# Patent

## Title
Implants, tools, and methods for treatment of pelvic conditions

## Abstract

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

## Background
PRIORITY CLAIM
The present non-provisional patent application claims priority under 35 USC §119(e) from United States Provisional Patent Application having Ser. No. 61/468,069, filed Mar. 28, 2011, entitled “IMPLANTS, TOOLS, AND METHODS FOR TREATMENTS OF PELVIC CONDITIONS,” the entirety of which is incorporated herein by reference.


FIELD OF THE INVENTION
The present invention relates generally to implants, tools, devices, systems, and related methods for treating pelvic conditions including but not limited to incontinence and prolapse conditions in men and women.
BACKGROUND
Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary), pelvic tissue prolapse (e.g., female vaginal prolapse), and conditions of the pelvic floor.
Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vagina and introitus. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems.
Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed.
In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times.
The tension of an implant (i.e., “sling”) is typically adjusted during an implantation procedure in a manner to take up slack in the sling and impart desirable and efficacious tension and positioning of the implanted sling and the supported tissue. New and improved methods and devices of intra-operative adjustment of an implant, are always desirable.
SUMMARY
Devices, systems, and methods as described can be applied to treat pelvic conditions such as incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), levator defects, and other conditions caused by muscle and ligament weakness, hysterectomies, and the like.
Various surgical implants, tools, and methods that relate to useful or advantageous surgical procedures are described herein. Certain embodiments of methods and implants involve an implant that includes an adjusting mechanism to adjust a length of an implant (e.g., a length of an extension portion or other portion or piece of an implant), intra-operatively.
Described devices and methods involve pelvic implants, including surgical implants (also referred to generally herein as “slings”) that include a central support portion and two or more end portions extending from the central support portion to sling ends. Herein, the terms “sling,” “implant,” and “incontinence sling” without further qualification are used interchangeably to include various forms of pelvic implants for supporting different pelvic tissues, and specifically include urethral slings adapted to be placed through a tissue pathway in a male or female patient, disposing the central support portion below the urethra or bladder neck (hereafter collectively referred to as the urethra for convenience) (and above the vaginal wall in a female patient) to alleviate urinary incontinence, and fecal slings adapted to be placed through a tissue pathway disposing the central support portion inferior to the anus, the anal sphincter, or the lower rectum (hereafter collectively referred to as the anus for convenience) to alleviate fecal incontinence.
In accordance with the present description, such slings include features that allow or enhance intra-operative adjustment of the tension applied to the urethra, anus, or other supported tissue, to enhance efficacy of the implant and method of treatment, and for improved patient comfort. Various specific embodiments of the implants and methods are described herein. The various embodiments are applicable to both male and female patients to address issues of incontinence in both, to address issues of prolapse repair in female patients, and to address perineal floor descent and fecal incontinence in both. Also, surgical techniques such as forming suprapubic, retropubic, transobturator, “inside-out,” and “outside-in” tissue pathways between two skin incisions, or a tissue pathway formed from a single incision through the vagina or perineal floor (in male or female patients), are also contemplated for placement of a sling.
In various embodiments an implant can include two or more pieces that can be assembled and adjusted as to their size (especially length), intra-operatively, to produce an implant of desired dimensions. A portion of each piece includes an adjusting surface. Each adjusting surface includes a structure or device that is capable of interacting and releasably engaging with a structure of an opposing surface at a different piece of the implant. An engagement is considered to be releasable if the engagement is non-permanent, such as being capable of being engaged, released (disengaged), then re-engaged, multiple times. In use, pieces of an implant can be placed at desired anatomical locations in a patient. The adjusting surfaces can be contacted together, then checked do asses the size, fit, and effect (position and tension) of the assembled implant on supported tissue, and then if necessary can be disengaged and then re-engaged to an improved size, fit, or effect.
Opposing adjusting surfaces of different pieces of an implant can be any useful surfaces that are able of being engaged, disengaged, and re-engaged, without substantially effecting the releasable bonding strength between the surfaces. Desirably, the force required to disengage the opposing surfaces (holding force) can be relatively low, to allow easy disengagement either manually or by use of one or more surgical tools, during a surgical procedure and through an incision. Also desirably the holding force should be sufficient hold the opposing surfaces together post-operatively, to maintain a therapeutic position of supported tissue for a time sufficient to allow the patient to recover, optionally with tissue ingrowth to maintain the position of the implant. For example, the holding force should be capable of maintaining the engagement between opposed adjusting surfaces for a time of at least two weeks, preferably three or four weeks, without yielding even in part.
An exemplary implant can include two pieces, each piece having a tissue fastener at one end and an adjusting surface at a second end. The opposing adjusting surfaces can engage releasably. The tissue fasteners can be placed at supportive tissue, and the opposing adjusting surfaces can be brought into contact to define a desired length of the implant between the tissue fasteners, intra-operatively. The opposing adjusting surfaces can, preferably, be located at portions of an implant that allow the adjusting surfaces to be accessed intra-operatively, e.g., through an incision in the patient that is also used to place the implant or implant pieces into the patient. Various designs of adjusting surfaces can be useful to create a releasable engagement, such as opposing magnets, releasable adhesive, opposing hook-and-loop structures, or other mechanical engagements.
In one aspect the invention relates to a pelvic implant useful to treat a pelvic condition, the implant comprising multiple pieces capable of an assembled state and an unassembled state. The implant includes: a first piece comprising a self-fixating tip and a first adjusting surface, and a second piece comprising a self-fixating tip and a second adjusting surface. In the assembled state the first adjusting surface is releasably engaged with the second adjusting surface and the implant comprises a tissue support portion and two opposing extension portions, with a self-fixating tip at an end of each extension portion.
In another aspect the invention relates to a method of treating a pelvic condition, the method comprising: providing a pelvic implant useful to treat a pelvic condition, the implant comprising multiple pieces capable of an assembled state and an unassembled state. The implant includes: a first piece comprising a self-fixating tip and a first adjusting surface, and a second piece comprising a self-fixating tip and a second adjusting surface. The method includes: placing the first self-fixating tip at supportive tissue of a pelvic region, placing the second self-fixating tip at supportive tissue of the pelvic region, and engaging the first adjusting surface and the second adjusting surface to assemble the implant in a manner to support pelvic tissue.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows an exemplary system or combination as described, including an embodiment of an implant and an optional insertion tool.
FIGS. 2 and 3 show placement of implants and selected anatomy.
FIGS. 4A, 4B, 4C, 4D, 4E, 4F, 4G, 4H, and 4I show exemplary devices as described.



