Patent Description:
Men, women, and children of all ages can suffer from urinary incontinence or involuntary loss of urinary control. Their lives are perpetually interrupted by thoughts of ensuring that they have ready access to a restroom. Everyday activities such as attending a theater or sporting event can become unpleasant. Sufferers often begin to avoid social situations in an effort to reduce the stress associated with their condition.

A variety of treatment options are currently available. Some of these include external devices, behavioral therapy (such as biofeedback, electrical stimulation, or Kegel exercises), prosthetic devices, and surgery. Depending on the age, medical condition, and personal preference of a patient, surgical procedures can be used to completely restore continence.

One type of surgical procedure found to be an especially successful treatment option for incontinence in both men and women is a sling procedure. Sling procedures typically entail surgically implanting a biocompatible implant or "sling" to support the bladder neck or urethra. Sling procedures are discussed in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT> and <CIT>.

Some "pubomedial" sling procedures involve an abdominal incision and installation of a sling between the rectus fascia in the abdominal region to a position below the urethra, and back again to the rectus fascia. A conventional procedure in females is to surgically place a sling by entering the abdominal cavity through an incision in the patient's pubovaginal region.

In males, one example of a conventional method involves surgical placement of a sling by entering the abdominal cavity through an abdominal incision. Unfortunately, to access the abdominal cavity a surgeon must incise the male patient's abdominal muscles. This procedure is more time consuming and uncomfortable for the male patient.

Other methods for treating pelvic conditions involve installation of a sling below the urethra through incisions made at the inner thigh (e.g., in the perineal skin facing the obturator and in the groin), and using a tissue path extending through the obturator. These procedures can be referred to as "transobturator" methods. See, e.g., <CIT> and Published <CIT>.

<CIT> describes implants, tools, and methods useful for treating pelvic conditions such as prolapse, by placing an implant to support pelvic tissue, the implants, tools, and methods involving one or more of an insertion tool that works in coordination with a sheath, adjusting engagements, specific implants and pieces of implants, placement of implants at locations within the pelvic region, and insertion, adjusting, and grommet management tools.

<CIT> is state of the Art in accordance with Art. <NUM>(<NUM>) EPC and relates to devices, implants and kits for treating incontinence in male or female patients.

While abdominal and transobturator methods of treating urinary incontinence can be effective, safe, and long-lasting, there is ongoing effort toward improving these methods.

The invention relates to a system of treating pelvic conditions, e.g., urinary incontinence, in males and females and provides a system according to claim <NUM>. Embodiments of the invention are defined by the dependent claims.

The present disclosure relates to implants, systems and exemplary methods for treating urinary incontinence involving placement of a tissue support portion of an implant below a urethra, preferably with placement of extension portions of the implant at tissue paths that extend from a location to support the urethra in a direction toward an obturator foramen. Methods described hereinafter are of exemplary nature and are not specifically claimed, but are presented for better understanding the present invention.

A tissue path may extend toward and end at pelvic fascia without reaching or passing into or through the obturator foramen. In other examples a tissue path may extend to the obturator foramen. In still other examples the tissue path may extend through an obturator foramen. The exemplary methods can involve two opposing tissue paths, as described, one on each of a left and a right side of the patient.

The implant may involve an adjustment feature that allows placement of the implant followed by or along with adjustment of the positioning or size of the implant, such as one or more adjustable extension portion. The adjustment feature may be a one-way adjusting engagement, a two-way adjusting engagement feature, a two-way adjusting feature that additionally includes a locking feature, etc. An exemplary method may involve adjusting the size of the implant by use of an adjusting feature or adjusting engagement between an extension portion and a support portion. The implant may be placed and optionally adjusted by use of a tool that can contact an implant to allow manipulation of the implant; optionally at the same time the tool may allow for or may be used to provide movement or approximation of tissue to be supported by the implant (e.g., tissue of a urethra).

The present disclosure relates to an exemplary system for treating urinary incontinence, the system including a multi-piece implant comprising a support portion piece and an extension portion piece, and an adjusting tool. The support portion piece comprises a tissue support portion sized and shaped for placement to support a urethra. The extension portion piece comprises a proximal end, a distal end, and a tissue fastener, and is adjustably connected to the support portion piece at an adjusting engagement. The adjusting tool comprises a surface capable of engaging the support portion piece, and a moveable holder capable of holding the proximal end of the extension portion piece and moving the proximal end relative to the adjusting engagement.

The present disclosure also relates to an exemplary system for treating a pelvic condition such as urinary incontinence, the system comprising an implant and a tool. The implant comprising a support portion, two extension portions, and two self-fixating tips, one self-fixating tip at an end of each extension portion, and a guide engaged with at least one of the self-fixating tips. The tool includes a shaft having a distal end capable of engaging the self-fixating tip, and a release mechanism at the distal end, the release mechanism capable of selectively engaging and releasing the self-fixating tip. The shaft is capable of engaging the guide to allow the shaft to be led along the guide to become engaged with the self-fixating tip.

The present disclosure also relates to another exemplary system for treating a pelvic condition incontinence. The system includes an adjustable implant comprising a support portion, two extension portions, and two self-fixating tips. One self-fixating tip is located at an end of each extension portion. At least one self-fixating tip is moveably engaged with one of the two extension portions. The support portion being is movable to adjust a location of the support portion along the implant between the self-fixating tips.

The present disclosure also relates to another exemplary system for treating urinary incontinence, the system comprising a multi-piece implant comprising a support portion piece and two extension portion pieces, and an adjusting tool. The support portion piece comprises a tissue support portion sized and shaped for placement to support a urethra. The extension portion pieces each comprise a proximal end, a distal end, and a tissue fastener. The first extension portion piece is adjustably connected to the support portion piece at a first adjusting engagement. The second extension portion piece is adjustably connected to the support portion piece at a second adjusting engagement. The adjusting tool comprises two adjusting surfaces, the two adjusting surfaces being capable of engaging the support portion piece in a manner to place tension along a length of the support portion piece.

The present disclosure also relates to another exemplary system for treating urinary incontinence, the system comprising an implant and a tool. The implant comprises a support portion, two extension portions, and a self-fixating tip at a distal end of each extension portion. The tool comprises a proximal end and a distal end, a surface at the distal end capable of approximating a urethra, two shafts that can be extended and retracted from the distal end, and an adjusting surface at each shaft distal end, each adjusting surface being capable of engaging a self-fixating tip.

The present disclosure also relates to another exemplary system for treating urinary incontinence, the system comprising a multi-piece implant comprising a support portion piece and an extension portion piece, and an adjusting tool. The support portion piece comprises a tissue support portion sized and shaped for placement to support a urethra. The extension portion piece comprises a proximal end, a distal end, and a tissue fastener, and is adjustably connected to the support portion piece at an adjustable connection. The adjusting tool comprises a surface capable of engaging the support portion piece.

The present disclosure also relates to an exemplary, non-claimed method of treating urinary incontinence in a male or a female patient. The method includes providing a system according as described herein, placing the implant below a urethra of the patient, and placing tissue fasteners at supportive tissue. Optionally the placement of the implant can be adjusted, the size of the implant or an extension portion can be adjusted, and the method can include using a tool to approximate tissue of the urethra.

The systems, devices, tools, implants, etc., described herein are directed to exemplary surgical instruments, assemblies, implantable articles, systems and related exemplary methods for treating urinary incontinence in a male or female, including stress urinary incontinence (SUI). An implant can be implanted in a male or a female to treat a condition such as urge incontinence, mixed incontinence, overflow incontinence, functional incontinence, and the like.

An implant can include a tissue support portion (or "support portion") that can be used to support a urethra or other pelvic tissue. Supporting a "urethra" refers to supporting tissue that includes the urethra (which can refer to the bladder neck) and that can optionally include tissue adjacent to a urethra such as bulbospongiosus muscle, corpus spongiosum, or both. According to various exemplary methods, for example, a support portion may either be placed below bulbospongiosus muscle to support both bulbospongiosus muscle and corpus spongiosum (along with the urethra), or alternately bulbospongiosus muscle may be dissected and a support portion may be placed to contact corpus spongiosum tissue (to support the urethra).

An implant can additionally include one or more extension portion (otherwise known as an "end" portion or "arm") attached or attachable to the tissue support portion. Normally, for treating incontinence, an implant can include two opposing extension portions. Extension portions are elongate pieces of material (e.g., mesh, suture, or biologic material) that extend from the tissue support portion and either are or can be connected to the tissue support portion, and are useful to attach to anatomical features or "supportive tissue" in the pelvic region (e.g., using a self-fixating tip or another form of tissue fastener) to thereby provide support for the tissue support portion and the supported tissue. Generally for treating incontinence, two extension portions can extend from the opposite ends of a tissue support portion as elongate "ends," "arms," or "extensions," and may attach to supportive tissue in the pelvic region by extending through a tissue path to an internal anchoring point (see, e.g., Applicant's copending United States Patent Application Publication number <CIT>, entitled SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS, the entirety of which is incorporated herein by reference), or may extend to an external incision, such as through an obturator foramen and through an external incision at a groin or inner thigh (see, e.g., Applicant's copending United States Patent Publication Number <CIT>). Also see U. Patent Publication number <CIT> and <CIT>.

In exemplary uses, each extension portion can extend from the location of attachment with the tissue support portion, through pelvic tissue, and optionally be attached to supportive tissue within the pelvic region. For certain procedures the supportive tissue can be tissue adjacent to the urethra such as pelvic fascia; tissue between the urethra and an obturator foramen such as pelvic fascia; or tissue of an obturator foramen such as obturator fascia, obturator internus muscle, obturator membrane, obturator externus muscle, etc. For alternate procedures an extension portion can be sized to extend from the tissue support portion, through an obturator foramen, around a pubic ramus bone, and threaded (subcutaneously) back to a medial location such as near a medial incision.

