Abstract: An implantable, adjustable male incontinence device. The device has an inflatable balloon affixed to a central portion of a reinforced nonextensible elastomeric strip. The balloon includes a first length of elastomeric tubing extending therefrom that provides fluid communication with the interior chamber of the balloon. The uninflated balloon is implanted to overlie the male urethra with the nonextensible strip oriented horizontally and facing away from the urethra. The lateral opposing ends of the nonextensible strip are sutured to the periosteum of respective left and right iliac bones and the inflation port is implanted beneath the skin in an accessible portion of the body, preferably in the scrotum or, less preferably, in the perineum. The inflation port, which also includes a second length of tubing in fluid communication therewith, is implanted beneath the skin and the first and second lengths of tubing are connected to one another.

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

Abstract: An implantable urodynamic system includes an implantable first device deployable in a patient's bladder, an implantable second device deployable in a patient's vaginal canal, and a data acquisition and analysis module or processing unit external to the body of the patient. The first device includes a magnet and an inductive coil, and the second device includes a magnet, an inductive coil and a battery. When deployed in the patient's body, attraction between the magnets maintains the two devices in close proximity to one another to effect an inductive coupling between the coils so that the first device may be powered by the battery of the second device. The urodynamic system is intended to facilitate measurement, collection, and wireless transmission of real-time, or near real-time, data (bladder pressure, abdominal pressure, and temperature) from an ambulatory patient.

Abstract: An apparatus for examining and curing urinary incontinence and exercising the pelvic floor muscles and vaginal muscles using bio-feedback including a controller main body, a probe, and a bio-feedback device. The probe includes: an insert frame extending in a longitudinal direction thereof, an insert expansion part surrounding adjacent to a front end of the insert frame and expandable therearound; an air supply path connected to the interior of the insert expansion part to supply air; a handle engaged with the insert frame; a fixing means for fixing the insert expansion part to the insert frame or the handle; a valve installed at the air supply path; and a PTC ceramic heater and a vibration motor installed at the insert frame. An elastic member includes a magnet, an insertion depth adjustment part, and leg support parts installed at the insertion depth adjustment part. The bio-feedback device includes a sound generating means, and an image display means.

Abstract: An adjustable incontinence device for implantation within the body of a female and a method for implanting and using the device for controlling urinary incontinence. The device includes an elastomeric tube having an elongate inflatable balloon affixed to one end thereof and an implantable inflation port affixed to the opposing end of the tube. At least a portion of the balloon in contact with the periurethral tissue is covered with a polyurethane foam. The device is implanted beneath the skin with the balloon disposed anterior and adjacent to the urethra and the tube threaded beneath the skin and attached to the inflation port which is implanted at a transdermally accessible point remote from the balloon. Fluid is introduced into the injection port by transdermal injection and conducted to the interior chamber of the balloon to inflate the balloon and compress the underlying urethra.

Abstract: Disclosed herein is an attenuation device, comprising a flexible housing and a high vapor pressure media having a vapor pressure approximately equal to the intravesical pressure of the bladder and 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: The present invention provides for a device and method for the treatment of female urinary incontinence (UI). The disclosed device has a unique and novel shape that supports the urethra and absorbs any leakage. The device is placed through the female labia into the lower part of the female vagina to provide the urethral support and decrease the occurrence of female incontinence.

Abstract: This invention relates to a three dimensional bioengineered sphincter such as a bioengineered internal anal sphincter (IAS) and three-dimensional physiological models of smooth muscle cells. The invention also related to methods for generating a bioengineered sphincter and smooth muscle rings in culture. In addition, the invention provides for methods of using a bioengineered sphincter or bioengineered smooth muscle ring to identify agents that modify contractile force and relaxation in smooth muscle cells.

Abstract: A method for treating morbid obesity in a body of a mammal having a gastrointestinal tract extending through a stomach and a pyloric sphincter and a wall forming the stomach and pyloric sphincter. At least one implant is formed in the wall in the vicinity of the pyloric sphincter to inhibit emptying of the stomach.

