Abstract: The present invention provides, in certain aspects, medical devices deliverable into passageways and other open spaces in the body. In one embodiment, the invention provides a fistula plug for delivery into a fistula tract. This fistula plug comprises an elongate plug body, and a removable core material that is received in the plug body and effective to increase the column strength of the plug body. The plug body may be formed with one or more of a variety of biocompatible materials including some that are naturally derived and some that are non-naturally derived. The present invention also provides apparatuses and methods for delivering these and other medical devices into the body. One such apparatus comprises a fistula plug having a plug body, and a removable delivery device received in the plug body, wherein the delivery device is effective to deliver the plug body into a fistula tract when advanced therethrough.

Abstract: An adhesively attachable bandage for an open wound. A one-way valve permits air or other fluids to move through the bandage in one direction, as to escape from a body cavity, but prevents fluids from moving in the other direction, as in entering the wound. A selectively sealable port can be opened to give access directly to the wound. The bandage may be transparent.

Abstract: A gastro-intestinal therapeutic device and method includes providing a therapeutic device having a body and an anchoring mechanism. The anchoring mechanism is adapted to resist distal migration of said body in a gastro-intestinal tract. The body is generally configured to a portion of the gastro-intestinal tract and has a first wall portion and a second wall portion. The first wall portion defines a generally sealed membrane. The second wall portion has a scar-forming agent.

Abstract: The present invention discloses devices, systems and methods for increasing blood pressure in a blood vessel by introducing an anchor within that traps a particle capable of increasing in volume as it is exposed to blood flow. As the particle increases in volume, it serves to decrease the cross sectional area of the blood vessel, resulting in decreased blood flow and increased blood pressure. This invention may be used to arterialize blood vessels in the venous system to prepare them for an exposure to arterial pressures.

Abstract: An implant capable of forming a differential image in an eye is shown. The implant comprises an elongated member having a pair of spaced ends wherein one of the pair of ends includes a distal section that extends in a direction substantially parallel to the central axis. The elongated member and the distal section are formed of a dimension to be inserted into and/or passed through a punctum opening of an eye and into the canaliculus. The implant incorporates into at least one of the elongated member and the distal section an energy obstructing material responsive to the application of an energy wave, such as an energy wave in the form of sound waves vibrating at frequencies greater than 20,000 cycles per second or electromagnetic radiation, which upon everting of an eyelid of an eye and exposing the implant to an appropriate energy wave, forms a differential image pattern showing the location of the implant in the eye.

Abstract: A blood vessel occluding device including a plug and an insertion device to temporarily occlude a blood vessel. In one embodiment, the plug has an axially symmetric shape and is made of a biocompatible material such as Silicone. The plug is inserted axially into the blood vessel and is gripped firmly by the walls of the blood vessel. A filament is attached to an inner surface of the plug. Pulling the filament exerts compressive force on the plug, causing the plug to collapse and facilitating the removal of the plug. The blood vessel occluding device allows the blood vessel to be occluded quickly and effectively. The insertion device is a spring loaded device that has a spring activated needle; this insertion device provides the axial force to insert the plug into the blood vessel.

Abstract: This invention relates to apparatus and methods for use in sealing a vascular puncture site and to apparatus and methods for properly locating and deploying a sealing device. The locating apparatus includes a lumen which extends from an opening in the distal region of the apparatus but located proximally of the sealing device, which lumen extends to another opening in the proximal region of the device. When the distal opening is in communication with blood in a blood vessel, blood flow through the lumen and out of the proximal opening signifies such location to the user. When the sealing device is withdrawn such that the sealing device is deployed such that it blocks the blood flow into the distal port, the user will know the location of the sealing device. In a preferred embodiment, the sealing device is then withdrawn proximally a predetermined distance to assure that no part of the sealing device extends into the blood vessel lumen. The sealing device is then detached from the delivery device.

Abstract: An apparatus for inhibiting blood loss from a puncture site. The apparatus may include means for locating a puncture site in a blood vessel wall. This apparatus is comprised of a tube and an elongated member that is positioned around the tube. The elongated member includes a proximal end and a distal end. Around the tube is also a dissolvable distal capsule, the distal capsule including a proximal end and a distal end, wherein the proximal end of the distal capsule attaches to the distal end of the elongated member. Inside the distal capsule is hemostatic material such as a sponge.