An implant may include portions, pieces, or sections that are synthetic or of biologic material (e.g., porcine, cadaveric, etc.). Extension portions may be, e.g., a synthetic mesh such as a polypropylene mesh, a suture, a biodegradable suture, etc. The tissue support portion may be synthetic (e.g., a polypropylene mesh) or biologic. Examples of implant products that may be similar to those useful according to the present description, include those sold commercially by American Medical Systems, Inc. , of Minnetonka MN, under the trade names Apogee®, Perigee®, and Elevate® for use in treating pelvic prolapse (including vaginal vault prolapse, cystocele, enterocele, etc.), and Sparc®, Bioarc®, Monarc®, and MiniArc® for treating urinary incontinence.

An example of a particular type of pelvic implant is the type that includes supportive portions including or consisting of a tissue support portion and two opposing extension portions extending from the tissue support portion. An implant that has exactly two extension portions can be of the type useful for treating urinary incontinence. The term "supportive portions" refers to portions of an implant that function to support tissue after the implant has been implanted, and specifically includes extension portions and tissue support portions, and does not include optional or appurtenant features of an implant such as a sheath, tensioning suture, tissue fastener, or self-fixating tip or other type of connector for attaching the implant to an insertion tool.

A preferred implant (e.g., sling) for placement against a corpus spongiosum for treatment of urinary incontinence in a male patient may optionally and preferably include a widened central support to provide increased contact and frictional engagement with the corpus spongiosum. See, for example, Assignee's copending United States Patent Publication Number <CIT> and <CIT>.

Dimensions of a tissue support portion can be any dimensions useful to support urethra tissue for treating incontinence. A tissue support portion can be of sufficient length to support and optionally partially surround a urethra or urethra-supporting tissue. A width of a tissue support portion may optionally and preferably be greater than a width of extension portions and can be sufficiently wide to increase contact area and frictional forces between a tissue support portion and a tissue in contact with the tissue support portion. Exemplary lengths of a tissue support portion can be in the range from <NUM> to <NUM> inches, such as from <NUM> to <NUM> inches. Exemplary widths of a tissue support portion can be in the range from <NUM> or <NUM> to <NUM> centimeters, such as from <NUM> to <NUM> or <NUM> centimeters. (A tissue support portion may be part of a support portion piece that includes the tissue support portion and optionally some amount of opposing extension portions extending from ends of the tissue support portion.

Dimensions of extension portions can allow the extension portion to reach between a tissue support portion placed to support a urethra (at an end of the extension portion connected to the tissue support portion) and a location at which the distal end of the extension portion attaches to supportive tissue at or about the pelvic region. Exemplary lengths of an extension portion measured for example between a connection or boundary between the extension portion and the tissue support portion, and a distal end of the extension portion, can be, e.g., from <NUM> to <NUM> inches, preferably from <NUM> to <NUM> inches, and the length can optionally and preferably be adjustable. As described elsewhere herein, a length of an extension portion may be fixed (i.e., the extension portion does not include any form of length-adjusting mechanism). Alternate examples of implants may include an adjusting engagement that allows a physician to alter the length of an extension portion before, during, or after implantation.

Implants as described can include a tissue fastener at a distal end or a distal portion of an extension portion, which is the end or portion not attached to a tissue support portion. (The term "distal" as used herein (unless noted otherwise) generally refers to a direction toward a patient and away from a surgeon installing a device. ) A tissue fastener at a distal end or portion of an extension portion can be any of various types, including: a self-fixating tip that is inserted into soft tissue and frictionally retained; soft tissue anchors; biologic adhesive; a soft tissue clamp that can generally include opposing, optionally biased, jaws that close to grab tissue; and opposing male and female connector elements that engage to secure an end of an extension portion to tissue. (See International Patent Application No. <CIT>; <CIT>, entitled SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS; <CIT>, entitled PELVIC FLOOR TREATMENTS AND RELATED TOOLS AND IMPLANTS; and <CIT>. ) An implant may also have one or more extension portion that does not include a tissue fastener, for example if the distal end is designed to be secured to tissue by other methods (e.g., suturing), or is intended to pass through an obturator foramen and a tissue path around a pubic ramus bone, in which case the extension portion may optionally include a connector, dilator, or dilating connector, which connects to an elongate tool that can be used to either push or pull the connector, dilator, or dilating connector through a tissue path (e.g., to a medial incision).

One example of a tissue fastener is a self-fixating tip. A "self-fixating tip" in general can be a structure (sometimes referred to as a soft tissue anchor) connected at a distal end of an extension portion (or extension portion piece) that can be implanted into soft tissue (e.g., muscle, fascia, ligament, etc.) in a manner that will maintain the position of the self-fixating tip and support the attached implant. Exemplary self-fixating tips can also be designed to engage an end of an insertion tool (e.g., elongate needle, elongate tube, etc.) so the insertion tool can be used to push the self-fixating tip through and into tissue for implantation, preferably also through a medial incision to reach the interior of the pelvic region, e.g., at a location of an obturator foramen. The insertion tool may engage the self-fixating tip at an internal channel of the self-fixating tip, at an external location such as at an external surface of the base, at a lateral extension, or otherwise as desired, optionally in a manner to allow the insertion tool to push the self-fixating tip through an incision in a patient and through and into supportive tissue.

Exemplary self-fixating tips can include one or more lateral extensions that allow the self-fixating tip to be inserted into soft tissue and to become effectively anchored in the tissue. A lateral extension may be moveable or fixed. The size of the self-fixating tip and optional lateral extensions can be useful to penetrate and become anchored into the tissue. Exemplary self-fixating tips are described in Assignee's copending international patent application<CIT>, titled Surgical Articles and Methods for Treating Pelvic Conditions. Other structures may also be useful.

According to exemplary embodiments, a self-fixating tip can have structure that includes a base having a proximal base end and a distal base end. The proximal base end can be connected (directly or indirectly, such as by a connective suture) to a distal end of an extension portion. The base extends from the proximal base end to the distal base end and can optionally include an internal channel extending from the proximal base end at least partially along a length of the base toward the distal base end. The optional internal channel can be designed to interact with (i.e., engage, optionally by means of a release mechanism that can be selectively engaged and released) a distal end of an insertion tool to allow the insertion tool to be used to place the self-fixating tip at a location within pelvic tissue of the patient. A self-fixating tip can be made out of any useful material, generally including materials that can be molded or formed to a desired structure and connected to or attached to a distal end of an extension portion of an implant. Useful materials can include plastics such as polyethylene, polypropylene, and other thermoplastic or thermoformable materials, as well as metals, ceramics, and other types of biocompatible and optionally bioabsorbable or bioresorbable materials. Exemplary bioabsorbable materials include, e.g., polyglycolic acid (PGA), polylactide (PLA), copolymers of PGA and PLA.

According to various systems as described, one or more instrument, insertion tool, adjusting tool, or the like, may be incorporated or used with the described implants and methods. Examples of useful tools include those that generally include one or more (stationary or moveable) thin elongate, relatively rigid shaft or needle that extends from a handle. The shaft can be a single elongate shaft or multiple separate elongate shafts extending from the handle, or one or more primary shaft that extends from the handle and that contains multiple branch or "tine" shafts that separate at the end of the primary shaft. The handle is located at a proximal end of the device and attaches to one end (a proximal end) of a shaft. According to some examples, a distal end of one or more shaft can be adapted to engage a portion of an implant, such as a tissue fastener (e.g., a self-fixating tip), in a manner that allows the insertion tool to engage and push the tissue fastener through a tissue passage and connect the tissue fastener to supportive tissue of the pelvic region. Examples of this type of tool can be used with a self-fixating tip that includes an internal channel designed to be engaged by a distal end of an insertion tool to allow the self-fixating tip to be pushed into tissue. Other general types of insertion tools will also be useful, but may engage a self-fixating tip or other tissue fastener in an alternate manner, e.g., that does not involve an internal channel.

According to other examples, a distal end of a tool (e.g., at one more shaft) can be adapted to engage one or more other portion of an implant, such as support portion, a proximal end of an extension portion, or both. The insertion tool may manipulate a tissue support portion and an extension portion of a multi-piece implant in a manner to allow the tool to adjust the size or positioning of the implant.

Exemplary insertion tools for treatment of incontinence and vaginal prolapse are described, e.g., in <CIT>, <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>, and <CIT>.

An exemplary tool can optionally include a mechanism by which a tissue fastener (e.g., a self-fixating tip) can be securely and releasable engaged with a distal end of an insertion tool such that the tissue fastener can be selectively secured to the distal end mechanically, then selectively released. With a releasable engagement, a tissue fastener (e.g., self-fixating tip) can be released from the distal end by releasing the engagement (e.g., mechanical engagement) by movement of an actuator at the proximal end of the insertion tool, such as at the handle. For example, an internal channel (or external surface) of a self-fixating tip can include an engaging surface designed to engage a mechanism at a distal end of an insertion tool while the self-fixating tip is placed at, on, or over the distal end. As an example, an internal or external surface of a self-fixating tip can include a depression, ring, edge, or ledge, that can be rounded, angular, etc. A mechanical detent such as a pin, ball, spring, deflector, or other surface or extension located at the distal end of the insertion tool can be moved, deflected, or extended relative to the distal end of the insertion tool to contact the surface of the self-fixating tip to securely and releasably hold the self-fixating tip at the distal end of the insertion tool and prevent removal of the tip from the distal end until removal is desired. The detent (or other surface or mechanism) can be cause to extend (or retract) from the distal end of the insertion tool by actuating a trigger or other mechanism located at the proximal end (e.g., handle or a proximal location of a shaft) of the insertion tool, to secure (or release) the self-fixating tip. Upon placement of the self-fixating tip at a desired location during a surgical implantation procedure, the insertion tool operator can release the self-fixating tip by use of the trigger or other mechanism at the handle to disengage the detent and cause the tip to become loose. The insertion tool can then be removed from the tissue path, and the self-fixating tip can remain in a desired implanted location.

