ml ). directly before immunization , af was mixed for 60 seconds with e7 protein in hanks balanced salt solution ( hbss ) such that each mouse received either 30 ug or 90 ug e7 protein 0 . 2 ml . alum ( pierce chemical co .) was mixed with e7 protein , according to instructions by the manufacture , such that each animal received 90 ug e7 protein in 0 . 2 ml per mouse . animals in a second treatment group received a second immunization 9 days later ( 19 days after tumor cell inoculation ). booster immunization were prepared immediately before inoculation , as described above . in this example ( table 6 : xp # 233 ), 41 days after tumor cell inoculation only 4 / 8 and 5 / 8 of mice receiving a single injection of soluble e7 in af ( 30 ug or 90 ug respectively ) had measurable tumors . in contrast , all of the mice immunized with e7 protein in alum ( 8 / 8 ) had actively growing tumors . additionally , as shown in fig1 , significant inhibition of tumor growth was observed only in treatment groups immunized with e7 protein in af as compared to control ( untreated ) or alum treatment groups . inhibition of tumor growth ( fig1 ) or increased tumor regression rates ( table 6 was not observed in mice that received a single injection of e7 in alum . similar results were also observed using treatment groups that received two immunizations at days 10 and 19 after tumor challenge ( table 6 and fig1 ), although some tumor growth retardation was observed with mice receiving two injections of e7 in alum . the results indicate that significant antitumor activity as measured by a decreased number of tumor bearing mice and inhibition of tumor growth was observed following immunization of soluble e7 in af . in contrast , all animals immunized with either a single or double injection of soluble e7 protein in alum had growing tumors . in summary , immunization with soluble e7 protein in af resulted in a significant inhibition of tumor cell growth that was not observed using soluble e7 immunization in alum . table 6______________________________________antitumor activity of soluble e7 immunization in adjuvantexp . # treatment dose ( ug / mouse ) tumor animals . sup . a day 41______________________________________223 control -- 7 / 8223 e7 in af 30 ug × 1 . sup . b 4 / 8223 e7 in af 90 ug × 1 5 / 8223 e7 in alum 90 ug × 1 8 / 8223 e7 in af 30 ug × 2 . sup . c 3 / 8223 e7 in af 90 ug × 2 1 / 4223 e7 in alum 90 ug × 2 8 / 8______________________________________ . sup . a number of tumor bearing mice / total number inoculated . sup . b all immunizations started on day 10 post implant . sup . c second immunization (× 2 ) on day 19 post implant

methods and compositions useful for inducing a cytotoxic t lymphocyte response in a human or domesticated or agriculturally important animal . the method includes the steps of providing the antigen to which the ctl response is desired and providing an antigen formulation which comprises , consists , or consists essentially of two or more of a stabilizing detergent , a micelle - forming agent , and an oil . this antigen formulation is preferably lacking in an immunostimulating peptide component , or has sufficiently low levels of such a component that the desired ctl response is not diminished . this formulation is provided as a stable oil - in - water emulsion .

referring first to fig1 to 3 , the waterslide bowl 20 is an annular - shaped element which forms part of a waterslide ride apparatus having ride elements upstream of the bowl . the waterslide bowl 20 can be , for example , a waterslide run - out bowl . the bowl 20 has a bowl wall 22 having a side wall portion 24 and a bottom wall portion 26 . these portions form a continuous , curved wall structure with no clear line of demarcation between the side wall and bottom wall portions . the side wall portion 24 is relatively steep and curved and includes an inwardly - turning portion 28 at its rim 30 . the bottom wall portion 26 is gently curved and has a shallower angle from the horizontal than the side wall portion 24 . a rider entrance port 32 is in the side wall portion 24 near the rim 30 . a rider 51 slides into the bowl 20 through this entrance from a flume 34 leading from a higher elevation . the bottom wall portion 26 defines an opening 36 at its center , such that the bowl wall 22 forms an annulus around the opening 36 . a circumferential wall 38 about the opening 36 extends upwardly from the bottom wall portion 26 . the wall 38 is low enough that the rider , standing on the bottom wall portion next to the circumferential wall 38 , can step over it into the opening 36 . the bowl 20 is supported above a floor 40 by a support framework 42 which comprises vertical members 44 and bowl - support members 46 which are arranged under the underside of the bowl wall 22 . a circular staircase is arranged within the support framework 42 , extending from the opening 36 in the bottom wall portion 26 to the floor 40 . the staircase comprises a central vertical post 50 , a landing 53 at the top of the staircase and stairs 52 . the landing 53 is at the same height as the bottom wall portion 26 adjacent to the circumferential wall 38 . a guard structure 54 extends upwardly from the circumferential wall 38 around three - quarters of the circumference of the opening 36 , so that only a portion 55 of the wall 38 can be stepped over . the landing 53 is adjacent to this portion 55 so that the rider can step over the wall 38 and onto the landing 53 . the guard 54 is a plexiglass barrier that prevents the rider from stepping over the other portion 56 of the wall where the landing 53 is not adjacent , for reasons of rider safety . water flows continuously into the bowl through the entry flume 34 , which reduces friction and facilitates the rider sliding through the flume 34 . a water pipe with a plurality of jets ( not shown ) placed below the rim 30 also provides a continuous supply of water to the bowl to wet its sides , reducing friction between the rider and the walls of the bowl . the water from these sources replenishes a volume of water 64 on the bottom of the bowl , adjacent to and held in by the circumferential wall 38 . it has a depth of about 2 to 4 inches adjacent to the wall 38 . water drainage openings 39 are provided at the base of the circumferential wall 38 to prevent the water level in the bowl from rising above the desired height . the openings are connected to a trap to regulate the water level and a drainage system ( not shown ) for removing the water . fig4 illustrates an embodiment of the invention in which the waterslide bowl 200 is positioned on or close to the floor rather than being supported above it as in the embodiment of fig1 . in fig4 , features that correspond to or are the same as features of the bowl 20 are indicated by like reference numerals . the bowl 200 has essentially the same structure as the bowl 20 except that it is adapted for a rider to exit from the opening 36 in the bottom wall portion 26 by traversing over the bowl wall 22 . the bowl 200 is supported on the floor 40 by a suitable support frame ( not shown ). a walkway 70 extends between the floor 40 inside the opening 36 and the floor radially outward from the bowl 200 . the walkway comprises a first staircase section 72 , a horizontal walkway section 74 and a second staircase section 76 . since the floor 40 inside the opening 36 is close to the level of the bottom wall portion 26 adjacent to the circumferential wall 38 , the bowl 200 does not require any safety guard around part of the wall 38 . the rider can step over the wall 38 at any point and then exit the waterslide by means of the walkway 70 . the bowl 20 is fabricated from a plurality of sections of a suitable and durable material , such as fiberglass , fastened together to form a strong , rigid structure . a liner may be applied to the inner surface to provide a continuous , smooth interior surface that will facilitate a rider &# 39 ; s sliding movement . the bowl may have a depth of about 5 feet and a diameter of about 30 feet . the height of the center wall 38 is about 2 feet . the inner diameter of the flume 34 is in the range of about 2 . 5 to 4 feet . fig5 illustrates an embodiment of the run - out bowl ( the staircase , guard and supports are not illustrated ) which can be used in place of the bowl 20 in the elevated structure of fig1 or the on - floor structure of fig4 . the bowl 10 is constructed of a plurality of segments 12 . the bowl wall 23 has an upper side wall portion 25 and a lower side wall portion 29 , and a bottom wall portion 27 . the entry port 33 leading into the bowl 10 from the flume 34 is partly raised above the level of the rim 30 of the bowl . the bowl wall is supported by vertical ribs 14 and a horizontal rib 16 . water drainage openings 39 are provided at the base of the circumferential wall 38 . a ring of spray holes 37 is provided in the bottom wall portion 27 for spraying water into the bowl . fig6 illustrates an embodiment of the invention in which the waterslide bowl 20 is tilted . the tilted waterslide bowl 20 can have , for example , a titled bowl wall 22 . the tilted waterslide bowl 20 has a high portion and a low portion . the high portion is elevated above the low portion . thus , the rider 51 moves from the high portion to the low portion and back towards the high portion . however , due to the tilt of the waterslide bowl 20 , gravity slows down the rider 51 as he moves from the low portion back towards the high portion . this can reduce a number of times the rider 51 traverses around the waterslide bowl 20 . in one embodiment , the rider 51 does not completely move from the low portion back to the high portion . instead , at some point the rider 51 can slide back down towards the low portion due to gravity . in another embodiment , optional nozzles such as nozzle 66 can be used to spray water onto the rider 51 , thereby slowing the rider 51 down further . any number of nozzles can be used , and they can be strategically placed to slow down the rider 51 . by reducing the number of times the rider 51 traverses around the waterslide bowl 20 , the rider 51 can exit the waterslide bowl 20 in a more expedient manner . this increases a number of people that can utilize the waterslide bowl 20 for a given period of time . fig7 and fig8 illustrate an embodiment of the invention in which the waterslide bowl 20 includes a slide 62 instead of the stairs 52 . in one embodiment , the slide 62 can be a wet slide . in another embodiment , the slide 62 can be a substantially dry slide . a dry slide can slow down a rider 51 faster than a wet slide since the contact of the wet rider with the dry slide can create more friction than the contact of the wet rider with the wet slide . the slide 62 allows the rider 51 to exit the waterslide bowl 20 by sliding down the slide 62 instead of walking down the staircase 52 . thus , the rider 51 can step over the circumferential wall 38 onto the landing 53 and slide down the slide 62 . sliding down the slide 62 can reduce the time it takes for the rider 51 to exit the waterslide bowl 20 . this can also increase a number of people that can utilize the waterslide bowl 20 for a given period of time . furthermore , since the rider 51 is already substantially slowed down through the circular or curved nature of the titled waterslide bowl 20 , the slide 62 can have a shorter length than conventional elongated flumes . fig9 illustrates an embodiment of the invention in which the staircase 52 extends upwards instead of downwards as seen in fig1 . furthermore , instead of utilizing the horizontal walkway section 74 in the walkway 70 ( fig4 ), only the staircase 52 is utilized . although the staircase 52 is depicted as extending upwardly in a spiral configuration , it can be formed in a variety of configurations . in one embodiment , the staircase 52 is configured to resemble the first staircase section 72 in fig4 . by having the staircase extend upwardly instead of downwardly , other configurations are provided for the waterslide bowl 20 which can be utilized , for example , where it may be undesirable for the rider 51 to exit below the bowl 24 . in another embodiment , the staircase 52 can be angled to obviate the need for the walkway 70 . instead of using a slide 52 or the staircase 52 , the waterslide bowl 20 can also include , for example , a pole such as a fireman &# 39 ; s pole . this can allow the rider to slide down the pole to exit the waterslide bowl 20 . in addition , a ramp can also be used instead of the slide 62 or the staircase 52 . the rider can walk down the ramp or slide down the ramp . although the invention has been described in terms of various embodiments , it is not intended that the invention be limited to these embodiments . various modifications within the scope of the invention will be apparent to those skilled in the art . for example , the bowl exit means can comprise any practical means for a rider to exit the bowl , for example a slide , tube , etc . leading into a pool of water or to a mat . the scope of the invention is defined by the claims that follow .

an annular - shaped waterslide bowl for use as an element of a waterslide apparatus serves to slow a rider down and bring him or her to a stop at the end of the waterslide ride . the bowl has a bowl wall with a rider entry port through which a rider slides from a flume into the bowl . the bottom wall of the bowl has an opening at its center and a low circumferential wall around the opening extends upwardly from the bottom wall . the rider comes to a stop in the bowl and can step over the circumferential wall into the opening . a staircase or slide located within the opening provides means for the rider to exit the bowl . the waterslide bowl provides a compact structure for slowing and stopping the rider and is particularly suitable for waterslide installations having limited space .

fig1 a . shows schematically a cow provided with a transponder 1 for allowing identification of the cow individual . the transponder communicates with a transmitter / receiver ( not shown ). the cow is in an animal space 2 , such as a milking stall , a feeding stall or a gateway , defined at its sides by a sideward limiting means 3 , such as a wall or a railing . according to a first embodiment , a movement sensor 4 in the form of a tactile sensor is provided on one side of the animal . the tactile sensor 4 may be in the form of a hydraulic or pneumatic cylinder ( also called air spring ) provided with an extension measurement means connected to a control means 5 . the control means 5 calculates the movement rate by taking into account the time elapsed for each breath or a row of breaths . a milking robot 6 is provided with a robot arm for cleaning the teats , attaching teatcups etc . and is connected to the control means 5 . a gate 7 is connected to the control means 5 to keep the cow in the stall or allow her to leave it . an alerter 8 is connected to the control means 5 , preferably , but not necessarily , wirelessly , so that the dairy maid can be made observant of an arisen extraordinary situation . the alerter may be a mobile telephone , a buzzer or a bell . in fig1 b , a pair of tactile movement sensors 4 connected to the control means 5 is provided for better resolution , as a pair of sensors 4 will increase the sensing accuracy . fig2 a shows an alternative sensor 4 for sensing the movement of the cow . the sensor 4 is associated with a control means 5 . such a sensor may be an ultrasonic distance meter sensing the time of flight of the sound waves , or a laser distance meter using a triangulation technique . in fig2 b , a pair of such breathing sensors 4 are provided for the same reason as in fig1 b . fig3 shows yet an alternative movement sensor 4 comprising viewing means , such as a video camera or a digital camera . the viewing means is connected to the control means 5 , which contains image analyzing means . as is the case , regarding the movement sensors described above , the control means 5 is arranged to control the movement of the robot arm and the opening and the closing of the gate 7 . in the following , a second embodiment of the invention will be described . fig4 . shows schematically a cow as seen from above . rigid lines indicate the state of her belly after exhalation , whereas the broken lines indicate the state of her belly after inhalation . the difference in displacement of one side of the belly is indicated at d . what is described in connection with fig1 a , 1 b , 2 a and 2 b is also applicable to the second embodiment however , with the following modifications . the movement sensor 4 as the tactile sensor shown in fig1 a in this embodiment is arranged to sense the displacement d in order to establish an existing breathing of the cow . however , the control means 5 instead calculates the breathing rate by taking into account the time elapsed for each breath or a row of breaths . the movement sensor 4 including a pair of tactile sensors as shown in fig1 b is in this embodiment adapted , together with the control means 5 , to establish the total displacement d + d = 2d . also , the movement sensor 4 may be a pair of breathing sensors which will increase the sensing accuracy , as movement of the cow will be possible to take into account . the sensor means of fig2 a and 2b is used as a breathing sensor 4 , which senses the displacement d of the belly from a distance . in fig5 a , the movement sensor 4 is arranged as a microphone on the sideward limiting apparatus 3 , and is directed towards the head , preferably the muzzle of the cow . the direction of the microphone may also be performed electronically . the microphone may be directed to other parts of the cow , e . g . the belly . it is , of course , only possible to establish the breathing rate , not the displacement by means of the microphone . in fig5 b , the movement sensor 4 is a microphone integrated with the transponder 1 in a common housing , attached to a collar to be worn by the cow . of course , the microphone may be attached to a separate collar or to a common collar , but in a different housing . the communication between the microphone and the control means is performed wirelessly . a cow that enters an animal space 2 — there may of course be a plurality such animal spaces at a farm — will be identified in a usual manner by means of the transponder 1 , when passing the not shown transmitter / receiver . the sensor 4 senses movement of the cow . regarding the breathing sensor embodiment , the sensor 4 senses the distance d corresponding to the difference in displacement of the belly of one side the cow . the control means 5 calculates the movement rate at a plurality of occasions , such that an average value is possible to establish . whenever the control means 5 establishes that the movement rate ( or the breathing rate and / or the displacement d differs from the average value , the control means 5 sends a signal in order to alert the milker — e . g . by ringing a bell or calling a mobile telephone . alternatively , during attachment of teatcups by means of a milking robot 6 , it may be that the cow runs into a state of panic . this will be apparent either by establishing an increased movement rate of the cow . the milking session may then be interrupted and restarted when the cow has calmed down . alternatively , the cow may be let out from the milking stall by opening the gate 7 . it is important that if it is suspected or has been established that the cow acts in an abnormal way , it should be possible to check that cow more intensively . this may be performed either by not checking other “ normal ” cows each time it is identified in order to allow the “ abnormal ” cow to be checked more often or by separating the cow to an area where more sensors are arranged . furthermore , in order to secure an abnormal behaviour or state of health , the control means 5 calculates the movement rate at a another plurality of occasions , such that a new average value is to established and can be compared to the average value of that cow at its normal state . as an alternative to calculating an average value , it is , of course , possible to set a predetermined value , even though this would be less precise . it should be noted that also other kinds of sensors may be used within the scope of the invention , such as inductive proximity sensors . furthermore , the acceleration may be established by the provision of a pendulum or an integrated circuit with a piezo - electric sensor . it should also be noted that the different kinds of sensors 4 described , may be used in combination to a so called sensor fusion , which creates an overall signal for increasing sensing accuracy . of course , the sensors may be situated in order to sense other parts of the animal than the belly , as shown in the figures . furthermore , it should be understood that the invention is not restricted to be used in connection with cows but with any milk animal , such as sheep , goats , buffaloes and horses .

an apparatus and a method are provided for monitoring an animal and having a controller . according to a first aspect of the apparatus and method , the controller has a sensor adapted to sense a movement rate of the animal and to establish a value of the movement rate regarding the animal . according to a second aspect of the apparatus and method , the controller includes a sensor provided to allow establishment of the existence of the breath of the animal , and a heart rate calculation device for establishing a value of the breathing rate regarding the animal .

in fig1 , number 1 indicates , in its entirety , a gymnastic machine validly usable for executing an aerobic gymnastic exercise , and therefore for training the cardiovascular system . it should be noted that , for the sake of practicality , without however limiting the protective scope of the present invention , the gymnastic machine 1 is of the type already described with reference to the italian patent application no . ra2008a000045 , whose description and mosaics shall be considered an integral part of the present description for saving text and drawings , when indicated , even if the reference numbers used to indicate identical parts different from each other for description requirements . with reference to fig1 again , the machine 1 comprises a frame 10 , an actuating device 40 provided with a pair of first levers 102 , each of which is supported by the frame 10 through the interposition of a second lever 104 , pivoted on the frame 10 and through a first flexible member 106 , better described below , which supports the first lever 102 in intermediate position through an articulated connection 114 . each first lever 102 is therefore connected to the frame 10 so as to oscillate similarly to a connecting rod of a four bar linkage relative to the frame 10 . each first lever 102 presents an end portion 108 shaped to couple with the lever 104 ; each first lever 102 furthermore presents a free end 110 at opposite side from the end portion 108 and provided with a footrest 112 . in view of the above description , each footrest 112 is arranged substantially overhanging behind the connection 114 in fig1 . each second lever 104 presents , at opposite side relative to the end portion 108 of the corresponding first lever 102 , a knob 116 , that is tiltable relative to the frame 10 in view of the above description and can be held by a user for moving the upper limbs . the machine 1 furthermore comprises a load device 300 arranged at the side of the end portion 108 of the first lever 102 , without however limiting the protective scope of the present invention . this load device 300 is provided with a flywheel 320 carried by the frame 10 in a freely rotatable manner around a given substantially horizontal pivot axis 30 , as shown in fig1 . this flywheel 320 is kinematically connected with the actuating device 40 through a transmission 200 , already described with reference to the patent application no . ra2008a000045 and functionally recalled hereafter with the minimum required detail , for the sake of practicality . in addition to the first flexible member 106 and to the respective return members , not described for the sake of practicality , this transmission 200 furthermore comprises , for each first lever 102 , a crank 322 , rigidly coaxially connected with the flywheel 320 . the transmission 200 furthermore comprises , for each crank 322 , a second flexible member 24 , already known from the patent application no . ra2008a000045 and connected with the corresponding first flexible member 106 through a joint 26 , which is associated with the frame 10 and is already known from the same patent application no . ra2008a000045 . the two cranks 322 are mutually opposite , i . e . they are in phase opposition , so as to put the flywheel 320 into rotation under the thrust of the two footrests 112 through the first and second flexible members 106 and 24 . the particular arrangement of the cranks 322 maintains therefore the levers 102 constantly in phase opposition . in view of the above description , in the machine 1 taken herein as a reference to illustrate an embodiment of the present invention , the footrests 112 are constrained to move along an horizontally elongated elliptical trajectory , extending vertically for a limited width , and therefore the machine 1 can be used for walking or running training . as it is well known , the flywheel 320 comprises a circular member with significant mass , whose object is , in use , to store rotational kinetic energy produced by actuating the footrests 112 and / or the knobs 106 to smooth the execution of the gymnastic exercise performed through the machine 1 . the flywheel 320 acts therefore as a power dissipater member until the rotation speed in the starting phase of the machine 1 achieves a substantially constant value and , during the use thereof under steady - state conditions , it acts as accumulated power “ reserve ” to facilitate preservation of a steady - state operation . the presence of the flywheel 320 therefore makes the stop times of the machine 1 longer , in phase of conclusion of the exercise . it should be noted that a stopping condition of the machine 1 can occur when the belt 24 is arranged according to the vertical , the cranks 322 are aligned with the belt 24 and the first levers 102 are arranged in a scissor manner , in the respective top and bottom dead centres . the loading device 300 furthermore presents a power dissipating member of the adjustable type comprising an electromagnetic brake 340 carried by the frame 10 and provided with a rotating disk 342 mechanically connected to the flywheel 320 in an angularly fixed manner through a further belt transmission 400 with parallel axes . the loading device 300 therefore combines partially fixed and partially adjustable mechanical characteristic , respectively set by the flywheel 320 and by the brake 340 . the transmission 400 can be single - or multi - stage . in particular , although without limiting the protective scope of the present invention , in the attached drawings this transmission 400 is double - stage . the object of this transmission 400 is to modify the kinematic parameters of the disk 342 of the brake 340 relative to those of the flywheel 320 and of the first levers 102 , responsible for the actuation of all the moving parts of the machine 1 to improve the performances of the brake 340 . the machine 1 furthermore comprises an anti - stopping device 50 associated with the flywheel 320 and comprising at least one magnet 52 carried by the flywheel 320 . in particular , with reference to fig3 , the anti - stopping device 50 comprises a pair of movable magnets 52 carried by the flywheel 320 . these magnets 52 are diametrically opposite , analogously to the cranks 322 , and are generally displaced relative to a quadrature condition with these latter for reasons that will be more apparent below . this anti - stopping device 50 furthermore comprises a fixed magnet 54 , carried by the frame 10 in a position facing each movable magnet 52 . in particular , the frame 10 carries the fixed magnet 54 at a height substantially identical to the distance of the trace of the axis 30 in fig1 relative to a pavement pv , on which the machine 1 stands , so that the two movable magnets 52 are substantially equidistant from the fixed magnet 54 when the flywheel 320 is arranged with the cranks 322 substantially horizontal , in an arrangement visible in fig1 and , in more detail , in fig3 . in view of the above description , the movable magnets 52 and the fixed magnet 54 are arranged at a substantially identical radial distance from the pivot axis 30 of the flywheel 320 , so as to exert on the flywheel 320 a torque of magnetic nature suitable to constrain the flywheel 320 to take a given operating position relative to the frame 10 . to achieve this , the movable magnets 52 and the magnet 54 present homologous opposite magnetic poles and the magnetic repulsion force exchanged between the homologous poles of each magnet 52 and of the magnet 54 is maximum when these magnets face each other . this repulsion force decreases significantly in case of even minimum displacement between a magnet 52 and the magnet 54 , i . e . the case where the magnetic torque on the flywheel 320 appears . this explains why the arrangement of the magnets 52 on the flywheel 320 in not in quadrature with the cranks 322 , as , in that case , the repulsion force could be maximum but the stopping condition could not be overcome easily due to the condition of a magnet 52 facing the magnet 54 . therefore , each crank 322 is normally displaced relative to the magnet 52 by an angle different than 90 °. a confirmation of this situation can be obtained graphically in fig2 and , in enlarged scale , in fig3 , observing the straight line l and the angle with the straight line connecting the centres of the two movable magnets 52 , and the inclination of the flexible member 24 relative to a vertical direction , in particular in fig2 . these figures show a situation of down time , wherein , due to the interaction between the adjacent magnets 52 and 54 , the cranks 322 move away from the vertical position , thus making impossible to detect the stopping condition . obviously , the choice of the movable magnets 52 and of the fixed magnet 54 is made to have available , when the movable magnets 52 and the fixed magnet 54 are slightly displaced from each other , a sufficient torque to move the cranks 322 from the stopping position and , consequently , the first levers 102 from the scissor position . to this position of the cranks 322 can therefore correspond any rest position of the first levers 102 , provided that it is different from the scissor arrangement of the first levers 102 visible in fig1 . in view of the above description , the anti - stopping device 50 can be interpreted as a second actuating device , that acts when there is no external load acting on the first levers 102 or on the second levers 104 . the use of the gymnastic machine 1 described above is readily apparent in view of the above description and requires no additional explanations . lastly , it is apparent that modifications and variants can be made to the gymnastic machine 1 described and illustrated herein , without however departing from the protective scope of the present invention . for instance , it is easily understood that the movable magnets 52 and / or the fixed magnet 54 can be of the permanent type or they can be electromagnets powered by an electric current adjustable in a known and therefore not shown manner , so as to produce a magnetic field with intensity variable also instant by instant , to avoid stopping conditions of the first / second levers 102 / 104 even with internal friction between the moving members of the machine 1 greater than the project conditions . for this purpose it should be advisable to complete the outfit of the gymnastic machine with a power - supply unit , no - load resistance sensors and an electronic unit to which connect the sensors and the magnets so as to vary adequately the parameters of the electric current to supply to these latter . in view of the above description it is clearly apparent that each gymnastic machine 1 structured as described above is suitable to be used , starting from the rest condition , also by deconditioned users or users who could feel awkward in performing opposite actuation operations of the machine they want to use to perform a cardiovascular training session .

a gymnastic machine comprising a frame supporting a first actuating device provided with at least a pair of first levers , each of which presents a respective implement suitable to act as user interface ; a load unit being provided in connection with the first levers so as to dissipate power applied to each implement in a proportion definable at will ; said load unit being designed to maintain the first levers in phase opposition ; second actuating devices of magnetic kind being associated with the load unit to bring and maintain the first levers at rest in a neutral position so as to prevent stopping conditions .

fig1 shows a stethoscope of a toy in accordance with the present invention . it has earphones 2 , a plastic tube 3 and an electronic device 6 . the earphones are used here both to function as conventional earphones and also as one pole electrode of a hear pulse transducer as will be explained hereinbelow . a signal lead 4 is connected with a metal tube of the earphones in a point 5 and extends through the rubber tube 3 to the electronic device 6 . the earphones are provided with metal tips 1 for better electrical contact with the child &# 39 ; s ears . the tube 3 serves as a sonic conductor between the earphones and a sonic transducer 16 which is a part of the electronic device 6 . it is also used signal lead 4 . the electronic device 6 is arranged in a round metallic cover as shown in fig2 . the device includes a battery 8 of a watch type , connected through a reed switch 9 and by leads 10 and 11 to a heart pulse transducer 12 and an audio generator and amplifier 14 . the sonic transducer 16 is connected to the audio generator and amplifier by a lead 15 . a small magnetic member 18 is installed under the surface of a doll 17 in the region of an imaginary heart . when the electronic device 6 is brought by its base 19 to or onto this region of the doll , the magnetic member 18 turns on the reed switch 9 and the device begins to work . fig3 shows some details of the electronic device 6 and its waveforms . the transducer 12 includes a difference amplifier 112 . 1 , a low - pass filter 112 . 2 , a threshold circuit 112 . 3 , a one - shot pulse generator 112 . 4 and waveforms 112 . 5 , 112 . 6 , 112 . 7 , 112 . 8 , 112 . 9 . the audio generator and amplifier 14 includes an audio generator 114 . 1 , an amplifier 114 . 2 and a waveform 114 . 3 . the heart pulse transducer 12 is connected with the audio generator and amplifier 14 by a lead 113 . the input lead 4 ( 104 ) extends from the earphones as a first bioelectrical electrode , and the lead 107 is connected to the metal cover of the electronic device 6 as a second electrode . they transfer bioelectrical signals 112 . 5 and 112 . 6 to the difference amplifier 112 . 1 . these signals are amplified and go through the low pass filter 112 . 2 . signal 112 . 7 is applied to the threshold circuit which generates square pulses 112 . 8 . a square pulse train is fed to the one shot pulse generator 112 . 4 to produce a constant amplitude and constant width pulse train 112 . 9 . the pulse train 112 . 9 sets the audio generator 114 . 1 to produce an audio signal 114 . 3 . the audio signal 114 . 3 is amplified by the audio amplifier 114 . 2 and feeds the sonic transducer 116 via the lead 115 to convert the electrical signals to sound . the sonic signals of approximately 200 cycles per second are applied through the rubber tube 3 to the earphones . a child actually hears his or her own heart beat , when he monitors his doll &# 39 ; s pulse . instead of biopotential electrodes as desribed above , an infrared transmission transducer on an ear lobe or a finger can be used , as shown in fig7 . in this case a difference amplifier 112 . 1 is replaced by a conventional voltage amplifier 112 . 1 &# 39 ;, and the waveform 112 . 5 will not be used . the toy of a somewhat simpler type is shown in fig4 . earphones of medical type 201 are used with a rubber tube 202 and an electronic device 203 . a small magnetic member 211 is installed under the surface of a doll 212 , as described before , and operates in the same manner . the magnetic member turns on the reed switch and the electronic device which includes batteries 205 , 206 , a pace generator 207 , an audio generator 208 and a sonic transducer 209 . a human pulse is immitated here by the pace generator 207 which controls the audio generator 208 . it produces the audio signal transduced by the sonic transducer 209 . this sound passes through the tube 202 to the earphones . when the device is removed from the region of the magnetic member , its operation is interrupted . fig5 shows a toy in which heart activity of the doll &# 39 ; s heart is visually illustrated . the toy has a plastic or metallic cover 301 , batteries 302 , 303 of watch type , a reed switch 304 , an electronic device 305 , light emitting diodes 306 , 307 , light conductors 308 , 310 , and masks 309 , 311 . as in the case of the above described stethoscope , a small magnetic member 312 is installed under the surface of the doll 313 . when the device is applied by its base on the region of the doll heart wherein the magnetic member is arranged , the magnetic member 312 turns the reed switch 304 and the device begins to operate . a pace generator 315 which is a part of the electronic device 305 produces rhythmic pulses of a square form , at about 70 cycles per minute . these pulses control , via a lead 316 both a lamp switcher 317 and an audio generator 318 . the lamp switcher turns on either of the light emitting diodes 306 or 307 , and turns them off . the diodes are lit alternatively . the diodes are set in colored plastic glass components . when either diode 306 or diode 307 is on , it illuminates the whole area of the respective light conductor 308 or 310 . the masks are installed in front of both light conductors 308 and 310 and formed as a smaller heart and a bigger heart respectively . when either diode 306 or 307 is on , the smaller heart 309 &# 39 ; or the bigger heart 311 &# 39 ; will be lit . on the other hand , the smaller heart can be always on , while the greater heart can be alternatively on and off . the pulses from the pace generator control the audio generator 318 as well . this generator produces an audio signal , about 800 cycles per second and is connected directly to a sonic transducer 319 . the operation of the audio generator 318 is synchronized with lighting of the hearts , for example of only the bigger heart , and is on when the latter is on . it is to be understood that the operation of the device shown in fig5 can be performed in accordance with pulse beats of a child , by connecting it to a child pulse sensors as described with reference to fig1 - 3 and 7 . in this case the audio generator 318 and the lighting of the hearts will be performed in accordance with the pulse beats of the child . as shown in the right upper corner of fig3 the toy can additionally include a computer 117 connected with the one - shot generator , and a display 118 connected with the computer . in this construction the pulse beat can be displayed , for example in a digital form , on the display . in this case the toy can simultaneously serve as a conventional human pulse monitoring device , thus performing not only the playing function , but also the function of a medical device . the range of use of the toy considerably widens , and the child is involved in serious relations with adults , other children by playing the role of a physician . in addition the child can take a pulse of his or her pets . fig6 shows a toy which corresponds to the toy of fig5 with the only difference that the magnetic member is installed in a small handle 320 , whereas the other parts of the electronic device are installed in the doll . the parts are identified with the same reference numerals , and the toy operates in the same manner as the toy shown in fig5 . finally , fig7 shows the toy in which an infrared sensor 401 is used , attachable to an ear lobe or settable on a finger . fig7 shows a block - diagram of this embodiment . fig8 shows the stethoscope of the toy with the respective sensors which can be used alternatively . a sensor 402 is attachable to an ear lobe , while a sensor 403 is settable on a finger . instead of or in addition to the embodiments described above in which the magnetic member is located in the region of the doll heart and the video signals are represented by the contracting and expanding heart , there can be ( instead or in addition ) a magnetic member located in the region of the doll &# 39 ; s wrist and the video signals can be represented by a flashing point - like light . the magnetic member can be arranged on the doll &# 39 ; s body , inside the doll &# 39 ; s body , and also on the clothes of the doll , in the region of the doll &# 39 ; s heart and / or wrist . the magnetic member on the body and on the clothes can be formed heart - shaped . in the case of the wrist pulse monitoring , the magnetic member can be located in the stethoscope ( or handle ), while the electronic means is located in the doll . the invention is not limited to the details shown , since various modifications and structural changes are possible in the invention without departing in any way from the spirit of the present invention . what is desired by inventor to be protected by a letters patent is set forth in particular in the appended claims .

a doll heart monitoring toy includes a doll element , a stethoscope element , an electronic device operative for producing signals imitating at least one characteristic of heart activity and arranged in one of the elements , and a magnetic member arranged to activate the electronic device upon bringing the magnetic member in proximity to the electronic device , or in other words upon bringing the stethoscope close to the heart region of the doll . the electronic device including a sensor and signal generators for activating a sound device and a light device in response to the sensor sensing pulse beats of a user .

as mentioned hereinabove , the present inventors have previously reported the flavor enhancement properties of an sts preparation ( at a 60 ° bx concentration ). this natural , additive - free product contains significant amounts of sugars ( fructose and glucose together account for about 37 - 39 % of the total weight of the sts ) and free amino acids ( approximately 8 . 5 %, of which 2 . 5 % is glutamic acid ). the process for producing sts ( at a concentration of 60bx ) is described in u . s . pat . no . 6 , 890 , 574 , which is incorporated in its entirety into the present disclosure . briefly , tomatoes are processed ( as described in u . s . pat . no . 5 , 837 , 311 , in order to obtain two fractions — an sts - rich tomato serum and a pulp . following heat treatment , the serum is then concentrated to a brix level higher than 4 . 5 °, for example 60 ° bx ( or any other desired bx strength ). this concentration step is commonly performed using a continuous evaporator , by means of feeding said evaporator with a continuous stream of serum at an elevated temperature , usually for a period of greater than 20 minutes , under vacuum . it is to be noted that the clear ( i . e . non - opaque ) property of the sts ( which relates to the absence of insoluble tomato solids ) is apparent only when it is diluted to brix value of about 4 . 5 ° bx . at higher bx levels ( including the 60 ° bx level as used in the sts of the examples of the present invention ), the product is opaque . the process of preparing sts described hereinabove yields at all bx values , a liquid product that is suitable for addition ( at , for example , 60 ° bx ) to liquid based foods and beverages . however , in order to incorporate the sts into solid food products ( in particular , into snack foods such as potato crisps ) a powdered form has been developed by the present inventors . this powdered form is produced by drying the sts ( by means of either spray drying on a suitable carrier such as maltodextrins ( as described in co - owned u . s . pat . no . 6 , 890 , 574 ), or by using any other suitable dehydration step that is well known to the skilled artisan in this field ). in this powdered preparation ( as used in the present invention ), the water in the sts 60 ° bx ( approximately 50 %) is substituted with maltodextrins . it has unexpectedly been found by the present inventors that the powdered form of sts may be used to partially reduce the level of salt normally used to flavor potato crisps and other food products , thereby reducing the total salt concentration in said products . furthermore , by carefully selecting the relative amounts of sts and salt , products having flavor properties very similar to those containing the regular salt level products ( i . e . equivalent levels of saltiness without the significant addition of tomato - derived flavors ) may be obtained . the use of the powdered form of the sts to partially replace the salt in potato crisps is described in example 1 , below . as mentioned hereinabove , the present inventors have now found that it is necessary to control certain properties of the sts within defined ranges in order to achieve optimal salty - taste enhancing characteristics . these properties include titratable acidity , formol number and color intensity . it is to be noted that the sts compositions having properties that fall within these ranges also possess other flavor - enhancing properties . however , it has been further found by the inventors that when said properties of the sts compositions fall within other defined ranges , said compositions possess flavor enhancing properties only ( i . e . they lack the specific ability to replace or partially replace salt ). the extensive investigations carried out by the inventors have led them to define the following ranges for the aforementioned properties : these defined numerical ranges now permit , for the first time , the manipulation of the indicated properties of sts in order to pre - determine the type of flavor enhancement that is to be obtained using sts - containing compositions . titratable acidity is a measure of the content of acids determined by titration with sodium hydroxide solution to a ph - value of 8 . 1 , the measurement of titratable acidity is well known in the art , and the details of one commonly used method may be found in the protocol ( reference number ifuma03 ) published by the international federation of fruit juice produce ( paris , france ; obtainable on - line at http :// www . ifu - fruitjuice . com / index_commande . php ). the titratable acidity determined by this method ( expressed in units of mmoles of h + per liter ) may be converted to the equivalent of citric acid by means of multiplying the titratble acidity value mentioned above by the specific conversion factor for citric acid , 0 . 064 , thereby yielding a result expressed in grams per liter . the determination of formol number ( a measure of the number of amino acid groups ) is also well known to all skilled artisans in the field . the method is based on titration of amino acids with formaldehyde in the presence of potassium hydroxide , in accordance with the following reaction : 1 ) neutralisation of titratable acidity by means of an end point titration at ph 8 . 2 with naoh 0 . 1 eq / 1 2 ) addition of an excess of formol ( hcho ) to the solution . this operation locks the nh 2 groups of amino acids due to the decrease in ph and allows titration of the cooh groups of amino acids with an end point titration at ph 8 . 2 3 ) second endpoint titration at ph 8 . 2 to determine total amino acid content . the details of one commonly used standard method for determining the formol number may be found in the protocol ( reference number ifuma30 ) published by the international federation of fruit juice produce ( details given above ). a color intensity value (√ a 2 + b 2 ) which may be used as a browning evaluation index may be calculated directly using the software associated with most modern tristimulus colorimetric devices ( e . g . the hunterlab type colorquest xe colorimeter ). the titratable acidity and the formol number of the sts may be influenced by means of selecting tomato strains having fruit that yield sera having these factors within the desired range . thus , in one preferred embodiment , the sts may be prepared from a tomato serum having an acidity level within the range of about 0 . 25 % to about 0 . 33 %, and a formol number of at least 40 ( at a concentration of 5 ° brix ). tomato strains suitable for preparing such sera include ( but are not limited to ): additional factors which may influence the titratable acidity and the formol number of the sts include the growth conditions use to cultivate the tomato plants ( including climate , soil type etc .). these factors are well known to the skilled artisan in this field and may be advantageously selected or altered in order to obtain tomatoes that yield serum having the desired acidity . further refinement of the acidity and formol number of the sts may also be achieved by blending sera obtained from two or more different strains . in addition to the selection of tomato strains yielding serum having the desired formol number , it is important to carefully control the exposure of the serum and of the sts prepared therefrom to heat during processing and storage , in order to prevent an undesirable reduction in said formol number . the browning evaluation index ( color value ) of the sts may similarly be controlled , such that said index has a value of 20 or less , by means of avoiding excessive exposure of the tomato serum to high temperatures with a combination of long time during sts preparation . this reduction in exposure to high temperature with a combination of time may be achieved by means of selecting tomato strains yielding serum having higher brix levels . in this way the evaporation ratio ( i . e . the ratio between the final concentration of the sts — usually 60 ° bx — and the concentration of the serum prior to evaporation ) is reduced . in such a situation , less harsh conditions of temperature and time may be used in order to obtain the final desired concentration . in one preferred embodiment , the evaporation ratio is not greater than 15 . in a still more preferred embodiment , the evaporation ratio is not greater than 10 . as already mentioned , sts ( in either its powdered or liquid forms ) may be used to replace the salt in many different products . the following non - exhaustive , non - limiting lists provide examples of such products : food products in which the salt may be partially replaced by powdered sts : 1 potato chips and / or crisps ( salted or seasoned , with or without added oil ) 2 . baked snacks ( salted and seasoned , with or without added oil ) 3 . fried snacks ( salted and seasoned , with or without added oil ) 4 . extruded baked and fried snacks ( salted and seasoned , with or without added oil ) food products in which the salt may be partially replaced by liquid sts : 1 . baked snacks ( salted and seasoned , with or without added oil ) 2 . fried snacks ( salted and seasoned , with or without added oil ) 3 . extruded baked and fried snacks ( salted and seasoned , with or without added oil ) the following examples are provided for illustrative purposes and in order to more particularly explain and describe the present invention . the present invention , however , is not limited to the particular embodiments disclosed in the examples . 1 . unsalted potato crisps ( walkers — smith uk ) were purchased in a local supermarket . a . 0 . 75 g salt ( 1 . 5 % in finished product )= reference . b . 0 . 625 g salt + 0 . 125 g sts . ( 1 . 25 % salt in finished product ) c . 0 . 5 g salt + 0 . 25 g sts . ( 1 % salt in finished product ) d . 0 . 325 g salt + 0 . 325 g sts ( 0 . 75 % salt in finished product 3 . a series of 50 g batches of crisps were put in a laboratory - scale conical tumbler and heated with an electric heat gun for 30 seconds . 4 . the appropriate salt and powdered sts blends were sprinkled onto each batch of the heated crisps while tumbling for 2 . 5 minutes . 5 . an internal taste panel was conducted in order to compare crisps flavored with the various salts and sts blends . the results are presented in the following table : the results of this study indicate that a salt reduction in potato crisps of up to about 50 % may be achieved with minimal taste change , by the addition of powdered sts to the seasoning . furthermore , salt reduction in said crisps of up to about 33 . 3 % may be achieved with no loss whatsoever of saltiness in the product . partial replacement of salt in barbecue ( bbq ) flavored potato crisps by powdered sts 2 . the following basic bbq seasoning composition was used in this study : 3 . the bbq seasoning was blended with powdered sts as follows : 4 . 50 g batches of crisps were heated in a microwave oven for 30 seconds . 5 . the batches of warm crisps were placed in plastic bags . 6 . 10 % ( w / w ) of the blends 1 - 4 were sprinkled on the potato crisps with the seasoning blends as follows : 8 . an internal taste panel was conducted in order to compare crisps flavored with the various salt and sts blends . the results are presented in the following table : the results of this study indicate that a salt reduction in potato crisps of up to about 50 % may be achieved with minimal taste change , by the addition of powdered sts to the seasoning . furthermore , salt reduction in said crisps of up to about 33 . 3 % may be achieved with no loss whatsoever of saltiness in the product . breads generally contain about 1 . 5 - 2 % salt . the purpose of this study was to reduce the salt level in bread by substituting part of the salt with liquid sts . mix the ingredients until a uniform mix is formed . remove portions of the dough and allow them to rest for 5 minutes . knead the dough by hand and flatten it with a rolling pin . roll the dough and put in baking dish and in warm chamber ( 40 ° c .) for 35 minutes until it doubles its volume . pre - warm a baking oven to 220 ° c . and place the baking dish , lower the temperature to 180 ° c . and bake for 35 minutes . remove the bread from the baking dish and place it on a steel net to cool . partial replacement of salt in roasted sunflower and pumpkin seeds by liquid sts roasted sunflower and pumpkin seeds , which are consumed as a snack food product in many countries , generally contain about 1 . 5 - 2 % salt . the purpose of this study was to partially replace the salt in these seeds by liquid sts . 1 . fresh de - hulled sunflower and pumpkin seeds were purchased in a local supermarket . 2 . salt and water or / and liquid sts were blended and sprayed on the seeds using a conical laboratory tumbler as follows : a . 1 . 6 % salt in finished product − 6 . 2 % of saturated ( 26 %) salt solution = reference . b . 33 % less salt with liquid sts − 6 . 2 % of a salt ( 17 . 5 %) and liquid sts ( 8 . 5 %) solution . c . 50 % less salt with liquid sts − 6 . 2 % of a salt ( 13 %) and liquid sts ( 13 %) solution . 3 . the seeds were heated and roasted with an electric heat gun for 2 . 5 minutes . 4 . the seeds were cooled in a dish . 5 . the samples were tested by a taste panel effect of sts acidity on salty - taste and flavor enhancement of tomato juice in this study , tomato juice was used as a model for the evaluation of salt and taste enhancement . the basic formulation used had the following composition : two separate batches of sts were selected for use in this study : one having an acidity ( measured as citric acid equivalent ) of 3 . 5 %, while the acidity of the other batch was 2 . 5 %. these two batches , together with a third sample from which the sts ( but not the salt ) was omitted were sampled by a professional taste panel , using a semi - quantitative 1 - 10 scale ( 0 = none ; 10 = extensive ). the results are presented in the following table : it may be seen from the above results that the sts batch with 3 . 5 % acidity resulted in a significantly greater enhancement of the saltiness of the tomato juice than the batch having an acidity of 2 . 5 %. both batches caused a similar , significant enhancement of other flavours (“ overall taste ” and “ tomato flavour ”). effect of sts acidity on salty - taste and flavor enhancement of potato chips four separate batches of potato chips were prepared with different amounts of salt and sts powder , as indicated in the following table . two different sts samples were selected for use in this study : one having an acidity of 3 . 5 % and the other having an acidity of 2 . 5 %. a comparison of these batches with respect to various taste and flavor properties was performed by a panel of professional tasters . scores are given on a 0 - 10 scale which 0 = none , 10 = extensive . as will be seen from these results , the batch that included sts with an acidity of 3 . 5 % performed much better as a salt replacer than the batch having an acidity of 2 . 5 %. both batches caused a similar , significant enhancement of other flavours (“ overall taste ” and “ potato flavour ”). effect of browning and formol number on sts efficacy in salty - taste enhancement and flavor enhancement in tomato juice it has been found that a high degree of browning influences the ability of sts to enhance both salty taste and flavor . this effect is illustrated in the following study that was performed using tomato juice with and without sts . in one of the batches the tomato juice included 1 % browned sts , while another batch included 1 % non - browned sts . the browned sts batch was prepared by exposing the tomato serum used to prepare said batch to an excessively high temperature during the evaporation stage . flavor evaluation was performed by a panel of professional tasters . scores are given on a 0 - 10 scale in which 0 = none and 10 = extensive . the panelists were also asked to indicate their preferred product . preference was scored as percentage against a reference product without sts . in addition , the formol number of each of the sts batches was measured . the results of these tests are shown in the following table : the results indicate that the non - browned sts sample ( i . e . the sample having a color intensity value of 15 or less and a formol number of 45 ) was greatly superior to the browned sts sample with regard to the ability of said samples to cause enhancement of saltiness and of other flavors . while specific embodiments of the invention have been described for the purpose of illustration , it will be understood that the invention may be carried out in practice by skilled persons with many modifications , variations and adaptations , without departing from its spirit or exceeding the scope of the claims .

the present invention is primarily directed to a method for reducing the amount of sodium chloride in a food product without adversely affecting the salty taste thereof , comprising adding soluble tomato solids to said food product and reducing the amount of salt normally added thereto . in a preferred embodiment of this method , the sts used is characterized in having an acidity level , formol number and color intensity within certain defined ranges or with defined minimal / maximal values .

as mentioned above , the composition of the invention is an aqueous solution of between about 1 and about 25 wt % based on water of a complex of alkyl lactam and between about 0 . 08 and about 0 . 25 wt % chlorhexidine free base based on the alkyl lactam . in preferred embodiments , the alkyl lactam is of the formula given above wherein n is an integer having a value of i . an especially preferred embodiment uses n - dodecyl pyrrolidone as the lactam which is complexed with chlorhexidine free base [ 1 , 6 - bis ( p - chlorophenylbiguanido ) hexane ]. especially preferred embodiments involve solutions of between about 0 . 1 % and about 0 . 3 wt % of the lactam - chlorhexidine complex based on water and wherein the complex contains between about 0 . 08 and about 0 . 25 wt % chlorhexidine . the method of the invention broadly contemplates formation of compositions of the invention as defined above by first forming a solution of chlorhexidine free base in the lactam and then adding water to form the composition of the invention . this is preferably done by first heating the lactam to an elevated temperature between about 40 ° c . and about 60 ° c . and then adding the chlorhexidine free base to the heated lactam so that the chlorhexidine free base dissolves in the lactam . during the mixing of the chlorhexidine free base with the lactam , the lactam is preferably maintained at a temperature between about 50 ° and about 60 ° c . it is also within the scope of the invention to mix the lactam with the chlorhexidine at lower temperatures such as room temperature and then heat the resulting mixture to complete dissolution of chlorhexidine in lactam . while varying proportions of lactam and chlorhexidine free base may be used , it is preferred that a solution of chlorhexidine free base in lactam contain between about 3 and about 15 wt . % chlorhexidine based on the total of lactam and chlorhexidine free base used . use of less than about 3 wt . % chlorhexidine free base in the solution with the lactam does not usually result in a significant increase of the water solubility of either the chlorhexidine or the lactam . use of more than about 15 wt . % of chlorhexidine free base requires excessive temperatures to insure complete dissolution in the lactam . when chlorhexidine free base has been dissolved in lactam , preferably in a heated solution as mentioned above , the solution is then mixed with water to form the desired aqueous solution containing both chlorhexidine free base and lactam . it is believed that the chlorhexidine free base and lactam are in the form of a complex and that it is this complex which is dissolved in the water . the non - aqueous solution of lactam and chlorhexidine free base may be mixed with water at elevated temperatures but it is generally preferred to allow the non - aqueous solution to cool to approximately room temperature , e . g . between 70 ° f and about 80 ° f , before mixing with the water . if the mixing occurs at elevated temperature the resulting room temperature aqueous solution may then be allowed to cool to room temperature . in either event , the resulting aqueous solution usually contains small amounts of precipitate which may be separated from the solution , e . g . by being allowed to settle or being filtered out so that the resulting aqueous solution is clear and therefore more suitable for most commercial uses . the clear aqueous solution may have some color , but this is not considered a disadvantage for at least most intended uses . aqueous solution of the invention may be used in a great variety of applications in which the use of either the lactam or the chlorhexidine alone would normally be considered desirable . these may include for instance , uses in germicidal and sterilizing solutions in which chlorhexidine is normally used as well as use in various personal care products in which the use of lactam solvents would normally be considered , such as use as preservatives in cosmetics and toiletries . compositions of the present invention have the advantage that aqueous solutions contain significant quantities of both the chlorhexidine and lactam components and may be made and used without the necessity of the other organic solvents which have in the past been needed for use with these components . by use of the present invention , it is possible to obtain room temperature aqueous solutions in which the lactam is present in water in amounts as great as 200 times the maximum amount normally considered soluble in water . likewise , the chlorhexidine may be present in amounts of as much as 20 times the maximum amount of chlorhexidine normally considered soluble in water . the following examples illustrate preferred embodiments of the invention , but are not intended to limit the scope of the invention . in preferred embodiments , compositions of the invention contain at lease 200 times the maximum amount of lactam normally considered soluble in water and at least about 20 times the maximum amount of chlorhexidine normally considered soluble in water . an aqueous solution of the invention was prepared by the method of the invention using following ingredients : ______________________________________ingredient amount______________________________________n - dodecyl pyrrolidone 90 gramschlorhexidine free base 10 gramswater 400 milliliters______________________________________ the chlorhexidine free base was added to the n - dodecyl pyrrolidone and the mixture was warmed to 45 ° c . with stirring until solution of the chlorhexidine base in the pyrrolidone was completed . the clear solution was then allowed to cool to room temperature . 200 grams of distilled water was then added with constant stirring , which resulted in a very viscous solution in which was dispersed white particulate material . an additional 200 grams of water was added and , after stirring , the resulting solution was allowed to sit overnight . the next morning he resulting room temperature product contained a supernatant , light tan colored liquid and a white precipitate . after filtration to remove the precipitate , the aqueous solution was found to weigh 475 grams and comprised 18 . 5 wt . % n - dodecyl pyrrolidone , 0 . 085 wt . % chlorhexidine base , and 81 . 5 wt . % water . the ph of the solution was 10 . 9 . the white residue weighed 28 grams . the residue was washed with acetone and dried in a vacuum . the dried material weighed 13 . 5 grams of which 5i . 35 % was n - dodecyl pyrrolidone and 48 . 55 % chlorhexidine base . the remaining 0 . 25 wt . % was water . based on a molecular weight of 253 for the n - dodecyl pyrrolidone and 505 for the chlorhexidine base , the dry residue was found to be n - dodecyl pyrrolidone and chlorhexidine base in a molar ratio of 2 to 1 . 5 grams of chlorhexidine base was dissolved in 95 grams of n - dodecyl pyrrolidone maintained in a water bath at 40 ° c . the resulting solution was clear and light tan in color . 10 grams of this solution was then cooled to room temperature and mixed thoroughly with 490 grams of distilled water . only a small quantity of solids precipitated . by ultraviolet absorption analysis , the filtrate contained 0 . 0997 wt . % chlorhexidine ( theory 0 . 1 %), -. 60 wt . % n - dodecyl pyrrolidone ( theory i . 9 %) and 98 . 16 % water ( theory 98 . 0 %). to illustrate the necessity of using an alkyl lactam having at least 10 carbon atoms in the alkyl chain , an attempt was made to practice the invention using n - octylpyrrolidone . in this experiment , 5 grams of chlorhexidine free base dissolved in 95 grams of n - octylpyrrolidone at 40 ° c . the resulting clear solution was allowed to stand at room temperature and remained clear . a 10 gram aliquot sample was mixed with 490 grams of water to give a two layer product . the top layer was 9 . 2 grams of n - octylpyrrolidine and the bottom layer was water . the chlorhexidine free base was precipitated out in the interface of the above layers . from the above examples and description it can be seen that aqueous solutions containing alkyl lactam and chlorhexidine base made in accordance with the invention provide new and highly desirable products which can be used without the presence of organic solvents and which contain far greater amounts of chlorhexidine and lactam than are possible using aqueous solutions of chlorhexidine or lactam alone . such products can , for instance , be used to formulate antimicrobial liquid soap , which will be stable at alkaline ph 8 - 8 . 5 .

solubility of chlorhexidine free base and hydrocarbon substituted lactams in water is substantially enhanced by forming an aqueous solution of a complex of chlorhexidine free base and lactam . this is preferably done by dissolving chlorhexidine free base in lactam and then mixing the resulting solution with water . the resulting aqueous solution contains between about 1 and about 25 wt % of a complex of lactam and chlorhexidine with chlorhexidine being present in amounts between about 0 . 08 and about 0 . 25 wt % based on lactam . lactam used is defined by the formula ## str1 ## wherein n is an integer having a value of from 1 to 3 and r is a linear alkyl radical containing from 10 to 14 carbon atoms .

[ 0026 ] fig1 is a first embodiment of the apparatus for treating and preparing food according to the invention . the apparatus 1 according to the invention comprises a housing 3 in whose front portion a cooking chamber 5 is formed which serves to accommodate food to be treated and / or prepared . the cooking chamber 5 is closed on the side from which it is filled by an apparatus door 7 and is accessible via this door . a spoiler 9 is formed on the side of the cooking chamber opposite from the apparatus door 7 , said spoiler serving to generate an appropriate flow pattern of the gas mixture ( e . g . hot air or vapor ) in the cooking chamber 5 . a gas supply and circulation mechanism 11 is positioned behind the spoiler 9 in a convention manner , said gas supply and circulation mechanism being in the form of a radial ventilation fan 12 according to the embodiment of fig1 . the radial ventilation fan 12 is seated on a shaft 13 , which is the drive shaft of an asynchronous motor 15 . in order to heat up the cooking chamber atmosphere , a heating means 17 is provided around the gas supply and circulation mechanism 11 , said heating means being shown schematically only . according to the embodiment of fig1 this heating means may consist of a plurality of heating pipes ( not shown ) extending , essentially parallel , around the ventilation fan . in order to introduce additional moisture into the cooking chamber , a water supply device 19 is provided that includes a controllable inlet valve 21 . the water supply device 19 opens adjacent to the front vertical section of the radial ventilation fan 12 assigned to the cooking chamber 5 and directed towards the central portion of said radial ventilation fan . furthermore , the apparatus according to the invention includes an air inlet channel 23 and a discharge or outlet channel 25 . the air inlet channel 23 includes a controllable moisture discharge device 27 for discharging moisture from the cooking chamber . according to the embodiment of fig1 the moisture discharge device 27 is in the form of a controllable flap 28 . the controllable inlet valve 21 serves vice versa as a controllable moisture supply device 20 for supplying moisture into the cooking chamber . in the rear portion of the device 1 according to the invention , a computer and control unit 29 is provided . this unit communicates via a first line 31 with the heating means 17 . the computer and control unit 29 further communicates via a second line 32 with a temperature sensor 33 , which detects the temperature of the gas mixture circulated by the radial ventilation fan 12 within the cooking chamber 5 . furthermore , the computer and control unit 29 is connected to a speedometer 35 of the asynchronous motor 15 via a third line 34 . in this embodiment , the unit 29 is able to detect the speed of the asynchronous motor 15 and the temperature of the gas mixture existing within the cooking chamber 5 . [ 0035 ] fig2 schematically shows an alternative embodiment of the device 1 ′ according to the invention , wherein the elements identical to the embodiment of fig1 are designed by identical reference numerals . in view of this , a description of these elements are not necessary . the embodiment according to fig2 differs only by the preferred design of the heating means 18 . the difference is that heating means 18 is in the form of a gas - burner heat exchanger device that preferably includes pipe strands 35 arranged in a triangle . these pipe strands 35 similarly extend substantially around the radial ventilation wheel 12 as in the heating means 17 of fig1 . reference is now made to fig3 where a graphic view of a characteristic line k is shown . this graphic view shows on the horizontal axis increasing values of the temperature t and on the vertical axis increasing values of speed n . the characteristic line k shown in fig3 can be explained as follows : it reflects a certain moisture value , e . g . 30 %, in the gas mixture and shows the relationship between the temperature t of the gas mixture and the speed n of the asynchronous motor 15 . as may be seen , at a constant moisture , the speed increases if temperature increases . reference is now made to fig4 . fig4 shows a graphic view of a plurality of characteristic lines k 1 to k 5 . this view uses the same system of coordinates as in fig3 . the characteristic line k 1 is the lowermost characteristic line and it corresponds to a dry cooking chamber atmosphere or a dry gas mixture . the characteristic line k 1 is detected as follows : apparatus 1 or 1 ′ is heated without adding moisture and thus with ambient air within the cooking chamber 5 . for the area of the apparatus that is being detected , the heating begins at room temperature , i . e . approx . 20 ° c ., and ends at the maximum process temperature . speed values at continuously detected cooking chamber temperatures are also continuously detected and combined to form the characteristic line k 1 , wherein these values are stored as characteristic line k 1 in the computer and control unit 29 . the moisture in the cooking chamber is calculated depending upon the temperature according to the formula the exponent , ( exp ) t , therefore depends upon the temperature . moreover , this exponent also depends on additional parameters that can be taken into consideration and given appropriate weight by the computer and control unit 29 . parameters of this kind are the direction of rotation of the ventilator , the size of the apparatus and possibly also the process of moisturization or de - moisturization of the cooking chamber . the characteristic lines k 2 to k 5 show speed values of the asynchronous motor 15 for different , however constant , moistures . the characteristic line k 2 may for instance correspond to a moisture of 25 %, the characteristic line k 3 may correspond to a moisture of 50 %, the characteristic line k 4 may correspond to a moisture of 75 % and the characteristic line k 5 may correspond to a moisture of 100 %. of course these values do not mean relative humidity but , depending on the temperature , the maximum degree of moisture saturation of the gas mixture . an example will now be given to elucidate the method according to this invention . the cooking chamber 5 is , for instance , at 150 ° c ., which is detected by the temperature sensor 33 , and the speedometer 35 detects a speed of 1440 revolutions per minute in the motor 15 . according to the characteristic line k 1 , a speed of 1420 revolutions per minute corresponds to dry air at 150 ° c . this results in a δn of 20 revolutions per minute . this δn therefore corresponds to a certain moisture that exists in the gas mixture and this moisture value may be displayed accordingly by the apparatus . the present invention also provides a method that controls the moisture level within the cooking chamber 5 . the present invention further provides for a cooking apparatus in which a moisture control of this kind is realized . the moisture value determined according to the above description is compared by the computer and control unit 29 to a moisture value ( target value / actual value comparison ) for moisture control in a corresponding program step . based on the comparison made , the unit 29 operates either the moisture discharge device 27 or the moisture supply device 20 via lines 37 and 38 , respectively . if the moisture is too high for the cooking process , the controllable flap 28 is opened and fresh unmoisturized air flows into the cooking chamber . this air partially displaces the gas mixture located in the cooking chamber 5 via the outlet channel 25 and thereby reduces the moisture in the cooking chamber 5 . if , according to the comparison , the moisture is too low , the controllable water supply means 19 is operated via the line 38 and water is sprayed into the ventilation fan , whereby the moisture in the cooking chamber 5 is immediately increased . the present invention is not restricted to the embodiments shown . the gas supply and circulation mechanism 11 may also be mounted on the side instead of in the back of the apparatus . the spoiler 9 may extend perpendicular to the door . the discharge channel 25 may also be formed as a separate channel . furthermore , the unit 29 may also be arranged laterally in the apparatus . it is evident that many other alternatives , modifications and variations will be apparent to those skilled in the art . accordingly , this invention is intended to embrace all such alternatives , modifications and variations that fall within the spirit and broad scope of the appended claims . thus , an extremely efficient method of detecting the moisture in an apparatus for treating and preparing food is provided by the present invention , as well as an especially simple solution for achieving an apparatus for treating and preparing food by means of which optimal cooking processes are obtained .

the present invention refers to a method of detecting the moisture in an apparatus for treating and preparing food , as well as to a method of treating and preparing food . in the method according to the invention , the current temperature values and speed values of the asynchronous motor driving a gas supply and circulation mechanism are compared to at least one characteristic line which is stored in a computer , and the current moisture in the gas mixture is determined from the deviation δn of the measured speed from the speed of the stored characteristic line . the present invention also comprises an apparatus for treating and preparing food that , in particular , serves to carry out the method of determining the moisture in a gas mixture .

fig1 , 2a , 3 , and 4 depict embodiments and views of an exercise apparatus 100 , such as a stair climber or stepper , having an air support system to assist fluid stepping motion performed by a user . in these figures the exercise apparatus 100 includes a housing 110 , one or more treadles 120 , one or more pivots 130 , one or more bellows 140 , one or more knobs 150 , and one or more displays 160 . the housing 110 includes a front section 112 , a back section 116 , and a middle section 114 located between the front section 112 and the back section 116 . the back section 116 contains or partially contains an air support system and / or components of the air support system , such as bellows 140 . bellows 140 include a top portion 142 and a bottom portion 144 . in the present embodiment of the invention , the back section 116 of the housing 110 is coupled to bottom portion 144 of bellows 140 . in use the bellows 140 deliver pressurized air , or an alternate fluid such as a gas , in a controlled quantity from an air transport pathway to the treadles 120 . in the present embodiment , the bellow 140 includes a deformable container and a nozzle or outlet located at the top portion of the bellow 140 . when a force is applied to a top portion 142 of the bellow 140 , via the vertical motion of the user applied to a treadle 120 , the size of the bellow 140 decreases and air escapes through the outlet . this fluid transfer provides a supporting force to the treadles 120 attached to the bellow 140 . an inlet is located at a bottom portion 144 of the bellow 140 and coupled to an air transport pathway to facilitate the intake of air into the bellow 140 . the bellows 140 is part of an air support system at least partially contained by the housing 110 . this air transport system is discussed in greater detail herein . the front section 112 of housing 110 contains or partially contains pivots 130 . in the present example , the front portion 112 of the housing 110 serves to couple to pivots 130 to allow for the clockwise and counterclockwise movement of pivots through a predetermined range . this desired movement facilitates a substantially vertical movement of treadles 120 , which are coupled to the pivots 130 . furthermore , the housing 110 includes and / or contains one or more knobs , such as the knob 150 . knob 150 serves to allow the apparatus user to adjust and control a valve or valves within the bellows 140 transfer components of the air support system contained , at least in part , within the housing 110 . as shown , the treadles 120 are attached to the pivots 130 . the treadles 120 are configured to receive an appendage of user , in this case a foot , and may be sized or shaped accordingly . in some examples , the treadles include various tread patterns and / or are sized or shaped to accommodate a foot , such as the right foot or left foot of a user of the exercise apparatus 100 . while the present embodiment serves to receive a foot of a user , one of ordinary skill in the art will readily recognize the application of the present invention for use with a hand of a user . in the embodiment of fig2 , the treadles 120 include back portions configured to attach to top portions of bellows 140 and front portions configured to attach to pivots 130 . in the embodiment of fig2 a the back portions 116 form other mechanisms that facilitate a rotation or lateral movement of the treadles 120 . the treadles 120 are attached to the pivots 130 and / or the bellows 140 such that they provide an angled reception surface for a foot of the user when the apparatus is in resting position . the angled attachment may be modified by the user based on the desired comfort angle . in one embodiment , the treadles 120 are angled toward the front section 112 of housing 110 , with the rear of treadles 120 at a higher elevation than the front of treadles 120 . according to various embodiments this angled surface is accomplished by attaching treadles 120 to angled pivots 130 , angled bellows 140 , or multiple bellows 140 , or by pressurization of bellows 140 . fig2 illustrates a top view of the exercise apparatus 100 having an air support system . as appears in fig1 , the exercise apparatus 100 includes a housing 110 , one or more treadles 120 , one or more pivots 130 , one or more bellows 140 , one or more knobs 150 , and one or more displays 160 . the housing 110 , comprised of front section 112 , a back section 116 , and a middle section 114 , contains a knob 150 or other control mechanism ( s ), electronic or manual , that control , adjust , modify , and / or otherwise operate one or more valves within an air support system contained within the housing 110 . knob 150 serves to facilitate controlling a valve to increase an amount of air taken in by a bellow 140 , to decrease an amount of air taken in by a bellow 140 , and to modulate between the two . as shown , knob 150 includes predefined setting increments 200 for establishing a certain pressure calibrated to a desired resistance . while four predefined settings are apparent in the present embodiment , one of ordinary skill in the art will readily recognized that any series of control mechanisms may be employed through a range for a myriad of resistance settings as is known in the art . the housing 110 contains a display 160 , such as a digital display 208 that provides information and / or data about an exercise workout sequence performed by a user with the exercise apparatus 100 . the display 160 , and associated computing system , is capable of tracking and presenting information associated with a number of steps taken during a workout , a duration of a workout , a number of calories burned during a workout , an estimated distance traveled during a workout , a range of values associated with a degree of difficulty of a workout , and so on . display 160 further includes a status button 202 , including an indicator light . status button 202 serves to perform multiple functions such as the ability to reset the computing system , enter user data , etc . one of ordinary skill in the art will appreciate that the exercise apparatus may include other components and / or devices not shown in the present embodiment , such as a body cord attachment component that facilitates attachment of a body cord to the housing 110 . such body cord attachment , may also allow the transmission of data related to the user exercise regimen to monitor the exercise workout , store data related to the exercise workout , etc . fig2 a shows another embodiment which is a variation of the embodiment in fig2 . in the embodiment of fig2 a , each treadle 120 includes an upper reception pedal 206 and a lower support pedal 204 both attached to the pivot 130 for vertical movement of the treadle . in each treadle 120 the upper reception pedal 126 lies in one plane and the lower support pedal 124 lies in a plane substantially parallel to the plane of the upper reception pedal . in each treadle 120 one of upper reception pedal 206 and lower support pedal 204 is fixed and the other one of upper reception pedal 206 and lower support pedal 204 is rotatable , relative to the pivot 130 , in its own horizontal or near - horizontal plane . this allows the pedals 204 and 206 to move substantially lateral to each other . in the embodiment shown of fig2 a , the upper reception pedal 206 of a treadle 120 is fixed and the lower support pedal 204 of the same treadle 120 is movable to the right . in another embodiment the upper reception pedal 206 of a treadle 120 is movable and the lower support pedal of the same treadle 120 is fixed . such substantially horizontal movement of the reception pedals 206 or substantially horizontal movement of the support pedals 204 permits the back ends 124 in each treadle 120 to separate and come together rotationally and thereby to allow for a narrow user stance or a broad user stance as desired by the user for the user &# 39 ; s comfort . further , such horizontal lateral movement between upper reception pedal 206 and lower support pedal 204 facilitates alternate muscle toning capabilities for the user . fig3 is a front view of the exercise apparatus 100 having an air support system and uses the same reference numerals as in fig1 . in fig3 the exercise apparatus 100 includes a housing 110 , one or more treadles 120 , one or more pivots 130 , one or more bellows 140 , one or more knobs ( not shown ), and one or more displays 160 . in the embodiments shown , the housing 110 is manufactured of substantially rigid material to sustain the forces applied by a user of various weight ranges . further , the housing 110 is substantially weighted to control movement of the exercise apparatus 100 while in use . as one of ordinary skill in the art will readily recognize , a workout regimen by a user of a “ stepping device ” places substantial forces at various angles and such a device must be able to withstand such applied forces , and to some degree counter such forces , while minimizing the travel of the housing 110 on the surface on which the exercise apparatus 100 stands . in addition to substantial weighting of the exercise apparatus 100 , an embodiment of the invention involves using appliqués on the bottom of the housing 110 for use on a rough flooring such as a carpeted flooring , and another embodiment involves attaching suctioning devices to the bottom of the housing for use on a smooth surface flooring such as a wooden floor , to increase the static friction of the exercise apparatus 100 depending on the surface on which the exercise apparatus 100 stands . fig4 depicts a side view of the exercise apparatus 100 having an air support system . in the present embodiment , exercise apparatus 100 is shown in an “ active state ”. here a first force 410 is applied to a treadle 406 ( corresponding to a treadle 120 ) connected to the pivot 130 , for example by a user &# 39 ; s foot ( not shown ). this force compresses bellow 408 ( corresponding to a bellow 140 ) and forces fluid transfer of air through an air support system . the transfer of air from bellow 408 results in an increased pressure in bellow 404 ( also corresponding to a bellow 140 ) and produces an upward force , or support force , to raise a treadle 402 ( also corresponding to a treadle 120 ) connected to the pivot 130 . this effectively creates an upward force on the user &# 39 ; s other foot ( not shown ). in turn , once a user of exercise apparatus 100 applies a downward force to treadle 402 , bellow 404 will compress and transfer air through the air support system to bellow 408 thereby raising treadle 406 . such transfer of force mimics the repetitious “ stepping ” action desired . while two bellows integrated as part of an air compression system are disclosed , it is readily apparent that independent bellows may be employed . further detail of the air support system of the exercise apparatus appears in fig5 . this figure shows a schematic diagram of an air support system 500 having angled support bellows . the air support system 500 includes bellows 140 having top portions attached to treadles 120 of an exercise apparatus and bottom portions attached to the housing 110 of the exercise apparatus 100 . the air support system 500 supports movement of treadles 120 of the exercise apparatus , providing a one - or two - dimensional support force to a treadle as the treadle moves down towards the housing 110 of the exercise apparatus . that is , the air support system may receive a force at a first treadle of the exercise apparatus ; and transfer the received force to a second treadle of the exercise apparatus , such as via an angled bellow or multiple bellows , thereby facilitating application of a targeted and / or two - dimensional force on a treadle moving downwards or upwards during operation of the exercise apparatus . the air support system 500 also includes a sealed air transfer pathway , conduit , or component 510 that contains air 525 and a valve 520 that controls the flow of air within the air transfer pathway 510 . in the present embodiment , the air transfer pathway 510 is coupled to an inlet component of a bellow 140 , which facilitates the input of air 525 from the air transfer pathway 510 to the bellow 140 . in some embodiments , the air pressure within the bellows 140 and / or air transfer pathway 510 are controlled by the valve 520 , which is connected to a knob , such as the knob 150 , to regulate resistance and calibrate the exercise apparatus , or other component of the housing 110 . this enables a user to adjust the valve 520 and the air pressure within the bellows 140 . in the present embodiment , the air transfer pathway 510 facilitates the transfer of forces between treadles 120 , such as between a right treadle and a left treadle . that is , a downward force received at a right treadle , such as a force caused by a foot of a user stepping down on the right treadle , may cause air 525 to leave an associate bellow 140 , travel through the air transfer pathway 510 , and apply a support force , such as a two - dimensional force , to the left treadle . in some embodiments , the bellows 140 are configured and / or positioned at an angle θ i with respect to a vertical axis v of the housing 110 of the exercise apparatus . that is , a bellow or bellows 140 are positioned such that an angle θ formed between a longitudinal axis l of a bellow 140 and the plane of the housing 110 of the exercise apparatus 100 is less than 90 degrees . in some cases , the angle θ is an acute angle , such as an angle between 90 and 60 degrees . in these embodiments , the bellows 140 are configured such that a longitudinal axis l of the right bellow and a longitudinal axis l of the left bellow intersect one another . in one embodiment of the present invention , the intersection of inner angle θ i is 45 degrees or less . the angled bellows 140 provide various targeted support forces to treadles 120 , such as support forces having vertical and horizontal components . for example , an angled bellow facilitates application of a first dimensional component of a support force and a second dimensional component of the support force to a treadle , among other things . although shown in fig5 as being at a fixed angle , according to an embodiment , the angle of attachment of the bellows 140 is adjustable . for example , the treadle 120 includes a coupling component that facilitates user adjustment of the angle θ of one or both bellows 140 . thus , a user may wish to make adjustments during a workout , by changing the angle of one or both bellows 140 to enhance comfort , target certain muscles . additionally and / or alternatively , in some embodiments the air support system may support treadles of an exercise apparatus via two or more bellows , such as bellows 140 . fig6 is a schematic diagram of an air support system 600 having multiple support bellows . the air support system 600 includes outer bellows 610 coupled to outer portions of treadles 120 and inner bellows 620 coupled to inner portions of the treadles 120 . the outer bellows 610 are coupled to a first air transfer pathway 630 that contains a valve 632 and compressed air 635 . similarly , the inner bellows 620 are coupled to a second air transfer pathway 640 that contains a valve 642 and compressed air 645 . in an embodiment , the outer bellows 610 are taller and expand to a greater degree than the inner bellows 620 . this allows an attached treadle 120 to provide an angled support surface , among other benefits . in some embodiments , the first air transfer pathway 630 is set at a higher pressure than the second air transfer pathway 640 . in some embodiments , the first air transfer pathway 630 is set at a lower pressure than the second air transfer pathway 640 . a knob , such as the knob 150 , of the housing 110 controls valve 635 and / or valve 645 , in order to adjust the air pressure within one or both air transfer pathways 630 , 640 . thus , in alternate embodiments , use of two or more bellows 610 , 620 facilitates the application of targeted support forces , such as a first force at an outer portion of a treadle and a second , optionally different , force at an inner portion of the treadle . these targeted support forces provide enhanced support and / or comfort for a user of an exercise apparatus , and provide a modified or targeted workout , among other benefits . in some embodiments , two or more bellows are positioned to provide support at various locations along a treadle . fig7 shows a side view of an exercise apparatus 700 having multiple support bellows . the exercise apparatus 700 includes a back bellow 710 located at a back portion 116 of a housing 110 and a middle bellow 720 located at a middle portion 114 of the housing 110 . as discussed with the air support system 600 , the exercise apparatus 700 may include two or more air transfer pathways , each associated with a set of bellows , such as back bellows 710 and / or middle bellows 720 . during use of the exercise apparatus 700 , the back bellows 710 provide a first support force to treadles , and the middle bellows 720 provide a second , and different , support force to the treadles . for example , the back bellows 710 may provide a support force that is lower than a support force provided by the middle bellows 720 . the variable support forces may provide enhanced comfort to a user , may provide a workout targeted to specific muscle groups , such as muscle groups within a user &# 39 ; s legs , among other benefits . in some embodiments , an exercise apparatus , such as exercise apparatus 100 or 700 , utilizes a support system that relies on fluids other than air to provide support to a user of the exercise apparatus . in one embodiment a fluid support system includes a hydraulic fluid and / or other compressible or incompressible fluids . various embodiments of an exercise apparatus having an air support system are described . in some embodiments , the exercise apparatus provides targeted support to a user of the exercise apparatus via angled bellows and / or multiple bellows , among other things . as shown , embodiments of the exercise apparatus take the form of a climbing or stepping apparatus , which employs a targeted air support or resistance system . in some implementations , the exercise apparatus includes an air support system configured to provide two - dimensional supporting or resistance forces during use of the exercise apparatus . depending on the particular embodiment disclosed , a single bellow configured to support a single treadle of the exercise apparatus is positioned and / or attached at various angles . such configuration serves to facilitate the application of two - dimensional forces to the treadles . in alternate disclosed embodiments , two or more bellows configured to support treadles of the exercise apparatus are positioned and / or attached to the treadles . in an embodiment the bellows are attached next to one another at one section of a treadle , and / or in another embodiment are attached next to one another along the length of the treadle . this facilitates the application of two - dimensional forces to the treadles . thus , the present apparatus or device described herein provides targeted support to a user of an exercise apparatus . such targeted support offers improved or enhanced support to the user during exercise , to assist in exercising certain muscle groups , to adjust or modify a workout . a detailed description of the aforementioned embodiments of the present invention is disclosed . however , techniques of manufacture and resulting structures in accordance with the present invention may be embodied in a wide variety of forms and modes , some of which may be quite different from those in the disclosed embodiment . consequently , the specific structural details disclosed herein are merely representative , yet in that regard , they are deemed to represent suitable implementations for purposes of disclosure and to provide a basis for the claims herein , which define the scope of the present invention . the above presents a detailed description of several examples of the present invention . moreover , well known methods , procedures , and substances for both carrying out the objectives of the present invention and illustrating the preferred embodiment are incorporated herein but have not been described in detail as not to unnecessarily obscure novel aspects of the present invention . the figures of various implementations set forth in the illustrations serve for an understanding of the present invention and objectives other than those set forth above . although the shown implementations illustrate certain aspects of the present invention , the apparatus and method of use of the invention , in general , together with further objectives and advantages thereof , may be more easily understood by reference to the drawings , examples , and the above description . the examples and figures are not intended to limit the scope of this invention , which is set forth with particularity in the claims as appended or as subsequently amended , but merely to clarify and exemplify the invention . the invention contrasts with other air compression systems that provide minimal operational improvement over mechanical based support systems in other exercise apparatuses . generally , such air compression systems merely facilitate up and down motion of a user . while certain aspects of the device are presented below in certain claim forms , the inventor contemplates the various aspects of the system in any number of claim forms . accordingly , the inventor reserves the right to add additional claims after filing the application to pursue such additional claim forms for other aspects of the system . unless the context clearly requires otherwise , throughout the description and the claims , the words “ comprise ,” “ comprising ,” and the like are to be construed in an inclusive sense , as opposed to an exclusive or exhaustive sense ; that is to say , in the sense of “ including , but not limited to .” as used herein , the terms “ connected ,” “ coupled ,” or any variant thereof , means any connection or coupling , either direct or indirect , between two or more elements ; the coupling of connection between the elements can be physical , logical , or a combination thereof . additionally , the words “ herein ,” “ above ,” “ below ,” and words of similar import , when used in this application , shall refer to this application as a whole and not to any particular portions of this application . where the context permits , words in the detailed description using the singular or plural number may also include the plural or singular number respectively . the word “ or ,” in reference to a list of two or more items , covers all of the following interpretations of the word : any of the items in the list , all of the items in the list , and any combination of the items in the list . the term “ air ” as used herein is intended to include not just air but any gas . thus , there has been summarized and outlined , generally in broad form , a plurality of the most important features of the present invention . while this summary is presented so that the novelty of the present contribution to the related art may be better appreciated , it will further be apparent that additional features of the invention described hereinafter ( which will form the subject matter of the claims appended hereto ) will further define the scope , novelty , and in certain instances the improvements upon any existing art . the above description provides specific details for a thorough understanding of , and enabling description for , various examples of the technology . one skilled in the art will understand that the technology may be practiced without many of these details and it is to be readily understood that the invention presented herein is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the various figures integrated and categorized herein . for example , in some instances , well - known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the examples of the technology . it is intended that the terminology used in the description presented below be interpreted in its broadest reasonable manner , even though it is being used in conjunction with a detailed description of certain examples of the technology . although certain terms may be emphasized below , any terminology intended to be interpreted in any restricted manner is overtly and specifically defined as such in this detailed description section . those skilled in the art will appreciate that the disclosure of the present invention may readily be utilized as a basis for forming other similar structures , methods and systems for carrying out the various purposes and objectives of the present invention . thus , the claims as set forth shall allow for such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention as described herein .

an exerciser , preferably in the form of a stepper with a fluid resistance system guides stepper treadles angularly downward and outward from the center of the stepper . according to an embodiment bellows that support treadles angle downward and outward .

the present invention relates to a system for attaching suction cup devices to a shower / bathtub wall , then connecting shower accessories to the devices . this will allow each member of the family to individualize his / her needs as they relate to height , or bristle stiffness ; and , more specifically the type of device , whether it be brush , rollers , sponge or cloth . referring now specifically to the drawings , the system of the present invention is shown in fig1 and includes a suction cup device , designated by reference numeral 14 and a removable shower accessory designated by numeral 23 . the cup device 14 is normally mounted to a vertical surface 15 such as a wall , or even a board that may be permanently or removably mounted to the wall . the cup device 14 is a one piece , all rubber construction comprising a basically conical cup 16 , which defines an empty chamber 30 , said cup 16 having a large opening 22 defined by a perimeter edge 31 . the conical cup is integral with a concentric base 17 , the base further having an elongated , concentric connector 19 . the rubber material of the conical cup 16 is very pliable and is thinnest at the large opening 22 . the connector 19 has a longitudinally , generally concentric exterior wall surface 21 and has one end integral with the base 17 and a distal end 20 extending outwardly from the device 14 . in this preferred embodiment , the entire suction cup device 14 is manufactured from one rubber material and can be made by an injection molding process . the device when applied to the wall surface will have as a point of air escape , the perimeter edge 31 of the large opening 22 of the conical cup 16 . for an accessory , a brush attachment 23 comprising of a plastic frame 25 and an adapter 24 is described . the adapter 24 includes a concentrically elongated coupling wall 26 which further defines an adapter opening 27 for slipping over the connector 19 resulting in a rotational fitting . although the attaching brush device 23 is shown with bristles 28 , it is to be understood that the attachment could also be a variety of accepted accessories such as sponges , cloth covered materials and massaging balls or rollers . a 360 ° finger hold 18 encircles the base 17 and is helpful when disconnecting the attachment 23 from the device 14 . this allows the attachment to be removed without braking the suction holding the device 14 to the wall . the device 14 and corresponding attachments 23 can be color coded to indicate individual family member ownership and also to various levels of bristle stiffness and other attachment preferences . the connector 19 , in addition to the concentric shape depicted , can also be square , triangular , hexagonal or octagonal which will make the attachment non - rotating ( not shown ). other connecting shapes for the connector 19 are possible such as a round or oval shaped balls ( not shown ). another embodiment of the invention would be to manufacture the cup device 14 out of two different grades of rubber . the suction wall 16 rubber would be very thin , especially at the opening area 22 . it would have a softer consistency and be more moldable , thus allowing it to displace air easier and therefore be easier to move . the base 17 , connector 19 and finger hold 18 would be made from a more durable , less deforming rubber . another modification of the device 14 is shown in fig2 wherein the connector 19 is further equipped with a plurality of concentric rings 32 , 33 , and 34 , deposed on the exterior surface of the connector 19 . the attachment would a female adapter 35 with an inner opening 36 for acceptance of the rings 32 , 33 and 34 . the adapter 35 having three channels 37 , 38 and 39 for cooperatively accepting the rings 32 , 33 and 34 respectively . fig3 depicts another embodiment of the suction cup device 14 . in this embodiment the device 40 has a plastic material substituted for rubber in both the base 17 and in the connector 19 . this plastic material allows for the opportunity to have an integral pressure indicator 42 , which has an internal seal disc 43 on one end ; this seal 43 having two surfaces , a concave surface 44 which will be the sealing surface and a convex surface 45 , which is in a face to face relationship to the wall 15 . when in operation the disc 43 will be propelled in a direction towards the distal end 20 of the connector 19 , the concave surface 44 biasing against the inner wall of the base 17 creates an internal seal , thus giving the device 40 two sealing areas . fig3 a shows a small opening 29 in the distal end 20 of the connector 19 , which is smaller in diameter than the diameter of the pressure indicator 42 and allows for the user to poke a finger into the opening 29 thus breaking the internal seal that is formed when the pressure indicator 42 is biased against the internal inner wall of the base 17 . the embodiment 46 , shown in fig4 is by far the most complex , of the present invention , and although it is probably the most expensive to manufacture , it has the best means for mounting and releasing the suction cup 16 . the cup device 46 includes the hollow pressure indicator 42 but with a plurality of air vent slots 51 defined within the longitudinal , cylindrical surface 49 of the indicator 42 . fig5 and 6 detail these vent slots 51 and their relationship to the seal 43 at one end and the sealing edge 50 , which biases against the distal end 20 of the connector 19 . longitudinally extending and integral with the indicator 42 is a rectangular ridge 52 . this ridge 52 acts in concert with a stabilizer 47 , which is disclosed in fig7 and 8 , to maintain the the pressure indicator 42 in the proper geometric relationship . the stabilizer 47 is generally disc shaped and has two flat surfaces 54 which define between them a central opening 53 and a slotted channel 55 . this slotted channel 55 accepts the ridge 52 of the pressure indicator 42 as the indicator penetrates the stabilizer 47 with the sealing edge 50 , and maintains the proper alignment by seating the ridge 52 within the slot 55 . the central opening 53 has an inner surface 60 defining the opening 53 as it extends through the stabilizer 47 . this inner surface 60 has an air opening hole 56 leading to a cylindrically , elongated , hollow cavity 57 , which is internally treaded 58 . at the outer end of the hollow cavity 57 is a screw opening 59 . this embodiment has an essentially hollow cylindrical vent screw 48 that is illustrated in fig9 a , 9b and 10 . the vent screw 48 has a longitudinal surface 62 which is externally threaded 65 . the vent screw 48 further having two opposite ends , an outer end with a finger grip 61 and a lower end having an aeration opening 63 which is inserted into the screw opening 59 of the stabilizer 47 . defined within the longitudinal surface 62 are a plurality of ventilation holes 64 . when in operation , this embodiment is placed on a wall surface by pressing it with the hand which will cause an escape of air through the perimeter of the cup opening 22 , and another escape of air through an internal seal which was created by the convex seal surface 45 biasing against the sealing surface 54 of the stabilizer 47 , which is now broken . the air will pass through and escape via ventilation holes 64 of the vent screw 48 . when a desired vacuum is created the user will close the vent screw 48 , the internal seal will be made by the outward projection of the pressure indicator 42 , thus causing the seal 43 to be biased against the sealing surface 54 of the stabilizer 47 and also causing the connector sealing end 50 of the pressure indicator 42 to be biased against the inner wall of the distal end 41 of the connector 19 . to remove this embodiment , one has to turn the vent screw 48 to expose the ventilation holes 64 to the atmosphere , thus allowing the air to enter through the stabilizer 47 , then pass through the air vent slots 51 of the pressure indicator 42 to the chamber 30 within the conical cup 16 . also , by the digital depression of the pressure indicator 42 , the internal seal will be broken causing the wall seal at the perimeter of the cup opening 22 to weaken . some lateral physical movement of the hand will help break the wall seal but in this embodiment , very little exertion is required . fig1 , 12 and 13 are environmental views of a plurality of devices 14 which are shown as examples of how the devices 14 can be utilized . fig1 and 12 show a plurality of the devices 14 mounted on a board 66 instead of directly to a wall surface . the board 66 itself can then be removably or permanently affixed to a wall surface . the arrangement as shown in fig1 is strictly a random selection . the present invention anticipates that these devices 14 can be placed in a myriad of numerical configurations and arrangements . each individual member of a family might have his / her own specially designed layout . fig1 depicts a typical cluster type arrangement whereby the devices 14 are interconnected by a connecting means 67 . for example , the cluster could consist of two devices 14 with the connecting means 67 being a cloth covered wooden bar for massaging purposes . another possibility would be hanging a bathroom accessory on the bar . the size of the devices 14 can be varied thus achieving various depths of protuberances from the wall which may therefore accommodate different types of attachments . an example would be to have a shorter extension from the wall for attachments around the buttocks region or longer extensions for those attachments reaching the middle of the back . all these various attachments can be color coded for ease of selection . it is to be understood that the present invention is not limited to the sole embodiment described above , but encompasses and and all embodiments within the scope of the following claims .

an improved system for attaching suction cup devices to bathroom or shower walls . the system includes attachments including brushes , sponges , cloths , massaging items etc ., which are primarily used to aid people in achieving proper bathing hygiene . the suction cups are intended for use individually or in clusters of two or more and are designed for quick connection and removal to any vertical surface .