All drawings are not to scale.
DETAILED DESCRIPTION
Pelvic floor disorders include urinary and fecal incontinence, prolapse, cystocele, rectocele, enterocele, uterine and vaginal vault prolapse, levator defects, and others, in male and female patients. These disorders typically result from weakness or damage to normal pelvic support systems. Common etiologies include childbearing, removal of the uterus, connective tissue defects, prolonged heavy physical labor and postmenopausal atrophy.
Vaginal vault prolapse is the distension of the vaginal apex, in some cases to an orientation outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons.
Vaginal vault prolapse is often associated with a rectocele, cystocele, or enterocele. It is known to repair vaginal vault prolapse by suturing to the supraspinous ligament or to attach the vaginal vault through mesh or fascia to the sacrum. Many patients suffering from vaginal vault prolapse also require a surgical procedure to correct stress urinary incontinence that is either symptomatic or latent.
Sling procedures for treating urinary incontinence include surgical methods that place a supportive implant such as a sling to stabilize or support the bladder neck or urethra. Various different supportive implants and sling procedures are known. Slings and methods can differ based on the type of sling material and anchoring methods used, and placement and technique for placing and supporting the sling, including tissue to be supported. In some cases, a sling is placed under the bladder neck and secured via suspension sutures to a point of attachment (e.g. bone) through an abdominal or vaginal incision. Other techniques place a supportive portion of a sling below a urethra or bladder neck, and support the sling by placement of ends at or through obturator foramen tissue. Examples of sling procedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.
As used herein the terms “anchor,” “tissue fastener,” and “self-fixating tip,” refer interchangeably and non-specifically to any structure that can connect an implant to supportive tissue of a pelvic region. The supportive tissue may preferably be a soft tissue such as a muscle, fascia, ligament, tendon, or the like. The anchor may be any known or future-developed structure useful to connect an implant to such tissue, including but not limited to a clamp, a suture, a soft tissue anchor such as a self-fixating tip, and the like.
An implant can include a tissue support portion (or “support portion”) that can be used to support a urethra (including a bladder neck), bladder, vagina, levator, rectum, sphincter, 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 specific methods involving treatment of urinary incontinence, a support portion may 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, molded implant material, suture, or biologic material) that extend from the tissue support portion, that are connected or connectable to the tissue support portion, and that are useful to attach to supportive tissue in a pelvic region (e.g., using an anchor such as 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 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 US 2010/256442, filed Aug. 8, 2008, by Ogdahl, 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 US 2006/0287571, the entirety of which is incorporated herein by reference). Also see U.S. Patent Publication number US 2011/0034759 and WO 2010/093421, PCT/US2010/057879, filed Nov. 23, 2010, and PCT/US2010/059739, filed Dec. 9, 2010, the entireties of which are incorporated hereby by reference.
In exemplary uses, each extension portion can extend from the location of attachment with the tissue support portion of the implant, through pelvic tissue, and to a location of supportive tissue within the pelvic region. The supportive tissue can be at an end of a tissue path used to perform a desired implant procedure, such as at a location near an external incision in the skin used to perform the procedure, e.g., at a location at or near an end of an extension portion placed according to a retropubic procedure or a transobturator procedure for placing a sling for treating urinary or fecal incontinence, at tissue of an obturator foramen or rectus fascia, at a ligament such as a sacrospinous ligament, etc.
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 molded implant material, or the like. The tissue support portion may be synthetic (e.g., a polypropylene mesh or a molded material) 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 Minn., 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®, MiniArc®, InVanceTM, and AdVanceTM 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 or four extension portions extending from the tissue support portion. An implant that has exactly two or four extension portions can be of the type useful for treating urinary incontinence or vaginal prolapse. 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.
Dimensions of a tissue support portion (of an assembled imlant) can be any dimensions useful to support a specific tissue, e.g., urethral or vaginal tissue, for treating a pelvic condition such as incontinence, prolapse, or another pelvic condition. A tissue support portion for use in treating incontinence 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 0.5 to 2 inches, such as from 0.75 to 1.5 inches. Exemplary widths of a tissue support portion can be in the range from 0.4 or 0.5 to 4 centimeters, such as from 1 to 2.5 or 3 centimeters.
