Abstract: A blood flow control system comprising a primary arteriovenous fistula connecting a blood source to a vein, and a secondary fistula connected to the first fistual leading to a venous sink. A blood flow control device is engaged with the primary fistula so as to impede the flow therethrough, and is disposed between the secondary fistula and the vein, and it is actuated transcutaneously, whereby restriction of the blood flow through the primary fistula increases the flow of blood to the venous sink.

Abstract: A urinary catheter forming a continent urethral endoprosthesis equipped with an artificial sphincter which is devoid of an exterior device. The prosthesis includes a tubular body having one end open and having at the other end a seat placed inside the bladder, with a valve urged elastically into the closed position, the seat of which is formed by the other end of the tubular body.

Abstract: A compact, hand-held instrument by which to permit a physician to accurately and controllably implant, dispense, and inflate an inflatable membrane at a predetermined target area within the tissues of a patient. In a preferred embodiment of the invention, the inflatable membrane is a genitourinary prosthesis, and the targeted area lies within the corpus spongiousum surrounding the urethra to enable a patient to overcome urinary incontinence by means of increasing both localized tissue volume and passive occlusive pressure upon the urethral mucosa. The instrument includes a trocar assembly having a plurality of telescoping trocar members which may be either retracted for dilating a tunnel through the urethral tissues of the patient or expanded for placing, dispensing and inflating the membrane at the end of the tunnel. The membrane is percutaneously infused with and inflated by material (e.g.

Abstract: The incontinence control device of the present invention as described includes a cloth strap adapted to encircle a penis, the strap having cooperative pressure adherence layers on portions of the inner and outer surfaces so that the strap can form a circumference when the inner adherence layer is engaged with the outer adherence layer of the strap. The inner surface of the strap also has a compressible pad adjacent the pressure adherence layer and another compressible pad in fixed relation to the first pad. An inflatable sac is affixed to the strap between the two compressible pads. A tube passes through the strap to communicate with the interior of the inflatable sac at one end of the tube. A check valve is attached at the other end of the tube. A syringe is adapted to engage the check valve so that air in the syringe can be injected through the tube into the sac to inflate the sac.

Abstract: A vaginal stimulator adapted to be inserted into a women's vagina to stimulate and constrict muscles therein and prevent the flow of urine through the urethra. A vaginal plug having a conical tip includes a power supply, pulse generator, on/off switch and intensity control switch mounted therein. Electrodes coupled to the pulse generator are positioned on an exterior surface of the vaginal plug. A disposable condom is unrolled over the vaginal plug and includes conductive elements which are positioned in electrical contact with the electrodes to carry the electric pulses to the muscles.

Abstract: A urethral catheter comprising a tube having openings at both ends and at least a portion of the tube having a flexural wall formation permitting compliance of the wall with the urethral shape in use. Longitudinal flexion in the oval-shaped tube is reduced optionally by incorporating a thickened wall portion extending along the catheter about the minor axis thereof, and/or flexural compliance in the lateral direction is reduced optionally by providing a thickened wall portion about the major axis. The catheter is suitable for male patients, and the wall formation can be selected for satisfactory performance under a number of different conditions.

Abstract: An implantable hydraulic urinary sphincter system is disclosed for maintaining continence in those patients unable to control or stop inadvertent urinary flow. The invented apparatus generally consists of an artificial urinary sphincter and a control means for automatically increasing or decreasing sphincter pressure with sensed bladder and/or intra-abdominal pressure. An improved mechanical actuation means is also disclosed which allows the patient to urinate. To urinate the patient presses a push button centered on a septum located on the outer wall of the subcutaneously implanted control unit.

Abstract: Apparatus for hypodermically implanting a genitourinary prosthesis comprising an extensible, inflatable tissue expanding containment membrane to be located in the proximal periurethral tissues to add bulk to these tissues and thereby overcome urinary incontinence by means of localized, controlled tissue volume increase. Hypodermic positioning, injecting and inflating instruments are also disclosed for implanting the containment membrane and for percutaneously infusing the membrane with biocompatible fluid or suspended particulate matter. The containment membrane functions as an envelope for retaining the fluid or particulate matter therewith in while controllably and advantageously increasing localized tissue volume and simultaneously preventing the migration of such fluid or particles. Accordingly, an increased passive occlusive pressure may be applied to the patient's urethra to achieve continence.