ready - to - use compositions of cyclosporine for parenteral administration have been described in inter alia ep - b - 0 570 829 . however , further developments of such compositions have been necessary in order to obtain compositions that are bioequivalent to the sandimmune ® product and in order to ensure a proper shelf - life . further developments are directed at ensuring formulations which can both have sufficient stability and shelf - life as to fulfill the requirements for marketing and distribution in commercial pharmaceuticals business while being bioequivalent and using ingredients which are beneficial to therapeutic targets such as mitochondrial metabolism and being non - toxic . in clinical practice , this also means that we can better achieve the goal of e . g . sandimmune ® and thereby ensure that in clinical practice it is possible to avoid the adverse effect of cremophor ® and ethanol and avoid having to premedicate with corticosteroids and / or antihistamines in cases where such pretreatment or multi - pharmacy approach is contraindicated . the present invention provides a cremophor - free cyclosporine composition for parenteral administration , notably intravenous administration . a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) a composition of the present invention has an osmolality in the isoosmolar range , i . e . the osmolarity is in a range of from about 280 mosm / l to about 305 mosm / l , preferably about 295 - 300 mosm / l , which correspond to the value of plasma , i . e . the isoosmolar value . the use of a cyclosporine - containing composition with an isoosmolar osmolality is important in order to ensure a good biocompatibility . many of the known cyclosporine emulsions are hyperosmolar in order to achieve a good penetration through the blood - brain barrier when such compositions are used e . g . in the treatment of stroke . however , cyclosporine emulsions of the invention may also be used in other important therapeutic areas such as , e . g ., in connection with cardiac reperfusion injury and immunosuppression , where the use of a hyperosmolar composition may lead to unwanted entrance into the brain of specific metabolites , substances , blood components etc ., which in turn may lead to toxic or adverse effects , all of which are unwanted . the terms osmolarity , osmolality and tonicity are often used interchangeably . for specific definitions see remington &# 39 ; s pharmaceutical sciences , 18 th edition , mack publishing company 1990 , pages 1481 - 1498 , which hereby is incorporated by reference . a composition of the present invention may also be used in the treatment of traumatic brain injury , where the composition crosses the blood - brain barrier due to breaches therein caused by the brain injury itself and where there is thus no need for a hyperosmolar composition to breach the blood - brain barrier . an isoosmolar composition is highly preferable to a hyperosmolar composition in such indications . the cyclosporine may be any therapeutically active cyclosporine or analogues and derivatives of cyclosporines . the cyclosporine may have immunosuppressive properties or non - immunosuppressive properties ( nicams ), or it may have any other known or unknown effect ( e . g . for cardioprotection or neuroprotection of for treatment in cardiovascular diseases such as myocardial infarction , reperfusion , or in neurodegenerative diseases , brain injury , ischemia , trauma , etc . it is known that cyclosporines have protective effects on mitochondria . preferred are cyclosporines that are suitable for use in immunosuppression . the cyclosporine may be a natural or synthetic cyclosporine . as it appears from the following several chiral carbon atoms are present . thus , any of these forms — either alone or in any combination — that have therapeutic activity are encompassed by the term “ cyclosporine ”. chirality : ciclosporin is a molecule of natural origin that possesses several chiral carbon atoms . egg lecithin and / or soy lecithin , particularly egg lecithin , are preferred as suppliers of phosphatidylcholine , notably 3 - sn - phosphatidyl choline or hydrogenated 3 - sn - phosphatidyl choline . lecithins with a content of more than 60 % of 3 - sn - phosphatidyl choline and / or partially hydrogenated 3 - sn - phosphatidyl choline and / or hydrogenated 3 - sn - phosphatidyl choline are above all suited . an alkali salt of a free fatty acid with 6 to 26 carbon atoms may be added to adjust the ph value or to facilitate the emulsification and homogenization process . the sodium and potassium salts of palmitic acid , palmitoleic acid , stearic acid , oleic acid , linoleic acid and linolenic acid are especially preferred . in a preferred embodiment sodium oleate is employed . as seen from the examples herein , glycerol has been employed to adjust the osmolarity of the composition to isoosmolar . however , other substances like sorbitol , xylitol , sodium chloride , glucose may also prove to be suitable . soy - bean oil or safflower oil or combinations thereof may be employed as natural oils . as it appears from the following , it seems that the presence of an mct - oil is important in order to achieve the desired stability of the emulsion , notably with respect to the physical stability of the emulsion . cyclosporine has a very good solubility in mct - oil and mct - oil thus contributes to avoid undesired precipitation of cyclosporine during storage . moreover , mct - oils seem to have a beneficial effect on the brain , e . g ., there are indications that it may be beneficial in the treatment of alzheimer &# 39 ; s disease and other condition where stabilization protection and support of mitochondrial function is important / needed . mitochondria are present and produce energy in almost all cells in the body . mitochondrial collapse may be associated with a variety of acute injuries , such as myocardial infarctions and traumatic brain injury and chronic diseases like amyothropic lateral sclerosis , multiple sclerosis , and other neurological disorders . in myocardial infarctions , reperfusion of the blocked artery can cause reperfusion injury and extra damage and disability to the heart muscle , as well as increased mortality . mitochondrial protection in heart muscle tissue may moderate the long - term impact of heart attacks . a suitable mct - oil is coconut oil , palm oil or a combination thereof . the water employed must have a quality suitable for parenteral products , such as water for injection ( pharmacopoeia standard ). a suitable method for manufacturing a composition of the invention appears in fig2 and in the examples herein . in all the compositions mentioned herein , the osmolarity is adjusted to the isoosmolar value of about 285 to about 305 mosm / l , preferably adjusted to about 295 to about 300 mosm / l . a cyclosporine in a concentration range of from 1 to 15 g / l , a phosphatidylcholine ( e . g . egg lecithin ) in a concentration range of from 5 to 25 g / l , a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) in a concentration range of from 0 . 1 to 1 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 6 to about 8 . 8 , glycerol in a concentration range of from 10 to 50 g / l , a natural oil ( long chain triglyceride ) ( e . g . soy bean oil ) in a concentration range of from 50 to 150 g / l , medium chain triglyceride - oil in a concentration range of from 50 to 150 g / l , and a cyclosporine in a concentration range of from 1 to 15 g / l , egg lecithin in a concentration range of from 5 to 25 g / l , a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) in a concentration range of from 0 . 1 to 1 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , glycerol in a concentration range of from 10 to 50 g / l , a natural oil ( long chain triglyceride ) ( e . g . soy bean oil ) in a concentration range of from 50 to 150 g / l , medium chain triglyceride - oil in a concentration range of from 50 to 150 g / l , and a cyclosporine in a concentration range of from 1 to 15 g / l , a phosphatidylcholin ( e . g . egg lecithin ) in a concentration range of from 5 to 25 g / l , sodium oleate in a concentration range of from 0 . 1 to 1 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , glycerol in a concentration range of from 10 to 50 g / l , a natural oil ( long chain triglyceride ) ( e . g . soy bean oil ) in a concentration range of from 50 to 150 g / l , medium chain triglyceride - oil in a concentration range of from 50 to 150 g / l , and a cyclosporine in a concentration range of from 1 to 15 g / l , egg lecithin in a concentration range of from 5 to 25 g / l , sodium oleate in a concentration range of from 0 . 1 to 1 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , glycerol in a concentration range of from 10 to 50 g / l , a natural oil ( long chain triglyceride ) ( e . g . soy bean oil ) in a concentration range of from 50 to 150 g / l , medium chain triglyceride - oil in a concentration range of from 50 to 150 g / l , and a cyclosporine in a concentration range of from 1 to 15 g / l , a phosphatidylcholin ( e . g . egg lecithin ) in a concentration range of from 5 to 25 g / l , a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) in a concentration range of from 0 . 1 to 1 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , glycerol in a concentration range of from 10 to 50 g / l , soy bean oil in a concentration range of from 50 to 150 g / l , medium chain triglyceride - oil in a concentration range of from 50 to 150 g / l , and a cyclosporine in a concentration range of from 1 to 15 g / l , egg lecithin in a concentration range of from 5 to 25 g / l , a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) in a concentration range of from 0 . 1 to 1 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , glycerol in a concentration range of from 10 to 50 g / l , soy bean oil in a concentration range of from 50 to 150 g / l , medium chain triglyceride - oil in a concentration range of from 50 to 150 g / l , and a cyclosporine in a concentration range of from 1 to 15 g / l , a phosphatidylcholin ( e . g . egg lecithin ) in a concentration range of from 5 to 25 g / l , sodium oleate in a concentration range of from 0 . 1 to 1 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , glycerol in a concentration range of from 10 to 50 g / l , soy bean oil in a concentration range of from 50 to 150 g / l , medium chain triglyceride - oil in a concentration range of from 50 to 150 g / l , and a cyclosporine in a concentration range of from 1 to 15 g / l , egg lecithinin a concentration range of from 5 to 25 g / l , sodium oleate in a concentration range of from 0 . 1 to 1 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , glycerol in a concentration range of from 10 to 50 g / l , soy bean oil in a concentration range of from 50 to 150 g / l , medium chain triglyceride - oil in a concentration range of from 50 to 150 g / l , and a phosphatidylcholin ( e . g . egg lecithin ) in a concentration of 12 g / l , a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) in a concentration of 0 . 3 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , a natural oil ( long chain triglyceride ) ( e . g . soy bean oil ) in a concentration of 100 g / l , a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) in a concentration of 0 . 3 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , a natural oil ( long chain triglyceride ) ( e . g . soy bean oil ) in a concentration of 100 g / l , a phosphatidylcholin ( e . g . egg lecithin ) in a concentration of 12 g / l , sodium oleate in a concentration of 0 . 3 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , a natural oil ( long chain triglyceride ) ( e . g . soy bean oil ) in a concentration of 100 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , a natural oil ( long chain triglyceride ) ( e . g . soy bean oil ) in a concentration of 100 g / l , a phosphatidylcholin ( e . g . egg lecithin ) in a concentration of 12 g / l , a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) in a concentration of 0 . 3 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , glycerol in a concentration of 25 g / l , soy bean oil in a concentration of 100 g / l , a pharmaceutically tolerable alkali salt of a free fatty acid ( e . g . sodium oleate ) in a concentration of 0 . 3 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , a phosphatidylcholin ( e . g . egg lecithin ) in a concentration of 12 g / l , sodium oleate in a concentration of 0 . 3 g / l , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , optionally , ph adjustment e . g . sodium hydroxide 1 m in a sufficient amount to reach a final ph value of the composition of from about 8 to about 8 . 8 , in all the above - mentioned compositions , the medium chain triglycerides may be coconut oil , palm oil , or combinations thereof . the composition of the emulsion that has been tested in a clinical study was produced according to the following formula ( 300 l batch size ): the mct - oil is coconut oil , palm oil or a combination thereof . as it appears from the experimental section a composition according to the invention , notably , the above - mentioned composition is bioequivalent to the sandimmune ® product , i . e . the concentrate diluted to a ready - to - use composition . the bioequivalence study has been carried out according to well - established guidelines ( emea — european medicines agency , london , january 2010 . guideline on the investigation of bioequivalence , or us department of health and human services , food and drug administration , march 2003 , guidance for industry , bioavailability and bioequivalence studies for orally administered drug product — general considerations ). the study also reveals that a composition according to the invention has a much better safety profile than the sandimmune ® product . thus , without premedication with corticosteroids , in 19 subjects two severe anaphylactic reactions were observed after administration with sandimmune ®, whereas no such reactions were observed after administration in 33 subjects with a composition according to the invention . to sum up from the clinical study the following table shows the adverse effects observed . two serious adverse events ( saes ) were reported . these were anaphylactic and anaphylactoid reactions that occurred after administration of sandimmune ® injection . the proportion of overall adverse effects was significantly higher in the sandimmune ® injection compared to the composition according to the invention . another advantage of a composition of the invention ( besides bioequivalence with sandimmune ® injection and better safety profile than the sandimmune ® injection ) is the excellent stability of the composition . it is currently believed that the presence of medium - chain triglycerides plays an important role in this respect . thus , based on stability studies carried out according to ich guidelines and reported in the examples , the overall conclusion is that a shelf - life of 30 - 36 months when stored below 25 ° c . and protected from light is reasonable . 1 . ready - to - use solution . sandimmune ® injection is marketed as a 50 mg / ml infusion concentrate that has to be drawn up by a syringe and then injected into a larger volume of saline or 5 % glucose . the concentrate solution is highly viscous , especially at room temperature or below , which makes it more difficult to extract and empty to the right amount than with a ready - to - use composition . further , following injection of the infusion concentrate into saline , careful mixing is required to avoid injection of large cyclosporine - containing cremophor ® lumps into the circulation , which also affects the concentration of cyclosporine given early and late in a treatment . 2 . no un - physiological emulsifier . the contents of a composition of the invention are physiological fats and phospho - lipids that can be metabolized by the human body . 3 . no risk of solvent - related severe hypersensitivity reactions , including anaphylactic reactions and death . 5 . eliminates the need for specialized iv tubing required for cremophor ®- containing products ( to prevent leaching of plasticizers ). 7 . no risk of penetration of unwanted substance over the blood - brain barrier . the emulsions of the invention are suitable to use in the treatment of disease where cyclosporine is indicated . examples are immunosuppresive disorders , reperfusion injury ( organ damage ), cardiac reperfusion injuty ( cardioprotection ), kidney reperfusion injury ( nephroprotection ), liver reperfusion injury ( hepatoprotection ), prevention of brain damage ( neuroprotection ). fig2 shows a method for the manufacture of an emulsion according to the invention fig3 shows arithmetic means with standard deviation of blood cyclosporine concentration in participants administered ciclomulsion or sandimmune . n = 52 fig4 shows mean blood cyclosporine concentration with standard deviation in participants administered ciclomulsion ( a ) or sandimmune ( b ) either with or without premedication consisting of 50 mg diphenhydramine orally , 10 mg dexamethasone intravenously and 50 mg ranitidine intravenously . a mixing tank is provided with the appropriate quantity of hot water for injection . all raw materials except the oil components are ground and dispersed in water for injection at 55 - 70 ° c . the suspension is dispersed by means of intense mixing . a solution of pre - heated oil components ( 50 - 60 ° c .) containing dissolved cyclosporine is added . aqueous suspension and oil phase are mixed at 55 - 70 ° c . if necessary , ph adjustment . the preparation of the final emulsion takes place by several homogenization steps . pressures of 400 ± 30 bar ( stage 1 ) and 100 ± 30 bar ( stage 2 ) are applied . the temperature of the emulsion is between 55 ° c . and 90 ° c . between the homogenization steps the emulsion is stored in intermediate storage tanks . depending on the capacity of the used equipment ( homogenizers and vessel ) the emulsion has to be diluted under stirring with the appropriate amount of water for injection . the resulting emulsion is cooled down to a temperature of 15 - 25 ° c . a sample of the final concentration is taken for in - process control and a ph - adjustment may be carried out . the emulsion is filtered through a 10 μm absolute pore size filter . the emulsion is filled under a nitrogen atmosphere into suitable infusion bottles . filled bottles are closed with rubber stoppers and aluminium caps with transparent flip - off caps . the composition of the emulsion that has been tested in a clinical study was produced according to the following formula ( 300 l batch size ): the composition of example 2 was subjected to stability studies in accordance with the ich guidelines . the ciclosporin 5 mg / ml emulsion for injection batch pp0915013 is put on stability at 25 ° c ./ 60 % rh and 40 ° c ./ 75 % rh in accordance with ich requirements . currently 12 months data are available . all results , at both temperatures , are well within specifications . the cyclosporine appears very stable with no decreasing trend . only small amounts of degradation products are found . the following tables summaries the results . a clinical study to compare the bioavailability and pharmacokinetics of cyclosporine cyclosporine is widely used to prevent rejection of grafts after transplantation . the intravenous formulation currently on the market , sandimmune ® injection ( sandimmune ), uses cremophor ® el ( crel ) as emulsifying excipient . crel is known to cause hypersensitivity reactions in some patients , ranging from skin reactions to anaphylactic shock and death . we have assessed the pharmacokinetics and tolerability of a new , crel - free lipid emulsion of cyclosporine , ciclomulsion ®, compared to sandimmune . fifty - two healthy subjects were treated with 5 mg / kg of each of the two formulations of cyclosporine as 4 h intravenous infusion . bioequivalence assessments according to current guidelines were performed . the geometric mean ratios for ciclomulsion / sandimmune ( 90 % confidence interval ) were 0 . 90 ( 0 . 88 - 0 . 92 ) for area under curve ( 0 h to the last quantifiable concentration ) and 0 . 95 ( 0 . 92 - 0 . 97 ) for maximum blood cyclosporine concentration . for all additional variables analyzed , the 90 % confidence intervals were also within the accepted bioequivalence range of 0 . 80 - 1 . 25 . one anaphylactoid and one anaphylactic reaction , both classified as serious adverse events , were reported after treatment with sandimmune . no serious adverse events were recorded after treatment with ciclomulsion . the proportion of overall adverse events was significantly higher for sandimmune . we conclude that ciclomulsion is bioequivalent to sandimmune and exhibits fewer adverse reactions . auc 0 - 4 area under curve for time 0 to 4 hours auc 0 - t area under curve for time 0 to the last quantifiable concentration auc 0 -∞ area under curve for time 0 hours extrapolated to infinity auc 4 - t area under curve for time 4 to the last quantifiable concentration auc 4 -∞ area under curve for time 4 hours extrapolated to infinity cyclosporine ( csa ) is a potent immunosuppressant first registered in 1983 that acts by reducing the function of t - lymphocytes through inhibition of calcineurin . csa is widely used to prevent organ rejection and graft - versus - host disease after solid organ or bone marrow transplantation , and to treat autoimmune conditions such as psoriasis , atopic dermatitis , pyoderma gangrenosum , ulcerative colitis , idiopathic nephrotic syndrome and inflammatory uveitis ( 1 - 7 ). the molecule is highly hydrophobic and requires a lipophilic solvent for administration . the intravenous ( iv ) form of csa currently on the market , sandimmune ® injection ( novartis pharma stein ag , switzerland ) ( sandimmune ), is a preparation with ethanol and polyoxyethylated castor oil , cremophor ® el ( crel ). crel is not inert ( a ) and there have been a number of reports of serious adverse effects after administration of iv csa due to reactions to this carrier medium ( 9 - 16 ). hypersensitivity reactions to crel have also been reported when used for other intravenous preparations of drugs such as diazepam and althesin ® ( 17 - 21 ). in rodents , neurotoxicity , cardiotoxicity and nefrotoxicity due to iv csa dissolved in crel have been demonstrated ( 22 - 25 ) and , in a canine model , crel has been shown to reduce cardiac output and hepatic blood flow in a non - dose - dependent fashion ( 26 ). the effects of crel include complement activation , histamine release and severe hypersensitivity reactions ( 8 , 17 , 19 , 21 ). csa in crel requires a dilution step prior to administration . improper preparation of crel - containing formulations has been reported to cause anaphylactoid reactions ( 27 , 28 ). an additional concern with the use of ethanol and crel is the leaching of plasticizers from polyvinyl chloride ( pvc ) bags and infusion sets used in routine clinical practice . consequently , preparation and administration should be done using glass or other non - pvc infusion sets ( 29 , 20 ). concern about the safety of crel as a carrier medium for iv drugs has been raised on numerous occasions and several drugs that previously were produced in preparations with crel are now available only with other carrying media such as lipid emulsions . known examples are propofol ( 17 , 21 ) and diazepam ( 32 ). others , such as the chemotherapeutic agent paclitaxel , are available both with and without crel as solvent ( 33 ), and the anesthetic drug althesin ® that contained crel is no longer marketed for use in humans ( 17 , 21 , 34 ). in this study , the objective was to assess the pharmacokinetics of a novel crel - and ethanol - free ready - to - use preparation of csa for iv administration , ciclomulsion ® ( neurovive pharmaceutical ab , lund , sweden ), in relation to the crel - containing product currently on the market ( sandimmune ® injection ) and to assess whether the two formulations are bioequivalent . a ready - to - use preparation without crel potentially offers increased patient safety with fewer adverse events due to improper handling or immunological reactions to crel . this was a single - center , open - label , subject - blind , laboratory - blind , single - dose , randomized , two - treatment , two - period , two - sequence crossover study of the pharmacokinetics of two formulations of iv csa . the primary objective was to assess the pharmacokinetics , and the secondary objective to compare the tolerability profiles of the two preparations . the study protocol , including amendments , subject information sheets and informed consent documents , were reviewed by the ethics committee of the faculty of health sciences of the university of the free state ( reference number etovs 65 / 09 ), and by the south african medicines control council ( reference number be 2009009 ), and written approval was acquired . the study was performed in accordance with the declaration of helsinki and guideline for good clinical practice issued by the international conference on harmonization . it was designed to comply with the guidance for industry — statistical approaches to establishing bioequivalence issued by the united states department of health and human services , food and drug administration ( fda ) ( 35 ), and the note for guidance on the investigation of bioavailability and bioequivalence by the european medicines agency ( ema ) ( 36 ). the reference formulation of csa used was sandimmune ® injection ( novartis pharma stein ag , switzerland , 50 mg / ml csa , united states pharmacopeia , usp ) containing cremophor ® el ( each 1 ml infusion concentrate was diluted in 20 ml 0 . 9 % saline solution prior to use ). the test product used was ciclomulsion ® ( neurovive pharmaceutical ab , lund , sweden ) 5 mg / ml ready - to - use cremophor - and ethanol - free cyclosporine ph eur / usp lipid emulsion . each ml of the lipid emulsion contains 100 mg of refined soya - bean oil , 100 mg medium - chain triglycerides , 12 mg egg lecithin , 25 mg glycerol , water , and sodium oleate and sodium hydroxide for ph adjustment . healthy male and healthy , non - pregnant , non - lactating female volunteers between 18 and 55 years of age with a body mass index within the range of 19 - 33 kg / m 2 were eligible . further inclusion criteria were body mass 60 - 100 kg , normal 12 - lead electrocardiogram ( ecg ) and vital signs , clinically acceptable findings in medical history and physical examinations , laboratory results within the reference ranges ( unless the deviation was considered irrelevant for the purpose of the study ), willingness to undergo pre -, interim - and post - study physical examinations and laboratory investigations , ability to comprehend and willingness to sign statement of informed consent , and abstinence from tobacco during and three months prior to study . female participants of childbearing age underwent a pregnancy test prior to each csa dosing and , if positive , were excluded from the study . during the study period , reliable , non - hormonal methods of contraception had to be used . exclusion criteria included evidence of psychiatric disorder , history of or current abuse of drugs ( including alcohol ), use of any medication within two weeks prior to first administration of study medication , participation in another study with an experimental drug with administration within twelve weeks prior to the current study , major illness during the last three months , donation or loss of blood exceeding 500 ml during the eight weeks before the first administration of the study drug , positive test for hepatitis b or c or hiv , positive urine drug screen , vaccination of any kind within four weeks of first dose or planning vaccination within three months of last dose , close family member receiving live vaccine during study or within three months post - study , and hypotension or hypertension during screening period . history of any of the following diseases was also criterion for exclusion from the study : any type of malignancy , immunodeficiency , tendency toward recurrent infections , known untreated parasitic infection , allergy to any compound in the reference and test product , or to egg or soybean , any bronchiospastic diseases , epilepsy , porphyria , psoriasis , atopic dermatitis , hypercholesterolemia , gout , rheumatoid arthritis or kidney disease . care was taken to include both female and male participants both of caucasian and non - caucasian race . written informed consent was obtained from all participants before study enrollment . subjects were randomized into two treatment sequences : the test product followed by the reference product or vice versa . there was a washout period set to 14 - 21 days between the first and second treatment period . participants reported to the clinic the night before treatment for laboratory testing , including blood samples , pregnancy test and urine drug screen . the subjects were instructed not to ingest any citrus fruits and / or apple or pineapple 72 h prior to start of infusion and , within 24 h , no alcohol or any caffeine - containing products were permitted . on the clinical day , the only food served before drug administration was a standardized breakfast . through an indwelling iv cannula , the subjects received either 5 mg / kg ciclomulsion ( test ) or 5 mg / kg sandimmune ( reference ), infused at a constant rate over 4 h with a syringe pump . the dose recommended for induction of immunosuppression with sandimmune in clinical praxis is 3 - 6 mg / kg / day . the same arm was used for administration during both treatment periods . all infusion equipment were compatible with both the reference and the test product . through an iv cannula in the contra - lateral arm , a total of 22 blood samples for csa analysis were obtained pre - dose and at 0 . 25 , 0 . 5 , 1 , 1 . 5 , 2 , 2 . 5 , 3 , 3 . 5 , 4 , 4 . 5 , 5 , 6 , 7 , 8 , 10 , 14 , 18 , 24 , 30 , 36 and 48 h after start of infusion . all samples were collected in vials containing ethylenediaminetetraacetic acid ( edta ), labeled and stored at − 70 ° c . until analysis . whole blood csa - concentration was assayed with liquid chromatography - mass spectrometry / mass spectrometry ( lc - ms / ms ). the method was validated according to current fda guidelines ( 37 ). the lower limit of quantification ( lloq ) was 39 . 39 ng / ml and the mean cv was 3 . 5 % for csa . complete sets of calibration standards and quality controls were included within each run . twenty - four hours after start of administration of study medication , subjects were allowed to leave the clinic , provided they returned for the subsequent collection of blood samples . vital signs were monitored during the infusion and measured 2 h after completion of infusion and after the last blood sample was drawn . meals and drinks during clinic days were standardized . water was allowed ad libitum before and after infusion of study medication . alcohol , caffeine , citrus fruit , apple and pineapple were not allowed until the last blood sample was drawn in each treatment period . each subject was carefully monitored for adverse events ( aes ) during infusion , and was questioned on the study day for any symptoms of such events . aes were graded as mild , moderate or severe according to the following definitions : mild : causing no limitation of usual activities ; the subject may experience slight discomfort . moderate : causing some limitation of usual activities ; the subject may experience annoying discomfort . severe : causing inability to carry out usual activities ; the subject may experience intolerable discomfort or pain . the investigator deemed each ae in regard of causality to the administered medical product as “ certain ,” “ probable ,” “ possible ,” “ unlikely ,” “ not related ” or “ not assessable .” every ae was coded with the medical dictionary for regulatory activities ( meddra ) and reported according to strict criteria . the proportions of overall aes and aes per organ class were compared between ciclomulsion and sandimmune by means of 95 % confidence interval ( ci ) for the difference between paired proportions and p - values from mcnemar &# 39 ; s test . pharmacokinetic variables for csa were calculated by use of non - compartmental methods using wnnonlin ® professional version 5 . 2 ( pharsight corporation , mountain view calif ., usa ). statistical analysis was made using sas ® software version 9 . 1 ( sas institute , cary , n . c ., usa ). all values below lloq prior to first positive sample were substituted with zero . for the pharmacokinetic assessment , the terminal values below the lloq were ignored . ciclomulsion was compared to sandimmune with respect to a number of pharmacokinetic variables using analysis of variance ( anova ) with sequence , subject within sequence , product and period effects on log - transformed data . the parameters compared were area under the csa time - concentration curves for time 0 to the time of last quantifiable concentration ( auc 0 - t ), time 0 h extrapolated to infinity ( auc 0 -∞ ), time 4 h extrapolated to infinity ( auc 4 -∞ ), time 0 to 4 h ( auc 0 - 4 ) and time 4 to the last quantifiable concentration ( auc 4 - t ), maximum blood csa concentration ( c max ), apparent terminal csa half - life ( t 1 / 2 . z ), blood csa clearence ( cl ) and mean residence time ( mrt ). c max , auc 0 -∞ , auc 0 - t and auc 4 -∞ were considered primary variables and the remaining secondary . point estimates and 90 % cl for the ciclomulsion / sandimmune geometric mean ratios of all variables were calculated . the two products were considered bioequivalent if the 90 % ci for the primary variables fell within the limits of 0 . 8 and 1 . 25 . based on the fda and ema recommended bioequivalence range of 0 . 80 to 1 . 25 for c max , auc 0 - t and auc 0 -∞ , an estimated within - subject coefficient of variation ( cv ) of 35 %, and a “ test / reference ” mean ratio between 0 . 95 and 1 . 05 , 52 subjects were needed to achieve a power of 80 % at an alpha level of 0 . 05 to show bioequivalence ( 38 ). the initial study design did not include any premedication , but , due to an unexpectedly high incidence of serious adverse events ( saes ) to the reference product , the remainder of the study was performed with premedication . an amendment to the study protocol was written and approved by the ethical committees named above . for the sake of consistency , premedication was used prior to both ciclomulsion and sandimmune even though the aes triggering the instatement of premedication were observed following sandimmune administration . thirteen subjects completed both treatment periods without premedication . eighteen subjects received the test product in the first treatment period without premedication , and received the reference product with premedication in second treatment period . the remainder ( 21 subjects ) received premedication during both treatment periods , and thus with both the test and reference product . the premedication consisted of one 50 mg capsule of diphenhydramine orally 1 h prior to commencement of infusion of test or reference drug , 10 mg dexamethasone by slow iv injection , and 50 mg ranitidine iv infusion over 5 minutes approximately 30 minutes prior to each dosing of study drug . the study was put on hold for the protocol amendments to be approved . this caused the washout period for the 18 subjects who received the test product in the first treatment period without premedication and the reference product with premedication in the second treatment period to be prolonged to more than six weeks . none of the premedications are known to change the pharmacokinetic properties of csa or affect the bioanalytical assay . sixty - five volunteers were enrolled in the study and randomized to a treatment sequence . two subjects were withdrawn before first dosing due to illness , and eleven more withdrew before completion . of these eleven , three were due to consent withdrawal , two due to investigator / sponsor decision ( uncertainty of dose received due to problems with infusion ), and six due to aes . none of these subjects were included in the bioequivalence analysis . fifty - two participants completed the study and were included in the pharmacokinetic evaluation . the demographics of the subjects completing the study are presented in table 1 . sixty - three participants received at least one dose of study medication and were included in the overall tolerability assessment . due to an unexpectedly high number of serious adverse reactions to sandimmune , the study protocol was changed and premedication as described above introduced . the statistical analysis of incidence of aes was performed solely including the thirteen participants who received both the test and reference drug without premedication . for each time point , arithmetic means with standard deviation were calculated for the whole blood csa - concentrations for the test drug ciclomulsion and the reference drug sandimmune . a graphical presentation of the csa concentrations over time is provided in fig1 . in fig4 a and b , time - concentration curves are presented separately for subjects receiving and not receiving concomitant premedication . the pharmacokinetic parameters are presented in table 2 . the part of the auc 0 -∞ that was extrapolated was approximately 5 % for both of the study medications , indicating that a reliable estimate of the auc 0 -∞ was obtained . no values below lloq were present between positive samples . the statistical analysis of bioequivalence after dosing with ciclomulsion or sandimmune is presented in table 3 . the point estimates of the ciclomulsion / sandimmune geometric mean ratios ( 90 % ci ) of the primary variables c max and auc 0 - t for csa were 0 . 95 ( 0 . 92 - 0 . 97 ) and 0 . 90 ( 0 . 88 - 0 . 92 ), respectively , and auc 0 -∞ and auc 4 -∞ for csa were 0 . 90 ( 0 . 88 - 0 . 92 ) and 0 . 87 ( 0 . 84 - 0 . 90 ), respectively . thus , the 90 % ci of all primary variables were within the range acceptable for bioequivalence of 0 . 80 to 1 . 25 . the 90 % ci for all secondary variables also met the criteria for bioequivalence . out of 63 subjects , 55 reported one or more aes . aes graded as at least “ possibly ” related to the study medication were predominantly reported from the meddra - coded organ classes of nervous system disorders and vascular disorders ( table 4 ). the nervous system disorders included headache , burning sensation , paresthesia , dizziness and sensory loss . the vascular disorders included events of hot flushes and orthostatic hypotension . when subjects received sandimmune without premedication , 84 % ( 16 / 19 ) experienced aes assessed as at least possibly related to the study medication , compared to 64 % ( 21 / 33 ) when they received ciclomulsion . with premedication , the figures were 76 % ( 31 / 41 ) for sandimmune and 67 % ( 16 / 24 ) for ciclomulsion . proportional analysis of aes was performed for the subjects treated with both ciclomulsion and sandimmune without premedication . there was a significantly higher proportion of overall aes ( p = 0 . 003 ) and vascular disorders ( p = 0 . 03 ) when subjects were treated with sandimmune . no other proportions were significantly different between the two formulations . two saes were recorded . the first affected a male , aged 21 , who in the first treatment period was randomized to receive the reference medication , sandimmune . directly after start of infusion he experienced shortness of breath and a flushing sensation . infusion was halted , treatment with 40 % oxygen via hudson mask was initiated , and he received promethazine 25 mg and hydrocortisone 200 mg iv . due to continuing dyspnea , inhalation with nebulized salbutamol was commenced . thirty - seven minutes after start of infusion the event was considered resolved and oxygen therapy was discontinued . the proceeding day , he left the clinic but reported feeling tired for another three days . the event was diagnosed as an anaphylactoid reaction . the second of the two saes reported regarded a 42 - year - old male who also received the reference drug sandimmune in the first treatment period . eleven minutes after infusion of the medication commenced he presented with coughing , facial flushing and dyspnea . chest auscultation revealed wheezing sounds and the peripheral blood oxygen saturation ( spo 2 ) measured via pulse oxymeter was 95 %. h is condition quickly deteriorated , he became pale and sweaty , and a systolic / diastolic blood pressure of 75 / 42 mmhg was recorded . the infusion was stopped and therapy with 40 % oxygen via hudson mask and iv infusion with ringer lactate commenced . blood pressure was not rising and the spo 2 dropped to 91 % after a couple of minutes ; he was treated with 0 . 5 mg adrenaline and 25 mg promethazine intramuscularly and 5 mg salbutamol as nebulized inhalation . an infusion of 200 mg hydrocortisone also commenced . five minutes after the first medical intervention his blood pressure was normalized ; within an hour all drug treatment could be discontinued . after 24 hours , treatment with iv fluids was halted and the subject could leave the clinic . he reported feeling fatigued for another five days but could carry out all normal activities . the event was diagnosed as an anaphylactic reaction . both subjects were excluded from the remainder of the study . due to the events described above , as well as an allergic reaction considered moderate and possibly related to sandimmune that also caused withdrawal of the subject , the study was put on hold and an amendment to the study protocol made with the addition of premedication as described above . three other subjects did not complete the study due to aes . these were all moderate and possibly or probably related to the study medication . out of these , two participants received the test product with premedication and one the reference product with premedication . no subjects receiving the test drug ciclomulsion without premedication were withdrawn due to aes . a summary of all aes at least possibly related to the study medication is presented in table 4 . there were no clinically significant or consistent changes in laboratory values or ecg - findings due to csa administration . vital signs and clinical findings remained essentially unchanged during the study for all participants except for the two saes described above . after a single iv dose of 5 mg / kg , ciclomulsion and sandimmune met the conventional criteria for bioequivalence . ciclomulsion was the better tolerated of the two csa formulations . three patients had to be excluded from the study due to adverse reactions to sandimmune , hence the study design was changed after a decision from local authorities . due to this high incidence of saes in subjects receiving sandimmune , premedication was introduced . the calculated pharmacokinetic parameters between subjects who did and did not receive premedication were similar , and bioequivalence could be established with a low intrasubject cv ( for most variables under 10 %) including premedicated and non - premedicated subjects . thus , the changes in protocol and the introduction of premedication did not affect the pharmacokinetic profile of csa . in clinical practice , most crel - containing iv drugs ( such as the anti - cancer agent paclitaxel ) are administered with premedication due to the known risk of hypersensitivity reactions to crel or , in the case of sandimmune , is often given as a part of a combined regime with corticosteroids . it is feasible to assume that the actual incidence of adverse reactions to sandimmune is obscured by the protective effect of the corticosteroids . a number of the reports of crel - reactions have been explained by improper dilution of the sandimmune injection concentrate . crel has a greater specific gravity than water and a high viscosity and , unless properly mixed , will not be equally partitioned in the infusion bottle . concentrations of crel and csa up to nine times higher than the intended dose have been reported during the first 10 minutes of infusion when mixed improperly ( 15 , 27 , 28 ). with a stable , ready - to - use preparation without the need for dilution , this would not be an issue . when althesin ® was withdrawn in the late 1980s because of serious side effects due to crel , some authors argued that crel should not be used as a solvent for future drugs ( 39 ). until now , csa for iv administration has not been available with any other emulsifying excipient ; this is surprising considering the extensive literature reporting serious or even fatal crel - related reactions ( 27 , 40 ) there are several previous studies comparing pharmacokinetics of orally administered csa - formulations , but few for iv administration . in its oral form , csa has frequently been found to have large variation in bioavailability between individuals ( 41 - 45 ) due to a number of factors , such as rate of gastric emptying , the rate of biliary , pancreatic and intestinal secretion , polymorphism in cytochrome p4503a enzymes , and different haplotypes of p - glycoprotein expressed in the gut wall mucosa . the intraindividual differences are usually explained by dietary factors and clinical condition ( 42 - 44 , 46 , 47 ). there are examples of iv drugs in which the pharmacokinetic profiles have been significantly altered when a lipid emulsion was introduced as an emulsifier ; known examples are propofol and diazepam ( 17 , 48 - 50 ). taking this into account , the estimated intraindividual coefficient of variation ( cv ) was estimated to 35 % when designing the study . it turned out to be under 10 % for all primary variables , supporting the view that most of the intrasubject variation in bioavailability is due to factors primarily relevant to the orally administered formulations of csa . the interindividual cv % in this study was between 10 % and 20 % for cmax , auc 0 - 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305 . 41 . gupta s k , manfro r c , tomlanovich s j , gambertoglio j g , garovoy m r , benet l z . effect of food on the pharmacokinetics of cyclosporine in healthy subjects following oral and intravenous administration . j clin pharmacol 1990 ; 30 ( 7 ): 643 - 653 . 42 . christians u , klawitter j , clavijo cf . bioequivalence testing of immunosuppressants : concepts and misconceptions . kidney int suppl ( 115 ): s1 - 7 . 43 . christians u , first m r , benet l z . recommendations for bioequivalence testing of cyclosporine generics revisited . ther drug monit 2000 ; 22 ( 3 ): 330 - 345 . 44 . kahan b d , dunn j , fitts c , van buren d , wombolt d , pollak r et al . reduced inter - and intrasubject variability in cyclosporine pharmacokinetics in renal transplant recipients treated with a microemulsion formulation in conjunction with fasting , low - fat meals , or high - fat meals . transplantation 1995 ; 59 ( 4 ): 505 - 511 . 45 . kees f , bucher m , schweda f , gschaidmeier h , faerber l , seifert r . neoimmun versus neoral : a bioequivalence study in healthy volunteers and influence of a fat - rich meal on the bioavailability of neoimmun . naunyn schmiedebergs arch pharmacol 2007 ; 375 ( 6 ): 393 - 399 . 46 . christians u , schmitz v , haschke m . functional interactions between p - glycoprotein and cyp3a in drug metabolism . expert opin drug metab toxicol 2005 ; 1 ( 4 ): 641 - 654 . 47 . kovarik j m , mueller e a , van bree j b , fluckiger s s , lange h , schmidt b et al . cyclosporine pharmacokinetics and variability from a microemulsion formulation — a multicenter investigation in kidney transplant patients . transplantation 1994 ; 58 ( 6 ): 658 - 663 . 48 . dutta s , matsumoto y , ebling w f . propofol pharmacokinetics and pharmacodynamics assessed from a cremophor el formulation . j pharm sci 1997 ; 86 ( 8 ): 967 - 969 . 49 . fee j p , dundee j w , collier p s , mcclean e . bioavailability of intravenous diazepam . lancet 1984 ; 2 ( 8406 ): 813 . 50 . fee j p , collier p s , dundee j w . bioavailability of three formulations of intravenous diazepam . acta anaesthesiol scand 1986 ; 30 ( 4 ): 337 - 340 . 51 . lee m , min d i , ku y m , flanigan m . effect of grapefruit juice on pharmacokinetics of microemulsion cyclosporine in african american subjects compared with caucasian subjects : does ethnic difference matter ? j clin pharmacol 2001 ; 41 ( 3 ): 317 - 323 . 52 . min d i , lee m , ku y m , flanigan m . gender - dependent racial difference in disposition of cyclosporine among healthy african american and white volunteers . clin pharmacol ther 2000 ; 68 ( 5 ): 478 - 486 .

the present invention relates to a cyclosporine emulsion containing : i ) a cyclosporine ii ) a natural oil iii ) a phosphatidylcholine , iv ) glycerol , v ) a pharmaceutically tolerable alkali salt of a free fatty acid , vi ) a medium chain triglyceride - oil vii ) optionally , hydrochloric acid or sodium hydroxide for ph adjustment viii ) water .

the present disclosure provides a method of performing blood and tissue constituent analysis using a mobile video camera , which includes an objective lens and a simple led flash light source . the disclosure provides a mathematical method of extracting concentration of glucose and glycated hemoglobin and other blood constitutes from soft tissue perfusion videos ( 20 seconds to 5 minutes in length ) of light absorbed , transmitted and scattered by the adjacent flash leds commonly used in mobile phone / watch cameras or other such portable devices . most if not all blood and tissue constituents are optically active in the near - infrared range ( nir ) range . a significant feature of this disclosure and unique art is to analyze the native ir - filtered complementary metal - oxide semiconductor ( cmos ) camera perfusion videos , in the presence of a non - ideal spectrally stochastic white flash led light source ( fig3 ), and correlating these data to blood and tissue constituents . the method comprises placing the video camera &# 39 ; s objective lens and led flash so both are completely obstructed by direct contact with soft tissue , which is a component of an individual &# 39 ; s appendage with active cutaneous blood flow . the appendage can be any soft tissue through which light can pass without obstruction of body hair and minimal underlying high - density structures . an example of this is a fingertip , which has hairless soft tissue surrounding the phalanges and has minimal bone mass . the appendage is placed firmly against the frame of the objective lens or against a restricting frame that obstructs part of the objective lens . the method does not require a focused image of the appendage . the video camera records for a short period of time while the led is simultaneously active , typically 20 seconds to 5 minutes . the resulting video data is characterized by analyzing spatial spectral and non - fourier cmos signals from the video camera to monitor absorption , transmittance and scattering . this embodiment is referred to as a perfusion video which is a digital video made up of cmos images collected at 15 to 120 frames per second of the led illumination of appendage tissue used to determine blood glucose levels . the changes in spatial phase space and spectral correlations are used to deduce information on the blood and tissue constituent analysis in the appendage . the process for transforming the video data to maximize informativeness and then linking the transformed data to levels of glycated hemoglobin and other blood constituents lies at the core of the disclosure . at each frame of the acquired video , the time averaged power spectral density ( psd ) of the light entering the camera and striking each pixel is represented by a triplet of intensity values where each member of the triplet ranges from 0 to 255 . these values are derived from three individual sensors , each with filters optimized to detect red light ( wavelength of 620 - 750 nanometers ), green light ( wavelength of 495 - 570 nanometers ) or blue light ( wavelength of 450 - 495 nanometers ). these filters however , will be redundant as the high intensity of the ir absorption , scatter and transmittance characteristics of various blood constituents , such as , e . g ., hba1c will bleed past the color filters . even though a single frame of video contains in the order of millions of pixels , the process herein will illustrate the generalization to a single pixel in a given frame , or triplet value . this formulation can be extended to a spatial average over many pixels in a region of a frame , a time average of a region of pixels over successive frames , or any other expansion using more complex signal processing techniques . rbg values are unsuitable for direct use in spectral analysis , as the three numerical members do not contain sufficient information to reconstruct the entire psd with sufficient fidelity . however , it is not necessary to reconstruct the entire psd for accurate prediction of glycolated hemoglobin levels since the psd for high levels of glycolation and low levels of glycolation are known . the psd of other blood constituents are also known and follow the same process . to approximately reconstruct the psd , the following three equations determine the rgb values from a given psd , with the knowledge that the light has first passed through a broadband red , green or blue filter , respectively , before encountering the sensor . r = ∫ 0 ∞ ⁢ ⅆ λ ⁡ ( t r ⁡ ( λ ) ⁢ i ⁡ ( λ ) ) [ 1 ] g = ∫ 0 ∞ ⁢ ⅆ λ ⁡ ( t g ⁡ ( λ ) ⁢ i ⁡ ( λ ) ) [ 2 ] b = ∫ 0 ∞ ⁢ ⅆ λ ⁡ ( t b ⁡ ( λ ) ⁢ i ⁡ ( λ ) ) [ 3 ] where λ denotes the wavelength of the electromagnetic energy , t ( λ ) is the transmittance function of the respective filter and i ( λ ) denotes the intensity of the light at a given wavelength in the incident beam , which is henceforth referred to as the intensity function . the three transmittance functions may be determined experimentally , or may be provided by the camera manufacturer . a candidate intensity function can be constructed , parameterized by three values ( generically named a , b , and c ) such that for some values of the parameters the candidate intensity function sufficiently matches the intensity function for glycolated hemoglobin , or whichever blood constituent is under examination , then equations 1 - 3 form an invertible system of equations . the solution to this invertible system of equations forms an approximation of the generating intensity function . the parameterization should also be chosen as to continuously span the space of intensity functions between the two extremes . in one instance of the claimed invention , these parameterizations are used because they are more useful metrics than rbg values for determining levels of glycated hemoglobin and other blood constituents . this is due to the incorporation of some prior knowledge of the physics and signal processing of the camera system , as well as the psd of blood constituents at various concentrations . a time series of the estimated psds can then be constructed using the methods mentioned above as the next step for linkage between video data and levels of blood constituents . the video data transformed to a time series of estimated psds can then be analyzed one or both of two main processes : model - based and signal density - based . model - based analysis transforms the psd time series to a noiseless model using modified matching pursuit ( mmp ). signal density - based segregates the signal into subspaces , which are then quantified . signal density - based analysis can be applied to the mmp model , or alternatively to the psd time series itself . subspace extraction analysis is applied to the mmp model . fig4 illustrates the steps of the model based analysis to derive a noiseless sparse model from the psd time series data using an mmp algorithm . firstly , baseline line cmos correction ( a ) is designed to normalize and compensate for differences in relative intensity between the rgb psd matrix . triplet values form a 3d phase space . the signal is then decomposed using candidate functions selected from the most suitable dictionary ( ies ). each dictionary d is a family of waveforms d ={ φ i | iεi }, of which there are many possible choices such as wavelet packets , cosine packets , chirplets , and so on . waveforms are selected iteratively from the dictionary based on pre - computed cross correlation with the target signal as well as a pre - defined cost function . once selected , the waveform is subtracted from the signal to deduct complexity . terms continue to be selected from the chosen dictionary until a predetermined stopping condition is satisfied . there are many ways of defining the stopping condition , and could be composed of the following exemplar metrics : mean squared error , number of terms selected , correlation between the signal and the model . once the stopping condition is fulfilled , then the coefficients of the chosen candidate functions are calculated . the model estimation steps are shown in fig5 . once the mmp model has been computed from the psd time series then different informative subspaces are extracted it . these subspaces may include , but are not limited to complex sub harmonic frequency ( csf ) trajectory , quasi - periodic and chaotic subspaces , low / high energy subspaces , and fractional derivatives of the low / high energy subspaces . these subspaces are exemplars of the family of subspaces that characterize the dynamics of the system , whether pathological or normal . the signal density analysis previously mentioned can be applied to the psd time series or the mmp modeled psd time series . the signal density analysis involves segmenting the space - time domain into a number of regions , which total at least 12 , from the center of gravity and the density of each segment is calculated . the density values contain specific information about non - linear variability of the psd over time that contains information related in a complex manner to levels of blood constituents . the overview of the feature extraction from the psd time series is shown in fig6 . in one implementation of the disclosure , the psd time series progresses directly to signal density analysis . in another implementation , the psd time series also progress to mmp modeling and subsequently to subspace extraction . quantifications of the dynamics of the system can be extracted at several points during this process . genetic algorithms are members of the class of evolutionary algorithms , which generate solutions to optimization problems using techniques inspired by evolution on a cellular scale as well as population scale . solutions to the optimization problem can be viewed as genetic code . on a cellular scale , alterations in the genetic code can occur via the mutation and crossover operations , where mutation stochastically changes the potential solution and crossover combines two potential solutions . on a population level , solutions are viewed as individuals . individuals are allowed to propagate through generations when they are well adapted to the problem . the level of adaptation of any given solution is measured by the fitness function , which compares the target attribute to the output of the equation through mean square error , mean absolute error , correlation coefficient , or any number of other metrics . the features summarized above become terms in the equation , which is the individual in the evolutionary paradigm . these terms in the equation are combined using many linear and nonlinear functions such as product , division , addition , subtraction , sin , cos , tan , tan h , cos h , sin h , gaussian , integral of the gaussian , exponential and logistic . a set of equations , of size 20 for example , form a population . as the population evolves and traverses the solution space , its members begin to converge with respect to similarity of solution and fitness function evaluation as they approach a maximum in the space , which is not necessarily the global maximum . fig7 illustrates an example implementation of a device to measure concentrations of glucose and glycated hemoglobin and other blood constituents using an external light source . for example , a ring containing a cmos array and laser diode may be placed on a subject &# 39 ; s finger or smartwatch . remote receiver ( smart watch or mobile phone ) 702 may receive information from the ring 701 and process the information using wireless low energy bluetooth , as described below with reference to fig8 . other implementations may be used , for example the cmos array and laser diode may be integrated into the remote receiver 702 , or the cmos array and laser diode may be contained in a device that is located elsewhere on the subject &# 39 ; s body in an area of soft tissue . fig8 illustrates an example high - level operational flow of the processes performed to determine concentrations of glucose and glycated hemoglobin and other blood constituents using an external light source . at 802 , a diode laser is activated to illuminate the soft tissue area of the subject . at 804 , soft tissue absorption , transmission and scattering is measured using , e . g ., a cmos array / laser diode ( at 806 ). at 808 , information received by the cmos array / laser diode transmitted by , e . g . a low - energy bluetooth connection ( 808 ) to a remote source ( 810 ), such as a smartphone running software that is adapted to process information received by the cmos array / laser diode . the cmos array / laser diode could be integrated into a smartwatch ( 702 ) and / or ring ( 701 ) and connected to smartphone via bluetooth . multiple frequencies of laser light could be used to detect varies blood constituents the process for creating an equation linking psd time series data to levels of glycated hemoglobin or other blood constituents is described in fig9 . the features are extracted from a database of perfusion videos , which have associated blood panels . the genetic algorithm is then employed to create an equation that models levels of blood constituents as a function of the features . a smart phone camera or smart watch camera is the ideal embodiment if the color cmos camera is 8 megapixels or higher resolution . mobile phone software can used to create perfusion videos ( 20 seconds to 5 minutes in length ) of light absorbed , transmitted and scattered by the adjacent led flash . videos can be sent wirelessly to cloud computers for processing levels of blood glucose , glycated hemoglobin and other blood constituents . this information may be stored as uncompressed time series data at 902 . at 904 , time series data is converted to cmos sectors . the cmos sectors from 904 are placed into matrices — a scatter matrix 906 , an absorption matrix 908 , and a transmittance matrix 910 . at 912 , mmp techniques may be used to model the psd time series , which may be model - based and / or signal density - based . at 914 , the signal density - based model segregates the signal into subspaces , which are then quantified . at 916 , the genetic algorithm is used to link level of glycated hemoglobin or other blood constituents to various features . with regard to the operational flow fig9 , cloud - based image analysis software can be used to compute levels of blood glucose and glycated hemoglobin based on the high resolution ( 15 to 120 frames per second ) perfusion video . in other implementations , image analysis may be performed locally on , e . g . a smartphone . the present disclosure may be used to monitor and record short - and long - term changes in glucose and glycated hemoglobin levels , respectively , in an individual over a period of time . this is not limited to other blood constituents of interest that can be linked with retrospective data to specific conditions , outcomes or pathology correlations that can be made between the data received from the individual during the test and a database of blood constituent data characteristics for diseases . when the comparison is made , the correlations between characteristics of the light - based tissue perfusion patterns for an individual and the characteristics for a particular condition or disease can be used to give an indication of a pathological state . appropriate therapies and dietary changes can be given to that individual and immediate feedback can be provided to observe the outcome and track the trajectory of the pathology with time . an untrained person can take frequent blood constituents measurements with a smart device such as a smart phone / watch , without requiring frequent skin punctures , blood handling nor a specialized medical device . the information can be analyzed by cloud software and the results transmitted to the mobile phone and presented to the user almost in real time . additional software can used to recommend dietary changes or medications in order to maintain healthy levels , such as glucose levels . the information can be transmitted to a medical center , and a warning can be triggered if there are any risks . in another embodiment , external light sources can be used to illuminate the appendage . various semiconductor lasers could be integrated into an external ring ( 701 ) to provide specific wavelengths to correlate light transmittance , absorption and scattering of different blood and tissue constituent analysis . it will be appreciated that the embodiments described above are given by way of example only and are not intended to limit the invention , the scope of which is determined by the attached claims . it is to be understood that the features described in one embodiment of the disclosure can be used either individually or collectively in other embodiments of the disclosure .

a light based method and technique for measuring the static and average plasma glucose concentration over a prolonged period of time . more specifically , the disclosure relates to a method that utilizes mathematical analysis of appendage mobile led flash ir light transmittance , absorption and scattering by using high resolution mobile camera data to estimate the concentration of glucose and glycated hemoglobin in millimoles per liter .

the present disclosure will be described more fully hereinafter with reference to the accompanying embodiments and examples . however , the present disclosure may be embodied in many different forms , and should not be construed as being limited to the embodiments set forth herein . fig1 is a schematic view of the film for oral hemostasis and wound protection according to the present disclosure . with reference to fig1 , the film includes an adhesive layer 10 and a backing layer 20 . the adhesive layer 10 comes , on one of its surfaces , in contact with and is attached to hard or soft tissue inside an oral cavity while the backing layer 20 is formed on the other surface of the adhesive layer 10 and prevents the adhesive layer from being dissolved by means of the tongue or saliva . the adhesive layer 10 includes any one or more among a surfactant , oil and a plasticizer along with a hydrophilic polymer and a disintegrant while the adhesive is capable of further including an additional drug . the hydrophilic polymer functions as the base material of the adhesive layer and a polymer which generates adhesive force when being hydrated is selected as the hydrophilic polymer . for example , one or more species can be selected as the hydrophilic polymer from a group consisting of : carboxymethyl cellulose , carboxypropyl cellulose or ones made of their salts , hydroxyethyl celluose , hydroxypropyl cellulose , hydroxypropylmethyl cellulose and hydroxypropylethyl cellulose as celluose based polymers ; gelangum , xanthan gum , guar gum , carrageenan gum , karayan gum , arabic gum and alginate gum or their salt derivatives as gum based polymers ; and povidone , polyvinyl alcohol , poloxamer , polyvinyl pyrrolidone , polyvinyl pyrrolidone - vinyl acetate copolymers , polyacryllic acid , carbopol , polyquatemium - 11 , 39 , pvm / ma copolymer : gantgrez an 119 , 139 , s - 97 and polyox as gelatins and synthetic polymers . the adhesive layer includes any one or more among a surfactant , oil and a plasticizer , wherein the surfactant is capable of maintaining the disintegrant or a lipophilic softener , which is described below , in their stable state in a hydrophilic solvent . various species of the surfactant can be used including negative ionic , positive ionic or amphoteric ionic ones which are pharmaceutically permissible . for example , at least one species can be selected as the surfactant from a group consisting of polyoxyethylene glycolized natural or hydrogenated castor oil , ester of mono - or tri - lauryl , palmityl , stearyl or oleyl , polyoxyethylene stearic acid ester , polyoxyethylene - polyoxypropylene copolymers , polyoxyethylene - polyoxypropylene block copolymers , sodium sulfosuccinate or sodium lauryl sulfate , phospholipids , propylene glycol dicaprylate , propylene glycol dilaurate , propylene glycol isostearate , propylene glycol laurate , propylene glycol recinoleate or propylene glycol caprylic - capric acid diester , reaction products of transesterification between a natural vegetable oil triglyceride and a polyalkylene polyol , capryl / capric acid mono - or diglycerides , sorbitan fatty acid esters , sorbitan monolauryl , sorbitan monopalmityl or sorbitan monostearyl , colesterol , phytosterol and sitosterol . silicone oil , liquid paraffin , rosin wax solutions , soybean oil , olive oil , sesami oil , castor oil , fat soluble vitamins , fat soluble vitamin acetates and others can be used as the oil while the oil functions also as the plasticizer . the plasticizer , which is used so as to provide the film with flexibility and elasticity , can be selected from a group consisting of acetyl triethyl citrate , citrate ester , triacetin and triethyl citrate . the disintegrant is dissolved and released when it reacts with blood , thereby forming microchannels inside the adhesive layer while the drug is released via the microchannels , wherein it is possible to control the size and the distribution of the microchannels by adjusting content of the disintegrant , thereby adjusting the amount of release of the drug . any one or more can be selected as the disintegrant from glycol , glycerin , sorbitol , polyol such as peg , xylitol lactose , magnesium stearate , crystalline cellulose and crospovidone . the drug includes all agents appropriate to absorption from oral mucosa and known therapies for oral cavities , periodontal wound dressings among otherscan also fall into the drug . for example , the drugs which can be used for the film according to the present disclosure include agents for treating oral diseases such as antiinflammatory agents and disinfectants , antihistamine medications , tissue restoring agents , hemostatic agents , hormone medications , hypertension medications , antibiotics , bronchodilators and others . the antiinflammatory agents include tranexamic acid , lysozyme chloride , sodium azulen sulfonate , dipotassium glycyrrhizate , glycyrrhizic acid , ammonium glycyrrhizate , glycyrrhetinic acid , bromelain , serrapeptase , pranoprofen , ibuprofen piconol , presteron , lithospermum root extract , epidihydrocholesterin , bufexamac , myrrh tincture , bupleurum falcatum l ., wolfporia cocos , phellodendron bark , hydrocortisone acetate , prednisolone acetate , prednisolone , hydrocortisone , triamcinolone acetonide and others . the disinfectants include potassium iodide , liquefied phenol , phenol , cetylpyridinium chloride , chlorhexidine gluconate , chlorhexidine hydrochloride , dequalinium chloride , creosote , thymol , triclocarban , benzalkonium chloride , benzethonium chloride , acrinol , oxydol , ethanol , isopropanol , mercurochrome , cresol , isopropyl methylphenol , phenyl salicylate , sulfadiazine , homosulfamin , cassia bark oil and others . the antihistamine medications include chlorpheniramine maleate , diphenhydramine salicylate , diphenylpyraline hydrochloride , mequitazine , triprolidine hydrochloride , carbinoxamine maleate , diphenhydramine hydrochloride , diphenhydramine tannate , dimenhydrinate , promethazine hydrochloride , promethazine teoclate , meclizine hydrochloride , isopentyl hydrochloride and others . the tissue restoring agents include sodium copper chlorophyllin , allantoin , aldioxa , methylmethioninesulfonium chloride , sucralfate , asiaticoside , cetraxate hydrochloride , sofalcone , gefarnate , trimeptin maleate , teprenone , heparin - like substsances and others . topical medications include dibucaine hydrochloride , dibucaine , lidocaine hydrochloride , lidocaine , ethyl aminobenzoate , oxethazaine , and others . the rest of the components includes local protectants such as glycerin and concentrated glycerin , local stimulants such as i - menthol , peppermint oil and dl - menthol , hemostatics such as carbazochrome , vitamin preparations such as ascorbic acid , calcium ascorbate , tocopherol acetate , tocopherol calcium succinate , pantothenol and pyridoxine hydrochloride , blood circulation improving drugs such as benzyl nicotinate , blood circulation improving drugs such as sodium polyethylene sulfonate and antibiotic substances such as minocycline hydrochloride . the adhesive layer can include , when the hydrophilic polymer is 100 parts by weight , 0 . 1 to 60 parts by weight of the surfactant , the oil or the plasticizer and 0 . 1 to 30 parts by weight of the disintegrant . the adhesive layer can include , when the hydrophilic polymer is 100 parts by weight , 0 . 1 to 60 , desirably 1 to 40 or more desirably 1 to 30 parts by weight of the surfactants or the oil . the adhesive layer can include , when the hydrophilic polymer is 100 parts by weight , 0 . 1 to 60 , desirably 1 to 40 , more desirably 1 to 20 or still more desirably 1 to 15 parts by weight of the plasticizer . when the hydrophilic polymer is 100 parts by weight , 0 . 1 to 30 , desirably 1 to 25 or more desirably 1 to 20 parts by weight of the disintegrant can be used . the adhesive layer can include , when the hydrophilic polymer is 100 parts by weight , 0 . 01 to 20 parts by weight of the drug . the adhesive layer can contain 0 . 1 to 30 wt % of water , thereby being partially swollen , and be stuck onto oral mucosa . when the adhesive layer contains water within the range described above , the adhesive layer is kept swollen for a long period of time , thereby being capable of absorbing blood or pus more rapidly . that the adhesive layer is partially swollen means that it is not fully swollen . the adhesive layer can further include 0 . 1 to 30 parts by weight of the lipophilic softener when the hydrophilic polymer is 100 parts by weight . although , the hydrophilic polymer and the drug included in the adhesive layer are gradually consumed because they are dissolved by means of saliva , the lipophilic softener raises its relative content in the adhesive layer over time because the lipophilic softener is not dissolved by saliva . the lipophilic softener , the relative content of which has been increased , slowly infiltrates into the adjacent backing layer and softens the backing layer 20 and , as a result , the backing layer dissolves by means of saliva . in other words , the softener of the present disclosure transfers over time from the adhesive layer 10 to the backing layer 20 making the backing layer , which is water insoluble , softened and dissolving . consequently , the adhesive layer is prevented from being rapidly decomposed and the drug is sustainedly released because the backing layer slowly dissolves , which explains the drug delivery system of the present disclosure . it is possible to control drug release time and drug release content of a drug carrier , or the film , depending on the content of the softener and the thickness of the backing layer . the softener can be any one selected from triethyl citrate , dibutyl sebacate , acetyl triethyl citrate and triacetin . the adhesive layer can be formed by dissolving the components in a solvent and then drying them . the solvent can be prepared by using water , methanol , ethanol , acetone , isopropanol , ethyl acetate and others and it may be required to use water for the solvent . the adhesive layer can have a thickness of 50 to 1 , 500 μm , desirably 100 to 1 , 200 μm or most desirably 600 to 1 , 200 μm . the backing layer 20 can be manufactured by blending a water insoluble polymer with a solvent . the backing layer is placed on the adhesive layer and plays a role in protecting the adhesive layer from the tongue and food inside an oral cavity . the backing layer 20 can be softened and lost by means of the softener of the adhesive layer as described earlier . the backing layer 20 can have a thickness of 5 to 300 μm , desirably 10 to 150 μm or most desirably 10 to 80 μm . the water insoluble polymer can be a separate one among or a mixture of polyvinyl acetate , ethyl cellulose , polymethyl methacrylate , methacrylic acid copolymers such as methacryloylethyl betaine / methacrylate copolymers ( yukaformer ), methacrylic copolymers and aminoalkyl methacrylate copolymers ( eudragit e , rl ), cellulose acetate phthalate , shellac , polyethylene , pvc , polyurethane and polyethylene . the backing layer can be manufactured by additionally dissolving the surfactant and the plasticizer or the oil and the softener in the solvent . the present disclosure is now described below more specifically with the following embodiments and comparative examples for the purpose of easy understanding , but not limited thereto . an adhesive solution and a backing solution were prepared by using the components listed in tables 1 and 2 . first , the adhesive solution was applied on a thin detached layer and then dried to manufacture an adhesive layer film . second , the backing solution was applied on the adhesive layer film and then dried . a double layer film manufactured according to the method was cut to a predetermined size . the films for oral hemostasis and wound protection ( hereinafter referred to as the ‘ hemostatic film ’) prepared in embodiments 1 through 3 and comparative example 1 were employed as the specimens for the dissolution rate test . the test was performed according to the second dissolution rate test method ( paddle method ) stipulated in the korean pharmacopoeia . more specifically , the dissolution was performed in an eluate of 900 ml , which was maintained at ph 6 . 8 and at 37 ± 0 . 5 ° c ., where a paddle rotated at 50 rpm . the eluted was sampled after 5 minutes through 1 hour at an interval of 10 minutes . substances dissolved were identified with blue # 1 , the pigment , and evaluated with naked eyes according to a 5 - step scale of the extent of the release . table 3 shows that embodiments 1 through 3 released the pigment in periods shorter than that of comparative example 1 . in addition , comparative examples 2 and 3 , which contained more of the disintegrant than embodiment 1 , released the pigment faster . in other words , table 1 reveals that specimens with more of the disintegrant released faster . therefore , controlling the content of the integrant can control the rate the substances are released at . degree of wound healing was evaluated with the hemostatic films prepared in embodiments 4 through 6 and comparative examples 2 through 4 . 72 male sprague dawley rats , 16 to 18 weeks old , were divided into 3 groups and stored in standard raising cases . the rats were anaesthetized with 5 % isoflurane , ketamine hydrochloride and xylaizne and topically with lidocaine . trephine burs were used to cut surgical defects on the rats , where a calvarial defect procedure was employed on the experimental group and the controlled group . the defects were sutured and , after 4 and 8 weeks , respectively , the degrees of wound healing were compared as listed in table 4 . as listed in table 4 , embodiment 3 had an effect higher , due to cpc , the disinfecting component , than that of embodiment 4 . although embodiments 4 and 5 showed effects similar to each other , embodiment 5 was slightly more effective because , presumably , embodiment 5 had a higher content of the disintegrant and water . this component can preferentially protect dried skin . reso - pac ® as comparative example 2 is an ointment preparation . the preparation vanishes over time when it is applied on a wound area , which explains why it is less effective in protecting such wounds . no surfactant was employed in comparative example 4 . therefore , it is thought that it was difficult to protect , with tight feel , a corrugated wound area on which oil - based components remained and that an overdose of alcohol also generated a reverse synergetic consequence . the hemostatic films prepared in embodiments 4 through 6 and comparative examples 1 through 3 were employed in evaluating degree of hemostasis prevention , as listed in table 5 . astm d570 , standard test method for water absorption of plastics , was applied as the evaluation method . the hemostatic films were cut to 10 mm by 10 mm and contained beneath a mesh . 0 . 9 % normal saline water solution was filled in a sprayer and sprayed on the hemostatic films beneath the mesh . the films were placed on nonwoven fabric to absorb remaining water . then , the films were compressed and pressed under a 10 g of weight to remove water formed on the surface . weight of the remaining specimens save for the mesh was calculated and absorption power was measured according to the formula described below . whether absorption of water or pus could be faster depending on the water content inside the adhesive layer was assessed . where wo and wa is weight of the film before the absorption and after the spraying , respectively . embodiments 4 through 6 showed absorption ratios higher than those of comparative examples 1 through 3 . the ratio was lowest in reso - pac ® of comparative example 2 . the gauze of comparative example 3 absorbed a certain amount of water when sprayed by the sprayer and discharged the absorbed water when pressed under the weight of 10 g . therefore , it is thought that such a phenomenon corresponds to that the gauze was easily detached when it physically came in contact with the tongue and others inside an oral cavity . lower water content was advantageous in preventing the hemostatic components . degree of swelling varied depending on the water content inside the adhesive layer , where it was shown that the faster the absorption of water or pus was performed , the lower was water content . usability of the hemostatic films prepared in embodiments 5 and 6 and comparative examples 2 through 4 was evaluated and listed in table 6 . degree of satisfaction with the specimens attached inside an oral cavity was determined as the usability . thirty subjects were selected for the evaluation . embodiments 5 and 6 gained higher scores than comparative examples 2 through 4 did . it is thought that embodiment 6 gained a still higher score because a synergetic effect generated by the surfactant , the plasticizer and the softener it contained . however , only the surfactant and the plasticizer / oil without the softener can show efficacy to a certain extent . it is thought that the components referred to above functioned when they provided conditions where the functional groups of the polymers of the preparation were combined well with the surface of oral mucosa at the microscopic level when the branches of the polymers of the preparation were softened at the molecular level . in contrast , comparative example 2 provided considerable , ointment induced foreign body sensation . although the gauze of comparative example 3 was capable of absorbing fluids due to its own nature , it showed poor performance of hemostasis , which brought out the lowest satisfaction . comparative example 4 , in which only the softener was employed , didn &# 39 ; t show high usability . those skilled in the art will appreciate that the conceptions and specific embodiments disclosed in the foregoing description may be readily utilized as a basis for modifying or designing other embodiments for carrying out the same purposes of the present disclosure . those skilled in the art will also appreciate that such equivalent embodiments do not depart from the spirit and scope of the disclosure as set forth in the appended claims .

the present disclosure relates to a film for oral hemostasis and wound protection and , more particularly , to a film for oral hemostasis and wound protection which , being attached to a wound area in an oral cavity , delays or prevents microbleeds and controls medicinal component release . the film provided by the present disclosure is capable of including a polyol , an alcohol and a biodegradable polymer in the state of partial swelling , thereby locally absorbing blood or pus or arresting hemorrhage . moreover , due to its high elongation ratio , the film provided by the present disclosure is capable of maintaining its adhesive force even when having blood , saliva and pus absorbed inside an oral cavity and conveniently deforming according to the shape of a seriously corrugated local area , which causes only slight foreign body sensation even after a long period of time of attachment on to the local area . in addition , the film provided by the present disclosure includes a disintegrant which is dissolved and released by reacting with blood to form microchannels that act as paths for drug release and is capable of adjusting the amount and the size of the microchannels , thereby controlling the amount of drug release . the present disclosure doesn &# 39 ; t require a patient to detach the film attached inside an oral cavity by hand because the adhesive layer and the backing layer dissolve entirely over time .

the presbyometer of the present invention comprises a frame 10 . the frame 10 comprises a back plate 12 , a pair of coextensive side portions 14 , and a viewing assembly 16 . the side portions 14 extend outwardly from either end of back plate 12 . the viewing assembly 16 is attached to the ends of the side portions 14 , giving the frame 10 a generally rectangular configuration . in the preferred embodiment , the back plate is located 14 - 18 inches away from the viewing assembly 16 . the viewing assembly 16 is comprised of an inner plate 18 and an outer plate 20 which form a rigid cross member to the horizontal frame 10 . the outer plate 20 has an upper flange 22 on its upper edge which extends to the inner plate 18 . the flange 22 provides protection , from dust , stray light , etc ., for the mechanisms located between the outer plate 20 and the inner plate 18 . the inner plate 18 and the outer plate 20 each have a pair of laterally disposed ocular slots 24 , as well as a nose relief area 26 . a pair of adjustment arms 28 are attached to the inner plate 18 at pivot points 30 . the adjustment arms 28 will be denoted by reference numerals 28a and 28b . each adjustment arm 28 can pivot about its attachment point 30 . rotatably attached to each adjustment arm 28 , is a lens wheel 32 . the lens wheels will be denoted by reference numerals 32a and 32b . a screw or similar stud 34 attaches each lens wheel 32 to the adjustment arm 28 with the end of each stud 34 protruding through an arced slot 36 located on the inner plate 18 . each lens wheel 32 is free to rotate about its respective attachment point . when the lens wheels 32 are installed between the outer plate 20 and the inner plate 18 , the outer area of each lens wheel will extend beyond the side edges of the outer plate 20 and inner plate 18 . the outer edges of the lens wheels can be slotted or knurled for easy grippability by the user . each lens wheel 32 has nine spaced apart apertures 36 denoted by reference numerals 36a - 36i . as seen in fig3 and 4 , the first lens wheel 32a has a number located next to each aperture beginning with the number 0 in the first aperture 36a and , proceeding in counterclockwise fashion , numbered consecutively upward to the number 8 corresponding to aperture 36 . located in apertures 36a - 36g is a series of lenses with differing diopter powers . located in the first aperture 36a on both the first lens wheel 32a and the second lens wheel 32b is a non - strength lens . located in the second aperture 36b on both the first lens wheel 32a and the second lens wheel 32b is a lens of strength + 1 . 00 diopters . located in the third aperture 36c on both the first lens wheel 32a and the second lens wheel 32b is a lens of strength + 1 . 25 diopters . located in the forth aperture 36d on both the first lens wheel 32a and the second lens wheel 32b is a lens of strength + 1 . 50 diopters . located in the fifth aperture 36e on both the first lens wheel 32a and the second lens wheel 32b is a lens of strength + 1 . 75 diopters . located in the sixth aperture 36f on both the first lens wheel 32a and the second lens wheel 32b is a lens of strength + 2 . 00 diopters . located in the seventh aperture 36g on both the first lens wheel 32a and the second lens wheel 32b is a lens of strength + 2 . 25 diopters . located in the eighth aperture 36h on both the first lens wheel 32a and the second lens wheel 32b is a lens of strength + 2 . 50 diopters . located in the ninth aperture 36i on both the first lens wheel 32a and the second lens wheel 32b is a lens of strength + 2 . 75 diopters . as seen , the apertures and their respective lens of the second lens wheel are disposed in similar fashion except their progression is in clockwise fashion . a raised stud 38 is located next to the imprinted number 1 on the first lens wheel 32a . this raised stud 38 engages the adjustment arm 28a when it contacts either side of the adjustment arm 28a , thereby preventing further lens wheel rotation in that direction . also located on the first lens wheel 32a , are nine spaced apart spherical indentations 40 . a gear ring 42 is located on each lens wheel 32 . as seen in fig9 each lens is sandwiched within a front plate 44 and a rear plate 46 comprising the lens wheel 32 . a body member 48 separates the front plate 44 from the rear plate 46 . the lens is held in place within its aperture by use of an open or closed - cell foam or other suitable cushioning material 50 . rotatably mounted to each adjustment arm 28 is a coordinating gear 52 . the gears will be denoted by reference numerals 52a and 52b . each gear is identical to the other and the two gears are continually meshed with one another . the first gear 52a is also meshed with the gear ring 42 of the first lens wheel 32 while the second gear 52b is meshed with the gear ring 42 of the second lens wheel 32b . rotation of one of the lens wheels , will cause that lens wheel &# 39 ; s gear ring 42 to engage its respective gear 52 which in turn will engage the other gear , which in turn engage the gear ring 42 of the other lens wheel causing the other lens wheel to rotate in lockstep , in counter - rotation fashion , with the rotated lens wheel . as seen in fig3 and 8 , the first adjustment arm 28 has an index spring 52 , which is a flat spring member . located underneath the front end of the index spring 54 is an index bearing 56 . the index bearing 56 protrudes through an aperture ( not shown ) on the first adjustment arm 28 and contacts the front plate 44 of the first lens wheel 32a . an index spring retainer plate 58 , which is a rigid plate member , is affixed to the top of the rear end of the index spring 54 in order to help clamp the index spring 54 down . when the lens wheels 32a and 32b are rotated , the bearing 56 will align with , and will partially drop into one of the spherical indentations 40 located on the first lens wheel 32 . this alignment occurs each time one set of corresponding lens is aligned with its respective ocular slot 24 . the bearing 56 will be held within the spherical indentation 40 by the index spring 54 thereby preventing rotation of the lens wheels . this provides the lens wheels 32 with a friction &# 34 ; click - stop .&# 34 ; also located within the viewing assembly 16 is an ocular width adjustment control 60 . the ocular width adjustment control 60 comprises a bracket 62 . the bracket 62 is mounted on two studs 64 . one stud 64 each is attached to an adjustment arm 28 at point 66 , and protrudes through diagonally disposed elongated slots 68 located on the bracket 62 . holding the bracket 62 in place against the inner plate is a screw 70 that protrudes through a vertically disposed elongated slot 72 on the bracket 62 . located at the base 74 of the bracket 62 is a coil spring 76 . one end of the spring 76 biases against the base 74 of the bracket 62 while the opposing end of the spring 76 biases against a lower flange 78 that extends outwardly from the outer plate 20 . attached to the top 80 of the bracket 62 is a threaded stud 82 . the threaded stud 82 protrudes through the upper flange 22 of the outer plate 20 . a second adjustment knob 84 is threadly attached to the threaded stud 82 . when the second adjustment knob 84 is rotated clockwise , the threaded stud 82 proceeds downward , which in turn pushes the bracket 62 downward . this causes each stud 64 to travel up its respective elongated slot 68 . the screw 70 , travels within its elongated slot 68 and does not impede this operation . this causes the upper end of each adjustment arm 28 to be brought closer to one another . by pivoting about its attachment point 30 , the lower end of each adjustment arm 28 swings outward . this action pushes each lens wheel 32 farther apart from one another thereby increasing the lateral distance the two exposed lens . in order to decrease the ocular width , the second adjustment knob 84 is rotated counterclockwise . this causes the bracket 62 , due to the biasing of the compressed coil spring 76 , to be raised upward . this causes each stud 64 to travel down its respective elongated slot 68 . again , the screw 70 , travels within its elongated slot 72 and does not impede this operation . this causes the upper end of each adjustment arm 28 to be farther apart from one another . by pivoting about attachment point 30 , the lower end of each adjustment arm 28 swings inward . this action pushes each lens wheel 32 closer together thereby increasing the distance between the exposed lens on the first lens wheel 32 relative to the exposed lens on the second lens wheel 32 . the capped stud 34 that attaches each lens wheel travels through its elongated slot 36 and does not impede the above operation . the device is designed so that when the device is adjusted to its widest ocular width , a particular lens on each wheel and the associated reference numeral on the first lens wheel 32a is exposed within the respective ocular slots on the inner plate 18 and the outer plate 20 . the device is also designed so that when the device is adjusted to the narrowest ocular width , the ends of each lens wheel extend beyond the sides of the inner plate 18 and the outer plate 20 . the device can be inserted directly into a otc glasses frame rack . the device is securely attached into the inner portion of the rack . alternately , the device can be designed to be freestanding . included in this alternate embodiment , is a base 86 having a pair of vertical supports 88 . a cross member 90 extends between the pair of vertical supports 88 , providing torsional rigidity . pivotally attached to the top of the vertical supports 88 is the frame 10 . one end of a coil tension spring 94 is attached to the lower portion of the back plate 12 while the opposing end of the coil tension spring 94 is attached to the cross member 90 . as the viewing assembly is relatively heavy and the frame 10 is free to pivot about the radial axis , relative to its points of attachment to the vertical supports 88 , the coil spring 94 provides counter - balance to the frame 10 . alternately , a counterweight , of suitable mass , can be affixed to the frame in proximity to the back plate 12 thereby dispensing with the need for the coil spring . in order to adjust the height of the viewing assembly 16 , the viewing assembly 16 can be pulled down to the desired height . a threaded shaft ( not shown ) protrudes out through an arc - shaped slot located on one of the arms 28 of the horizontal frame . a first knob 96 is attached to the end of the threaded shaft . rotating the knob 96 , clamps it into the arm 28 of the frame 10 , thereby holding the frame 10 stationary . in order to use the device of the present invention , a user first adjusts the height of the viewing assembly 16 ( if a base - mounted embodiment is used ) by loosening the first knob 96 and pivoting the viewing assembly 16 to the desired height and thereafter tightening the first knob 96 . thereafter the user selects the appropriate ocular width of the two lens wheels . this is performed by the turning of the second knob 84 desired . one of the lens wheels is rotated so that the first lens -- the plano ( non - strength ) lens located in aperture 36a and bearing reference numeral 0 , is exposed . the raised stud contacts the side of the adjustment arm to prevent further rotation of the lens wheels when this first lens is exposed . an optional small slotted portion 98 can be located on the first adjustment arm and index spring 54 , on either or both sides , to assure proper lens alignment within the ocular slot 24 . the raised stud 34 enters the optional small slotted portion 98 , in order to permit slight further lens wheel rotation in order to achieve the lens - ocular slot alignment . the plano ( non - strength ) lens corresponds to the user &# 39 ; s current vision situation . the user looks through the exposed lens toward the back plate 12 of the frame 10 . affixed to the back plate 12 will be a visual stimulus preferably some form of reading material . the back plate will be located at the normal reading distance of 18 inches away from the viewing assembly 16 . if the user looks through the non strength plano lens and can read clearly , then reading glasses are not called for . if the user cannot read clearly , then one of the lens wheels is rotated to bring the lens with reference numeral 1 into exposure . when the next lens is exposed , the first lens wheel will click - stop . if the user can now read clearly , then lens number 1 is called for . a legend located on or near the device will tell the user that lens number 1 corresponds to reading glasses of strength + 1 . 00 diopters , and the user will select glasses of that strength from the glasses rack . if user cannot reading clearly after looking through lens number 1 , one of the lens wheels is rotated to bring the lens with reference numeral 2 into exposure . if the user can now read clearly , then lens number 2 is called for . again the legend is consulted in order to select the appropriate strength of glasses . if lens number 2 is insufficient , the user proceeds through the remaining lens , in sequential order , until he arrives at the first lens through which he can read clearly . the user checks the legend for the correct strength glasses and makes a purchase . if the user still does not read clearly after reach lens number 8 (+ 2 . 75 diopters ), then instructions on or near the device would advise the person that otc reading glasses are not the source of solution for the user &# 39 ; s reading difficulty and that medical attention should be sought . while the invention has been particularly shown and described with reference to an embodiment thereof , it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the spirit and scope of the invention .

a presbyometer for aid in selecting the appropriate strength of over - the - counter reading glasses is disclosed . the device comprises a view assembly with a pair of rotational lens wheels . the lens wheels each have a plurality of spaced apart apertures , each having a lens of differing dioptric strength . a user looks through the first lens on each lens wheel toward a back plate having a visual target . the lens wheels are rotated , thereby bringing a lens of increasing diopter strength into exposure . when the user can adequately read the stimulus , the correct level of diopter strength correction is identified and corresponding otc glasses are purchased . a ocular width adjustment means is also disclosed .

the present invention may be understood more readily by reference to the following detailed description of the preferred embodiments of the invention and the examples included herein . however , before the preferred embodiments of the devices and methods according to the present invention are disclosed and described , it is to be understood that this invention is not limited to the exemplary embodiments described within this disclosure , and the numerous modifications and variations therein that will be apparent to those skilled in the art remain within the scope of the invention disclosed herein . it is also to be understood that the terminology used herein is for the purpose of describing specific embodiments only and is not intended to be limiting . unless otherwise noted , the terms used herein are to be understood according to conventional usage by those of ordinary skill in the relevant art . in addition to the definitions of terms provided below , it is to be understood that as used in the specification and in the claims , “ a ” or “ an ” can mean one or more , depending upon the context in which it is used . the term “ gas container ” as used herein is defined as any cylinder , tank , or other vessel used to confine and contain a gas for controlled release and use thereof . preferably as gas container is capable of storing gas under high pressure . the term “ component ” as used herein is defined as any gas valve , regulator , or other flow - through connector or attachment used to control the release and / or delivery of a gas from a container . the term “ coating ” as used herein is defined as a layer of material that may be used to cover the interior surface of any container or component . a coating according to the present invention may be applied to the surface of the container or component by painting , spraying , electrodeposition , or any other known coating process , or such a coating may be impregnated within the material that forms the interior wall of the container or component . a coating according to the present invention shall be chemically inert or otherwise non - reactive with regard to the specific gas contained within the container having the coating . moreover , a coating according to the present invention shall be non - toxic to human or other mammalian users . the term “ antimicrobial agent ” as used herein is defined as any antiseptic , an antibiotic , or other substance or material or combination thereof that inhibits the growth or sustenance of microorganisms . the term “ antiseptic ” as used herein is defined as a material that inhibits the growth or sustenance of microorganisms , including but not limited to alpha - terpineol , methylisothiazolone , cetylpyridinium chloride , chloroxyleneol , hexachlorophene , chlorhexidine and other cationic biguanides , methylene chloride , iodine and iodophores , triclosan , taurinamides , nitrofarantoin , methenamine , aldehydes , azylic acid , silver , other silver salts , silver benzyl peroxide , alcohols , metals and metal salts and acids , and carboxylic acids and salts . one skilled in the art is cognizant that these antiseptics can be used in combinations of two or more to obtain a synergistic effect . furthermore , the antiseptics may be dispersed along the surface of a container . some examples of combinations of antimicrobial agents include a mixture of chlorhexidine , chlorhexidine and chloroxylenol , chlorhexidine and methylisothiazolone , chlorhexidine and alpha - terpineol , methylisothiazolone and alpha - terpineol ; thymol and chloroxylenol ; chlorhexidine and cetylpyridinium chloride ; or chlorhexidine , methylisothiazolone and thymol . these combinations provide a broad spectrum of activity against a wide variety of organisms . the term “ antibiotics ” as used herein is defined as a substance that inhibits the growth of microorganisms . for example , the antibiotic may inhibit cell wall synthesis , protein synthesis , nucleic acid synthesis , or alter cell membrane function . classes of antibiotics that can be used include , but are not limited to , macrolides ( i . e ., erythromycin ), penicillins ( i . e ., nafcillin ), cephalosporins ( i . e ., cefazolin ), carbepenems ( i . e ., imipenem , aztreonam ), other beta - lactam antibiotics , beta - lactam inhibitors ( i . e ., sulbactam ), oxalines ( i . e . linezolid ), aminoglycosides ( i . e ., gentamicin ), chloramphenicol , sulfonamides ( i . e ., sulfamethoxazole ), glycopeptides ( i . e ., vancomycin ), quinolones ( i . e ., ciprofloxacin ), tetracyclines ( i . e ., minocycline ), fusidic acid , trimethoprim , metronidazole , clindamycin , mupirocin , rifamycins ( i . e ., rifampin ), streptogramins ( i . e ., quinupristin and dalfopristin ) lipoprotein ( i . e ., daptomycin ), polyenes ( i . e ., amphotericin b ), azoles ( i . e ., fluconazole ), and echinocandins ( i . e ., caspofungin acetate ). examples of specific antibiotics that can be used include , but are not limited to , erythromycin , nafcillin , cefazolin , imipenem , aztreonam , gentamicin , sulfamethoxazole , vancomycin , ciprofloxacin , trimethoprim , rifampin , metronidazole , clindamycin , teicoplanin , mupirocin , azithromycin , clarithromycin , ofloxacin , lomefloxacin , norfloxacin , nalidixic acid , sparfloxacin , pefloxacin , amifloxacin , gatifloxacin , moxifloxacin , gemifloxacin , enoxacin , fleroxacin , minocycline , linezolid , temafloxacin , tosufloxacin , clinafloxacin , sulbactam , clavulanic acid , amphotericin b , fluconazole , itraconazole , ketoconazole , and nystatin . other examples of antibiotics , such as those listed in sakamoto et al , u . s . pat . no . 4 , 642 , 104 herein incorporated by reference will readily suggest themselves to those of ordinary skill in the art . the term “ bacterial interference ” as used herein is defined as an antagonistic interactions among bacteria to establish themselves and dominate their environment . bacterial interference operates through several mechanisms , i . e ., production of antagonistic substances , changes in the bacterial microenvironment , and reduction of needed nutritional substances . the term “ effective concentration ” means that a sufficient amount of the antimicrobial agent is added to decrease , prevent or inhibit the growth of bacterial and / or fungal organisms . the amount will vary for each compound and upon known factors such as pharmaceutical characteristics ; the type of medical device ; age , sex , health and weight of the recipient ; and the use and length of use . it is within the skilled artisan &# 39 ; s ability to relatively easily determine an effective concentration for each compound . the term “ gram - negative bacteria ” or “ gram - negative bacterium ” as used herein is defined as bacteria which have been classified by the gram stain as having a red stain . gram - negative bacteria have thin walled cell membranes consisting of a single layer of peptidoglycan and an outer layer of lipopolysacchacide , lipoprotein , and phospholipid . exemplary organisms include , but are not limited to , enterobacteriacea consisting of escherichia , shigella , edwardsiella , salmonella , citrobacter , klebsiella , enterobacter , hafnia , serratia , proteus , morganella , providencia , yersinia , erwinia , buttlauxella , cedecea , ewingella , kluyvera , tatumella and rahnella . other exemplary gram - negative organisms not in the family enterobacteriacea include , but are not limited to , pseudomonas aeruginosa , stenotrophomonas maltophilia , burkholderia , cepacia , gardenerella , vaginalis , and acinetobacter species . the term “ gram - positive bacteria ” or “ gram - positive bacterium ” as used herein refers to bacteria , which have been classified using the gram stain as having a blue stain . gram - positive bacteria have a thick cell membrane consisting of multiple layers of peptidoglycan and an outside layer of teichoic acid . exemplary organisms include , but are not limited to , staphylococcus aureus , coagulase - negative staphylococci , streptococci , enterococci , corynebacteria , and bacillus species . the term “ mutant ” as defined herein refers to a bacterium that has been mutated using standard mutagenesis techniques such as site - directed mutagenesis . one skilled in the art recognizes that the term mutant includes , but is not limited to base changes , truncations , deletions or insertions of the wild - type bacterium . thus , the size of the mutant bacterium may be larger or smaller than the wild - type or native bacterium . yet further , one skilled in the art realizes that the term mutant also includes different strains of bacteria or bacteria that has been chemically or physically modified as used herein . the term “ non - pathogenic bacteria ” or “ non - pathogenic bacterium ” includes all known and unknown non - pathogenic bacterium ( gram positive or gram negative ) and any pathogenic bacteria that has been mutated or converted to a non - pathogenic bacterium . furthermore , a skilled artisan recognizes that some bacteria may be pathogenic to specific species and non - pathogenic to other species ; thus , these bacteria can be utilized in the species in which it is non - pathogenic or mutated so that it is non - pathogenic . one specific embodiment of the present invention is a method for coating the interior of a container comprising the steps of applying to at least a portion of the surface of said container , an antimicrobial coating layer , wherein said antimicrobial coating layer comprises an antimicrobial agent in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated containers ; and applying to at least a portion of the surface of said container , a non - pathogenic bacterial coating layer , wherein said non - pathogenic bacterial coating layer comprises a non - pathogenic gram - negative bacterium in an effective concentration to inhibit the growth of pathogenic bacterial and fungal organisms , wherein said non - pathogenic gram - negative bacterium is resistant to said antimicrobial agent . the linings or interior walls of containers that are amenable to impregnation by the antimicrobial combinations are generally comprised of a non - metallic material such as thermoplastic or polymeric materials . examples of such materials are rubber , plastic , polyethylene , polyurethane , silicone , gortex ( polytetrafluoroethylene ), dacron ( polyethylene tetraphthalate ), polyvinyl chloride , teflon ( polytetrafluoroethylene ), latex , elastomers , nylon and dacron sealed with gelatin , collagen or albumin . the amount of each antimicrobial agent used to coat an interior container wall may vary to some extent , but is at least a sufficient amount to form an effective concentration to inhibit the growth of bacterial and fungal organisms . the antimicrobial agent may be applied to the interior surface wall of a container in a variety of methods . exemplary application methods include , but are not limited to , spraying , painting , dipping , sponging , atomizing , bonding , smearing , impregnating and spreading . a skilled artisan is cognizant that the development of microorganisms in culture media is dependent upon a number of very important factors , e . g ., the proper nutrients must be available ; oxygen or other gases must be available as required ; a certain degree of moisture is necessary ; the media must be of the proper reaction ; proper temperature relations must prevail ; the media must be sterile ; and contamination must be prevented . a satisfactory microbiological culture contains available sources of hydrogen donors and acceptors , carbon , nitrogen , sulfur , phosphorus , inorganic salts , and , in certain cases , vitamins or other growth promoting substances . the addition of peptone provides a readily available source of nitrogen and carbon . furthermore , different media results in different growth rates and different stationary phase densities . a rich media results in a short doubling time and higher cell density at a stationary phase . minimal media results in slow growth and low final cell densities . efficient agitation and aeration increases final cell densities . a skilled artisan will be able to determine which type of media is best suited to culture a specific type of microorganism . for example , since 1927 , the difco manual has been used in the art as a guide for culture media and nutritive agents for microbiology . similarly , if one is to retard or prevent the growth of unwanted colonies of microorganisms within gas containers , the same factors necessary for microbial growth must be eliminated or controlled . in one specific embodiment according to the present invention , a gas container is provided with an interior antimicrobial coating layer to inhibit the growth of bacterial and fungal organisms relative to an uncoated gas container . referring now to an embodiment according to the present invention as shown in fig1 , a gas container 10 is provided in the form of a cylindrical tank , comprising tank walls 15 with an outer tank surface 20 and an interior tank surface 25 , and at least one tank portal 30 . the tank portal 30 is further provided with a tank connector 35 and a tank valve 40 , so that a gas may be introduced into the container 10 under pressure through said tank valve 40 , tank connector 35 , and tank portal 30 , and then retained within said container 10 by closing said tank valve 40 . the tank valve 40 is opened or closed by operation of a valve control 50 by a user . the tank valve 40 is further provided with a least one external port 45 through which gas within the gas container 10 may either be dispensed or refilled . the tank connector 35 serves to attach the tank valve 40 to the tank portal 30 , and may be removable to allow physical access to the interior tank surface 25 for cleaning or maintenance within . the gas container 10 may further be provided with a tank cap 55 to cover and protect the tank valve 40 when the gas container 10 is not in use . in the embodiment according to the present invention shown in fig1 , the interior tank surface 25 may be provided with an antimicrobial coating ( not shown ) that adheres directly to the interior tank surface 25 . in alternate embodiments according to the present invention , the interior tank surface 25 may be provided with an intermediate coating ( not shown ) that adheres directly to the interior tank surface 25 and then serves to receive an antimicrobial coating ( not shown ) that may adhere or be bonded directly to the intermediate coating . such an intermediate coating may be a metallic coating or a polymer , capable of being firmly adherent to the interior tank surface 25 , and further capable of receiving and retaining an antimicrobial coating ( not shown ). in various embodiments according to the present invention , the inner tank surface 25 may be constructed of metal , metal alloy , ceramic , plastic , other polymers , or any combination ( s ) of the preceding materials . coatings may be applied to the inner tank surface 25 using any conventional coating process , including , but not limited to , painting , immersion , spraying , ionic deposition , electron deposition , sputter deposition , or any other coating method . in such embodiments according to the present invention as described above , the interior tank surface 25 may be treated or re - treated at intervals to replenish the antimicrobial coating . this may be accomplished during the process of refilling or recharging the gas content , and may further involve cleaning the old coating with a suitable solvent , then rinsing and drying the tank interior , and then re - applying the antimicrobial coating , removing any excess , and drying the tank interior before gas is refilled into the tank for use . in still other embodiments according to the present invention , the interior tank surface 25 may be provided with a metallic coating that may have inherent antimicrobial properties , such as various organic and inorganic substances , including silver , titanium , copper , cobalt , magnesium , and other metal salts . alternately , other embodiments according to the present invention may employ materials which comprise the tank wall that inherently have such antimicrobial properties , such that the antimicrobial properties become an integral part of the structural wall of the tank . in such settings , the antimicrobial capabilities of the tank may be longlasting , and may or may not require periodic rejuvenation from instilled agents during cleaning / refill operations . the gas containers according to the invention can be fabricated from a wide variety of substrate materials , with the primary materials considerations being sufficient strength to withstand necessary internal pressures , chemical non - reactivity with respect to the contained gas , and weight considerations dictated by the specific application . such materials include metals metal alloys , ceramics , plastics , other polymers , and any combinations thereof . such metallic materials for gas containers according to the present invention include , but are not limited to , iron , steel , stainless steel , nickel , titanium , manganese , and aluminum . potential structural ceramics include compositions of inorganic elements , such as nitrides , borides , carbides , suicides , oxides , and mixtures thereof . ceramics also include glasses , glass ceramics , oxide ceramics , and other partially crystalline inorganic materials . potential structural plastics for gas containers include addition polymers , polycondensation products , and polyaddition compounds . specific examples include polyolefins , such as polyethylene and polypropylene ; copolymers of ethylene and propylene with one another and / or with other olefinically unsaturated monomers , such as 1 - butene , vinyl acetate and acrylonitrile ; polyesters , such as polyethylene terephthalate and polybutylene terephthalate ; polycarbonates ; polyamides , such as polycaprolactam and polylaurolactam ; polyalkylene fluorides , such as polyvinylidene fluoride and polytetrafluoroethylene ; and polyurethanes . articles of the present invention may also be made of a combination of the above mentioned metals , ceramics , polymers , and plastics . antimicrobial agents are chemical compositions that inhibit microbial growth or kill bacteria , fungi and other microorganisms . different inorganic and organic substances display antimicrobial activity . among the simple organic substances that possess antimicrobial activity are carboxylic acids , alcohols and aldehydes , most of which appear to act by protein precipitation or by disruption of microbial cell membrane . the antimicrobial activity of inorganic substances is generally related to the ions , toxic to other microorganisms , into which they dissociate . the antimicrobial activity of various metal ions , for example , is often attributed to their affinity for protein material and the insolubility of the metal proteinate formed . metal - containing salts are thus among the inorganic substances that act as antimicrobial agents . metal inorganic salts , including simple salts of metal cations and inorganic anions like silver nitrate , are often soluble and dissociable and , hence , offer ready availability of potentially toxic ions . but such salts may be quickly rendered ineffective as antimicrobial agents by the combining of the metal ion with extraneous organic matter or with anions from tissue or bodily fluid . as a consequence , prolonged or controlled bacteriostatic and bacteriocidal activity is lost . metal salts or complexes of organic moieties such as organic acids , on the other hand , are often less soluble and , therefore , are less dissociable than the soluble metal inorganic salts . metal organic salts or complexes generally have a greater stability with respect to extraneous organic matter , and anions present in the environment of the living cell than metal inorganic salts , but have less toxic potential by virtue of their greater stability . the use of heavy metal ions with polyfunctional organic ligands as antimicrobial agents has been disclosed , for example , in u . s . pat . no . 4 , 055 , 655 . the silver ion is an example of a metal ion known to possess antimicrobial activity . the use of silver salts , including both inorganic and organic ligands , as antimicrobial agents has long been known in the prior art . the dissociation of the silver salt provides silver ions which provide the antimicrobial activity . silver ions react with a variety of anions as well as with chemical moieties of proteins . precipitation of proteins , causing disruption of the microbial cell membrane and complexation with dna , is likely the basis of the antimicrobial activity . silver ions in high concentration will form insoluble silver chloride and thereby deplete chloride ions in vivo . in an exemplary embodiment according to the invention , pressurized gas containers are imparted with antimicrobial containment properties by coating the substrate of the interior tank surfaces with cyanoalkylated hydroxyalkylcellulose . a gas container is first opened at the tank portal to provide access to the tank &# 39 ; s interior . coatings may then be applied by any conventional coating technique such as dipping , spraying or spreading . typically , cyanoalkylated hydroxyalkylcellulose is dissolved in a volatile solvent , such as acetone , and coated onto the substrate . the solvent evaporates at , or slightly above , room temperature , leaving cyanoalkylated hydroxyalkylcellulose coating on the substrate surface . the resistance of the article to microbial growth is highest when the coating is completely smooth and pore - free . an smooth , pore - free coating is most easily produced when the underlying substrate is also smooth and pore - free . interior tank surfaces with smooth , pore - free substrates are therefore preferred , and may be prepared by polishing and or plating the tank interior surface using conventional metal polishing and plating techniques . a cyanoalkylated hydroxyalkylcellulose coating is hydrophobic and insoluble in water , but it can absorb water and swell , depending on the degree of cyanoalkylation . the coating can be modified so it will no longer absorb water , and will no longer be soluble in organic solvents like acetone . this modification involves exposing the coated article to a plasma treatment or corona discharge , or to high - energy radiation . high - energy radiation is defined here to mean radiation more energetic than visible light , and includes uv rays , x - rays , and radiation generated by electron beams . the preferred method to modify the cyanoalkylated hydroxyalkylcellulose coating is to expose it to uv radiation . the modified coatings have better adhesion to the underlying substrate than unmodified coatings , especially on smooth , pore - free substrates . the antimicrobial properties , the desired low coefficient of friction , and the low toxicity of the coatings are not diminished by their modification . the antimicrobial coating composition in another embodiment according to the present invention may comprise a metal - containing sulfonylurea compound , along with one or both of a water - soluble and a water - insoluble carboxylic acid compound , in a polymeric matrix . a single coating of the composition can provide antimicrobial activity . sulfonylurea compounds that are suitable for use in accordance with the present invention include acetohexamide , tolazamide and chloropropamide . a representative metal - containing sulfonylurea compound suitable for use in the present invention is silver tolbutamide ( agtol ), a white compound formed when equal molar amounts of silver nitrate and sodium tolbutamide , both in aqueous solution , are mixed . agtol incorporates a tolbutamide ligand that is a sulfonylurea , tolbutamide . the sulfonylureas are known for their hypoglycemic properties , but none are reported to be antimicrobial . accordingly , tolbutamide is understood not to contribute any antimicrobial activity to silver tolbutamide , in contrast to the sulfadiazine component of silver sulfadiazine . agtol has a medium value dissociation constant estimated to be greater then pk = 3 . 3 . it does not deplete chloride from tissue fluid , but is soluble in a variety of organic solvents , including solvents containing polymers . the solubility of agtol , which is not a polymer , is considerably greater than that of silver sulfadiazine . agtol is not photostable when present in a coating , yet is observed to be light stable as a solid . the light instability of agtol appears to be related both to the lack of stabilization of the silver ion in the compound and the nonpolymeric nature of agtol . silver salts are typically light sensitive , and this photoinstability affects their use in many applications . however , in an application according to the present invention , the silver salts are generally used within the confines of an opaque , pressurized gas tank or other container , where photosensitivity is generally not relevant for consideration . thus , one antimicrobial coating in an embodiment according to the present invention may include a metal - containing sulfonylurea , preferably agtol , and at least one of a water - soluble carboxylic acid and a water - insoluble carboxylic acid in a polymer matrix . the polymer material forming the matrix should permit suitable diffusion of the metal ions out of the matrix . an acceptable permeability is reflected , for example , in a high moisture - vapor transmission ( mvtr ) value , preferably in the range of about 100 to 2500 g / m . sup . 2 / 24 hours / mil of membrane thickness . polymers that can be used in this context include polyurethane , polyvinylchloride , nylon , polystyrene , polyethylene , polyvinyl alcohol , polyvinyl acetatae , silicone and polyester . exemplary of solvents which can be employed in the present invention are those characterized by a solubility parameter , expressed in terms of ( cal / cn . sup . 2 ). sup . 1 / 2 , of between about 9 and 12 , such as ( cal / cm2 ) tetrahydrofuran , benzene , diacetone alcohol , methyl ethyl ketone , acetone and n - methylpyrrolidone . a variety of water - insoluble carboxylic acids are conveniently employed in the present invention , including fatty acids , such as stearic acid , capric acid , lauric acid , myrisic acid , palmitic acid and arachidic acid , as well as cholic acid , deoxycholic acid , taurocholic acid and glycocholic acid . by the same token , numerous water - soluble carboxylic acids are suitable , such as citric acid , gluconic acid , glutamic acid , glucoheptonic acid , acetic acid , propionic acid and butyric acid . the molar amount of each type of carboxylic acid can be varied , preferably from about 0 to about 2 mole per mole of metal - containing sulfonylurea . the respective amounts used of water - soluble and water - insoluble acids will depend upon the level of antimicrobial activity desired from the coating . the coating can be applied to a medical device by dipping in the antimicrobial solution and thereafter allowing the solvent to evaporated . both inside and outside surfaces can be coated . alternatively , the medical articles can be sprayed with the mixture and the solvent allowed to evaporated . likewise , the medical device can be painted with the solution , and the solvent allowed to evaporate . all coating processes can be carried out at room temperature , but evaporation of solvent can be hastened by oven drying , for example , at about 40 . degree . c . for some 90 minutes . the thickness of the coating , regardless of coating method used , is preferably about 0 . 1 mil . alternatively , the rate of release of metal ions can be adjusted by using multiple coating layers characterized by differing carboxylic - acid components . a first layer , applied as described above , can thus incorporate a water - insoluble carboxylic acid and a second , overlying layer a water - soluble carboxylic acid . in such an arrangement , there is an initial high rate of release of metal ions from the latter layer , as the water - soluble carboxylic acid does not affect the antimicrobial activity of the metal - containing sulfonylurea . the release from the underlying layer , on the other hand , is slower , due to the presence of the water - insoluble carboxylic acid , which effects long - term release . the user of an antimicrobial pressurized gas container according to a preferred embodiment of the present invention is human . however , any other mammals may be users of such inventive gas containers . exemplary mammals include , but are not limited to , dogs , cats , cows , horses , rats , mice , monkeys , and rabbits . antimicrobial treatment of pressurized gas containers may also involved the induction of mutation to block colonization by microbes . mutations can arise spontaneously as a result of events such as errors in the fidelity of dna replication or the movement of transposable genetic elements ( transposons ) within the genome . they also are induced following exposure to chemical or physical mutagens . such mutation - inducing agents include ionizing radiations , ultraviolet light and a diverse array of chemical such as alkylating agents and polycyclic aromatic hydrocarbons all of which are capable of interacting either directly or indirectly ( generally following some metabolic biotransformations ) with nucleic acids . the dna lesions induced by such environmental agents may lead to modifications of base sequence when the affected dna is replicated or repaired and thus to a mutation . mutation also can be site - directed through the use of particular targeting methods . in alternative embodiments according to the present invention , chemical mutagenesis offers certain advantages , such as the ability to find a full range of mutant alleles with degrees of phenotypic severity , and it is facile and inexpensive to perform . the majority of chemical carcinogens produce mutations in dna . benzo [ a ] pyrene , n - acetoxy - 2 - acetyl aminofluorene and aflotoxin b1 cause gc to ta transversions in bacteria and mammalian cells . benzo [ a ] pyrene also can produce base substitutions such as at to ta . n - nitroso compounds produce gc to at transitions . alkylation of the 04 position of thymine induced by exposure to n - nitrosoureas results in ta to cg transitions . in other alternative embodiments according to the present invention , the integrity of biological molecules may be degraded by the ionizing radiation . adsorption of the incident energy may lead to the formation of ions and free radicals , and breakage of some covalent bonds . susceptibility to radiation damage appears quite variable between molecules , and between different crystalline forms of the same molecule . it depends on the total accumulated dose , and also on the dose rate ( as once free radicals are present , the molecular damage they cause depends on their natural diffusion rate and thus upon real time ). damage is reduced and controlled by making the sample as cold as possible . in addition to providing an antimicrobial surface for a gas container as shown in fig1 , and as discussed above , other embodiments according to the present invention may also incorporate similar or other antimicrobial coatings or agents in the valves , connectors , regulators , and other flow - through components which attach to such gas containers in their various applications . fig2 shows additional details for an exemplary gas flow regulator which may be provided with antimicrobial linings , coatings , or inherent properties in any or all of its components . the exemplary gas regulator of fig2 shows a valve 145 attached to a gas tank 110 at tank junction 135 . the exemplary gas regulator of fig2 is further provided with a pressure gauge 140 and a gas outlet 150 . in various embodiments according to the present invention , any or all of the components shown in fig2 may be provided with antimicrobial coatings , linings , or fabricated of inherently antimicrobial materials , using the coating or fabrication materials and methods previously described for the provision of antimicrobial properties with the interior of a gas container according to the present invention . finally , while there have been shown and described and pointed out fundamental novel features of the present invention as applied to preferred embodiments thereof , it will be understood that various omissions and substitutions and changes in the materials , form , and details of the devices and processes illustrated , and in their operation , and in the method illustrated and described , may be made by those skilled in the art without departing from the spirit of the invention as broadly disclosed herein . all of the above - discussed patents and publications are hereby expressly incorporated by reference as if they were written directly herein .

this invention relates to the field of gas - containing storage vessels , and more specifically to the provision for antimicrobial surfaces within such vessels and in the connecting hardware associated with various applications of such vessels , so that microbial colonization of the interior of such vessels may be eliminated or retarded . this antimicrobial feature may result in improved safety in the use of such vessels , with reduced risk of the transmission of infection to a user . the invention further includes methods to provide gas - containing storage vessels with antimicrobial surfaces , so that microbial colonization of the interior of such vessels may be eliminated or retarded .

please refer fig1 through 9 together with the brief description of drawing elements that illustrate the preferred embodiment of the present invention . the present invention is a hexagonal block and its stand that each of the blocks a to g ( 11 ˜ 17 ) is consistent of four hexagonal elements ( 10 ) in either horizontal or vertical connection in multiply layers constituting seven different three - dimensional block assemblies . the description of the embodiments of the present invention is by a basic unit of element ( 10 ) for explanation as follows : a block a ( 11 ) is in a form of a horizontal connection of a first element ( a 1 ) and a second element ( a 2 ) with a third element ( a 3 ) and a fourth element ( a 4 ) respectively attached to both sides of the horizontal connection . a block b ( 12 ) is in a form of a horizontal connection of a first element ( b 1 ) and a second element ( b 2 ) with a third element ( b 3 ) and a fourth element ( b 4 ) attached to a bottom of the horizontal connection . a block c ( 13 ) is in a form of a vertical connection of a first element ( c 1 ), a second element ( c 2 ) and a third element ( c 3 ) with a fourth element ( c 4 ) attached to a side of the first element ( c 1 ). a block d ( 14 ) is in a form of a vertical connection of a first element ( d 1 ) and a second element ( d 2 ) with a third element ( d 3 ) and a fourth element ( d 4 ) vertically connected to each other and then attached to a side of the first element ( d 1 ). a block e ( 15 ) is in a form of a vertical connection of a first element ( e 1 ), a second element ( e 2 ) and a third element ( e 3 ) with a fourth element ( e 4 ) attached to a side of the second element ( e 2 ). a block f ( 16 ) is in a form of vertical connection of a first element ( f 1 ) and a second element ( f 2 ) with a third element ( e 3 ) attached to a side of the second element ( f 2 ) and a fourth element ( f 4 ) attached to a side of the first element ( f 1 ). a block g ( 17 ) is in a form of a connection of a second element ( g 2 ), a third element ( g 3 ) and a fourth element ( g 4 ) with a first element ( g 1 ) attached to a top side of the second element ( g 2 ). please refer fig1 to 3 . a stand ( 18 ) is provided with a recess ( 181 ) can constitute a three - dimensional structure according to the recess ( 181 ) when accommodating the blocks a to g ( 11 ˜ 17 ) in a variety of assembly . as shown in figures , the shape of the recess ( 181 ) of the stand ( 18 ) is constituted by a central hexagon with its six edges connecting six other hexagons . the recess ( 181 ) has location a ( 182 ), location b ( 183 ), location c ( 184 ), location d ( 185 ), location e ( 186 ) location f ( 187 ) and location g ( 188 ). as shown in the figures , the stacked height is four layers and each layer has seven elements ( 10 ) resulting in twenty eight elements ( 10 ) in total . the way of stacking is that block g ( 17 ) is placed with its second element ( g 2 ), third element ( g 3 ) and fourth element ( g 4 ) underneath into the corresponding location c ( 184 ), location d ( 185 ) and location g ( 188 ) respectively and then the block f ( 16 ) is placed with its second element ( f 2 ) and third element ( f 3 ) into the corresponding location b ( 183 ) and location a ( 182 ) respectively with its fourth element ( f 4 ) above the third element ( g 3 ). then the block e ( 15 ) is placed with its third element ( e 3 ) into the corresponding location f ( 187 ) and the block c ( 13 ) is next placed with its third element ( c 3 ) into the corresponding location e ( 186 ) and its fourth element ( c 4 ) above the first element ( g 1 ) while the block d ( 14 ) is next placed with its second element ( 0 ) and fourth element ( d 4 ) underneath above two fourth elements ( g 4 ) and ( f 4 ) respectively . then the block b ( 12 ) is placed with its third element ( b 3 ) and fourth element ( b 4 ) above the fourth element ( e 4 ) and the third element ( 0 ) respectively while the block a ( 11 ) is placed with its first , second , third and fourth elements ( a 1 ), ( a 2 ), ( a 3 ) and ( a 4 ) above the first element ( c 1 ), the fourth element ( c 4 ), the first element ( d 1 ) and the first element ( e 1 ) respectively . thus the block assembly is completely stacked in position as shown in fig3 , illustrating the sequence of stacking the block a to g ( 11 ˜ 17 ). please refer fig4 illustrating another embodiment of the present invention . first the block a ( 11 ) is placed with its first , second , third and fourth elements ( a 1 ) to ( a 4 ) into the corresponding location g ( 188 ), location b ( 182 ), location c ( 184 ) and location a ( 182 ). afterwards the block b ( 12 ) is placed with its first element ( b 1 ) and second element ( b 2 ) into the corresponding location d ( 185 ) and location e ( 186 ), the block d ( 14 ) is placed with its second element ( d 2 ) into the location f ( 187 ) with its fourth element ( d 4 ) above the third element ( a 3 ). then the block c ( 13 ) is placed with its first element ( c 1 ) and fourth element ( c 4 ) above the second element ( a 2 ) and first element ( a 1 ) respectively , the block e ( 15 ) is next placed with its first element ( e 1 ) and fourth element ( e 4 ) above two third elements ( a 3 ) and ( b 3 ) respectively , the block f ( 16 ) is next placed with its fourth element ( f 4 ), second element ( 12 ) and third element ( 13 ) above the fourth element ( e 4 ), the fourth element ( b 4 ) and the first element ( d 1 ) respectively , and the block g ( 17 ) is next placed with its first element ( g 1 ), third element ( g 3 ) and fourth element ( g 4 ) above the fourth element ( c 4 ), third element ( f 3 ) and third element ( d 3 ) respectively . seven blocks a to g ( 11 ˜ 17 ) are thus completely stacked into an assembly . please refer fig5 through 8 illustrating the other embodiment using a stand ( 19 ) of different design . the stand ( 19 ) can accommodate the same blocks a to g ( 11 ˜ 17 ) in a horizontal direction so as to enhance the educational value for the present invention with a variety of assembly and sequence . the stand ( 19 ) is provided with an inside recess ( 191 ) having multiply planes 1 to 10 ( c 1 ˜ c 10 ) that plane 1 ( c 1 ) to plane 2 ( c 2 ), plane 3 ( c 3 ) to plane 4 ( c 4 ), plane 4 ( c 4 ) to plane 5 ( c 5 ), plane 6 ( c 6 ) to plane 7 ( c 7 ) and plane 9 ( c 9 ) to plane 10 ( c 10 ) are at an angle of 120 degrees while plane 2 ( c 2 ) to plane 3 ( c 3 ), plane 5 ( c 5 ) to plane 6 ( c 6 ) and plane 8 ( c 8 ) to plane 9 ( c 9 ) are at an angle of 240 degrees . thereby both angles of 120 and 240 degrees constituted by the multiply planes 1 to 10 ( c 1 ˜ c 10 ) can accommodate the blocks a to g ( 11 ˜ 17 ) in a height of three layers with respective quantity of eight , twelve and eight units of element ( 10 ) from bottom to top resulting in total twenty eight elements ( 10 ) as well as to provide easy maneuver by fingers . the blocks a to g ( 11 ˜ 17 ) of the present invention are in hexagonal form with an angle of 120 degrees between two adjacent edges such that the aforesaid planes at an angle of 120 degrees matches a hexagonal element ( 10 ) when it is placed into position so as to stabilize each of the blocks a to g ( 11 ˜ 17 ). for example , plane 4 ( c 4 ) to plane 5 ( c 5 ) at an angle of 120 degrees is in accordance with the hexagonal element ( 10 ). from the above - mentioned the stand ( 19 ) accommodates the height of three layers that the bottom layer has eight hexagonal elements ( 10 ) in an assembly sequence as shown in fig7 and fig8 of location a ′( 201 ), location b ′( 202 ), location c ′( 203 ), location d ′( 204 ), location e ′( 205 ), location f ′( 206 ) location g ′( 207 ) and location h ′( 208 ). when placing the blocks a to g ( 11 ˜ 17 ), first the block g ( 17 ) is placed with its third element ( g 3 ) into the corresponding location d ′( 204 ) and the block f ( 16 ) is placed with its second element ( f 2 ), first element ( f 1 ) and fourth element ( f 4 ) into the corresponding location h ′( 208 ), location g ′( 207 ) and location c ′( 203 ) respectively . then the block d ( 14 ) is placed with its fourth element ( d 4 ) and third element ( d 3 ) into the corresponding location b ′( 202 ) and location a ′( 201 ) respectively and the block b ( 12 ) is placed with its third element ( b 3 ) and first element ( b 1 ) into the corresponding location f ′( 206 ) and location e ′( 205 ) respectively . the bottom layer is thereby completely stacked . afterwards the block c ( 13 ) is placed with its third element ( c 3 ), second element ( c 2 ) and fourth element ( c 4 ) above the second element ( g 2 ), first element ( g 1 ) and third element ( b 3 ) respectively and the block e ( 15 ) is next placed with its third element ( e 3 ) and first element ( e 1 ) above the third element ( f 3 ) and fourth element ( b 4 ) respectively while its second element ( e 2 ) and fourth element ( e 4 ) at the right - hand - side of the second element ( c 2 ) and first element ( g 1 ) respectively . finally the block a ( 11 ) is placed with its third element ( a 3 ), second element ( a 2 ) and fourth element ( a 4 ) above the third element ( d 3 ), the first element ( b 1 ) and second element ( b 2 ) respectively so as to completely stack seven blocks a to g ( 11 ˜ 17 ) into the stand ( 19 ). please refer fig9 illustrating an alternative assembly of blocks a to g ( 11 ˜ 17 ) of the other embodiment . the block a ( 11 ) is placed with its third element ( a 3 ) and second element ( a 2 ) into the corresponding location d ′( 204 ) and location h ′( 208 ) respectively and then the block e ( 15 ) is placed with its first element ( e 1 ), second element ( e 2 ) and third element ( e 3 ) into the corresponding location c ′( 203 ), location b ′( 202 ) and location a ′( 201 ) respectively . the block c ( 13 ) is next placed with its first element ( c 1 ), second element ( c 2 ) and third element ( c 3 ) into the corresponding location g ″( 207 ), location f ″( 206 ) and location . e ″( 205 ) respectively so as to completely stack the bottom layer . then the block b ( 12 ) is placed with its second element ( b 2 ), fourth element ( b 4 ), first element ( b 1 ) and third element ( b 3 ) above the third element ( a 3 ), first element ( c 1 ), first element ( a 1 ) and fourth element ( c 4 ) respectively while the block d ( 14 ) is next placed with its third element ( d 3 ) at the right - hand - side of the first element ( hi ) and its fourth element ( d 4 ) and first element ( d 1 ) at the right - hand - side of the third element ( b 3 ) and fourth element ( c 4 ). the block f ( 16 ) is next placed with its fourth element ( f 4 ) and third element ( f 3 ) above the second element ( d 2 ) and third element ( e 3 ) respectively and finally the block g ( 17 ) is placed with its first element ( g 1 ) and second element ( g 2 ) above the second element ( c 2 ) and third element ( c 3 ) respectively while its fourth element ( g 4 ) at the right - hand - side of the second element ( 12 ) so as to completely stack seven blocks a to g ( 11 ˜ 17 ) into the stand ( 19 ). in summary , the hexagonal block and its stand of the present invention has various ways of assembly that can further use different stands in order to stack in either vertical or horizontal directions so as to derivate different combination of assembly . moreover , the hexagonal block and its stand can extend the types , forms and quantity of blocks in accordance with the quantity accommodated by the stand for achieving a diversity of block assembly that can effectively stimulate the players in thinking and learning through the block maneuver within the three - dimensional space .

the present invention is related to a hexagonal block and its stand consistent of various three - dimensional blocks and each of the blocks including one to multiply hexagonal elements constituted by multiply layers of connection in horizontal and vertical directions . thereby the same blocks can be stacked in either vertical direction in accordance with the corresponding stand with a recess or horizontal direction in accordance with a switched stand with a recess . the blocks are in hexagonal forms at a fixed quantity such that a stacking sequence is required to complete a three - dimensional assembly without vacancy . therefore certain difficulty is included in order to achieve the training of logic thinking .

while the making and using of various embodiments of the present invention are discussed in detail below , it should be appreciated that the present invention provides many applicable inventive concepts that can be embodied in a wide variety of specific contexts . the specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention . to facilitate the understanding of this invention , a number of terms are defined below . terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present invention . terms such as “ a ”, “ an ” and “ the ” are not intended to refer to only a singular entity , but include the general class of which a specific example may be used for illustration . the terminology herein is used to describe specific embodiments of the invention , but their usage does not delimit the invention , except as outlined in the claims . the laser pest control device uses a laser cutting means that is adjustable to project focused laser beams outwards at a plurality of angles to contact flying pests to destroy the pest , damage the pest of both . fig1 illustrates a laser pest control device 10 that includes a housing 12 having a laser contacting surface 14 with an outer perimeter 16 a and an inner perimeter 16 b being either circular or multi - sided . the laser contacting surface 14 and / or the continuous perforated side wall 18 may be made of or coated with a laser light absorbing material for absorbing and containing errant laser beams . the inner perimeter 16 b forms a central aperture 20 . the central may be of any diameter necessary for the particular application or may be not present and be a continuous surface . attached to the outer perimeter 16 a is a generally continuous perforated side wall 18 that connects the laser contacting surface 14 to the housing 12 . the continuous perforated side wall 18 is extended generally perpendicular around the outer perimeter 16 a , and generally upward to the housing 12 . fig2 is an image of the device illustrated in fig1 cut along the a - aa line . the housing 12 includes a second surface 24 opposite the laser contacting surface 14 , with an outer perimeter 16 a and an inner perimeter 16 b being either circular or multi - sided , the second surface 24 and the continuous perforated side wall 18 enclose an interior that opens at the central aperture 20 bounded by the continuous perforated side wall 18 . the laser pest control device includes a laser housing 30 connected at a central position 26 and extending downward from the second surface 24 underneath the housing 12 . the laser housing 30 includes a laser beam generator 32 oriented a sufficient distance below the second surface 24 , and a laser beam rotation mechanism ( not shown ) to allow the laser beam 34 when generated to rotate in a 360 degree pattern such that the laser beam 34 contacts the laser contacting surface 14 as it rotates . the laser beam generator 32 may generate one or more laser beams 34 as desired by the particular application . the laser beam 34 is transmitted generally radially outwards from the laser beam generator 32 and may include various optical enhancements known to the skilled artisan including but not limited to splitters , lenses , reflectors , detractors , and the like known to those skilled in the art . in addition , the path of the laser beam 34 may be adjusted by an adjustment means ( not shown ) for angular adjustments of the various paths . the laser beam 34 can be directed in a plurality of angles downward onto the laser contacting surface 14 . the laser beam 34 is generated by the laser beam generator 32 in a continuously rotating 360 degree arc that may be either clockwise or counter - clockwise , or a combination of clockwise and counter - clockwise , using a single or multiple laser beams 34 . the laser pest control device may include a multiple laser beam configuration that includes at least two opposed laser beams at different angles or two , three , four , five , six , seven , eight , nine or more laser beams at a plurality of angles and in opposed , concurrent paths , or a mixture thereof . for example , one embodiment can have up to about ten opposed laser beams with each beam being opposed to the next and generated at different angles . the laser pest control device may operate at specific rotation speeds and intensities of the laser beams , but is not limited to a certain constant rotation speed or direction . the speed of rotation of each laser beam 34 is dictated by the laser beam rotation mechanism to control whatever angular direction transmitted from the laser beam generator 32 , and can be increased or decreased as necessary depending on the particular embodiment . the limit of the rotational speed for the rotation of each laser beam is only limited by the physical limits of rotation of the laser beam rotation mechanism , as determined by those skilled in the art . the laser beam rotation mechanism is known to the skilled artisan and may be a mechanical device to rotate the laser generator , a mirror that oscillates , an electrical device or other device known to the skilled artisan . any scattered or reflected laser beams may absorbed by the laser beam absorbing materials such that any errant laser beams are contained within the housing 12 as a safety measure . the laser pest control device includes a laser housing 30 including a system control mechanism connected to and controlling the laser beam generator 32 . the laser housing 30 includes electronic circuitry within , and / or connected to a system control mechanism to control the laser beam rotation mechanism and in turn the angular directions of the laser beam ( s ), the rotation direction , the rotation speed and other operating parameters of the laser beam generator and the parameters of the laser beam rotation mechanism . the skilled artisan can adjust the circuitry to control the speed of rotation of the laser beam and / or the intensity of laser beam , and / or the angular direction of the laser beam as necessary . furthermore , the system control mechanism is capable of controlling a plurality of laser beams generated simultaneously by the laser beam generator and individually control the speed of rotation of each laser beam and / or the intensity of each laser beam , and / or the angular direction of each laser beam . the system control mechanism , the laser beam rotation mechanism and the laser beam generator are positioned within the housing 12 and electronically connected to a power source . the power source may be of any sufficient power to run the system . for example , the power source maybe a direct connection to a power grid , a rechargeable battery , a plurality of rechargeable batteries , a solar cell , a solar power pack , an electrical generator or a combination thereof . for example , in one embodiment , the power source includes a solar power source connecting a solar cell , and one or more batteries to the system control mechanism , the laser beam rotation mechanism and the laser beam generator . in another embodiment , the power source includes a direct connection to a power grid , a battery backup , a solar cell , and a power control switch to direct the power to / from the direct connection to recharge the battery or to power the device ; to use the solar cell to power the device ; to use the solar cell to recharge the battery ; or other variations thereof known to those skilled in the art . the system control mechanism may also have an interface that includes a display and or controls to allow the control of the parameters of the system control mechanism , the laser beam rotation mechanism and the laser beam generator . the interface can provide user control of the rotation speed and angular direction , and may optionally provide control of the intensity of the laser beams and / or a visual indication of the rotational speeds of the rotating laser beams . electrical circuitry is known to those skilled in the art . a number of associated electronic and mechanical components known to those skilled in the art are not illustrated , but can be incorporated without interfering with the objects and advantages of the present invention . in operation , the laser pest control device may be position in the desired location . upon applying power to the laser pest control device , the system control mechanism , the laser beam rotation mechanism and the laser beam generator positioned within the housing are electronically engaged . in one embodiment , the interface is used to control the parameters of the system control mechanism , the laser beam rotation mechanism and the laser beam generator and the angular directions of the laser beam ( s ), the rotation direction , the rotation speed , and other operating parameters are set . in another embodiment these parameters are present into the device and no further modification is allowed or required . the laser beam rotation mechanism and the laser beam generator produce a laser beam that contacts the laser contacting surface at a point and is rotated about the laser contacting surface . the rotating laser beam is only accessible from the central aperture and through the perforations in the continuous perforated side wall . as a pest enters the central aperture , it will at some point contact the rotating laser beam which will at that point either damage the pest , damage at least a portion of the wings of the pest , injure the pest or destroy the pest . similarly , the pest may enter the perforations in the continuous perforated side wall , and at some point contact the rotating laser beam , which will at that point either damage the pest , damage at least a portion of the wings of the pest , injure the pest or destroy the pest . in addition , the rotation direction , the rotation speed and other operating parameters may be adjusted to optimize the contacting of the pest and the laser beam . in another embodiment , power may be applied to the laser pest control device to engage the system control mechanism , the laser beam rotation mechanism and the laser beam generator positioned within the housing . the laser beam rotation mechanism and the laser beam generator produce a first laser beam that contacts the laser contacting surface at a first point , and is rotated in a first direction about the laser contacting surface , and the laser beam generator produce a second laser beam that contacts the laser contacting surface at a second point , and is rotated in a second direction about the laser contacting surface . this creates laser beams that are rotating in opposite directions . the rotating laser beams are only accessible from the central aperture and through the perforations in the continuous perforated side wall . as a pest enters the central aperture it will at some point contact at least one of the rotating laser beams which will at that point either damage the pest , damage at least a portion of the wings of the pest , injure the pest or destroy the pest . similarly , the pest may enter the perforations in the continuous perforated side wall and at some point at least one of the rotating laser beams which will at that point either damage the pest , damage at least a portion of the wings of the pest , injure the pest or destroy the pest . the laser pest control device may be of any size and scale desired by the skilled artisan . for example , the laser pest control device may be a personal use size ranging from a housing that is less than a foot in diameter and has a continuous perforated side wall of less than a foot in height . the laser pest control device may be a commercial use size ranging from a housing that is more than a foot in diameter and has a continuous perforated side wall of more than a foot in height . the laser pest control device may also be an industrial use size ranging from a housing several feet in diameter and has a continuous perforated side wall of several feet in height . the laser pest control device may be adapted for use in any environment , e . g ., warehouses , pool areas , fields , gardens , greenhouses and other environments where pests reside . the laser beam may be continuous or pulsed . the laser beam generator may be any type of commercially available laser of sufficient power , such as a co 2 , nd - yag , nd - glass , helium - neon , ruby , aluminum - gallium - arsenide , dye , helium - cadmium , argon , krypton , or ktp - yag laser . wavelengths for these known lasers vary from about 0 . 4 to 10 . 6 microns , but wavelengths outside this range , for example , all infrared , visible and ultraviolet light , could also be employed . the laser beam generator may be any type of commercially available laser of sufficient power , such as a 20 - 274 mw green laser , 250 - 849 mw green laser , 2 - 349 mw violet laser , 400 mw blue laser , 50 - 1299 mw blue laser , 0 . 6 - 5 . 0 mw blue laser , 0 . 6 - 59 mw yellow laser , 2 - 14 mw yellow laser , 200 - 671 nm red laser , 500 - 699 mw infrared laser , 1200 - 1300 mw infrared laser , 700 - 1399 mw infrared laser , 2000 - 2399 mw infrared laser . specific examples include a 447 nm blue laser , 473 nm blue laser , 532 nm green laser , 532 nm green laser , 589 nm yellow laser , 593 . 5 nm yellow laser , 635 nm red laser , 640 nm red laser , 658 nm red laser , 671 nm red laser , 808 nm ir laser , 808 nm ir laser , 1064 nm ir laser and 1064 nm ir laser . depending on the type of pest , the power level of the laser source should be at least about 0 . 1 watt for insects and other small or microscopic creatures , but may be between 0 . 1 watt and 1 watt , 1 watt to 2 watts , 2 watts to as high as 1000 watts . in addition , the present invention may be adjustable in the number of watts and power output produced by the invention . in embodiments where there are multiple lasers beams , each beam may have the same or a different wavelength and / or power . one specific example includes a blue violet laser beam ( about 405 nm ) with a power output of 1 watt , 0 . 75 watts or 0 . 5 watts . one embodiment of the laser beam rotation mechanism includes a commercially available moving mirror imaging unit , such as those of the lk series available from general scanning , inc ., or a unit driven by an oscillator or function generator such as the model 3020 sweep / function generator made by dynascan corporation , to rotate the laser beam . the laser beam rotation mechanism may also include accessories that focus the beam to a spot to maintain a desired beam diameter throughout the area . a lens or equivalent device , such as a combination of curved mirrors , may be used to cause the beam to diverge ( widen ) with increasing distance . the rotation speed may be varied depending on the specific pest being targeted , and may range from a rotation speed of 1 hertz ( cycles per second ), which is typical , with speeds up to 100 khz or more . in addition , instead of relying on the pest to randomly enter the laser pest control device , one or more attractants may be used and take a variety of forms . in general , anything that is effective to lure the target pests into the scanned area can be used , such as an ultraviolet light source which attracts a variety of insects . other possible attractants include an incandescent or fluorescent light , sound generator , pest hormone , odor generator , an object with a specific color , and bait known to the skilled artisan . optional accessories include a beam widening lens , a beam narrowing lens , and a cone - shaped shade for rigidly connecting lens . in addition , optional sensors may be connected to the pest control system for recording , storing and transmitting various data . for example , a camera , a microphone and a counting mechanism may be used to count the number of pests that contact the device at any unit of time . in addition , a storage device may be in communication with the counting mechanism to record various data relative to the number of pests / time , date and time , location , etc . optionally , a transmitter may be connected to the storage device , counting mechanism , or both to allow data transfer over wired or wireless systems . in addition , the housing may include various sensors and electronic devices including a camera , processors , storage devices , communication devices , timers storage device to store data , e . g ., time , date , gps location , etc . the invention may also include a wi - fi , bluetooth or cellular mechanism to send and receive data , and to allow the remote control of the mechanisms including laser wavelength , laser power , laser rotation , data acquisition , on and off of components , etc . in addition , the housing may include a mechanism to prevent tampering and removal of the device . this may include an alarm to sound and / or flash when tampered with or an alert signal sent to a remote location . it is contemplated that any embodiment discussed in this specification can be implemented with respect to any method , kit , reagent , or composition of the invention , and vice versa . furthermore , compositions of the invention can be used to achieve methods of the invention . it will be understood that particular embodiments described herein are shown by way of illustration and not as limitations of the invention . the principal features of this invention can be employed in various embodiments without departing from the scope of the invention . those skilled in the art will recognize , or be able to ascertain using no more than routine experimentation , numerous equivalents to the specific procedures described herein . such equivalents are considered to be within the scope of this invention and are covered by the claims . all publications and patent applications mentioned in the specification are indicative of the level of skill of those skilled in the art to which this invention pertains . all publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference . the use of the word “ a ” or “ an ” when used in conjunction with the term “ comprising ” in the claims and / or the specification may mean “ one ,” but it is also consistent with the meaning of “ one or more ,” “ at least one ,” and “ one or more than one .” the use of the term “ or ” in the claims is used to mean “ and / or ” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive , although the disclosure supports a definition that refers to only alternatives and “ and / or .” throughout this application , the term “ about ” is used to indicate that a value includes the inherent variation of error for the device , the method being employed to determine the value , or the variation that exists among the study subjects . as used in this specification and claim ( s ), the words “ comprising ” ( and any form of comprising , such as “ comprise ” and “ comprises ”), “ having ” ( and any form of having , such as “ have ” and “ has ”), “ including ” ( and any form of including , such as “ includes ” and “ include ”) or “ containing ” ( and any form of containing , such as “ contains ” and “ contain ”) are inclusive or open - ended and do not exclude additional , unrecited elements or method steps . the term “ or combinations thereof ” as used herein refers to all permutations and combinations of the listed items preceding the term . for example , “ a , b , c , or combinations thereof ” is intended to include at least one of : a , b , c , ab , ac , bc , or abc , and if order is important in a particular context , also ba , ca , cb , cba , bca , acb , bac , or cab . continuing with this example , expressly included are combinations that contain repeats of one or more item or term , such as bb , aaa , ab , bbc , aaabcccc , cbbaaa , cababb , and so forth . the skilled artisan will understand that typically there is no limit on the number of items or terms in any combination , unless otherwise apparent from the context . all of the compositions and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure . while the compositions and methods of this invention have been described in terms of preferred embodiments , it will be apparent to those of skill in the art that variations may be applied to the compositions and / or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept , spirit and scope of the invention . all such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit , scope and concept of the invention as defined by the appended claims .

