Abstract: A method for forming a valve-like mechanism in a body of a mammal having an esophagus extending through a lower esophageal sphincter to a stomach and formed by a wall having a muscle layer and a mucosal layer. The method comprises the step of forming at least one implant in the muscle layer of the wall in the vicinity of the lower esophageal sphincter. The at least one implant inhibits opening of esophagus at the lower esophageal sphincter and causes the mucosal layer to appose in the vicinity of the implants.

Abstract: A method for treating urinary incontinence includes the steps of inserting into the woman's vagina a first disposable device, removing the first disposable device, and inserting a second disposable device substantially identical to the first disposable device. The disposable devices have a working portion with opposed faces to provide support to an associated urinary system and an anchoring portion to maintain the disposable device in place during use. The anchoring portion has at least one member extending beyond at least one end of the working portion.

Abstract: The invention, in various embodiments, provides systems, devices, and methods for treating urinary incontinence.

Abstract: The invention provides, in various embodiments, systems, devices and methods relating to employing thermal treatment of tissue in combination with an implantable sling to treat urinary incontinence.

Abstract: An implantable restriction device can be configured to provide a restriction in a patient, for example as a function of the pressure of fluid. The implantable restriction device can include one or more sensors configured to sense a variety of parameters, such as pressure of the fluid within the implantable restriction device, pulse width, pulse amplitude, pulse count, pulse duration, or frequency, electrical characteristics, or other parameters. Data obtained by the one or more sensors (for example, the data representing pressure, pulse characteristics, and so on) may be communicated to a device located external to the patient, such as a data logger, using telemetry coils or other communicators. The data logger may store the data, and may communicate the data to a remote location via a network such as the Internet. A docking station may be provided to couple the data logger to a network and/or to recharge a cell in the data logger.

Abstract: Methods and devices for treating female urinary incontinence by injecting bulking material into the female urethral wall. Some devices include a handle, an elongate member attached to the handle, and a vacuum generating syringe removably secured to the handle. The elongate member can include a distal portion projecting distally from the handle, the distal portion having a wide proximal region, a narrowing shoulder, and a narrow distal region. The elongate member can include one or more vacuum ports on either side of the shoulder region. The shoulder can include a distally facing needle aperture allowing passage of a needle for injecting bulking agent. A rotatable connection between the elongate member and the handle facilitates rotatable positioning of the elongate member to permit injection of bulking material at different locations around the urethral wall.

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: 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: A body portion fabricated of an essentially rigid material is formed of similarly configured first and second segments each shaped to include a generally spherical interior enlargement, a generally spherical exterior enlargement, an intermediate section between the enlargements, and a slit extending through the exterior enlargement and the intermediate section. The body portion pivots between a collapsed orientation with the slit at a reduced spacing and an expanded orientation with the slit at an enlarged spacing. An operational zone has a plurality of operational components. Application of a radial force to the second section by a user's external anal sphincter muscle causes axial movement of the segments to both contract and retain expanded segments and expand and retain contracted segments to reorient the system between a collapsed orientation and an expanded orientation.

Abstract: The present invention is directed to, in one aspect, a medical apparatus having a nasogastric tube with hypopharyngeal suctioning capability. In one embodiment, the medical apparatus has a flexible nasogastric tube for insertion through a patient's nose. The nasogastric tube has a first end defining a first opening, a distal, second end that defines a second opening, and a length sufficient to allow the second opening to be positioned in a patient's stomach. The medical apparatus also has a flexible oropharyngeal tube for insertion through a patient's mouth. The oropharyngeal tube has a first end and a distal, second end that defines a suction intake. The oropharyngeal tube has a length that is less than the length of the nasogastric tube and which allows the suction intake to be positioned in a patient's hypopharynx region. In another embodiment of the invention, the medical apparatus has a laryngeal mask with hypopharyngeal suctioning capability.

Abstract: A bowel management system includes a rectal catheter; and at least one physiologic sensor. The rectal catheter has a portion in contact with a patient's body internally thereof during use of the system, to thereby determine a preselected physiologic parameter of a patient having the rectal catheter inserted into the patient's bowel. The position of the sensor relative to the rectal catheter portion is such that the sensor is disposed in close proximity to the internal tissue of the patient, or within the fecal flow, when the bowel management system is place for use within the patient.

Abstract: The present invention is an endo-prostatic stent and a detachable catheter apparatus including the same, allowing the correct positioning of the stent using tactile feed-back of the operator during insertion i.e. without the need for any imaging means like endoscopy or sonography.