An 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 US 2006/0287571 and U.S. Pat. No. 7,422,557, the entireties of these applications being incorporated herein by reference.
Dimensions of extension portions (of an assembled implant) can allow the extension portion to reach between a tissue support portion placed to support a pelvic tissue such as tissue of a urethra, vagina, anal sphincter, levator, etc. (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 for use in treating incontinence by placing ends of an extension portion at tissue of an obturator foramen, for example, measured 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 0.5 to 2.5 inches, preferably from 0.5 to 1.5 inches. These or other lengths will be useful for implants designed to treat other conditions.
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 in this context generally refers to location at an end of an extension portion away from a tissue support portion.) 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. PCT/US2007/014120, entitled “Surgical Implants, Tools, and Methods for Treating Pelvic Conditions, filed Jun. 15, 2007; U.S. patent application Ser. No. 12/223,846, filed Aug. 8, 2008, entitled SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS; U.S. patent application Ser. No. 12/669,099, filed Jan. 14, 2010, entitled PELVIC FLOOR TREATMENTS AND RELATED TOOLS AND IMPLANTS; and WO 2009/075800, the entireties of which are incorporated herein by reference.) 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 embodiment 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 that can be implanted into supportive tissue (e.g., muscle, fascia, ligament, or other soft tissue) 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 an incision to reach the interior of the pelvic region, e.g., at a location of an obturator foramen or other supportive tissue. 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, e.g., 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 supportive 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 PCTUS2007/004015, filed Feb. 16, 2007, titled Surgical Articles and Methods for Treating Pelvic Conditions, the entirety of which is incorporated herein by reference. 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, an insertion tool may be used with implants and methods as described. 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 handle is located at a proximal end of the device and attaches to one end (a proximal end) of a shaft. A distal end of the 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. 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.
Exemplary insertion tools for treatment of incontinence and vaginal prolapse are described, e.g., in U.S. patent application Ser. No. 10/834,943, now U.S. Pat. No. 7,500,945, Ser. No. 10/306,179, now U.S. Pat. No. 7,070,556; Ser. No. 11/347,553, now U.S. Pat. No. 7,422,557; Ser. No. 11/398,368, now U.S. Pat. No. 7,740,576; Ser. No. 10/840,646, now U.S. Pat. No. 7,351,197; PCT application number 2006/028828; PCT application number 2006/0260618; WO 2010/093421, and US Patent Publication No. 2010-0256442 the entireties of these documents being incorporated herein by reference. These and similar tools can be used as presented in the referenced documents, or with modifications to provide features identified in the present description.
An insertion tool can optionally include a release 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 shaft, 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, lever, 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 selectively prevent removal of the tip from the distal end until removal is desired. The detent (or other surface or mechanism) can be caused 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.
One exemplary form of implant useful for treatment of urinary incontinence is a “mini-sling,” or “single incision sling,” (e.g., as marketed by American Medical Systems under the trade name MINIARCTM). These types of implants can be modified as described, e.g., to include multiple pieces with opposing adjusting surfaces. Designs described herein are also useful for female pelvic floor repair products, male incontinence, for treating prolapse (e.g., vaginal prolapse), levator defects, anal incontinence, and other pelvic conditions. Devices and methods as described can be suitable for these and similar slings in the treatment of male and female urinary and fecal incontinence and to effect pelvic floor, perineal floor, and pelvic prolapse repairs that involve a variety of surgical approaches. For example, female pelvic floor repair slings may be implanted by techniques that involve transvaginal, transobturator, suprapubic, pre-pubic, or transperineal exposures or pathways. Male urinary incontinence slings may be implanted by techniques that involve transobturator, suprapubic, or transperineal pathways. Embodiments of the described devices and methods may be useful in treating fecal incontinence, by use of a transvaginal, transobturator, suprapubic or perineal floor pathway. In fecal incontinence applications, the disclosed embodiments can be used to correct the anorectal angle in the rectum to re-establish continence in patients. The above methods can, but are not necessarily limited to, use of helical needles of the type described in U.S. Pat. No. 6,911,003 or C-shaped needles or elongate needles of the type used to perform suprapubic procedures.