Abstract: This device is designed to effectively restore the muscles of the pelvic floor of a patient. Primarily, it consists of a main body with an upper front horn portion for engagement with the exterior of the vulva without pinching it. A pair of rearwardly extending wing portions are provided on the device and engage with the inner portions of the thighs of the patient, and a spring portion in the wings is provided, for returning the wings to their normal outwardly extending positions after being compressed.

Abstract: An implantable hydraulic urinary sphincter system is disclosed for maintaining continence in those patients unable to control or stop inadvertent urrinary flow. The invented apparatus generally consists of an artificial urinary sphincter and a control means for obtaining continence while causing the artificial sphincter to apply mininmal pressure to the urethra for all conditions of the bladder. The invented apparatus: (1) automatically causes sphincter fluid pressure to increase or decrease with sensed bladder and/or abdominal pressure, and (2) is manually actuated by the patient when he or she desires to urinate. The invented apparatus can be filled with fluid, or the fluid pressure can be reset, after implantation without necessitating a surgical procedure.

Abstract: A combination hypodermic syringe and manometer for simultaneously imparting fluid to an external device, such as a hollow occlusion cuff surrounding a patient's urethra, while at the same time providing an accurate indication of both the internal pressure within the manometer as well as the external occlusive pressure being applied to the patient's urethra by the occlusion cuff. The hypodermic manometer includes a piston assembly which is adapted for reciprocal movement through a fluid filled sleeve, whereby to force fluid from the sleeve into the occlusion cuff via a hypodermic syringe. Calibrated indicia marked on the manometer provides an indication of the internal pressure therewithin as well as the external occlusive pressure being applied to the patient's urethra.

Abstract: A combination container and air removal fixture for easily and precisely filling an implantable hydraulic device with a continuous air-free supply of hydraulic fluid. In accordance with a preferred embodiment, the hydraulic device is an elastofluidic prosthetic sphincter and the fluid is a radio-opaque fluid. A premixed and pre-proportioned supply of hydraulic fluid is contained within each of a plurality of gas-fluid exchange chambers. A hollow occlusion cuff and at least one reservoir-actuator of the prosthetic sphincter are placed in fluid communication with respective exchange chambers. When the occlusion cuff and actuator are compressed, associated pistons are moved outwardly through the exchange chambers, whereby fluid containing entrapped air is withdrawn from the cuff and the actuator and removed to the chambers.

Abstract: A prosthetic sphincter device in the form of a closed pressure-fluid system operable by the recipient to control a body duct comprises a pressure-fluid reservoir (10), an inflatable duct-obviator (8) typically of cuff form, a pump (9) operable to deflate the cuff, and a control mechanism (1, 14, 15) operable normally to hold the cuff inflated at a preset pressure to close the duct, the mechanism being adjustable in situ post-operatively to vary the preset pressure. In a preferred form the control mechanism includes a valve (1) communicating the reservoir and cuff, and a preset pressure-fluid source (14) connected to hold the valve normally closed, this source including a self-sealing septum (16) allowing preset pressure adjustment by injection. The valve preferably has a through passageway defined at least in part by a flexible wall (6) externally subject to the preset pressure.

Abstract: A device for controlling the flow of a fluid, more especially a biological fluid and in particular the urinary flow, the device including a rod which, in the rest condition, is sealingly clamped, by any appropriate clamping mechanism, inside a connecting tube, and which is made from a flexible plastic material presenting shrinkage on polymerization, and a mechanism which is adapted to prevent the axial movement of the valve rod along the connecting tube under the effect of the pressure of a fluid filling two flexible activating bags connected through the connecting tube, which may be incorporated with a third flexible bag.