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: Surgical instruments for prolapse repair are disclosed. The surgical instruments have straight portions and helical portions.

Abstract: A tunneling device is provided to assist in passing a suture or tape into a body. The tunneling device includes an outer assembly and an inner member or stylet, having a light transmissive distal tip, positioned within the outer assembly. The outer assembly is provided with a light port or guide to transmit light towards the distal tip of the stylet. The disclosed illuminated tunneling device is particularly adapted for use in an Intravaginal Slingplasty procedure. The illuminated tunneling device can be provided with an external source of light or may include an integral self-contained source of light. Additionally, a light guide, or light tube, may be formed integral with the outer tubular member or may be provided as a separate element.

Abstract: A therapeutic device is provided. The therapeutic device can include a flexible housing and can be configured to be positioned within an anatomical structure. The therapeutic device can also include at least one high vapor pressure media having a vapor pressure greater than the pressure within the anatomical structure and a permeability of less than 1 ml/day at body temperature through said outer wall.

Abstract: Devices for treating stress incontinence, having a horizontal proximal portion supported on the pubococcygeus muscle and a distal portion extending downward and away from the proximal portion at an angle approximating the vagina in an erect female as it passes down and between the anterior segments of the pubococcygeus. The distal portion may terminate with a protrusion that is positioned to provide midurethral support, thereby preserving the urethovesical angle.

Abstract: An apparatus for removing body fluids from a body cavity by suction, such as a thorax, gastric or any other human body cavity or a wound, comprises means (9) to increase the pressure difference between a pressure in a drainage lumen (3) and a pressure in the atmosphere when an auxiliary lumen (5) is open. The apparatus enables removal of clots or other plugs of the catheter and drainage tube in an efficient and not patient disturbing way.

Abstract: A disposable urinary incontinence device comprises a liquid-stable resilient member, and a cover sheet that envelops the liquid-stable resilient member to form an elongated member having a tubular profile. The elongated member has a first end, a second end, a first fold region disposed between the first end and the second end, a second fold region disposed between the first end and the first fold region, a third fold region disposed between the second end and the first fold region, a first portion located between the first end and the second fold region, a second portion located between the second end and the third fold region, a third portion located between the first fold region and a second fold region, and a fourth portion located between the first fold region and the third fold region to form a W-shaped incontinence device.

Abstract: A disposable urinary incontinence device comprises a liquid-stable resilient member and a cover sheet. The cover sheet envelops the liquid-stable resilient member to form an elongated member having a tubular profile. The elongated member has a first end, a second end. The cover sheet exhibits a skin-facing surface contact area of less than 30% at a depth of 10% of the cover sheet. In addition, the cover sheet has a static coefficient of 0.275 to 0.150, and a dynamic coefficient of friction of 0.230 to 0.150.

Abstract: An intravaginal urinary incontinence device has an insertion end and an opposed withdrawal end. The device has a resilient frame including a working portion disposed proximate the withdrawal end and an anchoring portion disposed proximate the insertion end. The working portion has a resilient structure having a plurality of connected elongate elements arranged and configured to define opposed working surfaces for providing support to an associated urinary system. The anchoring portion extends beyond the working portion and has a plurality of connected elongate elements arranged and configured to expand laterally within a user's vagina. The elongate elements are formed of a high modulus polymer having an elongation at yield of at least 3% and an elastic modulus of at least 2 Gpa.

Abstract: An intravaginal urinary incontinence device has an insertion end and an opposed withdrawal end. The device has a resilient frame including a working portion disposed proximate the withdrawal end and an anchoring portion disposed proximate the insertion end. The working portion has a resilient structure having a plurality of connected elongate elements for providing support to an associated urinary system. The anchoring portion has a plurality of connected elongate elements arranged to expand laterally within a user's vagina. The elongate elements are formed of a high modulus polymer having an elastic modulus of at least 2 or 3 GPa. Additionally, the polymer may have an Initial Stress @ 3% Strain of at least about 30 MPa, an elongation at yield of at least 3%, a Stress Ratio of at least about 0.5, and/or an Aged Stress (t=50 hrs @ 40° C.) @ 3% Strain is greater than about 35 MPa.

