Abstract: The invention provides, in one embodiment, a sling assembly including an implantable supportive sling and a biocompatible dissolvable protective treatment on at least a portion of the sling.

Abstract: Systems are delineated for treating urinary incontinence (UI). More generally, systems are delineated for providing medical treatment, wherein such systems include means for attaching a structure to a patient and removing the structure without damage to the structure or the patient. An exemplary system for providing medical treatment comprises a structure for attachment to a patient utilizing at least one retractable barb.

Abstract: An anal incontinence treatment apparatus comprises an adjustable restriction device implanted in a patient, who suffers from anal incontinence. The device engages a portion of the colon or rectum of the patient to restrict the fecal passageway. An adjustment device mechanically adjusts the restriction on device to restrict or release the fecal passageway, i.e. to normally close the fecal passageway and open the fecal passageway when the patient wants to relieve himself or herself.

Abstract: A fluid volume alarm system is presented. The alarm system has a container for storing fluid, and alarm module coupled to the container for notifying a user or observer that the fluid within the container has reached a predetermined level. The container has at least one exterior wall and defines an interior volume for at least temporary storage of fluid. In one aspect, there are at least two electrodes disposed on an interior portion of the exterior wall of the container and positioned at a position thereon an interior portion of the exterior wall corresponding to a predetermined fluid level at which it is desirable to receive an alarm. The system also has an alarm module configured to alert the practitioner that the fluid has met or has exceeded the predetermined level.

Abstract: Described are surgical implants that include a central support portion adapted to be positioned to support pelvic tissue, between mesh end portions adapted to be passed through body tissue, wherein edges of the end portions exhibit extensions that are resistant to deformation.

Abstract: The invention, in various embodiments, provides systems, devices, and methods for treating urinary incontinence. The present invention relates to prefabricated urethral suspension slings, methods of making the slings, methods of attaching suture to the slings, kits comprising the slings, and methods of using the slings to treat urinary incontinence. The slings comprise a biocompatible material having an elongate shape adapted for urethral suspension. The material has a central portion extending longitudinally between a first end portion and a second end portion. Each end portion of the sling contains at least one suture receiving site. The suture receiving sites are formed prior to surgery and may be reinforced through a variety of means. Sutures may be attached to the suture receiving sites during the manufacturing process or by the physician prior to or during surgery. Additionally, the end portions of the sling containing the suture receiving sites may be thicker than the central portion of the sling.

Abstract: Described are methods, implants, insertion tools, and related systems and kits, for placing an implant to treat urinary incontinence; the implants include soft tissue anchors that are capable of engaging needles of the insertion tools, and the implants are designed to place a central support portion at a location to support a urethra with extension portions and soft tissue anchors extending to tissue at regions of an obturator foramen.

Abstract: An implant delivery system can be configured to deliver an inflatable implant into a bladder via a urethra. The delivery system can comprise an elongate tubular body, an inflation tube and an implant decoupler. The tubular body can comprise a central lumen configured to hold an inflatable implant in an initial un-inflated state for delivery of the implant into the bladder. A method of use can include passing a distal tip of the elongate tubular body into the bladder. The implant can be inflated and released into the bladder.

Abstract: Disclosed are mesh materials adapted for use in an implantable sling. The mesh materials include biodegradable and non-degradable components that may be adapted to facilitate scar-tissue in-growth as the biodegradable components degrade.

Abstract: An incontinence treatment system for a male patient includes a support, a brace attachable to the support, and an introducer provided to deliver an anchor through the support and into periosteum tissue over a pubic bone of the pelvis of the male patient. The brace includes a base portion, a first post extending from the base portion and a second post extending from the base portion. A first hanger is attached to an end portion of the first post and a second hanger attached to an end portion of the second post. A first slot is formed between the end portion of the first post and the first hanger and a second slot formed between the end portion of the second post and the second hanger. The hangers are insertable into pockets formed in a pair of longitudinal arms of the support.