Abstract: A surgically implantable prosthesis system including at least one flexible inflatable member and an imperforate housing. A flexible combination reservoir and pump located within the housing for storing liquid when the inflatable member is deflated and for pumping liquid into the inflatable member and a flexible tube connecting the combination reservoir and pump and the inflatable member for the passage of a liquid between the combination reservoir and pump and the inflatable member. A rechargeable battery operates a reversible electric motor located within the housing operatively connected to the combination reservoir and pump to collapse the combination reservoir and pump to force liquid out of the combination reservoir and pump through the tube into the inflatable member and to expand the combination reservoir and pump to receive liquid from the inflatable member and a battery located within the housing to operate the motor.

Abstract: An indwelling urinary catheter having semi-rigid tubular portions for holding open the entrance of the bladder and the urethral exit and a collapsible tubular portion extending through the urethra. The collapsible tube is closed by the normal urethral mechanism and opened upon the flow of urine, thus blocking bacterial migration into the body and avoiding abnormal, continuous distention of the urethra and consequent discomfort to the patient. Avoided, as well, is the transmission of infection occasioned by the sliding motion of rigid-tube catheters within the urethra.

Abstract: An implantable, percutaneously accessed blood flow and occlusion pressure sensing sphincteric system including an inflatable occlusion cuff to surround a patient's urethra for occluding and relaxing the urethra to produce lumenal coaptation for the treatment of urinary incontinence. The occlusion cuff is electro-fluidically interconnected to a hyponometer by way of electro-fluidic coupling, a coaxial, electrically conductive hypodermic needle, and a fluid pressure regulating and control chamber. Thus, the occlusion cuff can be percutaneously and variably infused with a precisely measured supply of fluid from the hyponometer for inflating the cuff and thereby increasing the application of occlusive pressure to the urethra.

Abstract: A closure appliance for use in surgical ostomy comprising an upper member and a lower member. The upper member contains a cavity for receiving a closure. The closure is provided with filtration and absorbent materials. The lower member contains a plurality of tubular passageways which communicate with the cavity in the upper portion. Magnetic members surround the tubular passageways for magnetically securing the device to a magnetized annulus which has been implanted in the surrounding skin of the stoma. The closure appliance is utilized to tightly fit within the stoma and to selectively permit the evacuation of fluids from the interior of the stoma.

Abstract: A non-surgical method for implanting a genitourinary prosthesis comprising an extensible, inflatable tissue expanding containment membrane to be located between the urethra and the subcutaneous corpus spongiousum of a patient to overcome urinary incontinence by means of localized, controlled tissue volume increase. A disposable cartridge assembly is also disclosed for hypodermically positioning, injecting and inflating the containment membrane and for percutaneously infusing the membrane with biocompatible fluid or suspended particulate matter. The containment membrane functions as an envelope for retaining the fluid or suspended particulate matter therewithin while simultaneously increasing localized tissue volume and advantageously preventing the migration of such fluid or particles through the patient's body. Accordingly, an increased passive occlusive pressure may be applied to the patient's urethra to return the patient to continence.

Abstract: A semi-automatic functioning artificial sphincter including a means for occluding a body passage, a fluid reservoir, and a mechanism for transferring fluid between the occluding mechanism and the fluid reservoir, wherein the sphincter also includes a lock-out mechanism for occluding fluid flow between the fluid reservoir and the inflatable cuff and the occluding mechanism. The occluding mechanism is preferably a valve which is positioned in the fluid path between the reservoir and the occluding mechanism. The valve may be either manually or hydraulically actuated to control one or more aspects of fluid flow through the valve.

Abstract: A shut-off device particularly suitable for implantations in the urethra provided with a tubular housing having attaching means for permanent fitting on the wall tissue of the urethra, a valve system for closing off and making free the passage in said housing and means for disconnectably coupling said valve system in said housing, said valve system consisting of a cylindrical element wherein are arranged a valve seat having a valve co-operating therewith and magnetical means for pressing said valve and seat against one another, whereby the opening pressure can be determined by exerting downward pressure or by having the patient apply manual pressure to the abdominal wall.

Abstract: Described is an implantable device for selectively opening and closing tubular organs of the body such as the urethra. The device comprises a sleeve of an elastomeric plastic material, being of a stiff or rigid shape. The sleeve has a slit-like opening for receiving the organ, while the width of the opening is such that the organ is at least partially closed off in the rest condition of the device. Pressure can be applied manually, possibly by way of a remote operating means, to cause the opening to be temporarily enlarged whereby the organ which extends through the opening is also opened. The device may also have a continuously open position which is produced by means of a ball which can be displaced into a retaining seat to hold the opening of the device in an open position.