Abstract: A perineometer exercise probe for home or clinical use assesses the strength of pelvic floor muscles and provides audible, visual and tactile biofeedback signals as training aids during pelvic exercises. The exercise probe is selectively operable in a passive reaction mode, in which audible, visual and tactile biofeedback signals proportional to pelvic muscle contractions are generated, and in an active vibrating mode in which therapeutic vibrations are applied directly to internal pelvic musculature with or without co-generation of biofeedback signals proportional to the strength of pelvic muscle contractions; and in a combination of both modes simultaneously. The probe reacts the pelvic contraction forces and thus provides passive tactile feedback signals that are experienced simultaneously with audible, visual and vibration-induced tactile biofeedback signals for improving the endurance and strength of pelvic floor muscles.

Abstract: An endourethral device is provided having an elongate member having proximal and distal segments, the elongate member positionable within a lower urinary tract so as to at least partially traverses a prostatic urethra. A proximal anchor, adapted to abuttingly engage portions of a bladder neck so as to at least proximally anchor the device, is supported at least indirectly by the proximal segment of said elongate member. The proximal anchor includes bladder engaging elements radially extending from the proximal segment of said elongate member, urine being freely dischargable about at least the proximal segment so as to substantially bathe the bladder neck therewith.

Abstract: A kit and method for supporting a pelvic floor of a person with stress urinary incontinence or other symptoms. The method involves using barbed sutures as part of a sling for supporting the pelvic floor or urethra of a person experiencing stress urinary incontinence or other symptoms. A surgeon implants the sling along with the barbed sutures, using one of several known methods. The barbed sutures may be interwoven with the sling and the supports for the sling, so that once the sling and its supports are placed into the patient, barbs of the sutures will resist movement. The sutures may also be woven into the supports to resist movement.

Abstract: A medical retrieval device of an embodiment of the present disclosure includes an assembly for positioning a medical device includes a sleeve having a lumen configured to accept a medical device, and a tab. The tab includes a distal portion and a proximal portion. The distal portion is configured to receive the sleeve for positioning the sleeve proximate the proximal portion. The proximal portion is configured such that severing the tab along the proximal portion maintains the tab in one piece.

Abstract: Wound fluid blood detection systems and methods are described that are operable in conjunction with reduced pressure wound treatment (RPWT) systems, as well as ancillary therapy and monitoring systems applied concurrently with RPWT systems. The blood detection monitor operates by optically characterizing the content of wound fluids to the extent of identifying percentage blood content. This identification relies upon the transmission of select wavelengths of light across a volume of wound fluid to a photo detector (connected to signal processing instrumentation) capable of quantifying the absorption characteristics of the fluid. The detection components may be implemented in conjunction with either a fluid flow conduit (i.e. the reduced pressure tubing directing fluid away from the wound dressing) or more directly in association with the materials that comprise the wound dressing positioned within the wound bed itself.

Abstract: A suburethral implant for treating stress urinary incontinence (SUI) includes an elongated plate-like member which is slightly curved in transverse cross-section, and a pair of spaced apart arms having hooked ends or barbs which extend from the plate-like member. A device for deploying the suburethral implant for treating SUI includes a vaginal probe for insertion in the vaginal canal of a patient, and a urethra locator probe for the simultaneous insertion in the urethra of a patient. The urethra probe is spaced apart from and overlies the vaginal probe. The vaginal probe includes a wall in which is formed an exit port. A suburethral implant introducer assembly is extendable and retractable through the exit port on the vaginal probe. The introducer assembly has a distal end on which is removably mounted a suburethral implant.

Abstract: Described are methods of treating urinary incontinence using a urinary sling and a tissue path that passes through the obturator foramen, along with related surgical implants, devices, systems, and kits.

Abstract: An apparatus for achieving weight loss in a patient is disclosed. The apparatus has a barrier material and an applicator for dispensing the barrier material about the intestine. An injector is used to place the barrier material to block nutrient transfer from the intestine into the blood stream. The barrier material is a polymerizable adhesive that can be injected interstitially between layers of the intestine, or injected into vascular structures to partially block the flow of blood to the nutrient absorbing layers.

Abstract: A method for treating urinary incontinence includes the steps of inserting into the woman's vagina a first disposable device, removing the first disposable device, and inserting a second disposable device substantially identical to the first disposable device. The disposable devices have a working portion with opposed working surfaces to provide support to an associated urinary system and an anchoring portion to maintain the disposable device in place during use. The anchoring portion has at least one member extending beyond at least one end of the working portion.