Abstract: An apparatus (60) for use within a woman's urethra (9) for inhibiting urine outflow when her intra-abdominal pressure rises. The apparatus (60) includes a generally tubular device (50) having a proximal end and a distal end and defining a longitudinal axis. Device (50) comprises structure (5) that is constructed and arranged to define a longitudinal passageway (14) that extends entirely through the device (50) from the proximal end to the distal end. Structure (5) is further constructed and arranged to be altered via an increase in intra-abdominal pressure, from a first state in which the passageway (14) is open along its length and able to conduct urine to a second state in which the passageway (14a) is more restricted or is closed off, to inhibit the passage of urine.

Abstract: An incontinence treatment device includes a non-porous sling located between two anchors. A first line is attached between a first end of the sling and the first anchor, and a second line is attached to a second end of the sling and inserted through a channel of the second anchor. The second anchor is provided with a restrictor segment provided in the channel. The second line has an adjustment device attached to the second line and the restrictor segment is configured to resist movement of the adjustment device through the channel. The adjustment device is movable through the channel from a first position that locates the adjustment device between the second anchor and the sling to a second position that locates the second anchor between the adjustment device and the sling to thereby reduce an effective length of the sling between the first and second anchors.

Abstract: Systems for providing support to body tissue to alleviate incontinence are disclosed that comprise an elongated incontinence sling having a central support portion adapted to be positioned to support any one of the urethra or anus and first and second sling end portions extending from the central support portion through body tissue and a tension adjustment mechanism acting on or within one or both of the sling end portions. The sling tension adjustment mechanism comprises one or more of a sling tensioning suture or band, a tensioning device coupled to a suture or band free end, a tissue anchor coupled to one or more of a suture free end and a sling end, a mesh fold, a suture tube, and a sling sheath in various combinations.

Abstract: A urethral stabilization system includes a suspending member attached between a stabilizer and support member. The support member is implantable into a patient to support a urethra. A first suspending member is attached between a first end of the support member and a first stabilizer, and a second suspending member is attached between a second end of the support member and a second stabilizer. A first thread member continuously extends between a first end that is attached to the first stabilizer and a second end of the first thread member that is free, and a second thread member continuously extending between a first end that is attached to the second stabilizer and a second end of the second thread member that is free.

Abstract: The invention provides, in various embodiments, aspects of soft tissue anchors, adjustable length/tension slings, interconnects between slings and soft tissue anchors, delivery devices and systems for implanting supportive slings, and methods relating to anchoring, adjusting and implanting supportive slings.

Abstract: A body implantable fabric includes an organ support device separated from a knit material and has a filament forming a chain of loops that extend along a length of the knit material. The chain of loops are coupled together by having each loop suspended by a neighboring loop, and at least one loop in the chain of loops having the filament tied around that one loop to form a closed loop.

Abstract: An implantable article and method are disclosed for treating pelvic floor disorders such as vaginal vault prolapse. A surgical kit useful for performing a surgical procedure such as a sacral colpopexy is also described.

Abstract: Implantable devices are designed to provide support to the bulbar urethral region of a patient experiencing incontinence. Surgical methods are utilized to implant the devices, and surgical tools are utilized with the surgical methods.

Abstract: Surgical articles, implants and components suitable for female pelvic health procedures are described.

Abstract: An incontinence treatment system includes a urethral support extending between a first end and a second end, a first connector attached to the first end of the urethral support and a second connector attached to the second end of the urethral support, and an energy source. At least one of the first connector and the second connector is a cross-linked polymer connector having a glass transition temperature between 40-70 degrees Celsius. In this regard, the cross-linked polymer connector is stretched to provide a stretched cross-linked polymer connector having a product length. The energy source is adapted to provide energy from an extracorporeal location through intact skin to shorten the stretched cross-linked polymer connector to an implant length that is less than the product length.