the present invention provides an apparatus for damaging a flying pest comprising : a housing connected to a continuous perforated side wall to a laser contacting surface ; a laser beam generator and a laser rotating mechanism attached to the housing and positioned to transmit a laser beam generally radially downward toward the laser contacting surface in a 360 degree pattern on the laser contacting surface , wherein the laser beam contacts and damages a flying pest ; a control mechanism in communication with the laser beam generator to control the generation of the laser beam and in communication with the laser rotating mechanism to control one or more parameters relating to the pattern ; and a power supply in electrical communication with the control mechanism , the laser rotating mechanism , and the laser beam generator .

in one embodiment the ratio of acetate / propionate is in the range of 0 . 05 to 2 and even more preferred in the range of 0 . 5 to 1 . 5 while most preferred is a range of 0 . 6 to 1 . 2 , and the ratio of lactate / propionate is in the range of 3 to 15 and more preferred in the range of 3 to 12 , while most preferred is a range of 3 . 5 to 10 . the use of a combination of the potassium salts of propionic acid , acetic acid and / or lactic acid in particular combines a high activity against food spoilage bacteria in fresh meat products and against food pathogens such as listeria monocytogenes in cooked and fresh meat products with a good taste of the resulting meat product . the specific combination of the potassium salts as used in the method according to the present invention displays an unexpected satisfactory taste sensation . food and drink products , and especially meat products ( including fish and poultry ), treated with the method according to the present invention demonstrated remarkable differences in taste sensation with respect to sweetness , saltiness and acidity and in meat products , the meat / meaty taste . meat products treated with the method according to the present invention showed an improved red colour stability and water holding capacity . a higher water holding capacity can be linked to a higher juiciness and tenderness and may therefore result in an improvement of taste . it was further found that the composition as used herein was very suited for handling and for application in various food and drink products as a higher concentration could be used without running into viscosity - related problems . the higher concentration is further advantageous because of reduced transporting costs . in one embodiment of the present invention , the composition also contains sodium as cation . in this embodiment the ratio of sodium / potassium is generally in the range of 0 . 01 to below 1 and more particular in the range of 0 . 01 to 0 . 5 , most preferred is a range of 0 . 01 to 0 . 3 . in some food and drink applications some sodium is desired because it gives a salty taste . one can add sodium to the compositions as used in the method according to the present invention for further fine - tuning of the taste profile of said food and drink applications but the sodium / potassium ratio should remain below 1 . aqueous solutions having a sodium / potassium ratio of higher than 1 were found to have problems with precipitation occurring in said solutions . by adding sodium to the compositions as used herein and maintaining a sodium / potassium ratio of below 1 , the salty taste can still be achieved while keeping the advantageous properties of the potassium salts as mentioned above ( i . e . not running into viscosity and precipitation - related problems ). an aspect of the present invention is further related to the following preferred potassium and sodium - comprising compositions . a first preferred composition comprises lactate and propionate in a weight - based ratio of lactate / propionate ranging from about 5 to 10 , acetate and propionate in a ratio of acetate / propionate ranging from about 0 . 6 to 1 . 2 and sodium and potassium in a ratio of sodium / potassium ranging from about 0 . 1 to 0 . 25 . a second preferred composition comprises lactate and propionate in a weight - based ratio of lactate / propionate ranging from about 3 to 9 , acetate and propionate in a ratio of acetate / propionate ranging from about 0 . 8 to 1 and sodium and potassium in a ratio of sodium / potassium ranging from about 0 . 1 to 0 . 35 . these solutions when used in the present invention provide food and drink products and in particular meat products with a favorable taste profile . the composition as used herein may be made by blending or mixing the separate components in their salt or acid form together with optionally a base such as potassium or sodium hydroxide . the blend may be made for example ( and not limited to ) by blending water , potassium lactate , propionic acid , acetic acid and optionally potassium hydroxide or by blending potassium lactate , water , sodium propionate , sodium di - acetate and potassium hydroxide . a further option is to blend lactic acid , potassium hydroxide and sodium hydroxide with sodium propionate . in one embodiment the potassium and / or sodium salts of propionic and acetic acid are obtained by a fermentation process . lactic acid or lactate ( in potassium and / or sodium form ) may be added to the fermentation product in a later stage in order to obtain a composition as used in the method according to the present invention comprising propionate , acetate and lactate . similarly , an additional amount of acetic acid may be added to the fermentation product in a later stage in the form of acetic acid , vinegar or neutralised vinegar , acetate ( sodium / potassium ) or sodium di - acetate . in this embodiment , the composition of propionate , acetate and lactate may be prepared by the following specific process comprising the steps of providing a fermentation product comprising propionate and acetate and adding lactic acid to the fermentation product to obtain an acidified fermentation product with a ph in the range of 2 . 5 to below 8 ( hereinafter also referred to as the acidification step ). the amount of propionate in the fermentation product that is used as starting material in the process is generally in the range of 0 . 5 - 10 wt % ( weight - based percentage ), more in particular in the range of 1 - 5 % wt %. the amount of acetate in the fermentation product is generally in the range of 0 . 1 - 5 wt %, more in particular in the range of 0 . 5 - 2 wt %. the direct ph ( directly measured without dilution of the fermentation product to e . g . a 10 wt % solution ) of the fermentation product that is used as starting material is generally in the range of 6 - 9 , more in particular in the range of 6 . 5 to 8 . 5 . said fermentation product may optionally be purified by means of a partial or complete removal of the biomass from the fermentation product . said fermentation product may further optionally be concentrated to a fermentation product with a propionate concentration of maximally 30 wt %. in the acidification step lactic acid is added to the fermentation product to obtain a ph in the range of 2 . 5 to below 8 . in particular , the ph is in the range of 3 to 7 , and more particular in the range of 3 to about 6 . 6 or 6 . 8 . the end concentration of lactic acid is generally in the range of 0 . 1 - 60 wt % of the fermentation product , more in particular in the range of 10 - 50 wt % and most preferably in the range of 25 - 50 wt %. said acidification step may optionally be carried out simultaneously with the above - described concentration step . further , a heating step may be introduced to raise the temperature of the fermentation product before or during addition of said lactic acid . a next step of the process may comprise the addition of a base to the resulting acidified fermentation product , concentrated or not ) comprising propionate and acetate in order to obtain a product with a direct ph of at least 5 ( hereinafter also referred to as the base - addition step or the neutralization step ). more in particular , the ph after addition of said base may be at least 6 and preferably at least 6 . 5 . while the upper limit for the ph is not critical , the ph will generally be at most 8 and more in particular at most 7 . 5 . the composition obtained after addition of the base may optionally be concentrated . it was found that when use was made of a composition that comprises propionate and acetate made via a fermentation process as described in the embodiments above and optionally lactate , a food product was obtained with even more satisfactory sensory properties such as e . g . taste than compared to a composition comprising a blend of separately - prepared propionate and acetate and optionally lactate components . the fermentation - wise made composition apparently comprises other components or impurities that have a positive contribution on the taste and other sensory properties of the food product . particular satisfactory results were obtained when the method according to the present invention with the fermentative - wise made composition was applied to meat products ( including fish and poultry ). the lactic acid or lactate that is added to the fermentation product may also be obtained via fermentation using conventional production methods . in one embodiment , lactic acid or lactate is obtained via a separate fermentation process comprising the following steps : the fermentation of a sugar - based substrate to form a lactate - comprising fermentation product , a partial or complete biomass removal step , an acidification step to form lactic acid , optionally an alkalinisation step ( also referred to as neutralisation step ) to form the desired sodium or potassium salt of lactic acid and optionally a concentration step which may take place before or after the acidification and / or before or after the alkalinisation step . a further possible option is to obtain lactate via or in the same fermentation process that generates the fermentation product containing propionate and acetate . hereto , the fermentation reaction medium comprises propionate / acetate - producing micro - organisms and lactate - producing micro - organisms . examples of propionate - producing micro - organisms are bacteria from the family of the genus propionibacteriaceae ( e . g . propionibacterium acidi - propionici , propionibacterium freudenreichii , propionibacterium thoeni and / or propionibacterium jensenii ) or from the genus selemonas . the use of propionibacterium freudenreichii subsp . shermanii is preferred . examples of lactic acid - producing micro - orgamisms are fungi , yeasts and more preferably lactobacilli such as lactobacillus delbrueckii , lactobacillus acidophilus or lactobacillus paracasei or moderately thermophilic bacilli such as bacillus coagulans , bacillus thermoamylovorans , geobacillus stearothermophylus and bacillus smithii . an other possibility is to use lactate as substrate for fermentation and to use propionate - producing micro - organisms in fermentation that are able to convert the lactate into propionate such as mentioned in u . s . pat . no . 4 , 814 , 273 or in wo 85 / 04901 and u . s . pat . no . 4 , 794 , 080 , the contents hereof incorporated herein . these above - described embodiments wherein the lactate component is made via fermentation result in a composition comprising propionate , acetate and lactate and rich in other unknown components and impurities which cause further unexpected changes in the sensory properties of the food product and especially meat product that is treated with said rich composition according to the method of the present invention . the described compositions and method are suitable for improving the sensory properties and resistance of food and drink products to bacteria . it was found that the described compositions are in particular suitable for application in meat ( including fish and poultry ) products and especially for uncured meat products . as the skilled person very well knows , meat products are very sensitive to e . g . discoloration , changes in odour and changes in the ‘ bite and taste sensation ’ which may be linked to attributes such as texture , juiciness , tenderness , water holding capacity and taste in general and which may be caused due to the sensitivity of the many components that are present in a meat product and their interaction , such as the various fats , proteins , salt , phosphates and other components well - known to the person skilled in the art . the meat product may be cooked or uncooked ( also referred to as ‘ fresh ’) and the cooked meat product may be cured or uncured . it is noted that in the present specification the word meat also includes poultry and fish products . fresh meat may comprise untreated and treated meat in the sense that the meat has been treated and accordingly may comprise additives . examples of suitable uncooked / fresh real meat products are beef , ground beef , beef steak , beef oxtails , neckbones , short ribs , beef roasts , stew meat , beef briskets , pork , pork chops , pork steaks , cutlets , pork roasts , lamb , veal , game goat , filet américain , steak tartar , patties or carpaccio . examples of fresh poultry include chicken , turkey , duck and other poultry such as cornish hen , dove , quail and pheasant . examples of fresh fish includes both finfish ( fillet , anchovy , barracuda , carp , catfish , cod , croaker , eel , flounder , haddock , herring , mackerel , mullet , ocean perch , pike , pompano , porgy , ray , salmon , sardines , sea bass , shark , smelt , sturgeon , swordfish , trout , tuna , whiting ), shellfish ( abalone , clams , cronch , crab , crayfish , lobster , mussels , oysters , scallops , shrimp and snails ) and other seafoods such as jellyfish , octopus , roe , squid , turtle , frog legs . examples of suitable cooked meat products are roast beef , roast lamb , roast pork , ham , salami , frankfurters and other sausages . examples of suitable cured meat products are cured pork ham , frankfurters , and other cured sausages . examples of suitable uncured meat products are cooked chicken , turkey meat , and roast beef or lamb . because uncured meat products are more sensitive to the growth of micro - organism than cured meat products , the described compositions are particularly attractive for application in uncured meat and poultry products . the described compositions may be used against various micro - organisms such as yeasts , molds and bacteria . preferably the described compositions are used for improving the resistance of food and drink products and in particular meat products against food spoilage and food poisoning bacteria such as listeria ( in particular listeria monocytogenes spp ), escherichia coli ( in particular escherichia coli o157 : h7 spp ), salmonella ( in particular salmonella typhimurium spp , salmonella enteriditis spp ), pseudomonas spp , enterobacter ( in particular enterobacter sakazaki spp ), clostridium ( in particular clostridium botulinum and clostridium perfringens ) and campylobacter ( in particular campylobacter jejuni spp ). particular good results were found when the described compositions were applied against food spoilage bacteria in fresh meat products and against listeria monocytogenes in meat products ( cooked and uncooked / fresh ). in the earlier - mentioned food and drink products , and especially the meat products , the composition as used in the method is present as ingredient in the final food , drink or meat product . the components of the antibacterial composition may be present on the surface of said products or inside the products . the described compositions may be applied during one or more of the various stages in the food processing process including the stages of the manufacture , the handling , the storage and / or the preparation of said food or meat product . it may be applied not only in the final product stage but also during or in a washing step such as applied in the processing of fruit and vegetables . the composition as used in the method may be applied or introduced by various means such as for example as a spray , a rinse or a wash solution or as solution wherein the various food products are dipped . the components of the composition may also be introduced by injection into the food and meat product . further , the method and composition may be used to treat containers with prior to , simultaneously with or subsequently after packaging the food and meat products . dependent on the type of application and on whether the composition used in the method is used as active ingredient in the final product or as component of for example a wash solution or spray solution , the components of the composition will vary in concentration and in internal ratio . the propionate , acetate and / or lactate salts may be added separately or in combination . they may be added in solid , particulate , form or dissolved in an aqueous solution . the addition in an aqueous solution may be preferred , because it makes it easier to distribute the acids homogeneously through the meat product . if the salts are added in the form of an aqueous solution , the use of an aqueous solution comprising 3 to 10 wt % propionate , 2 to 8 wt % acetate and 15 to 60 wt % lactate , and a sodium / potassium ratio between 0 to 0 . 4 and more preferably 0 . 05 to 0 . 2 wt % whereby the potassium concentration is in the order of 10 to 20 wt %, is most suited for application in various food and drink products . for most meat products and applications , the above - mentioned solution preferably has a direct ph ( i . e . directly measured in the solution without further dilution ) between 6 to 9 % or , when diluted to a solution of 10 wt % a ph between 5 and 8 . aspects of the present invention further relate to the method wherein use is made of highly concentrated solutions containing potassium and sodium . by combining potassium and sodium - based solutions comprising propionate , acetate and optionally lactate it was found that much higher concentrated solutions with much favorable viscosities can be obtained then in the case the solution only comprises the sodium - based salts of propionate , acetate and optionally lactate . the high concentration and much favorable viscosity is advantageous in transport ( e . g . lower costs ) and in handling and application of the solutions in food and drink products . the highly - concentrated composition has a concentration of potassium of about 1 to maximally 35 wt %, more preferably 1 - 27 wt %, a concentration of propionate of about 1 to maximally 65 wt %, an acetate concentration of about 1 to maximally 44 wt % and a lactate concentration of about 0 to maximally 62 wt %. most optimal and providing favorable results when used in the method according to the present invention is a composition with the above - mentioned concentration ranges that further fulfills the criteria set as described in the various embodiments in the present application for the weight - based ratio for respectively lactate / propionate , acetate / propionate and optionally sodium / potassium . the following non - limitative examples further illustrate aspects of the present invention . a taste comparison test was done with cooked turkey rolls wherein a composition was used based on a potassium blend (“ potass . blend ”) of acetate , propionate and lactate ( 15 wt % potassium with about 4 wt % propionate , lactate / propionate ratio is about 9 , acetate / propionate ratio is about 0 . 7 , 2 wt % sodium ) versus a composition based on a sodium blend (“ sodium blend ”) of acetate , propionate and lactate ( the same blend as above but then with about 15 wt % sodium and no potassium ). for the taste test different rolls of 800 g of cooked turkey were prepared . the turkey meat was salted with brines containing sodium chloride , sodium triphosphate , maltodextrine , carrageenan , corn starch , water and a potassium based composition or a sodium based composition . the brine injection level is 25 %. no other preservatives were used . meat compositions are given in table 1 in percentage of the batch . 13 mm grounded turkey meat was stored for one day at 0 ° c . the ingredients of table 1 were mixed with the meat . the turkey meat was packed in bags ( no vacuum ) and tumbled 2 times for 2 hours with 30 minutes rest in between . the meat - paste was stored during 14 hours at 0 ° c . in a bag . turkey rolls were prepared with an average diameter of 5 - 5 . 5 cm and cooked during about 1 . 75 hours in a water bath at 80 ° c . the cooked uncured turkey breast rolls were chilled in cold water and stored for at least 7 days at 0 ° c . six taste panellists assessed the samples saltiness , sourness , sweetness and turkey taste . slices of 0 . 2 cm . were given to the panellists at room temperature . they ranked the attributes from 0 ( not perceived ) to 5 ( strong ). the results of table 2 indicate a distinct difference in the taste sensation and in particular to the undesired sweetness due to the potassium based blend used in comparison with the sodium based blend . solutions as used in the method according to the present invention were made having the following compositions as described in table 3 . the viscosity of these solutions was measured at 6 and 26 degrees celsius . the results are presented in table 4 . the solution having composition number 6 displayed precipitation in the form of large crystals and demonstrates that the sodium / propionate ratio should be below 1 . as compositions 2 , 4 and 8 indicate the viscosity unexpectedly rapidly increases as more sodium is present . it is thus advantageous to minimize the sodium content and preferably no sodium at all is present .

a method for improving the sensory properties and resistance of food and drink products , especially uncured meat products , to various kinds of micro - organisms and in particular food spoilage and food poisoning bacteria includes contacting the food or drink product with a composition comprising alkali metal salts having as anions propionate and a co - anion selected from lactate , acetate , and combinations thereof , and as cations potassium and hydrogen , wherein the weight - based ratio of lactate / propionate is in the range of 0 to 20 and the weight - based ratio of acetate / propionate is in the range of 0 . 05 to 3 . 5 .

a detailed description will now be given of embodiments of the sensor of the invention with reference to the accompanying drawings . fig1 shows a thin plate - like complex pressure sensitive element 4 constructed of a pressure sensitive layer 2 laminated over the underside of a rectifying layer 1 , which pressure sensitive layer 2 changes electric characteristic thereof by being subjected to external pressure . fig2 and 3 respectively show an arrangement of an upside and underside electrodes constructed in multiple row arrangement wherein longitudinal strip electrodes 50 . . . are provided in side - by - side relation spaced by insulating materials 71 . . . from one another . the reference characters a , b , c , d , . . . and 1 , 2 , 3 , 4 . . . designated leading - in wires conducted from the strip electrodes 50 . . . . the leading - in wires , as shown in fig1 , are housed in one flat insulating tube , conducted out of an occlusion pressure sensor and adapted to conduct occlusion pressure signals in the form of electric signals generated by the occlusion pressure sensor to outside . according to the occlusion pressure sensor shown in the embodiment , the strip electrodes 50 . . . ( 5 ) are arranged and constructed on the upside of the complex pressure sensitive element 4 of the construction shown in fig1 and strip electrodes 50 . . . ( 6 ) are arranged and constructed on the underside of the element 4 as shown in fig3 so as to sandwhich the element between the electrodes ( 5 ) and ( 6 ) in the manner that the strip electrodes 50 . . . on the upside and the underside of the element are arranged and constructed in mutually three - dimensionally intersecting relation . pressure sensitive blocks 51 . . . are constructed in three dimensionally duplicate portion of the strip electrodes 50 . . . on the upside of element 4 and the strip electrodes on the underside thereof with the element 4 sandwiched therebetween . the numeral 8 designates insulation covering that encircles and envelopes the pressure sensitive element 4 . fig4 is a longitudinal sectional view , broken in part , of the occlusion pressure sensor . fig5 is a perspective view of another embodiment of the pressure sensitive element . the pressure sensitive blocks 51 according to this embodiment are constructed by both marking off a complex pressure sensitive element of the construction shown in fig1 in lattice form by insulating members 71 . . . and by assembling a plurality of segment electrodes 50 . . . in regularly coordinated relation to both on the upside and on the underside of the thus marked - off portions . fig6 and 7 respectively show the arrangement of the upside and underside electrodes arranged on the upside and underside of the complex pressure sensitive element 4 shown in fig4 . in the figures , strip electrodes 50 &# 39 ; . . . arranged on the upside and underside of the element 4 are respectively connected in series by thin conductors 72 . . . in each file or in each rank arrangement . fig8 is a longitudinal sectional view , broken in part , of an occlusion pressure sensor wherein the numeral 8 designates an insulating film encircling and covering the complex pressure sensitive element 4 constructed as above . in the two embodiments illustrated , so long as the rectifying layer 1 has the property of permitting the flow of current in one direction but preventing that of current in the opposite direction , the layer 1 , irrespective of whatever material may form the layer , can be selected from all kinds of material or complex such as a selenium rectifying material of se layer and a complex laminated material fe consisting both of ods layer and ou 2 s layer , a selenium rectifying material al layer and se layer , a cuprous oxide rectifying material comprising cu layer and cu 2 o layer , a schottky rectifying material having a film as of au , ni , w , mo , v formed on the surface si , ge or gaas layer and a semiconductor formed by p - n junction of si or ge semiconductor . a material usable as a pressure sensitive layer 2 may be the one 21 ( such as vinylidene polyfluoride film ( pvdf film ), zirconium titanate film ( pzt film )) or may be the one 22 that changes the electric resistance thereof in response to the external pressure applied ( for example all materials such as pressure sensitive rubber possessed with pressure sensitivity by mixing metal or carbon particles into rubber , a film having a pressure resistant effect and in which a semiconductor such as si is used , a cell containing carbon particles ) and other complexes may suitably be selected so long as they change the electric characteristic thereof under external pressure , no matter whatever material they may be . on the other hand , the upside electrode 5 and the underside electrode 6 may be formed by directly vapor coating and metalizing an electroconductive metal as of aluminum and silver at suitable points on the respective sides of the pressure sensitive element 4 or may be formed separately by vapor coating or metalizing an electroconductive material such as aluminum and silver on an insulating substrate such as of ceramic and synthetic resin . in short , recourse may be had to any other means that is sufficient to constitute pressure sensitive blocks 51 . . . containing pressure sensitive element 4 and marked off in lattice form . fig9 is an equivalent typical electric circuit diagram showing electrical structure of the sensor of the invention , wherein the numerals 51 . . . designate pressure sensitive blocks and 1 designates diodes which show equivalently a rectifying layer . the structure of the sensor of the invention is electrically shown as a diode matrix of the type described above . the reference character sw1 designates a switching mechanism for energizing and scanning the upside electrode 5 of the sensor constructed of strip or segment electrodes 50 . . . and 51 &# 39 ; . . . and sw2 designates a switching mechanism for energizing and scanning the underside electrode 6 of the sensor constructed of strip or segment electrodes 50 . . . and 5 &# 39 ; . . . , and e designates a dc power source used when a change in the electric characteristic of the pressure sensitive blocks 51 . . . represents a resistance change , and the source is considered unnecessary when a change in the electric characteristic of the pressure sensitive blocks 51 . . . represents a resistance change . a description will now be given of the use of the sensor of the invention and of the operating principle thereof with reference to the drawings . a user bites a sensor s by the upper and lower teeth in the mouth as shown in fig1 . in this state , all that is necessary to do is to electrically and scan all the pressure sensitive blocks 51 . . . and derive an electric signal responsive to occlusion pressure from the blocks 51 . . . . this derivation of electric signal is effected by switching switches sw1 and sw2 , and this switching operation may readily be made by use of an electronic switch . more specifically , during the time that the electrodes connected in each rank out of the upside electrode 5 are energized by switching operation of sw1 ( to be referred hereinafter as rank - scanning ), the electrodes connected in each rank out of the underside electrode 6 are energized successively ( to be referred to hereinafter as file - scanning ). by so doing , the pressure sensitive blocks 51 . . . arranged in lattice form are successively scanned and a change in electric characteristic effected by occlusion pressure is electrically converted into an electric signal output . fig1 and 12 respectively show time charts both for rank - scanning pulse and for file - scanning pulse in scanning of the kind described above . fig1 is a diagram illustrating the occlusion pressure signal ( pulse ) outputted from the pressure sensitive blocks . in fig9 the electric signal if converted into voltage and is conducted outside through a resistor r . switching of switches from sw1 to sw2 is successively operated in synchronism with the horizontal and vertical scanning of crt 30 provided in housing 31 to thereby lead the output signal of occlusion sensor s to a brilliance modulation circuit and indication of the output signal of crt picture provides a picture of an occlusion pressure change in the teeth panoramically and at real time . in addition , the invention may be used in combination with a video tape recording device or graphic display equipment . it should be understood that combined use of other suitable devices makes it possible to provide information on occlusion pressure not only in the form of a moving image but also in the form of a still image . as described above , since the invention makes it possible to correctly detect an electric signal responsive to occlusion pressure in each pressure sensitive block , the invention is of great use to dental treatment in that it enables the operator to grasp the occlusion pressure distribution over the entire jaws more positively and at real time .

the disclosure relates to an occlusion pressure sensor of the construction in which pressure sensitive block changing in electric characteristic under external pressure are arranged in multiple rows . the occlusion pressure sensor is designed to detect an electric signal responsive to occlusion pressure from the pressure sensitive blocks by successively and electrically scanning the blocks in the state of a patient engaging his teeth .

the product according to the invention is prepared from natural extracts of microscopic algae from the genus chlorella , that are prepared according to the process illustrated in the attached drawings , in which : fig2 is a bar graph showing the distribution ( in percentages ) of amino acids in the final product ; and fig3 is a bar graph showing the molecular weight distribution of peptides in the final products . this process essentially consists in performing an alkaline grinding of the algae , in acidifying the extraction juice obtained , in eliminating the cellular wastes ( debris ) by tangential microfiltration on a filter the retention threshold of which is 0 . 22 μm , and in concentrating the remaining organic elements until there is obtained an extract that comprises 5 % of active materials , this extract constituting the product according to the present invention . there are listed below the organoleptic , physicochemical and biological characteristics of the product obtained . it must be noted that the high glucide content of the product contributes to its immunomodulating activity . the graph ( fig2 ) represents the distribution of the total amino acids in the product according to the present invention . there is observed an important proportion of alanine , of glycine and of proline in the product , which are the main amino - acids of the basic collagen unit . there is also observed an important quantity of lysine that together with proline , are precursors the collagen biosynthesis . the graph ( fig3 ) shows the molecular weight distribution ( expressed in daltons ) of the peptides in the product according to the present invention . the distribution of the peptides ( fig3 ) shows that 96 % of them have a molecular weight less than 10 , 000 daltons , there results from this a good potential for the assimilation of the product by the skin . in order to show the effects of such a product on the epidermis , there was proceeded to an experiment that consists , after radiation by ultraviolet rays of the a class ( u . v . a .) in visualizing and in counting the langerhans cells present in the epidermis , using a fluorescent microscope . samples of skin explants from a healthy subject , obtained following a plastic surgery intervention , are placed for survival in a suitable culture medium . three series of explants are prepared : the first series , or control series , is such that each explant that constitutes it does not receive the product according to the present invention and is not subjected to u . v . a radiation . the second series is such that each explant that constitutes it does not receive the products according to the present invention , but is subjected to an u . v . a radiation . the third series is such that each explant that constitutes it both receives the product according to the present invention , and is subjected to an u . v . a radiation . the explants of the third series are prepared in the following manner : the product according to the present invention is applied to them twice a day and this for four days . on the fifth day , the product is applied a fifth time to said explants , that are then subjected to a 7 j / cm 2 u . v . a radiation , at the same time as the explants of the second series . the three series of explants are then frozen by immersion in isopentane that is cooled to − 55 ° c . in liquid nitrogen . there are then made approximately ten frontal slices of 6μ inside a cryostat , at a temperature of − 16 ° c ., this having as its effect to stop the immunity activity of the langerhans cells . there is then proceeded to the incubation of a primary antibody and of a secondary antibody in each explant , which antibodies make it possible to reveal , by means of the immunofluorescence technique , the activity of the langerhans cells . indeed , the langerhans cells are active only when they play an antigenic part by blocking the antibodies , it being possible to observe this antigenic action under a fluorescence microscope . the primary antibody is chosen so that it recognizes the langerhans cells , and the secondary antibody , coupled with fluorescent molecules of tetramethyl - rhodamine - isothiocyanate ( tritc ) is provided to color these cells . the cut - up and incubated samples are observed under the fluorescent microscope , so that langerhans cells that characterize each sample can be visualized and counted . from 9 to 11 samples were photographed and studied for each series of explants , to make it possible to assess the average number of langerhans cells per unit of length of the epidermis for the entire group of samples observed . there is also indicated , for each series studied the mean standard deviation ( sem ), which is obtained by dividing the typical error obtained by the square root of the number of samples . the three tables i , ii and iii below , that respectively relate to three series of implants , give the account of these measurements . when comparing the respective results obtained for the first two series , there is seen that the number of langerhans cells decreses by 27 % following an u . v . a . radiation . when comparing the results obtained for the third series with those obtained for the first two series , respectively , it is seen that the explants treated with the product according to the invention , then irradiated with u . v . a ., contain 54 % more langerhans cells , relative to the explants of the second series , that was irradiated but not treated . it will also be noted that these explants treated and irradiated contain 12 % more langerhans cells than the explants of the first control series , the controls in which the cells are neither treated nor irradiated . the product according to the invention thus exerts a protective action , and especially a stimulating action on the langerhans cells contained in the epidermis , following a radiation of the latter with ultraviolet rays . consequently , the macrophagic activity of these cells is increased and the protection of the epidermis against external aggressions is improved . it will be noted that exposure of the epidermis to ultraviolet rays constitutes a simple test that makes it possible to validate the immunomodulating activity of the product according to the invention . it would also be possible to use to that end a test that doses the i - α interleukins , for example .

the present invention relates to the use of natural extracts of algae for the preparation of a product meant to prevent and to treat skin diseases . the invention also relates to natural extracts of algae meant to prevent and to treat these diseases . said use of natural extracts of algae consists in using concentrated extracts of algae of the chlorella type . the invention especially applies to diseases such as skin rashes or allergic reactions to cosmetic compositions .

fig1 a and 1b illustrate front elevation and back elevation views , respectively , of a backpack 10 that includes support arrangements , which can be deployed to convert the backpack into a resting platform such as a bed or a chaise . backpack 10 includes a sack section 12 usually made of a fabric or the like material . on the side 14 configured for resting against the user &# 39 ; s body ( back side ) are provided at least one , but usually two , shoulder straps 16 . the manner of use of a backpack is well known . therefore , how a backpack is used will not be described here . fig1 a and 1b illustrate the apparatus in a non - use state . thus , the support arrangements are in a stored state . however , pull - out handles 18 are visible in fig1 b . fig2 a and 2b illustrate front and side elevation views , respectively , of backpack 10 . for the sake of clarity , the sack section 12 and the shoulder straps 16 are only illustrated in outline form . a backpack 10 according to the invention includes at least one , but preferably two support arrangements . each support arrangement includes a pull out handle 18 , a compliant and rollable fabric 20 , which , in its stored state , is rolled around a spring loaded roller 22 ( similar to the one disclosed in the related applications discussed in the background section ) and a pair of telescopic arms 11 each coupled to an end of pull out handle 18 . each telescopic arm 11 includes an external extension tube 24 having a first internal diameter , a middle extension tube 26 having a second internal diameter smaller than the first internal diameter , and an internal extension tube ( or rod ) 28 having an outer diameter that is smaller than the first and the second internal diameters . internal extension tube 28 is received inside of middle extension tube 26 and middle extension tube is received inside of external extension tube 24 . thus , internal extension tube 28 may be extracted from the interior of middle extension tube 26 , and middle extension tube 26 may be extracted from the interior of external extension tube , whereby the three bodies can be extended / collapsed in a telescopic fashion . referring to fig3 a - 3d , in order to integrate tubes 24 - 28 , appropriate stoppers may be employed . referring to fig3 a ( identified as region s - 01 in fig2 a ), a pair of extension stoppers 30 are provided at the end of external extension tube 24 . extension stoppers 30 are configured to engage a section of middle extension tube 26 when middle extension tube 26 has been extended out a predetermined distance . thus , for example , each extension stopper 30 may be pivotably mounted about a pin 31 ( see fig3 c ) allowing the stoppers 30 to swing into features defined in internal extension tube 24 . referring to fig3 d , for example , middle extension tube 26 may be provided with stopper catcher 32 recesses at a short distance from an end thereof . when middle extension tube 24 has been pulled out far enough extension stoppers 30 swing into stopper catchers 32 of middle extension tube 26 and prevent its further longitudinal travel . note that the same mechanism is preferably used to stop the internal extension tube 28 from advancing beyond a predetermined point . specifically , extension stoppers 30 are provided at the end of middle extension tube 26 in the same manner as described above , and internal extension tube 28 is provided with stopper catcher 32 recesses ( see fig3 d ) which engage extension stoppers 30 at the end of middle extension tube 26 when internal extension tube 28 has been pulled out far enough . note that the end of internal extension tube 28 is coupled to pull out handle 18 . thus , when pull out handle 18 is pulled away from sack 12 , internal extension tube 28 is extracted causing the telescopic extension of the tubes . further note that external extension tube 24 includes extension stopper 30 ( see fig3 b and 3d ), which pivot about pivot pin ( see fig3 b ), and are received inside respective stopper catch 32 recesses , deployed in a common support tube 33 which houses the telescopic arms . common support tube 33 may be longitudinally aligned with tubes 24 , 26 and 28 , and disposed on or inside sack 12 backpack 10 . one purpose of common support tube 33 is to set how far out external extension tube 24 may be extended outwardly , thereby setting the limit for the length of the telescopic arm 11 in its extended state . referring now back to fig2 a and 2b , while only one telescopic arm 11 has been described , it should be noted that two telescopic arms 11 are used to realize a support arrangement . each telescopic arm 11 is positioned adjacent ( i . e . close to ) a respective side of two opposite sides of sack 12 in order to set the width of the support arrangement . furthermore , while one support arrangement may be employed in a backpack 10 according to the present invention , two support arrangements , each deployable from a respective side of two opposite sides of sack 12 , is preferred . note that the telescopic support arms of each support arrangement may be extended to the same length , or different lengths , or may be configured to be the same or different length when stored . while not shown in the figures , it will be understood that to use the present invention , the user will extend the telescopic arms by pulling out the handle 18 . the rollout fabric 20 , which may be coupled to pull out handle 20 , will be automatically pulled out ( i . e ., rolled out ). once telescopic arms 11 are fully extended , fabric 20 will provide a support for the user in generally the same manner as described in the related applications set forth in the background section . note that , optionally , a rigid plate 19 or the like ( fig3 e ) may be integrated with sack portion 12 between arms 11 at back side of sack 12 to provide further support for the weight of the user . preferably , the rigid plate is coupled to common support tubes 33 , but such coupling is not necessary and the rigid plate may be left uncoupled . fig4 a , 4b , 4c and 4d show front , right , left and back elevation views of a suitcase 34 that includes the same support arrangements as those of backpack 10 . thus , instead of a sack 12 , suitcase 34 includes a suitcase section 36 having one surface 37 which can provide , partial support for the user when the support arrangements are deployed , similar to the suitcases shown in the related applications discussed in the background section . fig5 a and 5b illustrate suitcase 34 . for the sake of clarity the suitcase section 36 is shown in outline form . note that like numerals are used to identify like features as those described above . fig6 a and 6b illustrate suitcase 34 with the support arrangements deployed for use . note that a compartment 38 is provided inside suitcase section 36 to house fabric 20 and its associated roller . such a component is also shown in the related applications discussed in the background section . also , note a pull - out handle support 39 , which is preferably hingedly coupled to handle 18 , may be optionally provided for further support as also illustrated in the related applications described in the background section . fabric 20 is permanently attached to handle 18 ; whereas , in the arrangements shown in the related applications described in the background section , the fabric is detachably attached . fig7 a , 7b and 7c illustrate the stopper catcher arrangements described above in a deployed state . fig8 a , 8b , 8c and 8d show front , left , right and back elevation views , respectively , of a suitcase 40 according to a new variation . suitcase 40 includes a suitcase section 36 having a surface 37 that can be used for partial support of a user . similar to the backpack 10 and suitcase 34 and also similar to the suitcases shown in the related applications described in the background section , suitcase 40 includes support arrangements , which when deployed , convert the suitcase into a bed or a chaise . however , suitcase 40 employs a novel configuration . fig9 a illustrates suitcase 40 with the arrangements deployed . the support arrangements in suitcase 40 include a rollable fabric 20 , a fabric roller 22 , which is disposed in a compartment 38 residing at or inside handle 18 , rather than at or inside suitcase section 36 . fabric 20 is permanently or detachably attached to suitcase section 36 at an edge which is adjacent to surface 37 of suitcase section 36 . note that suitcase 40 preferably includes two support arrangements each residing at one side of two opposite sides of suitcase section 36 , each side being preferably adjacent surface 37 . a support arrangement in suitcase 40 includes a one piece arm ( not a multiple piece telescopic arm 11 ) which resides in and is slidably supported within a support tube 42 . for example , one arm 44 is attached at one end to a handle 18 , and is provided with a rubber stopper 46 at another , opposite end . rubber stopper 46 is disposed on the exterior surface of arm 44 and is sized to make contact with the interior surface of support tube 42 . arm 44 may have a first interior diameter that is larger than the cross - section ( exterior diameter ) of another arm 48 . another arm 48 is coupled at one end to another handle 18 having another component 38 in which a roller 22 and fabric 20 reside ( in a stored state ), and includes another rubber stopper 50 at an opposite end . rubber stopper 50 preferably extends around the exterior surface of arm 48 and is sized so that it makes contact with the interior surface of support tube 42 . note that in the stored state , arm 44 is received inside of support tube 44 until it meets rubber stopper 50 , and arm 48 is moved , relative to rubber stopper 50 and received inside of arm 44 in the stored state . fig9 b , 9c and 9d illustrate arms 44 and 48 in their stored state . note that arm 48 may include a rubber top 52 or the like which is sized to engage the interior of arm 44 so that , in a stored state , arm 48 does not move around and cause rattling . arm 44 is configured to slide relative to stopper 46 , while stopper 46 is preferably fixed relative to support tube 42 and does not exit from support tube 42 when arm 44 is extracted . similarly , arm 48 is configured to slide relative to stopper 50 while stopper 50 is preferably fixed relative to support tube 42 so that rubber stopper 50 does not exit support tube 42 when arm 48 is extended . alternatively , stoppers 46 and 50 may be allowed to slide toward one another inside support tube 42 ; however , the respective ends of support tube 42 may be configured to prevent stoppers 46 , 50 from falling out of support tube 42 . it should be noted that while only support arms 44 and 48 are discussed a each support arrangement , as illustrated in the figures , would include two support arms , each positioned adjacent a respective side of opposite sides of a suitcase section 36 , and each connected at one end to a pull - out handle 18 . thus , one support arrangement would include two arms 44 each connected to a respective end of a pull - out handle 18 and another support arrangement would include a pair of arms 48 each connected at one end to a handle 18 . 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 claim .

a portable apparatus including a storage and a support arrangement that is convertible to a resting platform defined as a back pack or a suitcase .

in fig1 and 2 , comminuted fish is supplied at 10 to be treated in equipment to be described . regarding such supply , and in one example of the process , for forming a crustacean - like product such as shrimp , frozen blocks of surimi ( washed minced fish ) are tempered at room temperature until partially thawed . blocks of tempered surimi are then put into a grinder and ground . some hot water ( at about 70 ° c .) is added to the surimi in the grinder to raise the temperature of the mix , for example to about - 1 . 0 ° c . salt is then added to the formulation . after grinding for about 2 minutes , with temperature increased to about 3 ° c ., more salt is added and grinding continued for 6 more minutes . shrimp flavoring is added , and grinding continued for another 6 minutes . the temperature of the finished paste is then around 8 ° c . the paste is then separated into two portions . one such portion of the finished paste is spread on rectangular pans , and allowed to set at about 8 ° c . for 20 hours , during which the paste physically transforms into an elastic gel . after setting , the surimi gel is transformed to a steam cooker , and cooked at about 90 ° c . for about 80 minutes . the cooked gel is then shredded into small pieces , i . e . elongated pieces between 30 and 70 millimeters in length ; 5 to 15 millimeters in width ; and 0 . 5 to 1 . 0 millimeters in thickness . three percent ( by weight ) of citric acid is added to the shredded gel , and the mix is allowed to soak for 15 minutes . the citric acid concentration is 10 %. acid is then pressed from the shredded gel , which is then combined with the second portion of flavored surimi paste , and the mix transferred to a shrimp forming machine to be described . the ratio of shredded gel to flavored surimi paste is about 35 : 65 . the fish slurry ( such as a mix of fish paste and pieces of shredded gelled fish paste ), is supplied at 11 to injectors 12 for injecting the mix into heated molds 13 . a series sequence of such molds is shown as provided on an endless chain conveyor 63 entrained about sprockets 14 . the conveyor is driven at 15 so that the travel of each mold is interupted while the mold cavity or cavities are filled with the mix via the injector or injectors 12 . see for example fig4 showing an injector nozzle 16 in down position and discharging mix at 17 into a mold cavity 18 . as the injector is lifted , some of the mix is allowed to protrude from the mold vent 19 , as indicated at 20 , and typically overhangs at 20a the mold exterior surface 13a adjacent the vent . fig3 shows a typical mold 13 to include the elongated and like mold sections 13b , which form multiple cavities 18 and vents 19 , when the sections are closed together . fig6 shows the shrimp - shaped configuration of one half of the mold cavity , formed by one section 13b . note approximately c - shaped cavity region 18a corresponding to the shrimp body , narrowed region 18b corresponding to the shrimp tail , and vent region 19 corresponding to the shrimp neck . a cavity air vent is formed at 21 . the cavity 18 may alternatively have lobster , or other crustacean shape . prior to injecting the mix into the mold cavities , a suitable colorant may be sprayed or otherwise transferred into the mold section cavities and onto the cavity surfaces . such colorant may be water soluble , and conveyed from a tank source 22 , and via a line 23 , to injectors 24 . the injectors may be lowered so that their nozzle ends 24a penetrate the mold vents 19 , to spray colorant in water into the cavities . a suitable cavity lubricant , or release composition , may also be conveyed in the spray , to coat cavity surfaces . as the filled and heated molds are transported to the right , in fig2 they are further heated exteriorly as by gas flames 64 rising from gas burner 25 , or other heat source means . combustible fuel heating is preferred due to simplicity of equipment and temperature control . such heating is typically continued while the mold travels distance d over the flames , and for between 60 and 100 seconds , and optimally for about 72 seconds , and at a temperature or temperatures to cook the mix , causing it to cohere and form a unitary , soft product , discharged at 25 onto a second conveyor 26 . the product temperature upon such discharge is between 60 ° and 75 ° c . and preferably at least about 65 ° c . note that the vents 19 are directed upwardly , away from and out of the path of the flames 24 , so that the exposed mix outwardly of the vents 19 is not directly contacted by the flames . further , such cooking causes expansion of the mix in the cavity , and its outward expansion or displacement ( see broken lines 20b in fig5 ) from and relative to vent 19 , the portion thus protruding being randomly uneven in surface texture , to simulate the neck region of an actual shrimp after pull - off of the shrimp head . this is made possible due to the process described and to be described , and further characterized by an absence of pressurization of the mix in the continuously vented mold - cavity , during cooking in the mold . fig2 and 7 - 9 also illustate mold opening , to downwardly expose the mold section cavities , for product fall - out , by gravity , onto conveyor 26 . see for example the opened sections 13b in fig2 . a rotary brush 27 may be employed to brush against the underside of the molds to clean the cavities of any remanant cooked mix , and / or to assist in product discharge from the mold sections . fig7 shows the molds conveyed in direction 30 , with slidable camming units 31 attached to the section 13b . the units 31 are activated in response to sideward displacement of rollers 32 traveling along rails 33 , which diverge laterally at 33a . as rollers 32 are displaced laterally by the rails , cam unit slides 34 interact with followers 35 to pivot each mold section about 90 °, one forwardly and the other rearwardly , to open the mold . thereafter , the molds are closed as the rollers 32 travel along the rails that converge at regions 33b . see also mold section hinges 66 . referring back to fig1 . product 25 on conveyor 26 is tranferred to and by another conveyor 40 , to further processing equipment . such further processing typically includes broiling the product at 41 , for a time interval t 1 between 50 and 70 seconds , and at a broiling zone wherein the temperature is between 160 ° c . and 200 ° c . for best results , the product is broiled for about 64 seconds , and at a temperature or temperatures of about 180 ° c ., the product temperature at the end of broiling being about 60 ° c . such broiling is desirably carried out while the product is supported on a slowly traveling open - work metal grid that includes conveyor 44 in the broiling zone , and by combusting gas at upper and lower sides of the grid to directly transmit broiling heat to opposite sides of the product . subsequently , the product is cooked in an enclosed , steam filled zone 50 for a time interval t 2 , between 9 and 11 minutes . zone 50 is typically at atmospheric pressure , and the temperature therein is kept between 80 ° and 110 ° c ., and preferably at about 85 ° c . for best results . the product may be traveled on a conveyor 52 in zone 50 . finally , at the end of t 2 , the product is transferred into a cooling zone 55 , kept at a temperature around 0 ° c . the cooled product is then packed , for shipment . in the above , the mold may be metallic , with coating surfaces formed by teflon to prevent product adherence . due to the non - smooth configuration of the cavity surfaces having shrimp body shape , the sprayed - in reddish color will not coat the surfaces uniformly , so that the resultant color transferred to the product will impart a true shrimp surface look to the product .

a fish product is produced by heating , in a mold cavity , a mixture of fish paste and pieces of gelled fish paste , the cavity being vented to the exterior allows the mix to expand via the vent during such heating , to produce a simulated crustacean form . the gelled pieces may be acid treated prior to mixing with fish paste , and the molded product further processed , so that the final product has a simulated crustacean bite texture .

although this invention is applicable to numerous and various types of procedures and providing access to various hollow organs , it has been found particularly useful in the environment of providing intracardiac access in a beating heart open chest procedure . therefore , without limiting the applicability of the invention to providing intracardiac access in a beating heart open chest procedure , the invention will be described in such environment . referring now to fig1 , 2 a , and 2 b there is shown a first preferred implementation of an intracardiac access device having an expandable balloon , the first preferred implementation of the access device being generally referred to by reference numeral 100 . the access device 100 provides access into a hollow organ 102 , such as the heart , during an open surgical procedure . the access device has a body 104 that is inserted into an opening or incision 106 in a wall 108 of the hollow organ 102 . the body 104 is preferably cylindrical in shape and is typically fabricated from a medical grade thermoplastic and can be fabricated from any methods known in the art , such as conventional machining or injection molding . the body 104 has a bore 110 sized to permit at least a distal portion of an instrument ( not shown ) to pass through the bore 110 and into an interior of the hollow organ 102 . the bore extends in an axial direction a from an exterior of the hollow organ 102 to an interior of the hollow organ 102 . a valve 112 is disposed in the bore 110 of the body 104 for allowing passage of the instrument while substantially preventing a fluid in the interior of the hollow organ 102 from leaking outside the hollow organ 102 preferably , the valve 112 is what is commonly referred to in the art as a duckbill valve . the duckbill valve 112 is fabricated from an elastomer , such as silicone , and has a cylindrical portion 116 and a tapered portion 118 . the tapered portion 118 terminates in a slit 120 . the slit 120 is normally closed to provide a seal and is configured to conform to a shape of an instrument passed through the slit 120 to provide a seal around the instrument . the duckbill valve 112 further has a stepped portion 122 that rests on a corresponding shoulder 124 of the body 104 . the duckbill valve 112 can be press fit into the body or retained therein by way of a medical grade adhesive . alternatively , a flange ( not shown ) can be used to capture a portion of the duckbill valve 112 . although , duckbill valves are preferred , other types of valves known in the art can be used without limiting the scope or spirit of the present invention , such as a flexible membrane ( not shown ) having a small expandable aperture . the access device 100 also has securing means for securing the body 104 to the wall 108 of the hollow organ 102 . the securing means fixes the body 104 to the wall 108 such that it is not in danger of coming off or falling into the interior of the internal organ 102 . preferably , the securing means also provides a seal between the opening 106 and the body 104 of the access device 100 . in a first preferred implementation , the securing means comprises a balloon configuration . in such a configuration , a lip 126 , which is preferably cylindrical , is disposed on a proximal portion 104 a of the body 104 . the lip 126 is preferably integrally formed with the body 104 , but may also be formed separately and attached to the body 104 by any means known in the art , such as by ultrasonic welding , thermal welding , or with a medical grade adhesive . a balloon 128 is disposed on a distal portion 104 b of the body 104 . the balloon is shown in a deflated or relaxed position in fig2 a . the relaxed position of the balloon 128 may be due to the lack of a fluid , such as saline or air , therein , or by applying a vacuum to the balloon . a conduit 130 is preferably formed in the body for supplying the fluid from a fluid source ( not shown ) or applying a vacuum from a vacuum source ( not shown ) to the balloon for expansion or contraction , respectively , thereof . a port 132 is preferably provided in fluid communication with the conduit 130 to facilitate connection of the fluid or vacuum source to the conduit 130 . preferably , the fluid and vacuum source comprise a syringe ( not shown ) and the port 132 comprises a self - sealing needle port as is known in the art . fig2 b shows the balloon 128 in an expanded position in which the wall 108 of the hollow organ 102 is captured between the lip 126 and the balloon 128 . although not shown , it is preferred that the wall 108 be compressed slightly upon the expansion of the balloon 128 . referring now to fig3 a and 3b , the body 104 has a low - profile length l in the axial direction a of the bore 110 to increase a manipulative capability of the instrument 134 through the bore 110 . preferably , the length l of the body 104 in the axial direction a of the bore 110 is substantially within a range of 1 . 5 t to 5 t , where t is a thickness of the wall 108 . for example , the thickness for a typical heat wall varies between approximately 3 - 7 mm and the length l of the body 104 is in the range of 4 . 5 mm to 35 mm , most preferably about 10 - 15 mm . as clearly seen in fig3 a , the low - profile length l of the body 104 as compared to the thickness t of the wall 108 allows an instrument 134 to be manipulated at a greater angle α with respect to a central axis of the bore than the endoscopic access devices of the prior art . furthermore , as clearly shown in fig3 b , the low - profile length l of the body 104 as compared to the thickness t of the wall 108 allows insertion of a curved instrument having a radius r , which is not possible with the endoscopic access devices of the prior art . referring now to fig4 and 5 , there is illustrated a second preferred implementation of an access device of the present invention , the second preferred access device being generally referred to by reference numeral 200 . access device 200 also preferably has a low - profile shape as discussed above with regard to the first preferred implementation and has the same advantages as discussed above with regard to fig3 a and 3b . access device 200 includes a body 202 having first and second body portions 204 , 206 , respectively . the first and second body portions 204 , 206 are fabricated from any medical grade material , such as stainless steel or a polymer . the first body portion 204 includes a flange 208 and a cylinder portion 210 . the first body portion 204 further has a bore 212 that accommodates a valve 214 . referring now to fig1 , the valve 214 is preferably a duckbill or slit valve fabricated from a medically approved elastomer , such as silicone . the valve 214 has a flange 216 which fits within a corresponding stepped groove 218 in the bore 212 of the first body portion 204 . the valve 214 also has a cylindrical body portion 220 that fits within the bore 212 of the first body portion 204 . the valve 214 has a slit 222 on a conical nose 224 thereof to sealingly accommodate an instrument inserted through the access device 200 . the valve 214 is retained in the bore 212 by any means known in the art such as by adhesive or press - fit . the valve 214 , although shown disposed in the first body portion 204 may also be disposed in the second body portion 206 and although shown and described as a discrete part may be integrally formed with either of the first and second body portions 204 , 206 . referring back to fig4 and 5 , the second body portion 206 has a bore 226 , at least a portion of which accommodates the cylinder portion 210 of the first body portion 204 such that it is free to both rotate and translate within the bore 226 of the second body portion 206 . the second body portion 206 further has at least one shoulder or flange 228 on an exterior surface thereof . a seal , such as an o - ring 230 is provided to seal a fluid path between the first and second body portions 204 , 206 . the second body portion 206 further has a plurality of first longitudinal channels 232 corresponding to each of a plurality of hooks 234 disposed circumferentially about the second body portion 206 . each of the plurality of hooks 234 have at least a portion thereof which is slidingly disposed in a corresponding first longitudinal channel 232 . the second body portion also includes a plurality of second longitudinal channels 236 for housing an upturned portion 238 of the hooks 234 when the hooks 234 are in an unexposed position . referring now to fig1 , one of the plurality of hooks 234 is shown therein . the hooks 234 are fabricated from a medically approved metallic material , such as stainless steel and have a sharp pointed end 240 at the end of the upturned portion 238 . at a proximal end of the hook is a tuned - in portion 242 that engages with and is retained in portions of the first body portion 204 , such as in corresponding circumferential slots 244 in the bore 212 of the cylinder portion 210 . at the distal end of the hooks 234 is the upturned portion 238 . a straight portion 246 connects the in - turned 242 and upturned 238 portions with a curved portion 248 at a transition between the straight portion 246 and the upturned portion 238 . at least a portion of the straight portion 246 is slidingly disposed in a corresponding first longitudinal channel 232 . referring now to fig5 - 8 , an operation of the access device 200 of the second preferred implementation will be described . the access device 200 is securely positioned in an incision 106 in a wall 108 of a hollow organ 102 , such as the heart . the incision is made by any methods known in the art and may be a slit or a punched hole after access is provided to the hollow organ , such as by a gross thoracotomy . the wall 108 is shown in fig5 , but omitted from fig6 - 8 for the sake of clarity . referring first to fig8 , the upturned portions 238 of the hooks 234 are disposed in corresponding second longitudinal channels 236 such that the sharp pointed ends 240 are unexposed . the access device is inserted into the incision 106 while the hooks 234 are in the unexposed position as shown in fig8 . while the upturned portions 238 are shown as being disposed in the second longitudinal channels 236 in the unexposed position , they can alternatively be disposed in corresponding cut - outs ( not shown ) on the exterior of the second body portion 206 . referring next to fig6 , the first body portion 204 is translated relative to the second body portion 206 in the direction of arrow a to extend the upturned portions 238 from the second longitudinal channels 236 . referring now to fig7 , the first body portion 204 is then rotated in the direction of arrow b about a central axis c to turn the upturned portions 238 90 degrees and expose the sharp pointed ends 240 . when the first body portion 204 is rotated , the hooks 234 are rotated by an interference with the in - turned portions 242 of the hooks 234 and a wall of the corresponding slots 244 . once the hooks 234 are both extended and exposed as shown in fig6 , the first body portion 204 is translated in the direction of arrow d ( opposite to the direction of arrow a ) to embed the upturned portions 238 into the wall 108 of the hollow organ 102 circumferentially about the incision 106 , as shown in fig5 . the access device 200 is then secured to the wall 108 by sandwiching the wall 302 between the step or flange 228 and the curved portions 248 of the hooks 234 . referring now to fig5 and 9 , while the hooks 234 are embedded into the wall 108 , a locking clip 250 is disposed in a gap 252 between the flange 208 of the first body portion 204 and the second body portion 206 to prevent any translation of the first body portion 204 in the direction of arrow a . the thickness t of the locking clip 250 substantially conforms to a thickness t of the clip . the locking clip 250 is preferably fabricated from a medically approved polymer and has fingers 254 which elastically deform to fit within the gap 252 . the locking clip 250 further has a pull 256 for facilitating handling and inserting and removing the locking clip 250 into and from the gap 252 . locking clip 250 may have a tether attached to it on one end and to a point outside the operative field on another end to prevent locking clip 250 from inadvertently being left within the patient when the procedure is complete . alternatively , the locking clip 250 may be tethered to the access device 200 itself . while the access device 200 is secured and locked to the wall 108 , surgical instruments ( not shown ) are inserted through the valve such that the working ends thereof are inserted into an interior of the hollow organ for performing a necessary surgical procedure . after completion of the surgical procedure , the access device 200 is removed and the incision 106 is closed . to remove the access device 200 from the incision 106 , the clip 250 is removed and the first body portion 204 is translated in the direction of arrow a to dislodge the upturned portions 238 of the hooks 234 from the wall 108 . the first body portion 204 is then rotated in a direction opposite to that of arrow b about the central axis c to rotate the hooks 90 degrees such that the sharp pointed ends 240 are aligned with the second longitudinal channels 236 . the first body portion 204 is then translated in the direction of arrow d to return the up - turned portions 238 of the hooks 234 to the unexposed positions in the second longitudinal channels 236 . the access device 200 is then removed from the incision 106 and the incision 106 is closed by any means known in the art , such as with sutures or surgical glue . referring now to fig1 and 13 there is illustrated an automatic stitching device , referred to generally by reference numeral 300 . preferably , the automatic stitching device 300 comprises the access device 200 substantially similar to that described above used in combination with a suture holder 302 to provide an automatic stitching capability to the access device 200 for automatically stitching the incision 106 of the hollow organ 102 after completion of a surgical procedure . although the automatic stitching device 300 is described in combination with the access device 200 , those skilled in the art will appreciate that the same can be used without the features of the access device 200 that facilitate use therewith with surgical instruments . for example , the access device 200 can be configured without the bores 212 , 226 , and / or valve 214 . furthermore , although described as a separate piece , those skilled in the art will appreciate that the suture holder 302 may be integrally formed with the access device 200 . additionally , the incision 106 is described by way of example only as being in the wall 108 of a hollow organ 102 as described above . those skilled in the art will appreciate that the automatic stitching device can be used to automatically stitch any incision , wound , or damaged tissue , and can also be used to join two tissues together such as an anastomodic device or in a valve repair or replacement . lastly , the access device 200 is described as having a cylindrical distal portion 304 for insertion into the incision 106 , however , those skilled in the art will further appreciate that the distal portion 304 can be provided in many different shapes for use with different shaped incisions . for example , the distal portion 304 may by oval shaped for use with a linear incision . the suture holder 302 is preferably disk - shaped and has a bore 306 for acceptance of the distal portion 304 of the access device 200 . the suture holder 302 has a thickness t smaller than the length l 1 of the distal portion 304 of the access device such that when the suture holder 302 is inserted onto the distal portion 304 of the access device ( as shown in fig1 ), a portion l 2 of the distal portion 304 protrudes from the suture holder 302 . the suture holder 302 has two internal grooves 308 , 310 about a periphery of the bore 306 . a proximal one of the internal grooves 310 holds sutures ( one each for each of the hooks 234 ). a distal one of the internal grooves 308 holds a glue for , as will be described below , gluing an end of the suture onto each of the sharp pointed ends 240 of the hooks 234 . the glue is preferably a two - part medically approved pressure sensitive high viscosity epoxy wherein each of the two parts are separated in the groove by a membrane . examples of glues for use with the suture holder 302 are a medical cyanoacrylate glue or vitralit medical grade adhesive . alternatively , two grooves can be provided to hold the glue , one for each of the two parts of the epoxy . the suture holder 302 also has a linking groove 312 on a distal surface 314 of the suture holder 302 for accepting the upturned portions 238 of the hooks 234 and for linking the two internal groves 208 , 210 . alternatively , the linking groove 312 can be individual holes corresponding to each of the upturned portions 238 of the hooks 234 . the suture holder is preferably a disposable device where the glue and sutures are loaded into their respective internal grooves 210 , 208 and once used , it is discarded . however , those skilled in the art will appreciate that it can also be reusable where the glue and sutures are loaded into their respective internal grooves 210 , 208 prior to each procedure . referring now to fig1 - 23 , the operation of the automatic stitching device 300 will be described . as discussed above , the operation of the automatic stitching device 300 will be described with regard to the access device 200 described above . referring specifically to fig1 , the access device is operated to have the upturned portions 238 of the hooks 234 inserted into their corresponding second longitudinal channels 236 , as described above , by rotating the first body portion 204 relative to the second body portion 206 and translating the first body portion 204 relative to the second body portion 206 in the direction of arrow d . the distal portion 304 of the access device 200 is then inserted into the bore 306 of the suture holder 302 such that a portion 316 protrudes therefrom a distance l 2 . referring now to fig1 , portion 316 is inserted into the incision 106 . referring now to fig1 , the hooks are then extended , as described above , by translating the first body portion 204 relative to the second body portion 206 in the direction of arrow a . the hooks 234 are further rotated 90 degrees , as described above , by rotating the first body portion 204 relative to the second body portion 206 in the direction of arrow b . as shown in fig1 , the hooks 234 are then retracted , as described above , to embed the upturned portions 238 of the hooks 234 in the tissue wall 108 to secure the access device 200 to the tissue wall 108 . the access device 200 can then be used , if necessary , in combination with the locking clip 250 to perform a surgical procedure , as described above , by inserting an manipulating surgical instruments through the valve 214 and bores 212 , 226 . when the hooks 234 are retracted , each of the sharp pointed ends 240 further enter the linking channel 312 to engage a portion of a suture 318 and glue 320 disposed in the internal grooves 308 , 310 . if necessary , the sharp pointed ends 240 further puncture the membrane separating the two parts of the epoxy . thus , while a procedure is being performed , the sutures in one of the internal channels 310 are adhered to each of the sharp pointed ends 240 of the hooks 234 . preferably , a locating means , such as a key ( not shown ) in the bore 306 and a corresponding keyway ( not shown ) is provided to orient the suture holder 302 in a predetermined position with respect to the sharp pointed ends 240 of the hooks 234 such that an end of a suture can be located in the linking channel 312 at the location of the sharp pointed ends 240 . in this way , the sharp pointed ends 240 would pierce the membrane between parts of the epoxy glue 320 and then contact the suture 318 end to adhere the same to the sharp pointed ends 240 of the hooks 234 . although , the suture holder 302 described above is preferred , those skilled in the art will appreciate that such is given by way of example only and not to limit the scope or spirit of the present invention . many configurations of the suture holder are possible , such as a disk having sutures with looped ends , where the looped ends correspond to each of a hole or linking channel . in such a configuration , each of the upturned portions 238 of the hooks 234 would have a downwardly facing slit . in operation , on the upstroke through the linking channel , the hooks 234 would displace the loop ends from the hole and pass through the hole , however , on the down stroke , the loop end would be captured in the slit and be retained therein . referring now to fig1 , after the procedure has been completed and / or after the sutures 318 have been retained on each of the hooks 234 , the hooks 234 are again extended , as discussed above . as shown in fig1 , as the hooks 234 are extended , they withdrawn the suture 318 from the longitudinal channel 310 and pull the sutures 318 through the tissue wall 108 in an area surrounding the incision 106 . as shown in fig1 , the hooks 234 are rotated 90 degrees , as discussed above , to correspond with their respective second longitudinal channels 236 . as shown in fig2 , the upturned portions 238 of the hooks 234 are then retracted into the second longitudinal channels 236 along with a corresponding portion of suture 318 . it is preferred that the suture 318 be tightly retained in the second longitudinal channels 236 , and as such , the second longitudinal channels 236 are sized closely to that of the upturned portions 238 . referring now to fig2 and 22 , the automatic stitching device 300 is then removed from the incision 106 which in turn continues to withdraw suture 318 from the longitudinal channel 310 and the suture holder 302 is removed from the distal portion 304 of the access device 200 . as shown in fig2 , the sutures 318 are then cut free of the suture holder 302 and / or the access device . at this point , the sutures 318 are looped through the tissue wall 108 surrounding the incision 106 and can be pulled tightly to close the incision 106 and tied . furthermore , the sutures can alternatively be anchored in the device such that the removal of the device itself pulls the sutures and closes the incision . those skilled in the art will appreciate that the preferred implementation of the automatic stitching device 300 described above simplifies the stitching of incisions ( or wounds or damaged portions of tissue ) and results in a reliable , and uniform stitch that is quickly made and does not require special skills on the part of the surgeon . furthermore , when used in combination with the access device 200 , it provides a single device that provides access , secures to an area surrounding an incision in the tissue , and automatically closes and stitches the incision upon withdrawal of the device . as discussed above , the automatic stitching device 300 can also be used to create an anastomosis between vessels or to repair a damaged heart valve . referring now to fig2 - 26 there is illustrated an alternative embodiment of the suture holder of the present invention , the alternative suture holder being referred to by reference numeral 400 . although shown separately for the sake of clarity , the alternative suture holder 400 is intended to be used with the access device 200 substantially as shown and described above with regard to suture holder 302 . that is , the distal portion 304 of the access device 300 is disposed in a bore 402 of the alternative suture holder 400 similarly to that described above with regard to suture holder 302 . as also discussed above , the access device 300 and suture holder 400 may be integrally formed . the alternative suture holder has a channel 404 for holding one or more sutures 406 . the sutures 406 preferably have frayed ends 408 corresponding to the hooks 234 of the access device 300 . as discussed above , the alternative suture holder 400 and the access device 300 have locating means , such as a key and corresponding keyway ( not shown ) for locating the frayed ends 408 of the sutures 406 disposed in the suture holder 400 with the hooks 234 of the access device 300 . the alternative suture holder 400 has a main body portion 410 and an annular ring 412 rotatably disposed in a groove 414 in the main body 410 . preferably the main body 410 has upper and lower halves 410 a , 410 b , which when assembled , define the groove 414 and allow easy assembly of the ring 412 to the main body 410 . the annular ring 412 has a ring gear 416 on an inner surface of the annular ring 412 . the alternative suture holder 400 has a plurality of collet assemblies 418 disposed in a circular pattern about the bore 402 . although four such collet assemblies 418 are shown in fig2 , two or more are necessary to perform the auto - stitching of tissue as described above . each of the collet assemblies 418 includes an inner collet 420 having three or more slits 422 and an internal channel 423 in which is disposed the frayed ends 408 of the sutures 406 . a lower portion of the inner collets 420 has a tapered surface 424 . the collet assemblies 418 further have an idler 426 having a geared surface 428 meshingly mating with the inner - geared surface of the ring gear 416 and an inner threaded surface 430 . a sliding nut 432 is disposed in each of the collet assemblies 418 and having an inner bore disposed over the tapered surface 424 . the sliding nut 432 has an outer threaded surface 434 in mating relationship with the inner threaded surface 430 of the idler 426 . finally , each collet assembly 418 has a glue chamber 436 disposed in the internal channel 423 . the glue chambers 436 each have a dose of glue , as described above , disposed within a cavity in the chamber 436 . similarly to that described above with regard to the access device 300 and suture holder 302 , the access device 300 is disposed in the bore 402 of the alternative suture holder 400 and the distal portion 304 of the access device 300 is inserted into an incision or other opening in tissue to be sutured . the hooks 234 are deployed from the access device 300 , pierce the tissue , and are accommodated in the internal channels 423 . as discussed above , the locating means ( not shown ) preferably locates each of the hooks 234 to correspond with one of the collet assemblies 418 , although more hooks 234 can be provided which do not correspond to collet assemblies 418 or additional collet assemblies 418 can be provided for each of the additional hooks 234 . as the hooks 234 penetrate the internal channels 423 of the collet assemblies 418 , the sharp pointed ends 240 of the hooks pierce the glue chambers 436 to coat the sharp pointed ends 240 of the hooks 234 with a dose of glue . at this point , the inner bore of the sliding nuts 432 are engaged with a lowered end of the tapered surface 424 of the inner collets 420 as is shown in fig2 . the annular ring 412 is then rotated which in turn rotates the idlers 426 meshingly mated thereto by way of the ring gear 416 and geared surface 428 . as the idlers 426 rotate , the sliding nuts 432 move upward such that their inner bores further engage and push a corresponding tapered surface 424 due to the engagement of the inner threaded surface 430 of the idler and the outer threaded surface 434 of the sliding nuts 432 . as the inner bores of the sliding nuts 432 engage the tapered surface 424 the inner collets 420 close about the slits 422 to compress the frayed ends 408 of the sutures 406 against the sharp pointed ends 240 of the hooks 234 and the glue disposed thereon as shown in fig2 . after the glue has dried , thus adhering the sutures 406 to the hooks 234 , the access device is removed and the tissue opening is sutured as described above . alternatively , the frayed ends 408 of the sutures 406 can be pre - coated with pressure sensitive glue , eliminating the need for a glue chamber 436 . in such an alternative configuration , the radial pressure from the collet assemblies 418 will serve to attach the suture 406 to the hook 234 . referring now to fig2 a and 27 b , there are shown alternative hooks , referred to generally by reference numerals 500 and 550 , respectively . the alternative hooks 500 , 550 are similarly configured to the hooks described above with the exception of the sharp pointed ends 502 , 552 which are illustrated in fig2 a and 27 b , respectively . the sharp pointed ends 502 , 552 include means for mechanically capturing and swaging the suture 406 to the hook 500 , 550 . the alternative hooks 500 , 550 can be used together with the alternative suture holder 400 to swage the frayed ends 408 of the suture 406 to the sharp pointed ends 502 , 552 of the hooks 500 , 550 . the alternative hooks 500 , 550 replace the hooks 234 in the access device 300 and are used as described above to pierce the tissue surrounding a tissue opening and which are accommodated in the internal channels 423 of the collet assemblies 418 . however , as the annular ring 412 is rotated , the collet assemblies 418 act to mechanically compress the sharp pointed ends 502 , 552 of the hooks 500 , 550 to thereby capture the frayed ends 408 of the suture 406 . in the first alternative configuration , shown in fig2 a , the sharp pointed end 502 includes at least one projection 504 forming an opening 506 . as the collet assemblies 418 compress the projection , the suture 406 or frayed ends 408 thereof , are captured between the projections 504 and the sharp pointed ends 502 of the hook 500 in the opening 506 , thereby swaging the suture 406 to the hook 500 to provide a mechanical bond between the sutures 406 and hook 500 . in the second alternative configuration , shown in fig2 b , an opening 554 is formed in the sharp pointed end 552 , preferably in the shape of a diamond . as the collet assemblies 418 compress the diamond shaped sharp pointed end 552 , the suture 406 or frayed ends 408 thereof , are captured in the opening 554 , thereby swaging the suture 406 to the hook 550 to provide a mechanical bond between the sutures 406 and hook 550 . the glue chamber 436 may also be used with the alternative hooks 500 , 550 to both glue and swage the frayed ends 408 of the sutures 406 to the sharp pointed ends 502 , 552 of the hooks 500 , 550 . while there has been shown and described what is considered to be preferred embodiments of the invention , it will , of course , be understood that various modifications and changes in form or detail could readily be made without departing from the spirit of the invention . it is therefore intended that the invention be not limited to the exact forms described and illustrated , but should be constructed to cover all modifications that may fall within the scope of the appended claims .

an automatic suturing device including : a body for insertion into an opening in tissue ; a plurality of hooks movably disposed in the body between retracted and extended positions ; a suture holder having sutures disposed therein , the suture holder having a mechanism for engaging a portion of the hooks when in the retracted position and for attaching the sutures to a portion of the plurality of hooks ; and an actuator for actuating the plurality of hooks from the retracted position to the extended position and for embedding the exposed plurality of hooks with the attached sutures into the tissue surrounding the opening .

as stated above , preferred phosphonates of formula i for use in accordance with the invention are those of the following formula i r 1 and r 2 may be the same or different and are each selected from hydrogen , alkyl , haloalkyl , acyloxyalkyl , aryl , an alkali metal cation or an optionally substituted ammonium cation or r 1 and r 2 may form together with the oxygen and phosphorus atoms a dioxaphosphacycloalkane ring ; r 1 is selected from the group consisting of alkyl , aryl , aralkyl , cycloalkyl , heteroaryl , heteroaralkyl , heterocyclyl , heterocyclyl - substituted lower alkyl optionally substituted c 1 – c 10 aminoalkyl or c 3 – c 10 aminocycloalkyl , — oz or — sz where z is selected from optionally substituted alkyl , cycloalkyl , aralkyl , aryl , or r 3 is — nr 4 r 5 where r 4 and r 5 may be the same or different and are each selected from hydrogen , hydroxy , alkyl , cycloalkyl , alkoxy , aryl heteroaryl , aralkyl , heteroaralkyl , alkoxyalkyl , carboxyalkyl , alkoxycarbonylalkyl , aryloxycarbonylalkyl , acyloxyalkoxycarbonylalkyl heterocyclyl , heterocyclyl - substituted lower alkyl c 1 – c 10 aminoalkyl or aminocycloalkyl , guanidinoalkyl , guanidinocycloalkyl , amidinoalkyl , amidinocycloalkyl or r 3 is an aminoacid or an oligopeptide , said aminoacid or oligopeptide optionally being substituted at its n - terminus and / or at its c - terminus ; x is o or s ; or pharmaceutically acceptable salt thereof . examples of phosphonates of formula i above are shown in table 1 . these compounds may generally be synthesized using methods known in the art for the synthesis of alpha - oxo - or alpha - thioxophosphonates . specific methods that may typically be used are described below in the examples . table 1 further shows the inhibitory effect of these compounds on mmps . as a consequence of this effect the invasiveness of cancer cells is inhibited . the compounds examined have been added to the invasion or chemotaxis chambers respectively , at various concentrations . the resulted invasion and migrations were compared to untreated preparations and initially grouped according to their activity ; ‘++++’ denotes compounds that were active at submicromolar concentration , ‘+++’- compounds were active at 1 – 10 μm , ‘++’ were active at 50 – 100 μm , ‘+’ were active at 100 μm , ‘−’ compounds were not active at 100 μm . preferred compounds of formula i for use in the compositions of the present invention are phosphonoformamides ( also known as carbamoylphosphonates ). particularly preferred compounds in accordance with the invention are the novel compounds 25 – 37 shown in table 1 above . the active ingredients , i . e . alpha - oxo - or alpha - thioxophosphonates used in accordance with the invention may be formulated into pharmaceutical compositions by any of the conventional techniques known in the art . the pharmaceutical carrier may be solid or liquid . the compositions may be prepared in various forms such as capsules , tablets , suspensions , suppositories or injectable formulations for parenteral , e . g . intramuscular or intravenous injection . in tablets for example , the active ingredient is mixed with a carrier having the necessary compression properties in suitable proportions and compacted in the shape and size desired . suitable solid carriers include , for example , calcium phosphate , magnesium stearate , talc , sugars , lactose , dextrin , starch , gelatin , cellulose , methyl cellulose , sodium carboxymethyl cellulose and polyvinylpyrrolidine . liquid carriers may be used in preparing solutions , suspensions , emulsions or syrups . the active ingredient can be dissolved or suspended in a pharmaceutically acceptable liquid carrier such as water , an organic solvent , a mixture of pharmaceutically acceptable oils or fat . suitable examples of liquid carriers for oral and parenteral administration include water , alcohols , and oils . the preferred administration form in each case will depend on the desired delivery mode ( which is usually that which is the most physiologically compatible in accordance with the patient &# 39 ; s condition ), other therapeutic treatments which the patient receives , etc . without wishing to be bound by theory , it is believed that the alpha - oxo or alpha - thioxo function in the phosphonates of the present invention is necessary for the inhibitory effect on zinc containing proteinases , especially mmps . this is apparent from comparing the effect of p - chlorobenzylphosphonic acid sodium salt ( clc 6 h 4 ch 2 po 3 hna , compound 38 in table 1 ) to that of p - chlorobenzoylphosphonic acid sodium salt ( clc 6 h 4 c ( o ) po 3 hna , compound 8 in table 1 ). while the latter shows considerable mmp inhibiting activity at a concentration of 10 micromolar the former , having the same structure except for the lack of the oxygen at the alpha position , is completely devoid of inhibitory activity . out of the phosphonates of formula i , some are known , albeit for uses other than those of the compositions of the invention , and others are novel . the novel compounds of formula i which constitute another aspect of the invention are carbamoylphosphonates shown below : r 1 and r 2 may be the same or different and are selected from hydrogen , an alkali metal cation or an optionally substituted ammonium cation ; r 3 is selected from the group consisting of — nr 4 r 5 where r 4 and r 5 may be the same or different and are each selected from hydrogen , alkyl , cycloalkyl , alkoxy , aryl , heteroaryl , aralkyl , heteroaralkyl , alkoxyalkyl , carboxyalkyl , alkoxycarbonylalkyl , aryloxycarbonylalkyl , acyloxyalkoxycarbonylalkyl heterocyclyl , heterocyclyl - substituted lower alkyl , c 1 – c 10 aminoalkyl or c 3 – c 10 aminocycloalkyl , morpholino , guanidinoalkyl , guanidinocycloalkyl , amidinoalkyl , amidinocycloalkyl or r 3 is an amino acid or an oligopeptide , said amino acid or oligopeptide optionally being substituted at its n - terminus and / or at its c - terminus ; x is o or s , particularly preferred new compounds in accordance with the invention are those having formula i , wherein r 3 is 2 - dimethylaminoethylamino ( compound # 26 in table 1 ), cyclopentylamino , 2 -( 4 - imidazolylethl ) amino , or an oligopeptide , said oligopeptide optionally being substituted at its c - terminus , for example phosphonoformyl - leu - val - nhme , phosphonoformyl - phe - val - nhme , phosphonoformyl - leu - phe - phenethylamide , phosphonoformyl - leu - tyr ( me )- n - methylamide and phosphonoformyl - leu - phe - n - methylamide . these compounds were found active in the boyden chamber chemoinvassion assay at 1 μm concentrations or less and the structures of some of them are shown below : the invention will now be illustrated by the following non - limiting examples . to a solution of dimethyl p - chlorobenzoylphosphonate ( 1 mmol ) in dry dioxane ( 5 ml ), brme 3 si ( 3 mmol ) was added dropwise under magnetic stirring , in nitrogen atmosphere at room temperature . after 5 h the solvent was removed under vacuum and the brown residue was dissolved in meoh at 0 ° c . the solvent was evaporated and a solution of naoh ( 1 mmol ) in meoh ( 5 ml ) was added in portions . the white solid was filtered and dried under vacuum . yield : 76 %. nmr , 1 h : 7 . 54 ( d , 2h ), 8 . 11 ( d , 2h ); 31 p , − 1 . 48 ppm . a ) triethyl phosphite ( 1 mmol ) was added to ethyl chlorothiolformate ( 1 mmol ) at 0 ° c . under n 2 atmosphere and the resulting mixture was magnetically stirred at room temp . monitoring the reaction by 31 p nmr showed that after 3 h the reaction was completed . the clear yellow solution was purified by distillation ( b . p . 110 – 114 ° c . at 1 mm ). yield of the product triethyl phosphonothiolformate : 81 %, nmr , 1 h , 1 . 27 ( t , 3h ); 1 . 36 ( t , 6h ); 2 . 99 ( c , 2h ), 4 . 23 ( m , 4h ). 31 p − 4 . 22 ppm . b ) to a solution of triethyl phosphonothiolformate ( 1 mmol ), prepared in step a ), in dry dioxane ( 5 ml ), brme 3 si ( 3 mmol ) was added dropwise under magnetic stirring and n 2 atmosphere , at 60 ° c . after 10 h the solvent was removed under vacuum and the brown residue dissolved in meoh at 0 ° c . the solvent was evaporated and a solution of naoh ( 1 mmol ) in meoh ( 5 ml ) was added in portions . the white solid was filtered and dried under vacuum . yield : 76 %. 1 h nmr : 1 . 20 ( t , 3h ); 2 . 90 ( c , 2h ). 31 p nmr : − 1 . 37 ppm . to a solution of cyclohexylamine ( 1 mmol ) in acetonitrile ( 5 ml ) diisopropyl ethyl phosphonothiolformate ( 1 mmol ) was added dropwise under magnetic stirring , in n 2 atmosphere at 0 ° c . the reaction was monitored by 31 p nmr . it was complete after 8 h . the solvent was evaporated under vacuum and the crude product was dissolved in acoet , and purified by chromatography . yield : 62 %, nmr , 1 h , 1 . 10 – 1 . 30 ( m , 5h ); 1 . 35 ( t , 12h ); 1 . 60 – 1 . 95 ( m , 5h ); 3 . 82 ( m , 1h ); 4 . 75 ( m , 2h ); 6 . 82 ( m , 1h ). 31 p nmr : − 2 . 48 ppm . to a solution of cyclohexylamine ( 1 mmol ) in acetonitrile ( 5 ml ) triethyl phosphonoformate ( 1 mmol ) was added dropwise under magnetic stirring , in n 2 atmosphere at ambient temperature . the reaction was monitored by 31 p nmr . it was complete after 20 h . the solvent was evaporated under vacuum and the crude product was dissolved in acoet , and purified by chromatography . yield : 80 %. to a solution of n - cyclohexyl ( diisopropylphosphonylformamide ) ( 1 mmol ) prepared in example 3 , in dry dioxane ( 5 ml ), bromotrimethylsilane ( 5 mmol ) was added dropwise under magnetic stirring , in a n 2 atmosphere at 60 ° c . after 10 h the solvent was removed under vacuum and the brown residue was dissolved in meoh at 0 ° c . the solvent was evaporated and a solution of naoh ( 1 mmol ) in meoh ( 5 ml ) was added in portions . the white solid was filtered and dried under vacuum . yield : 76 %, nmr , 1 h , 1 – 1 . 20 ( m , 5h ); 1 . 40 – 1 . 69 ( m , 5h ); 3 . 58 ( m , 1h ). 31 p , − 2 . 56 ppm . the same compound was prepared also by dealkylation of n - cyclohexyl ( diethylphosphonylformamide ) prepared in example 4 above , by bromotrimethylsilane in dry acetonitrile at room temperature . the product was isolated in the same manner . examination of the activity of the product on pure mmp2 enzyme gave an ic 50 value of 80 nm . in the boyden chamber chemoinvasion assay the compound was active at 1 μm . a ) to a solution of n , n - dimethylethylenediamine ( 1 mmol ) in acetonitrile ( 5 ml ), triethyl phosphonothiolformate ( 1 mmol ), prepared in example 2 , was added dropwise under magnetic stirring , in n 2 atmosphere at 0 ° c . after 2 h the solvent was evaporated under vacuum . the residue , consisting of diethyl n -( 2 - dimethylaminoethyl ) phosphonoformamide betaine was practically pure . 1 h nmr ( cdcl 3 ): 7 . 45 ppm ( 1h , broad ), 4 . 19 ( 4h , m ), 3 . 35 ( 2h , m ), 2 . 38 ( 2h , m ), 2 . 1 ( 6h , s ), 1 . 33 ( 6h , t ). b ) a solution of n -( 2 - dimethylaminoethyl ) diethylphosphonoformamide ( 0 . 903 g ), prepared in stage a ) above , in acetonitrile ( 10 ml ) was treated with bromotrimethylsilane ( 2 . 32 ml ) at ambient temperature for 4 h . a few drops of methanol were added to hydrolyze the trimethylsilyl ester and the product was allowed to crystallize from the reaction medium . the product n -( 2 - dimethylaminoethyl ) phosphonoformamide was identified by 31 p and 1 h nmr spectroscopy . nmr ( d 2 o ): 31 p , − 2 . 01 ppm . 1 h , 3 . 82 ( 2h , t , j = 6 . 6 hz ), 3 . 57 , ( 2h , t , j = 6 . 6 hz ), 3 . 075 ppm ( 6h ). examination of its activity on pure mmp2 enzyme gave the ic 50 value of 25 nm . in the boyden chamber chemoinvasion assay the compound was active at 1 micromolar concentration . a ) to a stirred solution of triethyl phosphonothiolformate ( 1 . 72 g , 7 . 6 mmol ) in anhydrous acetonitrile ( 10 ml ) was added n -( 2 - aminoethyl ) morpholine ( 1 . 1 ml , 8 . 4 mmol ) at room temperature . 31 p nmr monitoring showed that the reaction was complete in 1 h . the volatile by - product etsh and most of the solvent were removed through distillation . the residue was purified using the preparative tlc to give a colorless oily product , identified as n -( 2 -[ 4 - morpholino ] ethyl ) diethylphosphonoformamide . nmr : ( cdcl 3 ): 31 p δ − 1 . 41 ppm . 1 h : δ 1 . 18 ppm [ t , 6h , ( 3 j hh = 6 . 3 hz ), 2 . 28 ( t , 4h , 3 j hh = 4 . 3 ), 2 . 33 ( t , 2h , 3 j hh = 6 . 2 ), 3 . 25 ( q , 2h , 3 j hcch = 3 j hcnh = 6 . 2 ), 3 . 49 [ t , 4h , 3 j hh = 4 . 3 ), 4 . 04 ( m , 4h ) 7 . 70 [ s ( br ), 1h ]. anal . calcd . for c 11 h 23 n 2 o 5 p : c , 44 . 89 ; h , 7 . 82 ; n , 9 . 51 . found , c , 44 . 53 ; h , 7 . 81 ; n , 9 . 40 . b ) bromotrimethylsilane ( 1 . 41 ml , 10 . 9 mmol ) was added to a stirred solution of n -( 2 - morpholinoethyl ) diethylphosphonoformamide ( 0 . 640 g , 2 . 2 mmol ) prepared in step a ) above , in anhydrous acetonitrile ( 10 ml ) at ambient temperature using a syringe . 31 p nmr monitoring showed that formation of the intermediate silyl ester ( 31 p nmr : − 18 . 55 ) was complete in 4 h at ambient temperature . the solvent and the excess bromotrimethylsilane were removed in vacuo , and the residue was dissolved in methanol ( 5 ml ). the solvent was evaporated to dryness under vacuum to give the desired product as a colorless viscous semi - solid ( 90 %). 31 p nmr ( d 2 o ): − 3 . 79 . anal . calcd . for c 7 h 15 n 2 o 5 p . 5 . 8h 2 o : c , 24 . 54 ; h , 7 . 76 ; n , 8 . 17 . found : c , 25 . 40 ; h , 5 . 43 ; n , 7 . 90 . in the boyden chamber chemoinvasion assay the compound was active at 100 μm . a ) to a stirred solution of triethyl phosphonothiolformate ( 1 . 189 g , 5 . 3 mmol ) in anhydrous acetonitrile ( 10 ml ) was added n -( 2 - aminoethyl ) piperidine ( 0 . 83 ml , 5 . 8 mmol ) at room temperature and the solution was stirred at room temperature for 3 h . the volatile by - product etsh and the solvent were removed through distillation . the residue was purified by vlc ( vacuum liquid chromatography ) using gradient eluents ( ethyl acetate / methanol , 95 : 5 to 50 : 50 ) to give n -( 2 -[ 1 - piperidino ] ethyl ) diethylphosphonoformamide as a colorless oily product ( 1 . 352 g , 87 . 9 %). nmr ( cdcl 3 ): 31 p , δ − 1 . 29 . 1 h , 1 . 20 ( t , 6h , 3 j hh = 7 . 2 ), 1 . 25 ( m , 2h ), 1 . 39 [ quintet , 4h , 3 j hh = 5 . 1 ), 2 . 22 ( t , 4h , 3 j hh = 5 . 1 ), 2 . 30 ( t , 2h , 3 j hh = 5 . 7 ), 3 . 25 ( q , 2h , 3 j hcch = 3 j hcnh = 5 . 7 ), 4 . 07 ( m , 4h , ( br . s 1h ). b ) bromotrimethylsilane ( 2 . 63 ml , 20 . 3 mmol ) was added to a stirred solution of n -( 2 -[ 1 - piperidino ] ethyl ) diethylphosphonoformamide ( 1 . 189 g , 4 . 1 mmol ) prepared in step a ) above , in anhydrous acetonitrile ( 10 ml ) at ambient temperature . 31 p nmr monitoring showed that formation of the intermediate silyl ester ( 31 p nmr : − 18 . 55 ) was complete in 4 h at ambient temperature . the solvent and the excess bromotrimethylsilane were - removed in vacuo , and the residue was dissolved in methanol ( 15 ml ). the solvent was evaporated to dryness under vacuum to give the desired product as a colorless viscous semi - solid product ( 94 . 4 %) nmr ( d 2 o ): 31 p − 3 . 37 . 1 h 1 . 18 – 1 . 69 ( m , 6h ), 2 . 69 ( t , 2h 1a , 3 j h1ah2a = 2 j h1ah1e = 11 . 5 ) 3 . 02 ( t , 2h , 3 j hh = 6 . 0 ), 3 . 32 ( d , 2h , 2 j h1ah1e = 11 . 5 ), 3 . 41 ( t , 2h , 3 j hh = 6 . 0 ). in the boyden chamber chemoinvasion assay the compound was active at 100 μm . a ) to a stirred solution of triethyl phosphonothiolformate ( 1 . 238 g , 5 . 5 mmol ) in anhydrous acetonitrile ( 10 ml ) was added n -( 2 - aminoethyl ) pyrrolidine ( 0 . 687 g , 6 . 1 mmol ) at room temperature . 31 p nmr monitoring showed that the reaction was complete in 2 h . the volatile by - product etsh and the solvent were removed by distillation . the residue was purified by vlc ( vacuum liquid chromatography ) using gradient eluants ( ethyl acetate / methanol , 90 : 10 to 50 : 50 ) to give n -( 2 -[ 1 - pyrrolidino ] ethyl ) diethylphosphonoformamide as a colorless oil ( 0 . 620 g , 40 . 7 %). nmr , ( cdcl 3 ): 31 p δ − 3 . 82 ppm . 1 h , δ , 1 . 06 ( t , 6h , 3 j hh = 6 . 6 ), 1 . 46 ( br . s 4h ), 2 . 23 ( br . s 4h ), 2 . 34 ( t , 2h , j = 5 . 7 hz ) 3 . 14 ( q , 2h , j = 5 . 7 ), 3 . 93 [ m , 4h ) 7 . 77 [ br . s , 1h ). b ) bromotrimethylsilane ( 1 . 1 ml , 7 . 9 mmol ) was added to a stirred solution of n -( 2 -[ 1 - pyrrolidino ] ethyl ) diethylphosphonoformamide ( 0 . 442 g , 1 . 6 mmol ) prepared in step a ) above , in anhydrous acetonitrile ( 10 ml ) at ambient temperature using a syringe . the reaction mixture was allowed to stir at ambient temperature , and the progress of the reaction was monitored by 31 p nmr . after 18 h the reaction was completed to give the intermediate silyl ester ( 31 p nmr : − 18 . 13 ). the solvent and the excess bromotrimethylsilane were removed in vacuo , and the residue was dissolved in methanol ( 15 ml ). the solvent was evaporated to dryness under vacuum to give the desired product as a colorless viscous semi - solid ( 100 %). nmr ( d 2 o ) 31 p : − 5 . 48 ppm . 1 h : δ 1 . 73 ( m , 2h ), 1 . 88 ( m , 2h ), 3 . 44 ( m , 2h ), 2 . 86 ( m , 2h ), 3 . 14 ( t , 2h , 3 j hh = 5 . 7 ), 3 . 40 ( t , 2h , 3 j hh = 5 . 7 ). in the boyden chamber chemoinvasion assay the compound was active at 100 μm . a ) to a stirred solution of triethyl phosphonothiolformate ( 1 . 612 g , 7 . 1 mmol ) in anhydrous acetonitrile ( 10 ml ) was added n - acetylethylenediamine [ 0 . 890 g , 7 . 8 mmol ] at room temperature . 31 p nmr monitoring showed that the reaction was complete in 2 h . the volatile by - product etsh and the solvent were removed by distillation , and the residue was purified by vlc ( vacuum liquid chromatography ) using gradient eluents [ from ethyl acetate / petroleum ether ( 50 : 50 ) to ethyl acetate / methanol ( 80 : 20 )] to give n -( 2 - acetamidoethyl )- diethylphosphonoformamide as a colorless oily product ( 1 . 217 g , 64 . 2 %). nmr ( cdcl 3 ): 31 p − 1 . 77 . 1 h , 1 . 26 ( t , 6h , 3 j = 7 . 0 ), 1 . 87 ( s , 3h ), 3 . 34 ( m , 4h ), 4 . 13 ( m , 4h ), 7 . 09 [ br . s , 1h ] and 8 . 31 [ br . s ), 1h ] anal . calcd . for c 9 h 19 n 2 o 5 p : c , 40 . 60 ; h , 7 . 14 ; n , 10 . 52 . found : c , 40 . 23 ; h , 7 . 35 ; n , 9 . 65 . b ) bromotrimethylsilane ( 3 . 0 ml , 22 . 9 mmol ) was added to a stirred solution of n -( 2 - acetamidoethyl ) diethylphosphonoformamide ( 1 . 217 g , 4 . 6 mmol ) prepared in step a ) above , in anhydrous acetonitrile ( 10 ml ) at ambient temperature . the reaction mixture was allowed to stir at ambient temperature for 6 h to yield the intermediate silyl ester ( 31 p nmr : − 19 . 30 ). the solvent and the excess bromotrimethylsilane were removed in vacuo , and the residue was dissolved in methanol ( 15 ml ). the solvent was evaporated to dryness under vacuum to give the desired product as a white solid ( 100 %). nmr ( d 2 o ): 31 p − 3 . 25 . 1 h : 1 . 66 [ s , 3h ) 3 . 04 ( m , 4h ). anal . calcd . for c 5 h 11 n 2 o 5 p . 2 . 1h 2 o : c , 24 . 22 ; h , 6 . 13 ; n , 11 . 29 . found : c , 24 . 26 ; h , 5 . 18 ; n , 10 . 52 . in the boyden chamber chemoinvasion assay the compound was active at 100 μm . a ) a mixture of 0 . 359 g ( 1 . 4 mmol ) of n -( cyclohexyl ) diethylphosphonoformamide , 0 . 276 g ( 0 . 7 mmol ) of lawesson reagent in 10 ml toluene was refluxed for 5 . 5 h . the resulting mixture was subjected to vlc ( vacuum liquid chromatography ) using gradient eluants [ from 5 % ethyl acetate in petroleum ether to ethyl acetate / petroleum ether ( 40 : 60 ) to give n - cyclohexyl diethylphosphonothioformamide as a yellow solid , 0 . 327 g ( 85 . 8 %, isolated yield ). nmr ( cdcl 3 ): 3 p − 1 . 66 . 1 h , 1 . 18 – 2 . 01 ( m , 16h ), 4 . 17 ( m , 4h ), 4 . 34 ( m , 1h ), 8 . 89 ( br . s , 1h ). b ) bromotrimethylsilane ( 0 . 69 ml , 5 . 3 mmol ) was added to a stirred solution of n - cyclohexyldiethylphosphonothioformamide ( 0 . 298 g , 1 . 1 mmol ) prepared in step a ) above , in anhydrous acetonitrile ( 10 ml ) at ambient temperature using a syringe . the reaction mixture was allowed to stir at ambient temperature for 8 h to yield the intermediate silyl ester as a mixture of two geometrical isomers : syn ( 31 p nmr : − 18 . 98 , 7 . 2 %) and anti isomer ( 31 p nmr : − 16 . 86 , 92 . 8 %). the solvent and the excess reagent were removed in vacuo , and the residue was dissolved in methanol . evaporation of the solvent in vacuum gave the desired product as a yellow solid , m . p . 122 ° c . nmr ( cd 3 od ): 31 p : 0 . 36 ( 72 %, syn ); 2 . 09 ( 28 %, anti ). 1 h : 1 . 28 – 2 . 01 [ m , 10h ], 3 . 83 [ s , ( br ), 0 . 28h , hb , anti ], 4 . 39 [ s , ( br ), 0 . 72h , ha , syn ]. diethyl n -( 2 - dimethylaminoethyl ) phosphonoformamide prepared in example 6 , has undergone ethyl group migration from oxygen to nitrogen after standing at ambient temperature for two weeks . yield : 100 %. nmr ( d 2 o ): 31 p : − 2 . 53 ( t , j = 7 hz ). 1 h , 3 . 74 ( 2h , dq , j = 7 hz ), 3 . 50 , ( 2h , t , j = 6 . 3 hz ), 3 . 23 ( 4h , m ), 2 . 87 ( 6h , s ) 1 . 13 ( 3h , t , j = 6 . 6 hz ), 1 . 02 ( 3h , t , j = 6 . 9 hz ). to a suspension of the monoethyl ester obtained in example 12 ( 0 . 62 g , 2 . 45 mmol ) in acetonitrile ( 10 ml ) bromotrimethylsilane ( 1 . 6 ml , 12 . 2 mmol ) was added , resulting in immediate dissolution of the betaine . after standing at ambient temperature overnight the silylation reaction was complete . the desired product was isolated in quantitative yield after treatment with methanol and evaporation of the solvents and volatile by - products . nmr ( d 2 o ): 31 p : − 3 . 81 ( s ). 1 h , 3 . 48 ( 2h , t , j = 6 . 6 hz ), 3 . 15 – 3 . 24 ( 4h , m ), 2 . 85 ( 6h , s ), 1 . 10 ( 3h , t , j = 7 . 2 hz ). a ) a solution of l - phenylalanylmethylamide trifluoroacetate ( 0 . 278 g , 0 . 95 mmol ), triethyl phosphonothiolformate ( 0 . 215 g , 0 . 95 mmol ) and diisopropylethylamine ( 0 . 165 g , 0 . 95 mmol ) in acetonitrile ( 5 ml ) was stirred at room temperature for 1 month . 31 p nmr showed 94 % reaction . the product n α -( diethylphosphonoformyl ) phenylalanylmethylamide was purified by chromatography eluted by 1 % meoh in acoet , 150 mg . nmr ( cdcl 3 ): 31 p : − 4 . 41 . anal . calcd . for c 15 h 23 n 2 o 5 p : c , 52 . 63 ; h , 6 . 72 ; n , 8 . 18 . found : c , 51 . 78 ; h , 6 . 90 ; n , 7 . 82 . b ) a solution of n α -( diethylphosphonoformyl ) phenylalanylmethylamide ( 0 . 098 g , 0 . 286 mmol ) prepared in step a ) above and bromotrimethylsilane ( 0 . 37 ml , 2 . 86 mmol ) was stirred for 3 days . after the reaction mixture was allowed to hydrolyze , the desired product was isolated as a white solid by centrifugation . nmr ( d 2 o + nahco 3 ): 31 p : − 3 . 81 ( s ). 1 h : 7 . 13 – 6 . 99 ( 5h , m ); 4 . 32 ( 1h , t , j = 7 . 2 hz ), 2 . 84 ( 2h , m ); 2 . 38 ( 3h , s ). anal : calcd . for c 11 h 15 n 2 o 5 p . 0 . 5h 2 o : c , 44 . 74 , h , 6 . 1 , n , 9 . 4 . found : c , 44 . 3 , h , 5 . 4 n , 9 . 31 . 1 . to a solution of diisopropyl ethyl phosphonothiolformate ( 6 . 11 g ) in ethanol ( 35 ml ) was added histamine ( 2 . 78 g ) and the solution was kept at room temperature for 24 h . evaporation of the solution gave 6 . 03 g of a solid , m . p . 90 – 92 ° c . nmr ( cdcl 3 ), 31 p − 3 . 27 ppm . 1 h : 7 . 01 ppm ( broad 1h ), 7 . 47 ( s , 1h ), 6 . 79 ( s , 1h ) 4 . 43 ( sext . 2h ), 3 . 61 ( t , 2h ), 2 . 82 ( t , 2h ), 1 . 32 ( dd , 12h ). anal . calcd . c , 47 . 52 ; h , 7 . 26 ; n , 13 . 86 . found : c , 47 . 55 ; h , 7 . 49 ; n , 14 . 12 . b ) phosphonoformylhistamine the solution of the diisopropyl ester ( 6 . 02 g ) in dioxan ( 30 ml ) was treated with bromotrimethylsilane ( 12 . 87 ml ) at 60 ° c . overnight . the solution was treated with methanol , evaporated to a foam , m . p 167 ° c . nmr ( d 2 o ) 31 p − 3 . 38 ppm . 1 h : 8 . 26 ( s , 1h ), 7 . 13 ( s , 1h ), 3 . 41 ( t , 2h ), 2 . 82 ( t , 2h ). anal . calcd . for c 6 h 10 n 3 o 4 p . 2h 2 o , c , 28 . 23 ; h , 5 . 49 ; n , 16 . 47 . found : c , 27 . 96 ; h , 4 . 42 ; n , 16 . 02 . to a solution of triethyl phosphonothiolformate ( 1 . 97 g ) in acetonitrile 15 ml was added cyclopentylamine ( 0 . 82 g ) and the solution was kept at room temperature overnight . evaporation of the solution gave 1 . 9 g of a oil . separation by chromatography gave 1 . 43 g , oil . nmr ( cdcl 3 ), 31 p − 3 . 55 ppm . 1 h : 7 . 1 ppm ( broad 1h ), 4 . 2 ( m . 4h ), 1 . 96 ( m , 5h ), 1 . 8 – 1 . 5 ( m , 4h ), 1 . 5 – 1 . 4 ( m , 2h ) 1 . 33 ( t , 6h ). anal . calcd . for c 10 h 20 no 4 p , c , 48 . 19 ; h , 8 . 03 ; n , 5 . 62 . found : c , 47 . 98 ; h , 7 . 87 ; n , 5 . 92 . the solution of the diethyl ester ( 1 . 02 g ) in acetonitrile ( 10 ml ) was treated with bromotrimethylsilane ( 2 . 24 ml ) at r . t . overnight . the solution was treated with methanol and evaporated . the residue was recrystallized from aqueous ethanol to give 0 . 18 g crystals , m . p . 135 – 8 ° c . nmr ( d 2 o ) 31 p − 2 . 73 ppm . 1 h : 3 . 89 ( quin , 1h ), 1 . 75 – 1 . 63 ( m , 3h ), 1 . 47 – 1 . 22 ( m , 6h ). anal . calcd . for c 6 h 12 no 4 p , c , 37 . 30 ; h , 6 . 22 ; n , 7 . 25 . found : c , 37 . 28 ; h , 6 . 38 ; n , 6 . 92 . to a solution of triethyl phosphonothiolformate ( 3 . 2 g ) in acetonitrile 30 ml was added s - benzylmercaptoethylamine ( 2 . 35 g ) and the solution was kept at room temperature 24 h . evaporation of the solution gave 4 . 63 g of almost pure reaction product as an oil . separation by chromatography gave by ethyl acetate - petroleum ether gave 2 . 848 g oil . nmr ( cdcl 3 ) 31 p − 0 . 518 ppm . 1 h : 7 . 7 ppm ( broad 1 h ), 7 . 2 – 7 . 35 ( m , 5h ) 4 . 3 – 4 . 15 ( m . 4h ), 3 . 70 ( s , 2h ), 3 . 44 ( q , 2h ), 2 . 55 ( t , 2h ), 1 . 393 ( t , 6h ). anal . calcd . for c 17 h 22 no 4 ps , c , 50 . 75 ; h , 6 . 65 ; n , 4 . 23 . found : c , 50 . 45 ; h , 6 . 73 ; n , 4 . 08 . the solution of the diethyl ester ( 2 . 5 g ) in acetonitrile ( 30 ml ) was treated with bromotrimethylsilane ( 10 ml ) at r . t . overnight . the solution was treated with methanol and evaporated to give a solid . nmr ( d 2 o ), 1 h : 7 . 26 ( m , 5h ), 3 . 67 ( s , 2h ), 3 . 24 ( t , 2h ), 2 . 49 ( t , 2h ). anal . calcd . for c 13 h 14 no 4 ps , c , 43 . 63 ; h , 5 . 09 ; n , 5 . 09 . found : c , 43 . 24 ; h , 5 . 34 ; n , 4 . 77 . in the following example 18 , is described a general procedure for the synthesis of phosphonoformylpeptides , such as the compounds in examples 19 , 20 and 21 . bocleu - val - nhme . ( 1 . 00 g , 2 . 9 mmol ) was dissolved in tfa ( 5 ml ), and the solution stirred at room temperature for 1 h . the volatile materials were removed in vacuo , and the residue was dried first by azeotropic removal of h 2 o with toluene , then in vacuo at room temperature for several hours to give the dry trifluoroacetate salt . hleuvalnhme . trifluoroacetate was dissolved in dry dmf ( 5 ml ), treated with triethylamine ( 0 . 64 g , 5 . 8 mmol ) and with triethyl phosphonothioformate ( 1 . 14 g , 5 . 0 mmol ) and was stirred at room temperature for 3 days . dichloromethane ( 50 ml ) and distilled water ( 30 ml ) were added , the phases separated and the organic layer washed with 4 % aqueous hcl ( 30 ml ), saturated nahco 3 solution ( 30 ml ), and with saturated nacl solution ( 30 ml ), dried over anhydrous na 2 so 4 . most of the solvent was evaporated in vacuo and the residue was purified by vlc ( vacuum liquid chromatography ) using gradient eluants ( ethyl acetate / acetone , 95 : 5 to 50 : 50 ) to give diethylphosphonoformylleuvalnhme as a colorless oil ( 0 . 86 g , 73 %). 1 h nmr ( cdcl 3 ) δ 0 . 88 – 0 . 94 ( m , 12h ), 1 . 32 – 1 . 39 ( m , 6h ), 1 . 50 – 1 . 70 ( m , 3h ), 2 . 04 – 2 . 17 ( m , 1h ), 2 . 80 ( d , 3h , j = 5 . 1 ), 4 . 10 – 4 . 29 ( m , 5h , one ch overlapping in it ), 4 . 53 ( q , 1h , j = 6 . 3 ), 6 . 21 ( q , 1h , j = 4 . 2 ), 6 . 73 ( d , 1h , j = 8 . 7 ), 7 . 61 ( d , 1h , j = 8 . 1 ). 31 p nmr ( cdcl 3 ) δ − 2 . 27 . bromotrimethylsilane ( 1 . 25 ml , 9 . 6 mmol ) was added to a stirred solution of diethylphosphonoformylleuvalnhe ( 0 . 79 g , 1 . 9 mmol ) in anhydrous acetonitrile ( 5 ml ) at ambient temperature . stirring the reaction mixture at ambient temperature for 72 h , it yielded the bis ( trimethylsilyl ) ester , ( 31 p nmr : − 18 . 65 ) which was alcoholyzed by meoh and evaporated in vacuo . the residue was dried in a desiccator over p 2 o 5 in high vacuo , to give the final product as a pale yellow foam ( 0 . 71 g , 100 %). nmr 1 h nmr ( d 2 o ) δ 0 . 64 – 0 . 70 ( m , 12h ), 1 . 30 – 1 . 50 ( m , 3h ), 1 . 70 – 1 . 84 ( m , 1h ), 2 . 48 ( s , 3h ), 3 . 75 ( d , 1h , j = 8 . 4 ), 4 . 23 ( dd , 1h , j = 7 . 5 , j = 4 . 5 ). 31 p nmr ( d 2 o ) δ − 3 . 60 . 13 c nmr d 2 o + nahco 3 ) δ 18 . 16 , 18 . 35 , 21 . 05 , 22 . 12 , 24 . 21 , 25 . 66 , 29 . 76 , 40 . 26 , 51 . 58 ( d , 3 j pc = 5 . 5 ), 60 . 00 , 173 . 61 , 174 . 77 , 179 . 65 ( d , 1 j pc = 191 . 4 ). ms ( esi ) 352 . 2 ( mh + ). analysis c 13 h 26 n 3 o 6 p . 2h 2 o : calcd . c , 40 . 31 ; h , 7 . 75 ; n , 10 . 85 ; p 8 . 01 . found c 39 . 93 ; h , 7 . 80 ; n , 10 . 79 ; p 7 . 86 . [ a ] 25 d − 31 . 7 ° ( c = 0 . 28 , meoh ). phosphonoformyl - leu - phe - nhme was prepared in a similar manner , as phosphonoformyl - leu - val - nhme and the following physical data was obtained for intermediate and end - product : a colorless solid foam 1 h nmr ( cdcl 3 ) δ 0 . 84 ( t , 6h , j = 6 . 3 ), 0 . 87 ( d , 3h , j = 5 . 7 ), 1 . 29 – 1 . 35 ( m , 6h ), 1 . 40 – 1 . 60 ( m , 3h ), 2 . 65 ( d , 3h , j = 4 . 5 ), 2 . 90 – 3 . 07 ( m , 2h ), 4 . 08 – 4 . 26 ( m , 4h ), 4 . 52 ( q , 1h , j = 7 . 8 ), 4 . 62 ( q , 1h , j = 8 . 1 ), 6 . 34 ( q , 1h , j = 4 . 5 ), 7 . 13 – 7 . 27 ( m , 6h , one nh overlapping in it ), 7 . 98 ( d , 1h , j = 8 . 1 ). 31 p nmr ( cdcl 3 ) δ − 2 . 17 . 13 c nmr ( cdcl 3 ) δ 16 . 19 ( d , 2c , 3 j pc = 6 . 0 ), 21 . 71 , 22 . 79 , 24 . 72 , 26 . 06 , 38 . 38 , 40 . 72 , 52 . 14 ( d , 3 j pc = 7 . 5 ), 54 . 49 , 64 . 46 ( d , 2 j pc = 4 . 5 ), 64 . 55 ( d , 2 j pc = 4 . 5 ), 126 . 68 , 128 . 36 , 129 . 21 , 136 . 78 , 165 . 97 ( d , 1 j pc = 224 . 1 ), 170 . 99 , 71 . 30 . a pale yellow solid foam ( 1 . 61 g , 100 %). nmr 1 h nmr ( d 2 o ) δ 0 . 59 ( d , 3h , j = 4 . 8 ), 0 . 65 ( d , 3h , j = 4 . 8 ), 1 . 16 – 1 . 31 ( m , 2h ), 1 . 40 – 1 . 50 ( m , 1h ), 2 . 42 ( s , 3h ), 2 . 71 – 2 . 95 ( m , 2h ), 4 . 13 ( dd , 1h , j = 7 . 5 , j = 7 . 7 ), 4 . 30 ( dd , 1h , j = 7 . 2 , j = 7 . 1 ), 7 . 01 – 7 . 19 ( m , 5h ). 31 p nmr ( d 2 o ) δ − 3 . 65 . nmr ( d 2 o + nahco 3 ) δ 20 . 98 , 21 . 92 , 24 . 04 , 25 . 84 , 36 . 64 , 40 . 09 , 52 . 07 ( d , 3 j pc = 5 . 6 ), 55 . 03 , 127 . 01 , 128 . 64 , 129 . 02 , 136 . 54 , 173 . 13 , 174 . 80 , 180 . 24 ( d , 1 j pc = 190 . 8 ). ms ( esi ) 400 . 2 ( mh + ). analysis c 17 h 26 n 3 o 6 p . 1 . 5h 2 o : calcd . c , 47 . 89 ; h , 6 . 81 ; n , 9 . 86 ; p 7 . 28 . found c , 47 . 97 ; h , 6 . 84 ; n , 9 . 84 ; p 6 . 96 . [ a ] 25 d − 20 . 5 ( c = 0 . 27 , meoh ). phosphonoformyl - leu - tyr ( me )- nhme was prepared in a similar manner , as phosphonoformyl - leu - val - nhme and the following physical data was obtained for intermediate and end - product : a colorless solid foam 1 h nmr ( cdcl 3 ) δ 0 . 77 ( d , 3h , j = 5 . 1 ), 0 . 79 ( d , 3h , j = 5 . 7 ), 1 . 19 – 1 . 27 ( m , 6h ), 1 . 40 – 1 . 60 ( m , 3h ), 2 . 60 ( d , 3h , j = 3 . 3 ), 2 . 72 – 2 . 94 ( m , 2h ), 3 . 61 ( s , 3h ), 4 . 00 – 4 . 20 ( m , 4h ), 4 . 52 – 4 . 66 ( m , 2h ), 6 . 63 , 6 . 66 , 6 . 97 , 6 . 99 ( aa ′ bb ′ spin system , 4h ), 7 . 01 ( br s , 1h ), 7 . 77 ( d , 1h , j = 8 . 1 ), 8 . 26 ( d , 1h , j = 7 . 8 ). 13 c nmr ( cdcl 3 ) δ 16 . 12 ( d , 3 j pc = 6 . 0 ), 16 . 16 ( d , 3 j pc = 5 . 5 ), 21 . 70 , 22 . 78 , 24 . 69 , 25 . 99 , 37 . 65 , 40 . 81 , 52 . 01 ( d , 3 j pc = 7 . 0 ), 54 . 58 , 54 . 93 , 64 . 35 ( d , 2 j pc = 6 . 6 ), 64 . 44 ( d , 2 j pc = 7 . 0 ), 113 . 61 , 128 . 76 , 130 . 21 , 158 . 21 , 165 . 83 ( d , 1 j pc = 224 . 1 ), 171 . 09 , 171 . 52 . 31 p nmr ( cdcl 3 ) δ − 2 . 21 . a pale yellow solid foam 1 h nmr ( d 2 o + nahco 3 ) δ 0 . 56 ( d , 3h , j = 6 . 0 ), 0 . 62 ( d , 3h , j = 6 . 0 ), 0 . 95 – 1 . 08 ( m , 1h ), 1 . 09 – 1 . 24 ( m , 2h ), 2 . 48 ( s , 3h ), 2 . 62 – 2 . 97 ( m , 2h ), 3 . 58 ( s , 3h ), 3 . 97 ( dd , 1h , j = 7 . 5 , j = 6 . 9 ), 4 . 32 ( dd , 1h , j = 6 . 6 , j = 9 . 3 ), 6 . 71 , 6 . 74 , 6 . 97 , 6 . 99 ( aa ′ bb ′ spin system , 4h ). 31 p nmr ( d 2 o + nahco 3 ) δ − 1 . 69 . 13 c nmr ( d 2 o + nahco 3 ) δ 20 . 74 , 21 . 58 , 23 . 78 , 25 . 63 , 35 . 50 , 39 . 91 , 52 . 05 ( d , 3 j pc = 5 . 7 ), 54 . 79 , 54 . 99 , 113 . 75 , 128 . 98 , 130 . 00 , 157 . 31 , 173 . 01 , 174 . 66 , 180 . 14 ( d , 1 j pc = 192 . 5 ). ms ( esi ) 430 . 1 ( mh + ). analysis c 18 h 28 n 3 o 7 p . h 2 o : calcd . c , 48 . 32 ; h , 6 . 71 ; n , 9 . 39 ; p 6 . 94 . found c , 48 . 19 ; h , 6 . 65 ; n , 9 . 05 ; p 7 . 18 . [ a ] 25 d − 29 . 50 ° ( c = 0 . 20 , meoh ). phosphonoformyl - phe - val - conhme was prepared in a similar manner , as phosphonoformyl - leu - val - nhme and the following physical data was obtained for intermediate and end - product : a white solid 1 h nmr ( cdcl 3 ) δ 0 . 83 ( d , 3h , j = 6 . 3 ), 0 . 86 ( d , 3h , j = 6 . 3 ), 1 . 15 ( t , 3h , j = 6 . 9 ), 1 . 22 ( t , 3h , j = 6 . 9 ), 2 . 03 ( m , 1h ), 2 . 69 ( c , 3h , j = 3 . 0 ), 3 . 05 – 3 . 19 ( m , 2h ), 3 . 80 – 3 . 98 ( m , 2h ), 4 . 05 – 4 . 10 ( m , 2h ), 4 . 33 ( dd , 1h , j = 8 . 1 , j = 8 . 1 ), 5 . 04 ( m , 1h ), 7 . 02 – 7 . 20 ( m , 5h ), 7 . 30 ( br s , 1h ), 7 . 89 ( d , 1h , j = 8 . 1 ), 8 . 35 ( br s , 1h ). 31 p nmr ( cdcl 3 ) δ − 1 . 90 . 13 c nmr ( cdcl 3 ) δ 16 . 02 ( d , 3 j cp = 6 . 0 ), 16 . 10 ( d , 3 j cp = 6 . 0 ), 18 . 35 , 19 . 17 , 25 . 99 , 30 . 98 , 37 . 47 , 54 . 10 ( d , 3 j cp = 7 . 1 ), 58 . 76 , 63 . 97 ( d , 2 j cp = 6 . 0 ), 64 . 27 ( d , 2 j cp = 6 . 6 ), 126 . 62 , 128 . 22 , 129 . 30 , 136 . 56 , 165 . 72 ( d , 1 j cp = 223 . 7 ), 170 . 29 , 171 . 71 . a pale yellow solid 1 h nmr ( d 2 o + nahco 3 ) δ 0 . 62 ( d , 3h , j = 6 . 9 ), 0 . 64 ( d , 3h , j = 6 . 9 ), 1 . 71 ( m , 1h ), 2 . 42 ( s , 3h ), 2 . 76 – 2 . 94 ( m , 2h ), 3 . 69 ( d , 1h , j = 7 . 8 ), 4 . 45 ( dd , 1h , j = 6 . 9 , j = 7 . 1 ), 7 . 01 – 7 . 15 ( m , 5h ). 31 p nmr ( d 2 o + nahco 3 ) δ − 1 . 73 . 13 c nmr ( d 2 o + nahco 3 ) δ 17 . 73 , 18 . 04 , 25 . 50 , 29 . 73 , 37 . 27 , 53 . 79 ( d , 3 j pc = 6 . 6 ), 59 . 46 , 126 . 91 , 128 . 46 , 128 . 97 , 135 . 46 , 172 . 43 , 172 . 64 , 179 . 11 ( d , 1 j pc = 191 . 4 ). ms ( esi ) 386 . 1 ( mh + ). analysis c 16 h 24 n 3 o 6 p . 2h 2 o : calcd . c , 45 . 60 ; h , 6 . 65 ; n , 9 . 97 ; p 7 . 36 . found c , 45 . 63 ; h , 6 . 60 ; n , 9 . 33 ; p 7 . 33 . [ a ] 25 d − 15 . 4 ( c = 0 . 19 , meoh ). the biological and therapeutic effects of some of the compounds , which may be used in the compositions of the invention , were evaluated in the following models , and will now be exemplified in the following non - limiting examples and summarized in table 2 . this assay measures the potency of the compounds to repress the invasiveness of cancer cells , by inhibiting the mmps produced by them . this assay uses a reconstituted basement membrane preparation , which is similar to the natural basement membranes that the tumor cells have to cross , in order to disseminate . the assay has greater predictive value than the one based on the determination of enzyme inhibition using pure enzyme preparation , since it measures the effect of the drug in an environment similar to the in vivo situation . the compounds examined have been added to the invasion or chemotaxis chambers respectively , at various concentrations , and the resulted invasion and migrations were compared to untreated preparations . table 1 ( above ) shows the results of preliminary screening of a variety of oxophosphonates and related compounds in this model . table 2 ( below ) shows the percentage of inhibition of invasion by the compounds examined at 50 micromolar concentration , in comparison with batimastat , a well recognized inhibitor of the hydroxamic acid class , synthesized by british biotech , ltd . as can be seen in the column headed by “ inhibition of chemoinvasion ” in table 2 , all the compounds listed inhibited chemoinvasion better than batimastat . a ) the chemoinvasion assays were performed in boyden chambers . matrigel ( 25 μg ) was dried on a polycarbonated filter ( pvp free , nucleopore ). fibroblast conditioned medium ( obtained from confluent nih - 3t3 cells cultured in serum free dmem ) is used as the chemoattractant . cells were harvested by brief exposure to 1 mm edta , washed with dmem containing 0 . 1 % bovine serum albumin and added to the boyden chamber ( 200 , 000 cells ). the chambers were incubated in a humidified incubator at 37 ° c . in 5 % co 2 / 95 % air atmosphere for 6 h in the presence of the indicated concentrations of the various compounds . the cells , which traversed the matrigel layer and attached to the lower surface of the filter , were stained with diff quick ( american scientific products ) and counted . b ) matrigel outgrowth assay - cells were harvested as described above , and added to a matrigel layer in a 24 well plate . after attachment , a second layer of matrigel was added . upon solidification of the second layer , culture media ( 1 ml ) was added and the plate was incubated as a monolayer culture . the plates were analyzed daily using hoffman optics . this assay was used to evaluate growth and invasion in the presence of inhibitory factors which may be added into the culture media . some of our compounds were examined as to their potency to inhibit capillary formation , which is an in vitro model of angiogenesis , an essential step in the development of primary tumor and metastatic lesions . endothelial cell migration to the newly formed tumor is the initial phase of angiogenesis , and is dependent on mmp expression . using this assay that measures endothelial cell tube formation , we evaluated the effects of some oxophosphonates on angiogenesis . table 2 lists results obtained from testing some representative carbamoylphosphonates in this model . the results shown in the column headed by “ inhibition of capillary formation ” indicate that at 50 micromolar concentration these compounds inhibit to the extent of up to 75 % tube formation . endothelial cells are harvested by 1 mm edta , and added to a matrigel layer in a 24 well plate at 50 , 000 cells per well . after attachment , culture media ( 1 ml ) is added and the plate is incubated as a monolayer culture . the plates are analyzed hourly using hoffman optics . this assay is used to evaluate inhibitory factors or stimulatory factors on capillary like structure formation , which may be added into the culture media . the abilities of some of the novel oxophosphonates to inhibit the formation of metastasis in vivo were examined in the murine melanoma model . in this model , tumor cells were injected into the tail veins of mice , which were then treated by injections of 50 mg / kg daily doses of the compounds examined for 21 days , and then the tumors formed on the lungs of the mice were counted after appropriate fixation . the results from the examination of 4 representative compounds are listed in the column headed by “ inhibition of metastasis formation ” in table 2 along with the results obtained for compound sc - 44463 , a well recognized inhibitor of the hydroxamic acid class , synthesized by g . d . searle in chicago . the compounds examined reduce the number of metastasis by 70 – 75 % compared to untreated animals similarly to sc - 44463 .