Abstract: A system for placing an implant in the body includes an elongated member having at least one inner lumen extending from a proximal end portion of the member to an opening in a distal end portion of the member. At least one compressible implant is in the inner lumen of the member. The implant optionally includes anchor members projecting from its outer surface to limit migration of the implant in the body. Structure is provided to push the implant through the opening in the distal end portion of the member. The implant is placed between layers of body tissue to bulk the tissue. In one of the disclosed methods, the system is used to treat gastroesophageal reflux disease (GERD) by placing the implant between layers of body tissue at or near the gastro-esophageal junction.

Abstract: A female condom is provided that includes a pouch of resilient membranous material and a hydrophilic cling mechanism. According to an embodiment of the invention, the cling mechanism includes three or more foam cling elements attached to an outer surface of the pouch. Upon insertion, the foam cling elements cling lightly to vaginal walls proximate a transition zone between the vagina's introitus and its rugated internal tissue. The foam cling elements may be shaped to permit them to nestle into a user's rugated internal vaginal tissue. An inserter may be coupled to the pouch for facilitating insertion of the condom. The inserter may retain a distal portion of the pouch in a collapsed form. The cling mechanism may be contained within the dissolvable inserter. The inserter may be dissolvable in the presence of vaginal moisture. Methods are also provided for collapsing the pouch and compressing it into an insertion package.

Abstract: A blood vessel occluding device including a plug and an insertion means to permanently occlude a blood vessel. In one embodiment, the plug has a tapered shape and is made of a biocompatible material such as Silicone. The plug is inserted axially into the blood vessel and is gripped firmly by the walls of the blood vessel. The insertion device is a spring loaded device that has a spring activated needle; this insertion device provides the axial force to insert the plug into the blood vessel. The blood vessel occluding device allows the blood vessel to be occluded quickly and effectively.

Abstract: A compression and ligation device includes a pair of jaws including one or more Doppler chips oriented to send and receive Doppler signals across the jaws, to assist a practitioner in determining whether or not a uterine artery is between the jaws. A suture leader with an attached suture can be pushed through a channel on one of the jaws, through tissue behind the uterine artery, into another channel on the other jaw, and proximally out the device so that the practitioner can ligate the artery and effect hemostasis.

Abstract: A punctum plug includes a body portion having a nose and rim portions which meet at an angle which facilitates both insertion and retention. In addition, the shaft of the plug includes a circumferential groove level with the top of the body which increases flexibility between the shaft and body of the plug. Furthermore, the groove locates the pivot point of the rim of the body radially inward which increases the flexibility of the rim.

Abstract: Disclosed is an adjustable occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device is removably carried by a deployment catheter. The device may be enlarged or reduced to facilitate optimal placement or removal. Methods are also disclosed.

Abstract: The present invention provides an occluder with a self centering system that keeps the occluder properly centered in a defect which allows the center of the occluder to remain properly positioned within the defect so that the left and right sides cover the entire defect which reduces the chance of blood shunting through the defect and increases the effectiveness of the occluder. The self centering system is comprised of a series of arms that provide tension to hold the right and left sides in place. The arms are shaped to provide a flexible intermediate zone comprising a left and a right conical shaped network, wherein each network extends from the right and left sides and narrows at the center section. The flexible intermediate zone centers the occluder and helps to hold it in place.

Abstract: Disclosed is an occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device includes an occlusion member and may also include a stabilizing member. The stabilizing member inhibits compression of the left atrial appendage, facilitating tissue in-growth onto the occlusion member. Methods are also disclosed.

Abstract: Methods and systems related to sealing punctures in blood vessels (such as following an angio or PTCA procedure) are disclosed. The position of a distal end of an introducer assembly in tissue is determined using a pressure sensor. The pressure sensor is connected to the proximal end of the introducer assembly. The introducer assembly has a fluid path between its distal end and its proximal end. Measured blood pressure is outputted as an indication of the position of the distal end of the introducer assembly in the tissue. Proper positioning of a seal is confirmed by placing the introducer assembly such that its distal end is in tissue outside a puncture in a blood vessel wall and observing a characteristic of blood at the proximal end of the introducer assembly.

Abstract: An adjustable occlusion device and a method of implanting the device in a body lumen such as the left atrial appendage. The occlusion device is removably carried by a deployment catheter. The device may be enlarged or reduced to facilitate optimal placement or removal. Methods are also disclosed.