Optionally, an implant can include a tissue fastener at a location of a tissue support portion, or at a location along a length of an extension portion. This form of tissue fastener can be in the form of reinforced (e.g., by coating, heat treating, or a reinforcing weave or strip) edge extensions, multiple layers of mesh and edge extensions in an extension portion, etc., as described, for example, at Applicant's copending <CIT>, and Applicant's copending <CIT>, <CIT>, and <CIT>. Other examples include relatively rigid structures such as metal, plastic, or other polymeric or non-polymeric structure that may be shaped to frictionally engage soft tissue, for example to include a tine, hook, chevron, barb, arrow, etc., combinations thereof, or any structure added to an edge or surface of an extension portion to improve fixation within tissue. The structure can have any shape or form that will increase frictional force between the implant and adjacent tissue, such as one or multiple pointed surface directed along a length of an extension portion, toward the tissue support portion, and extending away from a surface or edge of the implant (e.g., extension portion). The tissue fastener can be located at a position of an implant that will result in the tissue fastener being located at supportive tissue such as muscle or fascia when the implant is placed with a midline of the tissue support portion being located below a urethra. For example, a tissue fastener may be located on a tissue support portion or an extension portion of an implant, e.g., as close as <NUM> or <NUM> centimeters from a midline of a tissue support portion, and up to a distance that reaches tissue of an obturator foramen when the midline is located below a urethra, e.g., up to <NUM> centimeter from the midline.

According to various examples of implants described herein, an implant can include multiple pieces that are adjustably connected together by an adjusting engagement. A "multi-piece" implant refers to an implant that includes a "support portion piece" and one or multiple "extension portion piece" as separate pieces of the implant. An extension portion piece can be separate from a support portion piece, and the two pieces can be connected through an adjustable engagement. The support portion piece includes a tissue support portion.

An adjusting engagement may be for example a one-way adjusting engagement, a two-way adjusting engagement, or a locking two-way engagement, that allows a portion, piece, or a segment of an implant to be moved relative to another portion, piece, or segment if the implant and adjusted as to length, tension, or positioning. Examples of adjusting engagements are described, for example, in Applicant's copending <CIT>, entitled SURGICAL IMPLANTS AND TOOLS FOR TREATING PELVIC CONDITIONS, and <CIT>, entitled PELVIC FLOOR TREATMENTS AND RELATED TOOLS AND IMPLANTS.

Some adjusting engagements can allow two-way movement of one piece relative to another piece (e.g., a "two-way" adjusting engagement). This type of adjusting engagement allows movement of a segment of implant (e.g., of a segment or portion of an extension portion piece) in two directions through an adjusting engagement. The force needed to move the segment of implant in one direction is substantially equal to the force needed to move the segment in the opposite direction, and, optionally, the two-way adjusting engagement does not substantially hinder the movement of a segment of implant through the adjusting engagement with frictional surfaces such as extensions (e.g., "teeth") extending into an aperture through which the segment of implant is moved. As an example, a two-way adjusting engagement may include an open (smooth) aperture that may be circular, oval, square, elongate, or rectangular, such as in the form of a circle, slit, or slot, etc. The aperture may optionally be reinforced by a reinforced perimeter of a shape that is similar to the aperture, such as by a fabric or a polymeric material such as a grommet (e.g., a "loose grommet" or "eyelet"), which may be circular, square, rectangular, or of any desired shape. The reinforced perimeter (e.g., grommet) defines a reinforced aperture through which a segment of implant can pass relatively freely and with the same resistance two different directions.

A two-way adjusting engagement may optionally be capable of an open and a closed (e.g., locked) configuration, the open configuration allowing two-way movement between the pieces, and the closed (or locked) configuration preventing any movement between the pieces. Such an adjusting engagement may be referred to as a locking two-way adjusting engagement, and may include any form of mechanical securement device that can be configured in an open configuration (to allow two-way movement between pieces) and a closed configuration (to prevent movement between pieces). The locking two-way adjusting engagement may be selectively and reversibly moveable between the open configuration and the closed configuration, or may instead initially be an open configuration that, once placed in a closed configuration, cannot be re-configured to the open configuration. Examples of structures that may be part of a locking two-way adjusting engagement include a mechanical clip, staple, stitch, detent, or rivet; any form of spring-loaded or moveable frictional engagement; a non-moveable frictional engagement such as a slot, slit, cleat, or other non-moveable aperture or opening through which a portion of implant can be selectively engaged, released, and re-engaged; a deformable opening, ring, clip, staple, etc., which may be generally open and then permanently closed by mechanical deformation; and the like. One form of exemplary structure may be forceably closed (e.g. by bending a part until permanent deformation or closing a part until some latch or similar feature snaps shut), while others may be biased to close (e.g. a spring-loaded clip is held open until released so it can clamp shut). Changing from an open to a closed orientation could be performed by an independent tool, or may be an additional feature built into the adjustment tool. The clip or alternate opening-closing structure could be attached to larger structure of an adjusting engagement (potentially integrated into its design), or separate (so it could be loaded into the tool).

Other adjusting engagements may allow for one-way adjustment such as shortening of a length of an extension portion. These adjusting engagements can be referred to as "one-way" adjusting engagements, and allow adjustment of a length of an implant portion (e.g., extension portion) in one direction and not (or not easily) in an opposite direction. An exemplary one-way adjusting engagement can include an aperture through which a segment of implant (e.g., a portion of an extension portion piece) can extend, and one or multiple surfaces (e.g., extensions or teeth) that frictionally engage the segment of implant passing therethrough, e.g., by extending into or toward the aperture or otherwise contacting the segment of implant to inhibit movement of the segment of implant relative to the adjusting engagement. The one-way engagement can preferentially allow movement of the segment of implant through the aperture in one direction while inhibiting or preventing movement of the segment of implant in an opposing direction.

In use of a tissue support portion that includes a one-way adjusting engagement such as a round or rectangular grommet, a tissue fastener (e.g., a self-fixating tip) at one end of an extension portion is placed at tissue as desired, and the second (loose) end of the extension portion piece is passed through the one-way adjusting engagement. The engagement is adjusted to place the support portion piece at a desired position (length) of the extension portion piece to provide desired support to a urethra. The one-way adjusting engagement moves easily along the extension portion piece in a direction that tightens the implant against urethra tissue, and does not move easily in the opposite direction. Once placed in position below the urethra and tightened as desired, the support portion piece is prevented from moving along the extension portion piece in the direction to reduce support of the urethra. The extension portion piece may optionally be considered to be "smooth," without any visible frictional surface, or may alternately include bumps, detents, teeth, a jagged surface, or other frictional or mechanical structure to engage opposing structure at a surface of an aperture of the one-way adjusting engagement.

<FIG> illustrates a system that includes implant <NUM> (e.g., for treating male or female urinary incontinence) and insertion tool <NUM>. Implant <NUM> includes support portion <NUM>, end or extension portions <NUM>, and self-fixating tips <NUM>. Guide collars <NUM> are engaged with each of self-fixating tips <NUM>. Insertion tool <NUM> includes shaft <NUM>, distal end <NUM>, proximal end and handle <NUM>, release mechanism (e.g., comprising detents, teeth, or extensions) <NUM>, and trigger <NUM> located at a proximal region of shaft <NUM>. Trigger <NUM> can activate and de-activate release mechanism <NUM> to selectively securely engage and release self-fixating tip <NUM>, relative to distal end <NUM>.

<FIG> additionally shows a feature of two guides (e.g., guide tubes) <NUM>, each guide being removably engaged with one of the two self-fixating tips <NUM>. Each guide <NUM> allows a user to move a distal end of shaft of an insertion tool (e.g., <NUM>) into engagement with a self-fixating tip (e.g., <NUM>). In specific, guide <NUM> is in the form of a hollow guide tube, having an elongate hollow shaft and two ends, one opening at each end. A distal end opening engages a channel or bore of self-fixating tip <NUM>. The distal end removably engages self-fixating tip <NUM> through any removable or disengageable structure, such as a threaded engagement, a perforated engagement, a frictional engagement, or any other form of engagement that can be broken, disrupted, or disengaged by a separate mechanical mechanism located on tool <NUM>, e.g., between proximal handle <NUM> and distal end <NUM>.

During use, a distal end of an insertion tool (e.g., distal end <NUM>) can be inserted into a proximal end of a guide tube and guided through the guide tube to engage self-fixating tip <NUM>. The guide allows the distal end to engage the self-fixating tip while the self-fixating tip is engaged with the guide. This allows the distal end to engage the self-fixating tip outside of the patient so a surgeon can use the insertion tool to initially place the self-fixating tip through a medial incision and into engagement with supportive tissue. The initial placement may first be performed, after which the shaft and distal end may be removed from the guide and the patient, and the placement and tension of the self-fixating tip and implant may be tested to determine if adjustment is necessary. If so, the distal end and shaft may be re-engaged with the self-fixating tip previously placed at the tissue by re-inserting the distal end into the guide (which is accessible, e.g., a proximal end can remain outside of the patient) and passing the distal end through the guide to re-engage the distal end with the self-fixating tip. The guide leads the distal end to the self-fixating tip, and the distal end can re-engage the self-fixating tip. The insertion tool can then be used to push the self-fixating tip to a location of deeper penetration into the tissue.

