Abstract: A medical system is provided for assessing urinary function. The system includes a control device and at least one test module capable of being removably coupled to the control device such that, when coupled, the system is capable of performing a test to assess urinary function. The control device may include a processor and memory having stored therein a plurality of software subroutine, at least one of which directs a test to assess urinary function. The test module may include a module identification device, and the control device selects the software subroutine based upon information obtained from the module identification device. The test module may further include a tubing assembly forming a first fluid conduit between a first fluid inlet and a first fluid outlet and an insert member dimensioned for at least partial insertion into a patient's urinary tract and coupled to the first fluid outlet so that fluid infused through the first fluid conduit flows through the insert member.

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: 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 device to provide body fluid flow control in the form of a valve to be located within a duct or passageway. The device is controlled through pressure above a preselected threshold. Bulk resilience about a passageway in a valve body provides the mechanism for controlled flow. One-way valve operation may be provided through a flap or through a pressure differential on the valve body depending upon the direction of flow. A frame structure positioned within a resilient seal includes longitudinally elongate elements which may be of spring material, malleable material or heat recoverable material so as to accomplish an initial insertion state and an expanded anchoring state. A valve support transitions between the resilient seal portion and the valve body to insure that the states do not change the threshold opening pressure. Insertion devices may be employed to position and actuate a change of state of the frame in the body duct or passageway.

Abstract: A method, device, and system for treatment of urinary tract disorders is provided. The device includes a catheter having multiple lumens for insertion into a urinary bladder and for providing fluid flow within the bladder and within the fluid reservoir within the urethra. The device further includes an anchor to be placed within the bladder. A port hub having multiple ports is connected at a proximal end of the catheter. A method of treatment includes providing heated fluid to a urinary bladder and to a fluid reservoir for insertion into an adjacent organ such as the urethra. Simultaneous treatment or separate treatment may be done. Optionally, a medicated solution may be added to the heated fluid. Additionally, pressure may be adjusted so as to optimize the therapeutic effect.

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: A portable, self-contained medical diagnostic system is provided for assessing urinary function. The system includes a control device including a processor, a pump device, and a pressure sensor, and a test module removably coupled to the control device, and further including a pressure interface and a tubing assembly defining a first fluid conduit between a first fluid inlet and a first fluid outlet. The pump device is coupled to the first fluid conduit for pumping fluid therethrough. The system also includes an insert member having a first channel therethrough and coupled to the first fluid outlet so that fluid flowing through the first fluid conduit may flow through the first channel. The insert member is dimensioned for insertion into a patient's bladder through the urethral canal. When so inserted, the pressure interface transmits bladder pressure information to the pressure sensor.

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: Disclosed herein is an attenuation device comprising a flexible housing and a medium capable of transformation to inflate the housing from the first configuration to the second configuration. Also disclose herein are methods of treating a patient, comprising: providing a self-inflating expandable attenuation device, containing a medium which is transformable from a first, reduced volume to a second, expanded volume; positioning the attenuation device within the patient at a treatment site; and transforming the medium from the first volume to the second volume. In one embodiment, a self-inflating expandable attenuation device is used to treat urinary tract dysfunction. In another embodiment, a self-inflating expandable attenuation device is used to treat benign hypertrophy of the prostate.

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: Disclosed herein are devices for treating symptoms of a urinary tract dysfunction having an expanded volume within the range of from about 1 cc to about 400 cc. In one embodiment, the device comprises a valve having a first membrane and a second membrane with a flow passage therebetween for filling the attenuation device. In another embodiment, the device comprises a valve for permitting the filling of the attenuation device through a filling device.

Abstract: A urinary incontinence device for reducing the occurrence and/or severity of female urinary incontinence. The urinary incontinence includes a non-absorbent core structure and a resilient member having a generally trapezoidal shaped profile. The resilient member is adapted to expand the urinary incontinence device within a vagina, while also providing a soft tip for the facilitating the insertion of the device.

Abstract: A sterilization device which causes occlusion to the fallopian tubes of a patient is designed to be trancervically positioned in the intramural portion of the tube without perforating the tube. The device includes a flexible hollow catheter having an interior passageway, a distal end for insertion trancervically into a patient, and a proximal end opposite the distal end for grasping and manipulation by a physician. The device further includes a pair of diametrically opposed electrodes, each being movably mounted on the distal end of the catheter and radially movable with respect to the distal end.