Abstract: A method and apparatus for minimizing fecal incontinence in a subject, is disclosed. An inhibition action incontinence device includes a truncated cone with an angled concavity at a top portion. The truncated cone is positioned at the external opening of the anal canal. The truncated cone may be positioned to effect a positive pressure on the external sphincter muscles and the anal slit across the peri-anal tissues. It is believed that the truncated cone exploits the voluntary inhibition action of the external sphincter muscles and the simple mechanical closure of the anal slit to decrease fecal incontinence and soiling.

Abstract: Handles for needles suitable for pelvic floor surgical procedures are described.

Abstract: An incontinence inhibiting or prevention device is provided which can be inserted into the vagina by a wearer without complicated manipulation or folding of the device. The incontinence inhibiting or prevention device helps inhibit or prevent involuntary urination, including that which is stimulated by such bodily functions as coughing and sneezing, while allowing voluntary urination. The device may therefore be worn daily during normal activities and left in place for several days or weeks.

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

Abstract: A urinary control device for sealing off at a neck and along the inside wall of a bladder to prevent leaking and dislodging of the device from within the bladder is disclosed. The device includes an inner tubular member. The device also includes an expandable sealing member. A deployable stiffening member is positioned within the expandable sealing member. The stiffening member expands within the expandable sealing member to erect and shape the expandable sealing member. The deployable stiffening member strengthens the expandable sealing member, retaining the device within the bladder and sealing off the bladder against leaking.

Abstract: Active tissue augmenting agents, compositions and methods for use are disclosed. In a typical embodiment, the active augmenting agents of the invention can be used to form an artificial sphincter around a lumen of a human or animal body. In one embodiment, the active augmenting agent comprises magnitizable particles which can provide occlusion of a lumen, such as the urethral lumen, by circumferential attraction of the injected material toward the center of the lumen by the inherent magnetic flux field created from the magnetic dipoles of the magnetic particles.

Abstract: Improved bone anchors are disclosed for anchoring one or more sutures attached to soft tissue to a bone. The bone anchor has an anchor body that extends between a distal and a proximal end. A bore is formed axially in the anchor body and opens at the proximal end. One or more pins are fixed within the bore of the anchor body. One or more sutures can be looped on the pins for anchoring soft tissue to bone. The anchor body has a socket within the bore for receiving a driver tool. The distal end of the anchor body forms a non-threaded extension, which stabilizes the bone anchor, and helps prevent lateral movement during use. In one embodiment, the anchor body has coarse threads for engaging soft bone tissue and fine threads for engaging hard bone tissue.

Abstract: A leak point wetness sensor for urological investigations. A receptacle receives liquid which leaks past a catheter inserted in the urethra. A temperature sensitive detector sensor is contacted by the leaked liquid and provides a signal output responsive to the temperature of the liquid. A circuit produces a reference output simulative of a temperature below the anticipated temperature of leaked liquid. A comparator produces a signal when the difference between the outputs is sufficient to confirm leakage.

Abstract: Implantable mechanical device to apply traction to organs or anatomical tissues for its repositioning during and after a surgical intervention that comprises an implantable box in whose inside housing a drum with a toothed wheel that gears in a worm are housed to wind in a traction threads and a fixation screw for the traction threads fixation once passed through the implantable box; a base support placed under the box to spread the stress per square inch and stabilization of the said box against the supportive tissue; different systems to subject or support organs or anatomical tissues, such as a sling provided with a spread bars to maintain the sling fully open even under traction; and inserting elements to insert the traction system in the patients body.

Abstract: A urinary incontinence device includes a working portion having an insertion equivalent diameter ranging from about 10 to about 25 mm and a use equivalent diameter ranging from about 25 to about 35 mm under an expansion pressure of about 20 to about 150 cm H2O.

Abstract: A method for treating gastroesophageal reflux disease in a body of a mammal is provided. At least one nonaqueous solution is introduced into the wall in the vicinity of the lower esophageal sphincter. A nonbiodegradable solid is formed from the at least one nonaqueous solution in the wall to augment the wall. An apparatus for use in the procedure is provided.

