Abstract: The distal portion of a shape-memory filament extends from a needle containing at least one filament gripping element. To implant the shape-memory filament in tissue, the needle is inserted into a cannula with a flexible and removable hook. During partial withdrawal of the needle, the hook holds the distal portion of the filament stationary to deposit a section of filament in the distal portion of the cannula. The needle is re-advanced, pushing the section of the shape-memory filament to coil or fold within the tissue. Rotation of the needle with the filament gripping element further tightens the coiled or folded filament. Partial withdrawal, re-advancement, rotation and pushing of the needle are repeated to fill, pack, strengthen, enlarge or augment the tissue with the shape-memory filament.

Abstract: A system for treating pelvic organ prolapse includes a shell and an anchor. The shell is made of biodegradable material that is insertable into a vagina. The shell has a convex exterior apex that is sized to contact an interior apical portion of the vagina. The anchor has a proximal portion that is attachable to the apex of the shell and a distal portion that is provided with a tissue fixation device that is attachable to tissue exterior the vagina such that the anchor and the shell combine to support and elevate the interior apical portion of a vagina.

Abstract: According to an example embodiment, an implant assembly may include a first handle, a first elongated member defining a first lumen, and a tissue support member extending through the first lumen of the first elongated member, the tissue support member including a first end and a second end, the first end being attached to the first handle.

Abstract: This invention generally relates to devices and methods that allow an operator to deliver a suture and an implant coupled to the suture into the body of a patient without the need for direct-vision of the operator. In one aspect, a medical device includes a receiving arm that releasably holds an implant or suture in place for capture and a clamping arm that includes a needle deployment mechanism for advancing a needle directly to the implant for capture and for retracting the needle with the implant attached to deliver the implant into the desired location. The receiving arm includes a cavity with inner walls that are angled to direct the needle through the opening after the advancing needle pierces and goes through tissue of the patient. The angled walls facilitate movement of the needle into a position within the cavity where the implant gets engaged with the needle.

Abstract: The present invention discloses a medical assembly and method for the delivery of an implant inside a patient's body. The medical assembly includes a sling assembly including a dilator and an implant. The dilator can be configured to be coupled to the implant. The dilator includes a proximal portion and a distal portion such that the proximal portion includes a first locking feature. The medical assembly includes a delivery device configured to deliver the sling assembly. The delivery device includes a needle and a handle having a proximal portion and a distal portion. The distal portion of the handle includes a second locking feature configured to releasably mate with the first locking feature and inhibit axial movement of the dilator with respect to the delivery device. The first locking feature is sized to frictionally retain the second locking feature.

Abstract: This invention generally relates to devices and methods that allow an operator to position an implant into the body of a patient without the need for direct-vision of the operator or the need to hand-guide a needle in order to capture an implant. In one aspect, a multi-arm delivery device includes a receiving arm that releasably holds an implant in place for capture and a clamping arm that includes a needle deployment mechanism for advancing a needle directly to the implant for capture and for retracting the needle with the implant attached to deliver the implant into the desired location. In one embodiment, the needle includes a plurality of retaining slots. In another embodiment, an end portion of the implant is configured to receive a needle into the end portion and at least some of the end portion of the implant is configured to be retained into one or more retaining slots of the needle.

Abstract: An implant assembly for treating incontinence in a patient may include an implant and an elongated member. The implant may include a first arm, a second arm, and a central portion, the first and second arms extending from the central portion. The elongated member may extend along the first arm. The elongated member may include a tail portion at a first end portion of the elongated member, the tail portion having a planar portion, at least part of the tail portion extending beyond the central portion of the implant in a direction opposite from a direction that the first arm extends from the central portion of the implant, an envelope portion, the envelope portion defining a lumen through which the first arm extends, and a window portion comprising a single planar portion extending from the envelope portion.