Referring to FIG. 1, an exemplary embodiment of an elongated sling, sling 10, is depicted in which features of the present description may be advantageously implemented. Sling 10 includes two pieces, 10L, and 10R, each comprising mesh 20L and 20R, respectively. A tissue fastener 8 is located at each of two opposing ends of sling 10, which is also the location of an end of each of pieces 10L, and 10R. The ends of pieces 10L and 10R that are opposite of tissue fasteners 8, at a middle portion of implant 10, as illustrated, include opposing adjusting surfaces 12L and 12R, which can be placed into contact with each other to assemble pieces 10L and 10R into an assembled configuration.
As illustrated, sling 10 is shown in an un-assembled configuration, but may be assembled when implanted at tissue of a patient, and by placing adjusting surfaces 12L and 12R into releasable contact. Each piece 10L and 10R, in a non-assembled configuration, may be implanted by use of any of the hereindescribed manners and pathways through which at least end portions 42 and 44 of sling 10 are drawn to dispose central support portion 40 in operative relation to a urethra, bladder neck, anal sphincter or other supported tissue. In the assembled form, sling 10 includes end portions 42 and 44, two tissue fasteners 8 located at each end of the end portions, and two opposing adjusting surfaces 12L and 12R that at least partially contact each other in a releasable engagement. When placed in a patient, adjusting surfaces 12L and 12R can preferably be accessed through an incision during a surgical procedure by pieces 10L and 10R are placed within the pelvic region of the patient being treated.
Still referring to FIG. 1, sling 10 (i.e., non-assembled pieces 10L and 10R a illustrated) includes first anchor (or self-fixating tip) 8, second anchor 8, first extension portion 42, second extension portion 44, “central support portion” or “tissue support portion” 40, and opposing adjusting surfaces 12L and 12R. For use in treating urinary incontinence by a single incision method, the overall dimensions of sling 10, in an assembled configuration, may be 6-15 cm in length, in the range from 6 to 10, 8 to 10 centimeters in length, and 1-2 cm, more preferably 1-1.5 cm, in width (at the extension portions). For use as a single-incision sling for treating urinary incontinence, a total length dimension between opposing tissue fasteners 8 can be at least sufficient to extend from an obturator internus muscle on one side of the urethra to an obturator internus muscle on the opposite side of the urethra, with central support portion 40 placed to support tissue of a urethra. (These dimensions are for an implant designed to treat incontinence by a single incision method; dimensions can be substantially different for implants designed to treat a different conditions or for implantation by a different surgical placement method.) See FIGS. 2 and 3, showing relevant pelvic anatomy including a pelvic bone and opposed obturator foramen, implant 10, and urethra 58 or anus 67 being supported by central support portion 40.
Self-fixating tips 8 include a base, internal channel (not shown), and from two to four lateral extensions. Self-fixating tips 8 are designed to be inserted through a central (e.g., vaginal or perineal) incision in a patient by using insertion tool 60 (see FIG. 1), which includes handle 61 at a proximal end, shaft 62, tip 64 at a distal end of shaft 62, and optional actuator 67. Shaft 62 can be designed to extend from an external location, such as at an external medial incision at a perineum or vagina of a patient, to a location of placement of a tissue fastener, such as at an obturator foramen or other supportive tissue. Shaft 62 may be a single solid length of rigid metal or plastic. Alternately, shaft 62 may include an outer hollow sleeve and an inner (e.g., flexible) moveable shaft that can be moved for actuating to actuate a release mechanism at tip 64.
Sling 10 is designed to be implanted and then left in place chronically, and includes two pieces of elongated, rectangular (as shown at FIG. 1) braided or preferably knitted, mesh strips, or simply mesh 20L and 20R. Sling 10, when assembled, is subdivided into a central support portion 40 adapted to be placed below tissue to be supported, such as a urethra. In a female patient, support portion 40 can be placed between the urethra or bladder neck and the vaginal wall. End portions 42 and 44 extend from central support portion 40 to opposing distal ends, each of which includes a tissue fastener 8 attached thereto. It will be understood that implant 20 may alternately be dimensioned and shaped for treatment of male or female urinary or fecal incontinence or to effect pelvic floor, perineal floor, or pelvic prolapse repairs using a variety of surgical approaches. For example, sling 10 may include more than two end portions 42 and 44 coupled to any of a connector, dilator, or tissue fastener, and extending at a variety of angles from a particularly shaped center portion 40.