Abstract: There is disclosed a surgical instrument for inserting material into the body. The surgical instrument generally includes an outer tubular member. The instrument has a longitudinal section and an arcuate section having at least two different radii of curvature. An inner member is movably positioned within the outer tubular member and includes structure for engaging a length of material to draw the material through the outer tubular member and into the body. Methods of using the surgical instrument to position a length of tape beneath the urethra to form a support are also disclosed.

Abstract: This invention relates to a biomaterial comprising an injectable bioresorbable polysaccharide composition wherein the polysaccharide may be succinochitosan glutamate. This invention also relates to a biomaterial comprising an injectable bioresorbable polysaccharide composition in which resorbable particles may be in suspension, the said particles comprising or consisting essentially of chitin and/or chitosan, which may be free of any additional formulation modifying agents, and a process for manufacturing the same. This invention also relates to a medical device including said biomaterial and to a method of repair or treatment including the filling of cavities in the human face or body.

Abstract: An ostomy plug is described comprising first and second chambers having adjacent ends coupled to, and in fluid communication with, each other. The first chamber may be for insertion into a stoma. The second chamber may contain fluid for inflating the first chamber when the second chamber is squeezed or otherwise compressed. The plug may have a figure-of-eight configuration. The plug may be configured to permit venting of flatus while obstructing escape of other body waste from the stoma. The plug may incorporate an insertion aid for aiding insertion into a stoma. The plug may also incorporate a device for regulating the inflation pressure of the fluid to avoid undesirably high inflation pressures in the stoma.

Abstract: A method is provided for assessing urinary function including removably coupling a first test module to a portable control device, selecting from a plurality of different tests a first test to assess urinary function, the selection being made based on first module identification information obtained by the control device from the test module, and performing the first test. The method may also include one or more of the steps of inserting an insert member coupled to the first test module at least partially into a patient's urinary tract, infusing fluid through the insert member into the urinary tract, and measuring pressure within the urinary tract as fluid is infused therein.

Abstract: The invention consists in a couple of magnets in form of small plaques of variable dimensions and magnetic force, covered by a bio-compatible material, that are positioned by means of a special endoluminal delivery device or by means of a surgical intervention, close to the sphincters that are to be reinforced, with the opposite polarities face to face, so that, attracting to each other, they close the visceral lumen, preventing the reflux or the incontinence. This method may be applied to the lower esophageal sphincter in order to prevent gastroesophageal reflux, to the anal sphincter to prevent fecal incontinence, and to the urethral sphincter to prevent urinary incontinence.

Abstract: A method is provided for diagnosing detrusor instability. The method includes using an insert member having a channel therethrough positioned distal of the urethral sphincter, creating a substantially fluid tight seal to substantially block fluid flow into or out of the urethral canal other than through the channel, infusing fluid from a fluid source through the channel in the insert member and into the urethral canal at a location distal of the urethral sphincter, and measuring a pressure within the urethral canal at a location distal of the urethral sphincter as the fluid is being infused therein. The infusing step further involves infusing fluid until the urethral sphincter opens, and thereafter until at least one detrusor contraction occurs.

Abstract: A surgical guide and its use in medical procedures such as to treat female urinary incontinence are provided. The guide preferably includes a stem portion having a proximal end and a distal end and a cross-sectional shape having a recess therein along its length and first and second extension portions extending outwardly from opposites sides of the distal end of the stem portion. Each of said first and second extension portions further include a stationary portion that is fixedly coupled to the stem portion and a movable portion that is movably coupled to the stationary portion. The movable portions are movable relative to the respective stationary portions between a first position wherein the stem portions extends beyond the extension portions by a first distance and a second position wherein the stem portion extends beyond the extension portions by a second distance that is greater than the first distance.