the present invention relates to compositions useful for treating or controlling disease states or conditions associated with zinc containing proteinases , especially metalloproteinases . the active ingredient in these compositions is an alpha - oxo - or alpha - thixophosphpnate of formula . out of the phosphonates of formula , some are known and others are new . the novel compounds constitute another aspect of the invention .

the present invention will be described in relation to apparatus for producing potato chips for purposes of explanation . however , it will be apparent to those skilled in the art that the invention would be applicable to any distributed product manufacturing process in which uniform product characteristics are dependent upon distributed parameters during the manufacturing process . in a commercial potato chip manufacturing process , a supply of raw peeled potatoes is fed to a plurality of centrifugal slicers 10 a - 10 d , which cut the potatoes into substantially uniformly shaped slices of substantially uniform thickness . such slicers are well known in the art , see , e . g ., u . s . pat . no . 4 , 945 , 794 , and therefore a description of their operation will not be provided here . the raw potato slices 16 are conveyed from the slicers by a plurality of flumes 12 a - 12 d to a washer belt 18 , where the raw slices may be washed , before being fed to fryer 20 , which contains a circulating supply of hot frying oil . the slices are loaded onto belt 18 by a plurality of flume distributor chutes 14 a - 14 d . the slices are conveyed through the fryer by paddles or a like mechanism ( not shown ) for a predetermined period of time , after which the resulting chips are removed from the fryer by a conveyor 22 , such as an endless belt . the chips are then passed by a plurality of moisture sensor heads 24 a - 24 c , which detect the moisture levels of chips divided by location on the belt into left ( 24 a ), center ( 24 b ) and right ( 24 c ). such heads also are well known in the art , and are available from scientific industrial development corporation under the designation mm55 . the sensor heads 24 a - 24 c then convert the detected moisture levels into electrical signals and output the signals on signal lines 26 a - 26 c to a programmable logic controller ( plc ) 28 . based on the received moisture readings , the plc 28 will adjust the orientation of rotatable flume chutes 14 b and 14 c to redistribute raw slices 16 across belt 18 to compensate and correct for variations in moisture levels of chips exiting the fryer according to left , center and right designations . such variations may be caused by varying conditions such as oil flow through the fryer , oil temperature gradients within the fryer , slice migration , as well as other phenomena . according to a preferred mode of operation as illustrated in fig4 the plc 28 collects the moisture readings at step s 40 and averages left , center and right readings over a predetermined period of time at step s 41 . at step s 42 , the averaged readings are compared with preset variation limits , to determine whether significant moisture level variations are present . for example , as shown in fig5 and 6 , moisture levels within an acceptable range would be classified as “ o ” for “ on target ;” levels above the range would be classified as “ h ” for “ high ;” and levels below the range would be classified as “ l ” for “ low .” at step s 43 , the comparison results are inputted to look - up tables ( luts ) such as 50 in fig5 or 60 in fig6 to determine whether adjustment of rotatable flume chutes 14 b and / or 14 c is needed . the adjustments programmed into the luts are calculated by experimentation through measurement and observation over a sufficient period of time . it is noted that in the preferred embodiment , outer flume chutes 14 a and 14 d are stationary , and are oriented so that slices will be positioned just inside the outer edges of belt 18 , while inner flume chutes 14 b and 14 c are rotatable . fig2 is a side elevational view of chute 14 b . as shown , a motor 141 drives a pulley or belt 142 which rotates a column 143 attached to the bottom of chute 14 b . the flume chutes are rotated with the purpose of minimizing moisture level variations of chips exiting the fryer . the possible arc of rotation of the inside chutes is set between a position that places the slices in the middle of belt 18 and a position that places slices just adjacent to the corresponding outside flume chute . proximity sensors ( not shown ) detect when a chute is either at its outside limit , or in a zone where collision with the other controlled flume chute is possible . limit switches ( also not shown ) are provided within the motor housing to determine when the motors have reached their rotation limit . the range of positions of each controllable chute is calibrated to a range of zero to 100 , with 50 denoting the center position , zero denoting a fully counterclockwise ( ccw ) position , and 100 denoting a fully clockwise ( cw ) position . depending on the moisture readings , a chute may be rotated by a large adjustment , a small adjustment , or no change . the degree of rotation corresponding to “ large ” and “ small ” may be set appropriately by trial and error . fig5 and 6 give ad examples of adjustments based on the calculated moisture level readings . for example , as shown in fig5 where the right side of the fryer has a “ low ” moisture reading , and the center and left sides are within target level , chute 14 c will be moved counterclockwise by a “ large ” amount , while chute 14 b will be moved counterclockwise by a “ small ” amount . this adjustment has the effect of redistributing the slices across the fryer so that more slices are fed to the right side of the fryer . this is shown in fig3 a . as shown in fig3 b , when the readings indicate that the moisture level of chips at the left and right sides of the fryer are high , while the chips at the center of the fryer are within target range , chute 14 c will be moved in a clockwise direction by a “ small ” increment , while chute 14 b will be moved in a counterclockwise direction by a “ small ” increment . this has the effect of reducing the amount of chips fed to the left and right sides of the fryer to bring the moisture levels down to target range . the necessary adjustments are read from the luts by the plc controller 28 , and are converted into actuator signals inputted to the actuator motors 141 through signal lines 30 b and 30 c . fig7 explains operation of the plc when a slicer needs to be shut down , such as for changing of the slicer head . at step s 70 , the plc continuously monitors whether a slicer head has been shut off . when a shut off is detected , the present flume positions are stored in a memory at step s 71 . at step s 72 , the controllable flume chutes are rotated to positions depending on the slicer head which has been shut off , such that an even distribution of slices across the fryer will be maintained . the plc then continuously monitors whether the slicer head has been turned back on at step s 73 . once the plc determines that the slicer has been placed back in service , the stored flume positions are retrieved from memory , and the flumes are restored to their previous positions at step s 74 . according to the invention , the system may also include a manual mode wherein the flume positions may be adjusted manually . the system further provides for “ home ” positions at which the controllable flumes will be oriented at line start - up . the “ home ” positions are predetermined positions which represent optimal starting points for achieving minimum moisture level variations across the fryer at start - up . additionally , flip - up gates are provided at the inlets to the slicer heads , so that raw potato supply may be stopped to a specific slicer when it is necessary to shut down for slicer head replacement . while the present invention and the embodiments presented herein have been set forth and described in detail for the purposes of making a full and complete disclosure of the subject matter thereof , the disclosure herein presented is not intended to be limiting in any way with respect to the scope of this invention as the same is set forth in the appended claims .

apparatus and method for controlling the distribution of product items over a manufacturing line , in particular , for controlling the distribution of potato slices across the width of a fryer in a commercial potato chip manufacturing process , includes a number of sensors for measuring the moisture content of potato chips exiting the frying and a controller for determining whether a moisture content variation state exists that should be corrected . a number of rotatable flume distributors are provided which are controlled by the controller in accordance with position adjustment values in a look - up table corresponding to detected moisture content variations . the flume distributors are then adjusted to modify the distribution of potato slices across the fryer to reduce or eliminate the variation in moisture content of the chips leaving the fryer .

turning now to the drawings and particularly fig1 thereof , the rack 10 of the present invention is shown in an intermediate position whereby it can be converted from a standard triangular rack as shown in fig2 to a nine ball diamond shaped rack as shown in fig3 . the rack 10 has a pair of essentially flat upright oriented side members 12 which are opposed to each other and an intermediate base member 14 similarly shaped to the side members 12 . in essence , all the members 12 and 14 are essentially identically shaped and formed of a suitable rigid material such as plastic although metal or wood could be also utilized . the members 12 and 14 are interconnected at their end portions to define the standard triangular enclosure for receiving the billiard balls ( fifteen of such balls in the case of the standard triangular enclosure as shown in fig2 and nine balls as in the case of the diamond shaped alternate form enclosure as shown in fig3 ). it should be apparent that both the side members 12 and the base member 14 include inner and outer surfaces wherein the reference number 18 refers to the inner surfaces of the side members against which the billiard balls 15 are adapted to contact in either of the alternate use modes of the rack 10 and an inner surface 22 of the base member 14 . in addition , opposed to the inner side surfaces 18 of the side members 12 are outer surfaces 20 . in addition , the base member 14 is provided with an outer surface 24 opposed to the inner surface 22 thereof . each of the side members 12 is provided with an open longitudinally extending slot 26 . the slot 26 extends from a point proximal to one of the corners 16 upwardly to a point slightly past the middle of the longitudinal extent of each of the side members 12 . the slots terminate at their ends proximal the member corners in a generally t - shaped terminus formed by side slot extensions 27 . a pair of longitudinally directed ears 28 outwardly extend from the outer surface 20 of each side member 12 for a short distance at the upper end of the slot 26 and on opposite sides thereof . each of the ears 28 includes an inner slotted groove 30 . the grooves 30 are opposed to each other on either side of the slot 26 such that the terminal fingers 32 of a pin 34 may extend thereinto and be slidably captured thereby . such pins 34 are provided at the opposite ends of a pair of flat leg members 36 and are in turn adapted for disposition generally within the confines of the slots 26 when the legs 36 are in their storage position as when the rack 10 is used as a standard triangular rack as shown in fig2 . this storage position is best illustrated in fig4 a , 5 and 5a . referring particularly now to fig4 a , 5 and 5a , the inside surfaces of the pins 34 are adapted to rest against or frictionally engage the inner surfaces 27a of the slot extensions 27 . these inner surfaces are also preferably provided with a recess 27b as depicted such that the pins 34 in effect are received therein in their storage position . to accomplish such , it may be necessary to carefully dimension the relative lengths of the legs 36 and the slots 26 such that the leg length is slightly different than that of the slot such that a slight stretching or bowing of leg 36 is required to snugly fit it into the slot 26 . also , the recesses 27b into which the pins are preferably received or pocketed could be removed from the inner surfaces and placed in the outer surface 27c . such single recess 27d positioned on the outer surface 27c of the slot extension is shown in fig5 b -- it being apparent that the outer pin surfaces would engage recess 27d rather than the inner pin surfaces as in the case of recesses 27b . also as a further alternative structure , the pins 34 could be partially cut away at their inside surfaces to provide a flattened surface 32a adapted to particularly engage a similarly non - recessed or flat surface inner surfaces 27e as shown in fig4 b . the essential features of the above - explained variants being that the legs 36 are by these various alternatives adapted to move into the confines of the slots 26 in the storage position and be maintained there essentially out of the way of users &# 39 ; fingers , etc . while the rack 10 is used as a standard triangular rack as shown in fig2 . the leg members 36 are adapted to move from such storage position through the extent of the slot 26 to slide downwardly within grooves 30 while simultaneously swinging inwardly to a point intermediate the length of the base member 14 wherein connector means 40 are provided for the temporary engagement of the pins 34 provided on the opposite ends of the leg members 36 . generally , the fingers 32 and the pins 34 are integrally formed to the flat leg members 36 although in certain cases the fingers and pins could be integrally formed and then attached to separate leg members or even the pins could be of different materials than the fingers . the opposite action is carried out when the legs are moved from their alternate use position as shown in fig3 to their storage position generally within the lateral extent of the slot 26 . also , it should be brought out that while the disclosed format shows discrete pins 34 terminating in laterally extending fingers 32 , the fingers 32 could simply upwardly extend from opposite lateral edges of the legs 36 and need not be of rounded configuration as shown so long as the fingers at the upper ends of the legs provide the necessary slidable contact with the grooves 30 and that the fingers at the lower ends of the leg members are of such an extent to contact portions of the slot 26 in their storage position as previously explained in reference to fig4 a , 4b , 4c , 5a and 5c . one form of connector 40 is shown in fig1 and 6a wherein a stem 42 upwardly extends from the inner surface 22 of the base member 14 preferably laterally across the width thereof and is provided with a pair of angled fingers 46 forming a pair of grooves 48 for receipt of the pins 34 provided on the opposite or lower ends of the leg members 36 . in this manner then , the leg members 36 can be temporarily fastened to a position intermediate of the longitudinal extent of the base member 14 such that the upper portions of the side members 12 and the legs 36 form an equilateral diamond in which nine billiard balls may be racked as shown in fig3 . such alternate use position enables the rack 10 of the present invention to be used not only for standard fifteen ball games but additionally for a number of nine ball games without the necessity of having separate racks for each . when it is desired to reconvert the rack setup from the alternate nine ball configuration as shown in fig3 back to the standard triangular configuration , it is merely necessary to frictionally disengage the lower leg member pins 34 from the grooves 48 and then swing the leg members 36 towards the side members 12 about the pivot formed at the upper end of the leg members between the pins 34 and the grooves 30 whereupon the leg members may be thereupon moved through the slot 26 into the storage position as best shown in fig1 a and 5 . the connecting member 40 shown in fig1 and 6a is constructed so as to be flexible enough such that the billiard ball 15 in contact therewith when the rack 10 is used in the standard triangular format merely flattens or at least to some extent deforms the connector 40 so that it does not interfere with the placement of such central lowermost ball in the fifteen ball rack . in many cases however , standard racks provide finger space between the racked balls and the base member and thus the rack of the present invention can also be provided with such a gap in which case no forceful ball contact with the connector 40 or stem 42 occurs . in some case , such flattening action as above explained in regard to the connector 40 could cause some potential undesirable force against the ball in contact therewith which is then transmitted to the rack as a whole and should such be desired to be eliminated , then either of the alternate configurations as shown in fig7 and 9 can be utilized . referring now to the connector means shown in fig7 a pair of connectors 50 in the form of fingers 52 upwardly extending from the inner surface 20 and centrally open to form a groove 54 to accommodate the pins 34 are provided . the placement of the separate connectors 50 is such that they are disposed slightly laterally offset from the midpoint along the longitudinal extent of the base member 14 such that the center billiard ball 15 in the lower row thereof is disposed longitudinally between such separate connector member 50 such that very little , if any , pressure is transmitted to either such central billiard ball or those on opposite sides thereof . of course in racks provided with a finger gap between the base member and the lowest row of balls , no such pressure or contact would be present . turning now to another alternate connector means shown in fig8 therein , the connector is in the form of grooves disposed in the body of the base member 14 such that no upwardly extending fingers such as the fingers 52 as shown in fig7 or the fingers 46 as shown in fig6 are present . such grooves 56 may be slightly longitudinally offset from each other or may be contiguous but in either case they form the means for receipt of the pins 34 of the leg members 36 . in such embodiment , the thickness of the base member 14 is increased to provide the necessary thickness to form such grooves 56 . a further modification and one similar to fig8 is shown in fig9 wherein grooves 56a are , in effect , provided in a narrowed height pad 60 formed from a portion of the inside surface 22 of member 14 by reason of the , in effect , removal of adjacent material to form a recessed ramp 62 on either side of the pad . the fingers 32 which are adapted for engagement in the grooves 56a enable portions above and below the pad ( the pins 34 generally ) to overlie the ramps 62 . in this way , removal of the legs can easily be effected by slipping one &# 39 ; s finger or thumbnail beneath the extending portions of the pins 34 and simply popping them out of the connector . while there is shown and described herein certain specific structure embodying this invention , it will be manifest to those skilled in the art that various modifications and rearrangements of the parts may be made without departing from the spirit and scope of the underlying inventive concept and that the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claims .

a billiard ball rack for shaping a group of billiard balls on a pool table having leg members which when in a storage position enables the rack to be used as a standard triangular fifteen ball rack yet when moved to an alternate position such leg members in combination with other rack portions enables the rack to be alternately used as a diamond shape nine ball rack .

each one of fig1 , 4 , 5 and 8 shows an insertion cup 1 of a prosthetic hip acetabulum . this insertion cup 1 comprises : a substantially hemispherical convex outer anchoring face 2 , designed to be anchored in a prepared acetabular cavity of the pelvis of a patient , and a concave inner receiving face 3 , with an annular edge 4 and with an opening face 5 that is contained in an opening plane p , an annular receiving structure 6 designed in such a way that an impactor can be fixed to said annular receiving structure 6 for the impaction of the insertion cup 1 in the acetabular cavity of the pelvis of a patient . the annular receiving structure 6 is external and is situated set back from the opening plane p . in other words , the annular receiving structure 6 is offset , with respect to the opening plane p , in the direction of the summit s of the outer anchoring face 2 . the annular receiving structure 6 is therefore not situated in the continuation of the inner receiving face 3 continuing the latter past the summit s . it is thus possible to avoid limiting the angular clearance of the prosthetic femoral shaft , and the risk of metallosis and / or breakage is reduced . fig2 , 3 , 6 , 7 and 9 show an installation and orientation insert 7 intended to be joined to an insertion cup 1 . the installation and orientation insert 7 of fig2 and 3 is intended to be joined to the insertion cup 1 from fig1 . the installation and orientation insert 7 of fig6 and 7 is intended to be joined to the insertion cup 1 from fig4 , 5 and 8 . the installation and orientation insert 7 of fig9 is intended to be joined to the insertion cup 1 from fig8 . each installation and orientation insert 7 can be fixed removably to the outer annular receiving structure 6 of the insertion cup 1 and has an assembly structure 8 on which an impactor can be removably fixed . in fig1 , 5 and 8 , it will be seen that the outer annular receiving structure 6 comprises a continuous or interrupted peripheral radial shoulder d of the annular edge 4 , with a receiving face 9 directed toward the outside . it will be seen in fig2 , 3 , 6 , 7 and 9 that each installation and orientation insert 7 has a continuous or interrupted peripheral annular fixing structure 10 with a connecting face 11 directed toward the inside and designed to cooperate with the receiving face 9 of the outer annular receiving structure 6 . in the subject matter of fig1 to 3 , the receiving face 9 of the outer annular receiving structure 6 has an external thread 12 , while the connecting face 11 of the peripheral annular fixing structure 10 of the installation and orientation insert 7 has an internal thread 13 designed to cooperate with the external thread 12 by screwing . the subject matter of the present invention is illustrated in fig4 to 13 . in these figures , the outer annular receiving structure 6 and the peripheral annular fixing structure 10 are designed in such a way that the installation and orientation insert 7 is engaged with force around the outer annular receiving structure 6 and is retained forcibly by a radial clamping of the peripheral annular fixing structure 10 on the outer annular receiving structure 6 . in order to further improve the hold of the installation and orientation insert 7 on the insertion cup 1 , a supplementary cooperation can be provided between the installation and orientation insert 7 and the insertion cup 1 by means of one or more locking ribs that engage in a locking groove . in a first variant , illustrated in fig4 to 7 , provision is made that : the receiving face 9 of the outer annular receiving structure 6 has an interrupted peripheral locking groove 14 ; the connecting face 11 of the peripheral annular fixing structure 10 of the installation and orientation insert 7 has a plurality of locking ribs 15 a to 15 d which are distributed about the periphery and are designed so as to engage in the interrupted peripheral locking groove 14 . in a second variant , illustrated in fig8 and 9 , the receiving face 9 of the outer annular receiving structure 6 has a continuous peripheral annular locking groove 16 , while the connecting face 11 of the peripheral annular fixing structure 10 has a continuous peripheral annular locking rib 17 designed so as to engage in the continuous peripheral annular locking groove 16 . in this second variant , it is also possible that the connecting face 11 of the peripheral annular fixing structure 10 has an interrupted peripheral annular locking rib . the installation and orientation insert 7 can then be similar to that of the first variant of the second embodiment of the invention , illustrated in fig6 and 7 . fig1 is a partial sectional view of the annular edge 4 of the insertion cup 1 from fig8 . it will be seen more particularly in fig1 that the outer annular receiving structure 6 comprises a peripheral radial shoulder d with a receiving face 9 directed toward the outside . the peripheral radial shoulder d has a thickness e 1 of between approximately 0 . 7 mm and approximately 1 . 2 mm . the receiving face 9 has the continuous peripheral annular locking groove 16 . the continuous peripheral annular locking groove 16 has a radial thickness e 2 of between approximately 0 . 2 mm and approximately 0 . 6 mm . the insertion cup 1 has a thickness e 4 near its annular edge 4 . the thickness e 4 can be small , for example less than 3 mm . the peripheral radial shoulder d of the annular edge 4 has a height h 1 of between approximately 1 mm and approximately 4 mm . finally , the continuous peripheral annular locking groove 16 has a height h 2 of between approximately 0 . 4 mm and 3 mm . all the dimensions given above in connection with the second variant are valid for the first variant and also for the subject matter of fig1 to 3 . as will be seen from fig1 , the peripheral annular fixing structure 10 of the installation and orientation insert 7 has , with its connecting face 11 and its continuous peripheral annular locking rib 17 , a shape and dimensions matching the receiving face 9 and the continuous peripheral annular locking groove 16 . the installation and orientation insert 7 and the insertion cup 1 can thus be joined very intimately , as is illustrated in fig1 . in order to avoid any conflict of the installation and orientation insert 7 with the bone substance around the natural acetabular cavity of the pelvis of the patient , the installation and orientation insert 7 and the outer annular receiving structure 6 of the insertion cup 1 are designed in such a way that , when the installation and orientation insert 7 is fixed to the outer annular receiving structure 6 of the insertion cup 1 , the installation and orientation insert 7 does not protrude outside a substantially hemispherical surface s 1 ( illustrated by broken lines in fig1 ) defined by the substantially hemispherical convex outer anchoring face 2 of the insertion cup 1 . to do this , the peripheral annular fixing structure 10 of the installation and orientation insert 7 has a radial thickness e 3 substantially equal to or less than the thickness e 1 of the radial shoulder d of the annular edge 4 . so as not to risk damaging the insertion cup 1 , the installation and orientation insert 7 is advantageously made of plastic , preferably of polyethylene , which is an inexpensive material that is easy to machine . within the context of the invention , the concave inner receiving face 3 can be a slide face 3 a for receiving a movable articular insert , for example for an acetabulum with dual mobility . in this case , the slide face 3 a is intended to receive a spherical movable articular insert ( fig1 ). still within the context of the invention , the concave inner receiving face 3 can be designed to receive a stationary articular insert 18 , for example for an acetabulum with single mobility , as is illustrated in fig1 . the stationary articular insert 18 is immobilized in the insertion cup 1 by a conical engagement . it will be seen more particularly in fig1 that it is possible , at the place of manufacture , to carry out pre - assembly and sterile packaging of the articular insert 18 engaged in the insertion cup 1 with the installation and orientation insert 7 fixed to the insertion cup 1 . this results in a pre - assembled unit ready for impaction by the surgeon , as a result of which the operating times can be reduced . in addition , the articular insert 18 is already fitted in the correct place in the insertion cup 1 , which limits the risk of poor positioning thereof by the surgeon . this is particularly important when the articular insert 18 is made of ceramic , since poor positioning then very often leads to premature breaking of the ceramic . it will be seen more particularly in fig1 that the installation and orientation insert 7 has elastic means 19 for holding the ceramic articular insert 18 in the insertion cup 1 . the elastic means 19 prevent any displacement of the articular insert 18 in the insertion cup 1 during transport , storage and handling of the pre - assembled insertion cup and articular insert 18 . so as not to risk damaging the ceramic articular insert 18 during impaction of the insertion cup 1 , when the installation and orientation insert 7 is fixed to the insertion cup 1 , the installation and orientation insert 7 comes into contact with the articular insert 18 only via the elastic holding means 19 . it will be seen more particularly in fig1 that the installation and orientation insert 7 is designed in such a way that a space e remains between the installation and orientation insert 7 and the articular insert 18 . therefore , no impaction shock is transferred to the ceramic articular insert 18 , which is held in the bottom of the insertion cup 1 by the elastic means 19 . it will be seen more particularly in fig1 and 15 that the assembly structure 8 of the installation and orientation insert 7 comprises a fixation hole 20 with internal thread 21 . the internal thread 21 permits the screwing of a corresponding threaded portion of the impactor ( not shown ). after the impaction of the insertion cup 1 in the acetabular cavity of the pelvis of the patient , it is necessary to withdraw the installation and orientation insert 7 . this withdrawal has to be performed without inducing stresses between the outer anchoring face 2 and the acetabular cavity of the pelvis of the patient , so as not to destroy the join made between them during the impaction . a first solution to permit separation thus consists in the fixation hole 20 being a through - hole that is able to cooperate with a disconnecting tool having a threaded rod with a distal end designed to bear directly or indirectly against the concave inner receiving face 3 of the insertion cup 1 when the threaded rod is screwed into the through - hole . in fig1 and 15 , the fixation hole 20 has a first portion 20 a of diameter d 1 and a second portion 20 b of smaller diameter d 2 . the threaded rod of the disconnecting tool has an external diameter designed such that it can be screwed into the portion 20 b of diameter d 2 of the fixation hole 20 . the installation and orientation insert 7 is designed such that a free space e 1 remains between the installation and orientation insert 7 and the bottom of the concave inner receiving face 3 ( fig1 ) or , if appropriate , between the installation and orientation insert 7 and the articular insert 18 ( fig1 ), once the installation and orientation insert 7 is fixed to the outer annular receiving structure 6 of the insertion cup 1 , the installation and orientation insert 7 bears in a sealed manner across its connecting face 11 against the receiving face 9 of the outer annular receiving structure 6 , the fixation hole 20 is a through - hole via which the free space e 1 is brought into communication with the outside and which is dimensioned for leaktight engagement of the end of a syringe . in the case of fig1 and 15 , the syringe end has an external diameter designed to engage in a leaktight manner in the portion of diameter d 2 of the fixation hole 20 . a liquid such as water or physiological saline is thus injected at pressure into the free space e 1 in order to induce a force of separation between the insertion cup 1 and the installation and orientation insert 7 . in order to obtain a sealed contact between the installation and orientation insert 7 and the insertion cup 1 , use will preferably be made of the insertion cup 1 and the installation and orientation insert 7 that are illustrated in fig8 and 9 . within the context of the present invention , when assembling the unit comprising the insertion cup 1 and an installation and orientation insert 7 ( and if appropriate a stationary articular insert 18 ), it is important not to damage the annular receiving structure 6 and the peripheral annular fixing structure 10 . in order to achieve a radial clamping of the peripheral annular fixing structure 10 on the outer annular receiving structure 6 , it is necessary that the peripheral annular fixing structure 10 has diameter dimensions equal to or less than those of the outer annular receiving structure 6 . an assembly method involving expansion and subsequent shrinkage is therefore used , during which the installation and orientation insert 7 is heated so as to increase its dimensions , after which the peripheral annular fixing structure 10 is engaged around the receiving face 9 of the outer annular receiving structure 6 , and , finally , the installation and orientation insert 7 is brought back to room temperature in order to reduce its dimensions . such a method permits assembly without blunting or damaging the one or more locking ribs 15 a - 15 d or 17 , which thus retain sharp edges for a stronger connection between the installation and orientation insert 7 and the insertion cup 1 . this method of manufacture by heating also makes it possible to avoid the abovementioned disadvantages of the method of manufacture by cooling as described in document wo 2006 / 040483 a1 . on its return to room temperature , a radial clamping of the peripheral annular fixing structure 10 on the outer annular receiving structure 6 is obtained . for assembling the unit illustrated in fig1 , it is possible , before fixing the installation and orientation insert 7 on the insertion cup 1 , to insert an articular insert 18 in the concave inner receiving face 3 of the insertion cup 1 . it is then possible to proceed to a step of sterilization of the unit thus formed and packed in a microbial protection envelope . a satisfactory sterilization will be achieved by bombardment with gamma rays , preferably at a dose of between approximately 25 kgy and approximately 40 kgy . it is expressly underlined that the method of manufacture and assembly of the units in fig1 and 15 , by heating the installation and orientation insert 7 and then returning it to room temperature , can be used with an insertion cup 1 whose outer annular receiving structure 6 is not necessarily situated set back from the opening plane p . the method of manufacture may thus be the subject of protection independently of the position of the outer annular receiving structure 6 with respect to the opening plane p of the insertion cup 1 . the present invention is not limited to the embodiments that have been explicitly described , and instead it includes the variants and generalizations contained within the scope of the attached claims .

a method for manufacturing a prosthetic hip acetabulum includes the following steps . first , one provides an insertion cup having an inner concave receiving surface having an opening surface contained in an opening plane , and having an outer annular receiving structure . next , one provides an installation and positioning insert having a peripheral annular attachment structure shaped to engage with the receiving surface of the structure , fitting around that structure . next , one heats the insert in order to increase its size . next , one fits the attachment structure around the receiving surface of the receiving structure . finally , one cools the insert to room temperature to reduce its size and achieve radial tightening of the attachment structure on the outer annular receiving structure .

referring now to the drawings and especially to fig1 an apparatus embodying the present invention and generally identified by reference numeral 10 is shown therein . the apparatus 10 has a plurality of flexible guide tubes , catheters or lumens 12 . each of the flexible catheters 12 is composed of plastic , such as polytetrafluoroethylene , and has a stainless steel anchor 14 removably connected thereto . sealing means 18 is formed integrally with each of the anchors 14 . the anchors 14 and sealing means 18 are disposed in the respective distal ends 20 of the respective flexible catheters 12 . the distal ends 20 are to be disposed within the patient . the proximal end 22 of each of the flexible catheters 12 is adapted to receive a radioisotope as will be set forth in detail later . an anchor connector means 24 for releasably connecting each of the anchors 14 to its respective catheter 12 is connected to each of the respective anchors 14 . in addition , each of the anchors 14 has connected thereto a patient connection means 26 for connecting the anchors 14 permanently or semi - permanently to tissue deep within the patient . the multiple flexible catheters 12 are received by a silastic tubular common bushing 30 , as may best be seen in fig1 , and 5 . the bushing 30 , in addition to receiving the catheters 12 has an interior portion 32 filled with silicone 34 effectively to seal the inside of the bushing 30 . however , the flexible catheters 12 are somewhat free to be slid longitudinally through the bushing 30 . dacron felt cuff 36 surrounds the outside of the bushing 30 and is used to assist in the implant of the bushing 30 into a body wall of the patient . the apparatus 10 as stated above , is for use in in situ radiotherapy of a patient . in particular , the apparatus 10 is useful for in situ radiotherapy of deep lying tumors , for example within the abdominal cavity or the thoracic cavity of the patient . as is known from the prior art , certain cancers may be treated by implanting tubes through the tumor mass and periodically placing radioactive substances within the tubes . as described in the above said copending application , the radioactive substances are in the form of a wire having a radioisotope imbedded in a nominally nonradioactive material . the radioisotope is relatively localized and thus the wire may be extended into the guide tube with the isotope being relatively well positioned with respect to the tumor . however , treating physicians recognize that the guide tubes must remain relatively immobile in the patient during the entire treatment therapy . in some cases it is desirable for the treatment to last as long as two to three weeks . in the past , it has proven impossible to implant a deep dwelling tumor with guide tubes since it has been impossible to find anchor points outside the body for such tumors . recognizing this drawback , we have developed the apparatus 10 which includes a plurality of anchors 14 for attachment to healthy tissue within the body after the guide tubes 12 are drawn through the tumor . it is also important to seal the ends of the guide tubes to prevent the patient from being infected by any materials within the guide tubes . as may best be seen in fig3 and 4 , attachment means 26 includes an aperture or suture eye 40 formed integral with each of the anchors 14 and a slotted head portion comprising a first slot 42 and a second slot 44 also formed integral with the anchor 14 . the apertures 40 are adapted to receive or have threaded through them a suture for suturing of the anchors 14 to healthy tissue . typically a figure eight suture would be used . the slots 42 and 44 are adapted to be engaged by a vascular clip which would also engage healthy tissue and permanently or semi - permanently connect the anchor 14 to the healthy tissue . the slots 42 , 44 and the aperture 40 are alternative attachment means ; the surgeon may take his choice . of course , prior to the connection of the anchor it is necessary to introduce the flexible catheters 12 into the body . this is typically done during surgical procedures wherein the surgeon concludes that the tumor which has been examined or partially exposed is nonresectable . such tumors may be in the brain , the pancreas , the bowel and various portions of the thoracic and abdominal cavities . in order to implant the catheters 12 in the tumor , the surgeon typically uses a backbone stylet . he places it in one of the catheters 12 with a respective anchor 14 attached and drives the stylet through a tumor mass 50 , as may best be seen in fig5 to the other side and positions the anchor 14 in proximity to healthy tissue 52 . it may be appreciated that a penetrant point 53 connected to the anchor 14 and referably integral therewith aids in forcing the flexible catheter 12 , stiffened by the stylet , through the tumor 50 . a suture 54 may then be drawn through the aperture 40 and stitched into place in the healthy tissue 52 thereby anchoring the anchor 14 or permanently connecting it to the healthy tissue 52 . if the surgeon does not wish to use sutures as an alternative he may clip a vascular clip to the healthy tissue and to the slots 42 and 44 connected to the anchor 14 . in either case the anchor 14 is fixed with respect to the healthy tissue 52 thereby fixing the catheter 12 with respect to the tumor body 50 . it may be appreciated that the multiple catheters 12 may be flexed , although it is desirable from the standpoint of the surgical procedures to make sure that the radius of curvature of the guide tubes is kept large as to permit insertion of the radioactive source . the catheters 12 may be implanted in three dimensional patterns throughout the tumor 50 in conformity with well - known therapeutic regimens . such regimens provide the maximum radiation flux within the tumor body 50 and lower radiation flux outside the tumor body 50 . once the distal ends 20 of the catheters 12 have been so anchored it may be appreciated that because each catheter 12 is to remain in the body for a length of time , it is important that the catheter ends are sealed to prevent infection . the sealing means 18 consists of a collar 60 which is formed integrally with the anchor 14 . the collar 60 receives the distal end 20 of the catheter 12 thereon and slightly expands an opening 62 in the distal end 20 to form a tight seal therewith to prevent the entry into the body of any materials or contaminants from within a bore 64 of the catheter 12 . it may also be appreciated that each of the anchors 14 is connected removably to the distal end 20 of its respective catheter 12 by a thread 70 connected to the anchor 14 , preferably formed integrally therewith . the thread 70 is the means for removably connecting the anchor to the distal end 20 of the catheter 12 . this removable connection feature is important for reasons which will become apparent hereinafter . although the thread 70 was employed as the removable connection , other releasable connecting means might also be employed by one skilled in the art . it may also be appreciated that although the attachment of the anchors 14 to the healthy tissue 52 has been described herein as a permanent attachment , the attachment is permanent in the sense that during the period for which the catheter 12 is to remain in the body and for a period thereafter the anchors 14 will remain implanted . this may be for the life of the patient , however , should the treating physician so desire he or she is always free to perform another surgical procedure on the patient and remove the vascular clips or sutures 54 thereby releasing the anchors 14 from the healthy tissue 52 . however , since such a procedure will involve risk to the patient who has already been weakened by the malignancy , the primary advantage of this invention lies in the fact that the anchors 14 may be released remotely from the catheters 12 to which they are connected after the radiotherapy regimen is completed . the anchors 14 may be removed , if at all , after the patient has recovered . returning to the problems faced by the physician as he implants the apparatus 10 , the bushing 30 is positioned so that approximately one quarter inch to one inch will be free to extend outside a skin surface 80 of the patient to be treated . the dacron felt cuff is positioned so that it is slightly below the level of the skin 80 of the patient and in proximity with the subcutaneous fat layer and the dermis . the surgeon attaches the bushing 30 to the patient &# 39 ; s body by looping a suture around the bushing 30 and attaching it to the underlying tissue layers . the surgeon may also wrap a suture around the bushing 30 on the opposite side of the dacron felt cuff 36 to secure the proximal side of the bushing 30 to the dermis of the patient . the surgeon then trims the catheters 12 to a length of about twelve centimeters from the proximal end of the bushing 30 . the surgeon then seals the open ends of the catheters 12 . at this point , because the surgical procedure is being completed and radiotherapy will not be started until the patient recovers from his or her surgery typically the distal portions of the catheters 12 are coiled and a skin flap is pulled over the bushing 30 and the proximal ends of the catheters 12 thereby completely enclosing the apparatus 10 within the patient &# 39 ; s body while recovery takes place . once the physician elects to begin the radiotherapy treatment , the catheters 12 and the bushing 30 will be freed partially from the skin 80 so that the bushing now protrudes a short distance outside the skin surface 80 as may be seen in fig5 . the catheters 22 , which were previously sealed , for instance with machine screws after having been trimmed by the surgeon are connected to a radioisotope source afterloader such as that described in the aforementioned application of spako et al . via quick - connects of the type normally used in the medical art . the afterloader then feeds source wires down each of the catheters 12 . because the catheters 12 are immobilized with respect to the tumor 50 by the anchors 14 , the treating physician may easily select the axial points within the catheters 12 at which he wishes the iridium 192 in the source wire to be positioned during treatment . because only a single opening is made in the patient &# 39 ; s body , and the dacron felt cuff 36 allows inward growth of tissue into contact with the bushing 30 to take place , the risk of infection is drastically reduced . this will allow the catheters 12 to remain in place for several weeks during which time a sequence of treatments may be carried out on the patient exposing the patient to relatively high doses of radiation in the tumor region several times , a regimen that provides better therapeutic results . the prior art methods were more prone to infection , the catheters could be implanted only for shorter periods of time , for instance , two to three days . although the patient received the same total dosage of radiation , not all the cancer cells could be killed . this resulted from the fact that the sources were left in the patient for the entire two or three day period . the present invention allows the patient to be exposed to radiation for brief intervals . multiple exposures are employed which are spread over several weeks . the treatment destroys more of the tumor . once the physician has completed the radiotherapy treatment after two or three weeks , the bushing 30 , dacron cuff 36 and the catheters 12 may be withdrawn from the patient &# 39 ; s body . the surgeon dissects away the tissue from the dacron cuff 36 under local anesthetic and using aseptic procedures using a buttonhole incision . the sutures securing the bushing 30 are removed and the bushing 30 is elevated away from the tissue . the catheters 12 are then each clamped with a hemostat and cut away from the bushing 30 . at that point , the guide tubes 12 are each rotated causing the distal ends to be unthreaded from the threads 70 connected to the anchors 14 . the catheters 12 may then be withdrawn from the body while the anchors are left in . then the patient has the benefit of long - term radiotherapy on deep - lying tumor without many of the surgical risks . while there has been illustrated and described a particular embodiment of the present invention , it would be appreciated that numerous changes and modifications will occur to those skilled in the art , and it is intended in the appended claims to cover all those changes and modifications which fall within the true spirit and scope of the present invention .

apparatus for in situ radiotherapy has a flexible catheter having a proximal end for receiving a radiosotope and a distal end for positioning the flexible catheter within a patient to be treated . an anchor , which is permanently connectable to tissues deep inside the patient , has a sealing collar connected to it which seals the distal end of the catheter . the anchor has a penetration point connected to it to assist a surgeon in implanting the catheter within a tumor . a threaded fastener is connected to the anchor and screwed into the catheter . the flexible catheter can be released remotely from the anchor by unscrewing it . a suture eye is connected to the anchor . the suture eye may be sutured to healthy tissue within the patient when the apparatus is implanted to secure the anchor to the patient .

in the following detailed description , reference is made to specific embodiments in which the invention may be practiced . these embodiments are described in sufficient detail to enable those skilled in the art to practice the invention . it is to be understood that the various embodiments of the invention , although different , are not necessarily mutually exclusive . furthermore , a particular feature , structure , or characteristic described herein in connection with one embodiment may be implemented within other embodiments without departing from the scope of the invention . in addition , it is to be understood that the location or arrangement of individual elements within each disclosed embodiment may be modified without departing from the scope of the invention . the following detailed description is , therefore , not to be taken in a limiting sense , and the scope of the present invention is defined only by the specification and drawings , appropriately interpreted , along with the full range of equivalents to which the specification and drawings are entitled . the word “ exemplary ” is used herein to mean “ serving as an example , instance , or illustration .” any embodiment described herein as “ exemplary ” is not necessarily to be construed as preferred or advantageous over other embodiments . likewise , the terms “ embodiment ( s ) of the invention ”, “ alternative embodiment ( s )”, and “ exemplary embodiment ( s )” do not require that all embodiments of the method , system , and apparatus include the discussed feature , advantage or mode of operation . the following description of the preferred embodiment is merely exemplary in nature and is in no way intended to limit the invention , its application , or use . referring now to fig1 - 4 of the present invention , an aquarium 31 has fish f and water w therein . a planter 10 rests upon aquarium 31 . at the bottom of aquarium 31 is a layer of substrate 59 in which a solid waste capture funnel 11 ( fig2 and 4 ) embedded in it . on top of solid waste capture funnel 11 is an undergravel filter screen 12 , which then has aquarium substrate 60 above that . at the bottom of the solid waste capture funnel lies an opening 13 from lower riser tube section 14 . in the center of undergravel filter screen 12 lies a riser tube junction 15 ( that is connected to lower riser tube section 14 ) in which riser tube 16 is attached . riser tube 16 rises through the middle of the tank and connects to planter 10 via planter opening 17 . within planter opening 17 lies a ring structure 18 that serves to halt the advance of riser tube 16 into a watering tube adaptor 19 that connects to watering tube 20 . watering tube 20 is open on either end in this embodiment , with watering holes 21 drilled , molded , or equivalent through its surface . watering tube 20 connects to the planter via the watering tube adaptor 19 , which is connected to planter 10 . an airline runs from an external air pump ( not shown ) through airline tubing ( not shown ) to the back of the planter and connects to an airline input junction ( not shown ). connected to the airline input junction on the inside of the planter is a small piece of airline tubing ( not shown ) that connects to airline elbow 22 which transverses through watering tube adaptor 19 . airline elbow 22 points down toward the bottom of the aquarium in this embodiment , connecting to airline tube 23 that is located inside of riser tube 16 . when riser tube 16 is inserted into planter opening 17 , airline tube 23 and airline elbow 22 are aligned so that the opening at the top of airline tube 23 fits and locks into airline elbow 22 . airline tube 23 runs down the inside of riser tube 16 and connects at another airline junction 24 located within riser tube junction 15 . the bottom of airline tube 23 connects to airline junction 24 in a similar manner to airline elbow 22 . finally , airline 24 runs down the inside of lower riser tube section 14 until it nears opening 13 , where it releases air into riser tube 14 via an airline output 25 . air released in airline output 25 create a suction through opening 13 when the aquarium is filled with water w , which then sucks water and waste up and into watering tube 20 and out through a plurality of watering holes 21 . this water is then released over a mat of fibrous material 26 embedded with activated carbon 27 , zeolite 28 , and calcium carbonate 29 . water in the planter pools at the bottom of planter 10 and then drains via raised drainage holes 30 , where it is directed down into aquarium 31 via drainage lips 32 . planter 10 is shaped in a way that allows it to sit directly on a round aquarium and has bottom rim 33 to assist in its stability in sitting on said aquarium . there exists a cutout and groove ( not shown ) in bottom rim 33 at the back of planter under the aforementioned airline input junction . at the front of the planter exists a cutout portion 39 ( fig1 and 2 ). at the back of the planter exists a grow light bracket 34 that allows an expandable grow light support 35 to be mounted . expandable grow light support 35 is attached to a grow light hood 36 , which has a wired bulb socket 37 attached underneath said hood . a grow light bulb 46 is illustrated in fig2 that fits in said wired bulb socket 37 . a light switch 47 juts out of switch hole 48 within light hood 36 . wiring 38 from bulb socket 37 runs through an opening within the expandable grow light support ( not shown ), then out through the back of the grow light bracket 34 . this wiring system is meant to connect to a standard wall plug and then into a standard wall socket but is not shown in these figures . planter insert 40 holds net baskets 41 that are inserted through holes 42 within the planter insert . these net baskets also fit into holes 43 within the mat of fibrous material 26 , which allows the net baskets to sit on the bottom of planter 10 . in addition to holes 43 within fibrous material 26 are holes 45 which are located at the center of the material that allow riser tube junction 15 as well as raised drainage holes 30 to transverse the mat . inserted into the net baskets 41 are plant growth plugs 44 in which a terrestrial plants 48 are grown . another embodiment of this invention is shown in fig5 - 7 that show an embodiment suitable to a rectangular aquarium . all parts that are synonymous with the preferred embodiment are labeled with a ‘ b ’ suffix . there are a number of parts , however , that have been added to this embodiment that will be discussed here . removable intake screen 49 shown in fig5 acts in place of a funnel bottom system in one form of this embodiment . a standard undergravel filter 50 is also illustrated in this embodiment to show how removable intake screen 49 is an optional arrangement , where dual riser tubes 16 b have the ability to connect to undergravel filter 50 via intake openings 51 . alternatively , an undergravel filter design like that shown in fig8 could be used that implements the bottom funnel technology described in the previous embodiment that uses an equivalent undergravel screen 12 b and funnel system 11 b , but has an angled intake tube 52 that runs under the funnel portion lib to an intake opening 53 which then connects to riser tube 16 b . compressed air could power the pumping action of this system as well , as air from an external air pump travels through airline tubing ( not shown ) to airline input junction 63 , which connects in a similar fashion to the preferred embodiment to airline tube 23 b inside riser tube 16 b and then air is released at output 25 b . airlift suction may not be enough power for larger aquariums ; therefore it is assumed that an impellor pump system may be implemented in this or any other embodiment and that these systems would be equivalent . an aquarium light housing 53 and bulb 54 is also featured in this embodiment , and is located at the bottom of planter 10 b in fig6 and 7 . at the front of planter 10 b an aquarium cover 55 with handle 56 is shown that connects to planter 10 b via hinges 62 . attached to the bottom of planter 10 b there is a single stand pipe that functions as a raised drainage hole 30 b , but is attached to a drainage tube 57 and drain diffuser 58 . in the operation of this aquaponic invention , aquarium substrate 59 is set in the bottom of aquarium 31 , solid waste capture funnel 11 is pressed into the substrate until it reaches the edge of said funnel . at this point filter screen 12 is set on top of solid waste capture funnel 11 , and opening 13 in riser tube section 14 are aligned at the bottom of solid waste capture funnel 11 . filter screen 12 acts to stop aquarium substrate 60 from entering the solid waste capture funnel 11 , while having holes large enough so that solid waste can make its way down through the substrate and into the solid waste capture funnel 11 . aquarium substrate 60 is added to the top of filter screen 12 but not higher than riser tube junction 15 , keeping this junction clear and visible is necessary for riser tube 16 attachment . water w can now be added to the system , as well as aquatic animals such as fish f . riser tube 16 attaches to filter screen 12 via riser tube junction 15 , and airline section 23 connects to airline junction 24 within the riser tube junction 15 . riser tube 16 is then inserted into the planter via planter opening 17 until it is stopped from advancing into watering tube 20 by ring structure 18 . airline section 23 attaches to airline elbow 22 in planter opening 17 , which then connects to airline tubing toward an airline input junction located at the back of the planter ( not shown ). this connection system allows riser tube 16 to be removable for cleaning after the system has been in operation . having an airline tube on the inside of a riser tube , as in this embodiment , makes for a smoother appearance and easier connection to airline junctions at the top and bottom of said riser tube . positioning an airline tube on the outside of said riser tube , perhaps in an indented portion of the riser tube would work in a nearly identical fashion and is therefore considered an equivalent embodiment . to power the airlift pumping mechanism , a standard air pump ( not shown ) or equivalent pneumatic pump that is connected to a power source ( not shown ) can be used , or another source of compressed air such as a pressurized tank of nitrogen gas . airline tubing is connected from this pressurized gas port to the airline input junction at the back of the planter ( not shown ). air now flows through each airline junction described , down the riser tubes 16 and 14 , respectively , and is released out of airline output 25 , creating bubbles that rise in the riser tubes and out through the plurality of holes 21 in watering tube 20 . airline output 25 has a close juxtaposition to opening 13 to create enough suction within solid capture funnel 11 to transport solid waste accumulation up and into the mat of fibrous material 26 where it is trapped for the degradation by microorganisms and then the roots of terrestrial plants 48 . planter 10 is preferably , but not necessarily made of polyvinyl chloride or the like . planter 10 is designed in such a way that bottom rim 33 juts out from the bottom of the planter , creating a stable ring that resists tipping and falling off of aquarium 31 . the cutaway at the back of planter 10 in bottom rim 33 ( not shown ) creates an area for an aquarium heater to be mounted inside the aquarium . cutout portion 39 at the front of the planter allows a port at which to feed the aquatic animals , add water to the system , or take samples for water quality testing etc . in the center of planter 10 is watering tube adaptor 19 , which consists of a raised cylinder attached to the bottom of planter 10 . watering tube 20 is removable in this system and is attached to watering tube adaptor 19 . at the back of planter 10 exists a grow light adaptor 34 that allows a grow light accessory 61 to be supported above the plants for increased plant growth rates . at the bottom of planter 10 is a removable mat of fibrous material 26 that is embedded with activated carbon 27 and zeolite 28 as chemical filtration mechanisms to absorb nitrogenous and gas compounds dissolved in the water and act to concentrate waste particles for use by the absorption of the plant roots . these parts also act as the hydroponic growth media for this system . calcium carbonate particles 29 are also embedded within this mat of fibrous material 26 to aid with ph buffering of the aquarium water . raised drainage holes 30 fit through holes 45 within the mat of fibrous material 26 . these raised drainage holes 30 function to create a pool of water in the bottom of the planter that aids in small particle settling , increases the adsorption time for the activated carbon 27 and zeolite 28 particles , and are resistant to roots growing through them and into the aquarium below . drainage lip 32 acts to direct the water back into the aquarium , where if this lip did not exist water would bead across the bottom of planter 10 and drip off of bottom ring 33 . planter insert 40 holds net baskets 41 ( which fit through holes 43 in the mat of fibrous material 26 ), which in turn hold natural plant growth plugs 44 . this planter insert is removable as are the plant growth plugs and add a modular aspect to this invention . the growth plugs allow seeds to be germinated or plant clones to be propagated and removed easily while this invention is in operation . the plant growth plugs are made of inert material such as rockwool , coconut fiber or peat and is embedded with a small amount of organic fertilizer and lime to supplement nutrients to the plant and buffer the ph of the tank , respectively . a person skilled in the art could add extra layers of hydroponic media above the mat of fibrous material , remove the mat altogether , or replace the planter insert with a bed of hydroponic media such as expanded clay , rock wool , pearlite or the like without changing the scope of this invention . describing now the operation of grow light accessory 61 , an expandable light support 35 attaches to the light hood 36 , which contains a light socket 37 , bulb 46 , switch 47 , and wires 38 . the expandable light support 35 is expandable to be able to raise and lower the grow light as the plants grow . the light bulb 46 can be fluorescent , incandescent , led or the like while its only necessary requirement is to give off light in a suitable spectrum for efficient plant growth . presently , the wires from light socket run down through the expandable light support 35 , exiting near the airline input junction . a person skilled in the art could make the wiring for this socket in a variety of ways , shapes or forms for a safe and easy to use system to power this light , or perhaps utilize a solar panel and dc converter to power the air pump or light . in the operation of the embodiment of this invention shown in fig5 - 7 , filter screen 49 is attached to two riser tubes 16 b with similar construction to riser tube 16 , with the difference being that the airline outlet 25 b is at the bottom of riser tube 16 b . alternatively , riser tube 16 b can be attached to a standard undergravel filter 50 via input hole 51 as shown in fig7 and used to extract solid waste from the bottom of the aquarium as well as increase the total surface area available for natural biofiltration . fig8 illustrates a solid waste capture funnel design for a rectangular aquarium that is attached to riser tube 16 b in the same fashion as an undergravel filter . this design has distinct advantages over traditional undergravel filter designs in that the funnel concentrates waste toward the center , where a vacuum tube 52 pulls the waste up and into riser tube 16 b and then up into planter 10 b . connected to the front of this embodiment , as seen in fig5 , 6 , and 7 is an aquarium cover 55 with handle 56 , attached to the bottom of planter 10 b via hinges 62 . this cover is used to limit the evaporative water loss from the aquarium as well as provide and easy access area to the aquarium . at the back of planter 10 b exists light housing 53 and bulb 54 that is used to illuminate the inside of the aquarium . wiring is not shown for the aquarium lighting or plant lighting in this embodiment , as one skilled in the art could wire fluorescent , led or equivalent lighting solutions in a standard way that would be suitable for this embodiment . a gasket would also need to be included to be placed between light housing 53 and planter 10 b for this light to keep moisture from the aquarium out and decrease the chance of electrical shock . a similar aquarium lighting system could be implemented in the first embodiment of this invention but is not included at this time . attached to the bottom of planter 10 b is a stand pipe 30 b , shown in fig6 . this stand pipe functions similarly to raised drainage holes 30 , but connects to a drain pipe 57 and then to drain diffuser 58 that acts to distribute the water evenly without disturbing the aquarium components . a bell siphon system typically used in aquaponic systems could be added to this stand pipe as an equivalent but is not used in this specific embodiment . thus , it is apparent that there has been provided , in accordance with the invention , an aquaponic system for use with aquatic animals in aquariums that fully satisfies the objects , aims and advantages set forth above . although certain example methods , functions , features , components , and abilities have been described herein , the scope of coverage of this invention is not limited thereto . on the contrary , this invention covers all methods , functions , features , components , and abilities fairly falling within the scope of the description either literally or under the doctrine of equivalents . with respect to the above description then , it is to be realized that the optimum methods , functions , features , components , and operation of the aquaponic planter are deemed readily apparent and obvious to one skilled in the art , and all equivalent relationships to those described in the description are intended to be encompassed by the aquaponic planter . therefore , the foregoing is considered as illustrative only of the principles of the aquaponic planter . further , since numerous modifications and changes will readily occur to those skilled in the art , it is not desired to limit the aquaponic planter to the exact construction and operation shown and described , and accordingly , all suitable modifications and equivalents may be resorted to , filling within the scope of the aquaponic planter . while the above description describes various embodiments of the present invention , it will be clear that the present invention may be otherwise easily adapted to fit any configuration where an aquaponic planter for use in the home , office , or school is desired or required . as various changes could be made in the above methods , functions , features , components , and abilities without departing from the scope of the invention , it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense .

an inexpensive aquaponic conversion kit for aquariums that uses a combination of mechanical , biological , and chemical filtration components along with terrestrial plants to filter aquarium water . the system includes a funnel shaped undergravel filter that concentrates solid waste towards an airlift pump that transports solid and liquid waste into a planter containing terrestrial plants . these waste nutrients are trapped in the planter in layers of activated carbon and filamentous material that adsorb and trap waste particles where the roots of plants turn the waste into biological material and aid in cleaning the tank . a grow light and hood are able to be attached to a bracket at the back of the planter to grow healthy plants .

with reference to fig1 , an oral hygiene apparatus 100 generally comprises a water supply part 10 , an oral hygiene - ware part 20 and water utility part 30 . the water supply part 10 may have a pair of hoses 11 and 12 , a mixer valve 13 and an outlet 14 . the hoses 11 and 12 connect to cold and hot water suppliers 01 and 02 , respectively , from a water supply and coupled to the mixer valve 13 . the mixer valve 13 will mix the cold and hot water , controls water temperature and control water flow rate . the mixed water will flow out at an outlet 14 . the outlet 14 will connect to the oral hygiene - ware part 20 and the water utility 30 . for example , a shower water supply that is built into a wall can be used as the water supply part 10 . the oral hygiene - ware part 20 may have a soft hose 21 , a handle 22 and exchangeable tips 25 . the soft hose 21 should be flexible with proper diameter and long enough for oral hygiene purpose . the soft hose 21 diameter is preferably between 2 mm to 1 . 5 cm . the soft hose 21 length is preferably between 50 cm to 2 m . the soft hose 21 connects to the outlet 14 of the water supply part 10 to receive the mixed water . the handle 22 is coupled to the soft hose 21 . the handle 22 has a built - in valve 23 and a quick connecter 24 . the built - in valve 23 in the handle controls mixed water flow rate and can shut off the water flow . the quick connecter 24 has a mechanism that can quickly exchange the exchangeable tips 25 . the mixed water will flow through the handle 22 and pass through the quick connector 24 and then through the exchangeable tips 25 out to the mouth of user . each exchangeable tip 25 has special oral hygiene functions . for example , the swirl waterjet tip 251 could generate a waterjet beam and a swirl waterjet , fig3 - 3 . the swirl waterjet can do deep dental cleansing even inside the periodontal pocket . the waterjet brush tip 255 has nozzles 552 and bristle tufts 551 in the head of the tip , refers to fig3 - 4 . the waterjet ejected from the nozzles 552 and brushing by the bristle tufts 551 will significantly increase cleansing the plaque on the teeth especially in the interdental area . nozzles 552 should have a height of 0 . 2 - 4 millimeters less than the bristle tufts 551 that can vary in length from 5 - 15 millimeters preferably 10 millimeters . further , the opening at the end of the nozzle 552 is 0 . 3 - 0 . 8 millimeters in diameter . the waterjets described herein are intended to have a force of 60 - 200 psi . the nozzle 552 is shorter than the bristle tufts to maximize the accuracy of the waterjets and help guide a user to avoid placing the waterjet onto the or below the gumline . the mixed water from water supply part 10 flows into the oral hygiene - ware 20 and then ejects out from the exchangeable tip 25 into the month of user to perform oral hygiene functioning . the water utility part 30 may have a hose 31 , a pipe 32 , a valve 33 and connecter 34 which connects to a utility head 35 . the hose 31 connects to the outlet 14 of the water supply part 10 and pipe 32 . the pipe 32 will deliver the water to the utility head 35 . there is valve 33 installed in the pipe 32 and controls water flow rate . the valve 33 could be installed in any portion of the water utility part 30 . the connector 34 in the end of the pipe 32 could connect the utility head 35 . the utility head 35 could be a filter , nozzles , showerhead etc . the mixed water from the water supply part 10 flows into the water utility 20 then flows out for water utility purpose . with reference to fig2 , it shows an embodiment of oral hygiene apparatus 200 . the oral hygiene apparatus 200 could be installed in a bathroom as a sink fixture . the oral hygiene apparatus 200 may have a water supply that comprises hoses 11 and 12 . the hoses 11 and 12 could connect water supplies 01 and 02 from a wall mounted valve to receive cold and hot water . the hoses 11 and 12 coupled with mixer valve 13 . the water mixer valve 13 adjusts water temperature to a proper temperature for the user . the water flow rate could also be controlled by the mixer valve 13 . the mixed water will flow out at the outlet 14 to oral hygiene - ware 20 and water utility 30 . the oral hygiene apparatus 200 may have an oral hygiene - ware that comprises hose 21 . the mixed water from the outlet 14 will flow into the hose 21 . the hose 21 is coupled to the handle 22 . there is a built - in valve 23 that is inside the handle 22 . the built - in valve 23 could control the mixed water flow out pressure by adjusting the flow rate . at a proximate end of the handle 22 may have a quick connector 24 which could quickly exchange exchangeable tips 25 . the mixed water will flow from handle 22 to the exchangeable tip 25 out to the user &# 39 ; s mouth . various tips may be available for oral hygiene functioning . fig3 - 2 depicts some exchangeable tips 25 but is not intended to be limiting . such as swirl waterjet tip 251 , refers to fig3 - 3 ; rotatable brush tip 252 ; gumline brush tip 253 ; an interdental brush tip 254 and waterjet brush tip 255 , refers fig3 - 4 . the oral hygiene apparatus 200 may have a water utility that comprises a hose 31 , a valve 33 , pipe 32 , connector 34 and utility head 35 . the mixed water from the outlet 14 will flow into the valve 33 in the water utility . the valve 33 connects to the hose 31 that is coupled to the pipe 32 . the valve 33 may shut off automatically by raising the handle 22 . the pipe 32 will deliver the water to utility head 35 . at the proximal end of the pipe 32 may have a connector 34 for mounting the utility head 35 . to use the oral hygiene apparatus 200 for oral hygiene the user should first select an exchangeable tip . the tip 255 is recommended for general cleaning . if the user has periodontal disease the tip 251 should be used after the tip 255 . after a user selects a tip and installed in the handle 22 , user should turn on the mixer valve 13 and check the water temperature from out of the utility head 35 . when the temperature is preferred , raising the handle 22 and the arm 333 will lift , fig4 . the lifted arm 333 will shut off the valve 33 and no more water will flow out from the outlet 334 c . when the lifted arm 333 is lifted , water flow to the utility head 35 is stopped , fig4 . then the user can use the hygiene - ware freely . the tip 255 has nozzles 552 and bristle tufts 551 in the head of the tip 255 . the nozzles 552 will eject a waterjet . the tip 255 has a connecter 553 and water inlet 554 refers to fig3 - 4 . the nozzles 552 are narrowed top conical tube made of elastomer or flexible material . the nozzles 552 can detect the position on the teeth to directing waterjet & amp ; brushing and avoid bristle tufts 551 from passing beyond the gumline to harm the gum . for a user who has periodontal disease the tip 251 is recommended . the tip 251 comprises tube 512 and cap 511 with one hole 511 a in the cap 511 refers to fig3 - 3 . there is a swirl waterjet generator 513 in the front of the tube 512 . there are two holes 513 a to allow water out from tube 512 then through two parallel tangent lines 513 b out to cap 511 . for the sake of clarity the two holes 513 a are parallel but do not pass through a diameter of the swirl waterjet generator 513 . water exiting from tangent lines 513 b twist relative to one another causing a swirl waterjet . when the cap 511 is screwed tightly onto the tube 512 , a swirl waterjet will eject out from the hole 511 a . when the cap 511 is screwed onto the tube 512 in a slightly loose position , the waterjet beam will eject out from the hole 511 a . water will flow into tube 512 from handle 22 then through the swirl waterjet generator 513 to eject waterjet beam or swirl waterjet to mouth of user to cleansing gingival area and dental pockets . with reference to fig5 , it shows another preferred embodiment of oral hygiene apparatus 300 . this preferred embodiment one places the valve 33 in the water utility and utility head 35 . the valve 33 is a manually operated and installed at the outlet of the pipe 32 . the hose 21 and hose 31 will be installed accordingly . the utility head 35 is a spray nozzle . the spray nozzle 35 could save water up to 70 % than regular faucet . in preferred embodiments , the oral hygiene - ware devices will not need electricity or other energy source . it is greenness and environment friendly . thus , specific embodiments and applications of oral hygiene apparatus have been disclosed . it should be apparent , however , to those skilled in the art that many more modifications beside 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 spirit of the appended claims . moreover , in interpreting both the specification and the claims , all terms should be interpreted in the broadest manner possible 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 .

oral hygiene apparatus utilize the natural water and it pressure effectively performs oral hygiene functioning without electricity , batteries , mechanical pumps and motors . it could be a fixture in bathroom .

with reference to fig1 of the drawings , it shows a plan view of a midsole in the form of a separate and distinct drop - in insert shown generally as web 10 which is provided with a large number of upstanding plugs 11 . these plugs are disposed in this embodiment along the entire midsole 10 , which extends from the toe portion 12 through the ball portion 13 to the heel portion 14 . in this embodiment each p lug 11 is upstanding with respect to the web 10 , and is affixed to the web at its proximal end . each plug 11 in this embodiment displays a central aperture 16 . the entire midsole 10 is preferably manufactured by injection molding , in which case the web 10 of the midsole as well as the plugs 11 are of the same material , and in which case the web 10 is highly flexible but not air - permeable . such midsole then would be suitable for inclusion in an article of footwear , where the web 10 is in contact with the top of the outsole and the plugs 11 project upwardly . the most suitable material found for such midsole is that known as &# 34 ; supersoft &# 34 ; thermoplastic resin available from gls plastics of woodstock , ill . 60098 , u . s . a . ( sold by them under item # g3294 ). the material is made from a thermoplastic compound known as &# 34 ; kraton &# 34 ; (™) supplied by the shell chemical company . the preferred kraton compounds ( because they are softest having shore a hardnesses [ d - 2240 ] of 27 and 34 ) are kraton d - 2104 and kraton d - 3226 . the resulting supersoft thermoplastic yields a midsole material having durometer readings below 30 , and preferably in the vicinity of 20 . inspite of the softness of the resultant midsole , it still exhibits excellent elasticity and long life . of course , there are other materials besides kraton , such as estane , polyvinyl chloride or rubber . the requisite characteristics of the material is that they yield plugs 11 that are easily compressible and significantly deformable ( generally having durometer readings below appr . 30 ) but that have long life and good elasticity in order to spring back to their original shape once compressive forces have been removed . the shape of the plugs 11 is not critical , and whether they are hollow or solid does not generally affect their deformability . in the embodiment of fig1 they are made hollow in order to save thermoplastic resin . turning now to fig2 and 3 , these show portions of the midsole shown in fig1 in perspective view and side elevation respectively . in fig3 it can be seen that this embodiment is provided with lower projections 20 , which provide a small amount of ventilation below the midsole . in fig4 the plugs are shown as items 20 and 21 . it will be seen that in the embodiments shown in fig4 the plugs are of varying thickness ( i . e . height ). such thickness or height is of course discretionary , but values below 10 mm would appear reasonable . the plugs may have a height between 3 mm and 10 mm . in fig5 it will be seen that the plugs 22 are held in place in the midsole by a web 10 which is centrally located with respect to the plugs 22 . this , of course , adds to cushion ability of shocks . in fig3 and 5 , the central apertures 16 are shown in plugs 11 , 20 , 21 , and 22 as dotted lines . fig6 shows an embodiment in which a portion of midsole as shown in fig3 is provided with a top web 25 , which suitably can be prepared of porous material , or it can be a perforated material , thereby providing for some movement of air . in this figure , the plugs 11 are shown compressively deformed and bulging . fig7 shows a cut - away view of a shoe embodying one form of the present invention , in which the midsole shown in fig1 is in place on top of outsole 31 in a shoe . a flexible , air - permeable top - sole 30 is in place over the midsole . fig8 shows a variation wherein the outsole 31 in the embodiment shown in fig7 is replaced by outsole 32 , which is provided with a multiplicity of pockets 33 adapted to receive and retain plugs 11 of the type discussed above , thus eliminating the need for the web 10 to retain these plugs in place . plugs 11 may be retained permanently in holes 33 by adhesion means , or any other suitable means . fig9 shows an embodiment wherein an outsole 42 is provided during manufacture with cut - away portions 43 and 44 so that suitably sized and shaped sections 40 and 41 of web such as shown in fig2 , etc . fit directly into the spaces , thereby taking up less vertical room in the interior of the footwear . the web sections 40 and 41 comprising the &# 34 ; midsole &# 34 ; are also thus held effectively in place against lateral movement . it is , of course , possible to provide only one of the sections 40 and 41 . fig1 illustrates an embodiment of the invention in which a section of the web 10 such as shown in fig2 is provided with plugs 50 , which are solid plugs instead of the hollow plugs 11 shown in fig2 . it may be necessary to use even softer material for the plugs 50 , in order to maintain the desired high degree of compressibility , yielding a suitable extent to compression under the step of a wearer , while allowing the plug to bulge , and recover . fig1 shows still another embodiment of the present invention in which a portion of the web 10 similar to that in fig2 is provided with upstanding plugs 51 which are hollow , but essentially square in cross section . these various design parameters may be varied in order to achieve a maximum performance . such variables as the resiliency of the plastic material , the height and shape of the plugs , the distribution and number of the plugs per unit of area , variations in the heights of various plugs , or rows of plugs , hollow versus solid plugs , and the thickness of the walls in such hollow plugs , can all be varied for the purpose of achieving the objectives of the present invention . satisfactory results have been obtained using plugs having a cross - sectional area of appr . 0 . 5 cm 2 with a wall thickness of 1 to 3 mm if hollow . fig1 shows a further variation of the invention , in which the plugs are not all of the same length , wherein an insert 41 similar to the one shown in fig9 for the toe portion of a shoe or sandal . as may be seen from fig1 , the plugs 11 grow progressively shorter through plugs 52 to 53 as they approach the toe . the lengths of the plugs may be varied in any suitable manner to accommodate the geometry of the inside of the item of footwear . fig1 shows a further embodiment of a portion of a web in accordance with the present invention wherein the plugs in the upper and lower webs are facing each other for added cushioning . again , the upper web should be flexible and preferably also air - permeable . in fig1 , the inner part of a heel section 60 of an outsole or midsole is shown which has a square recess 61 in it . the recess 61 has inserted therein a single large diameter cylindrical plug 62 which is shown in its fully compressively deformed portion for explanatory purposes . as may be seen , the compressive deformation is causing the plug 62 to bulge but , of course , only to partially fill in the space between its circumference and the corners of the recess 61 , thus pumping air upwards everytime the plug 62 bulges . in fig1 , a heel section 70 of a women &# 39 ; s shoe or sandal is shown , which has shown in it , for purposes of explanation , cylindrical recesses 71 and rectangular recess 72 . of course , any other polygonal recess may be used . plugs 73 and 74 , when installed in the recesses stick out as desired due to the recesses being shallower than the thickness or length of the plugs .

a midsole , partial midsole , or the like , for inclusion in an article of footwear having a flexible , air - permeable top sole , characterized by at least one plug in the heel region having a thickness sufficient to permit significant compression deformation along its thickness dimension accompanied by simultaneous significant bulging deformation in its circumscribing surface perpendicular to the thickness dimension ; the deformations occurring solely due to normal walking activity by any wearer of the footwear ; and the deformations thereby providing simultaneously for shock - absorption and ventilation during said normal walking activity .

in the preferred embodiment the device consists of two separate bodies , an anchor body ( 1 ) as shown in fig1 and a main body ( 2 ) as shown in fig2 . said anchor body ( 1 ) and said main body ( 2 ) may be deployed into the lumen in sequence or may be deployed simultaneously . an anchor body ( 1 ) is shown in fig1 . it consists of a long cylindrical section ( 102 ) formed of a lattice of thin diagonal members ( 103 ) that can expand in the radial direction and transitions at one end to a short tapered section ( 104 ). the design and pattern of the lattice of diagonal members ( 103 ) depends on the application , material , and stiffness desired . one common device geometry comprises a lattice of diamond - shaped elements which are joined in a ring . these diamond - shaped elements are circumferentially expandable as the prosthesis is deployed from the small profile configuration to the large profile configuration . other common geometries include helically wound wires and filaments , zig - zag rings , braided filaments , woven helical filaments and the like . these geometries may be connected together by connectors or bridges of a straight or sinuous form . this lattice of structural elements is designed to accommodate radial expansion from a small profile configuration to a large profile configuration . in the case of a tapered , branched , or bifurcated lumen , the device may be designed to expand to different diameters at different points along the device length . and , in the case of longer device lengths , the network or lattice of structural elements may be connected together by connectors residing along the outer structural frame . depending upon the bridge design , the bridge may allow the prosthesis to conform to a more tortuous anatomy during delivery , or implantation , or both . in the preferred embodiment , they are simply shown as a diamond pattern . utilization of alternate patterns such as “ u ,” “ v ”, “ w ”, or “ s ” shapes that provide the ability for radial expansion will be apparent to one skilled in the art . the tapered section ( 104 ) is made of thin longitudinal members ( 105 ) and terminates in a straight tube section ( 106 ). in the preferred embodiment , the straight tube section ( 106 ) is a section of the original tube stock that the entire anchor body ( 1 ) is made from . in an alternate embodiment , longitudinal members ( 105 ) can be similar in form to diagonal members ( 103 ) so long as they taper to straight tube section ( 106 ). in a further alternate embodiment , straight tube section ( 106 ) could have the same cut pattern as cylindrical section ( 102 ) but has not been fully expanded so that in the deployed configuration it remains at a reduced radius from cylindrical section ( 102 ). the main body ( 2 ) is shown in fig2 . it consists of a long cylindrical section ( 202 ) formed of a lattice of thin diagonal members ( 203 ) that can expand in the radial direction and transitions at one end to a short tapered section ( 204 ). the design and pattern of the lattice of diagonal members ( 203 ) depends on the application , material , and stiffness desired . in the preferred embodiment , they are simply shown as a diamond pattern , but utilization of alternate patterns to provide the ability for radial expansion will be apparent to one skilled in the art . tapered section ( 204 ) is made of thin longitudinal members ( 205 ) and terminates in an intermediate straight tube section ( 206 ) that is a section of the original tube stock that the entire anchor body ( 1 ) is made from . in an alternate embodiment , longitudinal members ( 205 ) can be similar in construction to diagonal members ( 203 ) so long as they taper to straight tube section ( 206 ). in a further alternate embodiment , tube section ( 206 ) could have the same diagonal cut pattern as cylindrical section ( 202 ) but has not been treated to expand so that in the deployed configuration it remains at a reduced radius from cylindrical section ( 202 ). the intermediate tube section ( 206 ) transitions to a partially expanded spherical section ( 207 ) made of a lattice of slender diagonal members ( 208 ) that can be expanded in the radial direction . in an alternate embodiment the partially expanded section ( 207 ) could be oval in shape and mate with an oval shaped tube section ( 106 ). in this alternate embodiment , this would reduce the rotational freedom of the interface about the long axis of the device and therefore prescribe the angular orientation between the two . radiopaque markers could then be used to verify an certain angular orientation at deployment . again , the pattern of the diagonal members ( 208 ) can be varied and depends on the application , material , and desired stiffness . in the preferred embodiment they are simply shown as a diamond pattern , but utilization of alternate patterns such as “ u ,” “ v ”, “ w ”, or “ s ” shapes to provide the ability for radial expansion will be apparent to one skilled in the art . spherical section ( 207 ) transitions into an end straight tube section ( 209 ). end straight tube section ( 209 ) may have cut slots in it giving a diagonal brace pattern , but it is substantially unexpanded and is most conveniently the radius of the original tube stock from which the device is manufactured . in the preferred embodiment , anchor body ( 1 ) is installed through a catheter and deployed into the vessel at a location of relatively healthy tissue that is proximal to the damaged tissue . once the anchor body is satisfactorily located and deployed for example via a catheter delivery system , main body ( 2 ) is inserted into anchor body ( 1 ) and then the spherical section ( 207 ) is allowed to expand within anchor body ( 1 ) as shown in fig3 . the delivery system is removed and the main body ( 2 ) is held in place in part by contact with the vessel wall but more substantially by the reinforcing action of spherical section ( 207 ) trapped within or beyond tube section ( 106 ). when the spherical section ( 207 ) is contained within or beyond the tube section ( 106 ) it acts substantially as a joint which prevents relative lateral translation of the main body ( 2 ) and the anchor body ( 1 ) but allows relative rotation between the main body ( 2 ) and the anchor body ( 1 ). anchor body ( 1 ) thereby holds main body ( 2 ) in place through the contact at trapped spherical section ( 207 ), even in the absence of direct adequate friction between vessel wall and main body ( 2 ). in an alternate embodiment , main body ( 2 ) is inserted into anchor body ( 1 ) prior to deployment while still in the delivery system . the two bodies are then delivered and located into the vessel at the appropriate locations simultaneously and then allowed to expand , trapping spherical section ( 207 ) within tube section ( 106 ). in use with a bifurcated vessel ( 310 ), as shown in fig4 anchor body ( 1 ) is deployed above the bifurcation in a region of healthy tissue ( 311 ) that can support the necessary anchor load . main body ( 2 ) is deployed to cover the region of damaged tissue ( 312 ). in use with a tortuous geometry ( 410 ) as shown in fig5 , anchor body ( 1 ) is deployed above the damaged tissue in a region of relatively healthy tissue ( 411 ) that can support the necessary anchor load . main body ( 2 ) is deployed to cover the area of damaged tissue ( 312 ). changes in angulation and tortuosity ( 413 ) are accommodated by the ball - joint like connection between anchor body ( 1 ) and main body ( 2 ). changes in tortuosity may be rapidly or slowly varying with time . in the application to vessels with side branches ( 510 ) as shown in fig6 , anchor body ( 1 ) is deployed above the side branch ( 514 ) in a region of relatively healthy tissue ( 511 ) that can support the necessary anchor loads . main body ( 2 ) is deployed to cover the region of damaged tissue ( 512 ). the connection between anchor body ( 1 ) and main body ( 2 ) occurs at a region of reduced diameter . this reduced diameter region of the device is located adjacent to the entrance to the branch vessel ( 513 ) so that flow to / from the branch vessel is not obstructed . the application to bifurcated vessels ( 610 ) may require two or more main bodies ( 2 ) for treatment of two or more damaged vessels is shown in fig7 . anchor body ( 1 ) is deployed above the bifurcation in a region of relatively healthy tissue ( 611 ) that can support the necessary anchor load . anchor body in this case has two or more straight tube sections ( 106 ) in order to accommodate two or more main bodies ( 2 ). the connection between each main body ( 2 ) and anchor body ( 1 ) forms a connection similar to a ball joint as has been described . each main body ( 2 ) is deployed to cover the region of damaged tissue ( 612 ). in an alternate embodiment , an intermediate anchor body ( 7 ) is shown in fig8 , it consists of a long cylindrical section ( 702 ) formed of a lattice of thin diagonal members ( 703 ) that can expand in the radial direction and transitions at its first end to a short tapered section ( 704 ). the tapered section ( 704 ) is made of thin longitudinal members ( 705 ) and terminates in a straight tube section ( 706 ) of reduced diameter . at the second end of said intermediate anchor body , cylindrical section ( 702 ) transitions to a short tapered section ( 707 ). tapered section ( 707 ) is made of thin longitudinal members ( 708 ) and terminates in an intermediate tube section ( 709 ) of reduced diameter . the intermediate tube section ( 709 ) transitions to a partially expanded spherical section ( 710 ) made of a lattice of slender diagonal members ( 711 ) that can be expanded in the radial direction . spherical section ( 710 ) transitions into an end straight tube section ( 712 ). this intermediate anchor body allows chaining multiple anchor bodies together where the connection between each anchor body substantially acts as a ball joint allowing relative rotation between bodies and finally attaches to a main body as previously described as shown in fig9 . it is also possible to attach multiple main bodies in this manner . the foregoing description of the present invention describes an apparatus and method for excluding aneurysms occurring in the thoracic or abdominal aorta or for treating occlusive disease in the peripheral vasculature . it should be understood however , that the methods and apparatus of the present invention are equally applicable elsewhere in the human body where it is desired to repair a bifurcated vessel or organ , or to treat highly tortuous or angulated lumens . while preferred illustrative embodiments of the present invention are described above , it will be obvious to one skilled in the art that various changes and modifications may be made therein without departing from the invention and it is intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention .

the present invention is an endoluminal prothesis consisting of one or more anchor bodies and a main body for the treatment of vascular disease , especially when such disease requires the ability to anchor in a region remote from the diseased tissue . anchor bodies and main bodies attach together in a manner to allow significant relative rotation between bodies and to accommodate changes in lumen tortousity with time . the device has numerous advantages in the treatment of damaged vasculature . methods of deploying a stent , stent - graft , or filtering system constructed in accordance with the present invention are also provided .

hereinafter , the present invention will be described in detail with reference to the accompanying drowings and in comparison with the conventional make - up brush . a conventional make - up brush is shown in fig1 . a brushing head 2 and a stem 3 are tightly combined to form a make - up brush 1 . the brushing head 2 is composed of bristles 2a and a tubular body 2b . bristles 2a are inserted and kept into the upper portion of a metallic tube 2b , the upper portion of which is pressed to grip the bristles 2a tightly therein . the lower portion of the tubular body 2b still remains cylindrical . the stem 3 may be made of plastic or wood , the top end portion of which is so shaped as to match the lower portion of the above tubular body 2b and to be fixed in it . a make - up brush according to the first embodiment of the present invention is shown in fig2 in which a brushing head 10 and a stem 30 are separably combined by means of a connecting member 20 to form a brush 1 &# 39 ;. the connecting member 20 is provided with a screw hole 21 in the lower central portion thereof and fixedly inserted into the hollow of the tubular body 11 . since the connecting member 20 is located inside the hollow of the tubular body 11 , there is formed a supporting flange ` a ` at the edge of the tubular body 11 . the connecting member 20 may be made of plastic , metal , wood or other proper materials . meanwhile , on the top of the stem 30 , there is provided a screw bolt 31 to engage the screw hole 21 of the connecting member 20 . further , fig3 shows a modified make - up brush of fig1 with a solid screw bolt 31 buried in the stem 30 . as also shown in fig4 showing a make - up brush according to the second embodiment of this invention , the screw bolt 22 may be provided not in the stem 30 but in the lower end portion of the connecting member 20 . in this case , the upper end portion of the stem 30 is provided with a screw hole 32 to accept the above screw bolt 22 . the screw hole 32 may be formed in the stem 30 itself . however , a separate metallic connecting member 32 may also be buried in the wood or plastic stem 30 . fig5 shows a make - up brush according to the third embodiment of the invention , wherein the lower end portion of the connecting member 20 is projected out of the lower end of the tubular body 11 , while a supporting flange ` b ` to accept the lower end portion of the connecting member 20 is provided at the top of the stem 30 . the supporting flange ` b ` can be formed by the conventional methods . alternatively , the lower end portion of the connecting member 20 projecting out of the tubular body 11 and the upper end portion of the stem 30 may have a equal diameter and the two end portions may engage each other inside a separate supporting ring . meanwhile , although the supporting flange in the above embodiments function to ensure the fixation of the connecting member and the stem , it is not a essential element of the present invention . in other words , even without the supporting flange , the object of the present invention can be accomplished as far as the brushing head and the stem are separably connected . the brushing head and the stem may be combined with each other by utilizing the spring force of a simple elastic body such as a plate spring . this means that the connection methods between the brushing head and the stem are not restricted to the above screw type connection . as apparent from the foregoing , the present invention provides a make - up brush which enables a user to select its brushing head or its stem according to his preference or the cosmetic product to use and serves the user &# 39 ; s convenience thereby . further , according to the invention , the user does not have to discard the complete brush with a still usable stem , when the bristles of the brushing head had worn out or fallen off . accordingly , a considerable waste of resources and money can be prevented . although the preferred embodiments of the invention have been disclosed for illustrative purposes , those skilled in the art will appreciate that various modifications , additions and substitutions are possible , without departing from the scope and spirit of the invention as disclosed herein .

the present invention provides a make - up brush which comprises a brushing head and a stem , wherein both of the brushing head and the stem are separably combined . the user of the make - up brush can select a stem and a brushing head from a group of various stems and brushing heads to assemble brush .

as will be appreciated , the present invention provides glass - ceramic compositions comprising a glassy matrix and one or more micaceous phases ( e . g ., tetrasilic flourmica , fluorophlogopite mica and the like ). the glass - ceramics are useful in the fabrication of dental restorations . the micaceous glass - ceramic compositions contain inter alia , silica , magnesium oxide and fluorine in the ranges given in table 1 below . the glass - ceramic compositions have a combination of properties including high strength and chemical durability useful for dental restorations . the glass - ceramics have good machinability , i . e ., the ability to be cut or milled by a cutting tool into a dental restorative shape that accurately depicts the original shape of the tooth to be restored or replaced . in an important aspect herein , the micaceous glass - ceramics are provided in a plurality of shades and colors to adequately match the colors and shades of teeth found in 95 % or more of the human population . the shades and colors of the glass - ceramics provide the dental technician with the ability to closely and effectively match the color and shade of the patient &# 39 ; s tooth or teeth abutting or adjacent to the tooth or teeth that is / are being restored or replaced . in accordance with one embodiment of the method of the invention , the shaded micaceous glass - ceramics are manufactured by admixing pigments and other additives to the starting glass powder . the powder is formed into pre - forms or blanks and the blanks are concurrently sintered and crystallized . the resulting shaded blanks of various shades and translucency levels are consistent with current all - ceramic or porcelain - fused - to - metal ( pfm ) dental porcelain systems . the pre - forms or blanks may be machined into a dental restoration using a cad / cam device . in accordance with the process , the glass compositions within the ranges given in 20 table 1 are melted at a temperature in the range of about 1200 ° to about 1650 ° c . and for a time in the range of about 0 . 5 to about 8 hours , thereafter quenched , and pulverized into powder . this powder is sieved to obtain the required particle size and mixed with conventional additives such as pigments , opacifiers , and fluorescing agents , which will produce various colors , shades and translucency levels after sintering and concurrent crystallization have been performed . the powder that contains the additives is then used to form net - shaped or block - shaped pre - forms or blanks to be used in cad / cam devices . the blanks are dry - pressed and sintered using a one - or two - step heating cycle at a temperature in the range of about 600 ° to about 1200 ° c . and for a time in the range of about 0 . 5 to about 4 hours for each step in the cycle . the sintering is preferably conducted in a vacuum atmosphere . occurring simultaneously with sintering , surface crystallization of the starting glass powder yields an amount of mica phase of at least thirty volume percent ( 30 vol %) required for machinability as well as strength . copending commonly assigned u . s . application ser . no . 09 / 458 , 919 , filed on dec . 10 , 1999 , and u . s . pat . no . 5 , 968 , 856 to schweiger discuss volume crystallization and surface crystallization of lithium disilicate glass - ceramics and are hereby incorporated by reference . in mass - production of cad / cam blanks , uniaxial pressing or other forming techniques are utilized , e . g . cip / hip route whereby green bodies are formed in a cip ( cold isostatic press ) and subsequently sintered under pressure in an hip ( hot isostatic press ). as an alternative to the cip method , the powder can be mixed with binder and pelletized or extruded . useful cad / cam devices include the cerectm machine ( available from siemens ag ), the procamtm machine ( available from cad cam ventures llc in irving , tex . ) or copy - milling devices such as the celay ™ machine ( available from mikrona technologie ag ). essential for the present invention is an f content in excess of about 14 mole percent ( about 5 weight percent ). besides being a constituent of fluormicas , f facilitates surface crystallization . other ingredients that favor surface crystallization are b 2 o 3 , p 2 o 5 , bao and li 2 o . essential for the present invention is the volume fraction , size and aspect ratio of the mica phase in the resultant sintered glass - ceramic . the larger the mica plates and the higher their aspect ratio , the lower the volume fraction of mica that is required to attain machinability . an aspect ratio , i . e ., ratio of thickness to length , of the mica plate of ≧ 2 is preferred . at least thirty volume percent ( 30 vol . %) of mica is required to attain machinability . at least thirty volume percent ( 30 vol . %) of the residual glass phase is required for sinterability . therefore , the mica content is between about 30 and about 70 volume percent , and preferably between about about 40 and about 60 volume percent . some of the compositions of the present invention are extremely reactive and will dissolve additives ( e . g ., pigments and fluorescing agents ) during sintering of the cad / cam blocks . in this case , it was found that using coarser additives ( e . g ., pigments or fluorescing agents ) substantially alleviated this problem . normally , these additives ( pigments and fluorescing agents ) have an average particle size of about 4 to about 8 microns . for most reactive compositions , it was found to be critical to use additives of average particles size equal to or exceeding 15 microns . it is believed that , at the same time , particles exceeding 60 microns will compromise strength . thus , special care should be taken to remove particles greater than 60 microns . preferably , the average size of the additives is in the range of about 15 to about 35 microns , and more preferably in the range of about 20 to about 30 microns . application of pressure during sintering of blanks such as in the cip / hip route described above is more expensive than vacuum sintering of uniaxially pressed blanks but may be extremely beneficial in some cases . for example , the cip / hip route allows consolidation of powders having high pigment load , or powders yielding high mica content upon crystallization , or powders having high zro 2 content . extremely beneficial , especially for larger high aspect ratio mica , is post - machining heat treatment of dental restorations at temperatures between the glass transition temperature ( gtt ) and the dilatometric softening point ( dsp ). this heat - treatment affects surface crack healing and increases structural integrity of the restorations . in addition to fluormicas , other phases can be present such as cordierite , apatite , spodumene and zirconia . consequently the expansion of the resulting glass - ceramic can be varied in the range of about 7 to about 12 × 10 − 6 /° c . a coating is preferably applied over the core material manufactured from the micaceous glass - ceramic to provide an aesthetically pleasing surface . a suitable coating is a ceramic , glass - ceramic , a glass , a glaze and / or a composite material . it is advantageous that the coating has a coefficient of thermal expansion slightly less than the thermal expansion of the core material . the coating is typically applied by sintering the ceramic , glass - ceramic , glass , glaze a composite material onto the micaceous glass - ceramic core . a starting glass composition corresponding to the composition set forth in table 2 below was batched from conventional raw ingredients and melted at 1400 ° c . for 4 hours in a coarse - grained alumina crucible . the glass melt was quenched into water . the quenched glass was dried and milled into powder . the powder was screened to − 200 mesh . commercial pigments and fluorescing agents ( yellow from cerdec co . ( washington , pa . ), pink from engelhard corp . ( iselin , n . j .) and jet black from standard ceramic supply co . ( carnegie , pa .)) were added to and blended with the powder . the powder was dry - pressed into 18 × 18 × 25 mm 3 blocks . the blocks were fired in a vacuum of 20 torr using a two - step heating cycle at 10 ° c ./ min to 650 ° c . and held for 2 hours at this temperature and 10 ° c ./ min to 1100 ° c . and held for 4 hours at this temperature . the blocks were sectioned into bars for three - point bend strength tests and small squares for solubility measurements according to iso 9693 solubility testing standards . the measurements are listed in table 2 below . a starting glass composition corresponding to composition set forth in table 2 below was batched from conventional raw ingredients and melted at 1400 ° c . for 4 hours in a coarse - grained alumina crucible . the glass melt was quenched into water . the quenched glass was dried and milled into powder . the powder was screened to − 200 mesh . commercial pigments and fluorescing agents were used in concentrations given in table 3 below . since it is known that all dental shades can be produced by varying combinations of three basic pigments . i . e ., yellow , red ( or pink ) and blue ( or gray or black ), the glass - ceramic of this example was shaded using both individual yellow , pink and black pigments and their combinations . yellow pigments from cerdec ( washington , pa . ), pink pigments from engelhard corp . ( iselin , n . j .) and jet black pigments from standard ceramic supply co . ( carnegie , pa .) were used . the powder formulations were pressed into 2 . 5 gram disks and fired in a vacuum of 20 torr using a two - step heating cycle at 10 ° c ./ min to 650 ° c . and held for 2 hours at this temperature and 10 ° c ./ min to 1100 ° c . and held for 4 hours at this temperature . the resulting shades were evaluated using the colortec - scm ™ color computer from colortec corp . ( clinton , n . j .) and were found appropriate for simulating the color and shade of a person &# 39 ; s teeth . blocks of lightly shaded glass - ceramics of example 2 were sent to cad cam ventures llc ( irving , tex .) and to dentalmatic technologies inc . ( sainte - laurent , quebec , canada ) to be evaluated for machinability . they were machined into shapes roughly approaching that of a dental coping . the machinability was evaluated as satisfactory . the glass - ceramics of the invention have the capability to provide a wide selection of shades and colors for matching the shades and colors of a person &# 39 ; s teeth . the glass - ceramics are readily machinable and provide high strength and chemical durability to the dental restorations made therefrom . while various descriptions of the present invention are described above , it should be understood that the various features can be used singly or in any combination thereof . therefore , this invention is not to be limited to only the specifically preferred embodiments depicted herein . further , it should be understood that variations and modifications within the spirit and scope of the invention may occur to those skilled in the art to which the invention pertains . accordingly , all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention . the scope of the present invention is accordingly defined as set forth in the appended claims .

micaceous glass - ceramics are useful in the fabrication of single and multi - unit dental restorations including but not limited to orthodontic appliances , bridges , space maintainers , tooth replacement appliances , splints , crowns , partial crowns , dentures , posts , teeth , jackets , inlays , onlays , facing , veneers , facets , implants , abutments , cylinders , and connectors by machining the glass - ceramic using cam / cam devices . the micaceous glass - ceramics are provided in a plurality of shades and colors to adequately match the colors and shades of teeth found in 95 % or more of the human population .