In use, each of implant pieces 10L and 10R, in disassembled form, can be initially placed by using an insertion tool (e.g., 60, one or two tools may be used for two implant pieces) to engage each tissue fastener 8 and to insert tissue fastener 8 and both pieces 10L, and 10R through a surgical incision, placing tissue fasteners 8 at supportive tissue. Both pieces 10L and 10R can be so placed. A central support portion 40 can be placed below tissue (e.g., urethral, anus, or other pelvic tissue) and adjusting surfaces 12R and 12L can be engaged to result in desired positioning and effect (e.g., supportive force, approximation, or both) of the assembled implant 10 to support selected pelvic tissue. The user can assess the positioning and effect of assembled sling 10 on the supported pelvic tissue. If positioning and effect are not as desired, adjusting surfaces 12R and 12L can be disengaged to release the pelvic tissue. The pelvic tissue can be moved as desired and placed into a desired therapeutic position, and adjusting surfaces 12R and 12L can be re-engaged to place a central support portion 40 below the tissue. These steps can be repeated until desired positioning and effect of assembled sling 10, on the supported pelvic tissue, are achieved.
With reference to a transvaginal method of treating urinary incontinence, as shown at FIG. 2, exemplary method steps include an initial step of placing tissue fasteners 8 of implant pieces 10L and 10R at supportive tissue, followed by engaging adjusting surfaces 12L and 12R to assemble implant 10 within the patient in a manner to support desired pelvic tissue. The positioning and effect of the placement and sizing (e.g., length) of assembled implant 10 are assessed, and implant 10 can be dis-assembled and re-assembled at opposing adjusting surfaces 12L and 12R until desired positioning and effect are achieved. In a first step, self-fixating tip 8 can be placed at an end of an insertion tool 60 (optionally including a release mechanism), passed through an external (e.g., medial) incision in a patient (e.g., transvaginally), and placed securely into tissue of an obturator foramen. The second self-fixating tip 8 located on the opposite extension portion of implant 10 can be inserted into tissue of the opposite obturator foramen using the same insertion tool 60 or a second identical or similar tool 60, and using the same external incision. Optionally, each step of placing a self-fixating tip at tissue of an obturator foramen can include the use of a release mechanism capable of engaging a self-fixating tip 8 at tip 64 of insertion tool shaft 62, placing the self-fixating tip 8 at supportive tissue, releasing self-fixating tip 8 from tip 64, and withdrawing insertion tool 60 from the patient.
Still referring to FIG. 2, with opposing self-fixating tips installed at opposing obturator foramen, support portion 40 is located below urethra 58, to support urethra 58. The surgeon can asses the position, tension, length, etc., of implant 10 supporting urethra 58, and whether a length of implant 10 should be adjusted. If adjustment is necessary, the surgeon can disassemble implant 10 by disengaging adjusting surfaces 12L and 12R, and, with desired adjusting of the length of assembled implant 10 or location of the supported tissue, re-engage adjusting surfaces 12L and 12R, multiple times if necessary to achieve desired positioning of the supported tissue.
In preferred embodiments implant 10 can be assembled within a patient to achieve anatomically correct placement of supported tissue, e.g., a urethra 58, anus 67, or other supported tissue, to locate the supported tissue at an anatomical position relative to a midline of the patient.
FIG. 2 illustrates a method of treating urinary incontinence. Implants and methods as described can also be useful to treating other pelvic conditions, such as fecal incontinence, in a similar manner. FIG. 3 depicts a schematic illustration of fecal incontinence sling 10 having pieces 10L and 10R, implanted in a female (for example) patient's body for treating fecal incontinence. In this illustration, central support portion 40 extends underneath the anus or anal sphincter 67 or inferior portion of the rectum (not shown, hereafter collectively referred to as the anus 67 for convenience) to correct the anorectal angle in the patient. Implant pieces 10L and 10R are located to allow adjusting surfaces 12L and 12R to be accessed through an external surgical incision, e.g., a medial incision such as a vaginal or perineal incision, to allow intra-operative access to, placement of, or manipulation of, opposing adjusting surfaces 12L and 12R within the patient. While the illustrated embodiment shows self-fixating tips 8 placed at tissue of opposing obturator foramen, other surgical approaches can be used to place sling 10 to correct fecal incontinence, including suprapubic, transobturator, retropubic, prepubic, transperineal, and transvaginal (including a single incision approach transvaginally or transperineally).
FIGS. 4A through 4I illustrate examples of dis-assembled implant pieces 10R and 10L, and assembled implants 10, that include two pieces of implant material (e.g., mesh or molded implant material) that can be connected with length-adjusting, opposing, adjusting surfaces 12L and 12R.
The opposing adjusting surfaces can be any useful surface that can be releasably engaged and repeatedly disengaged and re-engaged during a surgical procedure.