After desired placement of the self-fixating tip, followed by disengagement and optional re-engagement of an insertion tool with the initially-placed self-fixating tip, and adjustment, the insertion tool can be removed from the guide and the guide can be removed from the self-fixating tip (optionally while the distal end is engaged with the self-fixating tip).

<FIG>, illustrate an exemplary method of using tool <NUM> to place implant <NUM>, with guides <NUM>, to treat urinary incontinence. Patient anatomy includes a medial (e.g., perineal) incision (not shown), a location of a urethra (not shown) and corpus spongiosum <NUM>, corpus cavernosa <NUM> and pubic ramus bones <NUM>, which bound an obturator foramen (not shown). A distal end of insertion tool <NUM>, passed through guide tube <NUM> and engaged with self-fixating tip <NUM>, is used to insert self-fixating tip <NUM> through a medial (e.g., perineal or vaginal) incision and place self-fixating tip <NUM> at supportive tissue in a region of an obturator foramen on a first side of the patient. Insertion tool <NUM> is then withdrawn from self-fixating tip <NUM> and guide tube <NUM>. Release mechanism <NUM> (e.g., detents) at distal end <NUM> can be selectively engaged and released as desired. For example, self-fixating tip <NUM> can be placed in supportive tissue with release mechanism activated to secure tip <NUM> at distal end <NUM>, and can be de-activated to disengage distal end <NUM> from self-fixating tip <NUM> after placement of the tip, followed by withdrawal of shaft <NUM> away from self-fixating tip <NUM> and back out of guide tube <NUM>.

As then shown at <FIG>, tool <NUM> can be used to engage the second self-fixating tip <NUM> of implant <NUM>, through second guide tube <NUM>, and the second self-fixating tip <NUM> can be placed at supportive tissue in a region of an obturator foramen on a second side of the patient. Tool <NUM> can optionally be disengaged (by use of trigger <NUM>) from self-fixating tip <NUM> and withdrawn from guide tube <NUM>.

Optionally tool <NUM> may be used to adjust the position (e.g., depth) of one or both of self-fixating tips <NUM> within supportive tissue by re-engaging one or both of self-fixating tips (<NUM>) through guide <NUM> to then push a self-fixating tip <NUM> to a deeper location within the supportive tissue. The opening at the distal end of each guide tube can be accessible, e.g., extends to a location outside of the patient, while the proximal end of the guide tube and the attached self-fixating tip (<NUM>) are located within the supportive tissue (e.g., at a region of an obturator foramen). Upon final adjustment, each of guide tubes <NUM> can be removed from self-fixating tips <NUM> and the patient. Removal of a guide tube <NUM> can optionally be performed with assistance of insertion tool <NUM>. For example, to remove a guide tube <NUM> from a self-fixating tip, tool <NUM> can be re-inserted into the guide tube and re-engaged with the self-fixating tip. The tool can engage the self-fixating tip to hold the tip at its location within supportive tissue and prevent undesired (proximal) forces from being applied to the properly-placed self-fixating tip while pressure is placed on the guide tube to separate the guide tube from the self-fixating tip.

<FIG> illustrates a system that includes implant <NUM> (e.g., for treating male or female urinary incontinence) and insertion tool <NUM>. Implant <NUM> includes support portion <NUM>, two opposing end or extension portions <NUM>, and self-fixating tips <NUM>. Support portion <NUM> is moveable along the length of the implant between self-fixating tips <NUM>. One of the self fixating tips includes a tightening buckle <NUM> through which extension portion <NUM> can be threaded and frictionally engaged. Tightening buckle <NUM> includes two frictional surfaces, one hinged frictional surface <NUM> and a second non-hinged frictional surface <NUM>. As illustrated, frictional surface <NUM> is stationary and frictional surface <NUM> is hinged to form a frictional engagement that allows for loose end <NUM> of implant <NUM> to be pulled (proximally) away from buckle <NUM>, after which, buckle <NUM> inhibits movement in an opposite direction. In use, a length of extension portion <NUM> can be threaded initially through hinged loop <NUM> and stationary loop <NUM> (see inset at <FIG>, lower image), adjacent to hinged surface <NUM> and stationary surface <NUM>, respectively. Extension portion <NUM> is then threaded back and over stationary frictional surface <NUM> (outside of loop <NUM>), past hinged frictional surface <NUM> and through hinged loop <NUM>, to contact the portion of extension portion <NUM> entering hinged loop <NUM>, then back in a proximal direction (now referred to as loose end <NUM>). Loose end <NUM> can be pulled to shorten the length of implant located between the two self-fixating tips <NUM> and to produce a taught length of implant supporting a urethra, after which buckle <NUM> inhibits loosening or lengthening of the implant within the patient.

Tool <NUM> includes handle <NUM>, shaft <NUM>, and distal end <NUM> capable of engaging an aperture of each of self-fixating tips <NUM>. Tool <NUM> is not specifically illustrated to include a release mechanism like that described with respect to tool <NUM>, but tool <NUM> could optionally include a release mechanism.

<FIG>, illustrate an exemplary method of using tool <NUM> to place implant <NUM>, having tightening buckle <NUM> at one end of an extension portion, and adjustable support portion location, to treat urinary incontinence. Patient anatomy is as described previously. A distal end of insertion tool <NUM>, engaged with self-fixating tip <NUM>, is used to insert self-fixating tip <NUM> through a medial incision and place self-fixating tip <NUM> at supportive tissue in a region of an obturator foramen on a first side of the patient. Insertion tool <NUM> is then used to engage the second self-fixating tip <NUM> for placement of the second self-fixating tip <NUM> at supportive tissue in a region of an obturator foramen on a second side of the patient. Loose end <NUM> can be accessible (e.g., can extend out of the medial incision) and can be pulled (proximally) to adjust a length of implant between self-fixating tips <NUM>, to provide desired tension on the length of implant, and desired approximation, placement, and support of the urethra. Loose end <NUM> can then be removed by cutting. Before, after, or simultaneously with tightening the length of implant by pulling loose end <NUM>, moveable support portion <NUM> can be moved (slid) in a direction toward one or the other obturator foramen to place moveable support portion <NUM> at a desired (central, medial) location below the urethra.

<FIG> illustrates a system that includes implant <NUM> (e.g., for treating male or female urinary incontinence) and insertion tool <NUM>. Implant <NUM> includes support portion <NUM>, end or extension portions <NUM>, and self-fixating tips <NUM>. Support portion <NUM> is moveable along the length of the implant between self-fixating tips <NUM>. Extension portions <NUM> extend through supports (or guides, having apertures) <NUM> located on support portion <NUM>, allowing each support (or guide) <NUM> of support portion <NUM> to be moved and positioned at a desired location along a length of each extension portion <NUM>. The effect is to allow a user to reduce or increase (i.e., lengthen) the effective size of each extension portion by sliding each support <NUM> toward a respective self-fixating tip <NUM>, on one or both sides of the implant and patient, thereby reducing the overall length of implant <NUM> between self-fixating tips <NUM>. Support (guide) <NUM> supports extension portion <NUM> by means of a one-way or a two-way adjusting engagement.

Upon desired adjustment, locking disk <NUM> can be moved distally (toward the patient and toward support portion <NUM> and self-fixating tips <NUM>) along proximal portions (or loop) <NUM> of extension portions <NUM>, to secure the location of support portion <NUM> relative to extension portions <NUM>. Locking disk <NUM> can be frictionally secured to proximal portions <NUM> to prevent movement of support portion <NUM> relative to extension portions <NUM> after desired placement of locking disk <NUM> relative to proximal portions <NUM>. Optionally an adjusting tool <NUM> (or "disk pusher tool" <NUM>) can be used to push disk <NUM> along lengths of proximal portions <NUM> and toward support portion <NUM>. Proximal portions <NUM> can be threaded through aperture <NUM> at a distal end of tool <NUM>, and distal surface <NUM>, which surrounds aperture <NUM>, can contact a proximal surface of disk <NUM> to push disk <NUM> distally along proximal portions <NUM> and toward support portion <NUM>.

Tool <NUM> includes handle <NUM>, shaft <NUM>, and distal end <NUM> capable of engaging an aperture of each of self-fixating tips <NUM>. Tool <NUM> is not illustrated to include a release mechanism like that described with respect to tool <NUM>, but tool <NUM> could optionally include a release mechanism.

<FIG>, illustrate an exemplary method of using tools <NUM> and <NUM> to place implant <NUM>, having adjustable support portion <NUM> and adjustable-length extension portions <NUM>, to treat urinary incontinence. Patient anatomy is as described previously. Distal end <NUM> of insertion tool <NUM>, engaged with self-fixating tip <NUM>, is used to insert self-fixating tip <NUM> through a medial incision and place self-fixating tip <NUM> at supportive tissue in a region of an obturator foramen on a first side of the patient. Insertion tool <NUM> is then used to engage the second self-fixating tip <NUM>, and the second self-fixating tip <NUM> can be placed at supportive tissue in a region of an obturator foramen on a second side of the patient. Proximal portions <NUM> can be pulled or tensioned (optionally with insertion tool <NUM> engaged with a self-fixating tip <NUM>, to prevent force being placed on the self-fixating tip) while adjustable support portion <NUM> is advanced distally toward the patient to adjust a lengths of extension portions <NUM> and the length implant between self-fixating tips <NUM>, and to provide desired tension on the length of implant and desired approximation, placement, and support of the urethra. Locking disk <NUM> (a one-way adjusting engagement relative) can be moved (e.g., slid) distally toward the patient to frictionally engage proximal portions <NUM> to maintain the position of adjustable support portion <NUM> relative to extension portions <NUM> and the urethra. Disk pusher tool <NUM> can be used to move locking disk <NUM>. Proximal portions <NUM> can be removed by cutting.