Abstract: A surgical assembly including a surgical introducer having a handle portion and a needle element extending to a free distal end, and a sliding mechanism including a compressible member and a sliding button slidably coupled to the handle portion for longitudinal movement relative thereto and having a first retaining device extending outwardly from a distal end and a projection extending outwardly to a position adjacent the compressible member. First and second sheath elements each have a proximal end, a closed tapered distal end region, a channel therein, and a side aperture at a predetermined distance from the distal tip. The needle element slidably extends through the side aperture and into the channel of the first sheath element. An implant having first and second ends is coupled to the proximal ends of the first and second sheath elements respectively.

Abstract: A sensor for use in a canister for fluid collection, the canister having a canister top and defining a fluid collection chamber. The sensor includes a first electrode and a second electrode. The first electrode includes a first portion and a second portion, wherein the first portion of the first electrode is supported by the canister top, and the second portion of the first electrode is configured to extend into the fluid collection chamber. The second electrode includes a first portion and a second portion, wherein the first portion of the second electrode is supported by the canister top, and the second portion of the second electrode is configured to extend into the fluid collection chamber. The sensor also includes an electric circuit configured to detect an electrical property associated with the first and second electrodes.

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 ingrowth as the biodegradable components degrade.

Abstract: A system and method for stimulating a target such as a nerve, wherein the system includes a first waveform generator adapted to generate a first waveform having a frequency capable of stimulating a predetermined target of the mammal, a second waveform generator adapted to generate a carrier waveform having a frequency capable of passing through tissue of the mammal, a modulation device electrically coupled to the first and second waveform generators and adapted to modulate the first and carrier waveforms to create a modulated waveform, and an electrode electrically coupled to the modulation device and positioned substantially adjacent to skin of the mammal, and adapted to apply the modulated waveform thereto.

Abstract: A system for providing support to an anatomical structure of the pelvis includes first and second soft tissue anchors, a suburethral support, an introducer, and a filament. The first soft tissue anchor has a proximal end and a distal end and includes a base having a hollow tubular structure, a plurality of barbs, and a tip. The sub-urethral support portion has first and second ends, the first and second soft tissue anchors extending from the first and second ends of the sub-urethral support portion. The introducer has an elongate shaft and a handle, the elongate shaft having a proximal end at the handle and a distal end with an aperture extending through the distal end. The filament extends through the hollow tubular section of the first soft tissue anchor and through the aperture in the distal end of introducer.

Abstract: A method of treating pelvic organ prolapse in a patient is provided. The method includes inserting a support device into a natural vaginal opening of the patient and placing the support device in contact with an interior apical portion of a vagina. The method additionally includes implanting an anchor in the patient and attaching a first end of the anchor to the support device and attaching a second end of the anchor to one of a sacrum and a ligament of the patient.

Abstract: A method of providing support to an anatomical structure of the pelvis includes making a vaginal incision for providing access for placement of a mesh support device below a urethra of a patient without penetrating an abdominal wall of the patient. The mesh support device includes a sling portion and first and second soft tissues connected to first and second ends of the sling portion. The mesh support device is delivered through the vaginal incision using an introducer including a curved elongate shaft having a distal portion and a proximal portion connected to a handle. A suture is passed through a hollow tubular section of the first soft tissue anchor. The suture passed through an aperture in a distal end of the introducer and the introducer is advanced over the suture until the first soft tissue anchor is located at the distal end of the introducer.

Abstract: A mesh delivery system for sacral colpopexy procedures is disclosed. The system uses a mesh stabilizer (30) that is introduced in a compressed configuration through a surgical port into the abdomen, and a vaginal probe (10) (inserted through the vagina) with a magnetic or non-magnetic head that engages with the mesh stabilizer (30), anchoring it in position. The mesh stabilizer (30) employs a pseudoelastic shape memory alloy, and folds compact to deliver multiple mesh straps or a single Y-shaped surgical mesh in a streamlined configuration into the abdomen for facilitating the sacral colpopexy procedure. After delivery, the stabilizer (30) expands to a functional configuration where it interfaces with the probe (10) head and stabilizes and adjustably feeds the mesh strap(s) for suturing while maintaining stabilization of the mesh on the vaginal apex and while keeping excess mesh from obscuring the surgeons view. After suturing, the stabilizer can be removed back through the surgical port.