Abstract: A sphincteric control system for controlling the function of a bodily organ, such as the bladder. The system comprises a first implanted sphincter (12) disposed about a portion of the bodily organ, a second implanted sphincter (13) disposed about a portion of the bodily organ, and a stimulator unit (20) that is adapted to apply electrical stimulation to each of the first and second implanted sphincters. One of the first or second implanted sphincters is made from a smooth muscle and the other of the first or second implanted sphincters is made from a striated muscle.

Abstract: A device and method for treating female urinary incontinence is provided. A device in accordance with the invention includes a sheath having a distal portion, a proximal portion, and a lumen extending therebetween. A distal member is elastically hinged to the distal portion of the sheath. A flow control valve unit is disposed within a lumen of the sheath. The distal member may be urged into axial alignment with the sheath, and the device may be inserted into a female urethra. Once the device is inserted sufficiently distally into the female urethra, the distal member will return to a position which is not in axial alignment with the sheath.

Abstract: A system for implanting an implant and method thereof is disclosed. In general overview, the system includes an implant, an envelope enclosing the implant, a delivery assembly and an attachment piece for attaching the envelope or implant to the delivery assembly. The envelope may include a drug coating, positioning aids, and means to ease envelope removal. In one embodiment, the delivery assembly is employed for implant and/or envelope delivery inside the patient's body. In another embodiment, the delivery assembly and an attachment piece are employed to deliver the implant or the envelope inside the patient's body.

Abstract: An anal incontinence treatment apparatus and method includes and uses an adjustable restriction device implanted in a patient, who suffers from anal incontinence. The restriction device engages the rectum of the patient to restrict the fecal passageway. An adjustment device is adapted to adjust the restriction device such that the rectum is temporarily released, in order to open the fecal passageway when the patient wishes to achieve defaecation.

Abstract: A closing system is described and a correspondingly suitable method for the selective opening and closing of a tubular body organ, comprising a closing element and a regulating system controlling the closing element.

Abstract: Disclosed is a delivery device for controllably delivering a prosthetic bulking device below a tissue surface such as below the mucosa to treat gastroesophageal reflux disease. The delivery device may be embodied in a deployment catheter, an endoscope, or an endoscope attachment. The bulking device may additionally be explanted from beneath the mucosa. In one embodiment, the bulking device comprises a hydrogel.

Abstract: Devices and methods for aligning a probe body and a treatment surface adjacent a target tissue. A guide shaft can be positioned in a urethra. The probe body can be positioned in a vagina and registered relative to the guide so as to position the treatment surface in alignment with the target tissue.

Abstract: The present invention relates to novel antimicrobial silver ion complex resinates. More particularly, the present invention contemplates silver ion complex resinate compositions comprising a silver-thiosulfate ion complex loaded onto an organic anion exchange resin. These silver thiosulfate ion complex resinate compositions are able to release stable antimicrobial silver ion complexes when placed in a saline environment. These antimicrobial silver-ion complex resinates are useful in the treatment and prevention of infections and diseases.

Abstract: An implantable medical device delivers augmentation therapy to intervene in a pattern of sleep-disordered breathing. Augmentation therapy includes the delivery of electrical stimulation to cardiac tissue above and/or below a capture threshold. PESP and NES/CCM are possible augmentation therapies that are used alone or in combination. In addition, augmentation therapies can be used with other pacing therapies such as atrial overdrive pacing and atrial coordinated pacing as a therapy for sleep-disordered breathing.

Abstract: The present invention relates to a valve assembly adapted to be positioned into a urethra in a mammal, including humans, the valve assembly comprising a) a valve holder and b) a valve housing comprising a valve controlling an urine flow from a patient's bladder, the valve assembly being arranged in a sealed manner between the walls of the urethra, said valve holder comprises a cylindrically shaped body to be inserted into the urethra.

Abstract: The invention relates to a surgical instrument and a method for treating female urinary incontinence. A tape or mesh is permanently implanted into the body as a support for the urethra. In one embodiment, portions of the tape comprise tissue growth factors and adhesive bonding means for attaching portions of the tape to the pubic bone. In a further embodiment, portions of the tape comprise attachment means for fastening portions of the tape to fascia within the pelvic cavity. In both embodiments the tape is implanted with a single incision through the vaginal wall.