referring now to the drawings , the implant 1 shown in fig1 and 2 is intended to be introduced in a bore 2 made in the lateral or fibular malleolus 3 . the implant 1 comprises a convex head 4 , substantially in the form of a spherical cap and of which the radius of curvature is substantially equal to that of the outer cheek of the astragalus of the ankle in question . the shank 5 of the implant 1 is provided with outer radial flanges 6 of which the outer diameter d . sub . 6 is substantially equal to the inner diameter d . sub . 2 of the bore 2 . according to the invention , two orifices 7 are provided in the shank 5 and are capable of receiving a suture thread 8 or other flexible tie . when such a thread is engaged in one of the orifices 7 , it is possible to exert on the thread 8 an effort of traction t which is transmitted by the thread 8 to the shank 5 as represented by arrow t ′ in fig2 . in this way , by pulling on the thread 8 , the surgeon introduces the shank 5 in the bore 2 without having to exert an effort of thrust on the head 4 which may be difficult to access due to the surrounding ligamentary system . in other words , it suffices for the surgeon to place a thread in one of the orifices 7 , to pass the two strands of the thread 8 in the bore 2 via the inner face of the malleolus , then to pull the strands via the outer side of the malleolus . the traction on the thread 8 has the effect of introducing the shank 5 of the implant 1 in the bore 2 and of applying the head 4 on the bone . the effort of traction t exerted on the thread 8 may be intense and directed parallel to the longitudinal axis x . sub . 2 of the bore 2 , with the result that the shank is efficiently drawn towards the inside of the bore 2 . in particular , taking into account the direction and intensity of the effort of traction t , the diameters d . sub . 2 and d . sub . 6 can be provided to be substantially equal , with the result that the shank 5 is firmly maintained in place after having been positioned . the shank 5 is provided with two bores 7 distributed along its axis x . sub . 5 , the bore 7 nearest the end 5 a of the shank 5 being used . the fact that the shank 5 comprises a plurality of orifices 7 makes it possible to use an orifice 7 relatively close to the end 5 a of the shank 5 and to avail of such an orifice including when the shank 5 is cut in order to adapt its length to the thickness e of the malleolus 3 . the number of bores 7 may , of course , be increased if necessary . the bore 2 is made via the outer face 3 a of the malleolus 3 with the aid of the ancillary tool shown in fig3 and 4 . this tool 10 comprises a spacer block 11 provided to be disposed between the tibia t and the astragalus a of an ankle to be fitted with the implant 1 . the block 11 comprises a substantially planar upper surface 12 intended to cooperate with a planar surface created by resection of the distal end of the tibia . the lower surface 13 of the block 11 is formed by two planar surfaces 13 a and 13 b inclined with respect to each other by an angle . alpha ., the surfaces 13 a and 13 b being provided to bear respectively on corresponding surfaces created by resection of the upper face of the astragalus a . the surface 12 of the block 11 comprises a c - shaped housing 14 intended to receive a shim 15 of which the upper surface 16 is in contact with the lower surface of the tibia t . the thickness e of the shim 15 shown in fig3 is such that its upper surface 16 is flush with the upper surface 12 of the block 11 . however , thicker shims may be used when the distance e ′ between the lower surface of the tibia and upper surface of the astragalus is greater than in the configuration shown in fig3 . the block 11 defines a housing 17 for receiving the end 20 of a substantially c - shaped lug 21 . the end 20 is provided with a bore ( not shown ) which , in the configuration of fig3 and 4 , is aligned with a bore 18 made in the block 11 and passing downwardly through this block , i . e . connecting the surfaces 12 and 13 . a screw 19 may be introduced in this bore which is at least partially tapped , this making it possible to immobilize the end 20 of the lug 21 inside the housing 17 . in practice , the clearance made when the screw 19 is tightened allows a limited pivoting about axis x . sub . 18 of the bore 18 . at its end 22 opposite the end 20 , the lug 21 supports a clamping system 23 adapted to be maneuvered thanks to a knurl 24 and making it possible to apply the malleolus 3 of the fibula p against a stop 25 formed on an extension 26 of the end 20 of the lug 21 . x . sub . 23 denotes the longitudinal axis of these clamping means . the clamping means 23 are hollow , with the result that a drill 30 may be introduced up to the level of the outer face 3 a of the malleolus 3 in order to make the bore 2 from the outside towards the inside of the malleolus 3 . in this way , the surgeon may easily aim at the suitable part of the malleolus 3 thanks to the clamping means 23 which also constitute a bore guide for the drill 30 . as the lug 21 is capable of pivoting about axis x . sub . 18 , the position of axis x . sub . 23 is variable in pivoting about this axis x . sub . 18 , which makes it possible optimally to adjust the orientation of the bore 2 as a function of the exact geometry of the malleolus 3 . . beta . denotes the maximum angle of pivoting of the axis x . sub . 23 about axis x . sub . 18 . in practice , the angle . beta . is of the order of 10 . degree . thanks to the tool 10 , a bore 2 may therefore be formed from the outside , allowing a rapid and efficient implantation of the implant 1 . when shims 15 of thickness greater than those shown in fig2 are used , they can be provided to overlap the bore 18 , as the screw 19 is placed in position before positioning of the shim 15 which is effected during operation as a function of the distance e ′. the invention has been shown with a total ankle prosthesis , which corresponds to the geometry of the surfaces 12 and 13 of the block 11 . however , it is also applicable to a partial ankle prosthesis , without modification of the implant 1 , the ancillary tool in that case being adapted to the geometry of the anatomical articulation surfaces between the tibia and the astragalus . various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention . for example , while the embodiments described above refer to particular features , the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features . accordingly , the scope of the present invention is intended to embrace all such alternatives , modifications , and variations as fall within the scope of the claims , together with all equivalents thereof .

a method of implanting in a fibula a malleolar implant including a head and a shank . the method comprises the steps of creating a bore in the fibula extending from an inner face to an outer face and applying a traction force to the malleolar implant so that the shank is pulled into the bore .

a computed combination of the data from a series of digitally acquired images will result in the same view obtained in the previously referred to film simulation mode and requires the combination of registered pixels from each of the digitized images . the method is described in appendix a . in addition , other view foils are possible to compute simply by changing the pattern of the voxel coordinates passed to the digitized tomography kernel as well as various image enhancements . the film mode simulation digitized tomography kernel math is described in appendix b wherein the kernel is limited to the axis of rotation of the object being perpendicular to the image plane . the film mode simulation geometry works in the film mode because the object plane is parallel to the film plane . referring to fig3 , the geometry is such that the geometric magnification of projected shadows of the features of the object plane 18 is uniform . thus the appropriate superposition of the film images places the projected shadows of the features of the view image plane in coincidence . referring to fig4 , in the alternate geometry , the object plane 18 is not parallel to the film plane and thus the geometric magnification varies over the film plane . since the film is dimensionally fixed , it is therefore not possible to superposition the film so that the projected shadows of the features of the object plane are in coincidence . in order to form an image by combining alternate geometry projections , one must accommodate the variation of magnification . if one specifies the geometry of image formation sufficiently , one can mathematically trace a ray from the source 20 , through the object space voxel to the image plane and compute the coordinate of the shadow of the voxel on the image plane . if done for each object rotation , the image data could be extracted and combined to form the estimate of the given object space voxel . since the ray tracing process includes the geometric magnification effects , both the current and alternate geometries are applicable , as are many other geometries . the geometry can be specified with sufficient accuracy and precision to achieve acceptable results . the first limitation is the spot size of the x - ray source 20 . each edge of the projected image has a penumbra caused by that spot size . its dimension is the spot size times the distance between the object feature and the image plane divided by the distance between source 20 and the image plane . since the usual spot size is in the order of a millimeter , the source distance in the order of a meter , and the feature distance is in the order of a few tens of millimeters , the penumbra is in the order of a few tens of thousandths of a millimeter or a few thousandths of an inch . the alternate geometry may have larger penumbra due to the larger distances between the object feature and the image plane . using a smaller spot size and / or longer source distances can reduce this effect . the second limitation is the pixel size of the image plate . since we use data from eight or more images , its possible to obtain resolutions better than the pixel size of the image plate . use of multiple images also tends to cancel a portion of the penumbra effect . the third limitation is the specification of the geometry . errors in the specification of the position of the source 20 have an effect similar in magnitude as the penumbra effect . those errors are attenuated by the ratio of the source distance to feature distance . errors in the identification of the center of rotation has a one to one impact . errors in specification of the various angles are dependent upon the distance over which the error is communicated . acceptable errors for the current image plate are in the order of a few hundredths of a degree . with such tight tolerance of angles and dimensions , the geometry must be either very carefully measured or calibrated by using the system and specially constructed objects . the assumption is that there is a fixed relationship between the source 20 and image plate , that the object is between the source 20 and the image plate , and that it is the object that is rotated about a fixed axes between each exposure cycle . this restriction can be removed by measuring the precise location and orientation of the source 20 , the object , and image plate . however , since the goal is to achieve a working system within the bounds of currently available technology , the above restrictions are necessary . relatively simple input transformations can be used , if required , to adapt to precise and accurate location and orientation measurements looking at the system as it is presented in fig1 and 2 , the x axis is left to right , the y axis is vertical , and the z axis is in and out . the origin of the system is the outer left most pixel on the image plate . one coordinate increment is equal to one pixel . this makes the image plate coincident with the x , z plane . the x , z plane in the new coordinate system is the same as the x , y plane of the original system . the change is necessitated by the three dimensional ( 3d ) math required by the alternate geometries . the original geometry only required two dimensional ( 2d ) math . 2 . the image plate dimensions ( width in z axis , height in x axis ) 4 . the center of rotation to image plate distance ( object distance ) the source to image plate distance is not critical . errors are diminished by the ratio of the feature to image plate distance to the source to image plate distance . the image plate dimensions and pixel size are given by the manufacturer . the center of rotation to image plate distance is also not critical . its used to compute the object plane level offset so that one can specify the view level as distance from the base of the object . the object radius of interest is perhaps the least critical . it simply sets the computed image size . it is necessary that it is sufficient to include the features of interest but not so large as to unnecessarily extent the computation time . 1 . the source to image plate plane angle in the yz and xz planes ( source angle ) 2 . the object axis of rotation to image plate plane angle in the yz and xz planes ( object angle ) in accordance with this invention , one defines , by manufacture and / or by measuring the source to image plate plane angles and the object axes ′ of rotation to image plate plane angle as closely as reasonably possible . small errors can be measured using the system and specially constructed objects and corrections can be computed . if the manufacture or measurement is precise and accurate enough , corrections won &# 39 ; t be required , in which case the ray tracing method is not limited to any particular geometries . it is apparent from our current system that the manufacture of the means to set the rotation angle of the object is sufficiently precise and accurate for the existing image plate . the existing system uses a two step geometry calibration . referring to fig5 , the object 22 is a round marker disk 24 with a central pin 26 made of a material suitably opaque to x - rays . referring to fig6 , in the first step , the disk 24 is retained on the object turntable 28 via insertion of the bottom of the pin 26 through the disk 24 and into a hole in the center of the object turntable 28 . an image is taken and is used to discover the coordinates of the center of rotation . in the alternate geometry , it is used in the same manner referring to fig7 , in the second step , a plastic post 30 carries the marker disk and pin assembly at its top end . the plastic post 30 has a similar pin at its bottom end , inserted into the central hole of the object turntable 28 , and a hole at its upper end to receive the bottom of the pin 26 through the round disk 24 . a second image is taken and is used to discover the misalignment coordinate . the central coordinate of the marker shadows is measured by the graphical interactive method , described in appendix c . the center coordinate , the misalignment coordinate , the length of the plastic post 30 , and the pixel size are used to compute corrections for the source and object angles . this calibration technique is the subject of my u . s . patent application ser . no . 09 / 709 , 586 , filed nov . 13 , 2000 , entitled “ tomosynthesis system and registration method ,” hereby incorporated herein by reference . however , it was not then extended to the alternate geometry . fig8 and 9 indicate how the marker disk 24 and misalignment post can be placed on an angled object turntable 32 to calibrate the alternate geometry . the digitized tomography process requires very precise image registration for it to produce high quality computed images . the requirement is such that every pixel in every source image must be known to the process to within a fraction of a pixel . a method that provides for such high resolution image registration of film x - ray images consists of a fixture , a setup process , and calibration procedure that assures a very specific geometry of exposure and allows each digitized film image to be transformed into a standard registration and format . because the x - ray source is position immediately overhead the center of rotation of the fixture and the fixture is tilted to the desired angle that axial misalignment of the x - ray images is not encountered . the current digitized tomography calculations assume the path between the center of the x - ray source and the center of rotation of the non - film fixture &# 39 ; s turntable 28 falls on a plane that is perpendicular to the non - film image plate &# 39 ; s surface , parallel to the long axis ( the “ y ” axis ) of the non - film image plate , and passes through the center of rotation of the fixture &# 39 ; s turntable 28 . since the current fixture is placed horizontally and the x - ray source is moved to the side and angled toward the center of rotation , an axial misalignment is possible without using special alignment procedures and tools . even a small misalignment can cause serious degradation of the resultant computed digitized tomography views . currently , the center of rotation is calibrated using an image of a circular marker placed at the center of rotation in a manner identical to the method used to identify the center of rotation of film images . because all images can be taken with an identical registration , the three reference mark technique used with film images is not required . however , a second reference mark must be used to measure the axial misalignment of the x - ray optical axis . that marker may be of the same size and material as the center reverence mark but must be displace above the center of rotation by some distance . since the center position of the marker can be determined to approximately ½ a pixel width , that distance need only be approximately ½ the maximum possible image radius . the current image plate is 2304 pixels wide with a 200 pixel “ gutter ” along one edge . that makes the effective radius ( 2304 − 200 )/ 2 = 1145 pixels at 0 . 005 inches per pixel , that is , 5 . 724 inches . one half of that is 2 . 86 inches . using the center coordinates of the two reference markers , the axial misalignment angle can be determined and a correction to the digitized tomography calculations can be applied to the “ x ” and “ y ” axis displacement values . the process is as follows : let x1 , y1 be the pixel coordinate of the center of the center reference mark image . let x2 , y2 be the pixel coordinate of the center of the elevated center reference mark image . let the x - ray optical axis be more or less parallel to the “ y ” axis in the positive direction . the distance between centers of the reference marks is computed by taking the square root of the sum of the squares of the differences between the first and second coordinates : distance = sqrt (( x1 − x2 )*( x1 − x2 )+( y1 − y2 )″( y1 − y2 )). that distance is divided into the differences between the coordinates to compute the sine and cosine of the misalignment angle : sine of misalignment angle =( x2 − x1 )/ distance and cosine of misalignment angle =( y2 − y1 )/ distance . the displacement is the normally calculated displacement value and is computed as a function of the image level . the “ x ” axis displacement value is computed as the displacement times the sine of the misalignment angle and the “ y ” axis displacement value is computed as the displacement times the cosine of the misalignment angle . the adjusted displacements are applied to their respective axis calculations as described elsewhere . a procedure similar to the one used with the film mode simulation geometry can be used to compute and apply the corrections to the alternate geometry . an additional calibration step can be applied to the alternate geometry — the distance between the image plate and the center of rotation ( object distance ). errors in that dimension can affect the accuracy of measurement of feature size , although simple measurement should be enough because the effect of that error is the size of error divided by the source distance . one way to calibrate that dimension is to place two marker disk 24 and pin 26 assemblies a known distance apart on the object turntable 32 , centered on the center of the turntable 32 and oriented so the line connecting the centers of the disks is parallel to the z axes . the following relationship are true : solving for the object distance gives a calibrated estimate of the required dimension . a . acquire centroid of center calibration marker shadow in image plane i . coordinate is x1a , z1 a by method in appendix c ii . note : the image plane is parallel with the xz plane iii . note : the origin of the image plane is at the coordinate system origin b . acquire centroid of misalignment calibration marker shadow in image plane i . coordinate is x1b , z1b by method in appendix c ii . note : if z1a equals z1b there is no misalignment i . convert height of misalignment calibration post to pixel units ii . source angle equals arctan (( misalignment post height )/( x1b − x1a )) iii . for current geometry , angle is source angle 1 . object angle is 0 ° 2 . presumes accurate construction 3 . implies object plane is parallel to image plane 4 . construction and calibration procedure seems adequate 1 . source angle is 90 ° 2 . presumes accurate alignment of image plane to source path 3 . implies optical axis is normal to image plane a . transform source distance to pixel units b . xs = x1a c . ys =( source distance )× sin ( source angle ) d . zs = z1a i . vx1 = 0 ii . vy1 = image width − 1 iii . vz1 = 0 iv . m1 = sqrt ( vx1 ^ 2 + vy1 ^ 2 + vz1 ^ 2 ) i . vx2 = 0 ii . vy2 = image height − 1 iii . vz2 = 0 iv . mz = sqrt ( vx2 ^ 2 + vy2 ^ 2 + vz2 ^ 2 ) c . normal vector = the normalized cross product of vector 1 and vector 2 4 . for each object voxel in desired digitized tomography view foil i . transform engineering units coordinate to pixel unit coordinate ii . two dimensional coordinate transformations in xz plane 1 . rotate about axis of rotation to misalignment angle 2 . rotate about axis of rotation to incremental angle a . rotate about center of rotation to object angle b . translate to the center of rotation b . use results of 1 and 4a to create a 3d line c . use results of 3 and 4b to compute intercept coordinates i . dx = xo − xs ; ii . dy = yo − ys ; iii . dz = zo − zs ; iv . mu =−( d + nvx × xd + nvy × yd + nvz * zd )/( nvx × dx + nvy × dy + nvz × dz ) v . xi = xs + mu × dx vi . yi = ys + mu × dy vii . zi = zs + mu × dz i . use results of 4c to extract projected ray pixel value e . combine pixel values from 4d by method in appendix a f . store result of 4e in destination digitized tomography view data matrix . the process of producing a computed tomographic view from multiple digitized x - ray images requires the combination of the registered pixels from each of the digitized images . the usual method used is a simple summation or averaging of the pixels to be combined . this method results in an image containing many confusing artifacts and visual blurring . the original absorption model for combining eight images is as follows : the minimum pixel value was assigned a transmission fraction of 0 . 5 the maximum pixel value was assigned a transmission fraction of 1 . 0 all other pixel values were assigned a transmission fraction proportionately between 0 . 5 and 1 . 0 successively multiply initial pixel value by the transmission fraction of that same pixel location in each of the eight images combined pixel = maximum pixel value for each of eight images in succession image pixel = image pixel + maximum pixel value image pixel = image pixel div 2 image pixel = image pixel − maximum pixel value image pixel = image pixel * combined pixel image pixel = image pixel div maximum pixel value combined pixel = combined pixel + image pixel note : while floating point arithmetic could be used , integer arithmetic is much faster on most computers note : while eight images were used in the present case , the method could be adapted to other numbers of images while the fixed absorption model gave generally good results , it was thought that other values of absorption might give improved results for some examinations . for example , examinations of very dense objects might benefit from higher absorptions while examinations with low density areas of interest might benefit from lower absorptions . the fixed absorption model has been modified to allow variable absorption using integer arithmetic as follows : combined pixel = maximum pixel value for each of eight images in succession image pixel =− image pixel + maximum pixel value image pixel = image pixel div 2 image pixel = image pixel − maximum pixel value image pixel = image pixel * combined pixel image pixel = image pixel div maximum pixel value image pixel = image pixel * scaled absorption fraction image pixel = image pixel div scaling factor combined pixel = combined pixel + image pixel note : while floating point arithmetic could be used , integer arithmetic is much faster on most computers note : while eight images were used in the present case , the method could be adapted to other numbers of images if the absorption fraction is one , the results are as before . given an absorption fraction greater than one , the effect is to increase the absorption . while , an absorption fraction less than one results in a decrease of absorption effect . visual results are as expected . a digitized image is a rectilinear matrix of numbers . each number represents the integral intensity of a small area of the original object , picture , or transparency . in order to transform the matrix to an image the eye can use , hardware must be provided such that each number can be presented as a small area of light or dark on a video display or printing device . when the eye looks at a small area of light , a perception of brightness results from an integration of area and intensity . that is a small area of bright will look as bright as a slightly larger area of slightly less brightness . this understanding lead to the following method of determining the value of a pixel whose coordinate fell between pixels . a two dimensional matrix of pixel values for a source image =& gt ; upper left = fx * fy * aspect ratio =& gt ; upper right =( 1 − fx )* fy * aspect ratio =& gt ; lower left = fx *( 1 − fy * aspect ratio ) =& gt ; lower right =( 1 − fx )*( 1 − fy * aspect ratio ) where : aspect ratio = y pixel resolution / x pixel resolution it was concluded that the eye will weight the four nearest pixels proportional to the opposing areas between ⁢ ⁢ pixel ⁢ ⁢ value = ⁢ ( upper ⁢ ⁢ left ⁢ ⁢ value * lower ⁢ ⁢ right ⁢ ⁢ area + ⁢ upper ⁢ ⁢ right ⁢ ⁢ value * lower ⁢ ⁢ left ⁢ ⁢ area + ⁢ lower ⁢ ⁢ left ⁢ ⁢ value * upper ⁢ ⁢ right ⁢ ⁢ area + ⁢ lower ⁢ ⁢ right ⁢ ⁢ value * upper ⁢ ⁢ left ⁢ ⁢ area ) / aspect ⁢ ⁢ ratio the between pixel value calculation is currently used for two applications in the dt33 and dt36 programs : rotation and translation of digitized images forming the measure feature profile line tests have been performed yielding very good results for two more applications : several additional applications should be quite possible but are as yet untested : variable image area selection calculation of arbitrary z - axis view correction of digital image distortion the digitized images must be rotated and translated for two reasons : 1 the acquired image must be rotated and translated to a standard reference rotation and position 2 the set of images for an examination must be rotated and translated so that the image combination will yield the computerized tomographic view at the desired level a two dimensional matrix of pixel values for a source image a two dimensional matrix of pixel value locations for a destination image a coordinate of the image center of rotation a reference coordinate for the image center of rotation an angle to rotate about the image center of rotation an x displacement of the image center of rotation an y displacement of the image center of rotation transform each integral coordinate in the destination image into a fractional coordinate in the source image : x . fx = ⁢ ( x ⁢ ⁢ destination - source ⁢ ⁢ center ⁢ ⁢ x - x ⁢ ⁢ displacement ) * ⁢ cos ⁡ ( rotation ⁢ ⁢ angle ) + ⁢ ( y ⁢ ⁢ destination - source ⁢ ⁢ center ⁢ ⁢ y + y ⁢ ⁢ displacement ) * ⁢ sin ⁡ ( rotation ⁢ ⁢ angle ) - ⁢ ( 2 . 0 * source ⁢ ⁢ center ⁢ ⁢ x - reference ⁢ ⁢ x ) y . fy = ⁢ ( x ⁢ ⁢ destination - source ⁢ ⁢ center ⁢ ⁢ x - x ⁢ ⁢ displacement ) * ⁢ sin ⁡ ( rotation ⁢ ⁢ angle ) + ⁢ ( y ⁢ ⁢ destination - source ⁢ ⁢ center ⁢ ⁢ y + y ⁢ ⁢ displacement ) * ⁢ cos ⁡ ( rotation ⁢ ⁢ angle ) + ⁢ ( 2 . 0 * source ⁢ ⁢ center ⁢ ⁢ y - reference ⁢ ⁢ y ) compute the between pixel value in the source image at x . fx , y . fy and place it in the destination pixel location x destination , y destination . the operator selects two points on the image which are the ends of a line passing through the feature of interest . if x1 & lt ;& gt ; x2 then slope =( y2 − y1 )/( x2 − x1 ) else slope = sign of ( y2 − y1 ) 1e20 or similar large number for each one pixel distance between the two points on the line compute the fractional coordinate : x increment = sqrt ( 1 /( 1 + sqr ( slope ))) y increment = slope * x increment x . fx = x1 + x increment * number of pixels from x1 , y1 y . fy = y1 + y increment * number of pixels from x1 , y1 for each fractional coordinate compute the between pixel value to be the corresponding feature profile line pixel value . previous applications were based upon the fractional coordinates being one image pixel apart . if the fractional coordinates are spaced closer than one pixel apart the destination image is effectively magnified . that is if they are ½ pixel apart the effective magnification is 2 ×; ¼ pixel apart is 4 × and so on . when such a magnification is done the result is a smooth magnification of the digitized image - that appears much like the image produced by a magnifying glass . the customary approach to the magnification of a digital image is the simple square replication of each pixel . that is for a 2 × magnification each pixel is replicated into a 2 by 2 square . the resulting image appears magnified but has a square tile effect which reduces the eyes ability to see the shape of the magnified features . magnification of digital images is becoming more important as the resolution of image digitizers and digital display devices improves . current resolution is such that it is difficult to see features that are a few pixels in size . this trend is expected to continue . the current method of locating the center of the registration reference marks is as follows : the computer scans on the x and y axis until it finds a maximum in the slope of the image intensity higher than the noise peaks the position of the maximum is determined by using the maximum slope along with the preceding and following slope values to form a second order curve the position of the maxima of the second order curve is assumed to be the position of the edge the trial center of the mark is then computed as the mean x , y coordinate the computer then takes the trial center and similarly computes a second trial center the compute then takes the second trial center and computes the final center coordinate the rotation and position of the image is adjusted by the rotation and translation procedure the computer then determines the new center coordinates of the reference marks the sequence is repeated until the errors in angle and position are reduced below a small amount the computer scans on the x and y axis until it finds a maximum in the slope of the image intensity higher than the noise peaks the position of the maximum is determined by using the maximum slope along with the preceding and following slope values to form a second order curve the position of the maxima of the second order curve is assumed to be the position of the edge the trial center of the mark is then computed as the mean x , y coordinate the computer then takes the trial center and similarly computes a second trial center the compute then takes the second trial center and computes the final center coordinate use the same method used to create a feature profile line to produce an x , y scan across the reference marks whose angle is adjusted for the angular error found above in a similar manner find the fractional coordinates of the maximum slope in the pixel intensity compute the center coordinates for both reference marks as the mean coordinate of each repeat the second process until the computed angle and position error changes less than some small amount the advantage of this extended method is that the true error in angle and position of the image is determined without the time consuming multiple rotation and translation adjustment . this becomes vary important as the resolution of the digitized image improves . current images are 3 . 1 meg pixels with a possible 12 . 6 meg pixels soon . the higher resolution image will take too much time and memory to allow such adjustment . the operator selects a packing fraction 1 to 1 4 to 1 9 to 1 16 to 1 the central area of the source image is packed into the destination image area the time and memory required to adjust the digitized image to standard position and rotation the inflexibility of the integral pixel packing approach not allowing optimum sizing of the area of interest after digitization demagnification of the digitized image should be possible in a manner vary similar to the magnification discussed above . compute the fractional coordinates so that they are more than a source pixel apart . any arbitrary demagnification should be able to be achieved . rotation and translation can be accomplished at the same time by using the extended reference mark find method coupled with the coordinate transformation procedure above . thus the excessive time and memory required for the current method can be eliminated along with allowing an optimum selection of the area of interest . the current method of computation of a z - axis view is limited to any x or y line in the currently formed computed tomography view series . a specific x or y line is taken from each stored computed tomographic view and displayed side by side . this is not quite satisfactory because : the entire series must be created first too much time is taken read all of the data from the disk the feature of interest may not be along the x or y axis the feature of interest may in fact be curved a list of fractional coordinates one pixel apart are generated from that path or possibly magnified or demagnified as required transform that list so that the appropriate rotations and translations are included acquire pixel data along that transformed path by the above between pixel method if an array of fractional coordinates can be computed to correct for the distortion in a digital image , the above between pixel calculation can be used to correct that distortion . thus linear distortion such as magnification or aspect ratio can be corrected with ease . non - linear distortion such as that resulting from a variable speed scanning camera can be corrected if that non - linearity were adequately known . the coordinate system to be used in this disclosure is as follows : the film is placed at the image plane the image plane is the x , y plane the image plane is tilted at some angle with respect to a base plane the y axis is parallel to be base plane the image is formed by x - rays projecting a shadow of an object at or near the image plane multiple images are formed by rotating the object about an axis of rotation the z axis is parallel to the axis of rotation the intersect of the axis of rotation and the image plane is the center of rotation the center of rotation is the desired origin of the coordinate system previous disclosures described a method of using reference marks to transfer the registration of the object to the computer . several methods of locating and using the centers of those markers were discussed . as the image resolution is pushed to higher levels , registration becomes a more demanding problem to be solved . for digitized tomography brand computerized tomography to work at its best , the multiple digitized images must be in registration to within a pixel . after digitization of the x - ray images , the two registration marks centers are located , the apparent center of rotation is computed based upon a previously established relationship between the registrations marks and the center of rotation . the image is then moved to a standard position and rotation : the line joining the centers of the registration marks is parallel to the y axis the center of rotation is positioned at the center of the digital image since the acquired images must be rotated to form the final ct view , the quality of the result is vary sensitive to variations in registration along the y axis . this is especially true as the area of interest is more distant from the center of rotation . when working with pixels as small as a few mills , the projected image of the reference marks becomes an ellipse rather than a circle . center find routines based upon the assumption of a circle fail to locate the center of the mark to within the required fraction of a pixel . in fact , variations in the position of the final image of more than five pixels , have been observed . 3 scan along the x axis to find maxima or minima of differential of pixel level 4 compute x coordinate of left and right edge of reference mark as position of maxima or minima of differential 6 scan along the y axis to find maxima or minima of differential of pixel level 7 compute y coordinate of top and bottom edge of reference mark as position of maxima or minima of differential 9 use computed mean x , y coordinate as center of reference mark method two — in use : 4 use a threshold pixel level based upon the pointed to inside and outside pixel levels 5 scan along the x axis until the first pixel equal to or less than the threshold level is found 6 use the x coordinate of the found pixel as the right and left edge x coordinate 8 scan along the y axis until the first pixel equal to or less than the threshold level is found 9 use the y coordinate of the found pixel as the top and bottom edge y coordinate 11 use computed mean x , y coordinate as the center of reference mark improvements being tested : instead of using the coordinate of the pixel equal to or less than the threshold level , use the interpolated factional coordinate : this improvement changes method two resolution to much better than its previous one half pixel . using either method one or two locate the approximate center of the reference mark . use the first found value of the center as the starting point of a second approximation of the center . this improvement changes the reproducibility of the found center to better than one tenth of a pixel . 3 adjust the image to an approximate standard position and rotation 4 find the new centers of the reference marks using the same find method 6 if the new angle error and center of rotation are too large go to step 3 this improvement changes the reproducibility of the rotation and position of the image to better than five hundredths of a degree and one pixel . this method can be performed using the current software . however , it requires repeated operator interaction and a substantial amount of time for the repeated adjustment to standard position and rotation . 1 find the centers of the reference marks by either improved method 2 use the right , left , top , and bottom coordinates to determine the size of the reference mark 3 use the same method used in the measure image feature to create the pixel pattern across the reference marks as follows : a : the diameter plus a small amount through the center parallel to the line between centers b : the diameter plus a small amount through the center perpendicular to the line between centers 5 compute the edge coordinates of the half way level in each pattern 6 use the mean coordinates as the center coordinates for step 3 until the difference between the new center and the previously found center is less than a to be specified fraction of a pixel 7 use the final found centers as a basis for adjusting the digital image to standard position and rotation this method has the advantage of requiring only one sequence of operator actions and only one adjustment to standard position and rotation . 3 compute the image coordinates of one pixel increments along that line a : the pixel pattern coordinates may be fractional coordinates b : the image pixels are at integral coordinates c : the pixel value will be determined by the same method used by the rotate - translate routine — an opposing area weighted mean of the nearest four pixel values although the present invention and its advantages have been described in detail , it should be understood that various changes , substitutions and alterations can be made herein without departing from the spirit and scope of the invention . moreover , the scope of the present application is not intended to be limited to the particular embodiments of the process , machine , manufacture , composition of matter , means , methods and steps described in the specification . as one of ordinary skill in the art will readily appreciate from the disclosure of the present invention , processes , machines , manufacture , compositions of matter , means , methods , or steps , presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention . accordingly , the invention is intended to include within its scope such processes , machines , manufacture , compositions of matter , means , methods , or steps .

a digitized tomosynthesis method , system and apparatus is provided for obtaining 3d volumetric imaging of an object wherein a ray of energy from a source travels through the object to impinge on an energy sensor defining an image plane and the object is rotated about an axis whereby an image is acquired by the energy sensor at successive rotational positions of the object , and wherein the object is rotated about an axis of rotation at a canted angle with respect to the image plane .

fig1 shows the joint visualization of ablation catheter , heart chambers and areas of risk when the medical treatment devices are being used . the diagram shows the left atrium 1 of a patient &# 39 ; s heart , pulmonary veins 2 to 5 and the esophagus 6 . likewise an ablation catheter 7 is shown , with which atrial fibrillation can be treated by cauterization of intracardiac tissue . as shown in fig1 , both the region to be treated , namely the heart chamber , and also the anatomical areas at risk , namely the pulmonary veins 2 , 3 , 4 , 5 and the esophagus 6 , are mapped by visualization devise 20 to a display or image 21 . the esophagus 6 is among the areas of risk for which movement is possibly variable , thus intraprocedural 2d and 3d real - time imaging is used in such cases . to this end and intracardiac ultrasound system ( ice ) is used which delivers two - dimensional or three - dimensional images of the left atrium . optionally the esophagus can also be mapped with the ice - us system in addition to the cardiac anatomy . in addition a transesophageal echocardiography ultrasound system ( tee ) can be used which delivers a corresponding visualization of the esophagus 6 . if the intervention concerned only affects the pulmonary veins 2 , 3 , 4 , 5 , these could also be mapped with pre - procedural 3d imaging , e . g . with a conventional x - ray system . the process visualization of the esophagus through pre pre - procedural 3d imaging is also possible , if the movement variance of the esophagus is estimated to be insignificant . a registration and subsequently an image fusion are carried out by the visualization device 20 in order to combine the different image data or representations . this is done using normal registration methods for a 2d - 3d or a 3d - 3d registration . as shown in fig1 , the electrophysiologist can recognize the current position of the ablation catheter 7 relative to potential areas of risk and perform the ablation with the appropriate care in the vicinity of these areas of risk , e . g . by a reduced ablation time or a reduced ablation power . provided it makes sense in medical terms , the ablation can also be performed at a slightly offset location or not at all . areas of risk 8 , 9 , 10 are extracted by the visualization devise 20 from the recorded image data . an area of risk can be a surface , for example the area of risk in the case of the esophagus 6 can be defined by a surface . with a heart valve the area of risk can be defined by a specific point . in the area of the mouths of the pulmonary veins 2 , 3 , 4 , 5 the area of risk can also be a three - dimensional surface . areas of risk can also be represented as flat surfaces ( e . g . cross section of pulmonary veins ) or as lines ( e . g . center line of the esophagus ). in the exemplary embodiment shown real - time imaging is used by the visualization device 20 for mapping the areas of risk 8 , 9 , 10 , the extraction of the areas of risk is thus also undertaken by the visualization device 20 continuously during the ablation procedure , meaning that the visualization and the determination of the areas of risk 8 , 9 , 10 is constantly being updated . a mapping of the esophagus is achieved by swallowing a stomach probe with a corresponding sensor of the mapping system . the surface or the position of the areas of risk 8 , 9 , 10 can be identified by this position sensor , the relative position of the area or areas of risk to the position of the ablation catheter 7 can then be determined by the visualization device 20 at the same time . this gives the user a visualization of the anatomy , of the areas of risk 8 , 9 , 10 and of the ablation catheter 7 . since the relative position of the ablation catheter 7 to the areas of risk 8 , 9 , 10 is known , the treatment device can give the user feedback about this spatial relationship . in this case the distance between the current position of the ablation catheter 7 or its tip and the surface or position of an area of risk 8 , 9 , 10 is determined by the visualization device 20 . if this distance falls below a predetermined limit value the ablation catheter 7 can be blocked , meaning that the power can be reduced , alternatively or additionally the temperature can be reduced or the ablation catheter 7 can switched off entirely . the primary aim of this is to give the user a warning , and therefore the blocking of the ablator can be cancelled by active operation of a user interface . if the distance between the current position of the ablation catheter 7 and the position or the surface of areas of risk 8 , 9 , 10 falls below a predetermined limit value , a visual , tactile or audible signal is output . in the medical treatment device different threshold values are provided for different areas of risk , different applications and for the imaging modalities used in each case for mapping the areas of risk . likewise the limit values can be configured or set differently for different users or user groups . the visual warning signal can be reproduced at one or more of the medical systems used during the ablation procedure , e . g . at the x - ray system , at an electromagnetic mapping - system or at an electrophysiological recording system . a tactile warning signal is output if the catheter is being guided with remote navigation , e . g . with a magnetic remote navigation system or a mechanical remote navigation system . in these cases the tactile feedback can be provided to the user via a user interface of the remote navigation system . the user interface can be a joystick or a 6d mouse for guiding the catheter for example . the warning signals or the power reduction for safety reasons is tailored to the different uses , this feedback or the blocking of the ablation catheter 7 is thus only initiated after a specific power has been output or if the ablation catheter has a specific temperature . where a limit value for the distance between the position of the ablation catheter 7 and the surface or position of an area of risk 8 , 9 , 10 is undershot , the duration of the ablation or power output is automatically limited . since the interaction of different medical engineering systems , devices and components which are used in an electrophysiological procedure is required for the treatment device 11 for imaging , 3d - 3d registration , determining distances from areas of risk , the treatment device 11 includes a communication interface 12 embodied as a data bus , via which information is exchanged between the different medical engineering systems , terminals or components involved which are used for electrophysiological ablation procedures . this information or messages is transmitted synchronously or asynchronously and contains status notifications , ecg information 2d or 3d information about anatomical or image - based features determined or position or orientation of instruments , registration information for reconciliation and for registration of device - internal coordinate systems or device - internal configuration information . to achieve ongoing joint visualization of the heart chamber to be treated , the areas of risk and the position of the ablation catheter 7 , an electroanatomical mapping system 13 is provided in the exemplary embodiment shown , in addition 2d real - time imaging is provided . in addition an x - ray system 14 and a intracardiac ultrasound system ( ice ) 15 are also used . furthermore a transesophageal echocardiography system ( tee ) 16 can be connected to the communication interface 12 . in addition the ablation catheter 7 , a stimulator 17 and an electrophysiological recording system 18 are networked with each other via the communication interface 12 . the treatment device keeps the user informed continuously during an electrophysiological ablation procedure about the distance between the ablation catheter 7 and areas of risk 8 , 9 , 10 . if necessary precautionary measures are taken automatically by the device , which prevent or restrict ablation in the vicinity of areas of risk 8 , 9 , 10 . in this way the risk of injury to the patient in ablation procedures is significantly reduced .

medical treatment device with an ablation catheter and a visualization device for joint display of the ablation catheter and the anatomy of a part of a patient &# 39 ; s body to be treated , whereby the visualization device is embodied for detection of areas of risk of the part of the body to be treated and for displaying the areas of risk jointly with the ablation catheter and the anatomy .

referring to fig1 a container 11 is shown with a handle 13 attached to container 11 . container 11 is a collection cup for specimen samples . container 11 is for collecting urine , stool , or other specimens for the diagnosis of a patient by a treating physician and for collecting urine for drug testing . in the preferred embodiment , container 11 is formed of a suitable plastic such as polypropylene . container 11 is substantially cylindrical , having inclined sides making the lower portion of container 11 smaller in diameter than the upper portion . container 11 has a bottom side enclosing the lower portion of container 11 . the top side of container 11 is open for receiving a specimen . handle 13 is an elongated member with an integrally formed hoop 15 on one end to slide over the outer surface of container 11 from the lower portion towards the upper portion of container 11 . a gripping region 17 is located on the end of handle 13 opposite hoop 15 . handle 13 is a plastic material strong enough for a person holding gripping region 17 to support container 11 after the specimen is deposited in container 11 . preferably , handle 13 is formed of polystyrene although other materials are suitable . handle 13 is fairly rigid . hoop 15 may be deformed , but does not readily stretch in diameter in the preferred embodiment so as to provide adequate stability . threads 19 are located on the outer surface of the upper portion of container 11 for receiving a conventional lid ( not shown ) having internal threads . container 11 is closed and sealed to prevent loss of the specimen when threads 19 receive the lid ( not shown ). referring to fig2 a downward facing annular shoulder 21 is located on the outer surface of the upper portion of container 11 for receiving the top surface of hoop 15 ( shown in fig1 ). shoulder 21 is below threads 19 . the outer diameter of shoulder 21 is larger than the inner diameter of hoop 15 ( fig1 ), and the top surface of hoop 15 engages shoulder 21 . shoulder 21 is a physical barrier to hoop 15 ( fig1 ) sliding up the outer surface of container 11 to the threads 19 . shoulder 21 prevents container 11 from sliding through hoop 15 when someone holding gripping region 17 supports container 11 . an annular engagement zone 23 is defined by the portion of container 11 below shoulder 21 . engagement zone 23 is surrounded by hoop 15 ( fig1 ) when hoop 15 engages shoulder 21 . engagement zone 23 has a vertical dimension or thickness that is slightly more than the thickness of hoop 15 ( fig1 ). in this embodiment , the outer diameter of engagement zone 23 is slightly less than the inner diameter of hoop 15 ( fig1 ). referring to fig2 a set of ribs 25 are located in engagement zone 23 around the circumference of container 11 below shoulder 21 . ribs 25 are preferably evenly spaced around the circumference of engagement zone 23 . also , preferably the circumferential space between each rib 25 and another rib 25 is much greater than the circumferential thickness of each rib 25 . the outer surface of each rib 25 is a small segment of a cylinder that defines an effective diameter . ribs 25 are oriented axially along the axis of container 11 so that ribs 25 extend from shoulder 21 towards the lower portion of container 11 , preferably terminating at the lower edge of engagement zone 23 . the outer diameter extending around the circumference of the portion of container 11 at the exterior surface of ribs 25 defines an effective diameter that is less than the outer diameter of shoulder 21 and slightly greater than the inner diameter of hoop 15 ( fig1 ). in the preferred embodiment , the effective diameter of ribs 25 is substantially the same around the upper and lower portions of ribs 25 . the material of hoop 15 ( fig1 ) is flexible enough for hoop 15 to deform as hoop 15 is pulled upward over ribs 25 . once installed , the inner surface of hoop 15 ( fig1 ) is in contact with the outer surface of ribs 25 when hoop 15 engages shoulder 21 . ribs 25 form an interference fit with the inner surface of hoop 15 ( fig1 ) when hoop engages shoulder 21 , the frictional engagement preventing container 11 from rotating inside of hoop 15 . although hoop 15 does not readily stretch when installed , it does tend to flatten between ribs 25 so as to be able to locate over the larger effective diameter of ribs 25 . in operation a patient or operator orients handle 13 ( fig1 ) relative to container 11 so hoop 15 ( fig1 ) is surrounding the lower portion of container 11 . the patient moves handle 13 and slides hoop 15 along the inclined sides of container 11 towards the upper portion of container 11 . the patient slides hoop 15 ( fig1 ) substantially perpendicular to the long axis of container 11 over ribs 25 until the upper edge of hoop 15 ( fig1 ) engages shoulder 21 . after the patient deposits the specimen in container 11 , the patient or a medical technician can disassemble the specimen collecting device . preferably a lid ( not shown ) is first installed . to disassemble the device , the patient tilts handle 13 ( fig1 ) to cause hoop 15 ( fig1 ) to disengage from ribs 25 and shoulder 21 . the patient or technician then slides hoop 15 down the inclined sides of container 11 until hoop 15 clears the lower portion and no longer surrounds container 11 . referring to fig3 a second embodiment of container 11 is shown having a set of axially oriented tapered ribs 29 in engagement zone 23 . like ribs 25 , ribs 29 are spaced around the circumference of container 11 . ribs 29 also have an effective diameter defined around the circumference of the radially outermost portions of ribs 29 that is less than the outer diameter of shoulder 21 and greater than the inner diameter of hoop 15 ( fig1 ). in the embodiment shown in fig3 ribs 29 have lower portions with inclined faces 33 angling inward from an axially middle portion of ribs 29 to the axially lowermost portion of ribs 29 . the effective diameter around inclined faces 33 of ribs 29 is substantially the same or slightly less than the inner diameter of hoop 15 ( fig1 ). the effective diameter around the portion of ribs 29 above inclined faces 33 is larger than the inner diameter of hoop 15 ( fig1 ). the effective diameter around inclined faces 33 allows hoop 15 ( fig1 ) to more slide over the lowermost portions of ribs 29 more easily than in the first embodiment . like the first embodiment , hoop 15 ( fig1 ) deforms as hoop 15 engages the portion of ribs 29 above inclined faces 33 because effective diameter is larger than the inner diameter of hoop 15 . the inner surface of hoop 15 ( fig1 ) is in frictional contact with the outer surface of the portion of ribs 29 above inclined faces 33 when hoop 15 engages shoulder 21 . ribs 29 form an interference fit with the inner surface of hoop 15 ( fig1 ) when hoop 15 engages shoulder 21 , preventing container 11 from sliding too easily from hoop 15 . once installed , the lower edge of hoop 15 ( fig1 ) is above inclined faces 33 . in operation , the patient attaches handle 13 ( fig1 ) relative to container 11 so hoop 15 ( fig1 ) is surrounding the lower portion of container 11 . the patient moves handle 13 ( fig1 ) and slides hoop 15 ( fig1 ) along the inclined sides of container 11 towards the upper portion of container 11 . the patient slides hoop 15 ( fig1 ) substantially perpendicular to the long axis of container 11 , first over inclined faces 33 then over ribs 29 until the lower edge of hoop 15 ( fig1 ) is above inclined faces 33 . inclined faces 33 allow the inner surface of hoop 15 ( fig1 ) to slide over the lower portions of ribs 29 more easily than the inner surface can slide over the lower portions of ribs 25 in the embodiment shown in fig2 . in the embodiment shown in fig4 a set of protuberances or bosses 35 are located around the outer surface of container 11 in engagement zone 23 below shoulder 21 . bosses 35 are substantially hemispherical in shape and define an effective diameter around the radially outermost portions of bosses 35 . bosses 35 are evenly spaced apart from each other . the spaces between bosses 35 are much greater than the diameter of each bosses 35 . the effective diameter around the radially outermost portions of bosses 35 is larger than the inner diameter of hoop 15 ( fig1 ) causing hoop 15 to deform as hoop 15 engages bosses 35 . the inner surface of hoop 15 ( fig1 ) is in contact with the radially outermost surface of bosses 35 when hoop 15 engages shoulder 21 . bosses 35 form an interference fit with the inner surface of hoop 15 ( fig1 ) when hoop engages shoulder 21 , preventing container 11 from sliding out of hoop 15 . in operation , the patient attaches handle 13 to container 11 in the same manner as the embodiment shown in fig3 . the lower portions of hemispherically shaped bosses 35 allow the inner surface of hoop 15 ( fig1 ) to slide over the lower portions of bosses 35 more easily than the inner surface of hoop 15 can slide over the lower portions of ribs 25 in the embodiment shown in fig2 . instead of single bosses 35 , two or more bosses could be located at each location , one above the other and perpendicular to the long axis of container 11 . in the embodiment shown in fig5 and 6 , engagement zone 23 comprises a polygonal engagement zone 43 that extends around the outer surface of container 11 below shoulder 21 . as shown in fig6 the cross - section of engagement zone 43 is substantially an octagon in shape . a series of points or comers 45 are defined by the intersections of each side of polygonally shaped engagement zone 43 . the effective diameter is defined for the circumference extending around points 45 of engagement zone 43 . the effective diameter is larger than the diameter of container 11 below engagement zone 43 and smaller than the diameter of shoulder 21 . engagement zone 43 can be other polygonal shapes such as hexagons , heptagons , nonagons , decagons , or the like so long as the effective diameter remains larger than the diameter of the portion of container 11 below engagement zone 43 , and smaller than the diameter of shoulder 21 . the effective diameter around points 45 is larger than the inner diameter of hoop 15 ( fig1 ). hoop 15 deforms as hoop 15 engages polygonal engagement zone 43 . the inner surface of hoop 15 ( fig1 ) is in frictional contact with points 45 when hoop 15 engages shoulder 21 . points 45 of polygonal engagement zone 43 form an interference fit with the inner surface of hoop 15 ( fig1 ), preventing container 11 from slipping . in operation , the patient attaches handle 13 to container 11 for this embodiment in the same manner as described for the embodiment in fig2 . referring to fig7 another embodiment is shown having a set of ribs 49 located in engagement zone 23 . ribs 49 are similar to ribs 25 ( fig2 ) but are semi - cylindrical . ribs 49 are evenly spaced apart and define an effective diameter of the circumference around the outermost portions of ribs 49 . a rounded surface 53 is preferably located on the axially lowermost portion of ribs 49 . rounded surfaces 53 have an effective diameter less than the effective diameter for the upper portion of ribs 49 . the effective diameter of rounded surfaces 53 is substantially the same or less than the inner diameter of hoop 15 ( fig1 ). in operation , the patient attaches handle 13 ( fig1 ) to container 11 in the same manner as described for the embodiment in fig3 . rounded surfaces 53 allow the inner surface of hoop 15 ( fig1 ) to slide over ribs 49 more easily . once installed , the lower side of hoop 15 ( fig1 ) will be above rounded surfaces 53 . referring to fig8 a polygonal engagement zone 55 is located in engagement zone 23 . polygonal engagement zone 55 is similar to engagement zone 43 ( fig6 ), having a set of points 57 at the interfaces of each of the sides of polygonal engagement zone 55 . points 57 define an effective diameter of the circumference around points 57 . engagement zone 55 differs from engagement zone 43 in that the lower portion has a rounded surface 61 . rounded surface 61 has an effective diameter less than the effective diameter for the upper portion of points 57 . rounded surface 61 has effective diameter substantially the same or less than the inner diameter of hoop 15 ( fig1 ) thereby allowing hoop 15 ( fig1 ) to slide over the lower portion of points 57 more easily . in operation , the patient attaches handle 13 ( fig1 ) to container 11 for this embodiment in the same manner as described for the embodiment of fig3 . once installed , the lower surface of hoop 15 ( fig1 ) is above rounded surface 61 . referring to fig9 - 11 , different shaped protrusions are spaced around the circumference of container 11 below engagement zone 23 . in the embodiment shown in fig9 the protrusions are substantially half - cylinders 65 evenly spaced around the circumference of container 11 at the lower edge of engagement zone 23 . the long axes of half - cylinders 65 are substantially parallel to engagement zone 23 and shoulder 21 . half - cylinders 65 define an effective diameter around the outermost portions of half - cylinders 65 that is greater than the inner diameter of hoop 15 ( fig1 ). in the embodiment shown in fig1 , a series of protruding hemispherical bosses 69 are evenly spaced around the circumference of container 11 at the lower edge of engagement zone 23 . bosses 69 define an effective diameter around the outermost portions of bosses 69 that is greater than the inner diameter of hoop 15 ( fig1 ). in the embodiment shown in fig1 , a barrier ring 73 extends continuously around the circumference of container 11 at the lower edge of engagement zone 23 . the outer diameter of ring 73 is greater than the inner diameter of hoop 15 ( fig1 ). the effective diameters for protrusions 65 , 69 , and 73 are larger than the outer diameter of engagement zone 23 and the inner diameter of hoop 15 ( fig1 ) for their respective embodiments . in the embodiments shown in fig9 - 11 , a portion of hoop 15 ( fig1 ) slides over half - cylinders 65 , bosses 69 , or ring 73 , then handle 13 ( fig1 ) is rotated upward . hoop 15 ( fig1 ) deforms as it slides over protrusions 65 , 69 , and 73 . once installed hoop 15 ( fig1 ) is located over engagement zone 23 below shoulder 21 and above protrusions 65 , 69 , or 73 . the inner diameter of hoop 15 ( fig1 ) is greater than the outer diameter of engagement zone 23 . referring to fig1 , the sidewall portion of container 11 at the lower edge of engagement zone 23 forms a physical barrier to downward movement of hoop 15 ( fig1 ). the outer diameter of the sidewall portion and engagement zone 23 define a lip 77 at the lower edge of engagement zone 23 . the diameter of lip 77 is larger than the diameter of engagement zone 23 and larger than the inner diameter of hoop 15 ( fig1 ). lip 77 , like protrusions 65 , 69 , and 73 ( fig9 - 11 ), prevents hoop 15 ( fig1 ) from sliding downward relative to container 11 . referring to fig1 , to install hoop 15 , the patient moves handle 13 along the exterior surface of container 11 as shown by movement a . the patient then places a portion of hoop 15 above lip 77 with handle 13 inclined as shown in fig1 . the user then rotates handle 13 upward as represented with movement b of fig1 . hoop 15 is removed from engagement zone 23 by rotating handle 13 in the opposite direction of movement b . lip 77 holds hoop 15 in engagement with shoulder 21 , which makes collection of specimen an easier task for the patient . the containers and handles in the embodiments described above are easy to manufacture in mass quantities . the handles do not need to vary depending upon the different embodiments that are chosen . the handle is easily positioned and removed from all of the different embodiments of the containers described above , which allows children or the elderly to assemble the collection device by themselves and in privacy . thus container and cup reduce the chances for soiling one &# 39 ; s hands . further , it will also be apparent to those skilled in the art that modifications , changes and substitutions may be made to the invention in the foregoing disclosure . accordingly , it is appropriate that the appended claims be construed broadly and in the manner consisting with the spirit and scope of the invention herein .

a device for collecting biological specimens having a container and a detachable handle . the handle allows a person to position the container so that contact between the person and sample is minimized or avoided . the handle includes a hoop into which the container slides from the container &# 39 ; s lower end . the container is configured with projections on its outer surface that frictionally engage the hoop . alternatively , the container can be configured with projections , a ring , or a lip over which the hoop is obliquely traversed to prevent the hoop from sliding downward on the outer surface of the container . the handle is constructed of a flexible material so that it may deform as needed when engaging the outer surface of the container .

referring to fig1 there is shown generally at 10 a backgammon game board construction in accordance with the instant invention . as will be noted , game board 10 is of generally rectangular configuration having opposed longitudinal edges 12 connected at their opposite extremities by shorter end edges 14 . a marginal border 16 may be provided around the periphery of board 10 and it will be noted that the board 10 is divided into three substantially equal sections 18 , 20 and 22 by virtue of transverse bar portions 24 , 26 which extend between opposite longitudinal edges 12 . if desired , hinge means ( not shown ) may be provided adjacent the bar portions 24 , 26 to enable the board 10 to be folded upon itself for more convenient carrying and storage . it will be understood that each of the sections 18 , 20 and 22 comprise an identical design and arrangement to that characterized by conventional backgammon playing sections now being used . more specifically , each section comprises six inwardly extending points 28 extending from opposite edges 12 of the game board whereupon each section comprises a total of 12 points . as will be noted , the points of each section are alternately colored and oppositely aligned points in each section are likewise alternately colored . still referring to fig1 it will be seen that two sets of playing pieces 30 , 32 are positioned in the sections 18 and 20 in conventional fashion , i . e . the sections 18 and 20 with the playing pieces 30 and 32 positioned thereon , as illustrated , identically duplicate the conventional existing two - sectioned backgammon board with the conventional initial positioning of playing pieces thereon . thus , two persons could engage each other in a completely conventional game of backgammon using only the sections 18 and 20 , with one player controlling movement of the playing pieces 30 and the other player controlling movement of the playing pieces 32 , all in a conventional manner and following the present rules of backgammon . in the play of such a game , the section 22 would not be used at all . it is important to note that playing pieces 30 and 32 are visually distinguishable from each other by any suitable means , such as being of a different color although other means of visual distinguishment could be used . referring now to fig2 it will be seen that fig2 is actually a duplication of fig1 except that the two sets of playing pieces 34 , 36 are now positioned in sections 20 and 22 whereupon a completely conventional game of backgammon could be played utilizing only these two sections . fig3 shows the game board 10 set up for play with four persons , it being apparent that the playing pieces 30 , 32 , 34 and 36 are positioned on the board 10 in precisely the same positions as illustrated in fig1 and 2 . assuming that player a is controlling movement of the playing pieces 30 ; player b is controlling the pieces 32 ; player c is controlling the pieces 34 ; and player d is controlling the pieces 36 , it will be understood that the players will sit or otherwise position themselves at the corresponding areas identified by the letters a , b , c and d in fig3 . thus , players a and b will only use sections 18 and 20 during the play of the game , while players c and d will only use sections 20 and 22 . if the players are competing against each other individually , then all rules of conventional backgammon will be followed ; it being understood that if a playing piece is &# 34 ; hit &# 34 ;, it will be positioned at the bar portion nearest its respective player , i . e . playing pieces 30 and 32 be positioned on bar portion 24 while playing pieces 34 and 36 would be positioned on bar portion 26 . the first player &# 34 ; bearing off &# 34 ; all of his men or playing pieces would be the winner of the game . where the game is to be played in a partnership format , each pair of partners would sit at diagonally opposite corners of the board , i . e . in fig3 a and c would be partners while b and d would be partners . note that although the playing pieces 32 and 36 , as well as the playing pieces 30 and 34 , are visually distinguishable , as by the affixing of cross lines thereover , they do have a common visual characteristic , such as being the same color . this permits playing pieces of one team to be visually distinguished from those of the opposing team , while at the same time permitting the playing pieces of one partner to be visually distinguishable from those of his partner , as is obviously necessary to permit each player to control movement of his own individual men or playing pieces . in the play of the partnership game , all basic rules of backgammon are followed , except that a player does not &# 34 ; block &# 34 ; or &# 34 ; hit &# 34 ; the playing pieces of his partner . quite to the contrary , partners may cooperate with each other to effect a &# 34 ; block &# 34 ; on a given point in the section 20 thus enhancing the skill and strategy of the partnership game . the game is won when both partners of one team have finished &# 34 ; bearing off &# 34 ; all of their men . when one partner has finished &# 34 ; bearing off &# 34 ; all of his men , the remaining partner assumes his turn , it being understood that otherwise the individual players all move in sequence , whether playing against each other individually or as teams . as previously emphasized , all of the basic rules of conventional backgammon are utilized during the play of the instant invention , reference being made to &# 34 ; hitting &# 34 ;, &# 34 ; blocking &# 34 ;, placing a man that has been &# 34 ; hit &# 34 ; on the &# 34 ; bar &# 34 ;, use of the large doubling cube , &# 34 ; bearing off &# 34 ; procedure etc . it will be apparent , however , that provision of the three - sectioned board , as opposed to the conventional two - sectioned board , permits four people to play the game , either individually or as partners , with each player having his own playing pieces and maintaining complete control over the movement thereof . when the four players compete against each other individually , four small doubling cubes are used , one for each player , in addition to the covnentional large doubling cube . specifically , the large doubling cube is used to designate which player has the option to double or redouble , and the highest wager offered . the small doubling cubes are used to designate the level of each individual players &# 39 ; s wager . while there is shown and described herein certain specific structure embodying the invention , it will be manifest to those skilled in the art that various modifications and rearrangements of the parts may be made without departing from the spirit and scope of the underlying inventive concept and that the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claims .

a modified backgammon game permitting play by four players either competing individually against each other or as two - man teams against each other , comprising a game board consisting of three conventional backgammon sections as opposed to the conventional two sections , each player having his own set of playing pieces and having a starting point at a different corner of the board , each player moving his pieces pursuant to conventional backgammon rules through a path located in and extending through the adjacent outer section and the common center section .

defibrillation of the human heart is effected by passing a large current through the heart for a time period of several milliseconds . a voltage is generated in the icd canister and transmitted to the heart through the lead and electrodes . the magnitude of current that is required to successfully defibrillate the heart is related to the pulse width of the shock pulse . this is demonstrated in the &# 34 ; strength - duration &# 34 ; curve ( s - d curve ) for a typical patient as shown in fig1 . the s - d curve shows that in order to successfully defibrillate the exemplary heart with a given set of electrodes , an average current of 6 amps ( a .) is required for a pulse width of 13 ms ., while an average current of i 1 . 5 amps is required for a pulse duration of 2 ms . since current is caused to flow by a high voltage stored on an energy or charge storage element , typically a capacitor , the impedance of the electrode path must be as low as possible . this is because current is related to voltage and resistance in accordance with ohm &# 39 ; s law : ## equ1 ## and , since voltage is determined by the maximum charge that the capacitor can store , the remaining critical variable in determining current flow for a given capacitor is resistance . it is also the case that the energy of the defibrillation shock pulse sought to be delivered is the primary determinant of the size of the icd device . this is because the largest component or components of the icd are the charge storage capacitor ( s ) and their size is directly proportional to the energy that they must store . typical icd devices store approximately 1 . 77 joules ( j ) per cubic centimeter ( cc ) of volume . thus , the size of the icd device is a linear function of the energy required for defibrillation . the defibrillation shock energy is given electrically as : where i is the current , v is the voltage and d is the duration of the pulse . this formula is exact for rectangular pulses , but is also an accurate approximation when current and voltage vary during the pulse , as is the case with capacitive discharge . in such a case , &# 34 ; v &# 34 ; and &# 34 ; i &# 34 ; are average values . taking into consideration ohms law the energy expression can be rewritten as : from this relationship it can be seen that the required energy per pulse is proportional to the electrode resistance . this in turn implies that the size of the icd device is a linear function of the electrode resistance . accordingly , in order to accomplish the goal of icd canister size minimization , while maintaining shock effectiveness , it is of extreme importance to keep the electrode resistance as low as possible . existing icd devices and methods deliver either a monophasic or biphasic defibrillation waveform to a patient &# 39 ; s heart . the monophasic waveform is shown in fig2 a . in this case , an icd capacitor is charged to a voltage of typically 650 - 750 v . the capacitor is then allowed to discharge through implanted defibrillation electrodes into the heart for a time period of approximately 6 - 12 ms . an alternative technique is the delivery of a biphasic waveform . in the case of the biphasic waveform the capacitor is inverted in polarity with an &# 34 ; h - bridge &# 34 ; switch , for example , to deliver current in a second phase in a polarity opposite to that of its first phase . this is contained for several additional milliseconds at which point the current flow is finally interrupted the biphasic wave is shown in fig2 b . referring to fig3 the apparatus 10 of the present invention basically comprises a battery b1 , a transformer t1 , a transistor q1 , an oscillator o1 , diodes d1 , a capacitor c1 , and switches s1 - 4 . electrodes e1 and e2 are preferably catheter - type electrodes known in the art and are inserted into the chambers of the heart . in the alternative , they may be patch style electrodes disposed on the exterior of the heart or the pericardium , or the device housing itself . the battery b1 is used to deliver a current through the primary of transformer t1 at a high frequency generated by transistor q1 and oscillator o1 . this generates a high voltage at the secondary of transformer t1 which is rectified by diode d1 and stored in the main capacitor c1 . preferably , the battery b1 generates a voltage of approximately 6 v . utilizing the teachings of this invention , a relatively small capacitor of approximately 60 - 100 microfarads ( μf ) may be used . to deliver a monophasic pulse through the heart , switches s1 and s4 are turned on for approximately 3 milliseconds ( ms ) and then turned off . to deliver a biphasic waveform switches s1 and s4 are turned on for 3 ms , as in the case of a monophasic pulse , and then turned off . switches s2 and s3 are then immediately turned on for approximately 3 ms to deliver a current in the opposite direction through the heart h . importantly , the device 10 further comprises a voltage multiplier 11 which multiplies the battery b1 voltage of approximately 6 v to a level of 12 - 18 v . voltage levels up to 50 v may be used , but they require more energy to perform the function more rapidly . this voltage is then delivered to either heart electrode e1 or e2 through additional switches s5 or s6 which are respectively in series with diodes d2 and d3 . this voltage is delivered in a pulse of relatively low voltage and of relatively longer duration for back charging purposes as is described further below . all of the switches s1 - s6 are communicatively connected to and controlled by a control circuit ( not shown ) of a design known in the art . the mode of operation of the apparatus 10 is as follows . after an arrhythmia is detected , the main capacitor c1 is charged up . while the main capacitor c1 is being charged , or during the end of such charging , or after such charging , the voltage multiplier 11 is engaged to generate a voltage of preferably 12 - 18 v . the switch s6 is turned on to deliver this lower voltage to electrode e2 . at the same time , switch s3 is turned on . this allows the flow of the relatively low voltage of 12 - 18 v from the voltage multiplier 11 through electrode e2 , through electrode e1 , through switch s3 and back to ground . this will deliver a small current flow through the heart h , with a relatively long pulse duration of approximately 1 second in an opposite polarity to that of the yet - to - come defibrillation pulse . this back charges or pre - charges the electrodes e1 and e2 . the switches s3 and s6 are then opened and switches s1 and s4 are turned on . this delivers the high voltage , high current , short duration defibrillation shock ( approximately 750 v , 5 ms . ), through the heart h from electrodes e1 and e2 . importantly , this shock is of opposite polarity to that of the current that was delivered for the back charging of the electrodes e1 and e2 . the polarity of the defibrillation pulse is defined as that of the largest voltage phase . because the defibrillation shock is delivered with a polarity opposite to that of the back charging flow them is a reduced impedance and more current will pass through the heart h . this results in increased efficiency of defibrillation for a given amount of energy and thus charge storage capacity . and since charge storage capacity is directly related to icd size , a smaller , more compact icd 10 is provided . the back charge voltage does not influence cardiac function significantly . an alternative embodiment of the apparatus and method of this invention is shown in fig6 and 7 . in a case where a patient is in a ventricular tachycardia ( vt ) rather than a ventricular fibrillation ( vf ), the application of a back charging precharging current may cause a ventricular fibrillation by stimulating the heart during the sensitive t - wave region 13 of the electrogram 14 . therefore , in such a case , a back charge current 15 is preferably delivered for only 100 ms after the start of the r - wave region 16 to avoid the t - wave region 13 . the apparatus 17 basically comprises , in addition to the elements described above in the main apparatus embodiment 10 , an amplifier 18 , connected to the heart h , an r - wave detector 19 connected to the amplifier 18 , and an icd control mechanism 20 . exemplary defibrillation waveforms are shown in fig4 for a monophasic pulse . fig4 part a shows the waveform in approximately real scaling . the long negative low voltage is approximately 1 - 2 seconds long in duration with a potential of a negative 18 v . the main defibrillation pulse lasts only several milliseconds ( i . e ., about 1 , 000 th as long ) but has an amplitude of around 700 v . fig4 part b shows the pulse in a more illustrative and less scaled fashion . here , the low voltage back charging pulse is shown preceding the main defibrillation pulse . the effects of back charging an electrode pair are shown in the graph of fig5 . here , the back charging is quantified by the charge in coulombs . the coulomb is a unit charge equal to approximately 1 / 100 , 000 of a mole of electrons . it is given electronically as the product of the current and the time . in other words , a current of 1 amp is 1 coulomb flow per second . it should be noted that the impedance in the electrode pair was found to vary from 69 ohms down to 64 ohms with the lower impedance found after a back charging charge of at least 1 coulomb . the example represented in fig5 is based on electrodes constructed of a stainless steel alloy known as mp - 35 which is commonly used in defibrillation catheters . the reduction in impedance from 69 to 64 ohms , a reduction of 7 percent , directly translates into a reduction in necessary shock energy of 7 percent . in summary , the delivery of the low voltage , long duration back charging voltage pulse , which is of opposite polarity to that of a subsequently delivered defibrillation pulse , reduces physiological electrode path impedance and increases efficiency of defibrillation for a given mount of energy . a major mechanism at work in back charging or pre - charging is the charging of the helmholtz double layer capacitor . this mechanism basically holds that when an electrode disposed in bodily fluids is charged with a positive voltage it will repel the positively charged sodium ions in a nearby vicinity . the sodium ions cannot move very far away from the electrode as space charge neutrality must be maintained in the fluid in general . this space charge neutrality attempts to force the sodium ions back close to the electrode . the balancing distance is very small and this results in a helmholtz capacitance . similarly , the chlorine ions form a helmholtz capacitance at the negative electrode . in the present invention , the helmholtz capacitance can be charged by back charging the electrodes . an additional mechanism present , may be an electrochemical reaction at the electrodes , for example , the formation of a titanium oxide . the descriptions above and the accompanying drawings should be interpreted in the illustrative and not the limited sense . while the invention has been disclosed in connection with the preferred embodiment or embodiments thereof , it should be understood that there may be other embodiments which fall within the scope of the invention as defined by the following claims . where a claim is expressed as a means or step for performing a specified function it is intended that such claim be construed to cover the corresponding structure , material , or acts described in the specification and equivalents thereof , including both structural equivalents and equivalent structures .

an implantable cardioverter defibrillator apparatus produces a capacitive - discharge cardioversion / defibrillation countershock to be delivered through defibrillation electrodes adapted to be implanted in a human patient . the icd apparatus is a self - contained human implantable device including a pulse - generating capacitor system , a battery system , a sensing system , and a control system . in response to a detected cardiac dysrhythmia , the icd apparatus selectively charges and discharges the capacitor system through the defibrillation electrodes to generate the capacitive - discharge cardioversion / defibrillation countershock . circuitry is added to the icd apparatus to deliver a back - charging pretreatment pulse to the defibrillation electrodes immediately prior to delivery of the cardioversion / defibrillation countershock . the back - charging pretreatment pulse is a low - energy pulse having a polarity opposite from an initial polarity of the cardioversion / defibrillation countershock . by delivering the back - charging pretreatment pulse , an inter - electrode impedance of the defibrillation electrodes is reduced and a current of the cardioversion / defibrillation countershock is increased . the voltage multiplier and second switch system deliver a low voltage back charging charge of a polarity opposite to that of the defibrillation pulse to the electrodes .

fig1 is a perspective view of a first ruler member 100 which measures the length l of the wound 800 , as shown in fig4 . the first ruler member 100 is a straight strip having measurement indicia 110 . the marking indicia 110 are markings along a top surface 120 of the first ruler member 100 . the indicia 110 markings are marked at equal intervals along the left or right top edge of the top surface 120 of the first ruler member 100 . a bottom end 125 or tip of the first ruler member 100 is marked with a “ 0 ” increment marking . a top end 126 of the first ruler member 100 is marked with the largest increment , the length of the measuring area of the first ruler member 100 . a direction identifier 130 extends from the top end 126 with a marking or symbol 131 that identifies a direction the first ruler member 100 should be positioned on an object or wound 800 to be measured . the direction identifier may also feature a design or symbol to identify the brand owner or hospital or other identifier which will identify the maker or owner of the tool . the identifier is preferably circular , however , alternate shapes may be used to display the identifier or marking symbol . when the first ruler member 100 is positioned over a wound , 800 , it is used to measure the length l of the wound 800 . the wound length l is a distance from an end 125 of the first ruler member 100 to a first end of a greatest opening of the wound . the length measurement l is taken when the first ruler member is positioned over the wound or object to be measured . fig2 is a perspective member of a second ruler member 200 which measures the width w of the wound 800 . the second ruler member 200 is a straight strip having measurement indicia 110 . the marking indicia 110 are markings along a top surface 220 of the second ruler member 200 . the indicia 110 markings are marked at equal intervals along the left or right top edge of the top surface 220 of the second ruler member 200 . a bottom end 225 or tip of the second ruler member 200 is marked with a “ 0 ” increment marking . a top end 226 of the second ruler member 200 is marked with the largest increment , the length of the measuring area of the second ruler member 200 . a handle 230 extends from the top end 226 of the second ruler member 200 . the handle 230 allows the user of the second ruler member 200 to manipulate the second ruler member 200 to take measurements . the handle 230 is rectangular in shape , however , an alternate shape may be used . the handle 230 also features an area which receives the wound owner &# 39 ; s information such as name , date , etc . a label may be placed on the handle with information or it may be written directly on the handle 230 . measurement indicia are not marked on the direction indicator 130 or the handle 230 . when the second ruler member 200 is positioned over a wound or object 800 , it is used to measure the width w of the wound 800 . wound width w is a distance from an end of the connected second ruler member 225 to a second end of the greatest opening of the wound . the tip 125 of the first ruler member 100 or the tip 225 of the second ruler member measures the depth of the object or wound to be measured . the tip 125 of the first ruler member 100 or the tip 225 of the second ruler member 200 is inserted inside of the wound or object its furthest distance inside of the wound or object to a surface of the wound to determine the wound depth . the first and second ruler members 100 , 200 are preferably light grey or transparent in color . when placed over the wound 800 or object , the light color or transparency affords the measurements to easily and accurately be taken and seen as well as it affords the measurer the ability to see the wound 800 or object to be measured underneath the rulers , 100 , 200 . additional light colors may be used so long as they do not obstruct the view of the measurer or conceal the object to be measured . the markings 110 are preferably in a black or other color that can easily be seen so that an accurate measurement may be identified . markings 110 shown in fig1 and 2 are in centimeters . ruler members 100 , 200 provide measurements up to 15 cm in width and 15 centimeters in length . the markings may be shown in alternate metric units and the measurements may be increased or decreased to measure larger or shorter objects . the ruler members 100 , 200 are flexible so they can be placed on curved body surfaces as well as flat body surfaces to accurately measure . furthermore , the ruler members 100 , 200 can easily be maneuvered over irregular sized objects to be measured . the rulers are sterilized for a one - time use . it is recommended for sanitary purposes that the rulers not be reused to avoid infections , for example . open packages and unused ruler members should be discarded . fig3 a is a top side 301 of a perspective view of a connecting device 300 which secures and connects the first ruler member 100 and second ruler member 200 . the connection device 300 allows perpendicular movement of the first ruler member 100 and second ruler members 200 so that the rulers move in a sliding motion independent of each other . the connecting device 300 top side 301 features a first connector 302 . the first connector 302 features parallel first connector flanges 303 , 304 . the flanges 303 , 304 form a first channel 305 sized to receive the first ruler member 100 . the flanges &# 39 ; 303 , 304 walls contact the left and right outermost edges of the first ruler members so that the first ruler member remains secure in the connector 302 . the first ruler member 100 can movely back and forth or in and out freely through the channel . the connecting device is also a light grey or transparent color so that the markings on the ruler members remain visible . the channel has a bottom that receives and contacts a bottom side of the ruler member 100 . however , the area between the flanges 303 , 304 remains open so the markings can easily be identified and measurements can be recorded . fig3 b is a bottom side 310 of a perspective view of the connecting device 300 which secures and connects the first ruler member 100 and second ruler member 200 . the bottom side 310 of the connecting device 300 is a second connector 311 having second connector parallel flanges 312 , 313 that form a second channel 315 sized to receive the second ruler member 200 . the flanges 312 , 313 walls contacts the left and right outermost edges of the second ruler members so that the second ruler member remains secure in the connector 310 . the second ruler member 200 can movely back and forth or in and out freely through the channel 315 . the channel 315 has a bottom that receives and contacts a bottom side of the ruler member 200 . however , the area between the flanges 312 , 313 remains open so the markings can easily be identified and measurements can be recorded . the first connector 301 and second connector 310 are attached so that the first connector &# 39 ; s bottom side is secured to the second connector &# 39 ; s bottom side . however , the first connector 301 is secured so that its channel 305 receives the first ruler member in a north to south direction so that the first ruler member 100 moves through the channel 305 in an up and down direction , as shown in fig5 . the second connector 310 is secured to the first connector so that its channel 315 receives the second ruler member in a east to west direction so that the second ruler member 200 moves through the channel 315 in a left to right direction , as shown in fig5 . the connecting device affords the first ruler member and second ruler member the ability to move independently of each other so that when the connecting device secures the first and second ruler members , there is always a perpendicular angle between the first and second rulers . fig4 is a perspective view of the device illustrating the connected first ruler 100 member and second ruler member 200 connected by the connecting device 300 measuring a wound 800 on a body part such as a leg , for example . the connected ruler members form a measuring tool which may be used to measure the length , width and depth of a wound . the direction identifier 130 on the first ruler member identifies a direction the first ruler member 100 should be positioned on the wound 800 to be measured . the identifier is preferably an arrow , but another symbol may be used to identify which direction the ruler 100 should be positioned . the arrow should point to the wound owner &# 39 ; s head , when the first ruler member 100 is placed over the wound opening . while keeping the arrow pointed towards the wound owner &# 39 ; s head , the first ruler member 100 is adjusted so it measures the greatest expanse or opening of the wound from that direction . this is the wound length l . without moving the first ruler member 100 , the second ruler member 200 is slide through the connecting device 300 so it measures the wound expanse or opening at the point where the greatest expanse or opening can be recorded . this is the wound width w . when connected , the first and second members , 100 , 200 move perpendicular to each other . the wound length l and wound width w are recorded . also , a time - marked camera may be used to take pictures of the placement and thus the measurements of the wound . using the first ruler member tip 125 or second ruler member tip 225 where the indicator starts with “ 0 ” cm , the width depth and undermining is recorded as described above . the use of the measuring tool is contraindicated for use in measuring burns , rash or other abrasions not resulting in a puncture , cut , scrape or tear . also , the tool is contraindicated for use in measuring surgical incisions other than those experiencing dehiscence . the invention has been described in detail with particular reference to certain preferred embodiments thereof , but it will be understood that variations and modifications can be effected within the spirit and scope of the invention .

a wound measuring device and system measures the length , width and depth of a wound . the device and system features first and second ruler members connected and secured by a connecting member which allows the ruler members to move to measure the length and width of a wound . the connecting member affords perpendicular movement of the ruler members providing accurate and consistent measurement of wounds irregular in shape and size . an end of the first or second member is designed to be inserted in the wound to measure the depth and undermining of the wound . use of the device provides little to no discomfort to the patient .

referring more specifically to the drawings , wherein like numerals refer to like parts throughout , fig1 shows a person pouring a liquid comestible from the container and lid combination which embraces the present invention , said container and lid combination shall be generally referred to by the numeral 10 . fig1 provides a view of the beverage container in a filled condition , and shows the overall relation between beverage container and lid 10 and a receptacle 34 located thereinbelow and situated to receive said liquid contents . the most prominent feature of this preferred embodiment of the present invention as illustrated is the fact that the beverage may be one - handedly poured without affecting the functioning of the floatingly retained follower lid 20 . fig1 best illustrates the present invention &# 39 ; s ability to pour hot liquids as for example , coffee , while keeping said beverage in a non - oxidized state and free from contamination . the lid , as one can see , floats on the top of liquid comestible 36 and within normal pouring angle limits will be retained within the uppermost boundaries of said liquid so that said liquid comestible may be poured from vessel 12 via spout 16 into awaiting receptacle 34 . lidded container 10 is designed for &# 34 ; easy - filling &# 34 ;, said container being acceptably adapted to be placed beneath any one of several electric drip - type coffee makers . lid 20 may be placed within empty vessel 12 before the electric drip maker is activated , thereby allowing said coffee to stream over the upper lid surface . preferably this surface is outwardly convex in shape as shown in fig2 and 3 . this upper arcing surface 24 of lid 20 acts as a channel to guide the dripping coffee over said upper surface and under said lid . as vessel 12 becomes filled , the lid 20 will float on top of finished beverage product 36 , the lid rising with the level of said beverage . an alternate method would be to allow the vessel 12 to fill and then grasping knob 22 manually place the lid 20 over and on top of the contents retained therein . as one can see , by fig1 the ability to pour the heated beverage from the lidded container 10 into a cup necessitates a bouyant lid that will adjust to the level and angle of the food product contained within . it is also within the scope of this invention to fashion a drip - type coffee maker wherein the coffee basket is placed directly on top of the floating lid which lid would be placed at the bottom of the coffee pot before the start of the coffee - making cycle . accordingly to this embodiment the lid and basket would move up in the pot as the pot fills with coffee . when operating in this manner exposure of brewed coffee to the air is further reduced , since the distance the brewed coffee must traverse between the bottom of the basket and the protection afforded beneath the floating lid is at a minimum . typically the basket will be in direct contact with the lid at only the central portion of the upper lid surface , in order that flow of liquid through the coffee basket is not hindered . fig2 clearly illustrates the relationship displayed by floatingly retained follower lid 20 as it tracks the angle of the liquid comestible held within the lidded container 10 . as a preferred embodiment , the lid 20 is essentially hollow , advantageously employing a boyancy line and a point of gravity that will , at all times , exert sufficient force downward to retain the lid within the upper surface of the beverage . in this configuration the forces which are explained or more fully elucidated hereinbelow , which interact against lid 20 in essence hold lid 20 within the surface of the liquid or comestible 36 . fig1 and 2 clearly elucidate a most unique feature of the present invention . when vessel 12 is utilized for pouring a liquid a unique phenomeon may be observed concomitant with said use . when a person grasps lidded container 10 by handle means 18 and pours liquid comestible 36 therefrom and into receptacle 34 said receptacle being like the illustrated coffee cup , follower lid 20 , remains relatively stationary within said vessel . hence , when vessel 12 is placed in a vertical orientation relative to the resting surface , said surface being like a heating unit of an electric coffee maker , lid 20 will track said beverage to effectively seal said beverage from outside contaminants and protect said beverage thereby from heat loss . floating lid 20 is held within the surface of the retained beverage for a variety of reasons , which are direclty related to the design of said lid . the lid is designed so that its bottom surface is essentially flat as shown in fig2 or slightly convex in shape as shown is fig3 . a biconvex - shaped lid will float at a higher level and facilitate grasping an upstanding knob or handle without the consumers fingers coming into contact with hot liquid . the floatingly retained lid is designed so that there is an equal material distribution of weight within said hollowed lid ; the result being that the center of gravity and bouyancy lie on the same vertical line . therefore , the force exerted by the top is such that it can be directed radially outward and downward relative to said product . hence , when a person grips handle 18 of lidded container 10 to pour contents from said vessel , floating follower lid 20 will be held within and on the surface of said pourable comestible 36 . moreover , the inherent design of said lid which allows for a shallow draught , permits floating follower lid 20 to reside within the upper boundary layer of a liquid comestible 36 . knob 22 provides a means for the extraction of lid 20 from vessel 12 . said knob assembly is preferably integral with upper convex surface 24 but as an alternate embodiment may be fastened thereto . fig3 shows most clearly the manner in which one embodiment of lid 20 is disposed within vessel 12 . lid 20 , as one can see , is of essentially hollow construction and possesses a void within upper arcing surface wall 24 and lower outwardly arcing wall 26 . the resulting bi - convex shape has a hollow void which may be filled with a variety of insulation materials including air or other inert insulating gases or perhaps even a vacuum . said void creates a superior heat - holding insulating area that will provide a barrier for keeping stored heat within the vessel , thereby reducing energy needs for maintaining desired temperatures . as shown in fig2 the internal surface of the bottom of the vessel is planar so as to eliminate the possibility of the edge of the float hanging up on any non - planar elements located on the bottom surface as the float edge passes across this bottom surface while the last portions of liquid are poured from the vessel . the lidded vessel shown in fig2 would be most suitable for use in combination with a heating platen which is equipped with temperature control means . in this manner boiling of the coffee can be avoided by regulating the temperature . should it be desired to use the vessel of fig2 in combination with conventional , existing electric drip coffee makers , which do not have temperature control and are set to maintain coffee having an exposed surface at serving temperature , it would be necessary to reduce the heat input to coffee which is protected and insulated by a floating lid . such heat reduction could be conveniently effected by spacer means ( e . g ., wire loop or screen ) inserted between the vessel and the platen so that at least a portion of the heat which is emitted from the heat source is dissipated to the surrounding air without passing into the coffee liquid . if the use of a separate insert element is desired to be avoided , the same function may be served by providing the exterior bottom of vessel with two or more protrusions such as multiple raised straight ribs , curved ribs or hemispherical members , such as shown in fig2 at reference numeral 17 . these protrusions must , of course , be uniformly spaced or oriented across the bottom of the vessel so that the vessel will be stable and not tilt while resting on a flat surface . preferably the vessel will be fabricated of glass or a clear plastic material and the desired protrusions will be molded with the bottom of the vessel . when the lid 20 is made of glass or glass like material , a hydrophobic food - approved polymeric material is desirable as a coating over the lid . the coating should , at a minimum , extend around the peripheral surface of the lid and can extend to envelope the entire lid , such as shown at reference numeral 30 in fig3 . the polymer must be heat resistant and not degrade under repeated exposure to acidic comestibles or high temperatures . moreover , the polymer should be of a type that does not readily bind aromas or absorb odors . for example , the following polymers are suitable , polypropylene , polyvinyl chloride , polyethylene terephalate , polycarbonate and nylon to name a few of what is an endless list of materials . hydrophobic polymers are especially suited for the above - stated task since they do not degrade upon exposure to high temperature and / or acid or alkaline environments . alternatively , it would be possible to fabricate the entire lid from polymeric materials . the vessel may be fabricated from glass , ceramic or metal material , but in the hand - held vessel form is preferably of glass . floating follower lid 20 is of a diameter that is from 90 % to less than 100 % of the internal diameter of the vessel depicted as the distance between the inner wall surfaces 32a and 32b shown in fig3 . preferably , the lid is at least 95 %, most preferably at least 99 % of the internal diameter of the vessel . as an alternate embodiment of the present invention , as shown in fig2 the lid according may be designed with an essentially flat bottom surface . a flat bottom construction for the lid might enable a less complex manufacturing method to be utilized .

the present invention provides a container for storing , preserving and dispensing flowable comestible products . a floatingly retained , insulation lid tracks the level of the beverage and prevents oxidation , loss of volatiles and contamination of a beverage contained therein . the liquid food product may be disposed by one - handed pouring with the lid retained therein .

in the accompanying drawings which form a part of the specification and are to be read in conjunction therewith and in which like reference numerals are used to indicate like parts in the various views : fig1 is a perspective view of an apnea monitoring instrument constructed according to a preferred embodiment of the present invention ; fig2 is a fragmentary sectional view taken through the transducer pad included in the apnea monitor ; fig3 is a fragmentary sectional view on an enlarged scale of one end portion of the transducer pad ; fig4 is a partial schematic diagram of the circuit which produces a transduced signal indicative of the respiratory function ; and fig5 is a block diagram of the complete electronic circuit included in the instrument . with initial reference to fig1 the apnea monitoring instrument of the present invention includes capacitance type transducer pad 10 and a cabinet 12 which contains the majority of the circuit elements and which has a visual display on its front panel 12a . a cord 14 extends from pad 10 and carries a plug ( not shown ) that may be inserted in a mating socket formed on the backside of cabinet 12 . referring additionally to fig2 and 3 , the transducer pad 10 includes a flat inner conductor 16 which forms one capacitor plate of the transducer . the inner conductor 16 is flexible and is preferably formed of a polyester fabric which is embedded with aluminum . two sheets of insulating film 18 adhere to the top and bottom surfaces of the inner conductors 16 . the insulating sheets 18 protect the inner conductor from liquids that might cause a short circuit in the high resistant element . preferably , sheets 18 are formed from a material such as polyurethane film or a similar substance . numeral 20 designates an outer conductor which is wrapped around the inner conductor 16 to provide an upper capacitor plate 20a spaced above and parallel to conductor 16 and a lower capacitor plate 20b spaced below and parallel to the inner conductor . the outer conductor 20 is flexible and is preferably formed of a polyester fabric embedded with aluminum . a pair of foam pads 22 are sandwiched between the inner conductor 16 and the upper and lower conductors 20a and 20b . pads 22 provide the dielectric material of the capacitor and are constructed of a soft resilient material such as polyurethane foam . a thin layer 24 of napped material such as velour adheres to the upper surface of the upper foam pad 22 . the upper portion 20a of the outer conductor 20 is located on top of layer 24 . layer 24 has a spring constant considerably less than that of the underlying foam pad 22 . in constructing pad 10 , after the inner conductor 16 has been enclosed between the film sheets 18 and the inner assembly has been sandwiched between the foam pads 22 , the velour layer 24 is applied to the upper pad and the outer conductor 20 is wrapped around the pad assembly . a flexible cover 26 contains the pad , and the pad cover 26 is constructed of a heat welded waterproof plastic material such as a polyurethane sheet . the underside of cover 26 provides controlled leakage to prevent pneumatic damping of the signal . in the assembled pad , the inner conductor 16 is parallel to portions 20a and 20b of the outer conductor 20 to provide parallel capacitor plates . the pad is generally rectangular and is sized to cover the entire bottom surface of a crib or bassinet . a small electronic package 28 is located in a cavity 30 formed in the foam pads 22 near the upper edge of the pad . a wire 32 connects the electronic package 28 with the outer conductor 20 in order to apply a constant electrical charge on the outer plate of the capacitor . another wire 34 connects the package with the inner conductor 16 in order to permit sensing of the charge which is induced on the inner plate and the voltage of the transduced signal . the cord 14 leads from the electronic package 28 . the electronic package includes an electrometer type amplifier such as a field effect operational amplifier 36 ( fig4 ) having a very high resistance 38 to provide the ground return . since the fixed charge q which is placed on the outer conductor 20 is substantially constant , the sensed voltage output v of the preamplifier 36 changes in accordance with the relationship δv = q / δc in response to changes in the capacitance c due to movement accompanying the respiratory effort of an infant lying on pad 10 . the output from the operational amplifier 36 thus provides a transduced signal indicative of respiration . the transducer requires an extremely high terminating resistance ( typically 200 megohms ), and it is thus preferred for the preamplifier to be housed within the transducer pad 10 in order to shield it from stray electrical fields . referring now to fig5 the preamplifier 36 serves primarily to provide impedance transformation and also offers some amplification and low pass filtering . the output signal from the preamplifier is applied to an attenuator 40 which , along with the remaining components of the circuit , is housed in the cabinet 12 . since the preamplifier 36 provides a more than adequate signal , the attenuator 40 is utilized , although an amplifier could be used instead if necessary . the attenuator 40 includes an active circuit element such as an operational amplifier or another adjustable gain element having its gain determined by a gain set device 42 which may be an optical coupler or a field effect transistor . the attenuated signal from the attenuator 40 is passed through an electronic filter 44 which , together with the filter in the preamplifier 36 , limits the pass band frequencies to 0 . 4 - 1 . 25 hz which characterizes infant respiration . respiration rates outside of this frequency band are abnormal , and common artifacts ( noise in the signal ) other than cardiovascular artifact are outside of these limits . most of the circuit gain is taken in a variable amplifier 46 which receives the signal from the filter 44 . the attenuator 40 , filter 44 and variable amplifier 46 condition the incoming transduced signal . the conditioned signal is applied by the variable amplifier 46 to a display drive circuit 48 and also to a control voltage generator 50 which will subsequently be described . display drive circuit 48 operates a display circuit 52 which controls a visual display located on the front panel 12a of cabinet 12 . as shown in fig1 the visual display on panel 12a includes a horizontal row of light emitting diodes that includes in its center four red leds 54 that serve to indicate an alarm condition . extending outwardly from both sides of the center red leds 54 are a number of yellow leds 56 which are connected in pairs that are symmetric about the center of the row . in other words , the second yellow led to the left of center is connected with the second yellow led to the right of center and so forth . the display circuit 52 lights the connectal pairs of yellow leds 56 in sequence such that yellow lights flash outwardly along the row on both sides of the center and , when the end of the row is reached , the yellow leds flash inwardly toward the center . the result is that the leds &# 34 ; swing &# 34 ; symmetrically inwardly and outwardly from the center to normally provide an analog signal indicative of respiration . a single green led 58 is located at each end of the row . referring again to fig5 the output from the variable amplifier 46 is applied to the control voltage generator 50 as previously indicated . the control voltage generator 50 generates a control voltage signal having a current which is proportional to the attenuated signal provided by the attenuator 40 . this control voltage signal is applied to an automatic gain control circuit 60 which provides automatic gain control for the variable amplifier 46 . short term shifts in signal strength are thus corrected by the automatic gain control circuit to maintain the display &# 34 ; on scale .&# 34 ; the control voltage signal is also applied to an alarm driver 62 which receives an adjustable time related voltage ( td set ) to provide an alarm time delay controlled by an adjustment knob 64 ( fig1 ) on the front panel of cabinet 12 . the time delay can be adjusted up to 25 seconds by properly positioning knob 64 . when the control voltage applied to alarm driver 62 drops to the level of the time related voltage introduced on the td set line , an audio alarm 66 is triggered and provides an alarm noise to indicate apnea . the alarm signal is additionally applied to the display circuit 52 to energize the red leds 54 in the center of the display . once the red leds 54 have been energized , they remain energized until manually reset by a reset button 68 located on the front panel of the cabinet . the current of the control voltage signal generated by the control voltage generator 50 is sampled by a gain - set voltage generator 70 which produces a gain - set voltage that is extremely sensitive to changes in the level of the input signal . a gain - set voltage level of about 0 . 4 volts indicates a properly attenuated input signal in the preferred embodiment of the invention . the gain - set voltage feeds a comparitor circuit 72 which compares the voltage with established voltage limits defining a normal range of the gain - set voltage . for example , the voltage limits can be 0 . 3 volts and 0 . 6 volts in order to maintain the gain - set voltage within range . if the gain - set voltage is between the established limits , the comparitor 72 provides a signal to the display circuit 52 which effects constant energization of the green leds 58 on the opposite ends of the display row . this provides information indicating that the attenuator 40 is properly adjusted as to its gain . if the gain - set voltage is outside of its normal range ( 0 . 3 volts - 0 . 6 volts ), the signal delivered by the comparitor 72 to the display circuit 52 causes the green leds 58 to initially flash and then become extinguished as the error increases . with the initial flashing of the green leds , comparitor 72 initiates a 60 - second timer 74 . after the elapse of a 60 second time delay , the 60 - second timer 74 sets a 15 - second timer 76 . if an alarm signal is delivered by the alarm driver 62 within the 60 second time delay period , a disable signal is applied to the 15 - second timer to disable the gain - set function , since it is not desirable to adjust the sensitivity in the presence of an alarm condition . if there is no alarm condition within the 60 second time delay , timer 74 resets itself and starts the 15 - second timer 76 which switches a sample and hold circuit 78 into the &# 34 ; sample &# 34 ; mode . the sample and hold circuit 78 controls the gain - set device 42 in order to adjust the gain of the active circuit element in attenuator 40 . the sample and hold circuit 78 includes a memory which retains the previous signal level applied to the gain - set device 42 . immediately upon activation of the 15 - second timer 76 , the previous signal level applied to gain - set device 42 is transferred from the memory of the sample and hold circuit 78 and applied to a summation amplifier 80 . the summation amplifier 80 receives the gain - set voltage generated by the gain - set voltage generator 70 and generates an error signal which is the difference between the ideal value of the gain - set voltage ( 0 . 4 volts ) and the actual output voltage of the gain - set voltage generator 70 . the voltage which is applied to the summation amplifier from the sample and hold circuit is added to or subtracted from the error signal , depending upon the polarity . the resultant signal is then applied to the sample and hold circuit 78 . the gain set device 42 then adjusts the gain of attenuator 40 in a manner to return the gain - set voltage to within its normal range . at the end of the 15 second period established by timer 76 , equilibrium is established , timer 76 resets , and the sample and hold circuit returns to the &# 34 ; hold &# 34 ; mode . in operation , the apnea monitoring instrument detects apnea and provides both a visual and audio alarm indicitive thereof . when an infant or other patient lies on the transducer pad 10 , the body weight distorts the inner conductor 16 slightly and the upper conductor 20a grossly , and also crushes the velour layer 24 between the body and the upper foam pad 22 . due to the body weight , very little movement of the outer conductor with respect to the inner conductor can occur directly under the body during respiration . however , around the periphery of the body where there is minimum body pressure , the velour layer 24 lifts the upper conductor 20a off of the surface of the upper pad 22 during respiration and there is thus considerable relative movement between the inner and outer conductors around the periphery of the body . as a consequence , the sensor pad is least sensitive where body weight is the greatest and where the effects of cardiovascular artifact are greatest . conversely , the pad is most sensitive where the body weight is the least but where respiratory motion is most significant . thus , during apnea , the transducer does not pick up cardiovascular motion and interpret such motion as respiration . the transduced signal which results from respiratory effort is applied to the attenuator 40 after impedance matching in the preamplifier 36 . the conditioned signal from the variable amplifier 46 is applied to the display drive circuit 48 which operates the display circuit 52 in a manner causing the yellow leds 56 to &# 34 ; swing &# 34 ; inwardly and outwardly in response to respiration . the automatic gain control circuit automatically adjusts the gain of the variable amplifier such that the conditioned signal has the proper amplitude to maintain the analog display &# 34 ; on scale &# 34 ;. if apnea should occur , the control voltage signal from the control voltage generator 50 immediately begins decaying exponentially and , when sufficient time has elapsed for it to drop to the level of the time related voltage entered into the alarm driver 62 , the audio alarm 66 is triggered and the red leds 54 are energized on the display surface of the cabinet . the contrast between the swinging movement of the yellow leds and the constant energization of the red leds permits the condition of the infant to be ascertained with a quick glance at the display panel of the cabinet . the audio alarm 66 can awaken the infant such that spontaneous resumption of breathing occurs . this terminates the audio alarm 66 , but the red leds 54 remain energized until manually reset by the reset button 68 . therefore , the parents and hospital personnel are alerted to the fact that an apneic episode has occurred even in those situations where resuscitation is not necessary . it is important to note that the alarm trigger circuit provides an adjustable time delay that is not objectionably prolonged by an active patient . since the current of the control voltage signal is proportional to incoming signal strength and operates a current sensitive light emitting diode , the voltage of the control voltage signal is virtually constant at 1 . 4 - 1 . 5 volts over a wide range of signal level . when apnea occurs , the voltage immediately begins decaying in exponential fashion . thus , if the infant should twitch during an apnea episode , the alarm is merely delayed momentarily rather than being completely reset . the exponential decay continues immediately after the twitch is terminated . the gain - set circuit and related components act to correct the setting of the attenuator 40 from time to time to compensate for long term or unusual short term fluctuations that are not handled by the automatic gain control circuit . also , the gain - set circuit maintains the incoming signal level at a prudently low value in order to set a limit on the gain level that can be achieved by the automatic gain control circuit during apnea . thus , the sensitivity of the system to extraneous physical movement or other artifact is limited during apnea . so long as the gain - set voltage remains within the normal range of 0 . 3 volts - 0 . 6 volts , the sample and hold circuit 78 remains in the &# 34 ; hold &# 34 ; mode and the gain of attenuator 40 is unaffected . however , if the gain - set voltage departs from its normal range , the comparitor 72 initiates operation of the 60 - second timer 74 and , if there is no alarm condition within 60 seconds ( the maximum time delay for the alarm is 25 seconds ), the sample and hold circuit is placed in the sample mode . immediately , the most recent signal level applied to gain - set device 42 is transferred from memory to the summation amplifier 80 and is added to or subtracted from the error signal . the gain - set device 42 then adjusts the gain of attenuator 40 appropriately such that the gain - set voltage returns to its normal range . when equilibrium has been established after 15 seconds , the sample and hold circuit returns to the hold mode . if the change in the input signal is due to apnea , the alarm signal generated by alarm driver 62 disables the circuit and prevents adjustment of the gain of the attenuator . it is thus apparent that the present invention provides an apnea monitoring instrument which is insensitive to cardiovascular artifact , primarily due to the unique construction of the transducer pad 10 . also , the circuit automatically adjusts the sensitivity in response to appreciable changes in the signal strength after first making certain that the change in signal strength is not due to an emergency condition . the visual display is improved in comparison to oscilloscope displays and other expensive displays that have been attempted in the past . the control voltage provided by control voltage generator 50 is important to the sophisicated operation of the device in a number of respects . in cooperation with the automatic gain control circuit , the control voltage corrects for short term shifts in signal strength . the current of the control voltage signal is sampled by the gain - set voltage generator which in turn generates a gain - set voltage used to automatically update the attenuator stage 40 . also , the control voltage is used in the alarm trigger circuit to provide a superior means for establishing an alarm time delay that is not sensitive to twitches of the infant . finally , the control voltage signal can be used in conjunction with an external chart recording device that provides a permanent record of apneic trends . the circuit can be used in other types of physiological monitoring such as monitoring of blood pressure where short term changes are often more important diagnostically than absolute values . from the foregoing , it will be seen that this invention is one well adapted to attain all the ends and objects hereinabove set forth together with other advantages which are obvious and which are inherent to the structure . it will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations . this is contemplated by and is within the scope of the claims . since many possible embodiments may be made of the invention without departing from the scope thereof , it is to be understood that all matter herein set forth or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense .

an apnea monitor having a capacitance type transducer pad providing a signal indicative of respiration . the resilient dielectric material between the capacitor plates is formed in two layers with the upper layer having a lesser spring constant to make the pad more sensitive around the periphery of the body to respond to respiratory motion while rejecting cardiovascular motion . the transduced signal is monitored and its gain is automatically adjusted to compensate for long term instability by a gain - set circuit arrangement having a time delay to assure that changes in the signal are not caused by apnea . a control voltage generated by the circuit operates the alarm without excessive time delay and is also used to provide a gain - set voltage for adjustment of the signal gain .

an aerial included in a game controller of a first embodiment of the invention , is is shown in fig1 - 3 . the aerial is a dipole aerial formed from two mirror image pieces of bent metal of which one is shown in fig1 which comprises a head 10 having a lug 12 and a tail 14 . as shown in fig2 the two mirror image halves of the dipole 10 are connected to a printed circuit board 16 upon which the circuitry 18 of the game controller is mounted . the lugs 12 of each dipole half engage corresponding openings in the circuit board to hole the aerial halves in place and provide electrical connections to driver circuitry . the aerial halves are mounted along a peripheral side of the game controller which , in use , would face away from the body of the game player and are arranged to fit within a plastic casing of the game controller which encases the aerial 10 , pcb 16 and circuitry 18 . the aerial is used to communicate wirelessly with a base station ( described below ) on the 900 mhz ism band from 902 mhz to 929 mhz . a duplex implementation used 902 . 2 mhz - 904 . 4 mhz for one way and 924 . 8 mhz and 927 . 5 mhz for the other way . for the dipole to be tuned to the transmission / reception frequencies , it is preferable for this to be at a one half wave length , l = 144 / f ( mhz ) m , with the length l being defined as the physical length which is 5 % shorter than the electrical length of the two dipole elements . however , due to space constraints within the controller casing , a short dipole is preferred of total length l of about 65 mm compared to an optimum length of about 157 mm based on a centre frequency of 915 mhz . driving circuitry for the aerial may be of any suitable form , for example as shown in fig6 in which a signal i ′ from a transceiver ( not shown ) is fed via a hf filtering capacitor c to a wide band transformer 20 having a transformation ratio n , the secondary of the transformer being fed to a matching circuit 22 which is connected to both dipole elements 10 . the matching circuit 22 is used to match the dipole impedance to the source impedance . in this embodiment , n equals 4 h is a 8 . 2 nh inductor and c is a 1 . 2 pf capacitor . the aerial is used for transmission and reception , with the signal flow being reversed . an aerial included in a base station of wireless game apparatus being a second embodiment of the invention is illustrated in fig4 and 5 . the base station may be enclosed within the housing of a game console or may be separately provided , connected by a wired link . the aerial selected for the base station is a loop aerial as shown in fig4 . although a circular loop is an ideal loop antenna since this maximises enclosed area for better efficiency while minimising resistive loss due to aerial length , such an aerial is not ideal for this application due to mechanical housing constraints . the length of the aerial is also preferably kept short to avoid resonance tuning problems for a long loop leading to impractical tuning capacitor size . thus , a rectangular loop design 30 of about 84 mm in total length , as shown in fig4 is selected . the loop includes four lugs 31 , 32 , 33 and 34 for securing the loop antenna 30 to a pcb 36 of the base station , as shown in fig5 . lugs 32 , 33 connect the aerial to the driving circuitry . as can be seen from fig5 the aerial 30 is mounted at the periphery of the pcb 36 at one edge which is arranged , in use , to face the game player holding the game controller . the aerial is formed from bent metal and attached to the printed circuit board to aid simple and inexpensive manufacturing and for aesthetic purposes is contained within the casing of the base station or console . any suitable driving circuit may be used , for example as shown in fig7 where the impedance of the loop aerial 30 is matched to signal source 32 via a matching circuit 34 of three capacitors c 1 - c 3 to provide a resonance frequency for the loop antenna at a centre frequency between 902 and 928 mhz . in this embodiment c 1 = 2 . 2 pf , c 2 = 3 pf and c 3 = 0 . 5 pf . the embodiment described is not to be construed as limitative . in particular , a loop antenna is also known to retain gain near the human body and may provide a ground enhancement effect when held close to the game player and thus an aerial , such as the rectangular loop aerial described with reference to fig4 and 5 , is suitable for use with the game controller as well as the base station .

game playing apparatus is disclosed comprising a game controller arranged to be held by a game player and a base station connected to or forming part of a game console , the controller and base station communicating over a wireless link and wherein the base station is provided with a loop aerial and the game controller is provided with either a dipole aerial or a loop aerial .