Abstract: A system for treating pelvic organ prolapse includes a plug, a skirt, and an anchor. The plug includes a base opposite an apex with the base wider than the apex. An exterior surface of the apex is shaped to conform to an interior apical portion of a vagina. The skirt is attachable to the plug and includes multiple pores that are sized to allow tissue of the interior apical portion of the vagina to grow through the skirt. The anchor has a proximal portion that is insertable through the vagina and the skirt for attachment to the apex of the plug. The anchor has a length that allows a distal portion of the anchor to be attached to a sacrum of a patient.

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

Abstract: Systems for providing support within the pelvic region of a patient. The systems can include an elongated incontinence sling having a central support portion adapted to be positioned to support any one of the urethra or anus, and a sling tension adjustment mechanism operatively attached to the elongated sling. The sling tension adjustment mechanism can include a plunger device adapted for traversal within an interior of the housing, and an inflatable bladder provided within the housing to selectively control traversal of the plunger. Alternatively, the adjustment mechanism can include a bobbin device within the housing and one or more retention devices to selectively restrict unwinding of a suture from the bobbin device.

Abstract: A system includes an adjustable implant configured for implantation internally within a subject and includes a permanent magnet configured for rotation about an axis of rotation, the permanent magnet operatively coupled to a drive transmission configured to alter a dimension of the adjustable implant. The system includes an external adjustment device configured for placement on or adjacent to the skin of the subject having at least one magnet configured for rotation, the external adjustment device further comprising a motor configured to rotate the at least one magnet and an encoder. Rotation of the at least one magnet of the external adjustment device effectuates rotational movement of the permanent magnet of the adjustable implant and alters the dimension of the adjustable implant. Drive control circuitry is configured to receive an input signal from the encoder.

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: A fixing device includes a vaginal insertion portion of a longitudinal shape which is inserted into the vagina, a urethral-insertion member having a urethral-insertion portion of a longitudinal shape which is inserted into the urethra, and an interlock portion which is interlock means configured to interlock the vaginal insertion portion and the urethral-insertion member with each other. The vaginal insertion portion has a form of a plate and is curved. Further, the vaginal insertion portion has, as a guide portion which supports a medical tool of a longitudinal shape for movement along a longitudinal direction of the medical tool so as to guide the medical tool in the proximity of the urethra and in a direction in which the medical tool bypasses the urethra, two guide holes and which extend through the vaginal insertion portion in a thicknesswise direction of the vaginal insertion portion.

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

Abstract: A sling for treating urinary incontinence includes a suburethral support and first and second elongated suspending members. The suburethral support has opposite ends, is formed from a polymer and has first physical properties including a density, a length and a width. The first and second suspending members are formed from the same polymer as the suburethral support and have second physical properties including a density, a length and a width. The density of the suspending members is different than the density of the suburethral support. The first and second suspending members are each formed separately from and attached to one of the opposite ends of the suburethral support. The length of each of the suspending members is greater than the length of the suburethral support, and the width of each of the suspending members is less than the width of the suburethral support.

Abstract: A urination control device includes a conduit to be inserted into the urethra, an upstream restraint member located upstream of the conduit and having a through hole, a control member located on the downstream side from the upstream restraint member in the conduit, and a downstream restraint member located on the downstream side from the control member in the conduit, wherein the upper restraint member and control member attract each other with magnetic force, and the control member is brought in contact with the opening portion of the through hole in the upstream restraint member at least in the state exerting no fluid pressure on the upstream side so as to block passage of fluid through the upstream restraint member and admit the passage of fluid through the downstream restraint member in the state engaged with the control member.