Abstract: A gastrointestinal sphincter to be surgically implanted around a lumen (e.g. bowel) of a patient to apply variable occlusive pressures for articulating the lumen. The sphincter includes an occlusion cuff having a hollow, expansible chamber formed therein to embrace the lumen. Communicating in a single, continuous fluid circuit with the expansible chamber are first and second fluid circuits having respective reservoir supplies of fluid located therein. Each of the reservoir supplies may be selectively actuated in order that fluid will be delivered to the expansible chamber to controllably expand the chamber and thereby produce variable occlusive pressure levels for achieving coaptive continence. A fluid filled physician control port is interconnected with one of the fluid circuits and surgically implanted so as to be accessible to a fluid filled syringe.

Abstract: A urethral sphincter cuff is adapted to be surgically implanted so as to encircle the urethra. When the sphincter cuff is filled, the urethra is squeezed, and the patient is continent. When the cuff is deflated pressure is released from the urethra and urine may flow therethrough.The sphincter cuff is provided with a tongue and buckle to allow adjustment during surgical implantation. The tongue, on one side of the cuff, contains apertures which are adapted to fit onto studs on the buckle part. After placement and adjustment of the cuff an adhesive can be applied to secure the tongue to the buckle.The cuff also contains an occluding diaphragm which, when filled, squeezes the urethra to inhibit fluid flow, and when unfilled remains in a second position in which no tension is applied to the urethra. Even when the diaphragm area is reduced to its minimum value (with pressure on the urethra) the diaphragm remains under tension so that its smooth surface does not wrinkle.

Abstract: The prosthetic sphincter includes a manually controllable actuating component for implantation at a convenient location in a patient's body. This actuating component is mechanically connected through a force applying cable to a responsive component positioned about an elimination passage in the patient such as the distal intestine. The actuating component is in the form of a ring so that manual squeezing of opposite portions causes an elongation of the ring to pull on the cable and thereby open up an occlusion orifice in the responsive component. The actuating component in the form of the ring can upon manual manipulation return to its circular form and thereby permit closing of the occlusion orifice in the responsive component. No batteries or electrical components are required for operating the prosthetic sphincter and no resection of luminal tissue is required for its implementation.

Abstract: A method and apparatus for achieving penile erection in a human male. The apparatus includes at least one distensible cylinder which is in communication with pressure reservoir means through a valve means. A fluid pressure generator acts upon a working fluid in the pressure reservoir means and when the valve means is opened, the distensible cylinder distends. The method concerns implantation and use of the apparatus.

Abstract: A latch for securing the ends of a belt together so as to encircle an inflatable cuff of an artificial sphincter. The latch includes two rotatable components with cavities which receive the belt ends when the components are suitably rotated and capture the belt ends within the latch when the belt is in tension.

Abstract: An elastomechanical sphincter comprising a prosthetic device for implantation about a patient's lumen such as the urethra for occluding or relaxing the lumen for the treatment of incontinence. The prosthetic sphincter includes a body of elastomeric polymer material configured to define an articulating structure having a normally closed elongated occlusion orifice arranged to embrace the patient's urethra with minimal ischemic interruption of circulatory blood flow. In a first sphincter embodiment, an integrally formed manually manipulable pressure relief cuff extends from a peripheral portion of the articulating structure in such a manner that physical pulling on the pressure relief cuff in a direction transverse to the elongation of the occlusion orifice will open the orifice and thereby open the lumen. The natural elasticity of the device results in occlusion of the lumen upon releasing of the pressure relief cuff.

Abstract: An elastofluidic sphincter comprising a prosthetic device for surgical implantation around a patient's lumen, such as the urethra. The sphincter includes an occlusion cuff which is positioned to surround and engage the patient's lumen for occluding or relaxing the lumen to achieve coaptation for the treatment of incontinence. The occlusion cuff includes hollow, expandable patient activated and physician controlled chambers arranged to generate diametric occlusive pressures for efficiently occluding the lumen with precise and minimal pressure, so as to minimize the interruption of circulatory blood flow. Expansion of the patient and physician chambers is independently and selectively controlled by the patient and physician, respectively, whereby to precisely and continously adjust the occlusive pressures applied from the occlusion cuff to the lumen.