Abstract: A method of addressing pelvic dysfunction in a patient includes forming an incision; placing an anchor that is attached to a support member by an interconnecting member onto a distal tip of a tool; inserting the distal tip of the tool and the anchor into the incision and guiding the anchor to an obturator foramen; pushing the anchor through a membrane extending over the obturator foramen; and adjusting the support member by sliding the interconnecting member relative to the anchor.

Abstract: An incontinence treatment device includes a band attached to a pendant. The band is implantable around a portion of a urethra and has a first magnet connected to a first end portion of the band and a second magnet connected to a second end portion of the band. The pendant is connected to and extends from the band. The pendant has a shape that configures the pendant to be implantable into a scrotum and a thickness that configures the pendant to be implantable into a labia. The pendant encloses a switch and a power source that are electrically coupled to the first magnet and the second magnet. The switch has an on position to constrict the band around the urethra and an off position in which substantially zero current is provided to decouple the first magnet from the second magnet.

Abstract: An intravaginal device having an aperture and a withdrawal assembly. The withdrawal assembly has a withdrawal member and an obstruction.

Abstract: A device for the in situ clearing of blockages in a tube includes a controller and a clearing member. The controller can have a housing and an actuator for generating repetitive motion. The clearing member can be releasably coupled to the controller and suitable for insertion in the tube. The tube can be at least partially disposed within a living being. The controller can be located external to the living being. The clearing member can have a first end releasably coupled to the actuator, at least one flexible section which permits axial displacement of the clearing member, and a second end suitable for repetitively engaging and disrupting the blockage. The flexible section permits the clearing member to repetitively engage and disrupt the blockage within one of a straight and a curved portion of the artificial tube.

Abstract: In an exemplary embodiment an adjustable urethral sling includes a flexible mesh support having a mesh envelope at a suburethral potion and an expansion chamber within the mesh envelope. A conduit may be provided that extends along the flexible mesh support and that is in fluid communication with the expansion chamber. When installed in a patient the sling may loop under the urethra and out exit sites. An access port may be provided in a subcutaneous pocket and attached to the conduit to allow for remote expansion of the expansion chamber from a desirable location to allow adjustment of the sling with the patient in a standing position. The mesh envelope allows tissue ingrowth around the container so that the container can be expanded for a long period of time after implantation. The expansion chamber may be U-shaped to provide lateral closing pressure to the urethra when expanded.

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

Abstract: A surgical implant and method for its use. The surgical implant includes a biocompatible mesh having first and second ends, a length greater than a width, and a centering device including a solid, button-like element having opposing first and second surfaces and a peripheral outer edge extending therebetween. The centering device further includes a filamentary element having first and second ends fixedly secured to the peripheral edge of the button-like element so as to form a loop therebetween. The filamentary element is woven through the mesh at its longitudinal center in a direction perpendicular to the length of the mesh.

Abstract: A system of medical devices implantable in the human body using transabdominal gastroscopy surgery to repair failing sphincters and to prevent obesity. A stainless steel non-magnetic spring covered with silicon or other long-term tissue friendly plastic can be installed in place of a natural sphincter by tunneling through a non-functional natural sphincter and pulling the artificial sphincter into the tunnel to form a ring. The device can be tied on the end with suture to form a permanent structure. Without pressure, the device will be continuously closed; however, it will open under natural pressure on it just as a natural sphincter. A intragastric suspended balloon can be sutured into the stomach to cut appetite. The balloon can be roughly the shape of a pepper and take up room in the stomach without closing it off.

Abstract: Various embodiments of an implant devices and systems are provided. The implant devices can include a mesh or implant encapsulated or otherwise coated, in whole or in part, with a film or coating. The coating or film can include methylcellulose or ethylcellulose to provide tissue regeneration as a hydrogel, while also providing a stiff polymer film when dry.

Abstract: Described are various embodiments of surgical procedures, systems, implants, devices, tools, and methods, useful for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to supportive tissue and adjusting the implant.