Abstract: A punctum plug system includes a punctum plug and an insertion tool therefor. In various embodiments of the invention, the plug includes an axial bore shaped in accord with a stepped cylinder, a cylinder having a tapered end, or a combination thereof. In each embodiment, a relatively proximal portion of the tip of the insertion tool extends within a relatively larger diameter proximal portion of the plug bore but does not frictionally engage such portion, and a relatively distal portion of the insertion tool tip frictionally engages the distal portion of the plug bore. The frictional engagement between the tool tip and the plug is preferably optimized such that once the plug is inserted into a punctum for which the plug is appropriately sized, the insertion tool may be removed simply by withdrawal of the tool, without wiggling the tool or stabilizing the plug with a second instrument.

Abstract: Disclosed is an occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device includes an occlusion member and a plurality of tissue retention structures. The tissue retention structures inhibits movement of the device from the left atrial appendage. Methods are also disclosed.

Abstract: A method and apparatus for closing a vascular wound includes a guidewire and/or other surgical implement extending from the wound. A hemostatic material is advanced over the surgical implement and into contact with an area of the blood vessel surrounding the wound. The surgical implement is removed. Blood soaks the hemostatic material, and blood clotting is facilitated by the hemostatic agent within the material. A sealing layer of adhesive can be applied to the hemostatic material, confining the blood flow to the material. Thus, the vascular puncture wound is sealed by natural blood clot formation.

Abstract: Apparatus for sealing a puncture includes an elongate occlusion member having a balloon attached to distal ends of telescoping inner and outer members. A housing on the proximal end of the outer member includes a piston coupled to the inner member and slidable within a chamber communicating with a fluid reservoir. A switch on the housing is actuated to direct fluid from the reservoir through the outer member into the balloon to expand the balloon and into the chamber to move the piston and pull the inner member, shortening the balloon as it expands. During use, the distal end of the occlusion member is introduced into a puncture communicating with a vessel until the collapsed balloon is disposed within the vessel. The balloon is expanded, and a tensioner is connected to the housing to apply a proximal force holding the balloon against the vessel wall to seal the puncture.

Abstract: Apparatus for sealing a puncture communicating with a blood vessel includes an introducer sheath, an occlusion member with a balloon thereon, a retraction assembly, and a syringe assembly including sealing material therein. During use, the introducer sheath is introduced into the puncture. With the balloon in a collapsed state, the occlusion member is introduced through the introducer sheath until the balloon is disposed within the vessel. The introducer sheath is coupled to the retraction assembly, the balloon is expanded, and the occlusion member is partially withdrawn to seal the puncture. A sealing compound is delivered from the syringe assembly through the introducer sheath into the puncture, the syringe assembly triggering the retraction assembly, whereupon the introducer sheath is automatically withdrawn at least partially from the puncture, delivering the sealing compound along the puncture.

Abstract: A punctum plug system includes a punctum plug and an insertion tool therefor. In various embodiments of the invention, the plug includes an axial bore shaped in accord with a stepped cylinder, a cylinder having a tapered end, or a combination thereof. In each embodiment, a relatively proximal portion of the tip of the insertion tool extends within a relatively larger diameter proximal portion of the plug bore but does not frictionally engage such portion, and a relatively distal portion of the insertion tool tip frictionally engages the distal portion of the plug bore. The frictional engagement between the tool tip and the plug is preferably optimized such that once the plug is inserted into a punctum for which the plug is appropriately sized, the insertion tool may be removed simply by withdrawal of the tool, without wiggling the tool or stabilizing the plug with a second instrument.

Abstract: A surgical aid to facilitate wound closure particularly, but not exclusively, in the abdominal region. The surgical aid includes a body portion and a tail portion. At least the body portion is made predominantly of a planar, flexible and resiliently stretchable material, preferably surgical grade silicone. In a preferred embodiment the surgical aid is fish shaped, having a roughly elliptical body and a smaller elliptical tail. The body and tail portions are integrally formed from a single sheet of surgical grade silicone. The invention also provides a method of using the surgical aid wherein the body portion is inserted into the wound prior to closure to act as a physical barrier between the peritoneum and the viscera. The peritoneum and posterior rectus sheath is then closed by suturing over the body portion. When the closure is almost complete, the body portion is withdrawn using the tail portion as a handle. The closure can then be completed.