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 packaging assembly for packaging a surgical device including first and second needle assemblies at least a distal portion of which having a curved configuration including an inner package member having first and second recesses sized and shaped for receiving at least a handle portion of the first and second needle assemblies. The recesses extend inwardly from the distal end of the inner package member a distance so that the distal curved portions of the needle assemblies extend beyond the distal end of the inner package. The distal end has a height such that the curved distal portions do not contact a surface on which the inner package member rests. The assembly further includes an outer package member dimensioned to removably receive therein the inner package member and the surgical device.

Abstract: There is disclosed a surgical instrument for inserting material into the body. The surgical instrument generally includes an outer tubular member. The instrument has a longitudinal section and an arcuate section having at least two different radii of curvature. An inner member is movably positioned within the outer tubular member and includes structure for engaging a length of material to draw the material through the outer tubular member and into the body. Methods of using the surgical instrument to position a length of tape beneath the urethra to form a support are also disclosed.

Abstract: A valve for a bladder control device including an elongate housing having a valve seat disposed therein. A stopper is also disposed within the housing and is moveable between a first position in which the stopper engages the valve seat and a second position wherein the stopper is moved distally of the valve seat. A tension spring can be connected to the stopper to biases the stopper toward the valve seat. A lumen is defined through the housing having a first portion disposed distally of the valve seat having a diameter approximately equal to a diameter of the stopper. A second portion of the lumen disposed distally of the first portion has a greater diameter than the first portion of the lumen. Yet a third portion of the lumen disposed distally of the second portion has a diameter less than that of the first portion.

Abstract: A tampon applicator including an insertion member adapted to house an absorbent tampon and receive a plunger. The insertion member has an outer surface and a fingergrip region disposed about the outer surface. The fingergrip region includes an indention region having a depth dimension X. The indention region includes raised portions has a height dimension Y, the height dimension Y being less than or equal to the depth dimension X.

Abstract: Disclosed herein are methods of treating a patient, comprising providing a compressible attenuation device that is moveable from a first, introduction configuration to a second, implanted configuration. The attenuation device is introduced into a treatment site. In one embodiment, the treatment site is the bladder. In another embodiment, the treatment site is the abdominal cavity. The volume of the attenuation devices changes in response to pressure changes in the treatment site and attenuates pressure changes in the bladder.

Abstract: A sling in accordance with the invention includes a synthetic material and a non-synthetic material positioned adjacent thereto. The non-synthetic material may be wrapped around or may be attached to the synthetic material. Additionally, the non-synthetic material may include slits. Methods for making such slings are also described.

Abstract: Described is a surgical instrument and method for treating female urinary stress incontinence. The instrument includes a first curved needle-like element defining in part a curved shaft having a distal end and a proximal, a mesh for implanting into the lower abdomen of a female to provide support to the urethra; a second curved needle element having a proximal end and a distal end, and a coupler for simultaneous attachment to the distal end of the first needle and the distal end of the second needle.

Abstract: A method for creating an implant in a wall forming a cavity in a mammalian body and having a muscle layer extending circumferentially around the cavity. A material is introduced into the wall so that the material extends along the muscle layer to form an implant in the wall.

Abstract: Devices and methods for aligning a probe body and a treatment surface adjacent a target tissue. A guide shaft can be positioned in a first body orifice. The probe body can be positioned in a second body orifice in a predetermined position relative to the guide so as to position the treatment surface adjacent the target tissue.

Abstract: The disclosure provides an incontinence prevention device provided with a loop type retention structure. The retention structure is in the form of a closed loop attached to the distal end of a shaft. The shaft is configured to function as an incontinence prevention device. The retention structure projecting laterally from and configured non-concentrically along the longitudinal axis of the shaft retains the incontinence prevention device within the patient. The retention structure may additionally include a protuberance extending therefrom. There is further provided a method for using the urethral catheter.

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