Abstract: An incontinence treatment device includes a non-porous sub-urethral sling provided with an adjustment device. The device includes first and second anchors coupled to the sling. The second anchor includes a channel formed through the second anchor and a restrictor segment provided in the channel. The adjustment device is movable through the channel formed through the second anchor. The resistor segment is configured to resist movement of the adjustment device through the channel.

Abstract: A method of treating anal incontinence in a patient comprises providing a sling having a central portion and first and second arms, creating a subcutaneous tunnel between a first buttock incision and a second buttock incision in the patient, mechanically widening the subcutaneous tunnel to create a pocket for the central portion of the sling, grasping the first arm of the sling and pulling the sling through the subcutaneous tunnel such that the central portion of the sling rests underneath the ano-rectum, inserting an introducer needle through a first thigh incision formed in the patient and advancing the introducer needle through the first buttock incision, pulling the first sling arm through the first thigh incision, inserting the introducer needle through a second thigh incision formed in the patient and advancing the introducer needle through the second buttock incision, and pulling the second sling aim through the second thigh incision.

Abstract: A method for treating fecal incontinence in a body of a mammal having a rectum formed by a rectal wall extending to an anus wherein the rectal wall includes a sphincter muscle surrounding the anus. At least one nonaqueous solution is introduced into the rectal wall in the vicinity of the anus. A nonbiodegradable solid is formed in the rectal wall from the at least one nonaqueous solution.

Abstract: A urethral stabilization system includes a support member adapted to be implanted into a patient to support a urethra. The support member has a first end and a second end. A first suspending member is attached between the first end of the support member and a first stabilizer and a second suspending member attached between the second end of the support member and a second stabilizer. A first thread member continuously extends between a first end that is attached to the first stabilizer and a second end that is free. A second thread member continuously extends between a first end that is attached to the second stabilizer and a second end that is free. The first and second stabilizers are configured to be advanced into the tissue to increase tension applied to the support member and withdrawn through the tissue to decrease tension applied to the support member.

Abstract: The embodiments described include graft devices for reinforcing patient tissue structures and methods of making and using the graft devices. In certain embodiments the graft devices have a remodelable extracellular matrix material graft body defining a slot and having a portion receivable through the slot to form a closed loop. Such graft devices can be used in encircling reinforcement of patient tissue structures such as anal sphincters or anastomosed vessel segments.

Abstract: An adjustable single-incision sling system, includes a tissue support portion, a first tissue anchor, and a second tissue anchor. The first tissue anchor connects to the tissue support portion via a first arm, which spaces the first tissue anchor from the tissue support portion a fixed first distance. The second tissue anchor connects to the tissue support portion via a second arm, which has a free end passing through the second tissue anchor spacing the second tissue anchor from the tissue support portion a variable second distance, such that movement of the free end with respect to the second tissue anchor decreases the second distance.

Abstract: Improved methods and apparatus to secure a urethral sling to pubic bone in a sub-urethral location to support the urethra and alleviate incontinence are disclosed. The urethral sling is preferably formed of a flexible sheet material extending between opposed first and second sling ends and bounded by opposed first and second sling sides. The urethral sling is selectively tensioned in a central portion intermediate the first and second sling ends and/or in one or both of end portions bracketing the central portion. In one embodiment, pre-positioned plicating lines in the central portion are selectively drawn and tied to slacken the central portion and tension the end portions. In further embodiments, bone anchor lines passed through locations displaced from the sling ends are drawn and fixed to tension the central portion between the displaced locations and slacken the end portions.

Abstract: An apparatus for treating urinary incontinence, comprising a node; a support section adapted for providing urethral support attached to the node; and, an anchoring section adapted for resisting movement of the apparatus attached to the node; wherein the node is no longer than 30% of the entire length of the apparatus comprising the node, support section and the anchoring section together.