Abstract: This invention relates to a fertility plug, for use by both humans and animals, constructed from an impermeable polymeric film membrane covering an elastically deformable, compressible interior, which, because of pressure from the vaginal walls on the unit (forming a seal), prevents escape of semen from a vagina immediately after ejaculation or injection of semen into the vagina, but instead remain for a limited time in the vicinity of the cervix and, thus available for fertilization. A string may be attached to the unit to assist the removal of the plug after the unit has been in the vagina for a sufficient time for sperm to have entered the uterus. A nonspermicidal lubricant can be used with the fertility plug to facilitate insertion into and removal from the vagina; the nonspermicidal lubricant also enhances the seal formed between the unit's surface and the vaginal wall, further restricting the loss of semen from the vagina.

Abstract: A device for temporarily preventing flow of urine out of the urethra in a person suffering from urine incontinence comprises a first composition (11) enclosed in a first container (10) capable of being fed into the urethra (17) which is thereby blocked. The first container (10) comprises a mouthpiece (12) for insertion into the urethra (17) and for transport of the first composition (11) from the container (10) into the urethra (17). The first composition (11) comprises or is capable of forming a gel for blocking of the urethra by a gelatinous plug. The plug may be mechanically removed if the person wishes to urinate; alternatively the device may comprise a second composition in a second container for removal of the gel plug. In the latter alternative injection of the second composition in the urethra (17) adjacent to the gel plug causes the breakdown of the plug. Also disclosed is a corresponding method and the use of the first and second compositions in urine incontinence.

Abstract: A flexible membrane is situated within a rigid or semi-rigid cap. The edge of the cap wall is adhesively fixed to the tissue surrounding the stoma. The interior of the cap is pressurized to press the membrane to seal the stoma against the discharge of solid and semi-solid waste. Gas escapes through a vent with a filter element. The cap can be pressurized by an external pump or an integral pump member situated on top of the cap. A relief valve prevents over pressurization. A collection pouch can be provided as part of a device. The device can be removably mounted on a standard two-piece faceplate.

Abstract: Apparatus and methods are provided for reducing the volume of a lung using a clip including a plurality of tines. The clip is advanced along an interior of a bronchial passage to a predetermined location with the tines in a contracted condition. The tines are expanded outwardly to engage surrounding tissue, and then collapsed towards the contracted condition, thereby drawing the surrounding tissue inwardly to substantially close the bronchial passage from air flow therethrough. Optionally, electrical energy may be applied to the surrounding tissue after collapsing the tines to the contracted condition, thereby fusing the surrounding tissue together. The clip is then released within or removed from the passage.

Abstract: A punctum plug generally includes a shaft and a head at a proximal end of the shaft. The shaft is provided with at least one circumferentially radiating flexible anchoring arm of varying radial extension at at least two locations along its length which is adapted to secure the punctum plug within the punctum of a wearer. The head has a concave proximal surface and a distal surface which tapers toward the shaft. A diameter of the head is substantially larger than a diameter of the shaft. According to a first embodiment of the invention, a plurality of anchoring arms in the form of symmetric circumferential rings are spaced a distance apart along a length of the shaft and define spaces therebetween. One or more of the rings has a diameter equal to or larger than the diameter of the head of the plug, and different rings preferably have different diameters.

Abstract: A device for closing and promoting the healing of a skin laceration in a predetermined skin portion of the body. The device comprising a first means engageable with a skin portion of the body for drawing such laceration together. A screen member disposed intermediate with the skin laceration and first means for maintaining closure of such skin laceration. A medical adhesive engageable with a screen member as a means for sealing the skin laceration together.

Abstract: The present invention is drawn to a valve control accessory for use with a dual balloon stent delivery catheter. The accessory device includes a bifurcated fluid line adapted to connect to an inflation device using a proximal luer connector. Additional luer connectors at the distal ends of the main fluid line and branched fluid line are engaged to connect to the proximal ends of a bifurcated catheter shaft, allowing the fluid lines to be in fluid communication with a parent and sidebranch balloon respectively. In one embodiment, stopcocks are formed in both the main and sidebranch fluid lines to allow independent or simultaneous expansion of each balloon. A pressure indicator may be placed on either fluid line to indicate which line is under pressure.

Abstract: A integral vascular filter system comprising a guidewire and an integral filter which can be used to capture embolic particulates during medical procedures, while allowing for continuous perfusion of blood, with minimal incremental blood flow turbulence. The vascular filter system addresses the clinical problem of minimizing profile or diameter, so as to enable or facilitate the crossing of a lesion or obstruction in the vessel, while also minimizing incremental blood flow turbulence which may result in thrombus formation.