Abstract: A urinary incontinence treatment apparatus comprises an adjustable restriction device (234) implanted in a patient, who suffers from urinary incontinence. The restriction device engages the urethra (244) of the patient to restrict, i.e. to close the urine passageway. An implanted adjustment device is adapted to adjust the restriction device such that the urethra is temporarily released, in order to open the urine passageway when the patient wants to urinate. An implanted powered hydraulic operation device (246) operates the adjustment device.

Abstract: A medical sling made from material that is suitably shaped for use in a medical application has sides, portions of which are smoothed to prevent abrasion of surrounding tissue.

Abstract: Bone anchors and bone anchor implantation devices can be used to maintain or improve urinary continence by suspending or stabilizing the bladder neck of a patient. The bone anchors have a generally cone-shaped head with two or more cutting edges which reduce the amount of force required to implant the bone anchor into bone.

Abstract: An applicator for placing an insert within a vagina. The insert can be a catamenial tampon, incontinence device, medicament, dressing, and the like. The applicator has orientation indicators to allow the user to properly orientate the insert within the vagina. The applicator also has an inwardly curved radius on the leading edge to reduce any resistance during insertion and withdrawal of the applicator. The applicator may also have at least one vent to facilitate expulsion of the insert or to deliver medicaments or lubricants inside the body cavity. The insert applicator has a rounded cross-section to maximize the available space for the insert, while also facilitating insertion of the applicator into the vagina.

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: A stent for maintaining an open passageway through a body lumen, such as the prostatic urethra of a male patient, includes an elongated segment including a flexible polymer material bridging a plurality of hoops. The elongated segment defines a lumen extending therethrough and has a distal end. A retention structure may be coupled to the distal end of the elongated segment to inhibit the distal end from migrating when the stent is placed within a body of a patient. The flexible polymer material is disposed between the plurality of hoops, thereby creating hinged members that allow for the spaces between the hoops to expand and contract longitudinally to accommodate prostatic swelling when the stent is placed within the prostatic urethra of the patient.

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 system and method for assessing urinary function is provided. The system includes a processor, a tubing assembly forming a first fluid conduit between a first fluid inlet and a first fluid outlet, and an insert member having a channel therethrough and coupled to the first fluid outlet so that fluid flowing through the first fluid conduit may flow through the insert member. The insert member is dimensioned for at least partial insertion into a patient's urethral canal distal of the patient's urethral sphincter, and dimensioned so that, when inserted, it substantially blocks fluid flow into or out of the urethral canal other than through the insert member channel.

Abstract: An ergonomically contoured, snail shaped rectal pad comprising a highly compressible pressure-producing node (2) contiguous to a thin blade-like structure called a tail (4) enveloped in an absorbent sheath. Surrounding these structures are two flap-like lateral wings (6), which form the posterior groove (12). Emerging from the posterior groove is the insertion aperture (10) and the removal tab (14). Encasing the pad is a highly absorbent sheath (16).

Abstract: A receptacle for storing and dispensing applicators for incontinence inserts. The receptacle includes at least one first individual package containing a carriage and including a first reference indicator and at least one second individual package containing a plunger that mates with the carriage to dispense an incontinence insert disposed within the carriage and including a second reference indicator.

Abstract: An elastic suspension device is disclosed. The elastic suspension device includes an element including an elastic connector and at least one anchor at an end portion of the connector, the at least one anchor is designed for anchoring the elastic connector to a tissue.

Abstract: An external incontinence device for use in male urinary incontinence. The device is easy to fasten and unfasten with one hand to selectively apply pressure against the urethra. In one embodiment, the device includes an outer strap, which overlaps itself through a gate, and locks in position at desired tension. A lever on the strap, which can be easily lifted to unfasten the strap, achieves release. Desired pressure is preferably applied against the urethra with an inner lining. The lining can be lifted to achieve pressure against the urethra by pressing a button. The button can be locked in position to achieve continence by either a groove or ridge mechanism or by a ballpoint pen ratchet mechanism. The pressure can be released by pressing and tilting the groove and ridge mechanism, or by pushing the ballpoint pen mechanism again. The present device preferably allows the user to void through the urethra without removal of the device.