Examples of systems, kits, methods, and devices as described also include adjusting tools for simultaneously contacting two surfaces of an implant, especially two spaced surfaces of a support portion piece, e.g., to manipulate or stabilize the support portion piece, to allow adjustment of extension portion pieces relative to the support portion piece. Preferred tools can include two adjusting surfaces that are capable of concurrently (e.g., simultaneously) contacting two spaced surfaces of a support portion piece, each of the two surfaces of the support portion piece being part of, at, or adjacent to a component of an adjusting engagement, e.g., a one-way adjusting engagement or a two-way adjusting engagement that can be closed or locked.

An adjusting tool can include any useful structure to support the adjusting surfaces of the adjusting tool, such as a handle (optional) at a proximal end, a shaft or multiple shafts extending from the handle, or alternate forms of support for the adjusting surfaces. An adjusting surface can be any surface that can contact or otherwise engage a surface of an implant or a component of an implant. Optionally an adjusting surface can be a structure that defines an aperture, slot, opening, channel, peg, slit, extension, insert, or other surface that is sized to engage a opposing or complementary component or surface of a single piece or a multi-piece implant, e.g., an extension portion piece (e.g., a proximal end of an extension portion piece), a support portion piece, or a tissue fastener (e.g., a self-fixating tip). Adjusting surfaces of an adjusting tool can be spaced from each other by a distance that will allow simultaneous contact with two locations on opposing sides of an implant during use of the adjusting tool to position and optionally adjust the position of the implant relative to urethral tissue being supported. For example, adjusting surfaces may be located on a line that is perpendicular to an axis of a shaft of an adjusting tool, or that is perpendicular to a line parallel to an axis of a shaft of a tool, and may be spaced by a distance in the range of <NUM> to <NUM> centimeters, such as a distance in the range from <NUM> to <NUM> centimeters or from <NUM> to <NUM> centimeters (depending on the locations of the implant that the adjusting surfaces are intended to contact). Optionally, the adjusting surfaces can be either stationary or moveable (e.g., extendable away from another component of the adjusting tool such as a handle or a primary shaft.

In certain examples, each of two adjusting surfaces can be located at an end of a single or of two separate shafts extending from a handle. In particular examples a single (e.g., primary) shaft may extend from a handle, two separate tines or extensions can extend in different directions from the single shaft at a distal location, and one adjusting surface can be at an end of each tine (or "extension"). For example, an adjusting tool may include a handle, a single shaft, and a "yoke" fixed or movably located at a distal end of the shaft; the yoke can extend in two directions from the shaft and can include one adjusting surface at the end of each extension. A line that connects the adjusting surfaces may be located to intersect a longitudinal axis of the shaft (the shaft, shaft extensions, and adjusting surfaces are contained in a single plane), or, in alternate examples, a line that connects the adjusting surfaces may be located to not intersect a longitudinal axis of the shaft (the shaft, shaft extensions, and adjusting surfaces are not contained in a single plane).

The adjusting surfaces can optionally be fixed or may be moveable, e.g., relative to a shaft or a handle of the tool. The adjusting surfaces may be fixed, or may be capable of being moved relative to a shaft or handle in a manner to allow the adjusting surfaces to contact and adjust an implant by contacting opposite ends of an implant (opposite self-fixating tips) or opposite ends of a piece of an implant (e.g., a support portion piece or an extension portion piece) simultaneously. For example, the adjusting tool may include a handle, a single shaft, and a "yoke" that can be stationary or that can be moved along a length of the shaft, the yoke extending in two directions from the shaft and including one adjusting surface at the end of each extension.

A distal end of a handle, shaft, or other feature of an insertion or adjusting tool may optionally be designed to contact tissue of a urethra to assist in approximating the urethra. For example, a distal end of a handle or a shaft may optionally be adapted to contact a urethra during placement or adjustment of an implant, for example by having a curved (e.g., concave) or a flat surface that approximates or matches a shape of a surface of urethral tissue (e.g., at a bulbospongiosus muscle or a corpus spongiosum) to be supported by the tissue support portion of the implant being adjusted.

<FIG> illustrates a system for treating urinary incontinence, the system comprising a multi-piece implant and an adjusting tool that includes two distal adjusting surfaces. Adjusting tool <NUM> includes handle <NUM>, shaft <NUM> extending from a proximal shaft end at handle <NUM> to junction <NUM> where the distal end of shaft <NUM> meets yoke (alternately opposing "yoke extensions") <NUM> extending in two directions away from shaft <NUM>. Yoke <NUM> includes opening (or "gap") <NUM> between its opposing extensions. Each of the two distal ends of each yoke extension <NUM> includes adjusting surface <NUM> that includes an extension (or "prong" or "insert" directed laterally) that is capable of engaging receiver <NUM>.

Each receiver <NUM> is located at an end of adjustable support portion piece <NUM>, and includes structure to receive adjusting surface <NUM> as well as a component, portion, or feature of extension portion piece <NUM>. As shown, extension portion piece <NUM> includes a mesh portion <NUM>, a non-mesh portion <NUM>, and a self-fixating tip <NUM>. Non-mesh portion <NUM> includes structure that frictionally engages receiver <NUM> to provide an adjusting engagement as described herein, e.g., a one-way or a two-way adjusting engagement. As illustrated, non-mesh portion <NUM> includes a slotted or apertured tab that has openings, slots, apertures, or surfaces that engage a one-way ratcheting structure of receiver <NUM>. The distance of separation of surfaces <NUM> is about equal to the distance of separation of receivers <NUM>, which is approximately the same as the length of support portion <NUM>. To engage the two surfaces <NUM> of the two opposing yoke extensions <NUM> with each of the two receivers <NUM>, one surface <NUM> can be initially inserted into one receiver <NUM>. Yoke <NUM> can be squeezed together, e.g., by hand, to allow the spacing between surfaces <NUM> to be reduced, so the second surface <NUM> can be inserted into second receiver <NUM>. Yoke <NUM> can be removed from the two receivers <NUM> in the same manner. The system also includes one or more insertion tool (e.g., <NUM>, <NUM>, or <NUM>) (not shown) for engaging self-fixation tips <NUM> for placing self-fixating tips <NUM> into supportive tissue.

<FIG>, illustrate an exemplary method of using tool <NUM> and an insertion tool (e.g. <NUM>) to place a three-piece implant having adjustable support portion piece <NUM> and two extension portion pieces <NUM>, to treat urinary incontinence. Patient anatomy is as described previously. A distal end of an insertion tool (e.g., <NUM>, not shown), engaged with self-fixating tip <NUM>, is used to insert self-fixating tip <NUM> through a medial incision and at supportive tissue in a region of an obturator foramen on a first side of the patient. The insertion tool is then used to engage the second self-fixating tip <NUM> and place the second self-fixating tip <NUM> at supportive tissue in a region of an obturator foramen on a second side of the patient.

Non-mesh portions <NUM> are inserted, one each, into each of the two receivers <NUM>, to assemble an adjusting engagement between receiver <NUM> and non-mesh portions <NUM>. Adjusting surfaces <NUM> of tool <NUM> are then inserted (e.g., with squeezing together of yoke extensions <NUM>) into receivers <NUM>. Each non-mesh portion <NUM> can be pulled through receiver <NUM>, while tool <NUM> is used to advance adjustable support portion <NUM> distally, toward the patient, to adjust lengths of extension portion pieces <NUM> extending from each receiver <NUM> to self-fixating tips <NUM>, and to adjust the length of implant between the two self-fixating tips <NUM>, and to provide desired tension on the length of implant and desired approximation, placement, and support of the urethra. Tool <NUM> can be removed, again by squeezing yoke extensions <NUM> together, allowing surfaces <NUM> to be removed from receivers <NUM>. Non-mesh portions <NUM> can be removed by cutting.

<FIG> illustrates a system for treating urinary incontinence, the system comprising a multi-piece implant and a tool that includes two distal adjusting surfaces. Adjusting tool <NUM> includes handle <NUM> that includes thumb ring <NUM> and two finger rings <NUM>. Shaft <NUM> extends from a proximal shaft end at handle <NUM>, to surface <NUM>, which includes two adjusting surfaces <NUM> defined adjacent to apertures <NUM>. Curved and lateral surface <NUM> extending between apertures <NUM> is sized and shaped to contact and assist in approximating tissue of a urethra (e.g., corpus spongiosum, bulbospongiosus muscle, etc.) during use of tool <NUM> to place an implant to support the urethra. Secondary shafts <NUM> extend alongside primary shaft <NUM>. A distal end of each secondary shaft <NUM> includes snap-fit component <NUM>, capable of receiving complementary snap-fit feature <NUM> of a proximal end of extension portion piece <NUM>. Shaft <NUM> and thumb ring <NUM> are moveable longitudinally relative to finger rings <NUM>, the movement being controlled by a ratcheting mechanism involving teeth <NUM> and reversible, lockable ratchet switch <NUM>. Secondary shafts <NUM> are secured to finger rings <NUM> and will move with finger rings <NUM> as finger rings <NUM> are moved longitudinally along primary shaft <NUM>.

