Abstract: The invention relates to a device for treating bladder emptying dysfunctions of a human, in which a catheter that can be inserted into the urethra is provided with a bladder emptying channel and with a balloon arrangement, which serves to seal the bladder and to hold the catheter inside the bladder lumen and which can be filled with a fluid. In addition, an automatically closing valve having an elastically held closure part is provided in a proximal end area of the catheter and is connected via a connecting channel filled with an actuating fluid to an actuating balloon placed at the distal end section of the catheter. Without the use of mechanical means, the closure part can be lead out of a sealing system solely due to a hydraulic action effected by the actuating balloon via the hydraulic pressure built up in the connecting channel at said proximal end section.

Abstract: The present invention discloses a passive trainer for incontinence treatment and rehabilitation. The trainer comprises an elongated effecter configured for being reversibly introduced entirely into the rectum via the anus; or into the vagina of a human patient; and, a stopper coupled to said effecter, said stopper being adapted to remain external and adjacent to said anus, for preventing slippage of said effecter deeper into said rectum or said vagina; wherein the treatment and rehabilitation are obtained passively without any application of external forces. The present invention further discloses a method of rehabilitating and treating incontinence.

Abstract: In one embodiment, an improved-customizability digital sound relaxation system having a sound card receiving port and a collectable sound card are cooperative to play prerecorded natural or other sounds by depressing one of a plurality of sound selector switches and a sound card selector switch. The new sounds of each collectable sound card customize the library of available sounds to individual taste. In another embodiment, an improved-flexibility digital sound relaxation system having at least two (2) prerecorded sounds stored at first and second memory locations of internal or external/internal memory devices may be selected and combined for concurrent and/or individual replay by depressing one of a plurality of sound selector switches and a combine switch, or by depressing one of a plurality of sound selector switches, a sound card selector switch and a combine switch.

Abstract: Described are implants, tools, and related methods, for use in pelvic surgery to treat conditions such as prolapse and incontinence, including one embodiment of a method that uses a transcoccyx tissue path; other embodiments that use particular implants with various features relating to, e.g., end portions; and other embodiments relating to particular tools.

Abstract: The device for reducing the effects of stress incontinence and/or strengthening pelvic floor muscles has a body and a retraction element connected at an end of the body. The body has an undulating surface profile in the longitudinal direction which stimulates the outer and inner pelvic muscles to work to grip and massage the device. The device can include a recess for receiving the cervix.

Abstract: An incontinence device for attachment to the inferior ischio-pubic rami in the anterior perineal triangle of a user. The device may include a generally semi-flexible bi-parabolic membrane configured to deflect from an engaged position in which the device exerts pressure upon the user's urethra, or a similar anatomical part. The membrane may deflect to a disengaged position with a first force applied by the user, and be configured to deflect back to the engaged position from the disengaged position upon a further second force applied by the user. Additionally, the device may include bolster connected to the membrane. The bolster may exert pressure upon the user's urethra, or similar anatomical part, when the membrane is in the engaged position and relieve pressure when the membrane is in the disengaged position.

Abstract: A bowel management system includes a waste collection catheter having at least two distinct sections. The first section is patient proximal when disposed in the patient's rectum and has durometer hardness in the range of about 50 A to about 90 A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5 A to about 49 A. A selectively collapsible, substantially spherical retention balloon is attached coaxially and exterior of the first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most end of the first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient's rectum without being so large as to trigger a defecatory response in the patient.

Abstract: The surgical device is for supporting a mammalian organ in need of support, and in particular for treating urinary incontinence. The device has at least one first support element of elongate shape for exerting a supporting action on the organ; and at least one first traction filiform element, to be fastened to the support element. One end of the traction element constituting at least one first anchor system, activated by traction exerted on the first traction element thereby simplifying the surgical procedure.

Abstract: An apparatus for cleansing and applying therapy or prophylaxis to wounds, in which irrigant fluid containing a physiologically active material from a reservoir connected to a conformable wound dressing and wound exudate from the dressing are recirculated by a device for moving fluid through a flow path which passes through the dressing and a means for fluid cleansing and back to the dressing. A biodegradable scaffold underlies the dressing on the wound bed to promote tissue growth. The cleansing means (which may be a single-phase, e.g. micro-filtration, system or a two-phase, e.g. dialytic system) removes materials deleterious to wound healing, and the cleansed fluid, still containing materials that are beneficial in promoting wound healing, is returned to the wound bed. The dressing, an assembly comprising the dressing and scaffold, and a method of treatment using the apparatus.