Abstract: Achieving lung volume reduction includes occluding a lumen of a bronchial tube of a lung to prevent air flow to at least a region of the lung. Bronchial occluders such as polymerizable materials and mechanical devices, such as sutures, staples, clips, clamps, foam, balloons, umbrellas and ball bearings are provided for occluding a bronchial tube. Methods include mixing thickeners or foaming agents with polymerizable compositions and introducing the mixture into a lumen of a bronchial tube. Mechanisms for mixing components and delivering the mixture to a lumen of a bronchial tube are also provided.

Abstract: An intravaginal device having an overwrap containing an enclosed material, and a withdrawal string passing through a portion of the overwrap formed into a loop, the withdrawal string enabling a user to remove the intravaginal device after use.

Abstract: With an object of providing an artificial sphincter for which repeated shape changes are possible, and for which the quantity of shape change is sufficient so as to be used as a substitute for a large natural sphincter, an artificial sphincter 11 that opens and closes, as required, either the anus of a living body or part of the intestine 19 led outside the body is provided, wherein this artificial sphincter 11 comprises a pair of shape memory alloy elements 13 that change reversibly between two opposite shapes upon changes in temperature and hinges 15 that link the shape memory alloy elements 1 together in a cylindrical shape.

Abstract: An apparatus for measuring a lacrimal punctum and a canaliculus is provided. The apparatus comprises a handle and a tip disposed at one end of the hand, said tip having a gauge portion of size and shape to allow measurement of the lacrimal punctum and the canaliculus. The apparatus may further comprise a dilator portion disposed between the gauge portion and handle.

Abstract: An apparatus for measuring a lacrimal punctum and a canaliculus is provided. The apparatus comprises a handle and a tip disposed at one end of the handle, said tip having a gauge portion of size and shape to allow measurement of the lacrimal punctum and the canaliculus. The apparatus may further comprise a dilator portion disposed between the gauge portion and handle.

Abstract: A urinary sphincter control device for application to a urethra to control flow of fluid through the urethra, comprises a cuff which can be fitted around the urethra. The cuff comprises a plurality of chambers which extend generally parallel to the axis of the cuff, and which can be inflated by supply of pressurised control fluid thereto. Inflation of the chambers causing the configuration of the cuff to change so as to alter the resistance that is provided by the cuff to flow of fluid along the urethra.

Abstract: A canalicular plug includes a throughbore provided with a valve. Preferably, the plug has a proximal occluding head, a central shaft and a distal body portion. The throughbore is preferably stepped and includes a large proximal portion for receiving an insertion tool and a smaller distal portion. The valve is preferably integrally molded with the canalicular plug, and the plug is preferably made from a resilient biocompatible material. According to a preferred aspect of the invention, the distal body portion includes at least one slot dividing the distal portion into a plurality of resilient portions which are biased apart and coupled by a foldable curtain portion extending between the resilient portions. The resilient portions are inwardly compressible about the slot. When compressed together, the distal ends of the resilient portions together form a generally conical or frustoconical shape which facilitates insertion through the punctal opening.

Abstract: A punctum plug for insertion through a punctum opening of an eye and into the canaliculus to occlude the punctum opening and canaliculus is shown. The punctum plug, or implant, comprises an elongated member having a pair of spaced ends wherein one of the pair of ends includes a distal section, preferably in the form of collapsible expanded section which terminates in a distal tip which extends in a direction substantially normal or perpendicular to the central axis. The other end of the pair of ends includes a thin retaining lip which extends in an anterior direction and which is adapted to be oriented to extend beyond the edge of the punctum opening and to engage the lip margin defining the eyelid. The elongated member, including the collapsible expanded section and distal section, are formed of a dimension to pass through a punctum opening of an eye. A method for treating external eye condition due to a deficiency of tears utilizing the punctum plug is also shown.

Abstract: The invention relates to a device for performing hemostasis at two symmetrically located puncture sites in the femoral arteries or veins of a patient. It comprises a beam member (6, 8) provided with two attachment devices (10, 12) for pressure pads. There are belts for securing the device to the patient to provide a pressure on the puncture sites, and means (18, 20, 24, 26) for adjusting the distance between said attachment. The invention also provides a method of controlled hemostasis at two puncture sites in each femoral artery or vein of a patient after catheterization, comprising providing a beam member having two pressure pads, adapted to bear against each puncture site, adjusting the center-to-center distance of said pressure pads by moving at least one of said pressure pads along said beam member, applying said pressure pads at said puncture sites, securing said beam member carrying said pressure pads to the body of said patient, by tightening a belt around the body.