A multi-piece implant includes support portion piece <NUM> and two extension portion pieces <NUM>. Extension portion pieces <NUM> include a mesh portion <NUM>, a non-mesh portion (or "adjustment portion") <NUM>, a self-fixating tip <NUM>, and a male snap-fit component <NUM>, which can engage female snap-fit component <NUM>. Support portion piece <NUM> includes a surface to support a urethra and two apertures <NUM>; each aperture <NUM> can be a component of an adjusting engagement with non-mesh portion <NUM>, e.g., a grommet or other one-way (or two-way, locking) frictional engagement. As illustrated extension portion piece <NUM> and a distal end of each secondary shaft <NUM> include opposing snap-fit components to allow the extension portion piece and secondary shaft to be snap-fitted together; any alternative type of connection (e.g., a non-snap-fit mechanical engagement such as a thread, ratchet, etc.) would also be useful. Also as illustrated, snap fit component <NUM> is a female component (aperture) and snap-fit component <NUM> is a male snap-fit component (insertable into the aperture of snap-fit component <NUM>). Alternate arrangements would also be useful. Non-mesh portions <NUM> include structure that frictionally engages aperture <NUM> to provide an adjusting engagement between aperture <NUM> and non-mesh portion <NUM>, the adjusting engagement being, e.g., a one-way or a two-way adjusting engagement. As illustrated, non-mesh portion <NUM> includes a polymeric rod that has surfaces that engage a one-way frictional structure (e.g., grommet) at each aperture <NUM>. The non-mesh portion of this or any other example may alternately be a mesh material or an alternate form of a mesh or a non-mesh material, such as a perforated strip, a slotted strip, a tubular mesh material, or a standard mesh (e.g., mesh strip or mesh tape). A tubular mesh material may be a mesh formed, in any manner, into a tube, such as being woven or knitted into tubular form, or treated with heat (e.g., thermoformed, melted) to form a tubular mesh.

In use, after placing each extension portion piece <NUM> at a desired patient location, e.g., with self-fixating tips <NUM> at supportive tissue, support portion piece <NUM> can be placed over distal surface <NUM> of tool <NUM> with apertures <NUM> seated against apertures <NUM>. Proximal ends of extension portion pieces <NUM> can be passed through aperture <NUM> and aperture <NUM>, and engaged with aperture <NUM> of secondary shaft <NUM>. A user can grasp handle <NUM> with fingers in finger rings <NUM> and a thumb at thumb ring <NUM>. Movement of finger rings <NUM> toward thumb ring <NUM> causes finger rings <NUM> to move in a proximal direction relative to (and toward) thumb ring <NUM>. Simultaneously, secondary shafts <NUM> move proximally relative to primary shaft <NUM>, distal surface <NUM>, and support portion piece <NUM>. In turn, extension portion pieces <NUM> (engaged with secondary shafts <NUM>) are pulled in a proximal direction relative to support portion piece <NUM>. Surface <NUM>, in contact with support portion piece <NUM>, can be inserted through the medial incision to contact tissue of a region of a urethra, to push or otherwise contact or place pressure on the urethra, to assist in approximating the urethra. The extension portion pieces can then be drawn through apertures <NUM> (using the tool as described) to adjust the length of the extension portions and the location of the tissue support portion.

<FIG>, illustrate an exemplary method of using tool <NUM> and an insertion tool (e.g. <NUM>) to place a three-piece implant having adjustable support portion piece <NUM> and two extension portion pieces <NUM> to treat urinary incontinence. Patient anatomy is as described previously. A distal end of an insertion tool (e.g., <NUM>, not shown), engaged with self-fixating tip <NUM>, is used to insert self-fixating tip <NUM> through a medial incision and at supportive tissue in a region of an obturator foramen on a first side of the patient. The insertion tool is then used to place the second self-fixating tip <NUM> at supportive tissue in a region of an obturator foramen on a second side of the patient.

Non-mesh portions <NUM> are inserted, one each, through apertures <NUM> and <NUM>, and snap-fit component <NUM> is engaged with aperture <NUM>. Finger rings <NUM> are moved proximally, toward thumb ring <NUM>, to cause secondary shafts <NUM> move proximally relative to primary shaft <NUM>. Proximal ends of extension portion pieces <NUM> (engaged with secondary shafts <NUM>) are pulled in a proximal direction relative to support portion piece <NUM>. Surface <NUM>, in contact with support portion piece <NUM>, can contact tissue of a region of a urethra approximate the urethra. Extension portion pieces <NUM> are drawn through apertures <NUM> to adjust the lengths of the extension portions <NUM> and the location of tissue support portion <NUM>. Upon desired placement of the assembled implant and urethra, tool <NUM> can be removed by cutting a proximal location of each support portion piece <NUM>, e.g., mesh portion or non-mesh portion of support portion piece <NUM> that has become located on a proximal side of aperture <NUM>.

<FIG> shows tool <NUM> and a multi-piece implant, as shown at <FIG>, with modifications as follows. Non-mesh portion <NUM> is a suture that can be threaded collet <NUM> (or another form of locking two-way adjusting engagement) and suture adjustment and lock <NUM>. Tube <NUM> seats against collet <NUM>, with locking collet engagement <NUM>; all are near surface <NUM> and capable of maintaining the position of collets <NUM> of support portion piece <NUM> near surface <NUM>. Suture adjustment and lock <NUM> is a locking or closeable two-way adjusting engagement that can be opened (to form an open two-way adjusting engagement) and closed (to lock non-mesh portion <NUM> relative to finger rings <NUM>). In use, tube <NUM> is inserted in a distal direction into locking collet engagement <NUM>, opening collet <NUM> (see inset). With suture adjustment and lock <NUM> (both of these) in open configurations, non-mesh portion <NUM> can be freely moved through each suture adjustment and lock <NUM>. Suture adjustment and lock <NUM> can be closed to lock suture <NUM> relative to finger rings <NUM>. Tool <NUM> can be used to pull non-mesh portions <NUM> in a proximal direction to adjust the size and position of the implant and urethra. Upon proper adjustment, tube <NUM> can be removed from collet engagement <NUM>, closing collet <NUM> and fixing the position of non mesh portion <NUM> relative to support portion piece <NUM>. Suture adjustment and lock <NUM> (both of these) can be opened to allow two-way movement of non-mesh portion <NUM> therethrough, and tool <NUM> can be removed proximally.

<FIG> illustrates a system for treating urinary incontinence, the system comprising a single-piece implant and a tool that includes two distal adjusting surfaces, each adjusting surface attached to a separate shaft that is moveable (extendable and retractable) relative to the tool. Tool <NUM> includes handle <NUM> and primary shaft <NUM>. Handle <NUM> extends from a proximal end to surface <NUM> useful for contacting tissue. Two adjusting surfaces <NUM> are located at distal ends of moveable shafts <NUM>. Each adjusting surface is capable of engaging a tissue fastener such as a self-fixating tip. Surface <NUM> extending laterally within space between shafts <NUM> is sized and shaped to contact and assist in approximating tissue of a urethra (e.g., corpus spongiosum, bulbospongiosus muscle, etc.). Shafts <NUM> are moveable (extendable and retractable) relative to handle <NUM> and surface <NUM>, and are connected to primary shaft <NUM>. Shafts <NUM> can be moved (extended and retracted relative to handle <NUM>) by any mechanism, such as by movement of primary shaft <NUM> forward and back relative to handle <NUM>. The angle or splay of shafts <NUM> (i.e., the angle of extended shafts relative to a longitudinal axis extending through the handle) can be adjusted by movement of angle adjustment <NUM>.

Implant <NUM> as illustrated is a single-piece, e.g., integral mesh implant comprising a central tissue support portion, extension portions extending in opposite directions from the tissue support portion, and self-fixating tips <NUM>.

In use, with primary shaft <NUM> extended proximally away from handle <NUM>, and shafts <NUM> retracted into handle <NUM>, implant <NUM> can be placed at the distal end of tool <NUM> with self-fixating tips <NUM> placed at each of two distal end adjusting surfaces <NUM>. A user can grasp handle <NUM>, and adjust the angle of the shafts <NUM> (relative to a longitudinal axis of the tool) by movement of angle adjustment <NUM>. This may be referred to as a "non-extended" configuration (shafts <NUM> are non-extended). The distal end of tool <NUM>, engaged with implant <NUM>, can be inserted through the medial incision, whereupon surface <NUM> (also in contact with implant <NUM>) can contact tissue of a region of a urethra to push or otherwise contact or place pressure on the urethra, to assist in approximating the urethra. Shafts <NUM> can then be extended (simultaneously) from handle <NUM> by movement of primary shaft <NUM> in a distal (toward the patient) direction while maintaining the position of handle <NUM> and surface <NUM>. Self-fixating tips <NUM> become extended at distal ends of shafts <NUM> to contact and become secured to supportive tissue (e.g., in a region of an obturator foramen) in the pelvic region of the patient.

<FIG>, illustrate an exemplary method of using tool <NUM> to place single-piece implant <NUM>, to treat urinary incontinence. Patient anatomy is as described previously. Referring to <FIG>, with tool <NUM> in a non-extended configuration and implant <NUM> located at the distal end of tool <NUM>, the distal end, including implant <NUM>, is inserted through a medial incision in a patient to locate implant <NUM> at a location generally below a urethra. The angle of shafts <NUM> relative to a longitudinal axis of the tool can be adjusted (increased or decreased) by movement of angle adjustment <NUM>. Surface <NUM> (also in contact with implant <NUM>) can contact tissue of a region of a urethra to push or otherwise contact or place pressure on the urethra, to assist in approximating the urethra. Shafts <NUM> are extended (simultaneously) from handle <NUM> by movement of primary shaft <NUM> in a distal direction while maintaining the position of handle <NUM> and surface <NUM>. Self-fixating tips <NUM> become extended at distal ends of shafts <NUM>, to contact and become secured to supportive tissue in the pelvic region of the patient.