Abstract: A system for treating urinary incontinence includes a suburethral support, first and second soft tissue anchors, and an introducer. The suburethral support is formed of a mesh material, the first and second soft tissue anchors each have a tip, a base, a first face, a second face, a plurality of barbs, and an aperture extending from the first face to the second face. The introducer is configured for delivering the first soft tissue anchor to a desired anchoring site of the pelvis, the introducer having an elongate shaft and a handle, the elongate shaft having a distal portion and a proximal portion, the elongate shaft being coupled at the proximal portion to the handle, the distal portion of the introducer forming a longitudinal recess adapted to receive the first soft tissue anchor such that a portion of the first soft tissue anchor engages a distal most end of the distal portion of the introducer.

Abstract: Minimally invasive slings for the treatment and prevention of female urinary stress incontinence and related disorders are provided. Such slings include those having a first mesh of synthetic, biocompatible, non-absorbable polymer which extends from one end portion to the other through the median portion and a second mesh of synthetic, biocompatible, non-absorbable polymer having average porosity lower than the average porosity of the first mesh.

Abstract: An implantable device arranged to contact the urethral sphincter allows for manipulation of the device from outside the body by the patient.

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

Abstract: The invention relates generally to surgical implants, and in various embodiments to surgical implants configured for promoting growth of collagenous tissue at an anatomical site.

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

Abstract: An incontinence treatment device includes a urethral support and first and second connectors. The urethral support extends between a first end and a second end and has porosity that is configured to allow tissue in-growth through the urethral support. The first connector is attached to the first end of the urethral support and the second connector is attached to the second end of the urethral support. At least one of the first connector and the second connector is a cross-linked polymer connector having a glass transition temperature between 40-70 degrees Celsius. The cross-linked polymer connector has an initial length that is elongated to an implant length that is greater than the initial length. Means for heating the cross-linked polymer connector from an extracorporeal location through intact skin is provided, thereby shortening the cross-linked polymer connector.

Abstract: A method of treating urinary incontinence in a patient includes implanting in the patient a device having a band, two magnets, and a power source; placing the band around a urethra; and implanting the power source outside of a pelvis. The power source is operable to electromagnetically couple the two magnets thus constricting a lumen of the urethra.

Abstract: An incontinence treatment device includes a band, magnets, and a power source. The band has a length extending between a first end and a second end. A first magnet is connected to a first end portion of the band and a second magnet is connected to a second end portion of the band. The band is implantable around a urethra and configured to constrict a lumen of the urethra when the first magnet is coupled to the second magnet. The power source is electrically coupled to the first and second magnets and configured to electromagnetically couple and decouple the first magnet relative to the second magnet.

Abstract: Methods and related systems for treating patients suffering from several disorders including bladder dysfunction, erectile dysfunction, and bowel elimination disorders are disclosed and described. The method can include identification of the disorder followed by the step of accessing a pudendal nerve of the patient. A microelectrode array having a plurality of electrodes thereon is inserted into the pudendal nerve of the patient. A controller is electronically associated with the microelectrode array which is programmed to provide selective activation and/or blocking of various muscles using the microelectrodes of the array. The selective stimulation can be tuned to selectively activate or block at least one muscle selected from the group consisting of the external urethral sphincter, the detrusor muscle, the anal sphincter, and the cavernous smooth musculature of the penis.

Abstract: Systems for providing support to body tissue to alleviate incontinence are disclosed that comprise an elongated incontinence sling (20) having a central support portion (40) adapted to be positioned to support any one of the urethra or anus (58, 67) and first and second sling end portions (42, 44) extending from the central support portion through body tissue and a tension adjustment mechanism acting on or within one or both of the sling end portions. The sling tension adjustment mechanism comprises one or more of a sling tensioning suture (312, 314) or band, and a tensioning device (310) coupled to a suture or band free end.

Abstract: The invention provides, in various embodiments, aspects of soft tissue anchors, adjustable length/tension slings, interconnects between slings and soft tissue anchors, delivery devices and systems for implanting supportive slings, and methods relating to anchoring, adjusting and implanting supportive slings.