Abstract: A urinary incontinence device for insertion in a urethra of a user. The device includes a non-absorbent body having an outer surface, the body having a leading end and a trailing end; a removal mechanism having a first end attached to the body and a portion of the removal mechanism located outside the user; a portion of the body having a generally bulbous shape for positioning within the urethra and providing a seal within the urethra preventing urinary leakage from the urethra; and a coating applied to the outer surface of the body for engaging a wall of the urethra and securing the device within the urethra of the user. Another embodiment relates to a method of controlling urinary incontinence comprising: engaging an applicator with the body of the device and introducing into the urethra the device wherein the device is positioned in the user's bulbar urethra.

Abstract: A sphincter exercising system includes a central detection unit for detecting an internal pressure of an air tube due to a constriction of a sphincter; a peripheral detection unit for detecting a pressure of a vicinity of the central detection unit; a control unit for generating an input signal for an external user terminal based on the pressures detected by the central detection unit and the peripheral detection unit; a first communication unit connected to the control unit, for outputting the input signal generated by the control unit; a second communication unit connected to the external user terminal, for receiving the input signal outputted from the first communication unit and inputting the received input signal to the external user terminal; and a power supply unit for supplying a power to the sphincter exercising system.

Abstract: An ostomy appliance is described in the form of a controlled discharge device for controlling discharge from the stoma and/or an ostomy pouch for collecting discharged waste. The appliance may include one or more of: an elastomeric stoma seal for providing a seal around or directly against the stoma; a stoma occluder for occluding the stoma without passing internally into the stoma; a peristomal foam wall; a confinement seal for confining at least solid excreta to a confinement region adjacent to the stoma; a stowable collector bag; and interchangeable controlled discharge devices and ostomy pouches. The foam wall may provide a barrier to stool, but allow escape of flatus. The foam wall and/or the stoma occluder and/or the confinement seal may apply a force in a direction to increase the sealing force on the stoma seal.

Abstract: A kit for treating a gastrointestinal tract of a mammal and including a package and a tubular needle, an end piece and a container of an implant-forming material carried within the package. The end piece has an outer surface provided with at least one recess and an internal passageway communicating with the recess. The end piece is mounted on the distal extremity of an elongate probe member and introduced into the upper portion of the gastrointestinal tract. A portion of the wall of the gastrointestinal tract is drawn into the recess and the tubular needle is extended through the elongate probe member and the internal passageway into the portion of the wall in the recess. Material from the container is loaded into the tubular needle and injected into the portion of the wall to form an implant in the wall.

Abstract: A system comprises a first signal handling unit sized and shaped for insertion to a reference distance within a first body cavity and a probe sized and shaped for insertion into a second body cavity the probe including an energy emitting head and a second signal handling unit, wherein one of the first and second signal handling units comprises a transmitter and the other of the first and second signal handling units comprises one of a receiver adapted to receive signals from the transmitter and a signal reflecting element, wherein, when the other of the first and second signal handling units comprises a signal reflecting element, the one of the first and second signal handling units comprises a receiver in combination with a controller operatively connected to the receiver, the controller generating an output varying as a distance between the first and second signal handling units varies.

Abstract: An implantable device for selectively controlling defecation has an outer body defining on one end a flange that is surgically attachable to the person's anus and/or tissue adjacent to the anus. A connector is mounted on the other end of the outer body and is secured to the distal end of the person's large intestine for connecting the large intestine in fluid communication with the device. An inner body is slidably received within the outer body. A macerator-type pump is mounted within the inner body and an inlet valve is mounted between the pump and the connector. An actuator in the form of an RF receiver is electrically coupled to the inlet valve and the pump and a remote transmitter is operatively coupled to the receiver. The receiver is responsive to control signals received from the transmitter to open the inlet valve and operate the pump in order to move fecal matter through the device.

Abstract: A gastrointestinal device including a casing including fixation elements adapted for intraluminal fixation of the device in a gastrointestinal tract (e.g., the anorectal wall), a valve disposed in the casing and controllable to move from a closed position, which significantly restricts passage of gastrointestinal (e.g., fecal) matter therepast, and an open position, which permits passage of gastrointestinal matter therepast, and a controller operatively connected to the valve for externally controlling the position of the valve between the closed and open positions.

Abstract: The invention relates to a gastroplasty ring formed by a flexible band (2) which comprises a first end part (5) and a second end part (6) and which is intended to be closed around the stomach toward its two end parts by a closure system in order to reduce the diameter of the opening of the stoma by forming a loop, the band comprising an adjustable-volume annular compression chamber (3) connected, at the first end part, by an adjusting catheter (7) to a device for adjusting the internal pressure of said chamber, so as to adjust its diametral expansion, the ring comprising at least one grab tab (11, 12, 13) which projects toward the outside of the loop to make it easier for the two end parts to be brought together and parted. Gastric implant for treating obesity.