fig1 shows in highly diagrammatical form a flexible endoscope 1 , where only the inner and outer walls are shown as a simple line . the endoscope 1 comprises a main body 2 from which an insertion hose 3 branches off , and which is intended to be inserted into the body , for example , into the intestine of a patient . a feed tube 4 also branches off from the main body 2 . inside the endoscope 1 , a channel system is located with an insertion channel 5 , which leads outwards from the distal tip of the insertion hose 3 . the insertion channel 5 also passes through the main body 2 . an access opening 6 is open to the outside and leads into the insertion channel . biopsy forceps or other suitably long and flexible working instruments can be advanced through the access opening 6 into the insertion channel 5 . the insertion channel 5 ends at a valve opening 7 , in which a control valve is normally positioned , which however is removed during cleaning . at the valve opening 7 , a supply channel 8 branches off from the insertion channel 5 and continues to the end of the supply hose 4 . rinsing fluid , for example , is fed through the supply channel 8 and can be controlled by the valve which is normally positioned in the valve opening 7 . around the channels 5 and 8 , i . e . between them and the outer wall of the endoscope , an internal space 9 is developed , which must be well sealed both from the fluid carrying channels and towards the outside , because it receives sensitive instruments , not shown in fig1 , such as electronic or optical instruments . the internal space 9 is accessible from the outside through an opening 10 . this opening is usually used to admit compressed air to the internal space 9 while the endoscope is in the washing machine , so that no water can penetrate as a result of leaks . fig1 shows the endoscope 1 illustrated in its connected state , as when it is being sterilised in a washing machine . the valve opening 7 is connected to a coupling piece 11 of a inspection adapter 14 , said coupling piece 11 being adjusted to the valve opening . the inspection adapter comprises the coupling piece 14 , a hose 12 and a coupling piece 13 at the other end of the hose . a further inspection adapter 15 is connected to the access opening 6 by means of a suitable coupling piece . a third inspection adapter 16 is correspondingly connected to the opening 10 of the interior space 9 . the coupling pieces of the inspection adapters on the endoscope side are suitably developed for the openings of the respective endoscope . the other coupling pieces fit the washing machine . if a different endoscope is connected , the set of inspection adapters must be changed as necessary . the washing machine , which is not shown in greater detail , comprises a flushing pump 17 , which pumps fluid , e . g . water or disinfectant in the direction of the arrow , into a distribution line 18 , of which a first connection 19 is connected via a corresponding coupling to the inspection adapter 14 . a parallel second connection 20 is connected to the inspection adapter 15 . in other words , fluid can be pumped in parallel into the valve opening 7 and the access opening 6 of the endoscope 1 . located in the two connections 19 and 20 in each case is a flow meter , 21 , 22 . as indicated in the drawing by a branch , further connections with flow meters can branch off from the distribution line 18 and these further connections can be connected to other openings of more complex endoscopes . the flow meters 21 and 22 are connected to an electronic device , not shown , in the washing machine , which knows the precise data relating to the connected endoscope 1 , in particular its channel structure and flow resistances . the evaluation of the flow values measured by the flow meters 21 , 22 therefore makes it possible to make statements about the patency of the channels 5 and 8 and also the patency of channel 5 in the area between the openings 6 and 7 . particularly a partially or completely blocked channel can be detected . during the sterilisation process not only a channel inspection device 23 is connected , to which the first connection 19 and the second connection 20 belong , but also a leak inspection device 24 , which is connected to the inspection adapter 16 and the interior space 9 . this leak inspection device 24 supplies to the interior space 9 a fluid in gaseous form , normally air , and for this purpose , it has a gas pump 25 , which pumps gas in the direction of the arrow through a switching valve 26 up to the coupling with the inspection adapter 16 . a manometer 28 is connected between switching valve 26 and connection 27 . the leak inspection device 24 pressurises the internal space 9 of the endoscope and then locks the switching valve 26 . the air pressure is then monitored by the manometer 28 . the extent of any leak can be calculated from the pressure drop curve . the test device 30 shown in fig2 is used to check the washing machine inspection device comprising the parts 23 and 24 shown in fig1 . the test device 30 in the embodiment shown comprises three compartments edged with broken lines , which may , for example , be positioned in a common housing and in each case have their own test devices . the housing is preferably water - tight so that the test device 30 can be fitted inside a washing machine . a leak testing device 31 comprises a test opening 32 shown in highly schematic form , which is to be connected to connection 27 of the leak inspection device 24 . this connection is made via the inspection adapter 16 , which does not , however , normally fit the test opening 32 . therefore an additional test adapter 33 , which on the one hand fits the test device 30 shown in fig2 and on the other , simulates the opening 10 of the endoscope 1 , is provided between the test opening 32 and the inspection adapter 16 . the leak testing device 31 is intended to simulate the interior space 9 of the endoscope 1 , but not only this but also interior spaces of other endoscopes . for this purpose the leak testing device 31 has a leak testing chamber comprising two chambers 34 and 35 of different size . the larger chamber 35 can be connected to the smaller chamber 34 by a switching valve 36 . the chamber 34 is connected to the test opening 32 . also connected to the latter is a manometer 37 , which is connected to a line 40 , which leads to the outside through a switching valve 38 and an adjustable flow resistance 39 . both chambers 34 and 35 and , if necessary , other additional chambers of the leak testing device 31 can simulate random internal space sizes of endoscopes . by adjusting the flow resistance 39 , random test leaks can be simulated and switched on and off using the switching valve 38 . the manometer 28 provided directly on the washing machine side can be tested using the manometer 37 . a channel testing device 41 has two test openings 42 and 43 , which , like test opening 32 , can be appropriately connected by way of test adapters 44 , 45 to the inspection adapters 14 and 15 . with the latter they can be connected to the connections 19 and 20 of the channel inspection device 23 . the test openings 42 and 43 must correspond to the access opening 6 or the valve opening 7 , so that , for example , the endoscope 1 shown in fig1 can be simulated . the channel testing device 41 comprises a series of channels , with which larger channel systems of very complex endoscopes can also be simulated . only some of the channels are required to simulate the endoscope 1 in fig1 . in order to simulate endoscope 1 in fig1 , the test opening 43 , which is connected to the inspection adapter 14 , shall correspond to the valve opening 7 . from there , a channel 46 , which simulates the supply channel 8 of endoscope 1 , runs to its free end with a drain that guarantees unimpeded drainage . a cross - channel 47 runs to the test opening 42 , which corresponds to the access opening 6 of the endoscope 1 . the channel 47 thus corresponds to that part of the insertion channel 5 , which lies inside the main body 2 of the endoscope 1 , between openings 6 and 7 . from test opening 42 , a channel 48 branches off , which likewise leads to a free discharge and which simulates that part of the insertion channel 5 of endoscope 1 , which runs from the access opening 6 to the distal end of the insertion hose 3 of endoscope 1 . no further parts of the channel system of the channel testing device 41 are needed to simulate the endoscope 1 illustrated in fig1 . for this purpose a switching valve 49 is closed . in order to simulate the precise dimensions of the supply channel 8 of endoscope 1 , its flow resistance is simulated by an adjustable flow resistance 50 in the channel 46 . channel 46 can be completely shut off using a switching valve 51 if , for example , it is not required when simulating another endoscope . appropriately , channel 48 is also adjustable and is fitted with a switching valve 52 and an adjustable flow resistance 53 . the cross - channel 47 between the test openings 43 and 42 is likewise fitted with switching valve 54 and adjustable flow resistance 55 for the sake of completeness . by adjusting the adjustable flow resistances 50 , 53 and 55 , the channel system of endoscope 1 can be precisely simulated . channels can be completely shut - off by operating the switching valves . this is particularly necessary , if other endoscopes are simulated . partial blockages may also be simulated by adjusting the adjustable flow resistances or complete blockages by closing the switching valves . the channel inspection device 23 of the washing machine must be monitored for corresponding reactions . as already mentioned , channel testing device 41 can simulate not only endoscope 1 in fig1 but also other endoscopes . if an additional test opening 56 is used with a channel 57 , which leads to the outside , a correspondingly developed endoscope can be simulated . if a further channel 58 leading to the outside is provided in the endoscope parallel to channel 57 , which leads to the outside , channel 58 can be connected or shut down using a switching valve 59 . the flow resistances in channels 57 and 58 can be adjusted by adjustable flow resistances 60 and 61 . if the switching valve 59 is operated , channel 58 is connected or shut down . the channel inspection device 23 should be able to detect this . if an endoscope is to be simulated , which corresponds to that in fig1 , but has an additional opening , the test opening 56 is used and the channels 57 and 58 are shut down by a switching valve 62 . the switching valve 49 is opened in order to establish the connection with the test openings 43 and 42 , if necessary , by restricting the flow with an adjustable flow resistance 64 . the description of the channel testing device 41 in fig2 is only intended as an example , to explain the possibilities of such a channel system . actual test devices may comprise even more channels and valves , in order to be able to simulate very complex endoscopes . in addition to the two compartments 31 and 41 discussed , the test device 30 also has a third compartment 65 , which acts as a flow testing device . in the embodiment , it contains two flow meters 66 and 67 , which are connected to test openings 68 and 69 . at the other ends , the flow meters 66 and 67 are connected to the outside by the lines 70 and 71 shown . the flow test device 65 can be connected , for example , using the test openings 68 and 69 and , if necessary , adapters to the connections 19 and 20 of the channel inspection device 23 , so that fluid flows successively through the flow meters 22 and 66 or 21 and 67 , thus making it possible to check directly the flow meters 22 and 21 on the washing machine side . with appropriate wiring provided by additional adapters or by internal channel connections and valves , the flow meters 66 and 67 of the flow testing device 65 can also , for example , be switched between the test openings 42 and 43 of the channel testing device 41 and the adapters that branch off from it , so that when the channel testing device 41 is used , the flow measurement is simultaneously tested . the flow testing device 65 can , for example , only have one flow meter or even more than the two illustrated . furthermore , additional manometers can also be provided in the flow testing device 65 . as shown in fig2 , a control device 73 is fitted at a suitable place in the test device 30 and is connected by control lines , not shown , to the switching valves shown and the adjustable flow resistances of the test device 30 , in order to set the latter by way of appropriate control signals . the control device 73 can preferably obtain information from a built - in memory , where the data from different endoscopes is stored . if , for example , the endoscope shown in fig1 is called up from this memory , the control device 73 of the test device 30 shown in fig2 will close the switching valve 49 and open the switching valve 54 , as well as the switching valves 51 and 52 . the adjustable flow resistances 50 , 53 and 55 would be set to the values of endoscope 1 . the control device 73 can , of course , also control the leak testing device 31 . additional electronic devices can be provided , which are built into the test device 73 or developed as separate instruments . data , for example , measurements from the manometer 37 and the flow meters 66 and 67 is collected in the test device 30 . the switching and control states of all switching valves and flow resistances can also be stored for logging . for this purpose , an internal memory can be provided , which stores all the measured values until the test process is concluded and the test device 30 can be removed from the washing machine in order to connect it by a suitable data interface to a computer from where the data can be called off . a data transmission device can also be provided , which regularly transmits the data obtained from the washing machine , for example , using suitable wireless transmission methods . as the test device 30 has to operate for a longish time inside a washing machine , a cable connection would be unsuitable . this applies not only to the data transfer but also to the power supply . for this reason a battery 74 , shown in fig2 , is provided , with which the control device 73 as well as the switching valves and adjustable flow resistances can be supplied .

the invention relates to a test device for testing the inspection device of a washing machine for endoscopes , the inspection device including a connection that can be sealingly connected to an opening of an endoscope and feeding a fluid under pressure , said connector having a flow meter and / or a pressure transducer and the test device comprising at least one test chamber that can be sealingly connected to the connector by means of a test opening , wherein the test chamber is designed to be adjustable .

nail enamel compositions of the present invention for coating natural or synthetic nails broadly include the ingredients of at least one film forming component , a solvent , light reflecting material such as glitters and a suspending agent for the light reflecting material consisting essentially of fumed silica . the resulting composition will provide a nail enamel composition having improved wet state clarity by being transparent . as used in this application , the term transparent means a base coat or nail enamel composition that transmits most of the incident light without diffusion or absorption . more specifically , it is generally intended that transparent refers to base coat or nail enamel compositions having an optical density less than 0 . 1 , corresponding to a light transmission greater than about 80 %. below the foregoing range of optical density and light transmission , base coat or nail enamel compositions are considered to be translucent in their wet state , as opposed to being transparent in accordance with the present invention . as used in this application , glitter refers to small pieces of light reflecting decorative material . by way of example , glitters can be manufactured from any number of a variety of materials such as previously described and as disclosed in gebhard , et al . the glitter may be in the form of a variety of shapes , sizes and colors to provide the desired decorative effect for the resulting transparent glitter nail enamel composition . for example , the glitter may be in the form of flat flakes having any desirable shape , such as irregular , square , round , oval , star , triangular and the like . the glitter may also have a more three dimensional form , for example , such as spheres , cubes , rods and the like . in addition , the glitter may be of any desirable color or combinations of colors , as well as any irregular , random or predetermined pattern of colors . the amount of glitter which can be incorporated in the nail enamel compositions of the present invention can widely vary depending upon the decorative effect desired . by way of example only , the amount of glitter may range from about 5 to 20 % by weight of the nail enamel composition . in addition to , or in the alternative , the nail enamel compositions of the present invention may include other large light reflecting particles such as micas and aluminum particles . preferably , the particles will have a particle size range greater than about 50 microns . accordingly , the present invention is not limited to the light reflecting particles being only glitter . the nail enamel compositions contain one or more film forming components such as film forming polymers , for example , cellulose acetate , cellulose acetate butyrate , ethyl cellulose , vinyl polymers , nitrocellulose , as well as methacrylate and acrylate type polymers , and mixtures thereof . nitrocellulose provides an unusual combination of properties of toughness , durability , solubility and solvent release . examples of nitrocellulose are the so called nitrocellulose rs ⅛ sec . and ¼ sec . ; nitrocellulose ½ sec . ; and nitrocellulose rs 5 - 6 sec . and 60 - 80 sec ., which have higher viscosities than the earlier grades . the term “ rs ” refers to the brand of nitrocellulose with a nitrogen content of about 11 . 2 - 12 . 8 % with solubility in esters , ketones and glycol ethers manufactured by hercules , inc . the terms ⅛ sec ., ¼ sec ., ½ sec ., 5 - 6 sec ., etc . represent viscosity and refer to the time it takes for a ball to fall to a given depth in the material . nitrocellulose is typically supplied in 70 % concentrations , wet with 30 % ethyl or isopropyl alcohol . as used in the present application , the percentage of nitrocellulose in a given composition will be on a wet basis . nail enamel compositions of the present invention may include film forming polymers and combinations thereof in an amount ranging from about 5 to 40 % by weight , and more preferably in the range of about 10 to 20 % by weight . in addition to the aforementioned film forming polymers , the nail enamel compositions can also include one or more film forming resins . exemplary film forming resins which may be used in the present invention either alone or in combination with the film forming polymers include , for example , drying and non - drying alkyd resins , polyvinyl resins for example polyvinyl acetate , polyester resins , epoxy resins , acrylic polymers and copolymers , maleic modified glycerol esters of rosin , and toluene sulfonamide / epoxy resins , e . g ., tosylamide epoxy resin . it is also within the scope of nail enamel compositions of the present invention to include aldehyde condensation products such as arylsulfonamide formaldehyde resins , specifically toluene sulfonamide formaldehyde resin which is a condensation product of formaldehyde and toluene sulfonamide . the amount of film forming resin and combinations thereof can range from about 5 to 25 % by weight of the composition , and preferably about 5 to 10 % by weight of the composition . in addition to the film forming components , the nail enamel compositions according to the present invention will generally include at least one plasticizer to soften and plasticize particularly the film forming polymer . the plasticizer may be in either liquid or solid form , as well as combinations thereof . the nail enamel compositions may include one or more of the known plasticizers which are suitable for use in nail enamel compositions . examples of such known plasticizers include tricresyl phosphate , dibutyl tartrate , benzyl benzoate , tributyl phosphate , butyl acetyl ricinoleate , butyl glycolate , butyl stearate , triphenyl phosphate , triethyl citrate , camphor , castor oil , esters of citric , stearate , phalic , oleic , phosphate , butyric and benzoic acid , glyceryl triacetate and glyceryl triproprionate , 2 , 2 , 4 - trimethyl - 1 , 3 - pentandiiol diisobutyrate and mixtures thereof . the nail enamel compositions of the present invention also contemplate the use of phthalate type plasticizers either alone or in combination with the aforementioned plasticizers , for example , diamylphthalate , dibutyl phthalate , diethyl phthalate , dioctyl phthalate , dibutoxy ethylphthalate and mixtures thereof . plasticizers included in the compositions of the present invention are in amounts sufficient to provide acceptable flexibility to the nail enamel film on the human or synthetic nail surface . in this regard , the amount of plasticizer and combinations thereof for use in the nail enamel compositions of the present invention range from about 2 to 15 % by weight , and preferably about 5 to 10 % by weight . the nail enamel compositions of the present invention also include one or more solvents such as those generally used in conventional nail enamel compositions . examples of these solvents include ethyl acetate , methyl acetate , ethanol , isopropanol , propyl acetate , n - butanol , aromatic ( containing phenyl groups ), amyl acetate , ethers , toluene , ketones , alkanes for example , pentane , cyclopentane , hexane , heptane , cyclohexane , cyclic ethers for example , tetrahydrofuran and 1 , 4 - dioxane , cellosolve , butyl cellosolve acetate , cellosolve acetate , methyl cellosolve acetate , butyl cellosolve , ethyl cellosolve , phenylated solvents for example , xylene , esters of acetic acid for example , methyl acetate , ethyl acetate , n - butyl acetate , chlorinated hydrocarbons for example , methylene chloride , chloroform and methylchloroform . the aforementioned solvents can be used alone or in mixtures thereof . in general , the amount of solvent used in the compositions of the present invention range from about 50 to 80 % by weight , and preferably about 65 to 75 % by weight . as previously described , the use of conventional suspending agents such as bentonite has resulted in known glitter nail enamel compositions having poor wet state clarity by having a translucent , cloudy or milky appearance . it has been discovered that by using fumed silica as a suspending agent in nail enamel compositions of the present invention , a glitter nail enamel composition having a transparent wet state clarity can be obtained . fumed silica is available from a number of companies , for example , degussa of germany sold under the trademark aerosil and cabot corporation of tuscola , ill . sold under the trademark cab - o - sil . various grades of fumed silica are available from either of the aforementioned companies which can be used as a suspending agent in accordance with the present invention . by way of one example , the particular fumed silica used in the examples to be described was aerosil 200 obtained from degussa . the amount of fumed silica used in the compositions of the present invention range from about 2 to 6 % by weight , and preferably about 3 to 5 % by weight . fumed silica was previously known for use in nail enamel compositions as a thickening agent for a pigmented composition where clarity was not required . for example , various photocurable nail enamel compositions which include fumed silica as a thickening agent are disclosed in patel , et al ., u . s . pat . no . 5 , 407 , 666 and marr - leisy , et al ., u . s . pat . no . 5 , 516 , 509 . in addition , there is disclosed in sheard , et al ., u . s . pat . no . 5 , 330 , 750 the addition of fumed silica as an additive particularly useful in nail ridge fillers . see also the prior discussion with respect to ramin , u . s . pat . no . 5 , 725 , 866 . it was not expected that fumed silica could be incorporated into a nail enamel composition to provide a transparent wet state , in view of the fact that it is known that fumed silica when used in a film forming composition produces a matte finish having substantially reduced glossiness in the resulting composition or a translucent wet state . to this end , it was known to use fumed silica in shellacs , lacquers , varnishes and other coatings to produce a reduced sheen which was often desirable in applications such as furniture , woodwork and other finished products . the incorporation of fumed silica , in and of itself , in a nail enamel composition will not produce a transparent wet state composition . it has been discovered that in order to provide a transparent nail enamel composition , the overall composition should generally have a refractive index approaching the refractive index of the fumed silica , i . e ., 1 . 46 . it has been discovered that nail enamel compositions formulated with toluene as a solvent have a greater tendency to provide a transparent composition than those formulated without toluene . in this regard , toluene has a refractive index of 1 . 497 which is higher than that of fumed silica . by way of theory only , it is believed that the presence of toluene will increase the refractive index of the nail enamel composition to more closely approach 1 . 46 where the other components have a lower refractive index , e . g ., ethyl acetate — 1 . 372 , butyl acetate — 1 . 394 , etc . in addition to toluene , other solvents such as xylene having a refractive index ranging from 1 . 40 to 1 . 50 are contemplated as suitable for use in accordance with the present invention which will provide a nail enamel composition having a transparent wet state when incorporating fumed silica . it is contemplated that a transparent nail enamel composition of the present invention can be formulated using conventional non - toxic components such as those components identified herein , and by including toluene or a toluene substitute as noted hereinabove . it is further contemplated that toluene or its equivalent should be present in the nail enamel formulation in an amount greater than about 20 %, and preferably in an amount greater than about 25 %. the use of toluene or a toluene substitute enables the use of traditional nail enamel components to provide a nail enamel composition having a transparent wet state suitable for incorporation of various glitters . one or more known organic colorants may also be added to these compositions to provide a color tint to the resulting film . suitable organic colorants are well known in the nail enamel art . in addition , a small quantity of one or more pigments can be added to the glitter nail enamel composition to provide a different color effect to the resulting glitter films . pigments for use in the present invention may include any of those pigments which are generally known for use in nail enamel compositions . in addition , there may also be included titanated micas , polyethylene terephthalates and pearl essence which is a suspension of crystalline guanine in nitrocellulose and solvents . although pigments can be used in the nail enamel composition of the present invention , the presence of pigments will affect the wet state clarity . however , various decorative effects can be achieved by the combination of the use of glitters and pigments if desired . in addition to the above described components , the compositions of the present invention may also include additional additives including stabilizers , uv light absorbers , fragrances , moisturizers and medicants , depending on the intended result . these components are well known in the art and may be included in amounts well within the teachings of the prior art . the nail enamel compositions in accordance with the present invention can be manufactured by thoroughly and intimately mixing together all the components in the amounts described in accordance with the present invention . examples of satisfactory equipment and how to use then are readily apparent to one of ordinary skill in the nail enamel art . the following examples are provided to illustrate the transparent nail enamel compositions of the present invention and should not be construed to limit the scope of the invention in any way . the above examples provide a glitter nail enamel composition having a transparent wet state unlike known nail enamel compositions which include , for example , known suspending agents such as bentonite in a glitter nail enamel composition . although the invention herein has been described with reference to particular embodiments , it is to be understood that the embodiments are merely illustrative of the principles and application of the present invention . for example , minor amounts of conventional suspending agents such as colloidal clays and montmorillonite may be added to the fumed silica with only a contemplated small decrease in wet state clarity , e . g ., optical density or light transmission . thus , the use of minor amounts of conventional suspending agents in combination with fumed silica is considered within the scope of the present invention where a transparent composition results . therefore to be understood that numerous modifications may be made to the embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the claims .

a transparent nail enamel composition includes small pieces of light - reflecting decorative material in the nature of glitters , micas and / or other large - sized particles . the glitter is suspended in the nail enamel composition using fumed silica . the nail enamel composition exhibits both transparent wet and dry state clarity .

embodiments of the invention relate to novel antimicrobial , bactericidal , and fungicidal applications of a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid . ideally , the compounds in the composition may be obtained from a hydrodistillate of prunus biomass as is described in u . s . pat . no . 7 , 195 , 788 incorporated herein by reference and / or the concentrated hydrodistillate itself ( which would include two or more of the aforementioned compounds ). the compositions contemplated herein have both agricultural and industrial applications . in some embodiments , the compounds of the invention may be incorporated into a wipe ( e . g ., impregnated or soaked into a paper or cloth or sponge or other suitable substrate ) to control or eliminate bacteria such as e . coli and salmonella , for example , in food service areas ( e . g ., by wiping surfaces contacted by the food or surfaces of the food itself ). as an example , in the medical environment , surfaces instruments , bedding , walls , etc . that patients and / or doctors may come into contact may be rendered safer by using the wipe to combat , for example , mersa . many compositions , having multiple compounds , show synergistic bactericidal and / or fungicidal activity . exemplary new developments include but are not limited to the use of a wipe , having a substrate which can be impregnated with or otherwise carry a composition having two or more compounds selected from the group consisting of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid to combat one or more bacteria by wiping on surfaces of objects to be protected including medical and surgical tools , hospital walls , hospital bedding , door handles , food surfaces , surfaces of containers or tables which come in contact with food , etc . this use may be accomplished with a hydrodistillate of prunus biomass . an additional application involves the use of a composition having two or more compounds selected from the group consisting of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid to combat growth of one or more bacteria in food processing applications , or harvesting applications , or in the field during growth phase of plants that produce the food products . this use may be accomplished with a hydrodistillate of prunus biomass . the compositions may be obtained from the reproductive and / or vegetative biomass of prunus species . representative compositions are extracted from the vegetative biomass of plants of the genus prunus . in a particular embodiment , the vegetative biomass comprises prunus stems and leaves . biomass may be obtained from most prunus species , including p . serotina , p . virginiana , p . emarginata , p . dulcis , and p . persica , cultivars and varieties thereof , and combinations thereof . the compositions of the invention are effective against both gram positive and gram negative genera of bacteria . exemplary gram positive bacteria include , but are not limited to , ralstonia , agrobacterium , xanthomonas , erwinia , enterococcus , staphylococcus , streptococcus , bacillus , corynebacterium , and listeria . exemplary gram negative bacteria , include , but are not limited to , escherichia , salmonella , pseudomonas , and helicobacter . the compositions may also be used for controlling other microbes such as fungi the composition of the invention may be administered to any subject , for example , mammalian subjects including humans or nonanimal subjects such as plants . the compositions may be applied directly or indirectly topically to the subject . the subject may be afflicted with or susceptible to be afflicted with a bacterial or other microbial infection . embodiments of the invention provide methods for controlling , preventing , treating or curing bacterial or other microbial infections affecting plants . in one embodiment , plants are exposed to prunus extracts or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid ( e . g . by contact ) to control plant pests and pathogens . in a particular embodiment , a method for controlling growth ( e . g ., killing or inhibiting growth of ) of a pathogenic organism is provided wherein the pathogenic organism is exposed to a composition obtained from prunus biomass or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid . exposure of the pathogenic microorganism to at least a component of the composition is maintained for a time sufficient to control the growth of the pathogenic microorganism ( e . g ., to kill or reduce or otherwise inhibit its growth ). in other particular embodiments , prunus extracts or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid are applied foliarly or directly to soil to control a disease or infestation . extracts may also be applied to soil as fumigants or as a drench , and to foliage as a spray , mist , or drench . prunus extracts or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid may be applied to control fungal and bacterial diseases . stored commodities such as fruit , vegetables , roots , grains and nuts may be treated with prunus extracts or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid as a in a spray , drench or fumigant to protect them from fungal infections and insect infestations to control post - harvest losses . prunus extracts or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid may be applied as an aqueous spray or may be made into a solution with an ionic , non - ionic or cationic emulsifier , such as any surfactant having an hydrophile - lipophile balance ( hlb , see , for example , w . c . griffin , j . soc . cosmetic chemicals , 1 : 311 , 1949 ) of 1 - 20 , and then applied as a spray . prunus extracts or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid may also be spray - dried and applied as a powder , for example , by incorporating the extracts into a substrate such as maltodextrin , dextrin , or disaccharide . the prunus extracts or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid may also be incorporated in a coating or wax used to treat foods or post - harvest commodities . prunus extracts or a composition containing two or more of 2 - propanol , hexenal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , trans - 2 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , and hydrocyanic acid may be used for disinfection by fumigation or drench of packaging or enclosed containers that will contain foods , such as harvest bins , storage chambers and shipping containers . fumigation may , for example , be accomplished by spraying an aqueous solution or powder , by vaporization of extracts , or by incorporating the extracts into a time - release device such as by encapsulation in a polymer matrix , polyvinylchloride strip , or rubber pellets . compositions comprising prunus macerate slurries , macerate solutions , hydrodistillates , and concentrated extracts may be formulated with various adjuvants to aid in their stability and effectiveness as bactericides or microbiocides . adjuvants include emulsifiers , surfactants ( including non - ionic surfactants , cationic surfactants and anionic surfactants ), stickers , stabilizers , penetrants , extenders , and corrosion inhibitors . for example , concentrated extracts may be made more water - soluble by adding of emulsifiers such as polysorbate 80 . emulsifiers include polyethyleneoxide derivatives ( e . g ., tween ® 20 series ). soil treatments comprising prunus compositions may benefit from formulation with a soil surfactant , such as ammonium laureth sulfate , sodium laureth sulfate , nonyl phenol ethoxylate , or combination thereof . when prunus compositions are applied foliarly it may be desirable to add non - ionic surfactants , such as octylphenol compounds or ethylated seed oils plus emulsifiers , to enhance spreading of the compositions on surfaces . extenders , such as blends of organic silicone and seed oils , may be desirable to reduce volatilization of composition constituents . likewise , addition of penetrants , such as ethoxylated and linear alcohols combined with silicone or organic silicone and esterified seed oils , desirably assist movement of the compositions into the pores of the target plant tissue . an additional aspect of the invention relates to methods of administering a composition as described herein to a mammalian subject , such as a human . the methods involve administering an effective amount of the composition , where the effective amount is sufficient to prevent the development of or lessen the extent of the development of a bacterial or fungal infection in the subject , when the subject is later exposed to the bacterium or contracts a bacterial infection . the compositions provided herein can be administered using any appropriate method . administration can be , for example , topical ( e . g . transdermal , ophthalmic or intranasal ); pulmonary ( e . g ., by inhalation or insufflation or powders or aerosols ); oral , or parenteral ( e . g . by subcutaneous , intrathecal , intraventricular , intramuscular , or intraperitoneal injection , or by intravenous drip ). the compositions of the invention can include a pharmacologically suitable vehicle or carrier . the preparation of such compositions for use as vaccines is well known to those of skill in the art . typically , such compositions are prepared either as liquid solutions or suspensions , however solid forms such as tablets , pills , powders and the like are also contemplated . the liquid may be an aqueous liquid . solid forms suitable for solution in , or suspension in , liquids prior to administration may also be prepared . the preparation may also be emulsified . the active ingredients may be mixed with excipients , which are pharmaceutically acceptable and compatible with the active ingredients . suitable excipients are , for example , water , saline , dextrose , glycerol , ethanol and the like , or combinations thereof . in addition , the composition may contain minor amounts of auxiliary substances such as wetting or emulsifying agents , ph buffering agents , and the like . the compositions of the present invention may further comprise an adjuvant , suitable examples of which include but are not limited to seppic , quil a , alhydrogel , etc . if it is desired to administer an oral form of the composition , various thickeners , flavorings , diluents , emulsifiers , dispersing aids or binders and the like may be added . the composition of the present invention may contain any such additional ingredients so as to provide the composition in a form suitable for administration . the final amount of active agents in the formulations may vary . however , in general , the amount in the formulations will be from about 0 . 01 - 99 %, weight / volume . in addition , the compositions may be administered in conjunction with other treatment modalities such as substances that boost the immune system , antibiotics , and the like . the term “ treating ” or “ treatment ”, as used herein , means reversing , alleviating , inhibiting the progress of , or preventing the condition to which such term applies , or one or more symptoms of such disorder or condition . a “ therapeutically effective amount ” is intended for a minimal amount of active agent which is necessary to impart therapeutic benefit to a subject . for example , a “ therapeutically effective amount ” to a mammal is such an amount which induces , ameliorates or otherwise causes an improvement in the pathological symptoms , disease progression or physiological conditions associated with or resistance to succumbing to an infection . before exemplary embodiments of the present invention are described in greater detail , it is to be understood that this invention is not limited to particular embodiments described , 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 invention 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 invention . the upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention , 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 invention . 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 invention is not entitled to antedate such publication by virtue of prior invention . further , the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed . it is noted that , as used herein and in the appended claims , the singular forms “ a ”, “ an ”, and “ the ” include plural referents unless the context clearly dictates otherwise . it is further noted that the claims may be drafted to exclude any optional element . as such , this statement is intended to serve as antecedent basis for use of such exclusive terminology as “ solely ,” “ only ” and the like in connection with the recitation of claim elements , or use of a “ negative ” limitation . 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 invention . any recited method can be carried out in the order of events recited or in any other order which is logically possible . the invention is further described by the following non - limiting examples which further illustrate the invention , and are not intended , nor should they be interpreted to , limit the scope of the invention . premier botanicals , ltd supplied two formulation of the prunus extract to an analytical laboratory to conduct a biocide efficacy trial against bacterial species representing gram negative and gram positive type . formulation identified as ‘ extraction # 2 ’ is an essential oil obtained by hydrodistillation of plant material collected from the prunus plants . formulation identified as ‘ extraction # 3 ’ is a redistilled oil from ‘ extraction # 2 ’. the samples consist of two proprietary formulations from premier botanicals as follows : the objective of analysis is to test samples 001 and 002 as follows : i . challenge testing to determine efficacy of biocide in inhibiting growth of selected microorganisms . 1 . each of the 3 microorganisms were streaked on standard methods agar ( sma ) slants and incubated at 35 ° c . for 24 hrs . each culture was washed off the agar slants and serially diluted until a concentration of approximately 300 - 500 colony forming units ( cfu )/ ml was reached . 2 . each of the 2 client formulations and a control sample were prepared using a gatorade / water mix ( 50 : 50 v / v ) to achieve the following concentrations : 3 . 9 . 0 ml of each formulation and control was aseptically transferred to a set of 3 sterile tubes . 4 . each of the 3 tubes were challenged with 1 . 0 ml of a different microorganism and vortexed to mix thoroughly so that each formulation was challenged with all 3 microorganisms . 5 . challenged samples were kept at room temperature ( approximately 25 ° c .) for a total of 2 hrs . 1 ml of each sample was plated onto sma at 0 and 120 minutes . the original inoculum was also plated at 0 and 120 minutes for comparison . inoculated plates were incubated at 35 ° c . for 48 hrs . 6 . the effect of the biocide on bacteria exposed to the formulations was assessed by comparing approximate counts of sample plates to the approximate count of the initial inoculum following incubation . as the data demonstrates , both formulations at the tested concentrations effectively inhibited growth of all the selected microorganisms , both initially and over the duration of the test period . any reduction of microorganisms in the control sample may be attributed to die - off or variations in the plated aliquot . while the invention has been described in terms of its preferred embodiments , those skilled in the art will recognize that the invention can be practiced with modification within the spirit and scope of the appended claims . accordingly , the present invention should not be limited to the embodiments as described above , but should further include all modifications and equivalents thereof within the spirit and scope of the description provided herein .

the foliage and stems of plant species from the family rosacea , genus prunus , yield natural pesticides when macerated . hydrodistillation of macerated plant biomass yields a concentrated solution of organic volatile compounds that act synergistically as a natural pesticide , and as provided herein , also act synergistically as antimicrobial compounds . volatile compounds liberated from prunus biomass include 2 - propanol , hexanal , trans - 2 - hexenal , 1 - hexanol , cis - 3 - hexenol , mandelonitrile , benzoic acid , benzaldehyde , benzyl alcohol , hydrocyanic acid and others . these compounds may be removed from the distillate and reformulated to form a standard concentrated solution , with benzaldehyde , mandelonitrile and hydrogen cyanide being the major components . provided herein are methods of using these pesticides as a broad - spectrum bactericide . components of the extract may act alone or synergistically to control both gram positive and gram negative genera of bacteria .

turning initially to fig3 the shoulder brace 10 selected for illustration is placed on the body a to stabilize the left shoulder b . the brace 10 is particularly effective in reducing the risk of shoulder dislocation or subluxation , while permitting limited mobility of the shoulder b . in the illustrated embodiment , the brace 10 is secured to the torso c and the left arm d for limiting movement of the arm d relative to the torso c in a manner that provides the desired degree of stability and mobility to the left shoulder b . however , the illustrated brace 10 may equally be used to treat the right shoulder e , with the brace 10 being similarly attached to the torso c and right arm f . in this respect , although the following description will involve the left shoulder b and arm d , it will be appreciated that the brace 10 may similarly be used to treat the right shoulder e . in fact , both shoulders b and e may be treated simultaneously , if desired . the brace 10 generally includes a torso attachment assembly 12 which generally defines an anchor to which the arm d is connected when the brace 10 is worn . the brace further includes a connecting member 14 for connecting the arm d to the torso attachment assembly 12 . as will be indicated below , the assembly 12 and member 14 are interconnected in a manner that restricts untoward shoulder movement yet permits desirable shoulder movement . as perhaps best shown in fig1 the attachment assembly 12 includes a flexible body wrap 16 preferably formed of an elasticized material such as a laminate of foam - type fabric and neoprene , although other suitable materials ( e . g ., a synthetic or natural cloth ) may be used . the illustrated body wrap 16 consists of a two lengths 16a and 16b of the preferred material stitched to one another along a central seam 17 ( see fig1 ), with the assembled wrap 16 being dimensioned to extend around the upper torso of the user ( see fig3 - 6 ). it will be noted that the wrap 16 includes a plurality of holes 18 that enhance ventilation and thereby the comfort of the brace 10 when it is worn . the wrap 16 is generally rectangular in shape and presents a pair of opposite end flaps 20 and 22 which are provided with complemental , adjustable fastening structure 24 and 26 . in the illustrated embodiment , the structure 24 and 26 comprises hook - and - loop fastening material stitched to the flaps 20 and 22 , although other suitable fastening devices ( e . g ., buttons , snaps , a belt and buckle , etc .) may be used . for purposes which will subsequently be described , the wrap 16 includes a series of spaced apart belt loops 28 , 30 , 32 , 34 , 36 , 38 , each of which is preferably formed of a length of nylon webbing attached at its opposite ends by suitable stitching to the underlying material length 16a or 16b . it is noted that each of the fabric lengths 16a and 16b is provided with three respective belt loops 28 , 30 , 32 and 34 , 36 , 38 . in addition , the loops associated with each fabric length are spaced generally the same distances from the seam 17 as the loops on the other fabric length . the wrap 16 is secured about the torso c by wrapping the wrap 16 about the back of the upper torso ( see fig4 ) and fastening the end flaps 20 and 22 to one another in the front ( see fig3 ). if desired , the fastening structure 24 and 26 may be used to tightly secure the wrap 16 about the upper torso so that a compressive force is exerted against the body by the wrap 16 . the adjustability of the fastening structure 24 and 26 permits this compressive force to be varied . however , it is often times undesirable to exert a compressive force against the chest , as this may restrict breathing and create discomfort for the user . in this respect , the assembly 12 includes a pair of adjustable suspenders 40 and 42 projecting from the upper edge of the wrap 16 ( see fig1 ). the suspenders 40 , 42 are configured to extend over the torso c to prevent migration of the wrap 16 downwardly along the body . thus , it is unnecessary to tightly secure the wrap 16 about the torso c for preventing movement of the wrap 16 out of the desired location . the suspenders 40 and 42 are essentially identical in construction . thus , it shall be sufficient to describe only the left suspender 40 in detail herein , with the understanding that the right suspender 42 is similarly constructed . the left suspender 40 includes a strap 44 attached to the fabric length 16a to project normally from the top edge of the wrap 16 in proximity to the seam 17 . the strap 44 is preferably formed of nylon webbing , although other suitable materials ( e . g ., elasticized fabric , cloth , etc .) may be used . in the usual manner , the strap passes through a buckle 46 , loops through a ring 48 attached to the wrap by a short strap 50 , and then is fixed to the buckle 46 . the overall length of the suspender 40 is consequently adjustable by sliding the buckle 46 along the strap 44 . this provides , among other things , the ability to accommodate various body sizes . as previously noted , the wrap 16 is provided with a series of belt loops 28 - 38 spaced along its length . the loops 28 - 38 are each configured to receive a belt 52 therein , with the belt 52 consequently being coupled to the wrap 16 by the loops 28 - 38 . as perhaps best shown in fig1 the belt 52 preferably includes a wide central section 52a and a pair of relatively narrow end sections 52b and 52c attached to opposite ends of the central section 52a by connectors 52d and 52e , respectively . the sections 52a , 52b , 52c of the belt are preferably formed of nylon webbing , although other suitable materials may be used . a buckle 54 is provided on the end section 52b for adjustably coupling with the end section 52c . similar to the wrap 16 , the belt 52 is dimensioned to extend around the torso c and may be securely fastened about the torso by intercoupling the end section 52c and buckle 54 ( see fig3 ). the adjustability of the belt 52 accommodates various torso sizes . the illustrated connecting member 14 includes an upper arm band 56 formed of the same material as the wrap 16 and dimensioned to extend around the upper arm ( see fig3 - 6 ). the band 56 is provided with suitable fastening structure for tightly securing the band about the arm . in the illustrated embodiment , the band 56 includes an end flap 58 having hook material ( not shown ) stitched to its underside , while the outer side of the remaining portion of the band 56 supports the complemental loop material 62 ( see fig1 ). the connecting member 14 further includes a strap 64 preferably formed of the same material as the belt 52 . the strap 64 includes a first section 64a and a relatively narrower second section 64b . the end of the first section 64a opposite from the second section 64b is formed into a loop by suitable stitching 66 , with the loop loosely receiving a d - shaped ring 68 therein . although not shown in the drawings , it will be appreciated that hook material is provided on the underside of the first section 64a so that the strap 64 may be removably attached to the arm band 56 . a buckle 70 is supported on the outer side of the first section 64a by a nylon strip 72 . as will be further described below , the second section 64b of the strap 64 is dimensioned to extend through the ring 68 and adjustably couple with the buckle 70 when the brace 10 is worn . contrary to the first section 64a , the second section 64b preferably does not include hook fastening material along its underside . as perhaps best shown in fig1 the illustrated arm band 56 and strap 64 are separate items removably attachable to one another . however , it is entirely within the ambit of the present invention to combine the band 56 and strap 64 into a single unitary element that is attached to the ring 68 and configured to be adjustably secured around the arm d . in the illustrated embodiment , the connecting member 14 is shiftably coupled with the attachment assembly 12 as a result of the ring 68 being slidably received on the belt 52 . in particular , the ring 68 is placed on the belt 52 between the loops 28 and 30 ( see fig2 ). this may be accomplished simply by pulling the left end of the belt out of the loop 28 , sliding the ring 68 over the belt 52 , and then reinserting the belt through the loop 28 . it will be appreciated that the ring 68 serves as a fastener for fastening the strap 64 to the belt 52 in the desired manner . as shown in fig5 and 6 , the loops 28 and 30 define stops that limit movement of the ring 68 along the belt 52 . that is to say , the ring 68 is limited to movement along the portion of the belt located between the loops 28 and 30 . in addition , the wrap 16 is dimensioned so that the loops 28 and 30 are located generally at the front and back margins of the left side of the torso c when the brace 10 is worn . accordingly , the portion of the belt 52 located between the loops 28 and 30 extends in a generally horizontal , fore - and - aft direction along the left side of the torso c . this portion of the belt 52 consequently defines an elongated element along which the ring 68 can slide . it is also noted that the ring 68 is limited to movement along the length of the belt 52 . that is to say , with the belt 52 secured about the torso c , the ring 68 is generally prevented from shifting vertically relative to the torso c and from shifting laterally relative to the torso c . consequently , the remaining portion ( i . e , the arm band 56 and strap 64 ) of the connecting member 14 is likewise permitted to move in a generally fore - and - aft direction and substantially prevented from moving in a vertical and lateral direction relative to the torso c . however , the arm d may be permitted to move vertically or laterally in a limited amount depending upon the slack provided in the strap 64 between arm band 56 and ring 68 , as will subsequently be described . it will be appreciated that the principles of the present invention are equally applicable to other variously constructed elongated elements along which the ring 68 can slide . for example , the wrap 16 may alternatively support a short metal or plastic bar ( not shown ) along the side of the torso , with the ring 68 being slidably received on the bar . alternatively , a relatively short strap ( not shown ) may have its opposite ends stitched to the wrap 16 at generally the same locations as the loops 28 and 30 , and the d - ring may be slidably received on the strap . yet another alternative involves eliminating the wrap 16 and suspenders 40 , 42 and providing only the belt 52 along which the ring 68 can slide . it is also noted that the construction of the ring 68 may be varied to correspond with the structure along which the ring slides . in use , the brace 10 is placed on the body a in the manner noted hereinabove . particularly , the arms d and f are inserted through the suspenders 40 and 42 and the wrap 16 is secured about the torso c . the suspenders 40 , 42 may be adjusted , if necessary , and the belt 52 is fastened about the torso and tightened as needed . the arm band 56 is tightly secured about the left arm d , and the strap 64 is then attached to the arm band 56 simply by placing the first section 64a of the strap on the outwardly facing loop material 62 of the band 56 . it is noted that the degree of abduction and external rotation of the shoulder b permitted by the brace 10 may be varied by the user . for example , in treating a recent shoulder injury , it may be desirable to prevent virtually all abduction and external rotation of the shoulder b . this may be accomplished by tightly securing the strap 64 to the arm band 56 while the arm d is against the torso c , such that there is virtually no slack in the strap 64 between the arm band 56 and ring 68 . in such a configuration , the arm d will be generally limited to swinging movement against the torso c . on the other hand , if the brace 10 is being used only as a preventative device for reducing the risk of recurring dislocation or subluxation , the shoulder may be slightly abducted ( i . e ., the arm d may be swung away from the midline of the body ) when the strap 64 is attached to the arm band 56 . this will provide slack in the strap 64 between the arm band 56 and the ring 68 so as to permit slight abduction and external rotation when the brace 10 is worn . the attachment of the strap 64 to the arm band 56 is enhanced by wrapping the second section 64b of the strap 64 through the ring 68 and coupling the section 64b with the buckle 70 , as shown in fig3 - 6 . as noted above , the belt 52 generally prevents laterally outward and vertical shifting of the ring 68 , which limits swinging of the arm d away from the torso c and thereby abduction of the shoulder b . such movement of the shoulder b is represented by the arrow 74 shown in fig3 . in the illustrated embodiment , the strap 64 has been attached to the arm band 56 in a manner that permits slight abduction ( see fig3 and 4 ), although the degree of permitted abduction may be fturther restricted as previously indicated . in addition , when the shoulder b is externally rotated ( such movement being represented by the arrow 76 in fig4 ), the arm band 56 moves with the upper arm and the strap 64 consequently pulls the ring 68 in a generally lateral direction away from the torso c . again , such movement of the ring 68 is generally restricted by the belt 52 . in the illustrated embodiment , the strap 64 is attached to the arm band 56 in a manner that permits some external rotation ( see fig4 ), although such movement of the shoulder b may be further restricted as previously indicated . moreover , because the ring 68 is slidable along the portion of the belt 52 extending across the left side of the torso c , the arm d may be swung in a generally fore - and - aft direction . particularly , the shoulder may be flexed until the ring 68 engages the loop 28 , as shown in fig5 and may be extended until the ring 68 engages the loop 30 , as shown in fig6 . it will be appreciated that the brace 10 similarly permits horizontal adduction and horizontal abduction of the shoulder b . particularly , as the shoulder b is horizontally adducted , the ring 68 slides forwardly along the belt 52 , with the loop 28 serving to limit such movement . on the other hand , the ring 68 slides rearwardly along the belt 52 when the shoulder b is horizontally abducted , until the loop 30 is engaged . it is also noted that the illustrated loops 28 and 30 are positioned on the wrap 16 so as to permit virtually the entire normal range offlexion , extension , horizontal adduction and horizontal abduction of the shoulder b . however , the location of the loops 28 and 30 may be varied to provide different limitations to such movement . in view of the foregoing , the brace 10 limits untoward shoulder movement which might cause dislocation or subluxation , yet permits shoulder movement that is useful in various sporting activities . as previously indicated , the brace 10 may similarly be used to treat the right shoulder e or both shoulders b and e simultaneously . with respect to the first alternative , it is again noted that the belt loops 36 and 38 are located along the right side of the torso c in locations corresponding to the points at which the belt loops 28 and 30 are located along the left side of the torso c . the d - shaped ring 68 may consequently be placed on the portion ofthe belt 52 located between the loops 36 and 38 to treat the right shoulder e in the same manner as that described above with respect to the left shoulder b . in addition , the brace 10 may be provided with a pair of connecting members for simultaneously treating both shoulders b and e , with one of the connecting members being shiftably coupled to the belt 52 between the loops 28 and 30 and the other connecting member being shiftably coupled to the belt 52 between the loops 36 and 38 . it may generally be said that the torso attachment assembly 12 and the connecting member 14 each include a nonelastic element that is generally fixed to the respective body part , with the elements being interconnected in a manner that limits abduction and external rotation of the shoulder but permits generally unrestricted flexion , extension , horizontal abduction and horizontal abduction of the shoulder . in the illustrated embodiment , the element of the torso attachment assembly 12 comprises the belt 52 , while the preferred element of the connecting member 14 comprises the strap 64 and d - shaped ring 68 . as previously indicated , it is entirely within the ambit of the present invention to alternatively configure either or both of the elements in any other suitable manner . the preferred forms of the invention described above are to be used as illustration only , and should not be utilized in a limiting sense in interpreting the scope of the present invention . obvious modifications to the exemplary embodiments , as hereinabove set forth , could be readily made by those skilled in the art without departing from the spirit of the present invention . the inventor hereby states his intent to rely on the doctrine of equivalents to determine and assess the reasonably fair scope of the present invention as pertains to any apparatus not materially departing from but outside the literal scope of the invention as set forth in the following claims .

a limited mobility shoulder brace limits abduction and external rotation of the shoulder to reduce the risk of dislocation and subluxation . however , the brace permits flexion , extension , horizontal adduction and horizontal abduction of the shoulder so as to facilitate the user &# 39 ; s ability to effectively participate in most sporting activities . the brace includes an attachment assembly which is secured about the torso , and a connecting member that is secured about the arm and shiftably coupled with the assembly in such a manner that the assembly and member cooperatively provide the previously noted degrees of stabilization and mobility .

the following description is provided to enable any person skilled in the field of electronic games to make and use the invention and sets forth the best modes contemplated by the inventor of carrying out his invention . various modifications , however , will remain readily apparent to those skilled in these arts , since the generic principles of the present invention have been defined herein specifically to provide a relatively desireable apparatus for use as an interactive electronic game . with reference to fig1 a generalized block diagram of one apparatus suitable for carrying out the present invention is shown . because there are numerous prior art microprocessors and bus systems suitable for practicing the present invention , the block diagram of fig1 and the following description are intended to be general . fig1 depicts a microprocessor 10 and various surrounding components . in particular , microprocessor 10 is connected to a rom 38 and a ram 36 in the usual fashion via an address bus 34 and a data bus 32 . the microprocessor is also connected to external rom cartridges 1 and 2 via the data bus 32 and address bus 34 . a multiline control signal 12 is provided to an address decode logic circuit 20 which provides enable signals 21 , 22 , 28 , and 30 to the external cartridge 1 , the external cartridge 2 , the ram 38 , and the rom 36 , respectively . the microprocessor 10 is further connected via an output line 40 to a d / a converter 42 , the d / a converter 42 then providing an analog output signal 44 to an amplifier 46 . the output of the amplifier 46 is provided to a speaker 50 via line 48 . the software employed with the foregoing hardware may include algorithms for producing synthetic speech or sound effects which may be provided to the speaker 50 by microprocessor 10 via the d / a converter and the amplifier 46 . a speech algorithm suitable for this application is disclosed in u . s . pat . no . 4 , 214 , 125 issued to ess of emeryville , california . in a preferred embodiment of the present invention , a program used in conjunction with the apparatus of fig1 and discussed further herein , is comprised of program segments or scripts , which when desired , are used to select one of several audio outputs or phrases suitable for a then current game state . fig2 a depicts an isometric of a preferred embodiment of a game assembly according to the present invention . a housing 52 is made of plastic , the arrangement of the housing being such that users may face each other while playing the game . when the game is played by two users , a set of pitching control buttons 54 faces one user while a set of batting control buttons 56 faces the other user . the two users simply turn the housing 52 around when taking the field or when coming to bat . as further shown in fig2 a , the housing 52 includes a center portion which resembles an authentic baseball diamond 58 , field 60 , and bleachers 62 . the baseball diamond 58 contains three base - runner leds 64 , 66 , and 68 which , when lit , represent runners on first base , second base , or third base , respectively . a three position coach / off / player switch 69 is located behind center field 60 on the housing 52 . an enlarged representation of home plate 70 is provided for encompassing a uniform array of leds 72 , the led &# 39 ; s being selectively lit to represent the flight of a pitch thrown by the user operating the pitching control buttons 54 . the speaker 50 ( not shown in fig2 a ) is provided behind a grill 74 molded into the bleacher portion 62 of the housing 52 . the speaker 50 provides the users with various audio outputs representative of the current game status or the current action taking place . detailed views of the pitching control panel 54 and the batting control panel 56 are shown in fig2 a and b , respectively . the pitching control panel 54 is comprised of numeric keypad 80 where several of the individual keys 0 - 9 of the numeric keypad have dual functions . the keys 1 , 2 , and 3 are operated by the user to select the type of pitch ( a fast ball , a curve ball , or a change - up , respectively ). the keys 4 , 5 , and 6 are operated to select a pitchout , a pickoff attempt , or an intentional walk , respectively . keys 7 and 8 correspond to bringing in a reliever or a substitute pitcher , and finally , key 0 may be operated to pitch an intentional ball . the pitching control panel is further comprised of an infield in key used to bring the infield in for an expected bunt or squeeze play , a score key for requesting a vocal report of the score , an instant replay for requesting a vocal replay of the most recent play , a time out key for temporarily delaying the game , and &# 34 ; yes &# 34 ; and &# 34 ; no &# 34 ; keys for answering vocal prompts . the batting control panel 56 , depicted in fig2 c , is very similar to the pitching control panel 54 . however , the dual functions of the numeric keys have been modified wherein the following keys have the designated dual function : 1 -- bunt , 3 -- power swing , 5 -- squeeze play , 7 -- steal attempt , 9 -- extra base , and 0 -- swing . the batting control panel further comprises a pinch hitter key , a pinch runner key . also , like the pitching control panel 54 , the batting control panel has a score button , a timeout button , and a &# 34 ; yes &# 34 ; and a &# 34 ; no &# 34 ; button for responding to vocal prompts . fig2 d is offered in order to demonstrate the positional correspondence that is intended between the numeric keys 1 - 9 of the two pitching and batting control panels 54 , 56 and the leds numbered 1 to 9 that comprise the led array 72 . in a preferred embodiment , the flight of a pitched ball is represented by sequentially flashing appropriate leds 1 to 9 . in one mode , a user pitches the ball by merely selecting the type of switch and then pressing the &# 34 ; enter &# 34 ; key twice . a ball pitched for a strike would be represented by six flashes where the first flash would correspond to the ball leaving the pitcher &# 39 ; s hand and the remaining flashes corresponding to the flight of the ball as it nears the catcher &# 39 ; s glove . at the fifth flash , the ball would be crossing the plate , and at the sixth flash , the ball would be in the catcher &# 39 ; s glove , in order to successfully hit the ball , the user operating the batting control panel 56 must time a depression of the swing button to occur somewhere between the fifth and sixth flashes . alternatively , the user operating the batting control panel 56 may &# 34 ; swing &# 34 ; at the pitched ball by observing the path of the ball based on the position of sequentially lit leds and by then depressing one of the numeric buttons 1 - 9 corresponding to the position the user expects the ball to be in as it crosses the strike zone . a pitch that is out of the strike zone for a ball would be represented by only four flashes of leds 72 . the position of the flashing leds represent the position of the ball as seen in the strike zone from the catcher &# 39 ; s point of view . the user operating the pitching control panel 54 may select the flight of the ball by keying in the desired flight on the numeric keypad 80 and the user operating the batting control panel may select the position of his or her swing by depressing the desired number on the numeric keypad 82 rather than simply the swing button . fig3 depicts a flow chart showing the main loop of a computer program employed in the preferred embodiment . a general reset takes place at step 99 when the coach / off / player switch 69 ( fig1 ) is switched from the &# 34 ; off &# 34 ; position to either the &# 34 ; coach &# 34 ; or the &# 34 ; player &# 34 ; position . during the reset step 99 , various internal tests are performed . following the reset step 99 , the flow proceeds to the setup routines step 100 . each of the individual setup routines which branch from step 100 , depicted in fig4 are used to initialize all the variables used by the program to a default state or to a particular state corresponding to particular user selections , describer further herein . step 101 sets up the two internal default teams unless an external rom cartridge is installed and a user elects to substitute the internal default statistics with a team contained on an external rom cartridge 24 , 26 . referring to fig5 at step 102 , the program scans the two cartridge ports 76 , 78 in order to determine the number of external rom cartridges that are installed . if no cartridges are installed , a branch occurs at step 103 to step 104 where the two internal default teams are randomly selected as the home team and the away team , respectively . if it is determined in step 103 that there is at least one cartridge , a decision is made at step 106 to determine whether only a single cartridge is installed . if the result of step 106 is &# 34 ; yes &# 34 ;, the program flow proceed to step 105 wherein the two teams will be selected from that cartridge . if the result of step 106 is &# 34 ; no &# 34 ;, indicating that two cartridges are installed , step 107 selects one randomly chosen team from each of the two cartridges . after the teams have been selected in step 104 , step 105 , or step 106 , the statistical data pertaining to each player are copied to the ram 38 from the internal rom 36 , or from one or both of the external rom cartridges 24 , 26 , as appropriate . at step 108 , the program setups the designated hitter rule if an american league team is the home team . step 110 , entitled &# 34 ; initialize play variables &# 34 ;, branches to step 111 ( fig5 ) wherein a group of global state variables is set to the proper values for entry into the game loop 200 . a state variable is a variable that operates as a selector ( not a scalar value ), and causes a particular reaction in the program based upon its value . exemplary state variables would include : runs , hits , errors , and initial pitcher fatigue rating . at step 115 of fig4 the set players routine sets up the program for zero , one , or two users based upon the position of the coach / off / player switch 69 ( fig2 ). at step 116 , as shown in fig7 a determination is made as to whether the switch 69 is in the &# 34 ; coach &# 34 ; position . if &# 34 ; no &# 34 ; ( i . e . the game is in the &# 34 ; player &# 34 ; mode ) the game will determine the number of users at step 117 by asking &# 34 ; will there be two players ?&# 34 ; if a &# 34 ; no &# 34 ; response is entered at step 118 , the number of users is set to one in step 119 . if a &# 34 ; yes &# 34 ; response is entered at step 118 , the number of users is set to two in step 122 . in either case , the game announces the number of users at step 120 . if the switch 69 is determined to be in the coach &# 34 ; position at step 116 , step 121 sets the number of users to zero and the computer plays for both the pitching side and the batting side . returning to fig4 the program proceeds to step 125 in order to announce the home and away teams as randomly selected in step 104 , step 105 , or step 107 of fig5 . at step 126 of fig8 the game announces the away team by saying &# 34 ;[ away - team ] is the away team and will bat first .&# 34 ; at step 127 , the game announces the home team by saying &# 34 ;[ home -- team ] is the home team and will start in the field .&# 34 ; the program replace &# 34 ; home -- team &# 34 ; and &# 34 ; away -- team &# 34 ; with the actual team names ( e . g . chicago or los angeles ). step 130 in fig4 branches to a routine which checks the number of users set in step 115 and , if there is only one user , determines whether that user will begin at bat or in the field . at step 131 in fig9 the program determines if there is only a single user . if there is only one user , the program flow proceeds to step 132 . at step 132 , if the user is to start at bat ( based upon the random selection of home versus away teams in step 101 , et . seq . ), the program will proceed to step 133 and announce &# 34 ; to start the game you are at bat with [ away -- team ]&# 34 ;. alternatively , if the user is to start in the field , program flow will proceed from step 132 to step 134 where the game will announce to the user &# 34 ; to start the game you are pitching with [ away -- team ]. as was done in step 126 and 127 , the program will substitute the actual team name for &# 34 ; home -- team &# 34 ; or &# 34 ; away -- team .&# 34 ; at step 140 of fig4 the user ( s ) is given the opportunity to change the current setup . at step 141 , the game asks the user &# 34 ; do you want to change this setup ?&# 34 ; if the user &# 39 ; s response is &# 34 ; yes &# 34 ; at step 142 , program flow then continues to the change team routine of step 143 . the change team routine of step 143 asks the user &# 34 ; do you want to change a team ?&# 34 ; if the user &# 39 ; s response is &# 34 ; yes &# 34 ;, the user will then be asked for two team identifying numbers which designate which designate the team to be input . if the team statistics corresponding to the team identifying numbers input by the user cannot be found , the game reports an error message and repeats the above prompt . if the team identifying numbers are correct , the statistical data pertaining to the players comprising each team are copied to the ram 38 from the internal rom 36 , or from one or both of the external rom cartridges 24 , 26 , as appropriate . if the users response to the step 143 prompt is &# 34 ; no &# 34 ;, program flow proceeds to the change lineup routine of step 144 . the change lineup routine of step 144 allows the user to change the lineup for either the home team or the away team . the user is prompted with &# 34 ; do you want to look at the lineup for the ( american or national ) team ?&# 34 ; the game queries the user with respect to first the american team and then the national team . if the user responds with a &# 34 ; yes &# 34 ; to either query , the game then queries the user with &# 34 ; do you want to hear the starting lineup ?&# 34 ; and , after reporting the batting order and field position for the entire lineup if the response is a &# 34 ; yes &# 34 ;, or immediately if the response is &# 34 ; no &# 34 ;, asks the user &# 34 ; do you want to put in an all new lineup ?&# 34 ; if the user responds with a &# 34 ; yes &# 34 ;, the game responds with a series of paired requests : &# 34 ; put in the player number of the man to bat ( first , second , etc ...)&# 34 ; and &# 34 ; put in the field position for ( first player name , second player name , etc ...). after the user enters a player number or a position , the entry is vocally echoed to the user and the user is given an opportunity to verify or correct the entry . after the user inputs the new lineup , or after having responded with a &# 34 ; no &# 34 ; to the new lineup prompt , program flow continues to step 145 . in step 145 , the user may enter a challenge mode wherein the user may set up any inning or score that is desired . the user is first queried with &# 34 ; do you want to start the first inning ?&# 34 ; if the user responds &# 34 ; yes &# 34 ;, program flow proceeds to step 146 . if the user responds &# 34 ; no &# 34 ;, the user is orally requested to first &# 34 ; put in the number of the starting inning &# 34 ; then to &# 34 ; put in the player number of the man at bat for the american team &# 34 ;, to &# 34 ; put in the player number for the man at bat for the national team &# 34 ;, to &# 34 ; put in the score for the [ home -- team ], and finally to &# 34 ; put in the score for the [ away team ]&# 34 ;. the game echoes each user response and asks for verification of the user &# 39 ; s inputs . at step 145 , the user is asked whether or not a fast pitch game is desired . in a fast pitch game , the blinking leds 72 used to indicate the flight of the ball blink at a faster rate . if the user responds to the game &# 39 ; s query with a &# 34 ; yes &# 34 ;, a flag is set to indicate that a fast pitch game is desired . if &# 34 ; no &# 34 ;, processing continues with no change . at step 146 , a single user playing against the computer is given the several different play options . for example , a single player may play for one team the entire game , bat the entire game , or pitch the entire game . a return to the setup routines loop then occurs . after completion of all of the setup routines of step 100 in fig3 the game begins execution of the game loop 200 . the game loop 200 operates by repeatedly looping while simultaneously polling various &# 34 ; state machines &# 34 ;, a &# 34 ; state machine &# 34 ; being a software module that performs specific actions based upon the value of its state variables ( discussed earlier ). however , each state machine may also change the value of a state variable used by another state machine , thereby causing that state machine to act differently the next time it is called in a loop . the game loop 200 continues in an idle loop until one of the various state variables employed by one of the state machines is altered . the game loop 200 consists of a simple loop / subloop structure comprising an inning loop routine 201 and a game over inquiry step 202 . if the game is not over ( i . e . the number of innings played is less than nine ), flow continues to step 203 wherein the inning number is incremented . if the number of innings played is nine , or eight and a half where the home team is ahead , flow proceeds to step 204 , the game stops , and the winner is announced . as shown in fig1 , the inning loop routine 201 is comprised of a new batter routine 210 , a throw ball routine 215 , and a run play routine 250 . as further shown in fig1 , the new batter routine 210 determines , in step 211 , whether or not the &# 34 ; tagged out &# 34 ; batter rule is necessary . the &# 34 ; tagged out &# 34 ; batter rule applies when the previous inning ended with a base runner being tagged out . if the &# 34 ; tagged out &# 34 ; rule applied , step 213 uses the same batter who was at bat when the previous inning ended . if the previous inning ended with the batter causing the out ( as is usually the case ), the &# 34 ; tagged out &# 34 ; rule does not apply , the lineup is incremented in step 212 , and the next batter in the lineup is brought to bat . after bringing a batter to the plate in accordance with either step 212 or step 213 , the game announces the batter &# 39 ; s name and batting average in step 214 . the inning loop 201 then proceeds to the throw ball routine of step 215 . as shown at step 246 of fig1 , the throw ball routine 215 will continuously loop until a pitch is thrown and hit . as further shown in fig1 , the throw ball routine 215 is comprised of a batter machine 216 , an advance runners and score routine 225 , a pitcher machine 230 , and a pitch announcer 235 . each of the above routines will now be described in detail with reference to the drawings . the batter machine 216 is shown in fig1 . first , it determined with step 217 and step 218 whether or not the user has pressed a key on the batter &# 39 ; s keyboard 56 . if &# 34 ; no &# 34 ;, the program continues to the next routine comprising the throw ball routine 215 . if a key has been pressed on the batter &# 39 ; s keyboard 56 , step 219 checks to see if the key was a control key ( e . g . time out , score , pinch hitter , or pinch runner ), and if so , the appropriate control routine is executed at step 220 . if the key press was not a control key , it is determined in step 221 whether or not the user has already entered a desired swing type and / or position since a pitch state variable indicates that the ball has left the pitcher &# 39 ; s hand and is in the air . the user may not alter his swing selection after the ball is in the air , hence processing will proceed to the next routine comprising the throw ball routine 215 . if this were the first time the batting user had entered a swing selection , processing would proceed to step 22 where the probability of a hit occurring is calculated based upon the timing of the swing key - press ( explained further herein ), the selected position of the swing ( if any ), the batter &# 39 ; s batting average , and the pitcher &# 39 ; s earned run average . next , processing continues with the &# 34 ; advance runners and score &# 34 ; routine 225 , the steps of which are depicted in fig1 . at step 226 , processing simply continues to the next routine of the throw ball routine 215 if not hit occurred in step 222 of the batter machine 216 . if a hit did occur , step 227 operates such that any runners on base are advanced to the next base or bases and such that the score is incremented for any base runner that is advanced across home . a return is then executed . as shown in fig1 , the pitcher machine 235 follows the &# 34 ; advance runner and score &# 34 ; routine 225 . the internal steps of the pitcher machine are generally depicted in fig1 . at step 231 , a check is made to a pitch state variable in order to determine the appropriate action . if the pitch state variable indicates that pitching user has not yet pressed a key on the pitching keyboard 54 or has to this point only selected the type of pitch but has not yet released the ball , processing proceeds to step 233 wherein the pitching keyboard is scanned for a pitching action or a control key - press . if however , the pitch state variable indicates that the pitch is &# 34 ; in the air &# 34 ;, processing continues with step 232 wherein a state variable representing the ball &# 39 ; s travel position is updated , the appropriate leds of the led array 72 being lit in response thereto . the program then returns control to the next routine of the throw ball routine 215 of fig1 . the next routine is the pitch announcer routine 235 , the flow of which is shown in fig1 . at step 236 , the pitch state is retrieved . if the pitch state indicates that the game is ready for a pitch selection from the pitching user , but a selection has not yet been entered , step 237 periodically prompts the user by announcing &# 34 ; he looks in for the sign &# 34 ; or something similar . in addition , step 237 will mix in other idle waiting phrases (&# 34 ; loitering phrases &# 34 ;) such as crowd sounds , the current score , etc ... if the pitching user had previously entered a pitch type ( fast , curve , or change - up ) in step 233 of the pitcher machine , the program proceeds to step 239 after retrieving the pitch state in step 236 . at step 239 , the game announces &# 34 ; he gets it &# 34 ;, &# 34 ; he sets &# 34 ;, or some other similar phrase . if the pitch state indicates that the pitch is on its way at step 236 , the game announces &# 34 ; the pitch &# 34 ;, &# 34 ; here comes the pitch &# 34 ;, &# 34 ; the pitch on the way &# 34 ;, &# 34 ; here it comes &# 34 ;, or some other similar phrase at step 241 . following either step 237 , step 239 , or step 241 , the program executes step 244 wherein the lead off status of any runner on base is checked and reported to the users . at step 245 , the result of the pitch is determined and reported to the users where appropriate . after completion of the pitch announcer routine 235 , a check is made at step 246 to determine whether the ball was pitched and hit during the immediately preceding pass through the throw ball routine 215 . if the ball was not hit during the preceding pass , the program loops around and continues to execute the throw ball routine . if the ball was pitched and also hit , the program exits the throw ball routine 235 at step 246 , returns to the inning loop , and then proceeds to the run play loop 250 of fig1 . the run play loop 250 , depicted in more detail in fig1 , is comprised of a play announcer routine 255 , a fielder machine 265 , a run bases routine 275 , and a check outs routine 285 . after a ball has been pitched and hit in the throw ball loop 250 , program processing continues in the play announcer routine 255 , the steps of which will now be described in reference to fig2 . at step 256 , a group of variables representative of the play state are checked to determine the appropriate script to be announced . exemplary variables indicative of the play state include a variable that represent the distance and direction of the ball &# 39 ; s flight , a variable that represent which zone , from a predetermined group on zones , the ball will land in , a variable representing the number of and position of runners on base , etc ... at step 257 , a script from a group of scripts set appropriate for the current play state is output to the user . at step 258 , a subsequent play state is determined . for instance , whether the ball is a grounder , a fly ball , or a home run ; whether the ball is caught or dropped , etc ... at step 259 , a check is made to determine whether the play is over or not . if the play is indeed over , the play state is set to indicate the play is over in step 260 , thereby causing the run play loop to terminate at step 290 of fig1 . if the play is not over , a return is executed and processing within the run play loop 250 continues . the fielder machine is entered at step 265 immediately after execution of the play announcer routine 255 . the fielder machine 265 , shown in fig2 , initially determines whether a play result has been calculated for the play state yet . if not , processing proceeds to step 289 where a probable play result is determined by examining a table of results . the contents of the table are outcome possibilities based upon the direction and distance of the hit ball , the zone where the hit ball will land , the type of hit ( pop - up , fly ball , line drive , etc ...), and the number of runners on base . at step 270 , the probable result of the play state is set based upon the contents of the table of results . if the play result had already been calculated in an earlier pass through the run play loop 250 , processing proceeds from step 266 to step 278 where it is determined whether or not the batting user has presses the extra base button . if so , the play state is set up to attempt to run an extra base . if not , processing simply returns to the run play loop 250 . the next routine of the run play loop 250 is the update play state routine 275 , the details of which are shown in fig2 . the update play state routine first checks the play state and the runner state at step 276 and then increments the base runners , strikes , and outs . at step 280 , the play state is updated if necessary . for example , if there three strikes , the play state is updated to reflect an additional out . the check outs routine 285 , shown in fig2 , determines if the number of outs is three at step 286 , and if so , modifies the inning state variable to indicate the end of an inning . if there are not three outs , control returns to the run play loop 250 where the play state is examined at step 290 in order to determine whether the play is over . if the play is not over , the run play loop 250 is repeated . if the play is over , a return is executed and the program returns to the inning loop of fig1 . at step 295 of the inning loop of fig1 , the play state setup by the check outs routine 290 of fig2 is examined . if the inning is not over , the inning loop is repeated . if the inning is over , a return is executed and control returns to the game loop of fig1 . as described earlier , a check is made whether the game is over at step 204 in fig1 . if not , the inning is incremented and the game loop is repeated . if the game is over , processing continues to step 204 where the winner of the game is announced . while the above features of the present invention teach an apparatus for an interactive audio baseball game , it can be readily appreciated that it would be possible to deviate from the above embodiment of the invention to , for example a football game or some other interactive game . as will be readily understood by those skilled in the art of electronic games , the invention is capable of many modifications and improvements within the scope and spirit thereof . accordingly , it will be understood that the invention is not to be limited by the specific embodiments but only by the spirit and scope of the appended claims .

in a microprocessor based interactive audio game for two users to play against one another , or for one user to play against the computer , the game having the ability to store and retrieve sets of statistical data corresponding to the performance of actual players , keys for the users to affect the state of the game , and an audio output for communicating the state of the game or the results of a game play to the users , the audio output for a particular game state or game play result being variable in order to maintain user interest . a plurality of visual indicators are arranged in a grid that represents the flight of a thrown ball through a vertical cross section of the strike zone . visual indicators are sequentially flashed a predetermined number of times and in a predetermined pattern for a particular variety of pitch .

in a first preferred embodiment of the present invention , a distribution of displacements illustrated in fig1 is initially stored directly within a storage device ( e . g ., a memory or hard disk drive ) provided in a computer 2 - 5 which includes a display illustrated in fig2 . moreover , this distribution may also be stored in a storage device in the computer 2 - 5 using an information storage medium such as a cd - rom . the present invention includes several methods of compensating for the distribution of displacements illustrated in fig1 and the results obtained from testing various methods are provided herein . in a first method , pixels of a topographic image which are spatially distributed are compensated in accordance with distribution of displacements illustrated in fig1 . validity of this method will be discussed with reference to fig1 , fig1 , and fig1 . fig1 illustrates the visualized distribution of displacements of fig1 obtained for the entire part of a measurement area . as is apparent from this figure , it is understood that a topographic image is displayed through attraction toward the sampling point 12 - 1 which is nearest to the central point of the brain activation area . fig1 is a diagram where an example of the topographic image indicating the brain activation is adhered to the distribution of displacements of fig1 . when the topographic image is adhered , the figure is rather complicated . therefore , the topographic image is converted to a binary data image , discriminating the hatched area ( the central point thereof exists at ( xc , yc )=(− 15 , 0 ) in fig4 ) and the non - hatched area . the results of compensation for the topographic image illustrated in fig1 based on the method for compensation for the spatially distributed pixels of topographic image in accordance with the distribution of displacements of fig1 are illustrated in fig1 . according to fig1 , it is shown that the topographic image which is expanded in comparison with the original image of fig1 is displayed . the cause of this expansion will be described with consideration of the distribution of displacements of fig1 . from the distribution of displacements , it can be understood that the topographic image is displaced toward the nearest sampling point . from the inverted point of view of this result , it is shown that when the topographic image displayed at the point nearest to the sampling point is compensated , the topographic image is displayed at a point which is far from the sampling point . therefore , if the compensation process is implemented to the topographic image , which is displayed in the manner that the central area of the brain activation area exists at the area near the sampling point and the image is spreading for display to the area near the central point as in the topographic image of fig1 , the image is further spread , resulting in a deterioration in the image quality . accordingly , an algorithm for compensating for the pixels of the topographic image which are spatially distributed in accordance with the distribution of displacements of fig1 is considered to have lower validity than other methods discussed herein . for this reason , another algorithm is proposed below . the distribution of displacements illustrated in fig1 has been obtained by attaining displacements to the central point of the brain activation area . therefore , there is a probability for discussion of the method for compensation for displacement in the case where the maximal area of the topographic image is established at the central point . in actuality , a user often determines the brain activation area from the maximal point thereof in the topographic image showing changes in blood volume . accordingly , this method of the present invention discuses an algorithm for : ( 1 ) extracting the maximal value of the topographic image from the image processes and determining the location of that point ; and ( 2 ) compensating for the location of the extracted point using the distribution of displacements illustrated in fig8 . more concretely , the following methodology is used as illustrated in the flowchart of fig1 . 1 . displacement information for each coordinate is collected by simulation before the system is utilized ( s 1 in fig1 ). 2 . measurement of δa at each sampling point is made ( s 2 in fig1 ). 3 . a signal intensity distribution using the space interpolation process is generated ( s 3 in fig1 ). 4 . a threshold value is set ( s 4 in fig1 ). 5 . no signal intensity distribution for the coordinates having the intensity which is less than the threshold value are generated ( s 5 in fig1 ). 6 . a location compensation process based on the displacement information of each coordinate for the coordinates having the intensity which is larger than the threshold value is undertaken ( s 6 in fig1 ). 7 . finally , a display of the signal intensity distribution after the compensation process is generated ( s 7 in fig1 ). the results of testing the validity of this algorithm are illustrated in fig1 , fig1 , and fig1 . these figures illustrate ( 1 ) the brain activation area , ( 2 ) a topographic image indicating a change in blood volume in the brain activation area , ( 3 ) the results of a threshold process for the topographic image , and ( 4 ) the results of compensating for the location of the topographic image having completed the threshold process on the basis of the distributions of displacements of fig1 and fig1 . hereinafter , each figure will be described in detail . in the arrangement of the light source and the light detector illustrated in fig1 ( measurement area = 90 mm × 90 mm ), a brain activation area with a diameter of 15 mm has been set at the inside of the measurement area . the size of this activation area with a diameter of 15 mm corresponds , for example , to the size of a human finger motor ( the brain function existing on the cortex for controlling the motor function of the fingers ). the topographic image indicating the brain activation at the brain activation area described in step ( 1 ) has been generated with computer simulation . more concretely , changes in the degree of light absorption at the preset brain activation area are detected at the 24 sampling points illustrated in fig4 , and the spatial distributions of such changes are visualized as an image with the interpolation process . with the threshold process , the topographic image described in step ( 2 ) is displayed as a binary data image . in this embodiment , the topographic image of step ( 2 ) is standardized by 1 to obtain the binary data image wherein the area having a value of at least 0 . 9 is defined as 1 , and the area having any other values is defined as 0 . the central point of the topographic image of step ( 3 ) has been compensated in accordance with the distribution of displacements illustrated in fig1 and fig1 . referring to fig1 , a topographic image showing changes in the degree of light absorption at the brain activation area when ( xc , yc ) is ( 5 , 0 ) has been generated . since the sampling point nearest to ( xc , yc )=( 5 , 0 ) exists at the point where ( x , y ) is ( 15 , 0 ), the topographic image is deformed in the manner that the image is attracted to this point . however , as a result of setting the threshold value to 0 . 9 and forming this topographic image as the binary data image , the circular image which is similar to the circular brain activation area shown at the original point has been obtained . that is , the image depicted in the column of the compensation for image location described above ( location corrected ) has been obtained as a result of a parallel transfer of such circular image by obtaining the central point of image and changing the central point thereof in accordance with displacements of fig8 . the location of the image is almost matched with the original location . from this result , it can be noted that compensation for location has been realized . further , in view of discussing the validity of this algorithm , an improvement in the location accuracy based on this algorithm has been verified by setting the brain activation areas to seven areas including the brain activation areas of fig1 . the result of this verification is illustrated in fig1 and fig1 . according to the results shown in these figures , since the original topographic image is not displaced under the condition that ( xc , yc ) is (± 15 , 0 ) and ( 0 , 0 ), any improvement by the compensation using this algorithm cannot be detected . however , when ( xc , yc )=( 10 , 0 ), (± 5 , 0 ), it is apparent that the location of the image in which the threshold value has been extracted and the location has been compensated is matched with the original brain activation area in comparison with the maximal point of the topographic image in which changes in blood volume at each sampling point has been space - interpolated . from this result , validity of the algorithm proposed has been confirmed . fig1 , fig1 , and fig2 illustrate exemplary display images for implementing the algorithm described above . fig1 is a display image format in which a conventional topographic image is displayed 18 - 1 designates a displayed topographic image in which the locations of the light source 18 - 2 and the light detector 18 - 3 are illustrated . indicated and non - indicated conditions of locations of these light sources 18 - 2 and light detectors 18 - 3 can be selected and indication can be switched with a selection button 18 - 4 . moreover , a color bar 18 - 5 for showing the distribution of concentrations of this topographic image is also displayed on the display image to show a clear correspondence between the physical amounts and the colors of the topographic image . this color bar 18 - 5 has usually been subjected to the gradation process to easily observe the concentration of changes in blood volume . fig1 and fig2 illustrate an embodiment of the present method of displaying the images compensated by the algorithm illustrated in fig1 , fig1 , and fig1 . this display image is referred to as the threshold processing mode . fig1 does not show the locations of the light source and light detector , but fig2 displays the locations of the light source 20 - 2 and the light detector 20 - 3 through the selecting operations of check boxes 19 - 1 , 20 - 1 . in these figures , 19 - 2 and 20 - 4 are color bars for showing the activation area and non - activation area . unlike the color bar designated as 18 - 5 , these color bars may be displayed with the binary data in place of the gradation display . the display of these color bars represents the display of the areas for activations of the brain . in addition , 19 - 3 and 20 - 5 designate the bars for setting up the threshold for the image processes . in fig1 and fig1 , the threshold is set to 0 . 9 to form the image with binary data in order to set 1 for the area of the threshold larger than this value and 0 for the area of the threshold not larger than this value . however , a problem is not generated even when the value 0 . 9 is freely set by a user . for example , when it is desired to observe only the central point of the brain activation area , it is sufficient to set the threshold to 1 . 0 . however , on the contrary , when it is desired to remove a little of the “ blur ” of the topographic image , it is sufficient to set the threshold to a value near 0 . 0 . as a result , a user is able to select the desired image display method . additionally , the present invention includes a computer program utilized in a living body light measurement system for measuring the inside of a subject by illuminating a plurality of areas of the subject with the light and detecting the light propagated within the subject at a plurality of areas of the subject . the computer program preferably causes a general purpose computer to carry out the following steps : generate a distribution of signal intensity on the subject on the basis of the light signal detected at a plurality of areas ; execute the threshold process for generating a signal intensity distribution with an intensity equal to or greater than a predetermined threshold for the signal intensity distribution ; and compensate for the displacement with the arithmetic process on the basis of the data , for the threshold processed signal intensity distribution , which is generated before the living body light measurement for displacement between the brain activation area and the maximal location of the signal intensity distribution generated when the signal intensity distribution is generated . preferably , the threshold value is set by a user of the computer program . nothing in the above description is meant to limit the present invention to any specific materials , geometry , or orientation of elements . many part / orientation substitutions are contemplated within the scope of the present invention and will be apparent to those skilled in the art . the embodiments described herein were presented by way of example only and should not be used to limit the scope of the invention . although the invention has been described in terms of particular embodiments in an application , one of ordinary skill in the art , in light of the teachings herein , can generate additional embodiments and modifications without departing from the spirit of , or exceeding the scope of , the claimed invention . accordingly , it is understood that the drawings and the descriptions herein are proffered only to facilitate comprehension of the invention and should not be construed to limit the scope thereof .

an image generating methodology for displaying brain activation areas with improved accuracy in a living body light measurement system for generating an image of the changes in blood volume of the brain . a spatial intensity distribution of changes in blood volume can be generated by detecting brain activation in many sampling points , and a spatial interpolation process is executed on this data . a threshold process is executed on the distribution to extract the distribution of coordinates having a signal intensity of at least the predetermined threshold . the displacement between the brain activation area and the maximal location of the distribution is stored in a recording unit of the system in order to compensate for the distribution extracted by the threshold process . accordingly , brain activation areas can be estimated with greater location accuracy , and the diagnosis and medial treatment for brain diseases can likewise be executed with greater accuracy .

fig1 is a perspective view of a snowboard according to one embodiment . as shown in fig1 , the snowboard a 1 comprises two snowboard bindings b 1 and a snowboard body b 2 . each snowboard binding b 1 is attached to the snowboard body b 2 . each snowboard binding b 1 is for binding a snowboard rider &# 39 ; s boots ( not shown ) to the snowboard body b 2 . fig2 is a front perspective view showing one of the snowboard bindings b 1 shown in fig1 . fig3 is an enlarged perspective view of the region iii in fig2 . fig4 is an enlarged perspective view of the region iv in fig2 . fig5 is another front perspective view showing the snowboard binding shown in fig2 . fig6 is a left side view showing the snowboard binding shown in fig2 . as shown in these figures , each snowboard binding b 1 includes a binding frame 1 ( also referred to as a binding frame means ), a highback 2 ( which can be considered part of the binding frame 1 ), a base plate 3 , an ankle cap assembly 40 with an ankle cap 41 ( also referred to as an ankle cap means ), an ankle cap buckle mechanism 42 , an ankle cap strap 43 , a toe cap assembly 50 with a toe cap 51 ( also referred to as a toe cap means ), a toe cap buckle mechanism 52 , a toe cap strap 53 , and attaching members 7 a , 7 b . fig7 is a right side view showing the snowboard binding shown in fig2 . fig8 is a left side view showing the snowboard binding shown in fig7 . fig9 is a top view showing the snowboard binding shown in fig7 . fig1 is a bottom view showing the snowboard binding shown in fig7 . fig1 is a front view showing the snowboard binding shown in fig7 . fig1 is a rear view showing the snowboard binding shown in fig7 . in these figures , illustration of the ankle cap 41 , parts of the ankle cap buckle mechanism 42 , the ankle cap strap 43 , the toe cap 51 , parts of the toe cap buckle mechanism 52 , and the toe cap strap 53 are omitted . as shown in fig1 , the binding frame 1 is attached to the snowboard body b 2 . the binding frame 1 can be made of , but not limited to , metal or plastic . as shown in fig2 , 6 , and 9 , the binding frame 1 includes a first outwardly facing side surface 11 and a second outwardly facing side surface 12 . the side surfaces 11 , 12 face in opposite directions . as shown in fig9 , the first side surface 11 and the second side surface 12 face outwardly when the binding b 1 is viewed in a top view . as shown in fig2 , and 6 , the binding frame 1 also includes upper edges 15 . in the illustrated embodiment , one of the upper edges 15 is located at the upper end of the first side surface 11 , and another of the upper edges 15 is located at the upper end of the first side surface 12 . with reference to fig2 , and 6 , the highback 2 is pivotally attached to the binding frame 1 by the attaching members 7 a , 7 b . examples of suitable attaching members 7 a , 7 b can include , but are not limited to , screws , bolts , or the like . the highback 2 is foldable relative to the binding frame 1 between an upright position ( shown in the figures ) and a folded position ( not shown ) as in conventional snowboard bindings . when the highback 2 is in the upright position , the highback 2 comes into contact with the rear part of the snowboard rider &# 39 ; s boot when the snowboard a 1 is used . the highback 2 can be made of , but not limited to , metal or plastic . as shown in fig2 and 5 , the base plate 3 is attached to the binding frame 1 , and the base plate 3 is attached to the snowboard body b 2 for mounting the bindings b 1 to the snowboard body b 2 . in addition , the base plate 3 helps to keep the sides of the frame 1 spaced apart , and supports the snowboard rider &# 39 ; s boots when the snowboard a 1 is used . the base plate 3 can be made of , but not limited to , metal or plastic . in the illustrated example , the base plate 3 includes two parts separated each other . each of these parts is attached to the binding frame 1 by attaching members 7 c . the attaching members 7 c can be , but are not limited to , screws , bolts , or the like . with reference to fig2 , 5 , and 6 , the ankle cap 41 is connected to the binding frame 1 . the ankle cap 41 helps to hold the snowboard rider &# 39 ; s boot to the binding frame 1 . the ankle cap 41 includes a first end portion 41 a and a second end portion 41 b . in the illustrated embodiment , the first end portion 41 a is disposed at one end of the ankle cap 41 in a width direction of the binding frame 1 . the second end portion 41 b is disposed at the other end of the ankle cap 41 in the width direction . the ankle cap buckle mechanism 42 connects the ankle cap 41 to one side of the binding frame 1 . in the illustrated example , the ankle cap buckle mechanism 42 is attached to the first end portion 41 a of the ankle cap 41 , and is releasably attachable to the first side surface 11 of the binding frame 1 . the ankle cap buckle mechanism 42 can have two primary conditions — a connected condition and a disconnected condition . when the ankle cap buckle mechanism 42 is in the connected condition , the ankle cap 41 and the binding frame 1 are connected by the ankle cap buckle mechanism 42 ( see fig2 , and 6 ). on the other hand , when the ankle cap buckle mechanism 42 is in the disconnected condition , the ankle cap 41 and the binding frame 1 are not connected by the ankle cap buckle mechanism 42 ( see fig1 ). as shown in fig2 , and 6 , the ankle cap buckle mechanism 42 includes a first buckle 421 ( also referred to as a first buckle means ), a first engagement member 424 ( also referred to as a first engagement means ), and a first binding hook 426 ( also referred to as a first engagement means ). the first buckle 421 is attached to the ankle cap 41 . specifically , the first buckle 421 is attached to the first end portion 41 a of the ankle cap 41 . the first buckle 421 can be made of metal , plastic , or other suitable material . the first buckle 421 includes a support base 421 a , a lever 421 c , and a traction element 421 e . as shown in fig3 and 6 , the support base 421 a is attached to the first end portion 41 a of the ankle cap 41 . the lever 421 c is pivotally attached to the support base 421 a through a pin 421 g . the traction element 421 e is pivotally attached to the lever 421 c through a pin 421 h . in the illustrated example , the traction element 421 e includes a rod 421 m and a housing 421 n . the rod 421 m of the traction element 421 e can be rotated into and out of the housing 421 n to adjust the length of the traction element 421 e . thus , the connection tightness of the ankle cap assembly 40 ( and the toe cap assembly 50 ) can be adjusted by adjusting the length of the traction element 421 e . in some embodiments , the rod 421 m of the traction element 421 e may not be adjustable . the buckle mechanism 42 ( and the toe cap buckle mechanism 52 ) is generally similar in construction and operation to buckle mechanisms used on conventional ski boots except for the binding hook 426 . the first engagement member 424 is connected to the first buckle 421 . specifically , the first engagement member 424 is pivotally connected to the traction element 421 e of the first buckle 421 through a pin 428 . the first engagement member 424 can be made of metal , plastic or other suitable material . the first engagement member 424 has an opening 424 a . though fig6 shows an example in which the opening 424 a is rectangular , the shape of the opening 424 a is not limited to rectangular . the first engagement member 424 includes an engagement portion 424 c , for example a pin or bar , that is engageable with the first binding hook 426 . the engagement portion 424 c defines a part of the opening 424 a . the first binding hook 426 is attached on the binding frame 1 . in this embodiment , the first binding hook 426 is non - rotatably attached to the binding frame 1 by the attaching member 7 a at a location to be engageable with the first engagement member 424 . the first binding hook 426 can be made of metal , plastic or other suitable material . as shown in fig6 , the first binding hook 426 includes a first base part 426 a and a first receiving part 426 c . the first base part 426 a is attached to the binding frame 1 by the attaching member 7 a . the first base part 426 a directly contacts the first side surface 11 of the binding frame 1 . the first receiving part 426 c is integrally formed on the first base part 426 a . the first receiving part 426 c receives a part of the first engagement member 424 ( specifically , the engagement portion 424 c ), when the first binding hook 426 is engaged with the first engagement member 424 . the first receiving part 426 c directly contacts the engagement portion 424 c of the first engagement member 424 when the first binding hook 426 is engaged with the first engagement member 424 . the first receiving part 426 c is disposed in the opening 424 a of the first engagement member 424 when the first binding hook 426 is engaged with the first engagement member 424 . as shown in fig6 , the first receiving part 426 c overlaps the binding frame 1 in a side view . the first receiving part 426 c includes a portion located below the upper edge 15 . in the illustrated example , a part of the first receiving part 426 c is located above the upper edge 15 . however , the entirety of the first receiving part 426 c may be located below the upper edge 15 . in some embodiments , the first binding hook 426 may include a plurality of first receiving parts to adjust the ankle cap 41 relative to the binding frame 1 . in some embodiments , there can be a plurality , for example two , of the first binding hooks 426 on each binding b 1 , each of which can include a first receiving part 426 c . in the case of two first binding hooks 426 , the first binding hooks 426 can be arranged serially / linearly so that one of the binding hooks 426 is disposed between the other binding hook 426 and the attaching member 7 a , or the binding hooks 426 can be arranged side - by - side so they are generally equally spaced from the attaching member 7 a . when the binding hooks 426 are arranged serially / linearly , the engagement member 424 can engage with either one of the binding hooks 426 so as to be selectively engaged by the user with either of the hooks 426 to add an additional tightness adjustment option . in another embodiment , the first engagement member 424 can include a plurality , for example two , of the engagement portions 424 c . in the case of two of the engagement portions 424 c and two of the binding hooks 426 , the engagement portions 424 c can be arranged serially / linearly so that one of the engagement portions 424 c is disposed between the other engagement portion 424 c and the traction element 421 e , or the engagement portions 424 c can be arranged side - by - side so they are generally equally spaced from the traction element 421 e . when the engagement portions 424 c are arranged serially / linearly , each one of the engagement portions 424 c can engage with one of the binding hooks 426 at the same time . as shown in fig5 , the ankle cap strap 43 is attached to the binding frame 1 , and to the ankle cap 41 . specifically , the ankle cap strap 43 is attached to the second side surface 12 of the binding frame 1 by the attaching member 7 b . in addition , the ankle cap strap 43 can be attached to the second end portion 41 b of the ankle cap 41 , for example by two attaching members 7 d . the two attaching members 7 d can be , for example , quick adjust screws . the ankle cap strap 43 can also include a plurality of adjustment holes 432 formed therein that are engageable with the attaching members 7 d to adjust the ankle cap 41 relative to the binding frame 1 . the ankle cap strap 43 can be formed of any materials that are suitable for performing the functions of the ankle cap strap 43 , for example plastic , carbon fiber , or kevlar . in one embodiment , the ankle cap strap 43 may include one or more thin metal cables coated in rubber / plastic so as not to wear into the boot . in another embodiment , the strap 43 ( and / or the strap 53 described below ) could be replaced with a buckle mechanism similar to the buckle mechanism 42 ( and / or the buckle mechanism 52 described below ). with reference to fig2 and 4 - 6 , the toe cap 51 is connected to the binding frame 1 . the toe cap 51 helps to hold the snowboard rider &# 39 ; s boot to the binding frame 1 . the toe cap 51 includes a first end portion 51 a and a second end portion 51 b . in the illustrated embodiment , the first end portion 51 a is disposed at one end of the toe cap 51 in a width direction of the binding frame 1 . the second end portion 51 b is disposed at the other end of the toe cap 51 in the width direction . the toe cap buckle mechanism 52 connects the toe cap 51 to one side of the binding frame 1 . in the illustrated example , the toe cap buckle mechanism 52 is attached to the first end portion 51 a of the toe cap 51 , and is releasably attachable to the first side surface 11 of the binding frame 1 . the toe cap buckle mechanism 52 can have two primary conditions — a connected condition and a disconnected condition . when the toe cap buckle mechanism 52 is in the connected condition , the toe cap 51 and the binding frame 1 are connected by the toe cap buckle mechanism 52 ( see fig2 , and 6 ). on the other hand , when the toe cap buckle mechanism 52 is in the disconnected condition , the toe cap 51 and the binding frame 1 are not connected by the toe cap buckle mechanism 52 ( see fig1 ). the toe cap buckle mechanism 52 includes a second buckle 521 ( also referred to as a second buckle means ), a second engagement member 524 ( also referred to as a second engagement means ), and a second binding hook 526 ( also referred to as a second binding hook means ). the second buckle 521 is attached to the toe cap 51 . specifically , the second buckle 521 is attached to the first end portion 51 a of the toe cap 51 . the second buckle 521 can be made of metal , plastic or other suitable material . the second buckle 521 includes a support base 521 a , a lever 521 c , and a traction element 521 e . as shown in fig4 and 6 , the support base 521 a is attached to the first end portion 51 a of the toe cap 51 . the lever 521 c is pivotally attached to the support base 521 a through a pin 521 g . the traction element 521 e is pivotally attached to the lever 521 c through a pin 521 h . in the illustrated example , the traction element 521 e includes a rod 521 m and a housing 521 n . the rod 521 m of the traction element 521 e can be rotated into and out of the housing 521 n to adjust the length of the traction element 421 e . thus , the connection tightness of the toe cap assembly 50 can be adjusted by adjusting the length of the traction element 421 e . in some embodiments , the rod 521 m of the traction element 521 e may not be adjustable . as indicated above , the buckle mechanism 52 is generally similar in construction and operation to buckle mechanisms used on conventional ski boots except for the binding hook 526 . the second engagement member 524 is connected to the second buckle 521 . specifically , the second engagement member 524 is pivotally connected to the traction element 521 e of the second buckle 521 through a pin 528 . the second engagement member 524 can be made of metal , plastic or other suitable material . the second engagement member 524 has an opening 524 a . though fig6 shows an example in which the opening 524 a is rectangular , the shape of opening 524 a is not limited to rectangular . the second engagement member 524 includes an engagement portion 524 c , for example a pin or bar , that is engageable with the second binding hook 526 . the engagement portion 524 c defines a part of the opening 524 a . the second binding hook 526 is attached on the binding frame 1 . in this embodiment , the second binding hook 526 is non - rotatably attached to the binding frame 1 by an attaching member 7 c at a location to be engageable with the second engagement member 524 . the second binding hook 526 can be made of metal , plastic or other suitable material . as shown in fig6 , the second binding hook 526 includes a second base part 526 a and a second receiving part 526 c . the second base part 526 a is attached to the binding frame 1 by the attaching member 7 c . the second base part 526 a directly contacts the first side surface 11 of the binding frame 1 . the second receiving part 526 c is integrally formed on the second base part 526 a . the second receiving part 526 c receives a part of the second engagement member 524 ( specifically , the engagement portion 524 c ) when the second binding hook 526 is engaged with the second engagement member 524 . the second receiving part 526 c directly contacts the engagement portion 524 c of the second engagement member 524 when the second binding hook 526 is engaged with the second engagement member 524 . the second receiving part 526 c is disposed in the opening 524 a of the second engagement member 524 , when the second binding hook 526 is engaged with the second engagement member 524 . as shown in fig6 , the second receiving part 526 c overlaps the binding frame 1 in a side view . the second receiving part 526 c includes a portion located below or flush with the upper edge 15 . in this illustrated example , the entirety of the second receiving part 526 c is located below or flush with the upper edge 15 . however , in other embodiments , a portion of the second receiving part 526 c may be located above the upper edge 15 . in some embodiments , the second binding hook 526 may include a plurality of second receiving parts to adjust the ankle cap 41 relative to the binding frame 1 . in some embodiments , like with the first binding hook 426 and the first engagement member 424 , there can be a plurality , for example two , of the second binding hooks 526 , and also a plurality , for example two , of the engagement portions 524 c . the plurality of the second binding hooks 526 and the plurality of the second engagement portions 524 c can be arranged and function like described above for the first binding hooks 426 and the first engagement members 424 . as shown in fig5 , the toe cap strap 53 is attached to the binding frame 1 , and to the toe cap 51 . specifically , the toe cap strap 53 is attached to the second side surface 12 of the binding frame 1 by one of the attaching members 7 c . the attaching member 7 c can be , for example , a quick adjust screw . in addition , the toe cap strap 53 can be attached to the second end portion 51 b of the toe cap 51 by two attaching members 7 c . the two attaching members can be , for example , quick adjust screws . the toe cap strap 53 can also include a plurality of adjustment holes 532 formed therein that are engageable with the attaching members to adjust the toe cap 51 relative to the binding frame 1 . the toe cap strap 53 can be formed of any materials that are suitable for performing the functions of the toe cap strap 53 , for example plastic . the toe cap strap 53 may include two thin metal cables coated in rubber / plastic so as not to wear into the boot . as shown in fig1 , the snowboard body b 2 includes an upper surface 81 and a lower surface 82 . the upper surface 81 and the lower surface 82 can be generally flat . however , opposite ends 83 , 84 of the snowboard can be curved upwardly in conventional manner . in the snowboard a 1 , the snowboard bindings b 1 are attached to the upper surface 81 . specifically , each binding frame 1 of the snowboard bindings b 1 is attached to the upper surface 81 via the base plate 3 . for this purpose , in the illustrated example , each base plate 3 of the snowboard bindings b 1 is attached to the upper surface 81 by a plurality of attaching members ( not shown ) in a conventional manner . the operation of the snowboard a 1 and the snowboard bindings b 1 should be readily apparent to a person of skill in the art from the foregoing description and the drawings . however , an example use of the snowboard bindings b 1 is briefly explained below . with the buckle mechanisms 42 , 52 initially disconnected from the hooks 426 , 526 , the user moves the assemblies 40 , 50 out of the way and steps into the binding frames 1 . when the user &# 39 ; s boots are properly positioned in the binding frames 1 , the user pulls the assemblies 40 , 50 over the boots and pivots the levers 421 c , 521 c upward to the position shown in fig1 . at the same time , the engagement portions 424 c , 524 c are positioned near the binding hooks 426 , 526 . referring to fig1 , the engagement portions 424 c , 524 c are then maneuvered behind the receiving parts 426 c , 526 c . the levers 421 c , 521 c are then rotated toward the closed position . as the levers 421 c , 521 c are rotated , they pull the traction elements 421 e , 521 e which in turn pull the engagement members 424 , 524 so that the engagement portions 424 c , 524 c gradually become locked behind the receiving parts 426 c , 526 c of the binding hooks 426 , 526 . the levers 421 c , 521 c continue to be rotated until they are fully closed ( shown in fig2 - 4 and 6 ) and the engagement members 424 , 524 are locked to the binding hooks 426 , 526 . removal works in an opposite manner , with the levers 421 c , 52 c manually rotated to the open position shown in fig1 which frees the engagement portions 424 c , 524 c from the receiving parts 426 c , 526 c . the described bindings permit connection of the engagement members to the binding hooks using one hand instead of requiring both hands . in addition , the described bindings have only two straps on each binding instead of four straps . further , the user can pre - adjust the straps 43 , 53 and the traction elements 421 e , 521 e to obtain the desired tightness . thereafter , each time that the user fastens the bindings , the same level of tightness can be achieved without requiring the user to adjust each time the user connects to the bindings . further , because the engagement members are received by the receiving part of the binding hooks , ice and snow are prevented from building up in the binding hooks . further , the binding hooks are non - rotatably attached to the binding frame . as a result , the snowboard a 1 can respond instantly to the rider &# 39 ; s movement ( for example when ollieing and spinning or applying nose or tail pressure ) and extra delay of the movement of the snowboard a 1 that can be caused by pivotally mounted straps can be prevented . fig1 is a front perspective view showing a snowboard binding according to another embodiment . the snowboard binding shown in fig1 is different from the snowboard binding shown in fig4 in that a puck or circular disk 34 is mounted on the base plate 3 . other structures in the snowboard binding in fig1 are the same as the foregoing embodiment in fig1 - 14 . the puck 34 shown in fig1 is a circular plate and can be used for adjusting an angle of the binding frame 1 on the snowboard body . for example , once the user loosens screws ( not shown ) that fix the puck 34 to the snowboard body , the user can rotate the binding frame 1 relative to the puck 34 . once the desired angle of the binding frame 1 is achieved , the user then tightens the screws of the puck 34 which clamps the base plate 3 and fixes the position of the binding frame 1 . the construction and operation of a binding frame with a puck - like disc permitting adjustment of the binding frame is known in the art . the examples disclosed in this application are to be considered in all respects as illustrative and not limitative . the scope of the invention is indicated by the appended claims rather than by the foregoing description ; and all changes which come within the meaning and range of equivalency of the claims are intended to be embraced therein .

a snowboard binding that eliminates the ratchet - type connection used in conventional snowboard bindings . instead , the snowboard binding incorporates a connection mechanism that is somewhat similar to a ski - boot style connector , and that uses only two straps on each binding compared to the traditional four straps . in addition , the connection mechanism can be pre - adjusted by the user to the desired connection pressure . once the desired pre - adjustment is reached , the user can simply step into the binding and connect the connection mechanism without needing to adjust the connection pressure or tightness during mounting the user &# 39 ; s foot or boot to the board as with conventional snowboard bindings .