Abstract: A kit to facilitate self-placement of an incontinence prevention device within the urethra includes a deployment base member, a deployment tube, a deployment pusher along with the incontinence prevention device in a sterile pack. The base member includes a rigid shaft of a predetermined length having a finger grip member at one end and a hook member at its opposite end. The shaft of the base member is adapted to fit through the lumen of the deployment tube with the hook projecting out from a proximal end of the deployment tube and with the hook engaging a retention loop on the incontinence prevention device when in its sterile package. Upon removal of the kit components, the deployment tube is slid off the deployment base member and, in doing so, the incontinence prevention device becomes loaded into the deployment tube. The pusher is then used to urge the incontinence prevention device from the deployment tube into the urethra.

Abstract: An insertion device is provided for use in assessing urinary function. The insert device includes an insert member for at least partial insertion into a patient's urethral canal having a length such that it is positioned distal of the urethral sphincter, and having an outer surface at least a portion of which is configured to engage the inner wall of the urethra to substantially prevent fluid flow therebetween. The insert member has a channel therethrough through which fluid from a fluid source can be introduced into the urethral canal. Also provided is a device for introducing fluid into a patient's urethral canal including a hand-sized casing having a fluid conduit therein between a fluid inlet and a fluid source assembly. The device further includes an activation device movable between a first position wherein it does not obstruct the fluid conduit and a second position wherein it does obstruct the fluid conduit.

Abstract: An absorbable pubovaginal sling system for surgical management of urinary incontinence, generally comprising: a latex-free, synthetic sling made entirely of absorbable materials of which at least one of the materials is adapted to stimulate fibroblast interposition; and a looped monofilament suture that is adapted to be transposed to the suprapubic position, supported by an external adjustable tension device, and connected to said sling.

Abstract: A surgical instrument includes an elongated cannula having a forward expulsion end and a rearward breach end, arranged to include a bio-compatible material; a drive member arranged to urge the bio-compatible material in a reciprocating motion having two alternating phases; and a directional brake disposed to contact the bio-compatible material. The directional brake has a preferred braking direction for resisting motion of the bio-compatible material. The preferred braking direction of the directional brake is oriented to resist retreat of said material during the retreating phase and to allow advance of said material during the advancing phase, thus producing a net advance of the material to expel it from the expulsion end. The directional brake is disposed nearer to the expulsion end than the breach end of the instrument, to prevent undesired axial compression of the bio-compatible material during ejection.

Abstract: The present invention provides methods, devices, and systems for supporting the urethra in a patient to treat urinary incontinence. Support of the urethra involves forming a loop under the urethra with a structure referred to as a urethral support and applying an upward force with the support to hold the urethra in a more desired position. The present invention utilizes the space of Retzius within which portions of the urethral support are positioned. Ingrowth by surrounding tissues to the urethral support material provide further stability and such ingrowth, combined with the position of the support, allow sufficient tension to be applied to support to hold the urethra in place. Placement of such a urethral support is achieved by minimally invasive techniques, such as with the use of laparoscopic instruments. Such techniques allows placement of the urethral support by accessing the space of Retzius through the vaginal wall without penetrating the abdominal wall.

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

Abstract: An 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: An apparatus comprising an elongate probe member having proximal and distal extremities for use with a suction source to treat a portion of a wall forming a cavity in a body having a natural body opening for accessing the cavity. The elongate probe member has a length so that when the distal extremity is in the vicinity of the portion of the wall the proximal extremity is outside of the body. The distal extremity of the elongate probe member has an outer surface and is provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess. When the suction source is coupled to the apparatus a suction is created in the recess by means of the passageway to draw the portion of the wall into the recess. A hollow needle is slidably disposed in the elongate probe member and has a distal end portion.

Abstract: A male urinary incontinence control device including a first element for applying preferential pressure to the penis shaft between the lateral superficial veins and the central dorsal vascular group, and a second element for applying pressure ventrally to the penis shaft at the urethra and the corpus spongiosum thereby substantially or completely closing the urethra and preventing or limiting the flow of urine through the urethra.

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: A urinary incontinence device is disclosed. The device is a compressible resilient insert having top that contacts at least two opposed vaginal walls and deforms and substantially conforms to the shape of the vaginal cavity or cervical fornices. A removal member may be provided on the device such that when the removal member is pulled the device is removed from the vagina.

Abstract: A male urinary incontinence control device including a circumferentially continuous inflatable cuff having a plurality of inflatable passages therein, optionally reinforced by rigid members, that slips over the glans of the penis for positioning along the longitudinal axis of the penile shaft. Upon inflation, the cuff applies radially inwardly directed compressive force to the shaft of the penis with a concomitant restriction of the urethral passageway. The inflatable cuff in one embodiment includes an integrated hand pump for convenient inflation and deflation.