Abstract: An implantable hydraulic urinary sphincter system is disclosed for maintaining continence in those patients unable to control or stop inadvertent urinary flow. The invented apparatus generally consists of an artificial urinary sphincter and a control means for obtaining continence while causing the artificial sphincter to apply minimal pressure to the urethra for all conditions of the bladder. The invented apparatus: (1) automatically causes sphincter fluid pressure to increase or decrease with sensed bladder and/or abdominal pressure, and (2) is manually actuated by a patient when he or she desires to urinate. The invented apparatus can be filled with fluid, or the fluid pressure can be reset, after implantation without necessitating a surgical procedure.

Abstract: An artificial sphincter includes an implantable clamp which selectively pinches closed or opens a vessel in a living body. The clamp includes a spring member and a shape memory member that has a memory configuration. Either the vessel opening operation or vessel closing operation is effected by deforming the shape memory member from the memory configuration thereof, the other operation being effected by heat recovering the shape memory member to the memory configuration thereof. The shape memory member is heated by means of an AC source external to the body, the source inducing a heat-generating current, via a coil, in the shape memory member or in a resistive heater element which transfers heat to the shape memory element. The coil is preferably positioned near the surface of the body and is connected with leads to the shape memory member or resistive heater element which may be at a distance form the body surface.

Abstract: A urethral catheter comprising a tube for insertion into the bladder and having an inlet (17) for the drainage of urine via the tube, and a wall portion (18) having reduced thickness and increased flexural properties such that this wall portion (18) will undergo substantially complete collapse under normal urethral pressure thus to comply with the irregular and slit-like lumen (11) but permit adequate distension for normal drainage.

Abstract: A prosthetic sphincter is designed to surround a waste elimination passage in a patient, such as the lower colon or urethra for realizing continence. The artificial sphincter itself comprises a stationary ring and a rotatable ring supported for rotation by the stationary ring. Three occlusion elements extend from 120.degree. circumferentially spaced points on the rotatable ring to similarly oriented points on the stationary ring, offset from the first dimensioned points by a given number of degrees. The length of the various elements is such that when the rotatable ring is in a first position, the elements follow the inner peripheral curvature of the rings to maximize the opening through the rings and thus through the elimination passage circumscribed by said rings.

Abstract: An elastomechanical sphincter comprising a prosthetic device for implantation about a patient's lumen such as the urethra for closing and opening the lumen. The prosthetic sphincter includes a body of flexible polymeric material configured to define an articulating structure having an elongated occlusion orifice arranged to embrace the patient's urethra with minimal ischemic interruption of circulatory blood flow. An integrally formed manually manipulable pressure relief cuff extends from a peripheral portion of the articulating structure in such a manner that physical pulling on the pressure relief cuff in a direction transverse to the elongation of the occlusion orifice will open the orifice which thereby opens the lumen. The natural elasticity of the device results in a closing of the lumen upon releasing of the pressure relief cuff. In one embodiment, by way of example, the pressure relief cuff may be positioned within the folds of the loose skin of the posterior scrotum.

Abstract: The inflatable cuff of an artificial sphincter is secured in place about a natural body passage by fastening means which consist of a reinforcing belt for encircling the cuff and a clip to hold the belt in place. The belt has a reinforcing intermediate section of substantially uniform thickness throughout and a pair of ends, each of which have enlarged beads at their tips. At least one of the ends of the belt has a pair of spaced apart fingers which are especially useful for extending through the mesentery without interfering with the blood supply of said passage and the clip has bead receiving and retaining cavities for securing the belt in place.

Abstract: A method of controlling urinary incontinence in a male comprises implanting in the penis of the male a relatively rigid backup support against which the urethra can be collapsed, anchoring said backup support to prevent it from migrating, and exerting pressure upon only one side of the urethra to collapse and keep it closed against the backup support. The preferred backup support includes a groove which receives the neurovascular bundle and protects the major blood and nerve supplies of the penis from the adverse effects of pressure exerted on the urethra. Devices for practicing the method are also disclosed.