Abstract: An injection device for use with tissue of a mammalian body comprising a first tubular member and a second tubular member slidably disposed in the first tubular member. The first and second tubular members have respective proximal and distal extremities. The distal extremity of the second tubular member is provided with a needle that is extendable from the distal extremity of the first tubular member. The proximal extremity of the second tubular member is lockable relative to the proximal extremity of the first tubular member. The second tubular member has a column strength when locked within the first tubular member for limiting retraction of the second tubular member relative to the first tubular member during puncture of the tissue by the needle.

Abstract: Devices and methods relating to percutaneous and hiatal approaches for treating urinary incontinence are provided herein. In particular, guide member placement devices, sling application catheters, tissue dissectors/dilators, sling application devices and a sling application system, tissue expanders, grasping devices, and balloon catheters are disclosed herein. Methods for using the preceding devices to stabilize the bladder neck or the urethral floor in order to maintain or improve urinary incontinence are also disclosed.

Abstract: Disclosed herein is an attenuation device, comprising a flexible housing and a high vapor pressure media having a permeability of less than 1 ml/day at body temperature through the outer wall of the flexible housing. In one embodiment, the high vapor pressure media comprises perfluorooctylbromide. In another embodiment, the high vapor pressure media comprises perfluorohexane. In yet another embodiment, the high vapor pressure media comprises perfluorodecalin. Also disclosed herein is a method of treating a patient, comprising providing a compressible attenuation device and introducing within the attenuation device at least one high vapor pressure media.

Abstract: A surgical fastener for use in surgical procedures comprises a first member, a second member, and an anchor. Surgical materials may be secured within the surgical fastener. Methods of securing the surgical fastener to an anatomical structure are disclosed herein.

Abstract: A highly flexible urological medical device for analyzing urethral properties and for optimally placing a periurethral injection and/or a support element, such as suburethral sling and/or a suspension suture, to treat urinary incontinence.

Abstract: A perianal support device is provided that is configured to inhibit the formation and/or progression of tissue damage in the perianal region of the body. A method is provided to apply the perianal support device to patients during childbirth to inhibit the formation and/or progression of tissue damage in the perianal region of the body.

Abstract: Vaginal splint assemblies and methods for their use for treating various pelvic floor conditions are provided. One embodiment of a vaginal splint assembly includes a base portion having a connecting portion and first and second sides extending outwardly from first and seconds ends of the connecting portion to first and second free ends respectively. It further includes a plurality of apical sections each of a different size and each having a connecting portion and first and second sides extending outwardly from first and second ends of the connecting portion to first and second free ends respectively, and at least first and second coupling elements. The first coupling element is capable of securing the first free end of the base portion to the first free end of any one of the plurality of apical sections, and the second coupling element is capable of securing the second free end of the base portion to the second free end of the one apical section.

Abstract: An anti-reflux drainage device includes an elongated member defining a lumen, and a valve disposed along the elongated member. The valve can include one or more lumens in fluid connection with the lumen of the elongated member, a socket, a shaft disposed in the socket, and a stopper connected to the shaft that occludes the second lumen when exposed to retrograde pressure. Another such device includes an elongated member and a ball valve. The ball valve can include a seat and a shoulder defined by the elongated member, and a ball disposed in the elongated member between the seat and shoulder that occludes lumen when exposed to retrograde pressure.

Abstract: An apparatus and a method for urine containment, storage, and release is provided for male and female patients suffering from incontinence. The device comprises a housing including a valve implanted generally in the bladder of a male or female patient. The device further comprises an access port connecting the housing and extending through the abdominal wall of the abdomen. The device replaces the functionality of the urethral valve and allows on demand drainage of the natural bladder which flows from the natural bladder into the urethra and exits the body. The access ports may provide a backup system for urine drainage as well as facilitate access to the gastro-intestinal region as well as the rest of the body.

Abstract: A anal incontinence disease treatment apparatus and method include and use an operable restriction device implanted in a patient and engaging the colon or engaging the rectum to form a restricted fecal passageway in the colon or the rectum. A source of energy external to the patient's body and a control device for releasing wireless energy from the source of energy from outside the patient's body are provided. The released wireless energy is used in connection with the operation of the restriction device, to enlarge or contract the restricted fecal passageway.

Abstract: A suture construction and method for forming a suture construction is disclosed. The construction utilizes a suture having an enlarged central body portion defining a longitudinal passage. First and second ends of the suture are passed through first and second apertures associated with the longitudinal passage to form a pair of loops. Portions of the suture lay parallel to each other within the suture. Application of tension onto the suture construction causes constriction of the longitudinal passage, thus preventing relative motions of the captured portions of the suture.