[ 0025 ] fig1 : the cervical cup 1 contains an inner layer comprised of an electrically conductive surface that is connected to an insulated wire 2 , which passes atraumatically out of the body and connects to a power source or electroporation device 3 . the inner layer of 1 may also be concomitantly interlaced with a series of channels that ultimately communicate to a tube 4 that passes atraumatically out of the body and ultimately connects to a port 5 and syringe 6 to be used as an injection device for therapeutics in liquid / gel / vapor / gas form . [ 0026 ] fig2 . the internal lead is charged opposite the cervical cup used in fig1 . 1 is the expandable balloon that has an outer electrically conductive surface that comes in direct adposition to the inner uterine lining when deployed by injecting liquid , gel or air via the syringe 4 traversing through a syringe port 3 that then attaches to a rubber tubing 2 , which ultimately communicates to the intrauterine balloon 1 . a seamless insulated wire 5 connects the conductive surface on 1 to an electroporation device or power supply 6 . [ 0027 ] fig3 . the same internal lead as described in fig4 however , the balloon device 1 is deployed upon injection with air / liquid / gel from syringe 4 . again 3 is the syringe port , 4 is the syringe and 2 is the tube that allows communication of balloon 1 to syringe 4 and also houses an insulated wire 5 which connects the conductive surface on balloon 1 to the power source / electroporation device 6 . [ 0028 ] fig4 . intrauterine balloon 1 and cervical cup 2 deployed in a standard therapeutic fashion with the balloon traversing through the inner opening of the cervical cup 2 and the balloon 1 fully inflated . the cup 1 is connected by an insulated atraumatic wire 11 connecting to a power source or electroporation device 10 . again the inner layer of 2 may also be concomitantly interlaced with a series of channels that ultimately communicate to a tube 3 that passes atraumatically out of the body and ultimately connects to a port 4 and syringe 5 to be used as an injection device for therapeutics in liquid / gel / vapor / gas form . furthermore connected to the intrauterine balloon is a tube 6 that allows communication with the port 7 and syringe 8 which deploys the balloon . wire 9 connects conductive surface on balloon 1 with power source or electroporation device 10 . wire 11 connects conductive surface of cup 1 to negative lead on power source 10 . [ 0029 ] fig5 . the same instrument set up as in fig4 however , the apparatus is depicted in vivo and as a vertical section of through the human female reproductive tract with the uterus and cervix as labeled and the fallopian tubes a . details of numbered objects are the same as described in fig4 . [ 0030 ] fig6 . a conceptual drawing of device stated in fig5 . for clarity , device is depicted as a cross - sectional representation of the cervical cup minus the wires , tubing , syringe and power source or electroporation device . when the device used in fig5 is triggered to deliver an electrical pulse , it will create electroporation of substances in the direction of the small arrows indicated . the polarity on surfaces of the cervical cup and intrauterine lead may be reversed in polarity , but typically opposite to one another , in order to enhance delivery of positively charged therapeutic agents . [ 0031 ] fig7 : the same device as in fig1 however , the inner surface of the cervical cup is composed of two separate electrically conductive surfaces surrounding the inner cylinder 1 and the inner aspect of the outer rim 2 . surface 1 would be in contact with the endocervical canal , whereas 2 is in direct contact with the outermost lateral aspect of the cervix . again 3 being an atraumatic insulated wire that connects conductive surface 2 to either an electroporation device or power source 5 . 4 is another insulated atraumatic wire which connects the conductive surface 1 to the same electroporation device or power source 5 , but typically in opposite polarity to conductive surface 2 . polarities of conductive surfaces 1 and 2 may be switched to suit the direction of electroporation according to the charge of the agent to be delivered . though not depicted , a tube connecting microfenestrated and embedded channels in any specific region of the cervical cup to a delivery syringe may be fashioned for delivery of therapeutic agents prior to electroporation . dashed lines in fig7 b ( top - view ) and 7 c ( vertical cross - section view ) represent electrically conductive surfaces . [ 0032 ] fig8 . device in fig7 shown seated in vivo with uterine and cervical tissues as indicated and shaded in medium gray tone . fallopian tubes are labelled as a . inner circumference conductive surface in dark gray tone is connected to the negative wire 6 and lead on power supply / electroporation device 7 . opposing conductive surface in light gray tone is connected by positive wire 5 , which connects to positive lead on same power supply / electroporation device 7 . [ 0033 ] fig9 . a conceptual drawing of device stated in fig7 and 8 . for clarity , device is depicted as a cross - sectional representation of the cervical cup minus the wires , tubing , syringe and power source or electroporation device . conductive surfaces 1 and 2 depicted as dotted lines are directly facing opposite one another and when activated ( i . e . electroporation device or power source is triggered to deliver a pulse or current ) will create electroporation of substances in the direction of the small arrows indicated . the polarity of surfaces 1 and 2 may be adjusted to suit the charge of the therapeutic agent being introduced into tissue . a further embodiment entails using the proposed inventions for electroporating various agents into a normal or diseased cervix for cervical ripening during prolonged pregnancies , especially in females refractory to conventional therapeutics such as pitocin . use of the internal intrauterine lead in this circumstance will not be used in conjunction with the cervical cup . electrical pulses and currents generated from the electroporation device or power source would be tailored for maximal delivery of therapeutic agent with zero to negligible effect ( s ) on the fetus . in a further embodiment of the invention the cup may be used solely with lipofection and drug agents added and held in place for extended time with any efficient and atraumatic clamp or holder . moreover greater extended therapy ( brachytherapy ) may be achieved by creating an internal holder that loops in the internal os and secures the cup snug against the cervix . in a further embodiment one may use the electroporation device without any agent and use the effects of electrical current on the cervix for increasing porosity of the cervix for systemic drugs . as electroporation fields in themselves have also exhibited a bystander effect . the electroporation field in itself may be used to affect cures for various diseases and disorders of the cervix . in yet another embodiment , the distal end of the cervical cup , that traverses through the cervical os and canal , may be fashioned of a resilient and flexible material with memory , that when shrouded in a holder is held in a cylindrical shape . when the central cylinder is advanced through the endocervical canal , the shroud may be released and removed allowing the distal cylinder to fold backwards on itself into the original molded shape enclosing the junction of the inner uterine lining and the beginning of the cervical outlet . this design modification would allow the electroporation of the internal intrauterine outlet leading into the cervical canal . the distal flexible end of the inner cylinder may also be designed to take any form suitable for electroporation of the intrauterine aspect of the cervix . in yet another embodiment the leads depicted in fig1 and 7 may be reversed in polarity ( but still maintaining bipolar configuration ) in order to force positively charged substances into cells . both magnitude and charge of bipolarity between positive and negative leads may be adjusted to increase efficiency of therapeutic agent delivery into cervical tissue . additionally the negative internal lead may be abandoned all together and multiple external patch leads or shorts with a conductive surface may be used to create tailored electrical fields to focus the direction of electroporation toward specific regions of diseased cervix . in a further embodiment the system may utilize alternate forms of energy transfer in place of electroporation / iontophoresis . these forms include , but are not limited to , phonophoresis and magnetophoresis . in another embodiment the inductive circuit can be designed as a resonant circuit tuned to the radio frequency range (& gt ; 9 khz ) capable of producing electrical current when exposed to an oscillating magnetic field tuned at the same frequency . ( stray magnetic field interference is mitigated with this design .) the power supply may also have an ac / dc converter to exclusively direct current to pass through the positive and negative leads .

a method and device for delivering therapeutic agents to the cervix . the method utilizes a diaphragm with an electrically conductive surface that is placed atraumatically over the outer surface and inner os of the mammalian cervix . the agent is delivered to the diaphragm after which the conductive surface of the diaphragm may be charged by a power source to deliver a electrophoretic field to force the agent deep into cervical tissue and cells . the diaphragm may be used with or without the aid of external or internal leads . a unique intrauterine lead designed in this patent may also be used with the diaphragm to enhance delivery of therapeutic agents .

the compounds of the present invention represent a new approach to targeted delivery of chemotherapy to cancer cells . unlike prior compounds for targeted chemotherapy , which have generally been designed to deliver toxic substances which interfere with cell reproduction , for example by disrupting dna replication processes , the compounds of the present invention rely on antibiotics which disrupt the normal processing of selected peptides and proteins , including receptors which may be the targets of the compounds of the invention . as shown in fig1 the compounds of the present invention comprise a targeting moiety and an ansamycin antibiotic , preferably joined via a spacer bridge to allow flexibility of the two ends of the compound relative to one another . in fig1 the antibiotic moiety is the benzoquinoid ansamycin geldanamycin . however , other ansamycin antibiotics , including herbimycin a ( fig2 ) and macbesin can also be used . the targeting moiety included in the compounds of the invention is one which will specifically bind to a protein , receptor or marker . the targeting moiety may be a hormone , hormone analog , protein receptor or marker specific antibody or any other ligand that specifically binds to a target of interest . preferred targeting moieties bind to steroid receptors , including estrogen , androgen and progesterone receptors and transmembrane tyrosine kinases , src - related tyrosine kinases , raf kinases and pi - 3 kinases . specific tyrosine kinases include her - 2 receptors and other members of the epidermal growth factor ( egf ) receptor family and insulin and insulin - like growth factor receptors . examples of targeting moieties include estrogen , estradiol , progestin , testosterone , tamoxifen and wortmannin . targeting moieties may also be antibodies which bind specifically to receptors , for example antibodies which bind to her2 receptors as disclosed in international patent publications nos . wo96 / 32480 , wo96 / 40789 and wo97 / 04801 which are incorporated herein by reference . other specific - binding peptides or hormones can also be used as targeting moieties . the spacer is preferably included to give the molecule the rotational freedom to adapt to the topology of the receptor . suitable spacers are linear chains having a length of 2 or more atoms , preferably 4 or more atoms . as demonstrated in the examples , the tether length can affect the specificity and effectiveness of the compound . the chains making up the tether will be predominantly carbon , but may include heteroatoms ( e . g ., n , s , o , or p ). the chain of the spacer be functionalized internally , e . g ., with a double bond , keto moiety or an amino group , where the heteroatom is outside the linear spacer chain , if additional reactivity is desired . fig9 a - f show the structures of various gm - estradiol compounds with differing tether lengths and functionalization . the compounds of the invention are useful in the treatment of cancer , where the cancer cells express proteins that interact with the targeting moiety and that are required for viability . thus , prostate cancer can be treated by administration of a compound with an androgen receptor binding moiety while estrogen receptor positive breast cancer can be treated by administration of a compound with an estrogen - receptor binding moiety . breast cancer cells have been found in some individuals to exhibit increased levels of various types of hormone receptors including estrogen receptors and erbb2 ( also known as her2 ) when compared to non - cancerous cells , and these proteins are important for growth of a significant proportion of breast cancers . gm - e2 , a compound in which estradiol is coupled to geldanamycin , has been found to selectively destroy these receptors , and to have less effect on other receptor types ( e . g ., androgen receptors , other tyrosine kinase receptors and the raf1 kinase ) than geldanamycin alone . thus , gm - e2 can be used to selectively inhibit or destroy breast cancer cells with less toxicity to other cell types . wortmannin - tethered ansamycin antibiotics are used to target the antibiotic to pi - 3 kinases . pi - 3 kinases are found in a variety of cancers . pi - 3 kinases are not degraded by exposure to untargeted gm . however , our studies have shown that gm coupled to an isomer of wortmannin which binds to but does not inhibit pi - 3 kinases is an active inhibitor of the enzymes . thus , ansamycin antibiotics can be used in combination with wortmannin to provide a valuable chemotherapy agent for cancer cells expressing pi - 3 kinases . further , this data supports the conclusion that such antibiotics can be used in combination with other species of targeting moiety to inhibit or destroy targeted proteins , even where the targeted protein is not affected by the ansamycin alone . thus , molecules in accordance with the invention provide therapeutic benefit in cases where the targeted protein is pathogenic . while not intending to be bound by a particular mechanism , it is believed that the hybrid compounds of the present invention work as a result of an interaction between the ansamycin portion of the hybrid and the chaperone protein hsp90 . hsp90 contains a deep binding pocket that tightly binds ansamycins . when this pocket is occupied by ansamycins , hsp90 forms a stable heterodimer with proteins to which it binds , such as steroid receptors , and these proteins are destroyed . the hybrid molecules described in this invention act as a bridge to create intracellular complexes between hsp90 and the targeted protein , with the ansamycin binding to the hsp90 and the targeting moiety binding to the targeted protein . this results in inhibition of the targeted protein and in many cases in the degradation of the targeted protein . however , because the function of the ansamycin is to provide an association with hsp90 , there is no requirement that the ansamycin be directly effective to inhibit or degrade the target protein . similarly , the targeting moiety need only bind to the targeted protein . it need not inhibit that protein . from this understanding of the mechanism , it will be appreciated that the present invention is not limited to hybrid compounds containing ansamycins , but in fact encompasses any hybrid compound in which a targeting moiety is coupled to a moiety which binds to the same pocket of hsp90 and thus create the same type of bridge . an example of a non - ansamycin that could be used in place of the ansamycin is radicicol . further , there is a family of closely related hsp90 - like chaperone molecules which contain binding pockets which are the same as or very similar to the pocket of hsp90 which binds ansamycins . hybrid drugs which bind to these molecules are also within the scope of the present invention . the same mechanism which permits targeted inhibition or degradation of pi - 3 kinases using ansamycin antibiotic complexes can be applied to the treatment of other diseases where a protein is implicated in the pathogenesis . thus , ansamycin antibiotics coupled to a targeting moiety which binds to pathogenic proteins associated with alzheimer &# 39 ; s disease could be used in treatment of alzheimer &# 39 ; s disease . similarly , antigens associated with autoimmune disorders such as multiple sclerosis might be degraded using a targeted ansamycin antibiotic . synthesis of the compounds of the invention is readily achieved by reacting an primary or secondary amino - derivative of the targeting moiety with the ansamycin antibiotic in dmso overnight in the dark . thus , as shown in fig3 a testosterone - geldanamycin product was obtained by reacting a 17 - alkylamino testosterone with geldanamycin . the 17 - alkylamino testosterone is prepared ( fig4 ) by alkylation of a monoprotected 17 - keto testosterone with the lithium acetylide of 8 - terbutyldimethylsilyloxy - 1 - octyne in tetrahydrofuran ( thf ) and hexamethylphosphorous triamide ( hmpt ). the resulting silyl ether was transformed into its corresponding mesylate in two steps : desilylation with tetrabutylammonium fluoride and mesylation ( mscl , et 3 n , ch 2 cl 2 ). the mesylate was then reacted with sodium azide ( nan 3 ) in dimethylformamide ( dmf ) at room temperature to give the corresponding azide . acid hydrolysis of the acetal , followed by triethylphosphite reduction of the azide gave the desired 17 - aminoalkyl testosterone in good yield . this was reacted with geldanamycin ( gm ) in dmso for 12 hours at room temperature to give 17 - testosterone - tethered - 17 - demethoxy - 17 - gm as a purple solid . the corresponding reaction using herbimycin a in place of geldanamycin proceeds the same way , albeit somewhat more slowly , to produce two products coupled to the spacer at the 17 and 19 positions in a ration of approximately 3 : 4 . fig5 shows the synthesis of an alkylaminoestradiol / gm compound in accordance with the invention . the synthesis is substantially the same as the testosterone synthesis , except that a different protecting group , i . e ., a benzyl group , is used on the phenolic hydroxy . fig6 shows a synthetic approach to making tamoxifen ( tmx ) tethered to gm with a spacer moiety . in this case gm is reacted with aziridine to produce a novel gm analog 17 - aziridino - 17 - demethoxygeldanamycin . this compound is reacted with cyanogen iodide ( icn ) in refluxing methylene chloride to produce 17 -( n - iodoethyl - n - cyano )- 17 - demethoxygm . this gm analog has been found to bind to hsp 90 as well as gm itself and is readily radiolabeled during synthesis through the use of radiolabeled icn . the radiolabeled compound can be used in binding studies in place of geldanamycin . corresponding 17 -( n - iodoalkyl - n - cyano ) compounds can be made by using azetidine ( 3 carbons ), pyrrolidine ( 4 carbons ) etc . in place of aziridine . again , the same reaction can be used with herbimycin a , although a mixture of 17 - and 19 - substituted products is produced . a further example of a compound in accordance with the invention is gm linked to the pi - 3 kinase inhibitor wortmannin . in this case , an unsymmetrical diamine linker having a primary and a secondary amine is preferably used as the spacer . this is the case because the primary amine adds most quickly at the 17 - position of gm , while the secondary amine reacts with the 21 - position of the wortmannin furan ring to produce a product with the e orientation which has been shown to be more active than the z orientation which is obtained upon reaction with a primary amine . the unsymmetrical amine linker is prepared starting with 6 - bromo - 1 - hexanol as shown in fig7 a . displacement of the bromine with methylamine in thf followed by protection of the secondary amine provides an intermediate alcohol which is converted to the azide using dppa , dead and pph 3 . reduction of both the azido group and the benzyloxycarbonyl using pd / c affords the 6 - carbon unsymmetrical diamine . the unsymmetrical diamine is combined with gm in chcl 3 to produce the intermediate gdn - diamine compound as shown in fig7 b . this compound is then reacted with wortmannin to produce the final wortmannin - tethered gm . it will be appreciated by persons skilled in the art that these synthetic methodologies are easily adapted to other targeting moieties and to spacers of different lengths and compositions . all that is required is the presence of a reactive group in the targeting moiety which can be converted to an alkylamine or which will react with a primary or secondary amine which is part of a spacer previously attached to the ansamycin antibiotic . as show in fig3 testosterone - tethered gm was prepared by reacting gm with a 17 - alkylamino testosterone . the 17 - alkylamino testosterone was prepared by adding octynyl tether in a convergent manner to monoprotected testosterone dione . the latter was prepared in two steps , according to literature procedures . the tether was synthesized starting from commercially available 6 - bromohexanol . 6 - bromohexanol ( 3 g , 16 . 6 mmoles ) in 33 ml of anhydrous dmf , under argon atmosphere , was treated with imidazole ( 2 . 72 g , 40 mmoles ) and the resulting homogeneous solution was cooled down to 0 ° c . then it was treated with tbscl in 12 ml of dmf . temperature was then allowed to warn up gradually to the ambient while reaction evolution was monitored by thin layer chromatography ( tlc ), silica gel ( sio 2 ) using ethylacetate ( etoac )- hexane ( hex ): 1 - 2 ( v / v ). after 2 hours at room temperature ( rt ) no starting material remained , and the reaction mixture was partitioned between water and etoac . after decantation , the aqueous layer was extracted with etoac thrice , and the combined organic layers were washed twice with h 2 o , and brine , dried over mgso 4 , and concentrated under reduced pressure . the resulting yellowish oil was purified by short path silica gel column chromatography using etoac - hex : 1 - 4 as eluent to afford the desired silylether ( 4 . 4 g , 90 % yield ) as a colorless oil . lithium acetylide ethylene diamine complex ( 0 . 65 g , 6 mmoles ) was added portionwise to anhydrous dmso under inert atmosphere . the resulting not completely homogeneous dark brown mixture was cooled down to approximately 5 ° c ., temperature at which the bromosilyl ether was introduced dropwise over 5 minutes . the cold bath was removed and reaction evolution was monitored by nmr of a quenched aliquot . after 5 hours at rt ( usually an hour is enough ) no starting material remained . the content of the flask was poured carefully into an erlenmeyer flask containing ice . this was extracted with etoac thrice , and the combined organic layers were washed three times ( 3 ×) with water and once with brine . brief drying over mgso 4 , and removal of the volatiles under reduced pressure gave a yellow oil . purification by short path silica gel column chromatography , using etoac - hex : 1 - 19 , gave 0 . 88 g ( 92 % yield ) of the desired true alkyne as a colorless oil . a solution of the alkyne ( 80 mg , 0 . 33 mmole ) in 1 ml of thf was cooled down to − 78 ° c . under argon , and it was treated with 0 . 22 ml of a 1 . 6 molar solution of n - butyl lithium in hexane . this was then warmed up to the ambient temperature for 20 minutes , then brought back to − 78 ° c ., temperature at which 0 . 2 ml of freshly distilled hexamethylphosphoramide ( hmpa ) was added , followed by monoprotected 17 - ketotestosterone ( 80 mg , 0 . 24 mmole ) as a suspension in 0 . 5 ml of thf . after an overnight stirring period at room temperature , the reaction was quenched with saturated ammonium chloride , decanted and extracted with etoac ( 3 ×). the combined organic layers were washed with brine , dried over mgso 4 , and concentrated under reduced pressure to give a light brown oily solid . column chromatography on a short path sio 2 column , using etoac - hex : 1 - 9 gave the desired alcohol ( 50 mg , 36 % yield ) as a colorless oil . the silylether ( 50 mg , 0 . 088 mmole ) was diluted in 2 ml of anhydrous thf under argon . the resulting colorless solution was cooled down to 0 ° c ., and it was treated with a one molar solution of tetrabutyl ammonium fluoride ( 115 microliters , 1 . 15 mmoles ), and the cold bath was removed . after 3 hours at room temperature , no starting material remained . thf was removed under reduced pressure , and the residual brown oil was diluted in minimum chloroform and loaded on a short path sio 2 column and eluted with etoac - hex : 1 - 2 to 1 - 1 . this 34 mg ( 85 % yield ) of the alcohol as a colorless oil . at 0 ° c ., the diol ( 34 mg , 0 . 0745 mmole ) in 0 . 5 ml of methylene chloride , was treated with triethylamine ( 22 . 6 mg , 31 microliters , 0 . 22 mmoles ) followed by mesylchloride ( 12 . 8 mg , 8 microliters , 0 . 11 mmoles ). after half an hour at this temperature no starting material remained . the reaction mixture was then concentrated to dryness under vacuum , and it was dissolved in 2 ml of anhydrous dmf and then added with an excess ( about 5 equivalents ) of sodium azide and the resulting suspension was allowed to stir at room temperature for an overnight period . this was then partitioned between etoac and h 2 o . after decantation , the aqueous layer was extracted with etoac ( 3 ×), then the combined organic layers were washed with water then brine , dried over mgso 4 , and concentrated under reduced pressure to leave a colorless oil . the desired azide 23 mg ( 64 % yield for 2 steps ) was isolated by short path sio 2 column , using etoac - hex : 1 - 4 as eluent . the azido acetal ( 11 mg , 0 . 0228 mmole ) in 2 ml of methanol was treated with 0 . 5 ml of 1 . 0 normal hydrochloric acid , at rt . for 3 hours . ph was made alkaline ( 7 - 8 ) by careful addition of saturated sodium bicarbonate , and methanol was removed under vacuum . the remaining white oily solid was extracted with chcl 3 until tlc indicated no organic material was present in the aqueous phase . the combined organic layers were dried briefly over mgso 4 , and evaporated under vacuum to give an oily solid film . this was dissolved in minimum chcl 3 , and loaded on a short sio 2 plug and eluted with etoac - hex : 1 - 4 . this gave 9 mg ( 90 % yield ) of the desired azido enone as a colorless film . at room temperature , the azide ( 33 mg , 0 . 0755 mmole ) in 1 ml of anhydrous thf , was treated with 0 . 23 ml ( 0 . 23 mmole ) of a 1 . 0 molar solution of triethylphosphine in thf . reaction evolution was monitored by tlc ; sio 2 , etoac - hex : 1 - 1 . within 1 hour , the reaction was over . this was then treated with 0 . 23 ml of water and stirring was continued for overnight period . the slightly yellowish reaction mixture was evaporated to dryness , under high vacuum to yield a yellowish film . this taken in h 2 o and ether while ph was made basic with concentrated ammonia . following decantation , the aqueous phase was extracted thrice with ether , and the combined organic layers were in turn extracted three times with 1 . 0 n hcl . the combined hcl extracts were then brought to basic ph with ammonia , and extracted with chcl 3 until the aqueous phase gave a negative ninhydrin test . the combined chloroform layers were then dried briefly over mgso 4 , and concentrated under reduced pressure to give a yellowish film ( 24 . 6 mg ). testosterone - gm product was obtained by reacting geldanamycin ( 5 . 6 mg , 10 micromoles ) with crude 17 - alpha -( 8 - amino - 1 - octynyl )- testosterone ( 24 . 5 mg , 60 micromoles ) in 0 . 5 ml of anhydrous dmso at room temperature , and in the dark . after 12 hours , the initially yellow solution turned deep purple . the reaction mixture was then partitioned between chcl 3 and h 2 o . following decantation , the aqueous phase was extracted with chcl 3 ( 5 ×). the combined organic layers were then washed with water ( 3 ×), dried over freshly ground sodium sulfite , filtered and evaporated under reduced pressure . the residual oil ( contains dmso ) was loaded on a short sio 2 plug and the desired material was purified using the gradient elution system , methanol 2 to 10 % in chloroform . this gave the desired drug ( 3 . 4 mg , 36 % yield ) as a purple solid . a prostate cancer cell line ( ln - cap ) was exposed in culture medium to geldanamycin alone at levels of 0 . 25 and 1 ug / ml and to testosterone tethered gm ( gm - t ) synthesized as in example 1 . the cells were monitored by immunoblotting for the presence of erbb2 a tyrosine kinase which is known to be degraded as a result of exposure to gm and for the presence of androgen receptors . all three treatments reduced the levels of erbb2 over time , but the least reduction was observed for cells treated with gm - t . ( fig8 a ) in contrast , the greatest reduction in the amount of androgen receptors was observed in the cells treated with gm - t . ( fig8 b ). thus , the gm - t exhibited the desired targeting and specificity for androgen receptors . as shown in fig5 the synthesis is to a large extent similar to that of testosterone tethered gm , though improvements are under way at this time . tertiary butyldimethylsilyloxy estrone was condensed with the dilithium anion of 1 - hexyne - 6 - ol in thf at − 78 ° c . to afford the corresponding 17 -( 1 - hydroxy hexynyl ) estradiol in moderate yield . mesylation , azide displacement , deprotection of the phenolic alcohol , and reduction of the azide into the primary amine gave the desired intermediate for coupling with gm . this was done in dmso at rt ., in the dark to afford a new 6 carbon tethered gm to estradiol . the 8 carbon tethered analog was done in the same manner as for testosterone . an estradiol - geldanamycin hybrid with a 4 - carbon tether containing a double bond ( fig9 c ) was synthesized as shown in fig1 . amine ( 40 mg , prepared from the published procedure by katzenellenbogen et al . j . org . chem . ( 1987 ) 52 , 247 .) was dissolved in 1 ml of dmso and 20 mg of geldanamycin was added . the mixture was allowed to stir overnight , concentrated in vacuo and purified by chromatography on silica gel to afford a purple solid . this material ( 17 mg ) was then dissolved 1 . 5 ml of thf and 2 drops of acoh followed by 0 . 02 ml of tbaf ( tetra - n - butyl ammonium fluoride , 1 . 0 m in thf ) was added and the mixture was allowed to stir overnight . the reaction mixture was then concentrated and purified by chromatography on silica gel to afford 13 mg of the hybrid as a purple film . the activity of this compound was compared with the activity of other gm - estradiol compounds as shown in fig9 f and 9g . the effects of these compounds on receptor of various types were evaluated by exposing mcf - 7 breast cancer cells , in vitro , to 1 μm levels of the compounds for varying periods of time , and then testing for the presence of the receptor using receptor - specific antibodies in an immunoblotting experiment . the results are summarized in table 1 , where gm - 4 - e2 indicates a geldanamycin - estradiol compound with a 4 - carbon tether . a + in the table indicates that the receptor was detected by immunoblotting , a − indicates that it was not detectable , and a ± indicates a weak or equivocal result . the results show that compounds with longer tethers are less active , although whether this is a function of tether length or the different substitution position in the estradiol has not been determined . nevertheless , all of the compounds in accordance with the invention show increased selectivity for estrogen receptors and erbb2 receptors compared to geldanamycin alone . this selectivity is most pronounced in gm - 4 - e2 . the immunoblotting experiment of example 4 was repeated using just geldanamycin and gm - 4 - e2 , but including insulin - like growth factor 1 receptor ( igf1 - r ) in the panel of proteins tested for . the results are summarized in table 2 . the same pattern of activity is observed , with gm - 4 - e2 being less injurious to igf1 - r than geldanamycin alone . the immunoblotting experiment of example 4 was repeated using a prostate cancer cell line , lncap , to determine the affect of gm - 4 - e2 on androgen receptors . the results are summarized in table 3 . geldanamycin alone destroys these receptors , gm - 4 - e2 does not . the compounds of fig9 a - 9g have been tested for activity with respect to erbb2 ( her2 ), raf - 1 and estrogen receptors . the relative activities are summarized in table 4 , where ++++ is most active and − is minimal activity . we have decided to use the amino group of tamoxifen as not only a potential entity for connection with a halide ( preferably an iodide — to accommodate for the safety of gm during the quaternization of the amine — that could be changed at will into another halide , cl , br , or another counter ion on an ion exchange resin ), but also to further increase the water solubility of the analog by creating a charge in the tether . to do so we required a gm analog with a primary iodide . this was not an easy task , since iodoalkylamines are not stable and could not be used in a single step type of strategy . usually , one has to use the aminoalcohol and introduce the iodide later , which is not compatible with the presence of gm . we have found that the von braun reaction on a cyclic amine could lead to that precise iodoalkylamine connected to gm in good yield . synthesis of the aminogm : at room temperature , gm ( 10 mg , 17 . 85 micromoles ) was dissolved in 1 ml of chloroform . the resulting yellow solution was treated with aziridine ( 100 mg ) in 1 ml of chcl 3 . this was allowed to stir in the dark for 2 hours . the reaction became orange , and the whole reaction mixture was loaded on a short path silica gel column , and the desired material ( 10 mg , 98 % yield ) was isolated as an orange solid . azetidine can be used in place of aziridine to make a longer tether . azetidine can be made following the literature procedure ( r . c . schnur , et al , j . med . chem ., 38 , 3806 , 1995 ). similarly 5 . 6 mg ( 10 micromoles ) of gm were reacted with 30 microliters of pyrrolidine in 0 . 5 ml of chloroform to give after an hour at room temperature 5 mg ( 83 % yield ) of the 17 - demethoxy - 17 - pyrrolidino gm as a deep purple film . synthesis of 17 - n - iodoalkyl - n - cyanogm analogs : in a typical experiment , 2 . 5 mg ( 4 . 38 micromoles ) of 17 - aziridino gm were dissolved in 0 . 25 ml of anhydrous 1 , 2 - dichloroethane . the resulting orange solution was treated with cyanogen iodide ( 3 mg , 19 . 6 micromoles ), and the reactivial was sealed with a teflon cap . temperature was then brought up to 65 - 70 ° c . for 12 hours in the dark . the reaction mixture became light purple . this was loaded on a short silica gel plug and the desired material 3 mg ( 94 % yield ) was isolated as a light purple film , using methanol 5 - 10 % in chloroform gradient elution system . similarly 5 mg ( 8 . 34 micromoles ) of 17 - pyrrolidino gm were reacted with 4 equivalents of cyanogen iodide in 1 , 2 - dichloroethane at 65 ° c . for 36 hours to give 5 mg ( 80 % yield ) of the iodobutyl analog . synthesis of tamoxifen tethered gm analogs : in atypical experiment , 3 mg ( 4 . 14 micromoles ) of 17 - n - iodoethyl - n - cyanogm were dissolved in 0 . 5 ml of anhydrous acetonitrile under argon atmosphere . the resulting purple solution was treated with 1 . 6 mg ( 4 . 14 micromoles ) of tamoxifen . this gave a suspension that was sealed in a reactivial and heated up to 75 ° c . for 18 hours . reaction evolution was monitored by tlc , sio2 , using 10 % methanol in chloroform . the lightly purple color reaction mixture was then cooled down to 0 ° c ., and filtered while cold . the product was washed with cold acetonitrile into a light purple solid . the product from the n - iodobutyl analog required higher temperature ( refluxing benzene for 12 hours ). starting with herbimycin a in place of the geldanamycin and reacting with aziridine , azetidine , pyrrolidine as in example 7 would give the corresponding 17 - and 19 - amino herbimycin a compounds . these are separated by silica gel chromatography . the action of cyanogen iodide on these compounds provides the corresponding 17 - n - cyano - n - iodoalkylamine and 19 - n - cyano - n - iodoalkylamine herbimycin a . their reactions with tamoxifen under the same conditions as for gm leads to the corresponding ammonium salts of tamoxifen . primary diamine : to a solution of geldanamycin ( 3 mg , 0 . 0053 mmol ) in 0 . 5 ml of chcl 3 was added 6 . 2 mg ( 10 eq .) of hexamethylenediamine in the dark for 1 hr . the reaction mixture was then washed with 4 × 500 ul of water and concentrated under high vacuum for 30 minutes to afford a purple solid . this material was dissolved in 0 . 25 ml of ch 2 cl 2 and 2 . 2 mg ( 0 . 0053 mmol ) of wortmannin was added in the dark at room temperature . after two hours the brown - orange reaction mixture was applied directly to chromatography on silica gel eluting with 5 % meoh in ch 2 cl 2 to afford 1 . 5 mg ( 27 %) of the geldanamycin - wortmannin hybrid as a yellow - brown film . unsymmetrical primary / secondary diamine : 6 -( n - methyl - n - carbobenzyloxyamino )- hexan - 1 - ol was synthesized as follows . to a solution of 6 - bromo - hexan - 1 - ol ( 2 . 0 g , 17 . 4 mmol ) was added 50 ml of a 2 . 0 m solution of methylamine (˜ 10 eq .) in thf and the reaction was allowed to stir overnight . the reaction mixture was diluted with 30 ml of ether , filtered , and concentrated . the crude material was then diluted in 30 ml of ether and 50 ml of saturated nahco 3 solution . carbobenzyloxychloride ( 2 . 5 g , 51 mmol ) was then added and the reaction mixture was stirred vigorously for 2 hours . the reaction was then diluted with 100 ml of ether , washed with brine , dried over mgso 4 , filtered and concentrated . silica gel chromatography ( 10 - 50 % etoac : hexanes ) afforded 3 . 1 g ( 76 %) of product as a clear oil . 6 - azido - 1 -( n - methyl - n - carbobenzyloxyamino ) was then synthesized by forming a solution of the alcohol ( 1 . 52 g , 6 . 4 mmol ) with triphenylphosphine ( 2 . 18 g , 8 . 3 mmol ), and diethylazidodicarboxylate ( 1 . 45 g , 8 . 3 mmol ) in 20 ml of thf and adding diphenylphosphorylazide ( 1 . 79 ml , 8 . 3 mmol ) dropwise over 15 minutes and the reaction was allowed to stir overnight . the reaction mixture was concentrated and purified via silica gel chromatography ( 10 - 30 % etoac : hexanes ) to afford 1 . 07 g ( 75 %) of a white - yellow solid . 6 - amino - 1 -( n - methylhexylamine ) was synthesized from the azide as follows . a solution of the azide 750 mg ( 2 . 25 mmol ) and 100 mg of 10 % pd / c in 5 ml of meoh was hydrogenated under 20 psi of h 2 at 45 ° c . for 48 hours . the reaction mixture was filtered through celite and concentrated to afford the diamine as a yellow oil . this material is used to prepare a geldanamycin - wortmannin hybrid using the procedure described above for primary diamines . wortmannin analogs were prepared with the tether linked to the amino group of the opened furan in either of two isomeric orientations , and these were designated as z - analog 1 and an e - analog 2 as shown in fig1 . each of these compounds was coupled to geldanamycin to form hybrid compounds in accordance with the invention ( see , fig1 ). these compounds were tested for inhibition of pi3 kinase activity . the results are summarized in fig1 . as is known from the art , wortmannin alone inhibits pi3 kinase activity , as does the e - analog 2 . the z - analog 1 , however is inactive , as is geldanamycin alone . surprisingly , however , substantial pi3 kinase inhibition is observed for both hybrid compounds . thus , a hybrid compound formed from two inactive species is capable of providing significant inhibition of pi3 kinase , substantiating the belief that the mechanism of action of the compounds of the invention is not a simple interaction of one portion of molecule with a normal target , but rather a synergistic interaction in which both parts of the hybrid molecule play an important role . further , these results establish the effectiveness of the compounds of the invention against targets which are not normally subject to degradation by geldanamycin .

compounds having an ansamycin anitibiotic , or other moiety which binds to hsp90 , coupled to a targeting moiety which binds specifically to a protein , receptor or marker can provide effective targeted delivery of the ansamycin antibiotic leading to the degradation of proteins and death of the targeted cells . these compositions may have different specificity than the ansamycin alone , allowing for a more specific targeting of the therapy , and can be effective in instances where the ansamycin alone has no effect . thus , these compounds provide an entirely new class of targeted chemotherapy agents with application , depending on the nature of the targeting moiety , to treatment of a variety of different forms of cancer . such agents can further be used to promote selective degradation of proteins associated with the pathogenesis of others diseases , including antigens associated with autoimmune disorders and pathogenic proteins associated with alzheimer &# 39 ; s disease . exemplary targeting moieties which may be employed in compounds of the invention include testosterone , estradiol , tamoxifen and wortmannin .

in order to cater for the desired wide selection of good - quality beverage types , having different characteristics , the present invention involves one or more significant improvements to known beverage preparation machines . the beverage machine may comprise a soda fountain , beer pump , or the like . the present invention enjoys particular benefit when used with beverage preparation machines for preparing hot beverages like coffee , tea , hot chocolate and hot milk . in particular , the improvements provided by the present invention enable the production of good quality espressos with a high - quality crema , yet provide a design that is easy to keep clean and hygienic , and that is capable of providing other high - quality beverages . the improvements will be described with reference to a known beverage preparation machine 10 that is illustrated in fig1 to 7 of the accompanying drawings . it should be noted , however , that the improvements find application in a wide range of beverage preparation machines which may or may not be capable of using a wide range of cartridges which , as noted above , include pods , pads , rigid and semi - rigid cartridges . the beverage preparation machine 10 of fig1 to 3 generally comprises a housing 11 , a tank 12 , a water heater 13 , a pump 14 , a control processor ( not shown ), a user interface 16 and a cartridge head 17 . the cartridge head 17 in turn generally comprises a cartridge holder 18 for holding , in use , a beverage cartridge 19 and cartridge recognition means 20 . the cartridge head 17 further comprises inlet and outlet piercers 21 , 22 for forming in the beverage cartridge 19 , in use , an inlet for liquid to enter the cartridge 19 and an outlet for the prepared beverage to exit the beverage cartridge 19 . beverage leaving the cartridge 19 through the outlet exits the machine 10 from a nozzle piece 70 . although water is likely to be the most common liquid used in preparing beverages such as coffee , the machine 10 is also capable of handling other liquids , such as milk or milk preparations , for mixing with the beverage ingredients . any references herein to water should also be taken to include any form of liquid used in preparing beverages . the housing 11 is preferably made in whole or in part from a suitable plastics material or metal . the housing 11 preferably comprises a clam - shell design having a front half 25 and a rear half 26 which allow access during assembly for fitting of the machine 10 components . the front half 25 of the housing 11 defines a dispensing station 27 where dispensation of the beverage takes place from the nozzle piece 70 . the dispensing station 27 includes a cupstand 23 with a drip tray located beneath . the machine user interface 16 is also located on the front of the housing 11 and comprises a plurality of control switches , for example , a start / stop button 28 , and a number of status indicators 29 - 32 . the status indicators 29 - 32 are preferably light emitting diodes ( led ) which , for example , indicate readiness of the machine 10 , whether an error has occurred in the machine 10 operation , and the mode of operation of the machine 10 . the start / stop button 28 controls commencement of the dispense cycle and is preferably a manually operated push - button , switch or similar . the tank 12 is located to the rear of the housing 11 and is preferably incorporated in , or connected to , the rear half 26 of the housing 11 . the tank 12 has an inlet for filling the tank 12 with water , or other liquid , which is closed off when the tank 12 is in position in the machine 10 . an outlet is provided towards a lower end of the tank 12 which communicates with the pump 14 . the tank 12 may be made from a transparent or translucent material to allow a consumer to view the quantity of water remaining in the tank 12 . alternatively , the tank 12 may be made from an opaque material but have provided a viewing window therein . in addition , or in place of the above , the tank 12 may be provided with a low level sensor which prevents operation of the pump 14 and optionally triggers a warning indicator , such as an led , when the liquid level in the tank descends to a preselected level . the pump 14 is operatively connected between the tank 12 and the water heater 13 , and is controlled by the control processor . the flow rate of water through the machine 10 can be controlled by the control processor . a volumetric flow sensor ( not shown ) is preferably provided in the flow line either upstream or downstream of the pump 14 . the heater 13 is located in the interior of the housing 11 . the water for the dispense cycle is delivered to the cartridge head 17 at a predetermined temperature . the heater 13 is able to adjust quickly the delivery temperature to the required temperature , generally between 80 ° c . and 98 ° c ., and possibly higher from the incoming water temperature . the heater 13 comprises an over - temperature cut - off which shuts off the heater 13 if the temperature exceeds 98 ° c . where desired , the machine 10 can incorporate a steam purge . the preferred means of generating the steam purge is to utilise a water heater 13 in the form of a flash heater ( also known as an instantaneous or flow heater ). typically such flash heaters comprise a tube through which the water passes wherein the tube is heated by one or more resistive elements . the flash heater can be used not only for heating water for forming beverages but also , at higher power settings , for generating a steam purge by boiling off water remaining with the flash heater tube after the beverage has been formed . an advantage of flash heaters is that there is no significant delay whilst water in a boiler heats up . flash heaters heat water on demand and switch off immediately after each brewing cycle and are therefore very energy efficient . water output from the heater 13 is fed via a suitable delivery system to the cartridge head 17 and cartridge 19 by means of a valve . if the pressure of the water flow is acceptable , the water is passed to the cartridge 19 . if the pressure is below or above predetermined limits then the water is diverted by means of the valve to a waste recovery receptacle . the delivery system comprises conduits that connect the tank 12 , the water pump 14 , the water heater 13 and the cartridge head 17 ( as shown in fig8 ) to transport the water from the tank 12 to the cartridge 19 . the cartridge holder 18 is designed to be capable of handling the opening forces generated by the pressure inside the cartridges 19 , which is around 250 kg for espresso beverages . during operation of the machine 10 the cartridges 19 attempt to expand , but the integrity of the cartridges 19 must be maintained . in addition the user must not be able to open the holder 18 whilst the system is pressurised and suitable locking mechanisms are provided to achieve this . one suitable design of cartridge head 17 , as described in wo - a - 2006 / 014936 , is shown in fig4 to 7 . the cartridge holder 18 of the cartridge head 17 comprises a fixed lower part 43 , a rotatable upper part 44 and a pivotable cartridge mount 45 positioned between the fixed lower part 43 and the rotatable upper part 44 . the upper part 44 , lower part 43 and cartridge mount 45 are rotated about a common hinge axis 46 . fig4 to 7 show the holder 18 with some components of the machine 10 omitted for clarity . the cartridge mount 45 is provided with a substantially circular recess 55 which receives in use the beverage cartridge 19 . the recess 55 includes an irregularity 56 for accommodating a handle portion of the beverage cartridge 19 which also acts to prevent rotation of the beverage cartridge 19 in the holder 18 . the cartridge mount 45 is sprung relative to the fixed lower part 43 such that in the open position , as shown in fig7 , the cartridge mount 45 is biased out of contact with the fixed lower part 43 . the cartridge mount 45 then moves out of contact with the outlet and inlet piercer members 21 , 22 . the cartridge mount 45 is provided with an aperture 57 for receiving there through the inlet and outlet piercers 21 , 22 and a head of the cartridge recognition means 20 when the cartridge mount 45 is moved into the closed position . the upper part 43 comprises a generally circular body 58 housing a circular viewing window 59 through which a consumer can view the beverage cartridge 19 during a dispense cycle and can also confirm visually whether a cartridge 19 is loaded in the machine 10 . the viewing window 59 is cup - shaped having a downwardly directed rim . in addition , the viewing window 59 is provided with a clamping member in the form of an inwardly directed tubular extension 61 as shown in fig7 . the extension 61 is directed towards the lower part 44 and lies within the volume of the cartridge head 17 when in the closed position as shown in fig6 . when the cartridge holder 18 is in the closed position , a distal end 62 of the tubular extension 61 of viewing window 59 bears against the clamping surface 19 a of the beverage cartridge 19 biasing it against the lower part 44 as shown in fig6 ( in which the arrangement is illustrated containing a cartridge 19 having a greater depth ). the pressure exerted by the tubular extension 61 ensures a fluid tight seal between the cartridge 19 and the holder 18 . the lower part 43 comprises the inlet and outlet piercers 21 , 22 and the head of the cartridge recognition means 20 . the inlet piercer 21 comprises a hollow needle - like tube having a sharpened end for perforating a laminate of the beverage cartridge 19 in use . the inlet piercer 21 is in fluid communication with a water conduit 65 , as shown in fig7 , which passes through the lower part 43 and is connected to an outlet conduit 66 of the water heater 13 . the outlet piercer 22 is similar in type to the outlet piercer described in the ep - a - 0389141 and ep - a - 0 334572 . an arcuate portion 67 of the upper end of the outlet piercer 22 is serrated to pierce and eventually cut the laminate of the beverage cartridge 19 . the remainder of the upper end is cut back longitudinally of the cylinder at least to the base of the teeth of the serrated portion , as shown at 68 , to fold or pull the cut laminate away from the outlet aperture before the beverage is dispensed there through . advantageously , the outlet piercer 22 is removable from the lower part 43 to enable it to be thoroughly cleaned , for example , in a dishwasher . the removable outlet piercer 22 is received in a recess in the lower part 43 where it is seated . the inlet piercer 21 and / or the outlet piercer 22 may be made of a metal , such as stainless steel , or from a plastics material . preferably , the inlet piercer 21 and the outlet piercer 22 are formed as a single , integral unit which is removable from the lower part 43 . in use , the upper part 44 of the holder 18 is movable from an open position in which it is orientated vertically or towards the vertical as shown in fig2 , to a closed position in which it is orientated substantially horizontally and in interengagement with the fixed lower part 43 and cartridge mount 45 . to close the upper part 44 , a user takes hold of it and pulls downwards . consequently , the upper part 44 rotates which first brings the tubular extension 61 of the viewing window 59 into contact with the clamping surface 19 a of the beverage cartridge 19 . continued rotation of the upper part 44 rotates the upper part 44 and cartridge mount 45 down into contact with the lower part 43 . with the upper part 44 closed , the piercer 22 has formed the outlet through the laminate provided in the cartridge 19 . the outlet piercer 22 has a hollow centre 22 a that extends downwardly through the fixed lower part 43 to communicate with the internal bore 71 of the nozzle piece 70 . as can be seen best in fig6 and 7 , a conduit extends from the outlet piercer 22 to the base of the nozzle piece 70 . the nozzle piece 70 is provided with a central dispensing passage 72 and a peripheral air inlet passage 73 . the entrance to the central dispensing passage 72 is positioned directly beneath the centre of the outlet piercer 22 such that beverage flowing from the cartridge 19 falls through the central dispensing passage 72 and out of the nozzle piece 70 . the air inlet passage 73 extends from the base of the nozzle piece 70 to the top of the nozzle piece 70 where it meets the base of the outlet piercer 22 . thus , air may be drawn up and to the cartridge 19 . the cartridge 19 may be designed to cause air to become entrained in the flow of beverage as it exits the cartridge 19 . for example , the cartridge 19 may include a venturi passage or other feature that causes air to become entrained in the flow of beverage . in this case , the air inlet passage 73 allows the air to be drawn up to the cartridge 19 for entrainment . where a foam is not desired , the cartridge 19 is designed such that air is not entrained . for example , the cartridge 19 may lack an inlet that is otherwise required to admit an air flow provided by the air inlet passage 73 . further details of such cartridge designs can be found in ep - a - 1440903 . while the airflow is important in forming the desired crema in drinks like espresso coffee , and foams in other beverages such as hot chocolate or milk , in practice it has been found that beverage may also flow down the air inlet passage 73 and then from the nozzle piece 70 . this flow of beverage has several disadvantages . the flow of beverage impedes the flow of air up the air inlet passage 73 to the detriment of the quality of the crema produced . also , the flow of beverage down the air inlet passage 73 necessitates that the passage 73 be cleaned regularly , an operation that is hampered by the fact that the air inlet passage 73 is generally much smaller than the central dispensing passage 72 . control of the brew cycle is effected by the control processor of the beverage preparation machine 10 , the central processor comprising a processing module and a memory . the control processor is operatively connected to , and controls operation of , the heater 13 , pump 14 , user interface 16 , and other components described below . the operational behaviour of the machine 10 is determined by software embedded in the control processor , for example as described in ep - a - 1440644 . the memory of the control processor includes one or more variables for one or more operational parameters for the beverage preparation machine 10 . in the prior art machines these are generally the temperature of the liquid passed through the beverage cartridge 19 during the operating stage , the speed of charging the beverage cartridge 19 , the presence or otherwise of a soak step , the total dispensed volume of the beverage , the flow rate of the liquid during the discharge stage , and the period of the purge stage . one purpose of the cartridge recognition means 20 is , inter alia , to allow the machine 10 to recognise the type of beverage cartridge 19 that has been inserted and to adjust one or more operational parameters accordingly . the variables for the operational parameters are stored in the memory . the cartridge 19 comprises a code provided on or in the cartridge 19 representing the operational parameters required for optimal dispensation of the beverage in that cartridge 19 . an example of the code is described in ep - a - 1440644 . the control processor memory further stores information on the type of beverage dispensed so that the operating cycle of the machine 10 may be adjusted for the next cartridge 19 . this is especially advantageous where two or more beverage cartridges 19 are used sequentially to form a beverage . for example a coffee cartridge may be used followed by a milk cartridge to form a cappuccino beverage . alternatively a chocolate cartridge could be used followed by a milk cartridge to produce a creamy hot chocolate beverage . by using a memory that stores information on the first beverage dispensed , the manner of dispensing the second cartridge , say a milk cartridge , may be altered to achieve an optimum beverage . in the above example the milk dispensed for hot chocolate may , typically , be diluted less than the milk added to the coffee . in addition , the milk dispensed for chocolate may be dispensed at a slower flow rate to lessen the degree of foaming of the beverage . many combinations of cartridges are possible and operating parameters as will be obvious to the skilled person . in addition , the memory may be used to allow the machine 10 to ‘ predict ’ the type of beverage that a user will next want to dispense . for example , if a user predominantly drinks one beverage type then the machine can instruct the water heater to remain at the optimum temperature for that beverage type . operation of the known prior art machines 10 comprises insertion of a beverage cartridge 19 into the cartridge head 17 , carrying out a dispense cycle in which the beverage is dispensed , and removal of the cartridge 19 from the machine . to insert the cartridge 19 , the cartridge holder 18 is opened as described above to expose the cartridge mount 45 . the cartridge 19 is then placed on the cartridge mount 45 received within the recess 46 . the cartridge holder 18 is then closed as described above . during closure the inlet and outlet piercers 21 , 22 pierce the cartridge 19 to form the cartridge inlet and outlet . to commence the dispense cycle , the user operates the start / stop button 28 . the operating cycle comprises the steps of cartridge recognition and the beverage preparation cycle . cartridge recognition is performed by the optical cartridge recognition means 20 as described . once the barcode has been decoded the operational parameters of the machine 10 are adjusted by the control processor . the preparation cycle is then automatically commenced . the preparation cycle has four main stages , although not all of these are used for all beverage types : in the pre - wet stage the cartridge 19 is charged with liquid from the storage tank 12 by means of the pump 14 . the charging with water causes the beverage ingredients in the cartridge to be wetted . the charging may take place at a “ fast ” flow rate of 600 ml / min or a “ slow ” flow rate of 325 ml / min . the slow charging rate is particularly useful for cartridges 19 containing viscous liquid beverage ingredients where the ingredients require some dilution before they are able to be pumped at a higher volume flow rate . the volume of liquid injected into the cartridge 19 is selected to ensure that liquid or beverage does not drip out of the cartridge outlet during this stage . the pause stage allows the beverage ingredients to soak in the liquid injected during the pre - wet stage for a predetermined period of time . both the pre - wetting and soaking stages are known to increase the yield of the extractibles from the beverage ingredients and to improve the end flavour of the beverage . pre - wetting and soaking are particularly used where the beverage ingredients are roast and ground coffee . in the dispense stage , liquid is passed through the cartridge 19 in order to produce the beverage from the beverage ingredients . the temperature of the liquid is determined by the control processor which sends instructions to the heater 13 to heat the liquid passing from the tank 12 to the cartridge head 17 . liquid enters the cartridge holder 18 via an inlet valve and the inlet piercer and then passes into the beverage cartridge 19 . brewing and / or mixing of the beverage in the beverage cartridge 19 occurs , as described in ep - a - 1440644 , before the prepared beverage exits the cartridge outlet , optionally entrains air into the beverage flow from the air flow provided by air inlet passage 73 , flows through the central dispensing passage 72 of the nozzle piece 70 and is directed into a suitably placed receptacle in the dispensing station 27 . during the purge cycle the temperature of the water heater 13 is raised sufficiently high to convert the water remaining in the system to steam and the pressurised steam is blown through the beverage preparation machine 10 and the beverage cartridge 19 . this ensures that all beverage is dispensed and that the flow path is cleared ready for dispensing another beverage . the purge cycle may not commence immediately on cessation of the brew / mixing stage to allow for the majority of the fluid to clear the flow path . once the operating cycle has been completed , the machine automatically stops and the consumer removes the cartridge 19 by opening the cartridge holder 18 and manually removing and disposing of the cartridge 19 . alternatively , the machine 10 may be provided with an automatic ejection mechanism for removing the cartridge automatically on opening the cartridge holder 18 . an embodiment of the present invention is shown in fig8 to 12 . an outlet nozzle assembly 100 is shown that comprises a piercer plate 110 and an nozzle piece 120 , broadly corresponding to those shown in fig5 and 6 . however , the outlet nozzle assembly 100 is advantageously modified to provide an improved air inlet . the piercer plate 110 provides an inlet piercer 111 and an outlet piercer 112 on its topside . the piercers 111 , 112 are akin to the piercers 21 , 22 described previously . thus the outlet piercer 112 may penetrate a laminate provided in a cartridge 19 to form an outlet . the outlet piercer 112 has a hollow centre 113 that extends through the piercer plate 110 from topside 115 to the underside 116 . the outlet piercer 112 surrounds the hollow centre 113 on the topside 115 , and is surrounded by a skirt 114 on the underside 116 . the hole 113 forming the hollow centre increases in size from topside 115 to underside 116 and in fact curves smoothly such that the internal wall 117 of the hole 113 blends smoothly into the underside 116 of the piercer plate 110 , save for the skirt 114 . the skirt 114 is provided with four interruptions 118 , equally spaced around the skirt 114 at ninety degree intervals . the nozzle piece 120 is generally cylindrical with a hollow centre 121 . the top of the nozzle piece 120 is provided with a brim 122 from which a collar 123 extends . the collar 123 is sized to received the skirt 114 of the piercer plate 110 . the piercer plate 110 and nozzle piece 120 may be secured to one another in any convenient fashion , e . g . a snap - fit , a bayonet fitting , screw thread , etc . when joined , the hollow centre 113 of the piercer plate 110 and the hollow centre 121 of the nozzle piece 120 form a passage through which the exiting beverage flows . this passage widens , thereby forming a head space around the flow of beverage exiting the beverage machine 10 . the collar 123 of the nozzle piece 120 is provided with four gaps 124 of a corresponding size to the interruptions 118 provided in the skirt 114 of the piercer plate 110 . the gaps 124 are also equally spaced around the collar 123 at ninety degree intervals . when assembled , the interruptions 118 in the skirt 114 are aligned with the gaps 124 in the collar 123 . the piercer plate 110 and / or the nozzle piece 120 may have indexing means to ensure that the interruptions 118 and gaps 124 align when the outlet nozzle assembly 100 is assembled . when aligned in this way , the interruptions 118 and gaps 124 form air passages 102 between the central bore 104 of the outlet nozzle assembly 100 and atmosphere . the air passages 102 are formed in the widened portion of the passage , thereby admitting air into the head space around the flow of beverage . the air passages 102 extend from atmosphere just under the fixed lower part 44 of the cartridge head 18 , and allow air to be drawn into the nozzle piece 120 . where air is being entrained in the beverage being dispensed , air entering through the air passage 102 may be drawn up into the beverage machine 10 to the cartridge 19 where it is available for entrainment into the beverage being dispensed from the cartridge 19 through the outlet nozzle assembly 100 . this airflow may assist in the formation of a crema or other foam , as described above . in addition to providing an air flow to replace air being entrained in the beverage as it exits the cartridge 19 , the air passages 102 allow an airflow into the nozzle piece 120 to replace air drawn down through the nozzle piece 120 by the flow of beverage . this air flow is present even when dispensing beverages such as tea where air entrainment into the beverage is to be avoided . thus , positioning the air passages 102 in the head space around the beverage flow as it does not lead to entrainment of air into the beverage flow within the nozzle piece 120 . yet , where entrainment is required , an air flow into the beverage machine 10 is provided that may continue to the cartridge 19 where the air is entrained into the beverage flow . moreover , the passages 102 formed by the interruptions 118 and gaps 124 are formed at the top of the nozzle piece 120 such that flow of beverage into the air passages 102 is minimised . this is further aided by the widening of the hole 113 through the piercer plate 110 from the outlet piercer 112 to where it meets the nozzle piece 120 . as beverage does not flow through the air passages 102 , they will stay clean for far longer . in addition , cleaning the air passages 102 is straightforward . the piercer plate 110 need only be removed from the fixed lower part 44 and , optionally , the nozzle piece 120 may be removed from the piercer plate 110 , and then the interruptions 118 and the gaps 124 are easily cleaned . this is to be contrasted with the narrow elongate air inlet passage 73 of fig6 and 7 . moreover , adopting the arrangement of fig6 and 7 by removing the air inlet passage 73 from within the nozzle piece 70 enlarges the passage through the nozzle piece 70 . it will be evident to the person skilled in the art that modifications may be made to the embodiment described above without departing from the scope of the invention as defined by the appended claims . for example , the number of air passages 102 formed through the outlet nozzle assembly 100 may be varied from the four shown in fig8 to 12 . for example more or less may be used . the size and positioning of the air passages 102 may also be varied , and the sizes of the interruptions 118 and gaps 124 need not be the same . preferably , an even number of air passages 102 are formed as pairs that are aligned across the skirt 114 and collar 123 . the size of the skirt 114 and the collar 123 may also be varied . moreover , the sizes of the skirt 114 and collar 123 may be varied , or may be reversed such that the collar 13 of the nozzle piece 120 is received within the skirt 114 provided on the underside of the piercer plate 110 . there may not be a requirement for an outlet piercer 112 . for example , the present invention may be used with coffee percolators that dispense brewed coffee through a filter funnel into the outlet nozzle assembly 100 . indeed , the present invention may be used with many types of beverage preparation machines , including those that merely hold and dispense a beverage ( e . g . soda siphons , beer taps , etc .). of course , other types of beverage preparation are envisaged , such as brewing coffee and / or tea or heating beverages such as milk . the outlet nozzle assembly 100 may comprise further parts , e . g . devices for ensuring the quality of a foam produced with the beverage . these devices may be provided in the central bore 104 , for example surfaces that provide a flow interruption . also , the outlet nozzle assembly 100 may comprise a further part that joins downstream of the one or more air passages 102 . for example , this part may include a surface for controlling the foam produced . thus , the air passages 102 may help form a foam , and further devices in the outlet nozzle assembly 100 may help preserve the foam .

a beverage preparation machine of the type which uses pre - packed cartridges of beverage ingredients . the cartridges may be designed so that air becomes entrained so as to produce a desired foam or crema . air inlets are provided in an outlet nozzle to allow air to enter the beverage preparation machine and so be available for entrainment . advantageously , the air inlets extend through the sides of the nozzle in an elevated position at a widened portion of the nozzle . this reduces the flow of beverage into and through the air inlets , aiding cleanliness .

as discussed above , embodiments of the present invention relate to a novel butane dispensing apparatus that includes a platform having a support column and trigger mechanism adapted to hold and press a butane liquid / gas can against a glass tube for mixing the butane liquid / gas contents with parts of a marijuana plant within the glass tube to thereby remove the thc from the marijuana plant and dispose it and the residual liquid / gasses into a capture member for further processing . referring now to the drawings fig1 - 4 , the improved compressed liquid / gas can dispenser apparatus 100 comprises a platform 120 including a panel member 122 having a center aperture 124 therethrough , at least three leg members 126 attached to said panel member and extending therefrom and adapted to hold said panel member in a substantially horizontal position with respect to a supporting surface ; an elongated support column 130 including at least two attachment members 140 spaced apart and each connected between a distal end and a proximal end thereof , wherein said support column is rigidly attached at said distal end to said panel member of said platform adjacent said center aperture , and extends substantially vertically therefrom ; a trigger member 150 including a handle portion 152 , a plunger portion 154 adjustably connected to said handle portion , and a locking member 156 adapted to hold said plunger portion in a chosen position , wherein said trigger member is rigidly connected to said proximal end of said support column ; an elongated cylindrical tube member 160 including a proximal end 162 , wherein said proximal end includes a nozzle receiver portion 164 adapted to allow a nozzle of a compressed liquid / gas can dispenser to be pressed there against and permit liquid / gas from within said compressed liquid / gas can to exit said liquid / gas can and enter an interior portion of said cylindrical tube member , and a distal end 166 , wherein said cylindrical tube member is releasably attached via one of said at least two attachment members to an end section of said support column adjacent said distal end , and is adapted to contact and fit within said center aperture of said panel member , and wherein said cylindrical tube member is adapted to allow said liquid / gas exited from said compressed liquid / gas can to pass therethrough ; and a capture member 170 , wherein said capture member is adapted to be placed below and in proximity to said platform aperture , and wherein said capture member is shaped and adapted to capture said liquid / gas exited from said cylindrical tube member passing therethrough ; wherein said improved compressed liquid / gas can dispenser apparatus is adapted such that a compressed liquid / gas can be removably retained via a second one of said at least two attachment members to an end section of said support column adjacent its said proximal end , such that said plunger portion of said trigger member can press against and push said liquid / gas can toward said nozzle receiver portion of said cylindrical tube member until said liquid / gas can begins to discharge said liquid / gas from said compressed liquid / gas can , and said second one of said at least two attachment members and said locking member of said trigger member together function to hold said liquid / gas can in place until all of said liquid / gas has exited said liquid / gas can . the second one of said at least two attachment members 140 and said locking member 156 of said trigger member 150 are adapted and function such that when all of said liquid / gas has exited said liquid / gas can they can be disengaged and said liquid / gas can removed from said apparatus and discarded . the at least two attachment members 140 are formed as flexible straps having hook and loop material 142 on respective ends thereof . further , the at least two attachment members 140 includes a third attachment member 144 adapted to be attached to a middle section of said support column 130 and releasably hold said proximal end of said cylindrical tube member 160 thereto . the third attachment member 144 can be formed as an adjustable screw bolt pipe clamp . the elongated support column 130 can have a curved cross - section . and , the platform 120 and said elongated support column 130 can be formed from a metallic material . the locking member 156 of said trigger member 150 can be formed as a linear ratchet mechanism 158 . the nozzle receiver portion 164 of said proximal end of said cylindrical tube member 160 includes an entrance aperture 166 through said proximal end and a retaining surface 168 in proximity to said aperture and adapted to engage said nozzle of said compressed liquid / gas can , such that when said compressed liquid / gas can is pressed there against said liquid / gas is forced to exit said compressed liquid / gas can and into said cylindrical tube member ; and wherein said distal end of said cylindrical tube member 160 includes an exit aperture 169 . the cylindrical tube member 160 is formed from glass . and the capture member 170 can be formed having a bowl shape . the compressed liquid / gas can 180 includes a cylindrical canister 181 , a compressed liquid / gas retained and compressed within said canister , and a nozzle 182 attached to a top section of said canister and adapted to selectively release said compressed gas / liquid . the embodiments of the invention described herein are exemplary and numerous modifications , variations and rearrangements can be readily envisioned to achieve substantially equivalent results , all of which are intended to be embraced within the spirit and scope of the invention . further , the purpose of the foregoing abstract is to enable the u . s . patent and trademark office and the public generally , and especially the scientist , engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology , to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application .

an apparatuses used for the safe dispensation of compressed liquid / gas butane from a compressed liquid / gas butane can for use in mixing this liquid / gas with parts of a marijuana plant within a glass tube of the apparatus to thereby remove the thc from the marijuana plant and disposing it and the residual liquid / gasses into a capture member for further processing .

a process for preparing an implant component in accordance with the present invention is shown in the flow diagram of fig1 . for the first step 10 of the process , an implant component is mounted on a machine such as a turning lathe . suitable implant components for mounting include a joint or bone prosthesis component such as a cup , shell , tray , stem , liner or head or any other implant component which has a face that possesses radial symmetry in a region , and that is a flat or curved surface which is to be subjected to contact or motion once implanted or during implantation . particularly suitable implant components are those made of ultra - high molecular weight polyethylene ( uhmwpe ) and include , but are not limited to , acetabular liners for hip prostheses and tibial trays , stems of tibial plateaus for knee prostheses . suitable turning machines include horizontal or vertical lathes and , in particular , a horizontal , chucking - type turret lathe which accommodates one or more surface cutting tools . milling machines or mill / turning machines may also be used for the practice of the invention . the machine may be adapted to operate with air bearings to move effectively isolate the implant component from mechanical vibration during the machining process . preferably , a turning machine is used that is adapted with air bearings and allows for a positioning tolerance of within 0 . 005 millimeters , with an electronic feed with ball screws to effectively eliminate backlash . the implant component is mounted via means capable of firmly grasping and holding , but not deforming , implant components that are made of various materials and have various dimensions . some of the suitable means for mounting the implant component include a collet or a chuck , which is preferably formed with a receiving shape closely adapted to be the outside profile of the component , and which may be configured for vacuum clamping in a production setting . the means for mounting the implant component may be operated via manual or automated control . on a lathe , the implant component is mounted on the turning axis of the machine while on a fly cutter , it is mounted along the axis of the tool movement . once the implant component is mounted in accordance with the first step 10 of the process of fig1 the process continues to the second step 12 . during the second step 12 of the process , the component comes into rotational contact with a cutting tool or tools . the contacting of the cutting tool ( s ) and the component may be accomplished several ways , including , but not limited to , rotating the component and feeding the tool against the component or rotating the cutting tool ( s ) to fly cut a component which is held stationary or translated . the cutting tool ( s ) of the turning machine should be made of material ( s ), and should have a shape , a geometry and a sharpness , and should be rotated at a rate sufficient to achieve the aforesaid surface profile and surface finish for the component being cut . generally , applicant has found a single diamond tool to suffice for the finish cut and for rough cuts if any of these are necessary . however , more cutting tools may be provided , and if more than one cutting tool is provided , these may include tools of high speed steel , carbide or the like for rough cutting . in any event , the final tool is a natural or synthetic diamond cutting tool . the diamond cutting tool may be brazed into a tool tip insert such as a steel or carbide insert . the cutting tool ( s ) should either be resharpenable or replaceable after a predetermined number of cuts or a predetermined amount of cutting time or when the tools ( s ) have achieved a predetermined level of dullness , and may be adapted to be easily retrofitted into existing turning machines . the diamond cutting tools for use in the present invention have sharpness and radii of the cutting edge that allow removal of up to ten or twenty mils in a pass while minimizing the appearance of feed lines on the cut component . each carbide cutting tool that is provided should have a sharp profile and a cutting radius . moreover , the sharpness and radius of each of the cutting tools may differ from the other cutting tools , with the sharpnesses being effective to form one or more rough cuts to finish the component sufficiently to allow the diamond to cut the profile in a single pass . in practice , the rough and finish cuts may both be performed with the diamond tool . the cutting tool ( s ) or the component , whichever is being rotated , should be rotated at a rate over 1000 revolutions per minute , and is preferably rotated at 3500 revolutions per minute or more , with an effective cross feed rate . the third step 14 of the process is the cutting and shaping of the component by advancing the cutting tool ( s ) to form the desired surface profile . when the component is rotated , the cutting tool ( s ) are fed across a multi - axis , controlled feed path a predetermined number of times ( with each time constituting one “ pass ”) in order to remove material from the surface of the component so as to achieve a final , predetermined surface profile on the component . depending on such factors as the material from which the component is made and the geometry of the component , the amount of material removed may vary . generally , for cutting a quasi - spherical surface , the feed path is an r , x & amp ; z feed path . the tool cross feed is slow , and the amount of time that elapses for cutting a quasi - spherical surface , or for the final cutting tool to complete its feed path , per pass , is about one minute , but may be set to be more or less time via numerical control . it should also be mentioned that manual or cnc - controlled r - 0 type machines may also be employed . in this case , the tool may pivot in an arc to form the desired surface contour rather than interpolating the profile as a series of steps . in order to provide a component with a surface finish that will significantly reduce or eliminate the formation of wear debris while not adversely affecting the microstructure of the component , the component is preferably cut so as to have a surface finish substantially free of tool marks visible to the unaided eye , for example , wherein the surface waviness of the component is under about 0 . 5 micrometers . the surface finish or roughness of the component should be substantially smoother than 0 . 5 micrometers , and is preferably a surface smoothness of approximately 0 . 05 to 0 . 10 micrometers . such surface waviness and surface roughness characteristics may be attained by providing numerical control of the position of the cutting tool , and , if necessary , augmenting the total number of passes the cutting tool makes on the component . the numerical control is provided by computer in a way known in the art . furthermore , although a component may be cut by one or more carbide tools and a diamond cutting tool , or by only a diamond tool in accordance with the process of fig1 the diamond cutting tool should always be the last of the tools to contact the face of the component in order to provide the desired low surface roughness and waviness characteristics . the third step 14 of the process may also include vacuum and / or cooling systems , for example , to cool the cutting surface and / or to remove swarf that accumulates during the cutting process . these vacuum and cooling systems are adapted to perform in conjunction with the cutting tool ( s ) and the turning machine in ways generally known in the art . in an alternate embodiment of the invention , an implantable polymeric prosthetic joint or bone component is so as to have a two - dimensional surface contour with an as - machined surface profile in a cross direction with peak to valley surface smoothness effective to achieve in vivo particle generation at a residual level . that is , when placed in use , a moving component generates wear particles due to small irregularities of the opposing surfaces rubbing against each other . typically , such particles are initially generated at a high rate , primarily from the irregularities of the polymeric components , and as the surfaces become more regular or better fitting , wear particles are generated at a lower or residual rate , which may approach a low or zero level . the present invention achieves this residual level with an as - machined surface of the polymeric component . referring now to fig2 a and 3 , two exemplary implant components that may be prepared in accordance with the three - step process of fig1 are shown . the exemplary component 16 of fig2 and 2a is an insert for a tibial tray and the exemplary component 16 ′ of fig3 is a liner for an acetabular component . other implant components that may be prepared in accordance with the process of fig1 include a joint or bone component such as a cup , shell , tray , stem , or head or any other implant component which has a face that , once implanted or during implantation , is a flat or curved surface which is to be subjected to contact or motion , including micro - motion such as that which occurs between nominally stationary , but contacting surfaces . in a preferred embodiment of the present invention , implant components prepared in accordance with the process of fig1 are made of ultra - high molecular weight polyethylene ( uhmwpe ). the insert 16 has an anterior surface 18 and a posterior surface 20 and also has medial and lateral surfaces or sides such as 22 . the implant has a superior face 24 of curved aspect that will be subjected to contact or motion when utilized in ways known in the art during , and subsequent to , the implantation of a hip prosthesis , and that face may be super finished in accordance with the process of fig1 such that the face has a surface finish substantially free of tool mark waviness visible to the unaided eye wherein its surface waviness is under about 0 . 5 micrometers and its surface finish has a surface roughness substantially less than 0 . 5 micrometers , preferably less than approximately 0 . 05 to 0 . 10 micrometers . similarly , an inferior surface 25 of the insert 16 may be fly cut to a flat non - wavy super finished profile . the liner 16 ′ is a concave shell of bearing material having an interior face 25 ′ and an exterior surface 24 . as is generally known to those in the art , the liner 16 ′ fits within a generally metallic external support or acetabular component ( not shown ), while a ball of a corresponding femoral component of the prosthesis ( not shown ) bears against the interior surface 25 ′ of the liner . the interior and exterior surfaces 25 ′, 24 ′ of the liner 16 ′ will be subjected to contact or motion when utilized in ways known in the art during , and subsequent to , the implantation of a hip prosthesis , and these faces may be super finished in accordance with the process of fig1 such that the faces have a surface finish substantially free of tool mark waviness visible to the unaided eye wherein its surface waviness is under about 0 . 5 micrometers and its surface finish has a surface roughness substantially less than 0 . 5 micrometers , preferably less than approximately 0 . 05 to 0 . 10 micrometers . referring now to fig4 a turning machine 24 that functions in accordance with the present invention is shown . specifically , this turning machine 24 is a horizontal , chucking - type , turret lathe adapted to be provided with a plurality of cutting tools . the lathe 24 includes a tool feed carriage 26 and a turning motor 28 with a component holding means 30 . the component holding means 30 may be provided as a chuck or a collet or any other suitable means known in the art to hold an implant component without deforming the component . preferably it is a collet or chuck with a fitted recess sized for gripping and supporting the particular component . the tool feed carriage 26 further includes a turret - type tool holder 32 and a tool feed compound 34 for one or more cutting tools 36 , and is adapted to move along a z - or longitudinal axis 38 that is parallel to the turning axis of the engine 28 and also to move along a cross - feed direction . any or all of the components of the turret lathe 24 are adapted to be numerically controlled by computer ( not shown ). the turret lathe 24 may also be adapted to include vacuum and / or cooling systems to remove swarf and heat generated by the cutting process . referring now to fig5 a top view of the tool holding assembly 32 of fig4 is shown . a four - way tool turret 32 is shown having four cutting tools 36 . generally all but one of the cutting tools 36 are carbide tools 36 a having sharpnesses , radii and rake angles appropriate for the material and shape being cut . however , the invention may be practiced using only the one diamond cutting tool 36 b , or with a total number of cutting tools 36 that is greater or less than four while still being able to provide the requisite super finishing characteristics to implant components . the carbide tools , if provided , may be identical tools , with redundant ones serving as replacements to minimize set - up time when one becomes dull ; or may be configured to make successively finer passes to reach the desired finish . super finishing characteristics are preferably achieved , through computerized numerical control , by cutting the component with one or a plurality of cutting tools 36 such that the component has a circularly symmetric finish region on a surface of the component that is to be subjected to motion and / or sliding against another implant component . if the component is not sufficiently smooth or centered in its raw ( e . g . cast , extruded or molded ) state , it is first cut to a predetermined preliminary contour at which point a different one of the plurality of cutting tools may be moved to cut the surface of the component . each cutting tool 36 may have a different sharpness and radius . moreover , a diamond cutting tool 36 b should be the last cutting tool to be introduced to the surface of the component , wherein it removes material from the preliminary cut surface to form the final super finished machine cut surface . one suitable turning machine as described with respect to fig4 and 5 is precitech &# 39 ; s nanoform 200 model . the nanoform 200 model is a two - axis , computer controlled , ultra - precision contouring machine which may be used with diamond cutting tools to form optical quality surfaces on a wide range of materials and which also may be equipped with a high - speed grinding attachment to form precision molds having high quality surfaces . the nanoform 200 model is built on a granite base and utilizes a passive vibration isolation system . high stiffness hydrostatic oil bearing slideways are arranged in a “ t ” configuration such that the x - axis ( spindle ) slide represents the cross - arm of the “ t ” and the z - axis ( tool holding ) slide represents the stem of the “ t .” the nanoform 200 model is available with a digital signal processor based control system which provides a one nanometer programming resolution , sub - count feedback signal interpolation and industry standard m and g code programming format . referring now to fig6 and 6a , an exemplary diamond cutting tool 36 for surface finishing of uhmwpe surfaces is shown . the tool has a shank length , l , of between about 70 millimeters to about 100 millimeters and an arc , a , of about 140 °. moreover , the exemplary tool has a rake angle , α , of about 50 to about 15 ° and a front clearance angle , β , of about 30 °. one of ordinary skill in the art will appreciate that these measurements may vary from tool to tool and / or may be greater or lesser than the above ranges . referring now to fig7 a graphical representation of surface waviness is shown . the graphical representation 40 notes the surface waviness , in micrometers , of prior art implant components and implant components as they relate to baseline variations of 0 . 5 and 0 . 05 micrometers . prior art implant components have machine cut surface waviness measurements 41 that are greater than about the 0 . 5 micrometer baseline which corresponds to surface texture that is visible to the unaided eye . these components may be polished to reduce roughness to below 0 . 4 micrometers , but they will retain this pattern of wavy cut lines . implant components prepared in accordance with the process of fig1 however , have a surface waviness 42 substantially less than approximately 0 . 5 micrometers and preferably lying approximately between the 0 . 05 baseline and 0 . 1 micrometers , or below . it is the ability of the process of fig1 to provide a smooth surface on implant components with a waviness of less than 0 . 5 micrometers that greatly reduces or eliminates the formation of wear debris during the “ breaking in ” or “ wearing - in ” of the components due to , among other things , micromotion and / or articulation and / or sliding . referring now to fig8 a schematic representation of surface contour is shown . the schematic representation 43 shows a baseline 44 that corresponds to an ideal flat or spherical surface contour of an implanted component . curve 48 shows the actual profile and resulting machine ridges produced during a surface cutting and finishing process of the prior art . the prior art residual machine ridges 48 depart greatly from the ideal contour baseline 44 during one period 50 ( corresponding to the feed per rotation of the component / tool ). similarly large excursions may occur over even shorter intervals when the prior art cutting tool has waviness or wear irregularities . conversely , small residual cut artifacts 46 are left by the super finishing cutting process of the present invention which depart from the ideal baseline 44 by a very small amount . that amount of departure is substantially less than 0 . 5 micrometers , and is not visible to the unaided eye . surface roughness is similarly very low , even without secondary polishing . having described the preferred embodiments of the invention , it will now become apparent to one of ordinary skill in the art that other embodiments incorporating their concepts may be used . it is felt therefore that these embodiments should not be limited to disclosed embodiments but rather should be limited only by the spirit and scope of the appended claims .

a method for preparing a contact surface of an implantable bone , joint or similar prosthetic component subject to contact or motion includes the steps of mounting the prosthetic component on a turning or cutting machine and cutting the face of the prosthetic component with a diamond cutting tool using computerized control of tool position along a cross direction to machine cut a super finished surface . the diamond cutting tool has a precise contact point and is shaped with a waviness under about 0 . 5 micrometers effective to cut a surface profile free of visible tool marks . as cut , the variations of contour and the surface roughness are both under about 0 . 5 micrometers , and preferably under about 0 . 2 micrometers or less . upon implantation , the super finished surface generates wear particles at an asymptotically low or residual level during wear - in which may enhance wear characteristics and reduce local reaction or systemic rejection effects . the component is preferably formed by a strong hard polymer , such as uhmwpe , and may be a cup , liner , stem , head , tray , insert shell or other wear surface element of an implantable joint assembly .

fig1 and 2 are a schematic view and a block diagram of a surgical navigation system 50 adapted to track a surgical tool 52 having a tool tracking device 54 associated therewith . the surgical navigation system 50 includes a personal computer 56 that has an internal cpu 58 , a memory 60 and a storage device 62 . also associated with the personal computer 56 are a pointing device or mouse 64 , a keyboard 66 and a monitor 68 . the surgical navigation system 50 also includes a camera 70 , which is comprised of three separate ccd camera arrays 72 , 74 and 76 . these camera arrays 72 , 74 and 76 are adapted to detect infrared signals generated by the tool tracking device 54 and also by a flexible tracking device 88 . the camera 70 can be conveniently mounted to a cart ( not shown ) or can be physically mounted or attached to an operating room wall ( not shown ) or to a operating room light ( not shown ). the surgical navigation system 50 also includes a localizer 82 that cooperates with the camera 70 to identify the location of led &# 39 ; s on the flexible tracking device 88 and led &# 39 ; s 90 on the tool tracking device 54 , as well as any other tracking devices that may be within the field of the camera 70 . the ccd camera arrays 72 , 74 and 76 contain their own calibration information and transmit the position data from the various led &# 39 ; s to the localizer 82 . the localizer 82 then converts the raw position data into position and orientation data using techniques well known to those of skill in the art . the localizer 82 communicates the position and orientation data to the personal computer 56 through a cable 112 . the camera 70 also includes two infrared transceivers ( ir ) 78 and 80 that are capable of communicating with the flexible tracking device 88 , the tool tracking device 54 , and any other suitable tracking devices within the view of the camera 70 . the transceivers 78 and 80 are directly connected to computer 56 through a separate circuit in a cable 84 . the flexible tracking device 88 has an ir transceiver 98 built into a battery pack 96 , which is attached to the flexible tracking device 88 by a cable 94 . similarly , the tool tracking device 54 has an ir transceiver 100 also capable of communicating with the ir transceivers 78 and 80 . the tool tracking device 54 also includes a status light 102 and a plurality of buttons 104 , 106 and 108 that are capable of being programmed to transmit certain signals through the ir transceiver 100 to the surgical navigation system 50 . the tool tracking device 54 also includes a battery 110 . with regard to fig3 , a second embodiment 120 of the flexible tracking device of the present invention is shown . the flexible tracking device 120 includes a flexible sheet 122 having a 6 × 8 array of led &# 39 ; s 124 affixed to the surface thereof . as shown in fig3 , the 6 × 8 array of led &# 39 ; s 124 are all powered by a power source such as a battery pack 128 which is attached to flexible sheet 122 by cable 126 . the battery pack 128 also includes an ir transceiver 130 similar to that discussed above . for simplicity , the wiring from the battery pack 128 to each of the led &# 39 ; s in the 6 × 8 array of led &# 39 ; s 124 is not shown , however each led in the 6 × 8 array of led &# 39 ; s 124 is connected to the battery pack 128 and is capable of being independently illuminated so that surgical navigation system 50 can determine the position of each individual led in the 6 × 8 array of led &# 39 ; s 124 . the flexible sheet 122 has a layer of light adhesive on one side and is stuck on to the patient 86 using this adhesive . the led &# 39 ; s in the 6 × 8 array of led &# 39 ; s 124 that are visible to camera 70 can be used by the surgical navigation system 50 for surface matching as well as patient tracking . the geometry of the sheet 122 can be initialized by tracking rigid tissues of the patient 86 after determining the spatial relationship of the 6 × 8 array of led &# 39 ; s 124 with the camera 70 . a second mode of initialization is to track soft tissue displacement or deformation over time . using the first mode , the positional information of the flexible sheet 122 and the 6 × 8 array of led &# 39 ; s 124 can be used to register the tracked feature of the patient to an image data set , such as a ct scan , using , for example , surface matching techniques . with reference to fig4 , a third embodiment of the flexible sheet of the present invention is shown . in this embodiment , a flexible tracking device 140 is similar to the flexible tracking device 88 and has a flexible sheet 142 having an array of led &# 39 ; s 144 spaced at known intervals from each other . the array of led &# 39 ; s 144 differs from the 6 × 8 array of led &# 39 ; s 124 in that it is not a rectangular array . nonetheless , each led 152 in the array of led &# 39 ; s 144 is in known relationship to its neighbor led &# 39 ; s . in the embodiment of the flexible tracking device 140 shown in fig4 , the flexible tracking device 140 is attached to surgical navigation system 50 directly by cable 146 , which is attached to the flexible tracking device 140 by a flexible cable extension 148 of the flexible tracking device 140 . flexible cable 148 is attached to cable 146 by a coupling 150 . the cable 146 includes a connection from an external power source ( not shown ) to each led in the array of led &# 39 ; s 144 through the flexible cable extension 148 . as shown in fig4 , the entire flexible tracking device 140 is capable of being sold as a disposable item in a pre - sterilized condition . the flexible tracking device 140 can be coupled with cable 146 at a distance from the patient 86 such that a sterile field can be maintained during a surgical procedure . as shown in fig4 , the flexible array 140 conforms to the features of patient 86 including the bony structures of the nose , forehead and cheekbones to provide a suitably firm surface such that the array of led &# 39 ; s 144 can be used for surface matching to register with previously scanned data . the detail of the electric connection 149 from the coupling 150 to the array of led &# 39 ; s 144 is shown in fig5 and 6 . with reference to fig5 , a cross sectional view of the flexible tracking device 140 is shown . as shown in fig5 , the electric connections 149 of the flexible tracking device 140 have a negative flexible conductive circuit 154 and a positive flexible conductive circuit 156 electrically connected to each led 152 in the array of led &# 39 ; s 144 . the negative flexible conductive circuits 154 are sequentially connected to the negative terminals of each led 152 . similarly , the positive flexible conductive circuit 156 is connected to the positive terminal of each of the led &# 39 ; s 152 . as shown in fig4 and 5 , the negative flexible conductive circuits 154 and the positive flexible conductive circuit 156 can be formed directly on the surface of flexible sheet 142 . the negative flexible conductive circuits 154 and the positive flexible conductive circuit 156 can formed from any suitable conductive material such as copper aluminum , silver , and the like . in addition , conductive inks can also be used to print the electric circuits 149 directly onto the flexible sheet 142 . examples of conductive ink materials include conductive copper inks , conductive silver inks and any other suitable materials that can be applied to form a flexible circuit that will transmit electricity and also can be sterilized at least one time . the electric connections 149 can be formed on the flexible substrate by any conventional method such as standard chemical etching techniques where a solid plane of copper is etched to remove the copper from the non - conducting areas to reveal the conductive traces or screen or other conventional printing processes used to print conductive circuits . the led 152 is bonded directly to flexible sheet 142 by soldering the led directly to the negative flexible conductive circuits 154 and the positive flexible conductive circuit 156 . in addition , the led 152 is coated with an essentially optically transparent coating to form an essentially transparent protective coating 160 . suitable materials for this coating include transparent epoxy compounds conventionally used in the industry . coating 160 protects the led 152 from inadvertent movement . it is not necessary for coating 160 to completely cover the entire surface of flexible substrate 142 . however , while it is not shown in fig5 , it may be desirable for the coating 160 also to cover the negative flexible conductive circuits 154 and the positive flexible conductive circuit 156 . typically this is not necessary because a protective coating is formed as part the normal flexible circuit manufacturing process that covers the negative flexible conductive circuits 154 and the positive flexible conductive circuit 156 . the protective coating formed during the manufacturing process is removed only where connections to the led 152 are to be made . the flexible sheet 142 can be formed from any suitable surgically acceptable flexible insulating sheet material such as industry standard flexible fr4 sheet materials . these flexible sheet materials are available from a number of commercial sources . the base materials for most flexible fr4 sheets are polymeric materials such as polyimide , polyester , and the like . lastly , as shown in fig5 , attached to the back of flexible sheet 142 is an adhesive 158 . the adhesive 158 can be any adhesive suitable for human contact . also , it is preferable that the adhesive 158 be a contact adhesive which while reasonably tacky to a patient &# 39 ; s skin is one that can be removed without damage to the patient &# 39 ; s skin . examples of suitable adhesives for use in the present invention include contact adhesives such as surgical adhesives , hairpiece adhesives or other similar adhesives that are suitable for use in contact with human skin . as shown in fig4 and 5 , the flexible circuits 154 and 156 are arranged on the flexible tracking device 140 such that the flexible tracking device 140 can be trimmed to fit a particular situation without disabling any of the led &# 39 ; s 152 that remain after the flexible tracking device 140 has been trimmed . with reference to fig6 that shows a flow diagram for creating a model of a surface for use in the method of the present invention . the method begins at a block 180 that initiates the formation of a model from the array of led &# 39 ; s on the flexible tracking device 140 . control passes to a block 182 that determines if a minimum number of led &# 39 ; s on the flexible tracking device 140 are visible to the camera 70 . if insufficient led &# 39 ; s are visible , the control passes to a display block 190 that instructs the user to turn the object so more led &# 39 ; s will be visible . based on the identity of the led &# 39 ; s that are visible , the block 190 will instruct the user as to which way to move the object . if sufficient led &# 39 ; s are visible , the block 182 will pass control to a block 184 that determines the identity of all visible led &# 39 ; s . after the identity of the visible led &# 39 ; s has been fully determined , a block 188 will determine the quality of the various led &# 39 ; s that are visible by comparing the location of the visible led &# 39 ; s with a database of relationships among the led &# 39 ; s within the array of led &# 39 ; s that has been stored in a block 186 . the quality of the led image relates to the direction each particular led is pointing . if an led points directly at the camera 70 , the quality of that led &# 39 ; s image is considered good . however , if an led is pointing in a direction that is not normal to the camera 70 , the positional data from that led is not as reliable . if there are insufficient led &# 39 ; s pointing normal to the camera 70 , the block 188 will again pass control to the display block 190 that will instruct the user to move the object . if the block 188 determines that the image quality of the visible led &# 39 ; s is acceptable , control passes to a block 192 that constructs a model of the shape of the object from the led &# 39 ; s that are visible . the model is created by determining a series of planes from groups of visible led &# 39 ; s . thereafter these planes are combined to create the model of the object . the more led &# 39 ; s that are visible , the more precise the model will be . if a previously created preliminary model has been created , the block 192 will combine the data from the preliminary model with the new position data for the additional led &# 39 ; s and create a more refined model . after the model has been constructed , control passes to a block 194 that determines if all led &# 39 ; s have been used to construct the model created by the block 192 . if less than all led &# 39 ; s have been used , then the block 194 will consider the model created by the block 192 as a preliminary model and control passes to the display block 190 that instructs the user to turn the object and the process is repeated until all led &# 39 ; s have been used to create the model . while the method has been described with a system that requires all led &# 39 ; s to be used to construct the model , if there are a large number of led &# 39 ; s on the flexible tracking device , the block 194 could be programmed to accept some number less that all led &# 39 ; s and consider the model complete . in this case , the system could update the model as more led &# 39 ; s become visible after registration as described below , in which case , the system would update the model with the newly created model created as the object is moved during a procedure . once the block 194 determines that sufficient led &# 39 ; s have been used to create the model , that the model is sufficiently described and is complete . control then will pass to a block 196 that stores the model in the memory 60 of the computer 56 for use in the registration process to be described below . control then passes to a block 200 that begins the registration process . turning now to fig7 that shows a flow diagram of the registration process that as an aspect of the present invention . the method continues at the block 200 that initiates the registration procedure . control passes to a block 202 that checks to see the number of registration procedures that have been planned and have not been executed . if there is only one remaining registration procedure planned , the system branches to a display and decision block 206 . if there is more than one unexecuted registration procedure , control passes to a display box 204 that displays a messaged that the user must select a particular registration procedure and the system also displays the unexecuted registration procedures that have been planned so that the user can select the next procedure to execute . after the user selects the next registration procedure , the system moves to the display and decision block 206 . the display and decision block 206 displays the following user selectable registration procedures : point matching , surface matching or auto registration . if the user chooses point matching at the display and decision block 206 , the system branches to a block 208 that determines how many reference sets are available . if the block 208 determines there are two or more reference sets , the system passes control to a block 210 that displays a message for the user to select a reference set . the system waits until a suitable set is selected . after one reference set is selected , the system moves to a block 212 that conducts a conventional point matching routine using well defined landmarks of the object , such as the tip of the nose or the inside of the ear . after the block 212 has conducted the point matching routine , the system moves to a block 214 that confirms success of the registration procedure . after the block 214 is executed , the system then determines by a block 216 if a further registration procedure has been planned . if the system determines there are no further registration procedures planned , the system moves to an exit block 218 . however , if the system determines there are further registration procedures planned the system loops back to the block 200 and the method is again conducted until there are no further unexecuted planned registration procedures . if the user chooses surface matching at the display and decision block 206 , the system branches to a block 220 that conducts an identical determination to that conducted by the block 208 previously described . if the block 220 determines there are two or more reference sets available , the system branches to a block 222 that conducts an identical determination to that conducted by the block 210 previously described . the system then passes to a block 224 that conducts a conventional point matching procedure . after the point matching procedure is concluded , the system moves to a block 226 that conducts a conventional surface matching procedure using the information generated by the point matching procedure . after the block 226 has conducted the surface matching routine , the system moves to a block 214 that confirms success of the registration procedure . after the block 214 is executed , the system then determines by a block 216 if a further registration procedure has been planned . if the system determines there are no further registration procedures planned , the system moves to an exit block 218 . however , if the system determines there are further registration procedures planned the system loops back to the block 200 and the method is again conducted until there are no further unexecuted planned registration procedures . if the user chooses auto registration at the decision and display block 206 , the system branches to a block 228 that determines if the flexible tracking device 140 , or a similar device , has been connected to the system . if the flexible tracking device 140 has not been connected , the system branches to a display block 230 that instructs the user to attach the flexible tracking device 140 to the system . the system then waits until the user either attaches the appropriate flexible tracking device or the user chooses to exit the procedure . after the system determines that the flexible tracking device 88 has been attached , the system moves on to an auto registration block 232 . the auto registration block 232 determines if a shape model has been constructed during the initialization procedure . if no model has been constructed , control passes to a display block 240 that instructs the user to initialize the system to create a model or exit . if a model has been constructed and has been stored in a block 235 , control passes to a block 236 that determines if the shape model from the block 235 matches the scanned image from a block 234 in the memory 60 of the computer 56 within a predetermined and prestored error level . if the image and the shape model are within the error level , a block 238 registers the location of the flexible tracking device to the scanned image and the system passes control to the block 214 that confirms success of the registration procedure and proceeds as described above . if the block 236 determines the scanned image and the shape model are not within the acceptable error level , the display block 240 instructs the user to reinitialize the model creation . alternatively , the user can choose to exit the auto registration procedure and choose a different registration method . in addition , while the invention has been described with reference to a surgical system using scanned images of a patient , the method and flexible tracking device can be used to register the shape of any article to a scanned image , such as manufacturing work pieces , and the like . the present invention is useful to quickly , easily and in a non - invasive manner enable a surgical system to track and register preoperative and intraoperative scanned images to a patient &# 39 ; s anatomy without the need for invasive marking procedures . numerous modifications to the present invention will be apparent to those skilled in the art in view of the foregoing description . accordingly , this description is to be construed as illustrative only and is presented for the purpose of enabling those skilled in the art to make and use the invention and to teach the best mode of carrying out same . the exclusive rights to all modifications which come within the scope of the appended claims are reserved .

an article to enable the creation of a model of a surface includes a flexible substrate and multiple optical tracking points attached to the flexible substrate at predetermined location . the optical tracking points can be tracked by a tracking system , and a data link enables communication from the flexible substrate to a tracking system . also disclosed is an article that enables the creation of a model of a surface including multiple light emitting diodes attached to the flexible substrate at predetermined locations . finally , a method of registering an article and a method for creating a model of a surface having a shape are disclosed .

the present invention is directed to a catheter introducer including a tapered tip which facilitates the insertion of the introducer into an incision in a duct , thereby enabling a surgeon to direct the catheter into the duct to the desired location . fig1 shows a cross - sectional diagram of one embodiment 10 of the invention . as shown in fig1 , the introducer 10 includes a tube 12 having a lumen 14 along a longitudinal axis 14 . a head portion 18 extends from a distal end 20 of the tube 12 . as shown in fig2 a – 2c , in which fig2 a is a side view of the head portion 18 of fig1 , fig2 b is a top view of the head portion 18 of fig1 and fig2 c is the same cross - sectional view of the head portion 18 of fig1 , taken along line 2 c — 2 c of fig2 b . as shown in these figures , head portion 18 is extends generally along the longitudinal axis 16 and includes a lumen extension portion 22 having an interior surface 24 which extends from the interior surface 26 of lumen 14 of tube 12 . head portion 18 further includes an exterior surface 28 which extends from the exterior surface 30 of the tube 12 . as shown in fig1 and 2c , the interior surface 24 and the exterior surface 28 converge toward each other to form a tip 32 which , as is described in more detail below , is used to facilitate the insertion of the head portion 18 into an incision in the cystic duct . lumen extension portion 22 of the head portion 18 terminates at an opening 34 of the head portion 18 , which opening 34 enables a catheter passing through the lumen 14 and lumen extension portion 22 to exit the head portion proximate the tip 32 at an angle which is relatively acute with respect to the relative plane within which the opening 34 lies . as shown in fig1 and 2 a – 2 c , head portion 18 tapers from its proximal end 38 , adjacent distal end 20 of tube 12 to the tip 32 . this taper occurs along outer sidewalls 31 as well as along exterior surface 28 with respect to two orthogonal planes which intersect along the longitudinal axis 16 of tube 12 . as a result , exterior surface 28 tapers circumferentially inwardly from planes tangential to the exterior surface 30 of tube 12 , the tangential planes being shown in the figures by dashed line 40 . the amount of taper , indicated by reference numerals 36 a and 36 b , may vary , depending on the particular application and procedural requirements . while the exterior surfaces of the head portion 18 taper as described and shown , the interior surface 24 of the head portion 18 remains parallel to the longitudinal axis 16 such that the direction of travel of the catheter through the head portion 18 remains along the longitudinal axis 16 . in use , a catheter ( not shown ) is directed through the lumen 14 of the tube 12 into a position in which the distal end of the catheter is located proximate the distal end 20 of the tube 12 . the introducer 10 is brought into close proximity to an incision in the cystic duct and the surgeon inserts the tip 32 of head portion 18 into the incision . depending on the size of the incision relative to the diameter of the head portion 18 , the surgeon may insert as much as the entire head portion 18 into the incision , thereby aligning the distal end of the catheter with the incision or , preferably inserting the distal end of the catheter into the incision . with the head portion 18 in such a position , the surgeon is then able to navigate the catheter into the cystic duct and through any obstruction within the duct , with the aid of the head portion 18 and particularly tip 32 . as shown in fig2 a – 2c , this embodiment includes a channel 42 formed between the lower interior surface 24 which extends from the proximal end 38 of the head portion 18 to the tip 32 and interior sidewalls 33 and which , by the nature of the interior surface of the lumen , is concave around the longitudinal axis . the catheter rides within this channel as it is directed out of the opening 34 and through the duct . fig3 a – 3c show another embodiment 44 of the straight head portion 18 . this embodiment is similar to that shown in fig2 a – 2c , with the exception that the channel 22 terminates at a lip 46 a of the tip 32 . in this embodiment , lip 46 a is formed to be continuous with exterior portion 48 of the head portion . shown in fig4 – 7 are various configurations of the lip 46 . each configuration is advantageous in enabling the surgeon to insert the tip and head portion into the incision in the cystic duct and through the valves and other obstructions in the duct that may be encountered by the surgeon during the procedure , while reducing the chance of causing any damage within the duct with the tip of the head portion . fig4 a – 4c show an embodiment 50 of the straight head portion , including a lip 46 b which is in the form of a flat bill shape . fig5 a – 5c show an embodiment 52 of the straight head portion , including a lip 46 c which is in the form of an extended flat bill shape . fig6 a – 6c show an embodiment 54 of the straight head portion , including a lip 46 d which is in the form of a pointed tip . fig7 a – 7c show an embodiment 56 of the straight head portion , including a lip 46 e which is in the form of a flat bill shape and which includes a more rounded transition between the sidewalls and the top portion of the outer surface 24 . in another embodiment of the present invention , the head portion may be curved with respect to the longitudinal axis to enable the interior surface of the head portion to impart a deflecting force on the catheter as it is directed through the head portion and beyond the opening therein . fig8 a – 8d show such an embodiment 60 , wherein fig8 a is a side view of the head portion 60 , fig8 b is a top view of the head portion , fig8 c is a cross - sectional view of the head portion 60 , taken along line 8 c — 8 c in fig8 b and fig8 d is a three - dimensional perspective view of the head portion 60 . as shown in fig8 a – 8d , head portion 60 is generally spoon - shaped , wherein interior surface 62 and the exterior surface 64 are curved upwardly with respect to the longitudinal axis 16 . the combination with sidewalls 66 and interior surface 62 result in a channel 68 that is concave in two - dimension , both along the longitudinal axis 16 and around it . this feature is particularly shown in fig8 d . similarly to the head portion 18 , head portion 60 tapers from its proximal end 74 , adjacent distal end 20 of tube 12 to the tip 76 . this taper also occurs along outer sidewalls 78 as well as along exterior surface 64 with respect to two orthogonal planes which intersect along the longitudinal axis 16 of tube 12 . head portion 60 may also include a circumferential shoulder portion 70 , for facilitating the taper described above . in the spoon - shaped configuration shown in fig8 a – 8d , the tip 76 includes a lip 80 a that is continuous with exterior portion 82 of the head portion 60 . lumen extension portion 69 of the head portion 60 terminates at an opening 72 of the head portion 60 , which opening 72 enables a catheter passing through the lumen 14 and lumen extension portion 69 to exit the head portion proximate the tip 76 at an angle which is relatively acute with respect to the relative plane within which the opening 72 lies . in use , when the tip 76 of head portion 60 is inserted into the incision and the catheter is directed through lumen 14 into channel 68 , it contacts surface 62 and is deflected laterally with respect to the longitudinal axis 16 . this lateral deflection facilitates navigation of the catheter through the duct by the surgeon by enabling the surgeon to laterally move the catheter within the duct by laterally moving the head portion of the introducer . shown in fig9 – 11 are various configurations of the lip 80 . each configuration is advantageous in enabling the surgeon to insert the tip and head portion into the incision in the cystic duct and through the valves and other obstructions in the duct that may be encountered by the surgeon during the procedure . fig9 a – 9c show an embodiment 84 of the spoon - shaped head portion , including a lip 80 b which is in the form of a flat bill shape . fig1 a – 10c show an embodiment 86 of the spoon - shaped head portion , including a lip 80 c which is in the form of an extended flat bill shape . fig1 a – 11d show an embodiment 88 of the spoon - shaped head portion , including a lip 80 d which is in the form of a pointed tip . in yet another embodiment of the present invention , the head portion may be curved with respect to the longitudinal axis to enable the interior surface of the head portion to impart a deflecting force on the catheter as it is directed through the head portion and beyond the opening therein , however , with shallower side walls and a lower profile than the spoon - shaped head portion described above . fig1 a – 12d show such an embodiment 90 , wherein fig1 a is a side view of the head portion 90 , fig1 b is a top view of the head portion 90 , fig1 c is a cross - sectional view of the head portion 90 , taken along line 12 c — 12 c in fig1 b and fig1 d and 12e are three - dimensional perspective views of the head portion 90 . as shown in fig1 a – 12e , head portion 90 is generally scoop - shaped , wherein interior surface 92 and the exterior surface 94 are curved upwardly with respect to the longitudinal axis 16 . the combination of shallow sidewalls 96 and interior surface 92 result in a channel 100 that is concave in two - dimension , both along the longitudinal axis 16 and around it . this feature is particularly shown in fig1 d and 12e . as shown in fig1 a – 12e , the interior surface 92 and the exterior surface 94 converge toward each other to form a tip 106 which , as described above , is used to facilitate the insertion of the head portion 90 into an incision in the cystic duct . in the embodiment of head portion 90 , channel 100 continuos until tip 106 with no lip between the channel 100 and tip 106 . lumen extension portion 108 of the head portion 90 terminates at an opening 110 of the head portion 90 , which opening 110 enables a catheter passing through the lumen 14 and lumen extension portion 108 to exit the head portion proximate the tip 106 at an angle which is relatively acute with respect to the average plane within which the opening 110 lies . similarly to the head portion 18 , head portion 90 tapers from its proximal end 104 , adjacent distal end 20 of tube 12 to the tip 106 . this taper also occurs along outer sidewalls 114 as well as along exterior surface 116 , the optional exception of portion 102 , with respect to two orthogonal planes which intersect along the longitudinal axis 16 of tube 12 . fig1 a – 13c show another embodiment 120 of the scoop - shaped head portion 18 . this embodiment is similar to that shown in fig1 a – 12c , with the exception that the channel 100 terminates at a lip 108 a of the tip 106 . in this embodiment , lip 108 a is formed to be continuous with exterior portion 122 of the head portion . shown in fig1 – 16 are various configurations of the lip 108 . each configuration is advantageous in enabling the surgeon to insert the tip and head portion into the incision in the cystic duct and through the valves and other obstructions in the duct that may be encountered by the surgeon during the procedure . fig1 a – 14c show an embodiment 124 of the scoop - shaped head portion , including a lip 108 b which is in the form of a flat extended bill shape . fig1 a – 15c show an embodiment 126 of the scoop - shaped head portion , including a lip 108 c which is in the form of an short flat bill shape . fig1 a – 16c show an embodiment 128 of the scoop - shaped head portion , including a lip 108 d which is in the form of a pointed tip . the head portion may be constructed such that the angle at which the catheter may exit the opening can vary from between approximately zero degrees , relative to the longitudinal axis , as shown in the embodiments of fig1 – 7 , or at any angle up to approximately 90 degrees . with respect to the spoon and scoop - shaped head portions , the preferable range of the angle of exit of the catheter with respect to the longitudinal axis is approximately zero to approximately sixty degrees , and more preferably , between approximately zero and approximately thirty degrees . the straight head , spoon - shaped head and scoop - shaped shaped head each have a suitably small profile . preferably the straight head and spoon - shaped head portions are constructed such that they remain within planes which are tangent to the exterior surface of the tube 12 . the smaller profile design of the protrusion allows insertion through the incision in the cystic duct , and placement within it . following such insertion of the tip of the head portion , a catheter may be inserted into the introducer from the proximal end , and extended out from the opening in the head portion , and is guided into the lumen of the cystic duct . the curved , spoon - shaped and scoop - shaped designs of the head portion also provide lateral and longitudinal support for the catheter if it encounters resistance from valves or other obstructions . the small profile design of the protrusion also makes it easier for the introducer to be inserted along the lumen of the cystic duct . during an operation , electro - cauterization may be utilized to stop any bleeding at the incision site , which may cause the duct tissue to shrink , or cause a buildup of dead tissue to obstruct the lumen of the cystic duct . the leading edge of the tip can be used to pass through this narrowed incision , and then can be positioned for navigating the catheter through the duct . referring to fig1 and fig1 , which are top and side perspective views , respectively , of the insertion of the catheter introducer of the present invention into a cystic duct during an operation , the catheter introducer 10 is inserted by a surgeon through a trocar into a patient &# 39 ; s abdomen . the introducer 10 is guided towards a transverse incision 138 in the cystic duct 140 . in the case of the straight head portion , the head portion is then inserted into the incision in the duct , and positioned so that the longitudinal axis 16 of the tube generally lines up with the longitudinal axis of the duct , such that the catheter can be directed through the lumen and out of the straight head portion into the duct . in the case of the curved spoon and scoop - shaped head portions , the head portion is inserted into the incision in the duct , and positioned so that the concave channel is substantially perpendicular to the longitudinal axis of the duct . the catheter is then advanced through the introducer 10 until it extends to the concave channel and is then deflected laterally out of the opening in the head portion and is guided into the lumen of the duct substantially in line with the longitudinal axis of the duct . as described above , the positioning of the introducer 10 in the cystic duct provides good lateral and longitudinal support for the catheter if it encounters resistance from valves or other obstructions . while the preferred embodiments and method of use of the invention have been illustrated and described in some detail in the drawings and foregoing description , it should be understood that this description is made only by way of example to set forth the best mode contemplated of carrying out the invention and not as a limitation to the scope of the invention which is pointed out by the claims below .

a catheter introducer includes a tube having a proximal end , a distal end and a lumen extending therethrough along a longitudinal axis of the tube for accommodating a catheter traveling along a longitudinal axis of the tube and a head portion coupled to the distal end of the tube . the head portion includes an aperture in fluid communication with the lumen at a proximal end thereof and a tip at a distal end thereof , an exterior surface extending from the proximal end thereof to an opening of the head portion along a first portion of the head portion and extending from the proximal end thereof to the tip along an opposing portion of the head portion and an interior surface extending from the aperture to the opening of the head portion along the first portion of the head portion and extending from the aperture toward the tip along the opposing portion of the head portion . the exterior surface circumferentially tapers from the proximal end to the distal end and the interior surface forms a channel for receiving a catheter passing through the lumen and the aperture , the channel being concave along at least one axis .

referring now to fig1 there is shown a food product generally designated 10 having an elongated edible inner core 12 , such as ground beef for hamburger , sausage for pizza or skinless sausage , received in a metallic outer tube 13 . as shown , the core 12 has a handle 14 , such as wood , extending from one end 16 of the core 12 . the core 12 is cooked in the tube 13 in order to remove fat and grease , and solidify and firmly attach the core 12 to the handle 14 . after the core 12 has been sufficiently cooked , the tube 13 is removed from the core 12 resulting in the initial food product shown in fig2 . with reference to fig3 a sheet 18 of dough is then wrapped about the core 12 to form a cover 19 for the core 12 , and the wrapped core 12 is placed in a metallic outer tube 20 shown in fig4 . with reference to fig5 a metallic prong 22 having a pair of spaced elongated rods 24a and 24b is placed in the product 10 with the rods 24a and b extending from an outer surface of the product 10 at the other end 26 of the product 10 , and with the rods 24a and b being located adjacent the interface between the cover 19 and core 12 along a substantial length of the core 12 . a mold 28 for the product 10 is shown in fig5 having a first part 30 and a complimentary second part 32 . the parts 30 and 32 have a cavity 34 to receive the product 10 and tube 20 , a first groove 36 communicating with the cavity 31 to receive the handie 14 , and a pair of second grooves 38a and 38b to receive a portion of the prong rods 24a and b . as will be apparent , a plurality of covered food products 10 may be placed in the mold 28 at a single time . the first and second parts 30 and 32 of the mold 28 are closed , and the mold 28 is heated to bake the food product at a suitable temperature and sufficient length of time in order to bake the product 10 . during this time , the metallic prong 22 conducts heat to promote the baking process more rapidly , and the tube 20 conducts heat to the dough in order to form the dough into a tight envelope which will prevent emergence of the core 12 and below described condiments through the outside wall of the dough . after the cooking has been completed , the parts 30 and 32 of the mold 28 are separated , and the prong 22 is removed resulting in the food product 10 shown in fig6 and 7 . this food product 10 has an outer crust formed by the cover 19 , and a pair of elongated cavities 40a and 40b extending from outer openings at the other end 26 of the product or sandwich 10 . a suitable condiment 42a and 42b such as mustard , catsup , or onion , may be readily placed in the cavities 40a and 40b through use of dispensers known to the art or other manner , such that the cavities 40a and 40b prevent spreading of the condiment and possible mess to the consumer . the handle 14 of the product 10 may be placed through an opening 44 of a wrapper 46 shown in fig8 and the wrapper 46 may be closed about the product 10 to facilitate consumption of the product 10 . according to a method of making the product of the present invention , an edible core is provided , an edible cover is placed over a substantial portion of the core , an elongated rod is placed in the product adjacent an interface of the core and cover at a location extending from an cuter surface of the product , the core and cover are heated with the rod in place , and the rod is removed from the product to form a cavity in the product . another embodiment of the food product 10 of the present invention is illustrated in fig9 in which like reference numerals designate like parts . in this embodiment , the food product 10 has a generally oval cross - sectional shape . also , in this embodiment , the handle 14 has an outer end 50 which projects past the other end 26 of the food product for a purpose which will be described below . the food product 10 of fig9 may or may not have the cavities 40a and b . in other respects , the food product 10 is similar to the one previously described in connection with fig1 - 8 . a device 52 for injecting a condiment into the food product 10 is illustrated in fig1 . the device 52 has a body 54 having a pair of cavities 56a and 56b communicating with a pair of respective injecton nozzles 52a and 58b in a cut - out 60 of the body 54 to receive the other end 26 of the food product 10 . the device 52 has a pair of tubes 62a and 62b communicating with the cavities 56a and b for passage of a heated condiment , such as chesse , into the cavities 56a and b and through the nozzles 58a and b . the device 52 has a bore 64 to receive the outer end 50 of the handle 14 , and a switch 66 in the bore 64 which activates when the outer end 50 of the handle 14 is placed fully into the bore 64 . in operation of the device 52 , the other end 26 of the food product 10 is placed in the cut - out 60 until the outer end 50 of the handle activates the switch 66 when the sharp tapered nozzles 68a and b are received in the other end 26 of the food product 10 . when the switch 66 is activated , the device 52 in response passes the heated condiment through the nozzles 58a and b into the food product 10 in order to automatically inject the condiment into the food product 10 . in this embodiment , the food product is free of the cavities 40a and b . the foregoing detailed description is given for clearness of understanding only , and no unnecessary limitations should be understood therefrom , as modifications will be obvious to those skilled in the art .

this invention relates to a food product in the nature of pizza in which meat and condiments in a dough shell or casing are secured to a stick - like handle , and in particular to the method of preparing such an edible product by forming and cooking in a form or mold and using a heat transfer prong inserted into the product to permit cooking of ingredients from within as well as from the outer surfaces of the product .