For example, FIG. 4A shows two implant pieces 10R and 10L of disassembled implant 10, connected by a VelcroTM or other type of hook-and-loop fastening system. Pieces 10R and 10L can be of any useful implant material, such as open pore mesh pieces or a molded implant material. Adjusting surface 12L, for example, can comprise surface loops placed on the open pore mesh, molded, or other type of implant material. Adjusting surface 12R, for example, can comprise surface hooks placed on the open pore mesh, molded, or other type of implant material. The hooks and loops are of small or micro scale dimensions extending from a base of the implant material, e.g., less than two millimeters, less than one millimeter, or less then 0.5 or 0.1 millimeter. The opposing hook and loop structures can become mechanically engaged and tangled upon contact, to connect the two opposing surfaces 12L and 12R of implant pieces 10L and 10R. The force required to disengage contacted adjusting surfaces 12L and 12R is relatively low, to allow manual disengagement during a surgical procedure, but is sufficiently high to prevent disengagement or movement between the opposing surfaces for a time after surgery, e.g., up to three weeks. During a surgical procedure the opposing hooks and loops can be engaged and dis-engaged multiple times to achieve desired and efficacious length and placement of assembled implant 10 (FIG. 4B), in supporting pelvic tissue 58 (urethra) or 67 (anus).
FIGS. 4C and 4D show alternate embodiments of adjusting surfaces 12L and 12R. Implant pieces 10L and 10R can function as described with respect to FIGS. 4A and 4B, but with alternate adjusting surfaces 12L and 12R. Pieces 10R and 10L can be of any useful implant material, such as open pore mesh pieces or a molded implant material. As shown at FIGS. 4C and 4D, adjusting surfaces 12L and 12R are opposed releasable adhesive surfaces. For example, surface 12L can include a pressure-sensitive adhesive, and surface 12R can be an uncoated implant material (e.g., mesh or molded implant material), or may include a coating such as a releasable coating or a low adhesion backsize, to allow surfaces 12L and 12R to be repeatedly engaged and disengaged.
FIGS. 4E, 4F, and 4G show alternate adjusting surfaces 12L and 12R. Implant pieces 10L and 10R can function as described with respect to FIGS. 4A and 4B, but with alternate adjusting surfaces 12L and 12R. Pieces 10R and 10L, can be of any useful implant material, such as open pore mesh pieces or a molded implant material. As shown, surface 12L includes small-dimension or micro-dimension pins or extension 11B, e.g., which are molded, and that can extend into and engage apertures 11A of surface 12R. Extensions 11B may be molded onto a surface of piece 10L, and can have a desired dimension (length) extending (substantially perpendicularly) from the base or surface of piece 10L. Aperture 11A of piece 10R may have a complementary shape and dimension. A length of extension 11B (and corresponding length of aperture 11A) may be sufficient to extend through a thickness of the mesh or molded implant material of piece 10R, e.g., a length of approximately 0.5 to 2 millimeters, e.g., 0.5 to 1.5 millimeters. Alternately, a length of extension 11B (and corresponding length of aperture 11A) may be less than the aligned thickness dimension of the mesh or molded implant material of piece 10R. The shape of extensions 11B may be uniform from base to end, or may be larger at the end (as shown at FIG. 4G) to improve the engagement force between surfaces 12L and 12R. For example, extensions 11B and apertures 11A may constitute small-scale mechanical “snaps.” Apertures 11A may be openings normally present in a mesh implant material, e.g., inter-strand pores formed by knitting or weaving strands into mesh. Alternately, apertures 11A may be molded apertures of a molded implant material, having size and shape features selected to correspond to size and shape features of molded extensions 11B, to provide effective releasable engagement of extensions 11B by apertures 11A. To fit and releasably engage such molded apertures 11A, a length dimension of extensions 11B (and corresponding length of aperture 11A) may be on a small or micro scale extending from a surface of the implant material, e.g., less than two millimeters, less than one millimeter, or less then 0.5 or 0.1 millimeter.
FIG. 4H shows alternate adjusting surfaces 12L and 12R. Implant pieces 10L, and 10R can function as described with respect to FIGS. 4A and 4B, but with alternate adjusting surfaces 12L and 12R. Pieces 10R and 10L can be of any useful implant material, such as open pore mesh pieces or a molded implant material. Adjusting surfaces 12L and 12R include opposing magnetic coatings. The magnetic coatings can be of sufficient strength to be engaged and disengaged during a surgical procedure, as described herein, and to remain in contact without slipping for a time sufficient to allow ingrowth of implanted and assembled implant 10, without movement of supported pelvic tissue, e.g., for at least three weeks.
FIG. 4I shows a modification of implant 10 of FIG. 4H. At FIG. 4I, adjusting surfaces 12L and 12R include opposing magnetic coatings placed on opposing ridge structures 11C. Ridges 11C can be uniform ridges, e.g., pyramidal, triangular. Ridges 11C can extend across surfaces 12L and 12R in a manner to prevent pieces 10R and 10L from slipping during a post-surgical ingrowth period.
The disclosed systems, their various components, structures, features, materials and methods may have a number of suitable configurations as shown and described in the previously-incorporated references. Various methods and tools for introducing, deploying, anchoring and manipulate device, implants, and the like as disclosed in the previously-incorporated references are envisioned for use with the present invention as well.
All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications.