Abstract: An implantable medical device (10) for insertion into a body cavity. The device comprises an expandable balloon having a torroidal shape defining a hole (80), and an insert (82) configured to be received and secured in the hole. The device may be used in a method for treating urinary incompetence, a method for releasing a substance in the body, a method for monitoring a body cavity, or a method for imaging a body cavity.

Abstract: A closing member (16) is disengageably fitted to one end of a cylindrical-shaped guide member (4) to close an opening (4a) of the guide member (4). A water-absorbing agent (3) made of water-absorbing resin powder is accommodated in the guide member (4) toward the one end. A column-shaped plug member (2) made of water-swellable fibers is accommodated in the guide member (4) at a location closer to the other end than the water-absorbing agent (3). A push rod (5) is inserted into the guide member (4) through an opening (4b) thereof located at the other end. With the opening (4a) at the one end of the guide member (4) inserted in an anus, the push rod (5) is operated to push the water-absorbing agent (3) and the plug member (2) through the opening (4a) at the one end of the guide member (4) into a rectum. The plug member (2) absorbs water in internal contents and expands to plug the rectum, while the water-absorbing agent (3) also absorbs water in the internal contents.

Abstract: Systems and methods employing a sling delivery assembly having a sling delivery device couplable to a sling assembly to deliver an implant through a transobturator incision point are disclosed. Successful coupling between the sling delivery device and the sling assembly can be verified through changes in an optical or electrical signal produced at the coupling location.

Abstract: An apparatus for treating urinary incontinence, comprising: a node; a support section adapted for providing urethral support attached to the node; and, an anchoring section adapted for resisting movement of the apparatus attached to the node opposite the support section. Optionally, the support section is adapted to treat incontinence according to at least one of: SUTFS, colpo-elevation or colpo-distension.

Abstract: A new, quick, simple, efficient, safe, and reproducible surgical technique for the treatment of female urinary incontinence, in which the posterior urethra is suspended using a tape passed through the obturator orifices from inside (underneath the urethra) to outside (thigh folds). A variety of specifically designed surgical instruments are utilized to perform this operative procedure.

Abstract: A vaginal wall which has been damaged by one or more prolapsed organs may be repaired by a surgical procedure including the steps of: (a) mobilizing the vaginal epithelium off of the underlying fascia of at least a portion of the damaged vaginal wall; (b) positioning a reinforcing material over the exposed fascia; (c) re-fixing the vaginal epithelium over the reinforcing material; and, thereafter, (d) locating an intra-vaginal splint into the vagina such that the splint supports the vaginal wall and prevents substantial movement and displacement of the reinforcing material.

Abstract: Vaginal splints and methods for their use for treating various pelvic floor conditions are provided. One embodiment of the vaginal splint includes a base portion having a configuration defined by first and second sides, a first connecting portion at a proximal side of the base portion and extending between a first end of each of the first and second sides, and a second connecting portion at a distal side of the base portion and extending between a second end of each of the first and second sides. The splint further includes an adjustable portion coupled to the base portion and positioned substantially adjacent to and distal of the second connecting portion of the base portion. The adjustable portion is removable by a user to thereby change the size of the splint.

Abstract: The present invention relates to apparatus and methods for treatment of male incontinence and a method for female cystocele repair in which a sling material is positioned between the descending rami of the pubic bone. In such an operation a “hammock-like” sling material is positioned below the urethra in males, or below the posterior bladder wall in the case of cystocele in females.

Abstract: Urinary incontinence such as stress incontinence, is alleviated in a mammal, in particular a human being, especially a woman, by correcting the internal urethral orifice and the urethra with an elastic form stable material. Such a material preferably a curable elastomer-precursor composition is injected in the body tissue surrounding the urethra, thereby correcting internal urethral orifice and the urethra substantially to its original shape, allowing the sphincter to act in a controllable way.

Abstract: An applicator for urinary incontinence devices has an insertion barrel, a deployment plunger, and an adjustable insertion depth indicator. The applicators are useful to correct for a consumer's body mass index to ensure that urinary incontinence devices are placed in the appropriate position to be effective.

Abstract: A pessary comprising a main stem and an inflatable bladder disposed about the proximal larger diameter section of the main stem. The main stem further comprises a distal smaller diameter portion having a cap at its distal tip and a check valve disposed there under. The check valve communicates with a central fluid passage that may extend into the proximal larger diameter section of the main stem. Secondary fluid passages connect the central fluid passage to the inflatable bladder volume disposed about the outer circumference of the proximal larger diameter section of the main stem. The main stem provides support to the pelvic structures and the inflatable bladder acts to hold the device in position. At least one void through the proximal larger diameter portion of the main stem allows bodily material to pass from the vagina through the pessary device thereby decreasing the amount of vaginal discharge.