<FIG> illustrates a system that includes implant <NUM> (e.g., for treating male or female urinary incontinence) and one or more insertion tool <NUM>. Implant <NUM> includes support portion <NUM>, end or extension portions <NUM>, tissue fasteners (chevrons or barbs) <NUM> located on extension portions <NUM> near support portion <NUM>, tail portions (e.g., sutures) <NUM> extending from a distal end of each extension portion <NUM>, connectors or dilators <NUM>, and sheaths <NUM> which can be located along the lengths of extension portions <NUM> to cover tissue fasteners <NUM> (see <FIG>)(as illustrated at <FIG> sheaths <NUM> are located over tail portions <NUM>). Insertion tool <NUM> includes shaft <NUM>, distal end <NUM>, proximal end and handle <NUM>, and an optional mechanical release mechanism (e.g., detent) and trigger located at a proximal region of shaft <NUM> (optional release mechanism and trigger are not shown). <FIG> shows a single tool <NUM>, having a helical shaft; optionally a system may include two tools <NUM> each having a helical shaft, one helical shaft suited to place an extension portion at a right side of a patient and one helical shaft suited to place an extension portion at a left side of the patient.

<FIG>, illustrate an exemplary method of using helically-curved tool <NUM> to place implant <NUM> to treat urinary incontinence. Patient anatomy is as described previously. On a first side of a patient, distal end of helical insertion tool <NUM>, engaged with connector <NUM>, is used to insert connector <NUM> through a medial incision, through an obturator foramen and related tissue, around a pubic ramus bone (<NUM>) and then subcutaneously back to the medial, midline perineal region. Insertion tool <NUM> is then withdrawn and used to place the second connector <NUM> at a second side of the patient in a similar manner. The implant can be adjusted and tensioned by adjusting the position of the implant and the urethra, including adjusting the position and tension of tail portions <NUM>, which extend back to an external location through the medial incision. Once the urethra and implant are positioned as desired, sheaths <NUM> can be removed to expose extension portions <NUM>, including tissue fasteners (anchors, barbs, or chevrons) <NUM> within tissue.

<FIG> illustrates a system that includes two-piece implant <NUM> (e.g., for treating male or female urinary incontinence), insertion tool (e.g., <NUM>, <NUM>, or <NUM>), and adjusting (pusher) tool <NUM>. Implant <NUM> includes a first piece that includes support portion <NUM>, one extension portion <NUM> integrally connected to support portion <NUM>, self-fixating tip <NUM>, tissue anchors (chevrons or barbs) <NUM>, and an aperture component <NUM> (e.g., grommet, channel, optionally comprising a one-way ratchet configuration) of an adjusting engagement, the aperture component <NUM> designed to engage a second component of the adjusting engagement. Extension portion piece <NUM> includes mesh portion <NUM>, self-fixating tip <NUM>, tissue anchors (chevrons or barbs) <NUM>, and non-mesh portion <NUM>, which includes a second component of an adjusting mechanism in the form of ratcheting "cones," teeth, or another form of ratchet surface, <NUM>. Optionally (but not as illustrated) support portion <NUM> can be moveable along the length of the implant between self-fixating tips <NUM>. Optionally an adjusting tool <NUM> can be used to engage aperture component <NUM> to assist in adjusting the adjusting engagement between aperture component <NUM> and ratchet surface <NUM>. A proximal end of non-mesh portions <NUM> can be threaded through aperture <NUM> at distal end <NUM> of tool <NUM>, and distal surface <NUM>, surrounding aperture <NUM>, can contact aperture component <NUM> to place pressure on aperture component <NUM> while non-mesh portion <NUM> is drawn in a proximal direction (see arrow).

<FIG>, illustrate an exemplary method of using an insertion tool (e.g., <NUM>) and adjusting tool <NUM> to place two-piece implant <NUM> to treat urinary incontinence. Patient anatomy is as described previously. A distal end of an insertion tool engaged with self-fixating tip <NUM> is used to insert self-fixating tip <NUM> through a medial incision and place self-fixating tip <NUM> at supportive tissue in a region of an obturator foramen on a first side of the patient. The insertion tool is then used to engage the second self-fixating tip <NUM>, and the second self-fixating tip <NUM> can be placed at supportive tissue in a region of an obturator foramen on a second side of the patient. A proximal end of non-mesh portion <NUM> can be placed through an aperture of aperture component <NUM> and pulled to adjust a length of implant between self-fixating tips <NUM>, to provide desired tension on the length of implant, and desired approximation, placement, and support of the urethra. Proximal end <NUM> may optionally be threaded through aperture <NUM> of pusher tool <NUM>, and pusher tool <NUM> may optionally be used to push aperture component <NUM> in a distal direction, toward self-fixating tip <NUM> located at the distal end of mesh portion <NUM> of extension portion piece <NUM>. A proximal portion of non-mesh portion <NUM> can then be removed by cutting. Before, after, or simultaneously with reducing the length of implant by pulling non-mesh portion <NUM> relative to aperture component <NUM>, an optional moveable support portion (not shown) can be moved (slid) laterally in a direction toward one or the other obturator foramen to place the moveable support portion at a desired (central, medial) location below the urethra.

<FIG> illustrates a system that includes implant <NUM> (e.g., for treating male or female urinary incontinence) and insertion tool <NUM>. Implant <NUM> includes support portion <NUM>, end or extension portions <NUM>, self-fixating tips <NUM>, and tissue fasteners (chevrons, barbs) <NUM>. Support portion <NUM> is moveable relative to self-fixating tips <NUM> by passage through supports <NUM> located on support portion <NUM>. Supports <NUM> are adjusting engagements that allow support portion <NUM> to be moved and positioned at a desired location along a length of each extension portion <NUM>. The effect is to allow a user to reduce (or optionally increase) the effective size of each extension portion by sliding each support <NUM> toward a respective self-fixating tip <NUM>, on one or both sides of the implant and patient, thereby reducing the overall length of implant <NUM> between self-fixating tips <NUM>. As illustrated, supports <NUM> include ratcheting springs <NUM>, which are biased toward and contact perforations <NUM> of extension portions <NUM>, resulting in a one-way adjusting engagement between a support <NUM> and a perforated extension portion <NUM>.

<FIG> shows details of an exemplary tool <NUM>, wherein handle <NUM> is moved proximally (away from the patient) to draw shaft <NUM> in the proximal direction. Tool <NUM> can also optionally include a gauge to measure a state of adjustment of the implant during placement and adjustment, including tension in the implant during adjustment. For example, a gauge may measure the amount of tension applied to the extension portions of the implant by use of a pressure gauge that measures pressure at surface <NUM>. Alternately, a gauge may be used to measure pressure of tissue (e.g., corpus spongiosum) that becomes applied to a distal end of the tool, e.g., at surface <NUM>.

In use, after placement of self-fixating tips at a left and a right side of a patient, tool <NUM> can be used to moved supports <NUM> distally along support portions <NUM>, toward self-fixating tips <NUM>, to shorten the length of implant between self-fixating tips <NUM>. Movement of supports <NUM> can be assisted by use of tool <NUM>, which includes distal surface <NUM> at an end of stationary shaft <NUM>. Surface <NUM> is capable of contacting and approximating support portion <NUM>, placed in contact with tissue of a urethra (e.g., corpus spongiosum, bulbospongiosus muscle). Puller <NUM> is located behind surface <NUM> and at a distal end of moveable shaft <NUM>. To adjust lengths of extension portions <NUM>, proximal loop <NUM> is placed on a proximal side of puller <NUM>, as surface <NUM> is placed against support portion <NUM>, in contact with tissue of a urethra, and after self-fixating tips are placed in supportive tissue. Moveable shaft <NUM> is advanced in a proximal direction (see arrows), causing support portion <NUM> to move distally along lengths of extension portions <NUM> and toward self-fixating tips <NUM>; i.e., proximal portions of extension portions <NUM> are pulled in a proximal direction through supports <NUM>. The result is to shorten the length of implant between self-fixating tips <NUM>, while approximating the urethra, and thereafter supporting the urethra with implant <NUM>.

<FIG>, illustrate an exemplary method of using an insertion tool (e.g., <NUM>, <NUM>, or <NUM>) and adjusting tool <NUM> to place implant <NUM> to treat urinary incontinence. Patient anatomy is as described previously. A distal end of an insertion tool is used to place self-fixating tips <NUM> at a region of an obturator foramen on a first side and a second side of the patient. Adjusting tool <NUM> is then used to adjust the placement of the implant and the location of the urethra. For example, proximal loop <NUM> can be placed on a proximal side of puller <NUM> as surface <NUM> is placed against support portion <NUM> and in contact with tissue of a urethra. Tool <NUM> can be used to approximate tissue of the urethra as desired. Moveable shaft <NUM> is advanced in a proximal direction causing support portion <NUM> to move distally along the lengths of extension portions <NUM> and toward self-fixating tips <NUM>; i.e., proximal portions of extension portions <NUM> are pulled in a proximal direction through supports <NUM>. The result is to shorten the length of implant between self-fixating tips <NUM> while approximating the urethra, and thereafter supporting the urethra with implant <NUM>. Tool <NUM> can be removed and proximal loop <NUM> can be cut away.

<FIG> illustrates a system for treating urinary incontinence, the system comprising a multi-piece implant and an adjusting tool. The system shares structural features with the systems illustrated elsewhere herein, including the systems of <FIG> and <FIG>, and can be used in exemplary as described for those systems to place an implant into a patient using steps analogous to steps identified as useful with those systems. Adjusting tool <NUM> includes handle <NUM> and distal adjusting surface <NUM>, in contact with support portion piece <NUM>. Shaft <NUM> extends from a proximal shaft end at handle <NUM> to surface <NUM> defined adjacent to aperture <NUM>. The curved distal surface <NUM> adjacent to aperture <NUM> is sized and shaped to contact and assist in approximating tissue of a urethra (e.g., corpus spongiosum, bulbospongiosus muscle, etc.) during use of tool <NUM> to place an implant to support the urethra.