## Claims

1. A pelvic implant useful to treat a pelvic condition, the pelvic implant having only two supportive members, the two supportive members being capable of an assembled state and an unassembled state, the pelvic implant comprising:
a first supportive member comprising a proximal end, a distal end, a self-fixating tip at the distal end, a first length extending from the proximal end to the distal end, a first surface, and second surface that is opposite to the first surface, the first surface comprising a first adjusting surface extending along a portion of the first length; and
a second supportive member comprising a proximal end, a distal end, a self-fixating tip at the distal end of the second supportive member, a second length extending from the proximal end of the second supportive member to the distal end of the second supportive member, and a first surface, and a second surface that is opposite to the first surface of the second supportive member, the first surface of the second supportive member comprising a second adjusting surface extending along a portion of the second length,
wherein, in the unassembled state, the first supportive member is separate from and uncoupled to the second supportive member, and the pelvic implant is configured to be placed within the assembled state when the first supportive member and the second supportive member is disposed within a body of a patient,
wherein, in the assembled state, the first adjusting surface of the first supportive member is coupled to the second adjusting surface of the second supportive member to produce a releasable engagement between the first adjusting surface of the first supportive member and the second adjusting surface of the second supportive member, the releasable engagement having a strength that allows the pelvic implant to support pelvic tissue without the releasable engagement releasing from the assembled state to the unassembled state.

2. The pelvic implant of claim 1, wherein, in the assembled state, the implant defines a tissue support portion.

3. The pelvic implant of claim 2 wherein the tissue support portion is configured to support tissue of a urethra or anus.

4. The pelvic implant of claim 1, wherein the first adjusting surface and the second adjusting comprise one or more of: magnetic structures, opposable mating aperture-and-extension structures, and releasable adhesive.

5. The pelvic implant of claim 1, wherein the first supportive member and the second supportive member are capable of extending from an obturator intemus muscle on a first side of a patient, under a urethra, and to the obturator intemus muscle on a second side of the patient.

6. The pelvic implant of claim 1, wherein the first adjusting surface of the first supportive member comprises a hook structure and the second adjusting surface of the second supportive member comprises a loop structure, wherein, in the assembled state, the hook structure is removably coupled to the loop structure.

7. The pelvic implant of claim 1, wherein the first adjusting surface of the first supportive member includes a first adhesive, and the second adjusting surface of the second supportive member includes a second adhesive, wherein, in the assembled state, the first adhesive is removably coupled to the second adhesive.

8. The pelvic implant of claim 1, wherein the first adjusting surface of the first supportive member comprises a pin structure, and the second adjusting surface of the second supportive member comprises an aperture structure, wherein, in the assembled state, the pin structure is removably coupled to the aperture structure.

9. The pelvic implant of claim 1, wherein the releasable engagement is formed between only the first adjusting surface of the first supportive member and the second adjusting surface of the second supportive member.

10. A method of treating a pelvic condition, the method comprising:
providing a pelvic implant, the pelvic implant having only two supportive members, the pelvic implant comprising;
a first supportive member comprising a proximal end, a distal end, a first self-fixating tip at the distal end, a first length extending from the proximal end to the distal end, a first surface, and a second surface that is opposite to the first surface, the first surface comprising a first adjusting surface extending along a portion of the first length,
a second supportive member comprising a proximal end, a distal end, a second self-fixating tip at the distal end of the second supportive member, a second length extending from the proximal end of the second supportive member to the distal end of the second supportive member, a first surface, and a second surface that is opposite to the first surface of the second supportive member, the first surface of the second supportive member comprising a second adjusting surface extending along a portion of the second length;

providing the pelvic implant in an unassembled state in which the first supportive member is separate from and uncoupled to the second supportive member;
placing the first self-fixating tip at supportive tissue of a pelvic region;
placing the second self-fixating tip at supportive tissue of the pelvic region; and
placing the pelvic implant within an assembled state by coupling the first adjusting surface of the first supportive member and the second adjusting surface of the second supportive member to produce a releasable engagement between the first adjusting surface of the first supportive member and the second adjusting surface of the second supportive member, the releasable engagement having a strength that allows the pelvic implant to support pelvic tissue without the releasable engagement releasing from the assembled state to the unassembled state.