Abstract: Systems and methods for determining whether an involuntary voiding event was attributable to stress or urge incontinence include determining an activity level of a patient that coincides with the occurrence of the involuntary voiding event or the activity level within a certain time range of the involuntary voiding event. Patient activity data may be collected via a signal that varies as a function of patient activity. The signal may be generated with one or more sensors that detect motion, such as an accelerometer or a piezoelectric crystal, and/or one or more sensors that monitor a physiological parameter of the patient that varies as a function of patient activity, such as heart rate, respiratory rate, electrocardiogram morphology, respiration rate, respiratory volume, core temperature, muscular activity level or subcutaneous temperature of the patient.

Abstract: A method for treating anal incontinence is provided, in which a support member is implanted in a tissue pathway extending from a first location posterior to and adjacent the anus, through the perineum anterior to the anus and terminating at a location posterior to and adjacent the anus opposite the first location.

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 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 50A to about 90A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5A to about 49A. 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: An inflated implant within an anatomical structure, such as the bladder, may require removal. A method of removing an inflated implant from an anatomical structure can include any of a number of different steps. A removal device can be placed within the anatomical structure. The implant is located within the anatomical structure. After it is located, the implant can be engaged by arms of the removal device. A portion of a surface of the implant can be compromised such that an inflation substance within the implant can escape. The inflation substance can be removed out of the implant through a deflation tube in at least one of the arms used to engage the implant. The implant can then be removed from the anatomical structure.

Abstract: The invention, in various embodiments, is directed to systems, devices, and methods relating to pre-pubic approaches to delivering a supportive sling to periurethral tissue of a patient.

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 implants that are useful for anchoring an implant to tissue.

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

Abstract: In a general aspect, a method of treating urinary incontinence can include slidably interfitting a first push tube into a first dilator tube disposed at an end of a sling assembly and slidably interfitting the first push tube onto an end of a shaft of a delivery device. The method can also include inserting the shaft transvaginally through a vaginal wall and removing the shaft to implant a portion of the sling assembly in periurethral tissue. The method can also include slidably interfitting a second push tube into a second dilator tube disposed at a second end of the sling assembly and slidably interfitting the second push tube onto the end of the shaft. The method can still further include inserting the shaft transvaginally through the vaginal wall and removing the shaft from the patient to implant a second portion of the sling assembly in periurethral tissue.

Abstract: The invention, in various embodiments, provides systems, devices, and methods for treating urinary incontinence. The invention also provides a driver and methods for advancing needles, cannulas, and other medical devices through the pubic bone. The driver may be used in connection with a driver frame assembly for proper positioning and stabilization of the driver, and with other devices for creating a cavity in the urethral floor and for positioning medical devices therein. The invention also provides simple connections for attaching a suture to a device within the cavity in the urethral floor or in the vagina, an also for attaching sutures to the pubic bone.

Abstract: An implant includes a support member having a first portion and a second portion. The support member is configured to be in contact with a wall of a vagina of a patient. The first portion defines apertures having a first size. The second portion defines at least one aperture having a second size. The second size is larger than the first size. The aperture having the second size is configured to be substantially aligned with a scar or an incision in the wall of the vagina. The second portion is configured to better prevent erosion of the wall of the vagina near the scar or incision than the first portion.

Abstract: The invention describes a surgical introducer comprising a proximal tip portion and a distal tip portion, wherein each tip portion comprises a notch, a base portion comprising an angle, wherein the base portion is between the proximal tip portion and the distal tip portion and wherein the base portion is wider than the remainder of the introducer. The introducer can be used for insertion of arms of a urethral sling into a patient.

Abstract: Surgical articles that are conveniently and securely coupled are disclosed. Improved surgical procedures are also disclosed.

Abstract: Technologies are generally provided for a trans-urethral sling delivery device for deploying a sub-urethral sling to support a urethra to treat urinary incontinence. A trocar and a delivery tube may be advanced through the urethra, and the trocar may puncture a hole in the urethral wall. The delivery tube may be configured to form a curved position such that a curved portion may extend from the hole in the urethral wall into an area surrounding the urethra near the bladder. A sub-urethral sling may be attached to a flexible delivery tool in a reduced delivery profile, and the flexible delivery tool with the attached sub-urethral sling may be advanced through the curved delivery tube. The delivery tube may be rotated to enable the delivery tool to anchor each end of the sub-urethral sling on each side of the urethra with a portion of the sling supporting the urethra from beneath.