Abstract: A connector device fluidly connects first and second sections of a highly elastic, highly compressible tubing of an implantable device such as an implantable penile prosthesis. The connector device includes a rigid connector component having a longitudinal main body with a fluid passage extending between first and second ends. The outer surface of the connector component includes a center surface section and first and second frusto-conical surfaces disposed at the first and second ends. The frusto-conical surfaces increase in diameter towards the center section, until the frusto-conical surfaces are larger in diameter than the center section. The tubing elastically engages the frusto-conical surfaces and a clamp surrounds the tubing preventing the tubing from "creeping" off the frusto-conical surfaces.

Abstract: An accessory for counteracting the consequences of vesical incontinency with males, comprising an annular tensioning means (8, 9) adapted to be tensioned around the penis (1) of the user, and further comprising a pressure element (7) with a rounded and relatively stiff pressing surface (10) having a curvature which is substantially adpated to the shape of the swelling bodies (3) of the penis (1) so as to pinch the urethra (5) elastically against said bodies (3) which are retained by the tensioning means (8, 9), said pressure element (7) being, in particular, a strip of a substantially rigid material having, more in particular, lateral portions (16, 17) which are substantially adapted to the shape of said bodies (3).

Abstract: An implant device having a passageway, an anchor for establishing a biological anchor and a grafting mesh annularly disposed about, and spaced apart from, the exterior of the implant device. The implant device passageway, anchor means, and grafting mesh are all formed from either pyrolytic carbon disposed on a graphite substrate or vitreous carbon.

Abstract: This invention relates to internally prestressed flexible capsule devices for insertion within or partly within the male and female urethra for the specific purpose of the automatic and/or manual control of urinary incontinence which is effected by a prestressed device deforming the lower interior of the urethra into a broadly elliptical shape stressed slightly in excess of the involuntary pressure, and such that the devices deform or collapse on their cross-section at the increased urine voiding pressure and open a free urine bypass cross-section area and when voiding ceases the capsule device returns to its maximum cross-sectional area for involuntary urine flow control ready for repeat cycles as selected.

Abstract: A device which can act as a manually operable valve to permit or to prevent flow of bodily fluids, particularly urine, within their normal channels. The device is surgically implanted completely inside the body to prevent infection. Pressure on a button under the skin permits flow, and release of the pressure terminates flow. This effect is caused by arms positioned on opposite sides of the flow channel which produce a clamping action.

Abstract: An improved pressure control valve for a medical device having a hydraulic system comprises a valve housing having an open top and a bottom and an inwardly directed shoulder partially closing the top. A poppet with an upwardly extending stem is mounted in the housing between the top and the bottom. The poppet has a sealing edge mounted on its top about the stem, and there is a calibrated spring urging the poppet towards the open top of the housing so that the sealing edge is in sealing contact with the underside of the shoulder thus closing the valve. The poppet has an internal passage extending therethrough from an inlet in the bottom of the base of the poppet to an outlet in the side of the stem. The outlet in the stem is normally closed by an elastic band which is circumferentially positioned about the stem.

Abstract: An anti-incontinent prosthesis comprising a support member formable into at least one generally spiral turn for location about the corpus spongiosum. A plurality of inflatable chambers are disposed on the turn and connected to a pump means for applying fluid pressure to said chambers to constrict the urethra.

Abstract: An implantable apparatus for controlling the flow of body fluids through a body passage includes a cuff which can be inflated with pressurizing fluids to close the body passage, a push button actuated and expandible reservoir for the pressurizing fluid and tubing connecting the cuff and the reservoir to form a closed system. The reservoir includes a pumping chamber having a tension spring positioned therein and a push rod located outside the pumping chamber. The push rod is attached to a push button which when actuated expands the volume of the reservoir to receive pressurizing fluids from the cuff thereby allowing the cuff to deflate and the body passage to open.