Abstract: A system and method are provided for transducing vaginal conditions, affecting vaginal or body conditions, and/or stimulating perineal musculature and nerves. A separate, portable, non-implanted intravaginally containable combination probe and transceiver is provided that can sense vaginal conditions, can deliver signals or medication, and/or can stimulate perineal musculature and nerves. This probe unit is provided with 2-way wireless communication for transmitting information that is transduced and for receiving control and programming signals. In addition, a separate combination controller and transceiver is provided for wirelessly sending signals to the probe unit and for receiving signals therefrom. A real time wireless signal feedback loop is thus provided between the controller and the probe and/or external devices, networks and databases.

Abstract: Disclosed is a female urinary incontinence-inhibiting device comprising a flexible torus including at least one slot configured to, under compression, flexibly reduce the outer diameter of the flexible torus, the flexible torus having a diameter configured to inhibit female urinary incontinence when placed in a vagina and a stabilizing element, coupled to the flexible torus, the stabilizing element having a size and position configured to stabilize the flexible torus within the vagina.

Abstract: An incontinence management device comprises a head having a first state and a second state. In the first state, the head is sized for insertion within a predetermined body orifice or cavity. In the second state, the head is sized to substantially seal the predetermined body orifice or cavity. In an aspect of use in an anal cavity, the device is configured so that the head forms a seal above the dentate line within the anal cavity. Further, in some aspects, the head substantially comprises a resorbable material. Additionally, in other aspects, the device further comprises a base, which limits insertion of the device within the body orifice, and an activator mechanism in communication with the head and movable relative to the base between a first position and a second position. The movement of the activator mechanism between the first position and the second position correspondingly causes the head to change between the first state and the second state or vice versa.

Abstract: This invention deals with inducing urination and/or defecation as well as gastrointestinal transit time through electro-magnetic induction. The claimed method provides a non-invasive procedure to stimulate excretory functions in paraplegic and quadriplegic patients.

Abstract: A system and method for placing surgical implants and having particular application for pelvic floor repair. The system includes an assembly having a guide element with a tissue penetrating tip, a cannula, and a retrieval device having a capture element at its distal end. A channel in the cannula is dimensioned to allow passage therethrough of the guide element, and of the retrieval element when removably coupled with an extension of the surgical implant.

Abstract: A bladder access apparatus and method of provided access into a bladder through a abdominal wall therewith is provided. The apparatus has an annular body extending between opposite ends with a through passage extending between the ends. A tubular sheath is attached to one end of the body in coaxial alignment with the through passage. The sheath is expandable from a first diameter to an enlarged second diameter. The apparatus has an elongate stylet with a rod sized for receipt in the sheath. The rod has a length greater than the tubular sheath and a diameter substantially the same as the first diameter of the sheath. The apparatus includes a rigid, tubular body having an outer diameter corresponding substantially to the second diameter of the sheath and a rigid, cylindrical member sized for sliding receipt in the tubular body.

Abstract: The present invention relates generally to dynamic support devices, methods of providing dynamic support to target tissues, and kits comprising these devices. These devices may have particular utility in providing support to the urethra. The dynamic support devices generally comprise at least one attachment member for attachment to bodily tissue, and at least one support member, where the device capable of assuming a first configuration and a second configuration. The dynamic support devices may be configured to support a target tissue when the device is in its second configuration. The support member may comprise one or more rotating components, one or more deformable components, one or more sliding components, or a combination thereof.

Abstract: A surgical instrument for correcting hypermotility of the female urethra in exertional urinary incontinence, comprising a rod-like body provided with a first rounded end and a second rounded opposite end provided with a slit.

Abstract: An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable element and a tubular elongate body, where the adjustable element includes a chamber and the tubular elongate body includes at least a first interior passageway which extends longitudinally in the tubular elongate body from a first opening at the proximal end to a second opening in fluid communication with the chamber. Fluid volume passed through the first passageway is used for adjustably expanding or contracting the adjustable element. The implantable medical device further includes a sheath, where the sheath includes a wall having an inner surface which defines a channel through which at least a portion of the implantable device can pass.

Abstract: An incontinence device for wearing by a female is disclosed. A urine collection trough has an elongated open top end that is adapted to fit around the labia area of the female, encompassing her urethra. The trough has at least one non-rigid side wall and includes a drainage aperture in a lower portion thereof and a vaginal anchor means at an upper portion thereof. The vaginal anchor means is preferably a resilient protruding member fixed to the upper portion of the side wall of the trough. A drainage conduit is fixed at an upper end thereof to the drainage aperture that has at a lower end a valve means having an open position and a closed position. Preferably, the at least one side wall includes at least one attachment aperture therethrough, such that the device may be fixed to articles of clothing with straps, buttons, or the like.