a fluid delivery device for delivering fluid medicament to a patient is described below . the device comprises a reservoir for storing a quantity of medicament and a dispensing interface for delivering the medicament to the patient . the device is configured to deliver the medicament from the dispensing interface by injection and to respond to physical inputs at the device by transmitting information regarding the injection to a separate user device . the injection and the transmission of the information can take place whilst the device is being worn against the patient &# 39 ; s skin . in other embodiments , the delivery device can include an autoinjector or a pen injector . the device is described below in the context of a bolus injector , but it will be appreciated that it could alternatively be another type of large volume device ( lvd ). referring to fig1 , the device 1 comprises a protective housing 2 in which the reservoir of medicament 3 and the dispensing interface 4 are located together with other components of the device 1 . the housing 2 is formed from moulded plastics or another suitable material . the reservoir of medicament 3 is provided in a capsule 5 , which may contain a single dose of the medicament . the capsule 5 is formed of inert material such as glass and is secured inside an internal cavity of the housing 2 . the capsule 5 may be replaceable to allow re - use of the device 1 . alternatively , the capsule 5 may be non - replaceable in the device 1 so that , once the contents of the capsule 5 has been exhausted , the device 1 can no longer be used to deliver medicament and must be disposed of . this single - use nature of the device 1 facilitates ease of operation and improves safety by ensuring that a patient cannot mistakenly install an incorrect replacement capsule . the dispensing interface 4 comprises an injection element for injection of the medicament from the device 1 into the patient . the injection element is explained below in the context of a cannula 6 , as illustrated in fig1 , although it will be appreciated that other types of injection element could alternatively be used . examples of alternative injection elements are discussed further below . the cannula 6 comprises a distal end 7 , which during use protrudes through the housing 2 of the device 1 into the body tissue of the patient . the cannula 6 also comprises a proximal end 8 , which is arranged to receive medicament from the reservoir 3 referred to above . for example , an opening 9 in the form of an exit port in the capsule 5 may allow medicament to flow out of the capsule 5 and , ultimately , into the proximal end 8 of the cannula 6 . the opening 9 in the capsule 5 is connected to the proximal end 8 of the cannula 6 by a flow channel , which is at least in part provided by a conduit 10 connected to the opening 9 and the proximal end 8 of the cannula 6 . this is described in more detail below . the cannula 6 may be controllably extendable and / or retractable through the exterior of the housing 2 in order to allow it to be safely stowed in the housing 2 when not in use . the device 1 may contain a user - operable actuator 11 to facilitate this . the actuator 11 is configured to cause movement of the cannula 6 relative to the housing 2 of the device 1 in order to extend and / or retract the cannula 6 . an example is an actuator 11 that comprises a sprung element 12 and a switch 13 for releasing the sprung element 12 . upon release by the switch 13 , the sprung element 12 may be configured to automatically extend and thereby drive the cannula 6 partially out of the housing 2 into an injection position . the actuator 11 may be electrically powered . for example , the switch 13 for releasing the sprung element 12 referred to above may be electrically powered . electrical power may also be used to retract the sprung element 12 back to its original non - extended position , thereby also withdrawing the cannula 6 . for this purpose , the actuator 11 may comprise an electrical motor 14 and a suitable drive mechanism coupled to the sprung element 12 . the electrical power may be provided by a battery 15 or other power source in the device 1 , which may be rechargeable . in particular , the battery 15 may be rechargeable if the configuration of the device 1 is such that the capsule 5 of medicament is replaceable . in this type of configuration , the device 1 comprises a sterile part and a non - sterile part . the sterile part of the device 1 is replaceable and comprises the replaceable capsule 5 . the non - sterile part of the device 1 is reusable and comprises reusable elements of the device 1 . the elements in the non - sterile part may include , for example , a rechargeable battery 15 . in general , the non - sterile part includes elements that do not need to be sterile for safe operation of the device 1 and can be safely reused . it will be appreciated , however , that there is no requirement for the elements that do not need to be sterile to be confined exclusively to the non - sterile part of the device 1 . for example , it is possible for the battery 15 to be included with other replaceable elements in the sterile part of the device 1 . in this configuration , the battery 15 is non - rechargeable since it is replaced each time the capsule 5 is replaced . as will be explained in more detail below , the device 1 may comprise an electronic controller 16 which is configured to control operation of the actuator 11 and / or other elements of the device 1 . the electronic controller 16 comprises a processor 28 and a memory 29 and may , for example , comprise an electronic microcontroller which is communicatively coupled to the actuator 11 and / or other elements of the device 1 using a system bus ( not shown ). the switch 13 , motor 14 , battery 15 and controller 16 are shown in the block diagram of the device 1 in fig2 , but are not shown in fig1 . an alternative is for the actuator 11 to operate under the control of a timing element , such as a mechanical timer . the timing element may be a count - down timer . the elapse of a count - down period of the timing element may indicate that an event has occurred , such as the completion of an injection of a dose of medicament . the elapse of the count - down period may cause the actuator 11 to move the cannula 6 or other injection element , for example by withdrawing the cannula 6 back into the housing 2 of the device 1 . the distal end 7 of the cannula 6 may be sharpened to facilitate its insertion into the body tissue of the patient . alternatively , the dispensing interface 4 may also comprise a separate needle ( not shown ) or trocar ( not shown ) for aiding the insertion of the distal end 7 of the cannula 6 into the body tissue . the needle may be controllably extendable and / or retractable from the housing 2 of the device 1 in a similar manner to the cannula 6 discussed above . the needle is configured to pierce the skin of the patient in order to allow the cannula 6 to move into the body tissue . the needle may , for example , be arranged to extend through the centre of the cannula 6 . once the skin has been pierced , the device 1 is configured to retract the needle back into the housing 2 before delivery of the medicament . in the case that the device 1 comprises a separate needle of the type described above , the device 1 may comprise an actuator similar to the one previously discussed in relation to the cannula 6 to facilitate the extension and retraction of the needle . another alternative is for the medicament to be delivered through the needle itself . in this case , the needle has properties which are similar to those of conventional injection needles . a proximal end of the needle is connected to the medicament reservoir 3 in a similar manner to the cannula 6 discussed above so that fluid medicament can flow through the needle into the body tissue of the patient . if the device 1 is configured in this manner , the cannula 6 may be omitted from the dispensing interface 4 . the flow of medicament into the cannula 6 , or other injection element , is controlled by a flow control apparatus 17 . as illustrated in fig1 , the flow control apparatus 17 may comprise a piston 18 which is moveable through the capsule 5 from one end to the other to drive medicament out of the capsule 5 through the opening 9 referred to above . a suitable drive mechanism ( not shown ) is mechanically coupled to the piston 18 and is operable to cause the piston 18 to move through the capsule 5 . movement of the piston 18 may be electrically powered . for example , an electric motor 19 may be connected to the drive mechanism . the electric motor 19 is powered by a power source in the device 1 , such as the battery 15 referred to previously . additionally or alternatively , the flow control apparatus 17 may comprise a seal 20 at the opening 9 in the capsule 5 to prevent medicament from flowing out of the capsule 5 before it is intended that it should do so . the seal 20 is breakable , or openable in some other way , to allow medicament to move from the capsule 5 into the cannula 6 or other injection element via the conduit 10 referred to previously . the device 1 is configured to operate the flow control apparatus 17 , for example by breaking the seal 20 and / or moving the piston 18 , in response to a patient - initiated trigger , as explained below . referring to fig3 , a contact region 21 of the housing 2 is arranged to be worn against the skin of the patient during use of the device 1 . the contact region 21 may , for example , be located on a bottom face of the housing 2 . the contact region 21 has geometric and tactile properties that are selected to be comfortable when worn against the skin of the patient . it is through the contact region 21 of the housing 2 that the cannula 6 , or other injection element , protrudes into the body tissue of the patient during delivery of the medicament . the contact region 21 may , for example , comprise an aperture 22 through which the cannula 6 protrudes during use of the device 1 . the aperture 22 is large enough to accommodate the cannula 6 and / or the separate needle referred to above , including during the extension and retraction operations previously described . during use of the device 1 , the contact region 21 is held against the skin of the patient by a fastener . the fastener is suitable for holding the contact region 21 in a stable position against the skin for a significant period of time , such as several hours , in order to ensure that the injection element is maintained in a fixed position relative to the body of the patient during use of the device 1 . as shown in fig1 and 3 , an example of a suitable fastener is an adhesive layer 23 for temporarily adhering the contact region 21 to the skin of the patient . the adhesive layer 23 may comprise a standard biocompatible glue , as used in common adhesive bandages . in order to protect the adhesive layer 23 from damage and to prevent it from sticking to unwanted objects prior to it being attached to the skin of the patient , the contact region 21 of the device 1 also includes a protective covering ( not shown ) which overlies the adhesive layer 23 . the protective covering is selectively removable from the contact region 21 in order to expose the adhesive layer 23 before use of the device 1 , for example by peeling the covering away from the adhesive layer 23 . the device 1 also comprises a feedback apparatus 24 for providing feedback to the patient regarding the delivery of the medicament . the feedback apparatus 24 is configured to provide the feedback in a discreet manner so that the patient can be informed of the progress of the injection without the possibility of the feedback being noticed or shared by other people in the vicinity of the patient . the feedback apparatus 24 causes the feedback to be provided from the medicament delivery device 1 to a separate user device 32 . the separate user device 32 is illustrated schematically in fig4 . examples of the separate user device 32 include a cell phone , a smart phone , a smart watch , a tablet or other hand - held computer , a desktop computer , a laptop computer , or another type of personal computing device or interface . at the separate user device 32 , the feedback may be displayed on a screen 37 . the feedback apparatus 24 causes the feedback to be transmitted to the separate user device in response to detecting a request from the patient in the form of a physical interaction with the medicament delivery device 1 . this involves the patient making physical contact with the medicament delivery device 1 in a predetermined manner . this predetermined manner is known to the medicament delivery device 1 . as such , the medicament delivery device 1 is able to recognize the physical contact as corresponding to a request for feedback , as described in more detail below . the recognition of the physical contact as a request for feedback may be performed in the feedback apparatus 24 , or may alternatively be performed elsewhere in the device 1 . the device 1 comprises a transducer 25 which is configured to detect physical inputs to the device 1 and to generate signals that are indicative of the detected physical inputs . the physical inputs may cause a degree of movement of the device 1 and the transducer 25 may be configured to detect the inputs by detecting these movements . the transducer 25 may comprise a motion sensor 26 . an example of a suitable motion sensor 26 is an accelerometer , such as a piezoelectric accelerometer , although other types of motion sensors capable of sensing movement of the device 1 and generating a signal describing the detected movements could alternatively be used . an example of a physical input that may be detected by the motion sensor 26 is a tap on the housing 2 of the device 1 . this can be provided by the patient using a knuckle or finger tip . the tap on the housing 2 causes temporary movement in the device 1 , for example in the form of a vibration . the movement caused by the tap is detected by the motion sensor 26 , which is configured to generate a signal indicative of the detected movement . the type of movement in the device 1 caused by a tap on the housing 2 will generally have similar characteristics every time the housing 2 is tapped . this means that signals generated and output by the motion sensor 26 in response to taps on the housing 2 will all have similar characteristics . these similar characteristics allow the feedback apparatus 24 to distinguish a signal representing a tap on the housing 2 from signals representing other movements of the device 1 . the kinds of repeated signal characteristics described above are applicable not only to taps on the housing 2 , but also to many other kinds of physical inputs to the device 1 . an example of another kind of physical input is a prolonged finger - press by the patient against the housing 2 of the device 1 . this may cause , for example , a prolonged deflection in the housing 2 , which is detected by the motion sensor 26 . the motion sensor 26 is configured to generate a signal which describes the deflection in the housing 2 in a similar manner to the signal described above in relation to a tap on the housing 2 . the signal describing the deflection has characteristics that are significantly different from signals describing taps or other kinds of physical inputs to the device 1 . this means that the feedback apparatus 24 can differentiate and identify the signal as being indicative of a prolonged finger - press on the housing 2 . the transducer 25 may additionally or alternatively comprise an electrical switch 27 on the exterior of the housing 2 , which the patient can operate by providing a physical input to the switch 27 . the physical input to the switch 27 connects electrical contacts in the switch . this causes the switch 27 to generate a signal which is communicated to the feedback apparatus 24 . on the basis of the characteristics of the signal , the feedback apparatus 24 is configured to identify the signal as being indicative of an operation of the switch 27 . it will be appreciated from the discussion above that , in general , a signal generated by the transducer 25 in response to a physical input to the device 1 has characteristics that are associated with the particular kind of physical input received from the patient at the device 1 . the physical inputs involve deliberate and premeditated contact by the patient at the device 1 . the signals are electrical signals and can be either analogue or digital . the signals are analysed by the feedback apparatus 24 to determine the physical input to which they correspond . in this way , the feedback apparatus 24 can differentiate between different requests for feedback from the user . the feedback apparatus 24 can also differentiate between contacts that are indicative of a request for feedback and contacts which are not , such as accidental contacts . this is explained in more detail below . the device 1 comprises a communication coupling connected between the transducer 25 and the feedback apparatus 24 . the signals generated by the transducer 25 are communicated to the feedback apparatus 24 via this communication coupling . any suitable communication coupling can be used , such as an electrical connection on a printed circuit board or similar . the feedback apparatus 24 may comprise the controller 16 referred to above . upon receipt of a signal from the transducer 25 , the controller 16 is configured to determine whether the signal is indicative of one or more pre - stored user inputs in the memory 29 of the controller 16 . these pre - stored user inputs comprise user requests for information about the injection of the medicament . for example , the pre - stored user requests may generally be requests for information concerning the progress of the injection , such as a request for an indication of how long is remaining before the injection will be completed . each pre - stored user request is linked , for example in a look - up table , in the memory 29 of the controller 16 to a pre - stored physical input . the physical inputs are stored in the memory 29 in the form of one or more signal characteristics associated with the physical input . these signal characteristics are those present in signals generated by the transducer 25 in response to receipt of the associated physical inputs at the device 1 , as described above . therefore , by matching the signal characteristics received from the transducer 25 with pre - stored characteristics in the memory 29 , the controller 16 of the feedback apparatus 24 is able to recognize whether a pre - stored physical input has been detected at the device 1 and , if so , to identify the pre - stored user request that is associated with the detected physical input . upon recognizing a user input , the feedback apparatus 24 is configured to respond by causing appropriate feedback to be provided to the patient . generating the feedback generally comprises the controller 16 identifying information in the memory 29 and using the information to compile an appropriate message for communication to the separate user device 32 referred to above . for example , in response to recognizing that the patient has requested an indication of the time of day at which the delivery of the medicament will be completed , the controller 16 may retrieve from the memory 29 the expected duration of the delivery process and the time of day at which the delivery process was commenced . the controller 16 may then calculate how long is remaining before the delivery of the medicament will be completed and compile a message containing this information . the device 1 also comprises a transmitter 30 for transmitting information to the separate user device 32 referred to above . referring to fig2 , the transmitter 30 may for example comprise an antenna 31 for transmitting signals wirelessly to another device . the medicament delivery device 1 comprises a communication coupling between the feedback apparatus 24 and the transmitter 30 . any suitable communication coupling can be used , such as an electrical connection on a printed circuit board or similar . the feedback apparatus 24 is configured to communicate with the transmitter 30 using this communication coupling to allow feedback to be transmitted to the user device 32 . in particular , the transmitter 30 may be configured to receive a message from the feedback apparatus 24 and to transmit the message to the user device 32 . the message may contain information assembled by the feedback apparatus 24 in response to recognition of a user request , as previously discussed . the transmitter 30 may be configured to transmit the message to the separate user device 32 using a wireless communication coupling . the transmitter 30 may identify the user device 32 by performing a search for nearby user devices and transmitting the information to the closest user device identified in the search . for example , referring to fig4 , the transmitter 30 may be configured to transmit the message directly to the user device 32 using radio - based communication . the power of the radio signal may be low , so that it has an effective propagation distance that is small . this propagation distance is sufficient for the signal to be received in a high quality form at the separate user device 32 , but may be insufficient for the signal to propagate much further . an example of a suitable distance is approximately one meter , since it is envisaged that the separate user device 32 will generally be on the patient &# 39 ; s person or otherwise in very close proximity to the medicament delivery device 1 . the message is transmitted by the transmitter 30 using a suitable , known wireless communication protocol . an example of such a protocol is bluetooth . an example of a standard that can be used for the communication is ieee standard 802 . 15 . 1 - 2002 . before transmitting the message , the transmitter 30 may be configured to initiate a pairing process with the separate user device 32 to establish a channel for sending the message . alternatively , the message may be transmitted to the user device 32 by sms or over the internet . referring again to fig4 , the message may , for example , be transmitted from the transmitter 30 to a server 33 over the internet . the communication between the transmitter 30 and the server 33 may be carried out in any suitable manner , such as over a 3g or 4g telecommunications network or through an adsl via a wi - fi connection between the transmitter 30 and a wireless router and modem 34 . the server 33 is configured to communicate the message to the user device 32 by any of these means , or similar . the message may be encrypted by the transmitter 30 or feedback apparatus 24 before it is transmitted to the user device 32 . this increases the security of the transmission . in order to communicate the message to the separate user device 32 , the server 33 may store an electronic address of the patient , or other user , in its memory . the address may comprise a cell phone number , an email address , a social media address , or similar . the address is accessible using the user device 32 , for example by accessing an sms , email or social media inbox . messages received at the address can be caused to display on the screen 37 of the user device 32 . the electronic address may be registered with the server 33 beforehand . for example , upon first ownership of the medicament delivery device 1 , the patient may register one or more electronic addresses in the server 33 . the user may communicate the address ( es ) to the server 33 over the internet or over another suitable communications link such as a 3g or 4g telecommunications network . the patient may at the same time communicate a serial number , or other unique identifier , of the medicament delivery device 1 to the server 33 . the server 33 may be configured to respond to this communication from the patient by linking the one or more electronic address ( es ) to the serial number , or other unique identifier , of the medicament delivery device 1 in the memory of the server 33 . this allows the server 33 to communicate feedback received from the medicament delivery device 1 to the linked electronic address ( es ), as described below . in one example , upon receiving a request for feedback in the manner previously described , the medicament delivery device 1 is configured to generate a message containing the feedback and a unique identifier of the medicament delivery device 1 . the device 1 is configured to communicate the message to the server 33 using the transmitter 30 previously described . upon receipt of the message , the server 33 is configured to read the unique identifier of the medicament delivery device 1 from the message and to look up the associated electronic address ( es ) stored in its memory . the server 33 is configured to then forward the message to the electronic address ( es ) for access by the patient using the user device 32 . the user device 32 may be configured to periodically check the electronic address ( es ) and download recently received messages into a memory of the device 32 . alternatively , the messages may be pushed to the user device 32 automatically , for example by an email server . this technique is secure in the sense that the unique identifier of the medicament delivery device 1 is communicated only to the server 33 . the unique identifier is not communicated to the electronic address ( es ). therefore , the unique identifier of the device 1 cannot be obtained by unauthorized access of the electronic address ( es ). the server 33 may operate from a secure location and may be administered by , for example , the supplier of the medicament delivery device 1 to the patient . the user device 32 may comprise a memory in which an application program is stored . the application program contains instructions that are executable by a processor of the user device 32 . the application program is configured to access messages sent by the transmitter 30 of the medicament delivery device 1 , for example by accessing the electronic address ( es ) referred to above , and to cause the information in the messages to be displayed on the screen 37 of the user device 32 . in this way , the patient is able to both request and receive the information in a discreet fashion . an example of a medicament injection and feedback process is described below with respect to fig5 . in a first step s 1 , the patient fastens the contact region 21 of the device 1 to an injection site on his or her body . the patient may , for example , peel the protective covering away from the adhesive layer 23 and press the adhesive layer 23 against his or her skin to adhere the device 1 to the injection site . in a second step s 2 , the patient actuates a switch 38 on the housing 2 of the device 1 to begin delivery of the medicament . the device 1 is configured to respond by causing the cannula 6 or other injection element to extend through the aperture 22 in the housing 2 and into the body tissue of the patient . the device 1 may optionally comprise a sensor ( not shown ) that is configured to detect the position of the cannula 6 or other injection element and report the position to the controller 16 . in this way , the controller 16 is informed of when the cannula 6 or other injection element has been fully extended through the aperture 22 in the housing 2 and is in position to inject the medicament into the body tissue . in a third step s 3 , the flow control apparatus 17 is configured to begin dispensing a dose of medicament into the cannula 6 via the conduit 10 . for example , the controller 16 may cause the power to be supplied from the battery 15 to the electric motor 19 coupled to the piston 18 in the capsule 5 . the electric motor 19 drives movement of the piston 18 through the capsule 5 to expel a dose of medicament through the opening 9 in the far end of the capsule 5 . if the flow control apparatus 17 comprises a seal 20 at the opening 9 of the capsule 5 , this seal 20 is opened to allow the fluid medicament to be released into the first length of conduit 10 . the seal 20 may be broken by fluid pressure in the capsule 5 caused by movement of the piston 18 or may be broken by some other means , such as an actuator ( not shown ) which moves in response to a signal from the controller 16 to pierce the seal 20 . the third step s 3 may be triggered by a predetermined amount of time passing since operation of the switch 38 by the patient . alternatively , the third step s 3 may be triggered in response to the sensor referred to above detecting that the cannula 6 has been extended into the patient . the device 1 may be configured to deliver the dose of medicament in a manner and at a rate which is dictated by the controller 16 . for example , the dose may be administered to the patient in a continuous way at a pre - set rate . alternatively , the dose may be administered to the patient in a plurality of discrete portions over a pre - set time period , or in any other manner , by appropriate movements of the piston 18 . in a fourth step s 4 , the feedback apparatus 24 is configured to monitor signals from the transducer 25 to detect physical inputs on the device 1 corresponding to requests for information from the patient . the feedback apparatus 24 identifies the requests by comparing signals from the transducer 25 with pre - stored signal characteristics indicative of physical inputs associated with the user requests , and identifying matches . in response to detecting a request for information , the feedback apparatus 24 compiles a message containing the information and causes it to be transmitted to a user device 32 of the patient via the transmitter 30 . the information is displayed on the screen 37 of the user device 32 in the manner previously described . in a fifth step s 5 , the controller 16 is configured to cause the actuator 11 to retract the cannula 6 out of the body tissue of the patient to end the medicament delivery process . retraction of the cannula 6 or other injection element may cause the feedback apparatus 24 to disable itself . retraction of the cannula 6 or other injection element may alternatively cause the feedback apparatus 24 to disable the transmitter 30 . this ensures that the medicament delivery device 1 can not transmit feedback messages when the device 1 is not in use . the disablements referred to above may additionally or alternatively be caused by detachment of the device 1 from the body of the patient . a suitable proximity sensor may be included in the contact region 21 in order to detect such detachment from the body . alternatively , the disablements may be performed a predetermined amount of time after a trigger event , such as activation of the device 1 by actuation of the switch 38 on the housing 2 . it will be appreciated that the alternatives described can be used either singly or in combination . although the device 1 has been described in terms of comprising an automatically extending / retracting injection element , it will be appreciated that the injection element may be fixed so that it permanently protrudes through the housing . in these circumstances the injection element may be protected by a removable guard to minimise any danger of the element being damaged , or accidentally damaging something else , before use of the device . it will also be appreciated that in these circumstances the injection element is generally introduced into the patient &# 39 ; s body tissue as the device is placed against the patient &# 39 ; s skin , rather than as a subsequent step as described above . the injection element may comprise the cannula 6 described above or may comprise a needle . as indicated above , in one example the injection element comprises a trocar ( which does not have a bore ) of a cannula arrangement which leaves a flexible tube in the tissue of the patient but does not leave the needle in the user during the medicament delivery . the operation of the device 1 has been described principally in terms of operating under the control of an electronic controller 16 . however , where possible , individual elements of the device 1 may alternatively operate without the electronic controller 16 . for example , the operation of certain elements may be triggered or otherwise controlled by a timing element such as a mechanical timer in the device 1 . the timing element may be relatively simple and may comprise a count - down timer . the elapse of a fixed count - down period of the timing element may cause the elements to operate in a particular manner . for example , the timing element may cause the actuator 11 to extend and / or retract the cannula 6 . additionally or alternatively , a separate timing element may cause the flow control apparatus 17 to control a flow of medicament into the cannula 6 , for example by commencing or ceasing the flow or by varying the flow rate . the timing element may be configured to count down the fixed count - down period in response to the initial activation of the device 1 by the patient ( e . g . following operation of the switch 38 referred to above ). alternatively , the timing element may be configured to count down the fixed count - down period in response to the extension of the cannula 6 or other injection element from the housing 2 . alternatively , the timing element may be configured to count down the fixed count - down period in response to the attachment of the contact region 21 of the device 1 to the body of the patient . one or more suitable proximity sensors in the contact region 21 may be used to determine when the device 1 has been attached . the device 1 is described above as being configured to deliver the medicament subcutaneously . however , it may instead be configured for intradermal injection , for instance using a microneedle , or for injection in some other manner . the bolus injector device may be of the type known as a large volume device ( lvd ). an lvd injection device is configured to dispense a relatively large dose of medicament , in particular at least 1 ml and typically up to 2 . 5 ml , but possibly up to 10 ml . the bolus injector device is configured to deliver a bolus of the respective medicament to bring a volume of the medicament into a patient &# 39 ; s body within a predetermined time . the injection rate , however , may not be critical , i . e . tight control may not be necessary . however , there may be an upper ( physiological ) limit to the delivery rate in order to avoid damage to the tissue surrounding the delivery site . the time taken to deliver a bolus dose of medicament may be between a few minutes and many hours depending on a number of factors including the quantity ( volume ) of medicament , the viscosity of the medicament and the nature of the injection site at which the injection device is intended to be used . from a user or health care professional perspective , it is desirable for an injection device to be configured to minimally impact the patient &# 39 ; s lifestyle and schedule , providing the patient with minimal reminder of his or her disease between the injections . the treatment schedule for therapies is usually intermittent , i . e . may be one injection per week , one injection every other week , or one per month . therefore , the patient usually has no routine in dealing with his or her disease , and hence has minimal routine / experience in performing the required injections . thus , configuration of the injection device to simplify its operation by patients is highly desirable . because it is intended for bolus operation , the configuration of the injection device is quite different compared to an injection device that is intended to be used for basal operation . also , its use is quite different . for instance , a basal type insulin pump generally is relatively expensive as it includes many sophisticated diabetes specific features like programmable delivery rate profiles , bolus calculators etc . further , the connection to the body via an infusion set allows the patient to handle and manipulate the pump in his / her field of view while the therapy is ongoing . further , diabetes patients usually have a routine in setting - up the infusion set , connecting and operating the pump , and disconnecting the pump temporarily for events like taking a shower so not to expose the pump to water . in contrast , the bolus injector devices described above can be relatively simple and inexpensive devices . they may be provided as single - use devices , which cannot be recharged with medicament , which further reduces complexity and cost . the actuators referred to above may comprise mechanical actuators , for example comprising one or more sprung elements . the actuators may alternatively comprise solenoids , piezo actuators , magnetic actuators or other mechanisms . the term “ drug ” or “ medicament ”, as used herein , means a pharmaceutical formulation containing at least one pharmaceutically active compound . in some embodiments , the pharmaceutically active compound can have a molecular weight up to 1500 da or may include a peptide , a protein , a polysaccharide , a vaccine , a dna molecule , an rna molecule , an enzyme , an antibody or a fragment thereof , a hormone or an oligonucleotide , or a mixture of the above - mentioned pharmaceutically active compound . various types or subtypes of compounds are also contemplated . for example , rna may include rnai , sirna , or mirna . in other embodiments , the pharmaceutically active compound can be useful for the treatment or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy , thromboembolism disorders such as deep vein or pulmonary thromboembolism , acute coronary syndrome ( acs ), angina , myocardial infarction , cancer , macular degeneration , inflammation , hay fever , atherosclerosis or rheumatoid arthritis . in some embodiments , the pharmaceutically active compound can comprise at least one peptide for the treatment or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy . the pharmaceutically active compound can also comprise at least one human insulin or a human insulin analogue or derivative , glucagon - like peptide ( glp - 1 ) or an analogue or derivative thereof , or exendin - 3 or exendin - 4 or an analogue or derivative of exendin - 3 or exendin - 4 or a pharmaceutically acceptable salt or solvate thereof . insulin analogues can include , for example , gly ( a21 ), arg ( b31 ), arg ( b32 ) human insulin ; lys ( b3 ), glu ( b29 ) human insulin ; lys ( b28 ), pro ( b29 ) human insulin ; asp ( b28 ) human insulin ; human insulin , wherein proline in position b28 is replaced by asp , lys , leu , val or ala and wherein in position b29 lys may be replaced by pro ; ala ( b26 ) human insulin ; des ( b28 - b30 ) human insulin ; des ( b27 ) human insulin and des ( b30 ) human insulin . insulin derivatives can include , for example , b29 - n - myristoyl - des ( b30 ) human insulin ; b29 - n - palmitoyl - des ( b30 ) human insulin ; b29 - n - myristoyl human insulin ; b29 - n - palmitoyl human insulin ; b28 - n - myristoyl lysb28prob29 human insulin ; b28 - n - palmitoyl - lysb28prob29 human insulin ; b30 - n - myristoyl - thrb29lysb30 human insulin ; b30 - n - palmitoyl - thrb29lysb30 human insulin ; b29 - n -( n - palmitoyl - y - glutamyl )- des ( b30 ) human insulin ; b29 - n -( n - lithocholyl - y - glutamyl )- des ( b30 ) human insulin ; b29 - n -( ω - carboxyheptadecanoyl )- des ( b30 ) human insulin and b29 - n -( ω - carboxyheptadecanoyl ) human insulin . hormones can include , for example , hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists , such as gonadotropine ( follitropin , lutropin , choriongonadotropin , menotropin ), somatropine ( somatropin ), desmopressin , terlipressin , gonadorelin , triptorelin , leuprorelin , buserelin , nafarelin , or goserelin . a polysaccharide can include , for example , a glucosaminoglycane , a hyaluronic acid , a heparin , a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof , or a sulphated , e . g . a poly - sulphated form of the above - mentioned polysaccharides , and / or a pharmaceutically acceptable salt thereof . an example of a pharmaceutically acceptable salt of a poly - sulphated low molecular weight heparin is enoxaparin sodium . antibodies can include generally globular plasma proteins (˜ 150 kda ) that are also known as immunoglobulins which share a basic structure . as they can have sugar chains added to amino acid residues , they may also be classified as glycoproteins . the basic functional unit of each antibody is an immunoglobulin ( ig ) monomer ( containing only one ig unit ); secreted antibodies can also be dimeric with two ig units as with iga , tetrameric with four ig units like teleost fish igm , or pentameric with five ig units , like mammalian igm . the ig monomer is a “ y ”- shaped molecule that can include four polypeptide chains ; two heavy chains and two light chains connected by disulfide bonds between cysteine residues . each heavy chain can be about 440 amino acids long ; each light chain can be about 220 amino acids long . heavy and light chains may each contain intra - chain disulfide bonds which stabilize their folding . each chain is composed of structural domains called ig domains . these domains typically contain about 70 - 110 amino acids and are classified into different categories ( for example , variable or v , and constant or c ) according to their size and function . they have a characteristic immunoglobulin fold in which two β sheets create a “ sandwich ” shape , held together by interactions between conserved cysteines and other charged amino acids . there are five types of mammalian ig heavy chain denoted by α , δ , ε , γ , and μ . the type of heavy chain present defines the isotype of antibody ; these chains are found in iga , igd , ige , igg , and igm antibodies , respectively . distinct heavy chains differ in size and composition ; α and γ contain approximately 450 amino acids and δ approximately 500 amino acids , while μ and ε have approximately 550 amino acids . each heavy chain has two regions , the constant region ( c h ) and the variable region ( v h ). in one species , the constant region is essentially identical in all antibodies of the same isotype , but differs in antibodies of different isotypes . heavy chains γ , α and δ have a constant region composed of three tandem ig domains , and a hinge region for added flexibility ; heavy chains μ and ε have a constant region composed of four immunoglobulin domains . the variable region of the heavy chain differs in antibodies produced by different b cells , but is the same for all antibodies produced by a single b cell or b cell clone . the variable region of each heavy chain is approximately 110 amino acids long and is composed of a single ig domain . in mammals , there are two types of immunoglobulin light chain denoted by λ and κ . a light chain has two successive domains : one constant domain ( cl ) and one variable domain ( vl ). the approximate length of a light chain is 211 to 217 amino acids . each antibody contains two light chains that are always identical ; only one type of light chain , κ or λ , is present per antibody in mammals . although the general structure of antibodies can be similar , the unique property of a given antibody is determined by the variable ( v ) regions , as detailed above . more specifically , variable loops , often three each the light ( vl ) and three on the heavy ( vh ) chain , are responsible for binding to the antigen , i . e . for its antigen specificity . these loops are referred to as the complementarity determining regions ( cdrs ). because cdrs from both vh and vl domains contribute to the antigen - binding site , it is usually the combination of the heavy and the light chains , and not either alone , that determines the final antigen specificity . an “ antibody fragment ” contains at least one antigen binding fragment as defined above , and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from . limited proteolytic digestion with papain cleaves the ig prototype into three fragments . two identical amino terminal fragments , each containing one entire l chain and about half an h chain , are the antigen binding fragments ( fab ). the third fragment , similar in size but containing the carboxyl terminal half of both heavy chains with their inter - chain disulfide bond , is the crystalizable fragment ( fc ). the fc contains carbohydrates , complement - binding , and fcr - binding sites . limited pepsin digestion yields a single f ( ab ′) 2 fragment containing both fab pieces and the hinge region , including the h — h inter - chain disulfide bond . f ( ab ′) 2 is divalent for antigen binding . the disulfide bond of f ( ab ′) 2 may be cleaved in order to obtain fab ′. moreover , the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment ( scfv ). pharmaceutically acceptable salts are for example acid addition salts and basic salts . acid addition salts are e . g . hcl or hbr salts . basic salts are e . g . salts having a cation selected from alkali or alkaline , e . g . na +, or k +, or ca2 +, or an ammonium ion . pharmaceutically acceptable solvates are for example hydrates . in some embodiments , medicaments of various viscosities can be injected . for example , viscosity could range from about 3 to about 50 cp . in other embodiments , viscosity could be less than about 3 cp or greater than about 50 cp . injection can further include delivering a medicament to a sub - cutaneous , an intra - muscular , or a transdermal location within a patient &# 39 ; s body . the medicament can be in the form of a liquid , gel , slurry , suspension , particle , powder , or other type . typical injection volumes can range from about 1 ml to about 10 ml . rates of injection may be about 0 . 5 ml / min , about 0 . 2 ml / min , or about 0 . 1 ml / min . such injection profiles may be generally constant in flow rate , generally continuous in duration , or both generally constant and generally continuous . these injections can also occur in a single step of administration . such injection profiles may be referred to as bolus injections . delivery devices functioning with such medicaments may utilize a needle , cannula , or other injection element configured to deliver a medicament to the patient , as previously discussed . such an injection element may , for example , have an external size or diameter of 27 g or less . further , the injection element could be rigid , flexible , and formed using a range of one or more materials . and in some embodiments , the injection element may include two or more components . for example , a rigid trocar may operate in conjunction with a flexible cannula as previously discussed . initially , both the trocar and cannula may move together to pierce the skin . the trocar may then retract while the cannula remains at least partially within the target tissue . later , the cannula may separately retract into the delivery device . the insertion mechanism for inserting the insertion element may take any suitable form . as described above , it may be a mechanical spring based mechanism . alternatively , the insertion element mechanism may for instance include an electric motor and a gear mechanism that causes insertion of the insertion element into the user . alternatively , the insertion mechanism may be a gas or fluid pressure operated mechanism , in which case the needle driving energy source is either a reservoir of pressurised gas or a chemical system in which two or more chemicals are mixed together to produce gas or fluid pressure .

a skin attachable drug injection device , comprising an accelerometer able to detect the user tapping against the housing of the device and to generate an electrical signal to the device controller , which recognizes the signal as a user request for information regarding the ongoing delivery of the medicament , and a transmitter which in response wirelessly transmits said information to a separate portable user device having a display . a user carrying the injection device under clothing can thus receive feedback about the status of the injection in a discreet way .

embodiments of the invention include systems and methods for outputting an aerosol . for purposes of this application , the term aerosol includes airflows containing particles , such as aerosolized liquids , powders , and combinations of the two . fig1 displays a schematic overview of a system for outputting an aerosol , according to an embodiment of the invention . in this embodiment , variable acoustic source 101 and microphone 102 are acoustically coupled to chamber 103 . volume 103 is divided into air region 103 a and fluid region 103 b . for purposes of this application , the term air includes any gas or combination of gases . processor 104 is configured to receive a signal from microphone 102 , and to determine a volume of air region 103 a . processor 104 is in communication with fluid valve 105 , and is configured to send a control signal to fluid valve 105 to open and close fluid valve 105 to allow an amount of fluid out from fluid region 103 b into target region 106 . the amount of fluid released into target region 106 is associated with the determined volume of air region 103 a . in one embodiment , chamber 103 is a fixed volume , and so the volume of fluid released into target region 106 is substantially identical to a determined change in volume of air region 103 a . target region 106 is coupled to atomizer 107 , which is configured to aerosolize at least a portion of the fluid that has exited fluid region 103 b . in one embodiment , the system includes a second processor 119 that is configured to calculate a volume of the aerosolized fluid , and is further configured to output a volume signal associated with the calculated volume . in this embodiment , the amount of fluid allowed to enter target region 106 is associated both with the volume of air region 103 a and with the aerosol volume . the second processor is configured to receive a signal from volume sensor 108 in communication with aerosol flow chamber 111 . volume sensor 108 can be any combination of hardware and software configured to collect information for determining aerosol volume . for the purposes of the invention , the terms pressure , air flow and flow rate are all used interchangeably , depending on the context . the second processor is not shown in fig1 , and for the purposes of the invention , processor 104 and the second processor can be the same processor , or can be separate from each other . for the purposes of the invention , the term processor includes , for example , any combination of hardware , computer programs , software , firmware and digital logical processors capable of processing input , executing algorithms , and generating output as necessary to practice embodiments of the present invention . the term processor can include any combination of such processors , and may include a microprocessor , an application specific integrated circuit ( asic ), and state machines . such a processor can include , or can be in communication with , a processor readable medium that stores instructions that , when executed by the processor , causes the processor to perform the steps described herein as carried out , or assisted , by a processor . for the purposes of the invention , “ processor readable medium ,” or simply “ medium ,” includes but is not limited to , electronic , optical , magnetic , or other storage or transmission devices capable of providing a processor with processor readable instructions . other examples of suitable media include , but are not limited to , a floppy disk , cd - rom , magnetic disk , memory chip , rom , ram , asic , configured processor , all optical media , all magnetic tape or other magnetic media , or any other medium from which a processor can read . also , various other forms of processor readable media may transmit or carry instructions to a computer , including a router , private or public network , or other transmission device or channel . also , various other forms of processor readable media may transmit or carry instructions to a computer , including a router , private or public network , or other transmission device or channel . target region 106 is coupled to air valve 109 and air source 110 . processor 104 can be further configured to send a control signal to air valve 109 to open and close air valve 109 , thereby selectively exposing air source 110 to target region 106 and to atomizer 107 . air source 110 can be a compressed air source or liquefied air source , an air source open to the atmosphere , or any air source useful for moving fluid from target region 106 to atomizer 107 , and / or for purging target region 106 . in one alternative embodiment , air source 110 may comprise a volume containing an amount of liquefied propellant gas , where air valve 109 is configured in such a way as to connect to the portion of the volume typically containing vapor . in one preferred embodiment , air source 110 is connected to target region 106 through air valve 109 in close proximity to fluid valve 105 . thus , when air valve 109 is opened , air from air source 110 will push a substantial portion of the volume of fluid in target region 106 toward the physical gap 112 in closed volume 113 and then to atomizer 107 . additionally , if the internal diameter of target region 106 is comparatively narrow , such as in a small bore capillary , utilizing air from air source 110 to push the volume of fluid in target region 106 toward atomizer 107 may have the additional advantages of reducing or eliminating blockage of the system , such as crystal growth , and biological contamination that could result from fluid remaining otherwise remain in target region 106 and improving accuracy of the system by ensuring that a substantial portion of the fluid exits target region 106 toward atomizer 107 . fig2 is a schematic diagram of a system for outputting an aerosol , according to an embodiment of the invention , in the context of aerosolized drug delivery . in this embodiment , acoustic volume sensor 201 is coupled to disposable drug cassette 202 . pressure source 203 is coupled to acoustic volume sensor 201 to assist in outputting the drug from acoustic volume sensor 201 to disposable cassette 202 . disposable cassette 202 includes drug reservoir 202 a , valve 202 b and atomizer 202 c , and is detachably coupled to acoustic volume sensor 201 . atomizer 202 c can be , for example , an electro - hydrodynamic atomizer . processor 204 is coupled to acoustic volume sensor 201 to calculate an amount of drug to output from drug reservoir 202 a , and to control valve 202 b . atomizer 202 c is coupled to air flow sensor system 205 . air flow sensor system 205 can be any known system for measuring air flow or pressure of the aerosolized drug to be output to a patient . for example , air flow sensor system 205 can include an anemometer , a pin - wheel sensor , or any other sensor operable to measure air flow , flow rate or pressure . in the embodiment shown , air flow sensor system 205 is a light scatter detection system that includes light source 205 a , light detector 205 b , and pressure sensor 205 c . processor 204 is coupled to light source 205 a , light detector 205 b and pressure sensor 205 c . processor 204 is configured to receive a light detection signal 205 b and pressure or air flow signal from pressure sensor 205 c , and calculate the aerosol volume inside air flow sensor system 205 . as stated above , this system is described in detail in u . s . patent application ser . no . 10 / 670 , 655 , titled “ detection system and method for aerosol delivery .” processor 204 is further coupled to power 206 to power the atomizer on and off at the appropriate time . fig3 is a schematic diagram of acoustic volume sensors that can be used with three embodiments of the invention . in each embodiment , the chamber has volume v 1 , and is acoustically coupled to port m 1 to form an acoustic system . microphone 301 ( or other suitable acousto - electrical transducer ) and an acoustic source 302 , such as a speaker , ( or other suitable electro - acoustical transducer ) are acoustically coupled to this acoustic system . the electrical output of the microphone is placed in communication with electrical input of acoustic source 302 , in such a way that the amplitude and phase relationships of the signals promote acoustic resonance of the system . a measurement of a quantity related to the system &# 39 ; s resonant frequency can permit determination of the chamber volume , as is described in u . s . pat . no . 5 , 349 , 852 , incorporated herein in its entirety . such a resonance frequency measurement can be achieved in a processor . alternatively , an additional chamber of known volume , configured with a port in a manner similar to one of the embodiments of fig3 , may be employed to produce a resonance , and a quantity related to the resonant frequency may be measured . this can , in turn , lead to a determination of the relevant volume . in embodiment ( 1 ) of fig3 , microphone 301 is placed within the chamber , and acoustic source 302 forms a portion of the wall of the chamber . because the resonance determination does not require that the chamber be sealed in the fashion required for acoustic - pressure type systems , the transducers employed in these embodiments do not need to be located in the chamber forming part of the system . it is necessary only that the transducers be acoustically coupled to the system . in embodiments ( 2 ) and ( 3 ) of fig3 , a second volume v 2 is associated with the system and is coupled to volume v 1 via port m 1 . in each of embodiments ( 2 ) and ( 3 ), acoustic source 302 forms a portion of the wall of volume v 2 , and can be , for example , a piezoelectric speaker . in embodiment ( 2 ), microphone 301 , which can be , for example , of the velocity type , forms a part of the wall between volumes v 1 and v 2 , and responds only to differences in pressure between the two volumes ; because the pressure difference between the two volumes tends to be near zero at frequencies below the frequency of natural resonance of the system , noise in microphone 301 is effectively canceled out . in embodiment ( 3 ), microphone 301 is disposed in volume v 2 . fig4 is a schematic diagram of an acoustic volume sensor according to an embodiment of the invention . in this embodiment , acoustic volume sensor enclosure 400 includes first volume 401 and second volume 402 , separated by printed circuit board 403 . first microphone 404 is acoustically coupled to first volume 401 , and second microphone 405 is acoustically coupled to second volume 402 . printed circuit board 403 contains an acoustic source , which can be , for example , a piezoelectric speaker . in one embodiment , one or both of first microphone 404 and second microphone 405 is attached to printed circuit board 403 . printed circuit board 403 can include , in one embodiment , an inner layer configured to pass electrical signals . printed circuit board 403 is coupled to acoustic volume sensor enclosure 400 in a way that forms a substantially air - tight seal . in one embodiment , printed circuit board 403 includes a hole to equalize pressure between the first volume and the second volume . in this embodiment , the hole is small enough so as to not adversely impact the acoustic qualities of the system . first microphone 404 and second microphone 405 are coupled to a processor ( not shown ). this processor is configured to receive a signal from the microphones , and is further configured to determine a volume of the variable - volume chamber based on the received signals . in one embodiment , the processor is contained on printed circuit board 403 . second volume 402 is coupled to third volume 407 via port 408 in such a way as to create an acoustic system including second microphone 405 and acoustic source 406 . third volume 407 is divided into air portion 407 a and fluid portion 407 b . in one embodiment , third volume 407 is a detachable cassette . air portion 407 a can contain air , or can contain any suitable gas for creating an acoustic resonance for volume determination . fluid portion 407 b can include any fluid , including medicine , ink , or any fluid for which a volume measurement is desired . in one embodiment , air portion 407 a is separated from fluid portion 407 b by a diaphragm 409 . diaphragm 409 is configured to allow for a volume measurement of air portion 407 a . fluid portion 407 b of third volume 407 includes fluid output fitting 410 for allowing fluid to escape from fluid volume 407 b in a controlled way . the basic theory behind the acoustic volume sensor according to an embodiment of the invention is that two chambers of air separated by a relatively small tube of air will resonate at a specific frequency when provided with an impulse to either of the air chambers or to the air in the tube that connects the chambers . the resultant resonant frequency is related to the volumes of the chambers , the tube dimensions and miscellaneous parameters of the gas that is used as a medium within the resonator . to ensure a resonance exists as described by the basic theory , some assumptions may be used . first , the wavelength associated with the resonant frequency should be significantly larger than any of the critical dimensions of the resonator . typically , the free - space wavelength associated with an acoustic wave of the resonant frequency should be approximately 20 times larger than the diameter of the chambers , and also of the length and diameter of the tube . this assumption provides that the air pressure within a given chamber is approximately uniform throughout the volume and that the air in the tube is also at a uniform pressure . resonators having resonant frequencies with wavelengths less than 20 times the critical dimensions can be designed with acceptable behavior . the applicability of the assumptions , however , and the relevance of the theory will be diminished as the wavelength is decreased ( or , conversely , the resonant frequency is increased ) for a given resonator design . second , the energy lost from the resonator should be kept small so that the resonator will be underdamped . the resonator is modeled as a second - order system and the corresponding losses ( damping ) should be kept small so that the resonance can be readily observed . no widely accepted “ rules of thumb ” exist to determine the acceptability of various losses . furthermore , no extensive studies have been performed to determine , without experimentation , the degree of losses that are expected for a given resonator geometry . most of the losses are believed to be the result of viscous losses to the walls of the tube as the air traverses the tube &# 39 ; s length . finally , at all frequencies of interest , the acoustic processes should be adiabatic . in other words , the acoustic processes should occur at a rate sufficient to keep heat energy from either leaving the system or equilibrating with the surrounding media . for the purposes of this document , acoustic processes at audible frequencies are always considered to be adiabatic . fig5 a - 5c is a schematic diagram of a number of acoustic volume sensors that further describe and explain embodiments of the invention . all of the following representations are considered equivalent with the only differences being required for practical implementation . fig5 a describes a simplified resonator using a piston 501 a to vary the v 1 volume and excite the system . fig5 b replaces the piston with a speaker 501 b for excitation and incorporates microphones 502 b and 503 b for determining the acoustic pressure levels present in the v 0 and v 1 volumes . fig5 c depicts the implementation details required to utilize the resonator for measurement of volumes that vary as a result of fluid movements using a diaphragm as an interface and valves for control . in this figure , speaker 501 c is used to excite the system , and microphones 502 c and 503 c for determining the acoustic pressure levels present in the v 0 and v 1 volumes . volume v 2 is acoustically coupled to volume v 1 via port 504 c . volume v 2 can be detachable from volume v 1 at port 504 c . volume v 2 includes gas region 505 c and fluid region 506 c . in one embodiment , fluid region 506 c can be bounded by delivery input valve 508 c and patient valve 509 c . delivery input valve 508 c is configured to be coupled to a fluid source that allows fluid to flow into the volume for metering upon output . patient valve 509 c can be processor controlled to open and close to allow a specific volume of fluid to exit fluid region 506 c . the theoretical acoustic behavior can be modeled using a simple mechanical analog . air volumes have frequency - dependent performance analogous to springs . air ports have frequency - dependent performance analogous to masses . acoustic dampers within air ports have an analogous effect on performance as a frictional surface over which a mass is forced to slide . fig6 is a schematic diagram of a mechanical analog of an acoustic volume sensor according to an embodiment of the invention . in fig6 , to make the analogy explicit , spring 601 has a spring constant k 0 analogous to the volume v 0 , spring 602 has a spring constant k 1 analogous to volume v 1 , and spring 607 has a spring constant k 2 analogous to volume v 2 . reference force sensor 603 is analogous to the reference microphone , and front force sensor 604 is analogous to the front microphone . piston 605 can excite the system in a way analogous to the speaker , driving mass 606 analogously to the air port . similarly , embodiments of the acoustic volume sensor can be modeled as an electrical circuit ( not shown ), with capacitors taking the place of springs ( or volumes ), a current source driving the system in place of the piston ( or speaker ), and inductors and resistors representing the mass ( or port ). fig7 is a cutaway view of a detachable cassette for which a volume determination can be made , according to an embodiment of the invention . in this embodiment , housing 701 contains selectable volume 702 , which is divided into air chamber 703 and fluid chamber 704 . air chamber 703 and fluid chamber 704 are , in one embodiment , separated by a diaphragm . housing 701 includes air port 705 for coupling to an air source such as a condensed air source . housing 701 further includes avs port 706 for acoustically coupling volume 702 to an acoustic volume sensor . in one embodiment , housing 701 can contain multiple selectable volumes 702 , each with a corresponding avs port 706 , air port 705 , valve 707 and fluid / air path 708 . in one embodiment , one selectable volume 702 can share an avs port 706 , an air port 705 , a valve 707 and a fluid / air path 708 with another selectable volume 702 . each selectable volume 702 is configured to be individually selectable for acoustic coupling with an acoustic volume sensor . in one embodiment , fluid chamber 704 is coupled to valve 707 by fluid / air path 708 for outputting a selected amount of fluid from fluid chamber 704 , based on a volume determined in air chamber 703 . fluid / air path 708 is further configured to be coupled to an air source for purging parts of the system . in one embodiment , valve 707 is configured to be coupled to fluid chamber 704 when fluid chamber 704 is coupled to an acoustic volume sensor . valve 707 is further configured to be coupled to a processor ( not shown ), and configured to receive a control signal from the processor to open and close based on a volume determined in air chamber 703 . valve 707 is configured to be coupled to an atomizer . fig8 is a top view of a detachable cassette for which a volume determination can be made , according to an embodiment of the invention . in this embodiment , the detachable cassette includes 7 selectable volumes , which can be seen from the corresponding air ports 805 and acoustic volume sensor ports 806 . in principle , housing 801 can include any practicable number of selectable volumes . valve 807 can be seen attached to acoustic volume sensor coupling 809 . acoustic volume sensor coupling 809 is configured to detachably couple the detachable cassette to a fluid volume sensor in a way that allows any selectable volume to be selectably coupled to an acoustic volume sensor . acoustic volume sensors can employ a number of signal processing techniques to determine the resonance and volume of a variable volume chamber . fig9 - 23 illustrate several exemplary methods of signal processing . in fig9 , a speaker is driven with a fixed frequency sinusoid and the phase difference between microphones 901 and 902 is measured . in this embodiment , the microphone outputs are passed through zero - crossing detector 903 to create digital square waves in phase with their analog sine outputs . the two square waves are then passed through an exclusive or gate , xor 904 ; the duty cycle of the xor 904 output , which is proportional to the phase difference , is measured . after determining the phase difference , a different frequency is output from speaker 905 , and the new phase difference is measured . this is repeated until the system finds the frequencies for which the phase difference straddles 90 degrees . linear interpolation can then be used to calculate the system &# 39 ; s resonant frequency . phase difference is measured , and the system is controlled , by processor 906 . fig1 is a flow chart describing the steps of acoustic volume sensing using the digital duty - cycle technique illustrated in fig9 . in one embodiment , at step 1001 , a duty - cycle counter is configured , and transmission to a speaker is initiated . the speaker is configured in this embodiment to output a fixed frequency sinusoidal signal . at step 1002 , counter data is accumulated as the speaker transmission is completed . the phase difference between the two microphones , at step 1003 , is then calculated using the duty cycle of the xor output using the equation phase ( in degrees )= 180 * duty cycle ( 0 - 1 ). once the phase difference is determined , then at step 1004 , a determination is made as to whether the phase difference is within some predetermined window of 90 degrees . if not , then at step 1005 , the drive frequency is changed to move the phase measurement closer to 90 degrees . if the phase difference is within some predetermined window of 90 degrees , then at step 1006 , the speaker drive frequency is changed so that the next phase measurement is on the other side of 90 degrees . at step 1007 , a determination is made as to whether the last two phase measurements straddle 90 degrees . if not , the system is reset back to step 1001 . if so , then the last two phase measurements ( and their corresponding frequencies ) are used to calculate the resonant frequency , using a linear interpolation to find the frequency at which the phase difference is 90 degrees . at step 1009 , the temperature of the system is measured . using the known variables , the relevant volume is measured using the equation ( volume = k 1 /(( f ^ 2 / t )− k 2 ), where k 1 and k 2 are calibration constants ( e . g ., the physical geometry and molecular properties of the gas ), “ f ” is the calculated resonant frequency , and “ t ” is the measured temperature in degrees kelvin . fig1 is a schematic diagram of signal processing techniques according to an embodiment of the invention . the technique illustrated is similar to the technique displayed in fig9 , except that a voltage - controlled oscillator , or vco 1106 , is used instead of a processor to generate speaker drive signals , with vco 1106 input driven by the output from xor 1104 and then passed through integrator 1105 . in principle , this circuit will automatically find the system &# 39 ; s resonant frequency by locking onto the 90 degree phase difference . the integrator output is only stationary with 50 % of the xor 1104 output duty cycle . the vco input and output is then altered to maintain a 50 % xor duty cycle . with this technique , an external processor ( not shown ) can either measure the input voltage to vco 1106 ( with voltage being substantially proportional to frequency ), or can measure the frequency of the signal driving speaker 1107 , or can measure the frequencies of microphones 1101 and 1102 , or can measure the output from xor 1104 . fig1 is a flow chart of the signal processing technique illustrated in fig1 , according to an embodiment of the invention . in this embodiment , at step 1201 , a frequency measurement counter is configured , possibly using a high - speed timer to measure the frequency output from the vco , or measured by the microphones . at step 1202 the temperature of the system is measured . using this information , the volume is calculated using the equation ( volume = k 1 /(( f ^ 2 / t )- k 2 ), where k 1 and k 2 are calibration constants ( e . g ., the physical geometry and molecular properties of the gas ), “ f ” is the calculated resonant frequency , and “ t ” is the measured temperature in degrees kelvin . fig1 is a schematic diagram of a signal processing technique using a speaker impulse , according to an embodiment of the invention . in this embodiment , driver 1304 applies an impulse to speaker 1305 . the microphone output from microphone 1301 will deliver a resonant response to processor 1303 . the frequency can , in principle , be determined by either time between the edges at the timer / counter , or by processing the analog input stream for spectral content . this embodiment would , in theory , eliminate the reference microphone . in a related embodiment , if the speaker dynamics are well behaved , the reference microphone can , in theory , be eliminated ; the phase difference between the microphone &# 39 ; s output and the speaker drive signals can be measured instead . fig1 is a flow chart of the signal processing technique illustrated in fig1 . at step 1401 , the frequency measurement hardware is configured . this can be performed using either a high - speed timer to measure the time differences between the microphone &# 39 ; s zero crossing , or by using an analog to digital converter using high - frequency sampling and algorithms to examine the spectral content of the output . at step 1402 , an impulse is sent to the speaker . at step 1403 , data is recorded as the microphone &# 39 ; s output reacts to the second - order ringing of the resonator and finishes decaying . the resonant frequency is measured at step 1404 using the microphone &# 39 ; s output . the frequency is associated with the underdamped second - order system . the temperature is then measured at step 1405 , and at step 1406 , the relevant volume is then calculated using the equation ( volume = k 1 /(( f ^ 2 / t )- k 2 ), where k 1 and k 2 are calibration constants ( e . g ., the physical geometry and molecular properties of the gas ), “ f ” is the calculated resonant frequency , and “ t ” is the measured temperature in degrees kelvin . the signal processing techniques described above can be performed using amplitude ratios instead of resonances . this technique does not specifically require the presence of an acoustic port , although with standard electronics , amplitude measurements typically lack the accuracy and precision of phase measurements . with newer , higher performance analog to digital converters and digital signal processors , amplitude ratio measurements can be an accurate substitute . fig1 is an embodiment of the invention that does not require the presence of an acoustic port . variable volume 1501 can be measured by driving the speaker sinusoidally and measuring the ratio of the amplitudes at microphone 1503 and microphone 1504 . given that the speaker is a displacement device , the pressure increase in the variable volume will be proportional to the pressure decrease in reference volume 1505 . when reference volume 1505 and variable volume 1501 are equal , both microphones output the same signal level and are 180 degrees out of phase ( assuming identical microphones ). if the variable volume is one half the size of the reference volume , the output from microphone 1504 is twice that of microphone since , for the same speaker displacement , the acoustic pressure change in variable volume 1501 ( as a portion of its nominal value ) is twice as large as the change in the reference volume . the relationship is true as long as the drive frequency for the speaker produces an acoustic wavelength much longer than any of the volumes &# 39 ; dimensions . the above amplitude ratio technique is also useful when implementing an acoustic volume sensor with an acoustic port . at frequencies much less than the resonances of the system , the acoustic port becomes effectively transparent ( as in fig1 ), and the “ fixed ” and “ variable ” volumes cannot be distinguished . this embodiment can be considered a low - frequency approximation of acoustic volume sensing . at frequencies much higher than the system resonances , the acoustic port &# 39 ; s impedance becomes significant and no acoustic energy passes from the port into the variable volume , as is shown in fig1 . at such frequencies , the ratio of the amplitudes between microphone 1701 and 1702 is fixed , and is independent of the variable volume ( ratio = reference volume / fixed volume ). fig1 is a flow chart of a signal processing technique using amplitude ratio measurements , according to an embodiment of the invention . in this embodiment , at step 1801 , the speaker is set into sinusoidal oscillations at a fixed frequency . if an acoustic port is present , the frequency used can be much less than the resonant frequency of the acoustic volume sensor . at step 1802 , the amplitudes output from the two microphones are measured . if desired , the phase of the two outputs can be confirmed to be 180 degrees out of phase . at step 1803 , the variable volume is calculated using the equation volume = reference volume *( reference microphone amplitude / front microphone amplitude ). if desired , one can cycle through multiple frequencies to confirm the volume measurement . the measurement should be independent of frequency , the presence of air bubbles within the variable fluid volume , or other “ acoustic leaks ” or microphone or electronics errors that may be detected . if desired , using an amplitude ratio technique , a volume measurement may be performed using a frequency much larger than the resonant frequency of the system . the volume measurement in this case should be approximately equal to the fixed volume and approximately independent of the variable volume . the foregoing description of the embodiments of the invention has been presented only for the purpose of illustration and description and is not intended to be exhaustive or to limit the invention to the precise forms disclosed . numerous modifications and adaptations thereof will be apparent to those skilled in the art without departing from the spirit and scope of the present invention .

a method to deliver medication . the apparatus has an acoustic volume sensor that acoustically excites a reference volume and variable - volume chamber with an acoustic source and measures the acoustic response with microphones acoustically coupled to the reference and the variable - volume chamber . a disposable drug cassette is coupled to the acoustic volume sensor and includes a drug reservoir and valve . the method includes receiving a volume signal and inputs from a user input or a second sensor and controlling the valve based on these inputs .

referring to the drawings , apparatus 10 comprises a main supporting body 12 ( fig2 ) having means for attachment to an instrument ( e . g . an air - pulse tonometer ) to be tested and / or calibrated . to this end , main body 12 is afforded an apertured collar 14 at each of its ends , only one of which is illustrated . collars 14 are adapted to fit about typical tonometer browrest uprights such as are illustrated in u . s . pat . no . 3 , 889 , 518 , for example . a set screw 16 in each collar is used to lock supporting body 12 in a desired adjusted position on the tonometer instrument . it should be understood that the illustrated collar 14 and set screw may alternatively comprise any other suitable form of clamping means such as c - clamps or specially designed sliding locks . fixed to main body 12 is slideway 18 carrying slide 20 upon which is mounted fluid column monitoring means which includes the following : swivel mounted on slide 20 is bracket 22 having spaced uprights 24 in which opposite ends of tube 26 are socketed for rotational adjustment when needed and selective locking in place by clamps 28 . extending longitudinally , approximately centrally through the hollow interior of tube 26 , is torsion wire 30 ( fig2 and 5 ). wire 30 is held taut in tube 26 with clamping plates 32 . intermediately of the extension of wire 30 between uprights 24 is depending lever arm 34 ( fig2 and 5 ) preferably also formed of wire and soldered , brazed or otherwise fixed to wire 30 . lever arm 34 supports disc 36 and the combined arm 34 and disc 36 which will be referred to hereinafter as paddle 38 . cutout 40 in tube 26 affords clear space for swinging paddle 38 about the axis of carrier wire 30 as will be described in detail shortly . adjacent lever arm 34 is adjustable stop 42 which is supported by an extension 44 of bracket 22 . following longitudinal adjustment ( e . g . by threading ) and fixing of stop 42 in extension 44 , counterclockwise rotation of tube 26 as viewed in fig5 affords tilting of paddle 38 relative to the axis 46 of a path of fluid 48 ( fig5 ) to be monitored . this counterclockwise rotation of tube 26 to the extent of causing arm 34 to just reach stop 42 affords substantially no torque in the paddle carrying wire 30 but , forcing paddle 38 to return to a vertical dependency from tube 36 by incidence of a stream or pulse 50 of fluid ( e . g . air ) induces a readily mathematically determinable torque in wire 30 upon arrival of paddle 38 at the aforesaid vertical dependency . thus , the force of stream or pulse 50 becomes known for verification of the tonometer instrument reading of force emitted from nozzle 52 . those desiring greater details of operation and function of air pulse tonometer mechanisms and their respective pressure reading systems may refer to the aforementioned u . s . pat . no . 3 , 889 , 518 and / or references cited therein . in instances of need to monitor greater than the above discussed minimum air pulse pressure , counterclockwise rotation of tube 26 ( fig5 ) continued after bringing arm 34 into contact with stop 44 applies a torque to wire 30 which increases the force needed to return paddle 38 to the aforesaid vertical dependency . adjustment of stop 42 in extension 44 regulates the angular travel a ( fig5 ) required of paddle 38 to reach a vertical dependency from tube 26 . rotational adjustment of tube 26 is facilitated by provision of lever 54 ( fig1 and 4 ) which is clamped to tube 26 and backed by stationary protractor 56 . indicia on protractor 56 may be so graduated as to indicate angular adjustment of lever arm 34 directly or to read in increments of torque applied to wire 30 and / or units of force required to move paddle 38 to verticality . since accurate centering of disc 36 of paddle 38 upon axis 46 is critical to precision in tonometer instrument reading verification , the following alignment means and procedure are provided : vertical adjustment of disc 36 relative to axis 46 may be accomplished by movement of main body 12 as needed along the aforesaid headrest supports of the tonometer instrument . rotational adjustment or pivoting of disc 36 may be accomplished by rotating bracket 22 on slide 20 about swivel post 58 which also functions as a clamp screw . horizontal alignment of disc 36 , together with the aforesaid vertical alignment , may be accomplished with simulated ocular cornea 60 which also provides for setting of the distance between disc 36 and nozzle 52 of the tonometer instrument , i . e . by movement of nozzle 52 toward and away from cornea 60 . artificial cornea 60 is carried by support 62 on slide 20 the former being independently vertically adjustable for initial establishment of leveling of center of the artificial cornea with center of disc 36 . adjustable stop 64 ( fig1 ) fixed to slideway 18 locates artificial cornea 60 at a given position relative to main body 12 whereupon manipulation of nozzle 52 with the usual tonometer joy stick allows centering of its axis 46 with the center of artificial cornea 60 . the usual tonometer instrument sighting through nozzle 52 permits the above alignment procedure . thereafter , movement of slide 20 away from stop 64 , ( e . g . to the left as viewed in fig1 ) and against stop 66 brings disc 36 of paddle 38 into exact correspondence with the previous position of artificial cornea 60 . emission of fluid from nozzle 52 may now be monitored by the reaction of paddle 38 for verification and / or calibration of the tonometer instrument reading . upon completion of instrument calibration , apparatus 10 is removed from the tonometer . it should be appreciated that there are many modifications and adaptations of the precise form of the invention here shown which may suit particular requirements such as , for example , the monitoring of transient force of columns of fluid originating from sources other than air - pulse tonometers . accordingly , the precise forms of the invention here shown and described are not to be interpreted as restrictive of the invention beyond that necessitated by the following claims .

a device for verifying instrument readings of transient force of a moving fluid column including a paddle depending from a taut wire torsion bar . the unit is adaptable to instruments utilizing fluid pulses in testing objects for resistance or vulnerability to fluid stream pressure , e . g . ophthalmic tonometers . with disposition of the paddle in an instrument fluid path and a known torsional force applied to the supporting wire , the force required of a fluid column to displace the paddle may be established for verification of instrument readings and / or indication of defective instruments .

the casing may have a thickness of between 0 . 1 mm and 10 mm , preferably from 1 to 7 . 5 mm , e . g . from 2 to 5 mm . the hydrocolloid used in the casing may be carrageenan , alginate , agarose , gellan gum , pectin , or a cellulose derivative . the casing may be aerated to create opaqueness . the food product of the invention is capable of exhibiting a contrasting appearance between the casing and the centre . the contrast may reside in the texture , colour , flavour or acidity of the centre compared with the casing . some liquid - filled gummy products are already on the market based on gelatin . however , food - grade gelatin is obtained from bovine or porcine raw materials and the use of gelatin is undesirable for the vegetarian population , as well as for certain ethnic groups who have concerns about the nature of meat used in certain food products and / or who observe certain dietary constraints concerning the consumption of meat and dairy products . we are not aware of any liquid - filled confections that are gelatin - free . the amount of hydrocolloid in the casing may vary from 0 . 5 to 80 % by weight depending on the thickness of the casing , e . g . for casings having a thickness of from 0 . 1 - 2 mm , the amount of hydrocolloid in the casing may be from 5 - 80 % by weight the proportion of hydrocolloid preferably being higher the thinner the casing , and for casings having a thickness of from 2 - 10 mm , the amount of hydrocolloid in the casing may be from 0 . 5 to 5 % by weight and preferably from 1 to 4 % by weight based on the weight of the casing . the other main ingredients are water and sweetener . the water may be in an amount of from 3 % to 50 %, preferably from 7 . 5 to 40 % and especially 10 to 20 % by weight based on the weight of the casing . if desired , sugar , sugar syrup or sugar substitutes such as maltitol , lactitol , mannitol , xylitol , sorbitol , or artificial sweeteners may be present in the casing , e . g . the casing may , if desired , be sugar - free . small amounts of acid , buffer or colourant may also be present in the casing the final solids content of the casing may be from 50 to 97 %, preferably from 60 to 95 % and especially from 75 - 85 %. the texture of the casing can vary from a plastic - like film to a water jelly to a fruit gum to a chew type texture ( elastic to non - elastic ). the liquid or soft centre may contain water and sweetener , e . g . sugar , sugar syrup or sugar substitutes such as maltitol , lactitol , mannitol , xylitol , sorbitol , or artificial sweeteners , optionally together with oil / fat and other ingredients such as colour , flavour , acid or functional ingredients such as minerals , vitamins or herbs . the liquid centre can have a viscosity varying from that of water to the fluidity of glucose syrup at 25 ° c . ( the viscosity of water @ 25 ° c . is 0 . 89 cp and that of glucose syrup 42de @ 25 ° c . is 159000 cp ). the soft centre can vary from a paste , e . g . a chocolate , fat , or fruit paste , to a jelly to a chew texture . the solid centre may be , for instance , nut pieces , chocolate , fruit pieces , cheese , or hard - boiled pieces . the particulate centre may be a powder , granular or an agglomerate having a particle size of from 25 to 2000 microns and may contain , for instance , sherbert , popping candy , sugar or sugar - substitutes such as maltitol , lactitol , mannitol , xylitol , sorbitol , or artificial sweeteners , and other functional ingredients such minerals , vitamins or herbal extracts . the solids content of the liquid or soft centre may be from 50 to 90 %, preferably from 60 to 85 % and especially from 75 - 80 %. the solids content of the hard centre may vary from about 50 to 99 % e . g . for hard cheese ( eg cheddar ) it may be from 60 - 65 %, and for hard - boiled pieces it may be from 95 - 99 %. the weight ratio of the casing to the centre may range from 90 : 10 to 10 : 90 , for example from 75 : 25 to 25 : 75 . the product may be used in hot , ambient , chilled and frozen applications , e . g . the product may be dropped in hot liquids at , for example , 80 ° to 100 ° c . to make hot drinks . the product of the present invention may be a refreshing , clean eating sugar and / or sugar - free gelatin - free food product that is texturally interesting and visually attractive . the product of the present invention may be a food product containing a single or multi - component centre with or without pieces . it may have a wide variety of shapes , e . g . spheres , hemispheres , cubes , cuboids , lentils , teardrops , pyramids , or cylinders . the product of the present invention may conveniently have a diameter from 4 mm to 50 mm , preferably from 8 mm to 40 mm and more preferably from 10 mm to 25 mm . the product of the present invention may deliver a centre of contrasting texture , flavour , colour , acidity to the coating and can offer significant differentiation to existing products . the product may also deliver active or functional ingredients such as minerals , vitamins or herbal extracts , etc . the present invention also provides a process for the production of a food product comprising a gelatin - free water - based hydrocolloid - casing enclosing a hard , liquid , soft or particulate centre which comprises partially setting a liquid hydrocolloid mass to form the casing , e . g . in two halves or as a balloon and filled with a hard , liquid , soft or powder centre , and injecting with a hard , liquid , soft or powder centre and finally completing the setting of the hydrocolloid mass . the injection of the liquid or soft centre may be carried out by means of a syringe or by one - shot depositing such as generally described in u . s . pat . no . 1 , 711 , 750 . most hydrocolloid systems set fairly quickly usually at about 40 ° to 90 ° c . when there is difference in temperature gradient , i . e . the gel sets quickly when in contact with something lower in temperature than itself . the bigger the temperature difference the quicker the setting . one exception is alginate which sets on contact with calcium ions . therefore , for water - based hydrocolloid casings excepting alginates enclosing a liquid or soft centre , the food product may be prepared by depositing a liquid hydrocolloid mass at a temperature above its setting temperature , e . g . 40 °- 90 ° c ., in a mould which is at a lower temperature than the liquid hydrocolloid mass , and injecting with a liquid or soft centre at a temperature lower than the temperature of the hydrocoloid mass while the hydrocolloid mass is still soft until it sets . preferably , the hydrocolloid mass is cooled to speed up the setting of the gel and to ensure the centre stays central . the injected centre at a lower temperature than the liquid hydrocolloid mass is conveniently at a temperature from 5 ° c . to 50 ° c ., preferably from 8 ° c . to 30 ° c ., and especially from 10 ° c . to 15 ° c . the injected centre at a lower temperature than the liquid hydrocolloid mass causes the hydrocolloid mass to set immediately on contact , thereby encasing the centre within the gel . if desired , the liquid hydrocolloid may be deposited into a bubble pack lining the mould or into pots which form the packaging , for instance , by one - shot depositing . for water - based hydrocolloid casings excepting alginates enclosing a hard or particulate centre , the food product may be prepared by lining a mould with a liquid hydrocolloid mass at a temperature above its setting temperature , e . g . from 40 ° c . to 100 ° c ., the mould being at a lower temperature than the liquid hydrocolloid mass , to form a shell open at one end , inserting the hard or particulate centre into the shell , and backing off with a layer of hydrocolloid casing . for a water - based alginate casing , the food product may be prepared by depositing a liquid alginate mass in an aqueous medium containing preferably calcium ions to form a semi - set pliable casing instantaneously , surrounding the liquid alginate mass , injecting with a liquid or soft centre and finally completing the setting of the alginate mass . the setting will occur with time but , if desired , cooling will help speed up the setting , e . g . in an aqueous medium around 10 ° c .- 20 ° c . for achieving the desired shape , the liquid alginate mass is deposited into a mould submerged in the calcium bath , the mould having fine holes in the base which allows the aqueous medium to circulate around the mass thereby causing it to set . the aqueous medium containing calcium ions may contain from 0 . 1 % to 5 % preferably from 0 . 5 to 2 %, depending on the solids content of the hydrocolloid mass of an edible calcium salt , e . g . calcium acetate , calcium citrate , calcium tartrate , calcium lactate , calcium propionate or calcium carbonate but preferably calcium chloride . the thickness of the casing depends on the length of time the alginate gel is in contact with the calcium ions . in a further embodiment , the present invention provides a food product comprising two or more gelatin - free water - based hydrocolloid casings connected together each casing enclosing a solid , liquid , soft or particulate centre . the centres within the casings may be the same or different . when the centres are different , they may comprise materials which are reactive with one another , the reaction taking place when the casings are destroyed on consumption . for example , the reaction may include the release of a gas such as carbon dioxide , e . g . where one centre comprises an alkali such as sodium bicarbonate and another centre comprises an acid , e . g . a fruit acid such as citric acid . advantageously , in addition to the reactive materials , at least one of the centres may comprise other materials such as flavours , e . g . champagne concentrate . the two centres may be made , for instance , by injecting with two needles . the food product comprising two or more gelatin - free water - based hydrocolloid casings connected together may be made by sticking two or more casings together when they are wet . the product of the invention is a sugar / sugar - free / functional food product that is gelatin - free , visually interesting and extremely striking , combining a textural difference and an immediate flavour impact , and which delivers clear differentiation from existing products on the market . compared with the fat - based capsule described in ep - a - 64155 , the product of the invention has a different texture ranging from plastic to elastic to non - elastic and the absence of fat ( only if the centre doesn &# 39 ; t contain fat or oil ) makes the product cleaner and more refreshing to eat the following examples further illustrate the present invention . parts and percentages are given by weight . a carrageenan gum mass having a total solids content of 77 % and a ph of 3 . 8 to 4 . 0 for the gel casing is prepared by mixing the ingredients of the following recipe : gum recipe % sugar syrup 57 sugar 20 water 19 carrageenan 2 . 4 acid 1 . 6 buffer 0 . 8 the gum mass at a temperature of 90 ° c . is deposited into a mould at 25 ° c . and is injected by a syringe with a liquid centre at 15 ° c . while still soft . the liquid centre is prepared by mixing the ingredients of the following formulation : liquid centre % sugar syrup 99 . 5 colour 0 . 004 flavour 0 . 4 this results in a visually extremely striking product . one processing option for these products might be to mould directly into bubble packs or deposit into pots or moulds by one - shot depositing . an alginate gum mass having a total solids content of 75 % and a ph of 3 . 8 - 4 . 0 for the gel casing is prepared by mixing the ingredients of the following recipe : % sugar 48 sugar syrup 20 alginate 1 . 5 water 30 glyceryl monostearate 0 . 2 trisodium orthophosphate 0 . 3 flavour 0 . 04 the alginate mass at 85 ° c . is deposited into a calcium bath containing 99 . 5 % water and 0 . 5 % calcium lactate at 20 ° c . and allowed to set . a semi - set casing forms after about 5 minutes leaving the centre of the product liquid . the liquid centre at a temperature of 15 ° c . is injected with a syringe through the semi - set casing . the casing sets fully over a period of time which may vary from 5 minutes to 120 minutes . this results in a soft product with a liquid centre . the liquid centre is prepared by mixing the ingredients of the following formulation : liquid centre % sugar syrup 99 . 5 colour 0 . 004 flavour 0 . 4

a food product that includes a casing of a gelatin - free , water - based , set hydrocolloid gel that forms an enclosure , and at least one solid , liquid , soft or particulate center enclosed by the casing . the casing is made of a carageenan , alginate , agarose , gellan gum , pectin or cellulose compound , and the food product can withstand changes in temperature . also , a process for the production of such a food product , wherein a liquid hydrocolloid mass is partially set and a hard , liquid , soft or particulate center is injected therein with the final completing or the setting of the hydrocolloid mass providing the encapsulation of the center .

the present invention is operative as an insertion contraption , which places a mesh after insertion , and devices and methods for its applications . the principles and operation of the device and method according to the present invention may be better understood with reference to the drawings and accompanying descriptions . before explaining at least one embodiment of the invention in detail , it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of the components set forth in the following description or illustrated in the drawings . the invention is capable of other embodiments or of being practiced of carried out in various ways . also , it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting . here will be explained a one , specific example for the application of the present invention ; furthermore , other applications to the present invention are possible . first will be described the stages of constructing the present invention , then , the method of using the present invention . refereeing to the drawings : the core of the present invention is the specific method of rolling the mesh — the double roll . therefore , fig1 - 3 will schematically illustrate the rolling method , without referring to further elements of the present invention that will be explained , illustrate , and discuss in the rest of the drawings . fig1 is a schematic illustration of the spread mesh ( 1 ). the mesh showed here is 15 × 12 cm , the one used for groin hernia . fig2 is a schematic illustration of the rolling of the mesh . the mesh showed here is laid at the horizontal positioning , and the rolling is of the right side , from side toward the center . fig3 is a schematic illustration of the already double - rolled mesh to the midline . detail 1 of fig3 is a schematic illustration of the end result of the double - rolled mesh . following will be described the double - rolling of the mesh ( 1 ) with the different elements . referring further to the drawings , fig4 schematically illustrates the position of the spreading element ( 6 ), fully extended , in its ‘ free ’ form after spreading the mesh ( 1 ). in this specific example , in a diagonal position , one side of the element positioned upwards and the other side positioned downwards , that for the purpose that when rolled with the mesh ( 1 ) will create a spiral , and not a bulk . detail 2 of fig4 schematically illustrates the spreading element ( 6 ) connected to the distal part of the leading element ( 2 ) as an extension of it , though it can be as well a flexible metal wire that is connected to the distal part of the leading element ( 2 ), as shown is detail 2 a of fig4 . also shown in fig4 is the holding element ( 7 ) that will be later referred to . in fig5 schematically illustrates the mesh ( 1 ) that is rolled from side to center with the spreading element ( 6 ) within , and is held by the holding element ( 7 ), that is as well connected to the distal part of the leading element ( 2 ), though in a proximal positioning to the spreading element ( 6 ). it can also be from the same material of the leading element ( 2 ), or can be made from a different material . detail 3 of fig6 is a schematic illustration of the holding element ( 7 ), connected to the tip of the leading element ( 2 ), goes around each side of the double - roll , through the back of the mesh ( 1 ) itself and into the hole ( 8 ), and reconnects to itself to the breaking point of the holding element ( 9 ). the purpose of this is to establish a location that will be used to disengage the holding element ( 7 ) from the double - rolled mesh ( 1 ). that can be done in two ways . either a . to create a ‘ breakage button ’ that will be held by a grasper and snap , or b . will be cut by scissors . fig6 is a schematic illustration of the mesh ( 1 ) double - rolled from both sides to center , and is held by the holding element ( 7 ), as shown in detail 3 of fig6 . referring further to the drawings , fig7 is a schematic illustration of the leading element ( 2 ), in this specific case , 8 cm long , is connected to the long rod ( 3 ). detail 4 of fig7 is a schematic illustration of the form of connection between the proximal part of the leading element ( 2 ), that enters into the distal side of the long rod ( 3 ). in this specific case , the long rod ( 3 ) is 35 cm . in its proximal side there are shoulders ( 10 ) that prevent its sliding into the abdominal cavity . the pushing pin ( 4 ), with the button ( 11 ) in its end is inserted through the entire long rod ( 3 ). push of the button ( 11 ) of the pin ( 4 ) by its distal part ( 15 ) through the long rod ( 3 ), will result in the disconnection of the leading element ( 2 ) plus the double - rolled mesh ( 1 ) that is connected to it . this connection , between the double - rolled mesh ( 1 ) to the leading element ( 2 ) is flexible , allowing a range of movement , as shown in fig7 . referring further to the drawings , fig7 schematically illustrates the mesh container cylinder ( 5 ), in this specific case 11 - 12 mm in diameter that matches the diameter of the trocar ( 13 ). the cylinder ( 5 ) has shoulders ( 12 ) that act as a stopper to prevent the slide of cylinder ( 5 ) further into the trocar ( 13 ). the cylinder ( 5 ) is used as a container for the double - rolled mesh ( 1 ) plus its elements , as illustrated in fig8 . referring further to the drawings , fig8 is a schematic illustration of the present invention assembled together , combining all the elements , named lhmp — laparoscopic hernia mesh placement . referring further to the drawings , fig8 - 15 schematically illustrate the operative procedure of the application of lhmp . fig8 is a schematic illustration of the ‘ ready - to - use ’ lhmp , combining all the elements , as a device . fig9 schematically illustrates the insertion of the device into the trocar ( 13 ), in this specific case 11 - 12 mm in internal diameter . this trocar is used during the surgery for the insertion of the laparoscopic scope of the camera . the scope is being pulled out for the purpose of insertion of the cylinder ( 5 ) into the trocar ( 13 ), when the shoulders ( 12 ) are being used as a stopper to prevent from the cylinder ( 5 ) to slip through the trocar ( 13 ) into the abdominal cavity . fig1 schematically illustrates the insertion of the double - rolled mesh ( 1 ) through the cylinder ( 5 ) into the abdominal cavity . the release is performed by the pushing of the long rod ( 3 ) with the help of the shoulders ( 10 ) that , as well , prevent the sliding of the long rod ( 3 ) into the abdominal cavity . fig1 schematically illustrates the disconnecting of the double - rolled mesh ( 1 ) with the elements attached to it from the long rod ( 3 ). this act is performed by pressing the button ( 11 ) of the pushing pin ( 4 ), causing the distal end of the pushing pin ( 15 ) to disconnect the leading element ( 2 ) from the long rod ( 3 ). as a result of that , the double - rolled mesh ( 1 ), with all its elements attached to it , is left placed on the bottom of the abdominal cavity . what remains in the trocar ( 13 ) is the pushing pin ( 4 ), inside the long rod ( 3 ), inside the cylinder ( 5 ). all of the above is being pulled together out of the trocar ( 13 ), and the scope of the camera is being inserted back into the trocar ( 13 ). fig1 is a schematic illustration of the pushing pin ( 4 ), inside the long rod ( 3 ), which has been replaced as a unit inside a different trocar ( 14 ), in this specific case 5 mm in inner diameter . this thinner trocar ( 14 ) has already been placed laterally to the central 11 - 12 mm trocar ( 13 ). under the supervision of the camera , and with the help of an endoscopic grasper , the leading element ( 2 ) is being held by the grasper , lead to the long rod ( 3 ) and the two are being reconnected . at this stage , the double - rolled mesh ( 1 ) is in the abdominal cavity , the leading element ( 2 )— which has just been reconnected to the long pin ( 3 )— is attached to the exact center , horizontal and vertical , of the double - rolled mesh ( 1 ). this point of connection has been chosen in this manner to ease the placement and centering of the double - rolled mesh ( 1 ) and provide the most comfortable way of controlling the maneuvering of the double - rolled mesh ( 1 ) to its proper placement at the center of the defect . ( in the example before us the mesh is double rolled toward the vertical center line , suitable for repair of groin hernia , whereas in abdominal wall hernia repair the mesh is double rolled toward the horizontal center line .) under the supervision of the camera , the double - rolled mesh ( 1 ) is now in place over the center of the defect , vertically . fig1 schematically illustrates the cutting of the holding element ( 7 ) from itself , by a breakage point ( 9 ) or by scissors , resulting in the releasing of one side of the double - rolled mesh ( 1 ). fig1 is a schematic illustration of the spreading of one roll of the double - rolled mesh ( 1 ). this stage is being carried out — and due to the fact that the holding element ( 7 ) was cut — by the fact that the spreading element ( 6 ) that was rolled within the mesh is straightens , due to its material memory , or flexibility . if there is a need to complete the spreading of the mesh , the surgeon can do that with the help of the grasper , since the mesh is being held at its place . the spread side of the mesh is being fixed to the abdominal wall by surgical staples , as needed . the same process is being applied to the other roll of the mesh ; the cutting of the holding element ( 7 ), the release of the roll , the spreading of the mesh ( 1 ) and the fixation to the abdominal wall . throughout the mentioned above process ( of both sides of the mesh ) the device is kept in its place , since the two arms of the spreading element ( 6 ) help keep the mesh ( 1 ) in its proper place . fig1 is a schematic illustration of the mesh ( 1 ) spread in its entire and fixed to the abdominal wall . the entire device ( elements 2 , 3 , 4 , 6 , 7 ) is being withdrawn out of the abdominal cavity , through the trocar ( 13 ), by pulling out the long rod ( 3 ). since the flexibility of the spreading element ( 6 ) and of the holding element ( 7 ), and the fact that they are both connected to the leading element ( 2 ), this stage is being carried out effortlessly .

the present invention relates generally to surgical mesh , and in particular to the manner in which the mesh is pre - rolled , which allows its insertion to the abdominal cavity , and its comfortable lead and spread to its proper location for every average surgeon , and to devices and methods of its application . according to the present invention , there is provided a pre - rolled mesh , double rolled from two opposite directions , one toward the other . there is a device that holds , leads , releases and spreads the mesh in its proper location , related to the hernia defect , and comprising an element holds the double - rolled mesh , and allows its releasing ; another element allows the spreading of the double - rolled mesh ; additional element allows the leading and locating of the double - rolled mesh . a second shape assumed when spreading the mesh , as the center of the mesh matches the desired location , while the elements , which held and spread each side of the double rolled mesh had been released .

while this invention is susceptible of embodiment in many different forms , there is shown in the drawings and will herein be described in detail specific embodiments , with the understanding that the present disclosure of such embodiments is to be considered as an example of the principles and not intended to limit the invention to the specific embodiments shown and described . in the description below , like reference numerals are used to describe the same , similar or corresponding parts in the several views of the drawings . the terms “ a ” or “ an ”, as used herein , are defined as one or more than one . the term “ plurality ”, as used herein , is defined as two or more than two . the term “ another ”, as used herein , is defined as at least a second or more . the terms “ including ” and / or “ having ”, as used herein , are defined as comprising ( i . e ., open language ). the term “ coupled ”, as used herein , is defined as connected , although not necessarily directly , and not necessarily mechanically . reference throughout this document to “ one embodiment ”, “ certain embodiments ”, “ an embodiment ” or similar terms means that a particular feature , structure , or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention . thus , the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodiment . furthermore , the particular features , structures , or characteristics may be combined in any suitable manner in one or more embodiments without limitation . the term “ or ” as used herein is to be interpreted as an inclusive or meaning any one or any combination . therefore , “ a , b or c ” means “ any of the following : a ; b ; c ; a and b ; a and c ; b and c ; a , b and c ”. an exception to this definition will occur only when a combination of elements , functions , steps or acts are in some way inherently mutually exclusive . there is a need for a device that can be easily dispensed and quickly placed into an undergarment or bathing suit that a prospective customer wishes to try on while in the fitting room of a store . the invention described is a disposable hygienic strip , enclosed in a sealed package which is able to be dispensed or carried in personal packaging , intended to provide a protective barrier against the genital area and any similar article of clothing that is being tried on in the dressing room of a store . commercial retail establishments encourage individuals to try on articles while at the store , so as to reduce the rate of return on certain items . often times , prospective purchasers of bathing suits and other undergarments will try on multiple items at once while at the store . without the barrier provided by the hygienic strip , the customer is exposed to a number of potentially hazardous fluids that could be present on the garments . to avoid such exposure , there is a need for prospective purchasers to be able to obtain multiple hygienic strips from a dispenser and place them into the garments as they try them on themselves . the ability for the prospective purchaser to place their own hygienic strip provides a peace of mind as to the integrity of the strip and the strips placement inside the garment . it is necessary for the hygienic strip device to be an approximate thickness of a standard sheet of paper to prevent any bulk which may alter the fit of the garment on the body when the prospective purchaser tries on the garment . the objective of the hygienic strip is to be easily dispensed and quickly applied to garments to give prospective buyers the peace of mind needed to facilitate confidence while trying on such items . among related prior art patents are those which fall into three categories for which arguments can be composed to distinguish each from the aforementioned device . the categories are absorbent materials pads , special garments or undergarments , and maternity wear . a hygienic garment liner for use by women while trying on clothing after the removal of conventional lower undergarments having an oblong shaped hygienic garment liner with tabs which extend from each side . the hygienic garment liner has only a smooth surface and no layer of absorbent material on the body facing side and an adhesive bottom on the garment facing side . the hygienic garment liner has an approximate thickness of a standard sheet of paper . turning now to fig1 , consistent with certain embodiments of the invention this figure presents an exemplary view of the top of the liner while placed in the undergarment or bathing suit . as shown in the image , the side facing the body is a smooth surface having no absorbent properties . a 1 and a 2 of fig1 show the side wings which wrap around the edge of the garment to provide stability and additional sanitary protection . a 1 and a 2 have adhesive which extends out allowing a 1 and a 2 to fasten themselves to the underside of the garment . b demonstrates the front portion of the hygienic liner which extends toward the front portion of the garment , providing coverage to the frontal region of the female anatomy . c demonstrates the back portion of the hygienic liner which extends toward the rear portion of the garment , providing coverage for the posterior . b and c are intended to provide coverage to areas which may leave fluids or residue behind or be exposed to fluids or residue that may be left behind from a previous fitting . d demonstrates the under - side of the hygienic liner which has an adhesive applied to it to help hold the hygienic liner in place throughout the process of trying on clothes . once the prospective customer is finished trying on the garment , the hygienic liner is easily removed , without causing damage to the garment , and discarded . turning now to fig2 , consistent with certain embodiments of the invention this figure presents an exemplary view of the sealed packaging e in which the hygienic liner is contained . each liner is contained in its own separate sealed package that is to be opened by the prospective purchaser while in the fitting room . turning now to fig3 , consistent with certain embodiments of the invention this figure presents an exemplary view the sealed packaging e and of how the packaging may be torn open and the liner removed . the torn away edge of packaging e exposes one hygienic liner for the prospective customer to remove from the package . this embodiment is one potential way in which the packaging may be opened to expose the hygienic liner . turning now to fig4 , consistent with certain embodiments of the invention this figure presents a perspective view of the hygienic liner . fig4 again demonstrates the non - porous upper surface of the liner which could consist of but not limited to a plastic , polypropylene or similar non - porous material . the hygienic liner is in the range of 5 to 8 inches in length between b and c so as to extend fully under the female genitals . the wings a 1 and a 2 range in approximate width of 2 to 4 inches so as to extend slightly over the side edge of the garment and wrap around to provide stability for the liner and additional protection for the prospective purchaser . turning now to fig5 , consistent with certain embodiments of the invention this figure presents a top view of the liner demonstrating the smooth surface of the top of the hygienic liner . the top of the liner does not possess any lines or ridges because it is not meant to provide any absorption , only a hygienic barrier between the prospective purchaser and the garment . turning now to fig6 , consistent with certain embodiments of the invention this figure presents a side view of the hygienic liner demonstrating the lack of bulk . the hygienic liner has an approximate thickness of a standard sheet of paper , so as not to alter the appearance of the garment on the body while it is being tried on . turning now to fig7 , consistent with certain embodiments of the invention this figure presents a view of side d which demonstrated the extent of the adhesive that is placed on the bottom portion of the hygienic liner . the adhesive stretches out to portions a 1 , a 2 , b and c to make sure the hygienic liner is kept in place while the item tried on and off for possible multiple fittings . turning now to fig8 , consistent with certain embodiments of the invention this figure presents a non - limiting example of a dispenser f in which the hygienic liners may be contained and dispensed while entering the dressing room of a department store . the dispenser could be hung on the wall or pedestal at the entrance to a fitting room , allowing a prospective purchaser to pull a liner or liners as needed while entering the fitting room . only one liner is dispensed per packaging e per dispense but the prospective purchaser has the option of removing multiple sealed packages e from the dispenser . the dispenser could be refilled with either a stack of liners or a roll of liners that are easily torn off and used depending on the most efficient arrangement of the sealed package e inside the dispenser . turning now to fig9 , consistent with certain embodiments of the invention this figure presents a non - limiting example of a dispenser f in which the hygienic liners may be contained and dispensed while entering the dressing room of a department store . the lever on the side of the dispenser could dispense out one hygienic liner at a time . the dispenser is approximately 1 to 2 inches wider than the width of the sealed packaging e . depending on the arrangement of the hygienic liners inside the dispenser ; the dispenser could hold several hundred liners once filled .

an apparatus is described that forms a disposable hygienic liner , in order to provide a sanitary barrier while trying on garments such as bathing suits and underwear . using the hygienic liner while trying on garments helps to minimize the exposure to potentially harmful bodily fluids while simultaneously minimizing damage to the garments .

looking to fig1 the amusement device according to this invention , generally designated 10 , includes a housing , generally designated 12 , a push - button panel 14 and a display screen 16 . as shown in fig2 , 5 and 7 , the device also includes a control means , generally designated 18 , an actuating means , generally designated 20 and a serving mechanism generally designated 22 . referring to fig1 the housing 12 comprises side walls 26 , a front wall 28 and an apron wall 30 which supports the push - button panel 14 . the housing 12 also includes an inclined rear wall 32 ( fig2 ) and a base plate 34 . the base plate 34 includes a flange 36 therearound which supports the housing on a table top or the like . the push - button panel 14 supports a lefthand actuating button 38 and a righthand actuating button 40 . the actuating buttons 38 and 40 are formed in the shape of small paddles . in the center of the push - button panel 14 is a raised surface 42 which supports a serve button 44 . the display screen 16 is mounted on the housing 12 in an approximately vertical orientation , slightly inclined to the rear , as best seen in fig1 and 2 . the display screen 16 is a substantially translucent sheet of glass , plastic or other suitable material , which is designated by indicia according to the game being simulated . fig1 shows a display screen for a table tennis game and therefore a pair of fig4 are shown at opposite ends of a table 50 . the figures each are depicted as holding a simulated table tennis paddle 52 . the translucent properties of the display screen 16 allow a beam of light passing through the screen 16 to appear as a dot 56 on the display screen which simulates a table tennis ball passing back and forth between the two characters 48 , along a predetermined but varying path 58 . the operative components of the device will be broken down into three major subdivisions : ( 1 ) the control means 18 for creating the simulated path of travel of the ball 56 ; ( 2 ) the actuating means 20 for operating the control means 18 and detecting whether the simulated table tennis ball 56 has been successfully returned or missed ; and ( 3 ) the serving mechanism 22 for initiating play of the game . the control means 18 is provided to simulate the path of travel 58 of the ball 56 back and forth between the figures 48 and the paddles 52 on the display screen 16 . for ease in understanding of the description , a short explanation of the principles involved is in order . a single light source is used to create a beam of light which is focused by a series of lenses successively onto a pair of pivotally mounted mirrors . the mirrors are caused to pivot about their respective axes in a manner predetermined by a plurality of cam surfaces of the control mechanism 18 . the reflected light beam will sweep back and forth across the display screen 16 which gives the visible dot 56 the appearance of a ball bouncing across the table tennis table 50 back and forth from one player to the other if kept in play . the control means 18 generally includes a light source 70 ( see fig2 and 3 ), a &# 34 ; vertical mirror &# 34 ; 72 , a &# 34 ; horizontal mirror &# 34 ; 74 , a &# 34 ; horizontal &# 34 ; cam 76 ( fig5 ) and a &# 34 ; vertical &# 34 ; cam 78 . the control means 18 also includes drive means , generally designated 80 ( fig2 ), for effecting rotation of the cams 76 and 78 . mirror 72 and cam 78 are designated as the &# 34 ; vertical &# 34 ; mirror and cam since they control the vertical element of the reflected light beam on the display screen 16 . mirror 74 and cam 76 are designated as the &# 34 ; horizontal &# 34 ; mirror and cam since they control the horizontal element of the reflected light beam on the display screen . more particularly , looking to fig2 the light source 70 is a miniature lightbulb secured in a socket 82 which is mounted on a raised platform 84 near the front center of the housing . a transformer 86 ( fig3 ) provides power to the lightbulb through an on - off switch 88 ( fig1 and 3 ) near the center of the display panel apron 14 . light rays from the lightbulb 70 passes through a first focusing lens 90 mounted in a frame 92 on the platform 84 . the light beam is focused again by a lens 94 mounted in a frame 96 . frame 96 is mounted on a horizontal platform 100 which is supported on three upwardly protruding studs 102 ( fig5 ) attached to the base 34 of the housing 12 . the light beam is then directed onto the vertical mirror 72 and reflected off of the vertical mirror towards the horizontal mirror 74 . the horizontal mirror 74 finally reflects the light beam onto the display panel 16 . the vertical mirror 72 is circular in shape and mounted on a base 110 . the base 110 is secured to a rotatable shaft 112 which is mounted on the horizontal plate 100 through two upstanding flanges 114 . a portion of the shaft 112 extends through the rear flanges 114 and is secured to a crank arm 116 for rotation on the shaft 112 . the crank arm 116 is associated with the vertical cam 78 to pivot mirror 72 and cause the light beam to sweep the display screen 16 in a vertical plane . more particularly , the vertical cam 78 is secured to a sleeve 120 ( fig5 ) which slides over a stud 122 secured to the base 34 . looking to fig3 a cam follower arm 124 is seen in contact with the vertical cam 78 . the cam follower arm 124 is pivotally mounted below the horizontal plate 100 by pin 126 . the other end of the cam follower arm 124 is pivotally connected to a connecting arm 128 . the connecting arm 128 is finally pivotally connected to the crank arm 116 . a spring 130 , attached to the crank arm 116 and the horizontal plate 100 , keeps the cam follower arm 124 in constant contact with the vertical cam 78 . thus , as the vertical cam 78 rotates , the motion of the cam follower arm 124 is transmitted to the mirror 72 through the connecting arm 128 and the crank arm 116 . the vertical mirror 72 is mounted on the shaft 112 at approximately a 45 ° angle with the axis of the shaft 112 , such that rotation of the shaft 112 will cause the light beam to be reflected in varying vertical directions toward the horizontal mirror 74 . a similarly designed mechanism is provided to control the pivotal movement of the horizontal mirror 74 . the horizontal mirror 74 is generally rectangular in shape and pivotally mounted on the horizontal plate 100 . the horizontal cam 76 is secured to the sleeve 120 in a position above the vertical cam 78 . a cam follower 134 is in constant contact with the horizontal cam 76 and pivotally mounted below the horizontal plate 100 by a pin 136 . the pin 136 extends upwardly through the horizontal plate 100 and is secured to a lever 138 . the lever 138 is pivotally connected to a second lever 140 . the lever 140 is pivotally connected to a crank arm 142 secured to the pivotal support of the mirror 74 . a spring 144 , connected to the crank arm 142 and the horizontal plate 100 , keeps the cam follower 134 in constant contact with the horizontal cam 76 . thus , as the cam 76 is caused to rotate , the mirror 74 will pivot back and forth as the cam follower 134 follows the periphery of the cam 76 . thus , the horizontal mirror 74 , which receives a light beam from the vertical mirror 72 of varying vertical directions , will add to the light beam horizontal components and cause the ball 56 to appear on the screen to move from left to right as it moves up and down in a programmed manner . to provide for a more realistic game , the device 10 also includes means for making a bouncing sound as the ball 56 bounces on the table 50 and from the paddles 52 . more particularly , a sound cam 150 ( fig2 and 5 ) is secured to the sleeve 120 below the vertical cam 78 such that it is conjointly rotatable with the cams 76 and 78 . a cam follower arm 152 ( fig3 and 5 ) is in constant contact with the sound cam 150 . the cam follower arm 152 is pivotally mounted on the horizontal plate 100 by means of a pin 154 . the opposite end of the cam follower arm 152 is connected to a slide arm 156 ( fig3 and 5 ). the slide arm 156 is supported by an ear 158 and includes a 90 ° extension 160 thereon as shown in the right of fig5 . the extension 160 supports a tapper 162 which strikes the base 164 of a flexible diaphragm 166 in programmed timing with the control cams 76 and 78 each time the ball 56 appears to bounce from the surface of the table 50 or the paddles 52 . the audible signal escapes through a plurality of holes 170 ( fig1 ) in the side wall 26 of the housing . the cam follower 152 is kept in constant contact with the cam 150 by a spring 172 connected to the cam follower 152 and the base plate 34 . to add additional excitement and competition to the game , the horizontal cam 76 and the vertical cam 78 are non - symetrical about their peripheries to provide a plurality of different paths of travel and speed for the simulated ball 56 . more particularly , the cams 76 and 78 comprise a plurality of angular segments . each segment corresponds to the movement of the dot 56 from one paddle 52 to the other . the segments on the vertical cam 78 vary in angular size or shape so as to cause the dot 56 to bounce relatively higher and lower during contact of the cam follower 124 with different segments of the cam 78 . the segments of the horizontal cam 76 also vary in angular size to cause the dot 56 to move relatively faster or slower during contact of the cam follower 134 with different segments of the cam 76 . the angular size of corresponding or superimposed segments of both cams 76 and 78 are necessarily indentical to cause the vertical and horizontal elements of the light beam to simultaneously approach the paddle 52 at the limits of the path of travel 58 . the drive means 80 is provided for effecting conjoint rotation of the cams 76 , 78 and 150 and generally includes a motor 180 and a gear train 182 . more particularly , an additional horizontal plate 184 ( fig2 and 3 ) is secured to two studs 186 and 188 on the horizontal plate 100 . the variable speed electric motor 180 is mounted on the horizontal plate 184 and is provided with a pinion gear 190 which extends below the horizontal plate 184 . the pinion gear 190 is in engagement with a gear 192 which is mounted on a rotatable shaft 193 and includes an integrally formed pinion gear 194 . the pinion gear 194 is in meshing engagement with a similar gear 196 which is mounted on a rotatable shaft 197 and is formed integrally with a pinion gear 198 . the pinion gear 198 is in meshing engagement with a gear 200 mounted on a shaft 202 which extends below the horizontal plate 100 . the shaft 202 is provided with an increased diameter below plate 100 to give it additional support . a gear 204 is mounted on the shaft 202 in engagement with a large gear 206 . the large gear 206 is secured to the sleeve 120 below the sound cam 150 to give rotation to the cams 76 , 78 and 150 . the motor 180 also is powered through the transformer 86 ( fig1 ). a hand held speed control device 210 is connected in series with the transformer 86 and the motor 180 by a wire 212 . the speed control device 210 permits a player of the game to remove a resistor 213 ( fig8 ) from the motor circuit by depressing a button 214 thereon . as can be seen in fig8 the speed control device includes a switch 215 connected in parallel with the resistor 213 in the motor circuit so that the resistor will be removed from the circuit when the button 214 is depressed and the switch 215 is closed . this allows the motor to run faster while the button 214 is depressed . a receptical 216 is provided on the front of the apron wall 30 to hold the speed control device 210 when it is not in use . a slip clutch also is provided between the gear 204 and the shaft 202 to allow for slippage , without damage to the motor 180 , when the large gear is stopped by the actuating means , to be described in greater detail hereinafter . actuating means for operating the control means and detecting whether the ball has been successfully returned or missed the game device 10 is provided with an actuating means 20 ( fig2 and 6 ) to operate the control means 18 and keep the ball 56 in play ( i . e ., moving ) if the actuating buttons 38 and 40 are depressed during a predetermined interval of time as the ball 56 approaches the paddles 52 . the actuating means also is a miss detecting device for detecting whether a ball 56 has been successfully returned to the opponent as in the game being simulated . the actuating means 20 generally includes the actuating buttons 38 and 40 , and their connecting linkages , and a plurality of guide surfaces 254 , a plurality of reset surfaces 256 , a plurality of stop surfaces 258a and 258b , and a plurality of leading edge ribs 262 mounted on the lower side of the gear 206 , as best seen in fig6 . a complete set ( equal to the number of volleys per revolution of the cams ) of guide surfaces 254 , reset surfaces 256 , stop surfaces 258a and 258b , and leading edge ribs 262 are provided for each of the actuating buttons 38 and 40 concentrically on the gear 206 . the guide surfaces 254 , reset surfaces 256 , stop surfaces 258a and 258b and leading edge ribs 262 which are operatively associated with the lefthand actuating button 38 are disposed concentrically inward of those associated with the righthand button 40 . a pair of movable contact pins 264 and 266 are associated with the actuating buttons 38 and 40 , respectively . the operation of the contact pins 264 and 266 in conjunction with stop surfaces 258a and 258b , the guide surfaces 254 , the reset surfaces 256 and the leading edge ribs 262 will be described after the linkage associated with the actuating buttons 38 and 40 is set forth . each actuating button 38 and 40 is associated with its respective contact pin 264 and 266 by similar linkages therefore both will be described and designated by similar numbers with reference to the actuating button 38 ( fig4 ). the actuating button 38 is mounted on a slidable shaft 270 . the shaft is supported by a slot 272 in the pushbutton panel 14 and another slot 274 provided in a tab 276 mounted on the apron wall 30 of the housing 12 . the shaft 270 is provided with a pin 280 which is connected by a spring 282 to an ear 284 depending from the push - button panel 14 to bias the button 38 toward its uppermost position . the pin 280 also serves to limit the upward travel of the button 38 as it contacts the tab 276 . the lower end of the shaft 270 is provided with a cam surface 286 in contact with a tab 288 on a crank arm 290 . the crank arm 290 is secured to a shaft 292 which is pivotally mounted on the base plate 34 of the housing . another crank arm 294 is provided on the opposite end of the shaft 292 . the shaft 292 is biased in a clockwise direction , as seen in fig4 by a spring 296 connecting the crank arm 294 to the base plate 34 . an extended control arm 298 is pivotally connected to the crank arm 294 by a pin 300 . a flanged tab 302 is provided on the opposite end of the control arm 298 and is connected to another crank arm 304 by a pin 306 . the crank arm 304 is pivotally mounted on a pin 308 which is secured to the base plate 34 . a journal 310 connects the crank arm 304 with another crank arm 312 such that when a button 38 is depressed the described linkage causes the crank arm 312 to rotate in the direction of arrow a ( fig3 and 4 ). similarly designated elements are connected to actuating button 40 , as seen in fig3 which causes a complementary crank arm 314 to rotate in the direction of arrow b ( fig3 ). each crank arm 312 and 314 is provided with a raised or notched portion 316 . the notched portions 316 engage with mating notched portions 318 and 320 ( fig5 ) on connecting links 322 and 324 , respectively . the connecting links 322 and 324 are each biased by a spring 326 connected to the base plate 34 . thus , upon depressing one of the buttons 38 or 40 , the associated crank arm 312 or 314 will rotate as indicated by arrow a or b and will permit the connecting links 322 or 324 to rotate in a clockwise direction as shown by arrow c in fig5 under the force of the biasing springs 326 . the connecting links 322 and 324 are finally connected to a pair of control arms 330 and 322 , respectively . the control arms 330 and 332 support the contact pins 264 and 266 as best seen in fig5 and 7 . the control arms 330 and 332 are pivotally supported by means of pins 334 and 336 in a generally rectangular frame 338 . the rectangular frame 338 also is pivotally supported by means pf pins 340 in ears 342 on the base plate 34 for relative vertical movement of the contact pins 264 and 266 as required for the serving mechanism , to be described in greater detail hereinafter . therefore , when the buttons 38 and 40 are depressed the control arms 330 and 332 , rotate in the direction of arrow e as shown in fig6 and 7 under the force of the springs 326 . an explanation of the miss detecting component of the actuating means will aid in the description . the control means 18 , as previously described , simulates a ball bouncing back and forth between the simulated players 48 on the display screen . the actuating buttons 38 and 40 are used by the players of the game to cause an approaching ball 56 to appear to bounce off a particular paddle 52 and return to the opposing player . the ball 56 will continue to pass back and forth between the players unless the gear 206 of the control means 18 is prevented from rotating . a slip clutch in the gear train 182 allows the gear 206 to stop without damaging the motor 180 or other components . for this result the contact pins 264 and 266 on the control arms 330 and 332 are utilized to stop the gear 206 and thus indicate that a ball 56 has been missed as described below . as the ball 56 is approaching a particular player , the actuating buttons 38 or 40 can be operated generally in one of three manners : ( 1 ) it can be activated too early , which causes the gear 206 to stop ; ( 2 ) it can be operated too late , which also causes the gear 206 to stop ; or ( 3 ) it can be actuated timely which causes the gear 206 to continue to rotate and thus the ball 56 to continue to be volleyed . the operation of the actuating buttons 38 and 40 along with the miss detecting mechanism will therefore be described in that order . as previously mentioned , actuation of either button 38 or 40 causes the control arms 330 and 332 to rotate outwardly in the direction of arrow e . the view in fig6 ( which is a bottom view ) shows a position when the actuating button 38 , which controls the control arm 330 , has been actuated too early and the control arm 330 has rotated outwardly and contacted the guide surface 254 . then , as the gear 206 continues to rotate , the contact pin 264 will be guided by the guide surface 254 and contact the stop surface 258b . this will stop the gear 206 from rotating and indicates that a player has failed to return the ball 56 . on the other hand , if the player had not actuated the button 38 or actuated it too late , the contact element 264 would have abutted the stop surface 258a and similarly stopped the gear 206 from rotating . thus , either too early or too late actuation of the actuating button will cause the gear 206 to stop rotating and thus cause the ball 56 to come to rest on the appropriate paddle 52 indicating that a player has failed to return the ball . in this event , a point is awarded to the opponent player as in the game of table tennis . the third alternative is to actuate the button 38 or 40 as the ball approaches the paddle and cause the contact element 266 or 264 to pass between the stop surfaces 258a and 258b and thereby permitting the gear 206 to continue to rotate . in order to make this more feasible , a leading edge rib 262 is provided adjacent each stop surface 258b of sufficient length to allow approximately an interval of 6 ° of rotation in which the player may timely actuate his button . thus , when actuated , the control arms 330 or 332 rotate in the direction of arrow e and the contact elements 264 or 266 on the end of the control arms will contact the leading edge rib 262 and be guided through the space between the stop surfaces 258a and 258b . of course , it is the object of the game to timely actuate the actuating button 38 or 40 so as to permit the ball 56 to return to the opposing player . the control arms 330 and 332 are biased in the direction of arrow e after the contact element 264 and 266 passes between the stop surfaces 258a and 258b . therefore , a reset surface 256 is provided to rotate the control arms 330 and 332 back to their original position . as the control arms 330 and 332 resume their original position the connecting linkages 322 and 324 will be reset and catch on the notches 316 of the crank arms 312 and 314 . therefore , the control arms 330 and 332 will remain in that position until the buttons 38 or 40 again are actuated . at this time , it should be pointed out that the number of stop surfaces 258a and 258b along with the number of guide surfaces 254 , reset surfaces 256 and leading edge ribs 262 is determined by the number of volleys provided for on the horizontal cam 76 for each revolution of the cam 76 . the device will continue to operate and the ball will continue to move back and forth until one of the contact pins 264 or 266 abuts a stop surface . the serving mechanism , generally designated 22 , is provided to initiate a volley at the beginning of a game or after one of the players has failed to return the ball by allowing his contact pin 264 or 266 to abut one of the stop surfaces 258a or 258b . more particularly , the serving mechanism 22 comprises the serving button 44 ( fig2 ) on the raised portion 42 of the push button panel 14 . the operation of the serve button is similar to that of the actuating buttons 38 and 40 . the serve button 44 is mounted on a slidable plunger 350 which is supported in a slot 352 in the top of the raised surface 42 and a second slot 354 provided for in a tab 356 ( fig2 ) attached to the apron wall 30 of the push button panel 14 . the lower end of the plunger 350 contacts a tab 358 located on a crank arm 360 ( fig3 ). the crank arm 360 is mounted on a pivotally supported shaft 362 . another crank arm 364 is mounted on the shaft 362 and is pivotally connected to an extended connecting arm 366 by means of a pin 368 . the opposite end of the connecting arm 366 is pivotally connected to another crank arm 370 by means of a pin 372 . the crank arm 370 is mounted on a shaft 374 which is pivotally mounted on the base plate 34 . the shaft 374 has a second crank 376 secured thereon and pivotally connected to a final link 378 by means of a pin 380 . the link 378 is secured to the pivotally mounted rectangular control arm support 338 . the serve button 44 is biased in an upward direction by means of a spring 382 connected to the crank arm 364 and the base plate 34 . actuation of the serving button 44 will therefore cause the control arms 330 and 332 to rotate downwardly in the direction of arrow f , as shown in fig7 and 2 . an integral part of the serving mechanism 22 is the dimensions of the stop surfaces 258a and 258b and guide surfaces 254 on the gear 206 . the stop surfaces 258a and 258b are approximately 1 / 16 of an inch lower than the surface of the gear 206 . the guide surfaces 254 and the reset surfaces 256 are approximately 1 / 8 of an inch lower than the surface of the gear 206 . the serving mechanism provides that the pins 264 and 266 on the control arms 330 and 332 will move downwardly in the direction of arrow f ( fig7 ) approximately 1 / 16 of an inch when the serve button is depressed in order to clear the stop surfaces 258a and 258b . however , the contact elements 264 and 266 cannot move downwardly far enough to clear the guide surfaces 254 and the reset surfaces 256 and therefore they will always be kept in proper orientation . thus , to initiate a new volley after a contact element 264 or 266 has abutted a stop surface 258a or 258b , a player merely depresses the serve button 44 allowing the contact pins 264 and 266 to pass under the stop surfaces 258a or 258b , allowing the gear 206 to continue to rotate , this rotation causes the ball 56 again to traverse a path across the display screen 16 for the resumption of play . it may be noted that as described above , the player who has just missed returning a ball to the opposing player would always necessarily serve the next ball thus being an unrealistic representation of the actual game of table tennis , since the rules of table tennis require a player to serve five consecutive balls before the other has an opportunity to serve . in order to be more realistic , however , the players may wish to return the ball to a particular server under the rules of table tennis . to achieve this more realistic game rule , the players need only depress the serve button one time and allow the ball to return to the player who should be serving , where it will stop since neither of the actuating buttons has been depressed , and then permit that player to initiate the next volley . the foregoing detailed description has been given for clearness of understanding only and no unnecessary limitations should be understood therefrom , as some modifications will be obvious to those skilled in the art .

an electrically and mechanically operated competitive amusement game , simulating the game of table tennis . the game includes a display screen so arranged that a game can be simulated thereon where two players appear to hit a ball , in the form of a light image , back and forth on the screen . the game includes a serve button for initiating a serve at the beginning of the game . the players continue to &# 34 ; volley &# 34 ; the simulated ball back and forth by timely actuation of two &# 34 ; volleying &# 34 ; buttons until a miss is detected . when a miss is detected , the ball comes to rest and a new serve is initiated to start the process again .