Abstract: An artificial sphincter comprises a closed hydraulic system which includes an inflatable occlusion means which is normally inflated with hydraulic fluid under pressure to cut off flow through a body passage. An accumulator balloon having a relatively inelastic shell serves as a reservoir for hydraulic fluid for the inflatable occlusion means and includes a gas filled bladder within the inelastic shell to maintain a constant pressure in the system. The system also contains a pump to suck fluid from the occlusion means to deflate it and open the body passage to fluid flow and tubing connecting the inflatable occlusion means, the accumulator balloon and the pump to complete a closed system. The sphincter also includes a pressure intensifier which temporarily increases the pressure in the occlusion means to compensate for an anticipated increase in fluid pressure in the body passage.

Abstract: A prosthetic sphincter for controlling urinary incontinence is provided with a dual-mode pressure regulating system designed to establish continence yet prevent damage to the bladder from excessive pressures. In a conventional four-valve system, the valve controlling output of the deflation pump is replaced by a two-stage valve unit having a cracking valve and a holding valve in parallel relationship, both valves permitting only one-way flow with the pressure required to open the holding valve. A flow resistor is placed in parallel with the cracking valve and in series with the holding valve.

Abstract: An occlusive device is disclosed for surgical implant to occlude the lumen of an internal organ. The device includes a cuff A having a backing collar (10) and two isolated cuff chambers B and C. The fluid pressure of chamber B is regulated by a pump/valve reservoir unit E. Chamber C is unregulated in pressure but its fluid volume is adjusted by removing or adding fluid to a septum/reservoir D by means of a hypodermic needle. Pressure changes are transmitted between the two cuff chambers via faying surfaces (12) and (14) which are sufficiently large in contact area and thin as to transmit pressure generally without attenuation. By adjusting the fluid volume of septum D, the operating pressure of the device may be adjusted to accommodate tubular organs of different diameter sizes as well as to compensate for changes in the organ following implant without re-operation.

Abstract: The control valve is arranged to surround the anal-terminating descending intestine of a patient for realizing continence; that is function as an artificial sphincter. The valve itself comprises a stationary ring and a lower rotatable ring in an axially aligned position. A plurality of rods extends from the lower rotatable ring through aligned openings in the upper stationary ring. When the lower rotatable ring is rotated through an angle, the rods twist and their center portions radially contract inwardly in such a manner as to reduce the cross sectional area of the passage through the rings. By lining the rings and rods with a toroidal member, having an inner flexible part, rotation of the rotatable ring by an appropriate reversible drive motor will gently close off or open up the descending intestine portion of the patient.

Abstract: The invention concerns an artificial sphincter comprised of a strip to be wrapped around the intestine, conduit, tube of the wearer's body, or the like. The strip carries either a single inflatable chamber that extends along its length, or parallel longitudinally extending chambers, or rows of separate chambers, wherein the chambers in adjacent rows are staggered longitudinally along the strip. Passages communicate among the chambers to maintain uniform pressure. A tube communicates into the chambers for selectively delivering fluid to inflate them or to permit them to be deflated. At least one wall of the chamber is flexible and elastic, and that wall faces in around the intestine, or the like, so that upon inflation of the chambers, the intestine, conduit, tube or the like is compressed and occluded. In a variant, the chambers are shaped to have a smaller cross-section toward one longitudinal edge of the strip and a larger cross-section toward the other longitudinal edge thereof.

Abstract: An artificial sphincter comprises an inflatable occlusion means which is normally inflated with hydraulic fluid under pressure to cut off flow through a body passage, an improved accumulator balloon having a relatively inelastic shell which serves as a reservoir for hydraulic fluid for the inflatable occlusion means and a gas filled bladder which controls fluid pressure in the closed system, a pump to suck fluid from the occlusion means to deflate it and open the body passage to fluid flow and tubing connecting the inflatable occlusion means, the accumulator balloon and the pump to form a closed system. The sphincter also includes a first check valve at the inflatable occlusion means which allows fluid to freely flow out of the inflatable occlusion means, a second check valve at the accumulator balloon which allows fluid to freely flow into the accumulator balloon and resistance means which restricts fluid flow into the inflatable occlusion means and out of the accumulator balloon to a low rate of flow.