A multi-piece implant includes support portion piece <NUM> and two extension portion pieces <NUM>. Extension portion pieces <NUM> include a mesh portion <NUM>, a non-mesh portion <NUM>, and self-fixating tip <NUM>. Support portion piece <NUM> includes a surface to support a urethra having two apertures <NUM>; each aperture <NUM> can be a component of an adjusting engagement with non-mesh portion <NUM> or mesh portion <NUM>. Non-mesh portions <NUM> include a surface or structure that can frictionally engage an aperture <NUM> to provide an adjusting engagement between aperture <NUM> and non-mesh portion <NUM>, the adjusting engagement being, e.g., a one-way or a two-way adjusting engagement. As illustrated, non-mesh portion <NUM> includes a polymeric rod that has surfaces that engage a one-way frictional structure (e.g., grommet) at each aperture <NUM>.

In use, after placing each extension portion piece at a desired patient location, e.g., as described herein with self-fixating tips at supportive tissue, support portion piece <NUM> can be placed at distal surface <NUM> of tool <NUM> with apertures <NUM> seated to be accessed through aperture <NUM>. Proximal ends of extension portion pieces <NUM> can be passed through aperture <NUM> and aperture <NUM>. A user can grasp (by hand or by use of a tool) a proximal end of each support portion piece <NUM> to pull the proximal end in a proximal direction. Simultaneously, surface <NUM> can be used to approximate tissue of a urethra by inserting the distal end of tool <NUM> through a medial incision to contact tissue of a region of a urethra, to push or otherwise contact or place pressure on the urethra, to assist in approximating the urethra. The extension portion pieces can be drawn through apertures <NUM> to adjust the length of the extension portions and the location of the tissue support portion.

<FIG> illustrates a system for treating urinary incontinence, the system comprising a multi-piece implant and an adjusting tool. The system shares structural features with the systems illustrated elsewhere herein, including the systems of <FIG>, <FIG>, and <FIG>, and can be used in exemplary methods as described for those systems to place an implant into a patient using steps analogous to steps identified as useful for those systems. Compared to the system of <FIG>, the system of <FIG> includes similar features that include adjusting tool <NUM>, handle <NUM>, distal adjusting surface <NUM>, support portion piece <NUM>, extension portion pieces <NUM>, shaft <NUM>, and surface <NUM> defined adjacent to aperture <NUM>. As one difference, extension portion piece <NUM> of <FIG> includes a proximal portion made of mesh (as a replacement for the non-mesh portion). Also, tool <NUM> includes moveable holder (e.g., slider or "shuttle") <NUM> moveable along a length of shaft <NUM>, and guides <NUM> located at a distal end of shaft <NUM>, near surface <NUM>. During use, proximal mesh portion <NUM> is guided through aperture <NUM> of support portion piece <NUM>, through guide <NUM> at a distal end of shaft <NUM>, and then can removably engage slider <NUM> by a removable mechanical connection such as a cleat, slot, slit, moveable jaws, a moveable frictional device, or any mechanical securing device. Slider <NUM> can be moved in a proximal direction to pull extension portion pieces in a proximal direction (toward handle <NUM> along shaft <NUM>) relative to support portion <NUM> located against surface <NUM>, while the distal end of tool <NUM> is used to approximate urethral tissue.

<FIG> illustrates a system for treating urinary incontinence, the system comprising a multi-piece implant and an adjusting tool. The system shares structural features with the systems illustrated elsewhere herein, including the systems of <FIG>, <FIG>, <FIG>, and <FIG>, and can be used in exemplary methods as described as useful with those systems. Compared to the system of <FIG> and <FIG>, the system of <FIG> includes similar features, identified numerically in a consistent manner. As one difference, extension portion piece <NUM> of <FIG> includes a non-mesh portion <NUM> that includes apertures. Non-mesh portion <NUM> can be threaded through buckle <NUM> of support portion piece <NUM> to allow apertures of the non-mesh portion to selectively engage and disengaged buckle <NUM>. The adjusting engagement between support portion piece <NUM> and extension portion pieces <NUM> is capable of being engaged, disengaged, adjusted, re-engaged, and disengaged, adjusted, and re-engaged as necessary. The adjusting engagement is a two-way engagement that can be selectively secured (e.g., "locked into place"), unsecured, and re-secured. Each support portion piece <NUM> can be used as described, by engaging supportive tissue, then threading support portion pieces <NUM> through buckles <NUM>. Each support portion piece <NUM> can then be individually engaged (through an aperture <NUM>) with buckle <NUM> and the implant can be tested for positioning, tension, or support of the urethra. If desired, each support portion piece can be independently disengaged from buckle <NUM>, adjusted, then re-engaged. Upon proper placement, support, tension, etc., a proximal portion of each support portion piece can be trimmed.

<FIG> illustrates another system for treating urinary incontinence, the system comprising a multi-piece implant and an adjusting tool. The system shares structural features with systems illustrated elsewhere herein, including the systems of <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, and can be used in exemplary methods described as useful for those systems. Compared to the system of <FIG>, the system of <FIG> includes similar features that include adjusting tool <NUM>, handle <NUM>, distal adjusting surface <NUM>, support portion piece <NUM>, extension portion pieces <NUM>, shaft <NUM>, slider or "shuttle" <NUM>, and surface <NUM> defined adjacent to aperture <NUM>. As a difference, aperture piece <NUM> (e.g., of a metal such as stainless steel) is a two-way adjusting engagement that can be closed or locked (e.g., mechanically crimped) to prevent subsequent movement of non-mesh portion <NUM> after adjustment of extension portion piece <NUM>.

According to certain exemplary methods of treating incontinence in a male, using implants as described, an implant can be placed below a urethra to contact tissue of a corpus spongiosum (by dissecting bulbospongiosus muscle), and the urethra can be approximated to improve continence without requiring the urethra to be compressed.

As described more specifically in <CIT>, according to exemplary methods of treating incontinence using any of the implants or tools described herein, a tissue support portion of an implant can be placed in a position to approximate and support a urethra, optionally without placing compressive forces on the urethra, to effect improved continence (e.g., in a male patient). Preferably, for treatment of a male patient, a tissue support portion can be placed to contact tissue of a corpus spongiosum and then tensioned to cause approximation of the corpus spongiosum and urethra in a direction toward a bladder, optionally with use of a tool as described herein for placing pressure on or moving the urethra. Accordingly, examples of the present disclosure generally, in a male patient, can relate to placement of a tissue support portion at a location that supports and is tensioned to re-position a urethra toward a bladder. The implant can be tensioned to cause the urethraespecially the posterior portion of urethra above a perineal membrane -- to be moved from an abnormal (e.g., prolapsed or descended) position to a position of normal healthy urethral tissue capable of being fully coapted upon contraction of the rhabdosphincter. Alternate methods can cause compression of the urethra, but compression is not required in methods that result in approximation of the urethra to improve continence.

An exemplary method of surgically installing a urethral implant can include providing a medial incision at the perineum of a male patient to expose bulbospongiosus muscle, optionally and preferably dissecting through bulbospongiosus muscle to expose corpus spongiosum, and placing a tissue support portion of the implant to contact the corpus spongiosum tissue. Optionally the tissue support portion can be fixed to the corpus spongiosum, such as by use of a medical attachment in the form of a suture, staple, adhesive, or the like. The implant can be adjusted, tensioned, etc., e.g. based on the use of an adjusting engagement, an adjustment tool, or another means, to approximate the urethra to improve continence, and tension can optionally and preferably maintained chronically.

According to exemplary methods, the implant can be inserted through a single medial (perineal or vaginal) incision (no external incision is required) and an extension portion of the implant can be attached to supportive tissue within the pelvic region, such as tissue at a region of an obturator foramen, or to tissue (e.g., fascia) that lies between a urethra and tissue of an obturator foramen, or other supportive tissue. According to such methods, a tissue fastener such as a self-fixating tip at a distal end or distal portion of an extension portion can be engaged at a distal end of an insertion tool (e.g. a curved elongate needle). The insertion tool can be used to place the tissue fastener and extension portion through a medial incision (of a male or female patient) and extend the tissue fastener and extension portion in a direction of an obturator foramen, e.g., to tissue of the obturator foramen or to other supportive tissue. Features of the exemplary methods, implants, and tools that are described herein can be incorporated into such a technique, such as placement of the urethral sling below a urethra at a tissue of a bulbospongiosus muscle or a corpus spongiosum, approximation of the urethra to improve continence (without the need for compression of the urethra), etc., use of an implant that includes adjustable engagements (and steps of adjusting the implant), use of an adjustment tool. This method avoids the need for lateral incisions at the inner thigh and adjacent to each opposing obturator foramen.

Claim 1:
A system for treating urinary incontinence, the system comprising a multi-piece implant comprising a support portion piece (<NUM>) and two extension portion pieces (<NUM>), and an adjusting tool (<NUM>), wherein
the support portion piece (<NUM>) comprises a tissue support portion sized and shaped for placement to support a urethra,
the extension portion pieces (<NUM>) each comprise a proximal end, a distal end, and a tissue fastener,
the first extension portion piece (<NUM>) is adjustably connected to the support portion piece (<NUM>) at a first adjusting engagement (<NUM>), the second extension portion piece (<NUM>) is adjustably connected to the support portion piece (<NUM>) at a second adjusting engagement (<NUM>), and
the adjusting tool (<NUM>) comprises two adjusting surfaces (<NUM>), the two adjusting surfaces (<NUM>) being capable of engaging the support portion piece (<NUM>) in a manner to place tension along a length of the support portion piece (<NUM>);
wherein at least one of the two extension pieces comprises a mesh portion (<NUM>), a non-mesh portion (<NUM>) and a self-fixating tip (<NUM>);
characterised in that:
the non-mesh portion (<NUM>) comprises a slotted or aperture tab that has openings, slots, apertures, or surfaces that engage a one-way ratcheting structure of the adjusting engagement (<NUM>).