Abstract: An apparatus for treating pelvic organ prolapse in a patent is provided. The apparatus includes a support portion having first and second ends. A first elongated end portion is connected to the first end of the support portion. The first elongated end portion includes a first dilator configured to attach securely with a tip of a needle. A second elongated end portion is connected to the second end of the support portion. The second elongated end portion includes a second dilator configured to attach securely with a tip of a needle. The first and second needles include a straight portion, a tip, a first radius, and a second radius distinct from the first radius. The first radius and the second radius are disposed between the straight portion and the tip. A method and kit for the treatment is further provided.

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: A permanent, biocompatible material for soft tissue augmentation. The biocompatible material comprises a matrix of smooth, round, finely divided, substantially spherical particles of a biocompatible ceramic material, close to or in contact with each other, which provide a scaffold or lattice for autogenous, three dimensional, randomly oriented, non-scar soft tissue growth at the augmentation site. The augmentation material can be homogeneously suspended in a biocompatible, resorbable lubricious gel carrier comprising a polysaccharide. This serves to improve the delivery of the augmentation material by injection to the tissue site where augmentation is desired. The augmentation material is especially suitable for urethral sphincter augmentation, for treatment of incontinence, for filling soft tissue voids, for creating soft tissue blebs, for the treatment of unilateral vocal cord paralysis, and for mammary implants. It can be injected intradermally, subcutaneously or can be implanted.

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: A sense head comprises a plurality of coils and a needle window. The sense head is operable to receive RF signals communicated from a needle target such as an injection port located within a patient. A user interface is configured to visually display an indication to a user relating to the positioning and orientation of the sense head relative to the needle target. The positioning and orientation may be determined based on RF signals received by the coils in the sense head. With the sense head positioned based on information provided through the visual display, the user may insert a needle through the needle window to reach the needle target. The sense head may also receive communications relating to the pressure of fluid in an implanted device. The user interface may further display information relating to the fluid pressure in the implanted device.

Abstract: A suburethral sling device and method for treating female urinary stress incontinence which is anatomically configured to implant into the lower abdomen of a female in a manner providing support to mid-urethral and bladder neck sphincteric continence sites with the sling defining in part, mesh and tissue remodeling portions. The sling is deployed via a sling transfer instrument having distal and proximal ends with the instrument comprising in part a progressively curved shaft portion positioned between the distal and proximal ends. An insertion handle of the transfer instrument is secured to the curved metal shaft section guiding the shaft tip through the tissues of the abdomen in an anterior/posterior direction as well as a cephalad/caudad direction.

Abstract: A method for forming a valve-like mechanism in a body of a mammal having an esophagus extending through a lower esophageal sphincter to a stomach and formed by a wall having a muscle layer and a mucosal layer. The method comprises the step of forming at least one implant in the muscle layer of the wall in the vicinity of the lower esophageal sphincter. The at least one implant inhibits opening of esophagus at the lower esophageal sphincter and causes the mucosal layer to appose in the vicinity of the implants.

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 and a sleeve, where the sheath includes a wall having an inner surface which defines a channel through which at least a portion of the implantable device and the sleeve can pass.

Abstract: The invention concerns a device for minimizing involuntary urination in females adapted for being inserted into the vagina comprising both a pressure providing member and an anchoring member to prevent slippage of the device in the vagina. The invention further concerns a system comprising the device as well as an applicator for inserting the device to the vagina.

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: An indwelling catheter is positioned in a urinary tract to drain urine from the bladder to a position distally adjacent to a sphincter muscle. A balloon of the catheter is inflated through an inflation tube extending through the urinary tract. A coiled section of the inflation tube contacts the constriction caused by the sphincter muscle. The balloon and the coiled section resist movement of the indwelling catheter while still permitting natural urination. The indwelling catheter is inserted by an insertion tool which is separably connected to the catheter. Once the indwelling catheter is positioned, the tool is disconnected and withdrawn from the urinary tract. Risks of blood clots obstructing the flow of urine through the indwelling catheter immediately following a surgical procedure on the prostate gland are avoided by flushing fluid through the insertion tool and the catheter to clear an internal urine flow passageway in the catheter.