Abstract: An apparatus for treating urinary incontinence, comprising: a support section adapted for providing urethral support; an anchoring section for resisting movement of the apparatus; an insert, a portion of which is adapted to be positioned where the support section attaches to the node; and, wherein the insert urges the support section radially outwards from a central axis of the apparatus.

Abstract: The invention emulates the operation of a healthy urethra by providing a valve with a large differential between the opening pressure and the closing pressure. The differential is achieved by using a snap action created by the action of the urine flow on a force that drops off rapidly with displacement. A preferred way to achieve such as force is by using permanent magnets. The valve is installed simply by insertion into the urethra and can easily be removed. No surgical procedure is involved.

Abstract: The present invention relates generally to dynamic and/or adjustable support devices, methods of providing dynamic and/or adjustable support to target tissues, and kits comprising these devices. These devices may have particular utility in providing support to the urethra. The dynamic support devices generally comprise at least one attachment member for attachment to bodily tissue, and at least one expandable member capable of assuming an unexpanded configuration and an expanded configuration. The adjustable support devices generally comprise at least one attachment member for attachment to bodily tissue, and at least one shape-changing portion that is capable of assuming first and second configurations, each with different shapes. Additionally, the dynamic support devices may comprise features of the adjustable support devices, and vice versa.

Abstract: The present invention relates to methods of preventing or treating anal incontinence comprising injecting muscle-derived cells into a site of interest via an injection device, where the injection site of interest is, or is adjacent to, muscle-tissue providing for anal continence.

Abstract: Devices and methods relating to percutaneous and hiatal approaches for treating urinary incontinence are provided herein. In particular, guide member placement devices, sling application catheters, tissue dissectors/dilators, sling application devices and a sling application system, tissue expanders, grasping devices, and balloon catheters are disclosed herein. Methods for using the preceding devices to stabilize the bladder neck or the urethral floor in order to maintain or improve urinary incontinence are also disclosed.

Abstract: An apparatus for treating an anal or urinary incontinent patient includes an elongate adjustable constriction member adapted to extend in a loop around and constrict the patient's large intestine or urethra to close the intestinal or urethral lumen and release the large intestine or urethra to open the intestinal or urethral lumen. A connection device releasably connects the end portions of the constriction member to each other and an adjustment device adjusts the longitudinal extension of the constriction member in the loop to change the constriction of the large intestine or urethra. The connection device includes a female part and a male part fitting into the female part to lock them together. The design of the connection device facilitates laparoscopic surgery for implanting the constriction member.

Abstract: Transvaginal delivery instrumentation and methods are disclosed for delivering a biocompatible bulking mass transvaginally into a target tissue mass between the vaginal and urethral walls to constrict the urethra to alleviate female incontinence. Delivery is effected by urging a selected portion of the tissue structure between the vaginal and urethral walls into the vaginal cavity as a target structure, and passing a bulking mass from the vaginal cavity through the vaginal wall and into the target structure. Particular transvaginal delivery instrumentation comprises a vaginal and urethral probes adapted to be introduced into the vagina and urethra and bulking mass delivery instruments adapted to be introduced through a vaginal probe lumen and port into the target tissue structure.

Abstract: An method and apparatus for an adjustable sling for treatment of urinary stress incontinence. The present system includes apparatus and methods for postoperative adjustment of sling tension using adjustable elements in the sling assembly. The present system also provides a number of demonstrative embodiments for an adjustable sling where positioning of the bladder is controlled using the adjustable sling and where coaptation of the urethra is controlled by postoperative inflation of one or more balloons mounted in a sling cup. Methods and apparatus are provided for adjusting the adjustable sling after surgical implantation. In one embodiment a self sealing septum is located near the skin for convenient filling using a syringe. Multiple port embodiments are also discussed.

Abstract: Apparatus and method for retrieving a remotely located device equipped with a magnetic coupler is provided. The apparatus includes a magnetic coupling carried at an end of an elongate member for attracting the magnetic coupler of the remotely located device, and aligning the magnetic coupler with the magnetic coupling. A frictional engagement device, substantially housing the magnetic coupling therein, is adapted for trapping the magnetic coupler therein such that a retrieval force applied to the apparatus is transferred to the remotely located device via the frictional engagement device to thereby facilitate sure retrieval of the device as by magnetic mechanical entrapment.