Abstract: A bowel control probe and method of detecting and preventing bowel incontinence. The probe has a body with a distal end which is permeable to gas. Conductivity sensors on the probe will establish an electrical circuit in the presence of fecal matter to send an alert signal to a control unit. The sensors may be partially shielded by a removable sleeve to reduce false alarms resulting from moisture. The control unit may issue an audible or visual alarm and may transmit a signal to a remote nursing station. An air cuff about the probe body is cyclically inflated and deflated to block passage of fecal matter and to protect tissue and capillaries in the rectal area.

Abstract: An apparatus and method of use are disclosed to treat urological disorders. The invention is a repositionable handle for an arcuate needle configured to be minimally invasive. The invention is for use with a sling assembly that allows a sling to be controllably implanted in a therapeutically effective position. The device and treatment procedure are highly effective and produce little to no side effects or complications. Further, operative risks, pain, infections and post operative stays are reduced.

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 male urinary incontinence control device including a circumferentially continuous inflatable cuff having a plurality of inflatable passages therein, optionally reinforced by rigid members, that slips over the glans of the penis for positioning along the longitudinal axis of the penile shaft. Upon inflation, the cuff applies radially inwardly directed compressive force to the shaft of the penis with a concomitant restriction of the urethral passageway. The inflatable cuff in one embodiment includes an integrated hand pump for convenient inflation and deflation.

Abstract: The invention concerns a device (10) for preventing female stress incontinence designed to be arranged longitudinally inside the vagina. The device comprises a proximal part (22) extending between a first free end (22a) and a second end (22b), designed so as to be substantially undeformable under pressure, and adapted to be placed in the sub-urethral zone of the vagina, and a distal part (24) extending the second end (22b) of the proximal part (22), made of a material reversibly deformable under pressure, designed to be placed in a sub-bladder zone of the vagina and having a height not more than 80% of the height of said proximal part (22).

Abstract: A molar shaped urinary incontinence device is disclosed. The device is a flexible molar shaped insert having a cross-sectional area at the top that is larger than the cross-sectional area of the bottom. The top respectively contacts at least two opposed vaginal walls. A channel may be provided to connect an aperture on the top surface and an aperture on the bottom surface to allow normal discharge of secretions. A removal member may be provided on the device such that when the removal member is pulled in a direction away from the device, the top collapses upon itself.

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: 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 receptacle for storing and dispensing applicators for incontinence inserts. The receptacle includes at least one first individual package containing a carriage and including a first reference indicator and at least one second individual package containing a plunger that mates with the carriage to dispense an incontinence insert disposed within the carriage and including a second reference indicator.

Abstract: An expandable umbrella-like device for insertion into the urinary bladder of an individual. The umbrella may be used in the treatment of urinary incontinence or in treating urinary bladder dysfunctions.

Abstract: A kit to facilitate self-placement of an incontinence prevention device within the urethra includes a deployment base member, a deployment tube, a deployment pusher along with the incontinence prevention device in a sterile pack. The base member includes a rigid shaft of a predetermined length having a finger grip member at one end and a hook member at its opposite end. The shaft of the base member is adapted to fit through the lumen of the deployment tube with the hook projecting out from a proximal end of the deployment tube and with the hook engaging a retention loop on the incontinence prevention device when in its sterile package. Upon removal of the kit components, the deployment tube is slid off the deployment base member and, in doing so, the incontinence prevention device becomes loaded into the deployment tube. The pusher is then used to urge the incontinence prevention device from the deployment tube into the urethra.

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: An exercise system comprising a main subassembly having a rounded conically shaped tip, a rounded upper surface and a flattened recessed lower surface. The main subassembly has a cantilever beam. The main subassembly has a hinge. Next provided is a lower subassembly. The lower subassembly has a slot with a plurality of recesses. The lower subassembly has a hinge to couple with the hinge of the main subassembly. Next provided is an adjustment subassembly having a dome and a locking pin. The adjustment subassembly allows the user to loosen and lock the dome to thereby alter the resistance to movement. Next provided is a bellows with a nipple. Next provided is a cycle counter and resistance feedback mechanism subassembly with a pneumatic actuator and counter device. Lastly provided is a flexible tube coupling the bellows and the actuator for the transmission of the pneumatic force from the bellows to the actuator.