Abstract: The invention concerns a meatus plug for lachrymal canal capable of being screwed, consisting of a substantially cylindrical body (1) whose side surface comprises a helical thread similar to that of a screw for placing or removing the meatus plug by screwing or unscrewing with a tool having a polygonal or cruciform blade used as a screwdriver, the plug comprising or not a through conduit for the passage of a predetermined flow of lachrymal fluid. It is designed for controlling the flow of tears running on the surface of the eye towards the nasal cavity through the lachrymal canals or ducts.

Abstract: An ocular plug design and method of insertion is described for the treatment of dry eye. This ocular plug is a narrow rod-like cylinder of appropriate diameter, which is tapered at one end, for insertion into an ocular channel. The plug is prepared from either (or both) of two specific classes of polymeric materials having both viscous and elastic properties. The first class of polymeric materials have a glass transition temperature (Tg) at or below human body temperature (37° C.). The second class of polymeric materials have a melting temperature (Tm) at or below human body temperature (37° C.). The plug is stored in a frozen, rigid, elongated state prior to insertion into an ocular channel. Once inserted into an ocular channel, the smart plug responds to an increase in temperature, due to the surrounding physiochemical environment, whereby it becomes soft and the plug subsequently expands to adapt to the size and shape of the patient's punctum or canaliculum.

Abstract: A method for inserting a plug into a hole formed in a cranial bone by rotating the plug to insert. The plug having a body with a first end, a second end, and a peripheral surface interposed there between, the first end is slightly larger than the second end. The peripheral surface further includes irregularly distributed projections.

Abstract: The present invention relates to a self-expanding device for sealing a defect in a wall, such as a septal defect. The device of the present invention has a fluoropolymer membrane that is supported by an embedded wire structure having elastic properties which is capable of being compressed and inserted in the defect by a catheter and thereafter returning to its memory induced configuration. The device of the present invention can be employed in a variety of applications where a small hole needs to be sealed.

Abstract: A punctum plug includes a proximal head, a distal body, and a shaft between the head and the body. The shaft of the plug is provided with one or more foldable portions, thereby permitting the length of the shaft to vary depending upon the degree to which the folds are folded or unfolded. In addition, the folds permit the wall of the shaft to easily bend, permitting the head and body of the plug to lie along different axes. As a result, the plug is shaped to accommodate both relatively long and short vertical puncta and the body of the plug may be angled relative to the head to accommodate a variety of anatomical structures.

Abstract: A punctum plug includes a proximal head, a distal body, and a thin-walled flexible shaft between the head and the body. The thin wall of the shaft of the plug is preferably provided with accordion-like folds, thereby permitting the length of the shaft to vary depending upon the degree to which the accordion-like folds are folded or unfolded. In addition, the accordion-like folds permit the thin wall of the shaft to easily bend, permitting the head and body of the plug to lie along different axes. As a result, the plug is shaped to accommodate both relatively long and short vertical puncta and the body of the plug may be angled relative to the head to accommodate a variety of anatomical structures. According to another aspect of the invention, the body of the plug may be provided with a thread which rotationally guides the plug into the small punctal opening when insertional and rotational forces are applied to the plug. As a result, a relatively larger body size may be used.

Abstract: An urinary incontinence device for use by a male includes an undergarment worn closely to the body and including an opening or hole through which the penis passes and is kept upright and close to the body by a flap across the opener in the undergarment. The flap may include an occlusion device integrally incorporated therein and aligned with the opening to be positioned between the base of the shaft of the penis and the scrotum to occlude the urethral passage of the penis. The occlusion device is designed to apply sufficient pressure to occlude the urethral passage without cutting off circulation of blood within the penis through the dorsal vein. The flap design maintains and retains an optimum position of the penis and occlusion of the urethral passage to prevent urine discharge in a form fitting undergarment that allows significant freedom of movement by the wearer.

Abstract: A device for insertion into a puncture in a tracheoesophageal wall includes a cylindrical body and a flexible first flange provided on an outside surface of the body. The flange has a use orientation in which it projects generally outwardly from the outside surface of the body and an insertion orientation in which it is resiliently folded toward the axis of the body. A retainer constructed of a material soluble in fluids present in the tracheoesophageal wall and esophagus retains the flange in its resiliently folded orientation.