11. The method of claim 10 comprising adjusting a length of the pelvic implant by disengaging the first adjusting surface of the first supportive member from the second adjusting surface of the second supportive member, moving the pelvic tissue, and re-engaging the first adjusting surface and the second adjusting surface to re-assemble the pelvic implant in a manner to support the pelvic tissue.

12. The method of claim 10, wherein the pelvic condition is selected from the group consisting of: fecal incontinence and urinary incontinence.

13. The method of claim 10, wherein the pelvic condition is urinary incontinence, the method comprising:
creating a medial incision in a patient;
placing a tissue support portion of the pelvic implant to support a urethra;
placing the distal end of the first supportive member in a tissue path extending toward a first obturator foramen of the patient; and
placing the distal end of the second supportive member in a tissue path extending toward a second obturator foramen of the patient.

14. The method of claim 10, wherein the pelvic condition is selected from the group consisting of: fecal incontinence, urinary incontinence, vaginal prolapse, anal prolapse, uterine prolapse, perineal descent, a levator defect, and rectal prolapse.

15. The method of claim 10, wherein the pelvic condition is vaginal prolapse, and wherein the vaginal prolapse condition is selected from the group consisting of: enterocele, cystocele, rectocele, and vaginal vault prolapse.

16. The method of claim 10, wherein a patient is a male or a female patient and the pelvic condition is urinary incontinence, wherein the urinary incontinence is selected from the group consisting of: stress urinary incontinence, urge urinary incontinence, and mixed urinary incontinence.

17. The method of claim 10, wherein the releasable engagement is formed between only the first adjusting surface of the first supportive member and the second adjusting surface of the second supportive member.

18. A pelvic implant useful to treat a pelvic condition, the pelvic implant having only two supportive members, the two supportive members being capable of an assembled state and an unassembled state, the pelvic implant comprising:
a first supportive member comprising a proximal end, a distal end, a self-fixating tip at the distal end, a first length extending from the proximal end to the distal end, a first surface, and a second surface, the first surface comprising a first adjusting surface extending along a portion of the first length; and
a second supportive member comprising a proximal end, a distal end, a self-fixating tip at the distal end of the second supportive member, a second length extending from the proximal end of the second supportive member to the distal end of the second supportive member, a first surface, and a second surface, the first surface of the second supportive member comprising a second adjusting surface extending along a portion of the second length,
wherein, in the unassembled state, the first supportive member is separate from and uncoupled to the second supportive member,
wherein, in the assembled state, the first adjusting surface of the first supportive member mates with the second adjusting surface of the second supportive member to produce a releasable engagement between the first adjusting surface of the first supportive member and the second adjusting surface of the second supportive member, the releasable engagement between the first adjusting surface and the second adjusting surface being sufficient for the implant to support pelvic tissue without the releasable engagement releasing from the assembled state to the unassembled state, and to allow manual disengagement of the first adjusting surface from the second adjusting surface,
wherein the first adjusting surface of the first supportive member includes a first magnetic coating, and the second adjusting surface of the second supportive member includes a second magnetic coating, wherein, in the assembled state, the first magnetic coating mates with the second magnetic coating.

19. A pelvic implant useful to treat a pelvic condition, the implant having only two supportive members, the two supportive members being capable of an assembled state and an unassembled state, the pelvic implant comprising:
a first supportive member comprising a proximal end, a distal end, a self-fixating tip at the distal end, a first length extending from the proximal end to the distal end, a first surface, and a second surface, the first surface comprising a first adjusting surface extending along a portion of the first length; and
a second supportive member comprising a proximal end, a distal end, a self-fixating tip at the distal end of the second support member, a second length extending from the proximal end of the second supportive member to the distal end of the second supportive member, a first surface, and a second surface, the first surface of the second support member comprising a second adjusting surface extending along a portion of the second length,
wherein, in the unassembled state, the first supportive member is separate from and uncoupled to the second supportive member,
wherein, in the assembled state, the first adjusting surface of the first supportive member mates with the second adjusting surface of the second supportive member to produce a releasable engagement between the first adjusting surface of the first supportive member and the second adjusting surface of the second supportive member, the releasable engagement between the first adjusting surface and the second adjusting surface being sufficient for the implant to support pelvic tissue without the releasable engagement releasing from the assembled state to the unassembled state, and to allow manual disengagement of the first adjusting surface from the second adjusting surface,
wherein the first adjusting surface of the first supportive member comprises a first ridge structure and a first magnetic coating disposed on the first ridge structure and the second adjusting surface of the second supportive member comprises a second ridge structure and a second magnetic coating disposed on the second ridge structure, wherein, in the assembled state, the first magnetic coating mates with the second magnetic coating.