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

Abstract: The invention provides, in various embodiments, systems, devices and methods relating to adjustable length implantable sling assemblies for providing support to anatomical locations. In certain embodiments, the sling includes at least one elastic member to aid in the placement and tensioning of the sling.

Abstract: An implant for use in the treatment of urinary incontinence includes a suburethral support and an anchor portion extending from the support portion. The support portion is operatively positionable at or distal to the bulbar urethral complex and the anchor portion is operatively extensible through the obturator foramen.

Abstract: An implantable device includes a body member having a bottom side that is parallel to a top side; a pair of legs extending from the bottom side of the body member; and a pair of arms extending from the body member perpendicular to the pair of legs and a second arm extending from the body member perpendicular to the pair of legs.

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: 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: A fixation device can be delivered to the body of a patient by coupling the fixation device to a delivery instrument at a head of the fixation device. Engaging the fixation device to the delivery instrument at the fixation device's head allows the fixation device to be secured to a tissue and/or ligament of the patient. The fixation device can be a sling for placement around the bladder neck of a female patient.

Abstract: A method of treating urinary incontinence includes making an incision and exposing tissue of a urethra. The method additionally includes inserting a non-porous sheet into the incision and forming a cuff around the urethra with the non-porous sheet by directing a first end of the non-porous sheet through a slot formed in a second end of the non-porous sheet. The method additionally includes directing an extending member that is attached to the non-porous sheet to a location exterior of a pelvis. The method further includes configuring the cuff to tighten around the urethra when pulling on the first end of the non-porous sheet, and configuring the cuff to be loosely positioned around the urethra when pulling on the extending member.

Abstract: An instrument including a grip portion, a first substantially rigid extension arm projecting outwardly from the grip portion along a first longitudinal axis, and a second substantially rigid extension arm projecting outwardly from the grip portion along a second longitudinal axis. The first has a straight portion adjacent the grip portion that lies substantially within a first plane, and a distal portion extending from the straight portion to a first distal end along a length of which the first extension arm extends upward relative to the first plane and rotates about its first longitudinal axis. The second has a second straight portion adjacent the grip portion that lies substantially within the first plane, and a second distal portion extending from the straight portion to a second distal end along a length of which the second extension arms extends downward relative to the first plane and rotates about its longitudinal axis.

Abstract: Technologies are generally provided for a trans-vaginal sling delivery device for deploying a sub-urethral sling to treat urinary incontinence. A delivery tool coupled with an interior of a delivery tube may be advanced through the vagina, and a pointed end of the delivery tube may puncture the vaginal wall. A sub-urethral sling may be attached to the delivery tube, and the sling may be longitudinally wrapped into a reduced delivery profile around the delivery tool within the delivery tube. The delivery tube may include a longitudinal slit opening, and the sling may be deployed from the delivery tool by rotating the delivery tool. Two delivery tubes and delivery tools may be employed to deploy each end of the sling, such that each end of the sling may be anchored on a right and left side of the urethra with a portion of the sling supporting the urethra from beneath.

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

Abstract: An implantable vessel occlusive device and method for occluding a vessel are described, for example to occlude the urethra or bladder neck. The devices and methods described utilize an occlusive member connected to a control mechanism. The occlusive member is reversibly changed from a non-occlusive condition to an occlusive condition, for example by depressing an activation button contained within a resilient, elastomeric cover surrounding the control mechanism. In the occlusive position, an initial tension is applied to the occlusive member through a tensioning suture. The tension is translated into an occlusive pressure applied to the urethra or bladder neck that is sufficient to prevent urinary leakage. The non-occlusive position can be obtained by depressing the de-activation button. The occlusive member is constructed to allow elution of drugs, such as may be required to combat infection or tissue encapsulation from its surface.