Title of Invention

A PELVIC IMPLANT ASSEMBLY

Abstract Abstract SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS A pelvic implant assembly (100) comprising a support portion (128) and an extension portion (124), a self-fixating tip (10, 120) connected to the extension portion, the self-fixating tip comprising a base (12) comprising a proximal base end (14) and a distal base end (16), the proximal base end being connected to the extension portion, the base comprising an internal channel (18) extending from the proximal base end and at least partially along a length of the base toward the distal base end, a fixed lateral extension (20) extending from the base.
Full Text SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS
Priority Claim The present nofl-provisional patent Application claims priority under 35 USC §119(e) from United States Provisional Patent Application having serial number 60/775,039, filed on February 16,2006, by Lund et al., titled SINGLB INCISIOK SLING AND METHOD OF IMPLANTING SAME IN PATIENT; United States Provisional Patent Application having serial number 60/S04,3S3. filed June 9,2006 by Westrum et al., titled SURGICAL ARTICLES AND METHODS FOR ADDRESSING URINARY INCONTINENCE; United States Proviaional Patent Application having serial number 60/806,073, filed June 28,2006, by Anderaon et al., titled SURGICAL ARTICLES AND METHODS FOR ADDRESSING URINARY INCONTINENCB: and United States Provisional Patent Applioation having serial number 60/805,040, filed June 16,2006, by Montpetit et al., titled PELVIC FLOOR REPAIR TISSUE FIXATION, wherein the entirely of said provisional patent applications are incorporated herein by reference.
FIELD OF THE INVENTION The invention relates to apparatus and methods for treating pelvic conditions by use of a pelvic implant to support pelvic tissue. The pelvic conditions include conditions of the female or male anatomy, and specificaily include treatments of female or male urinaiy and
I fecal incontinence, and treatment of fbmale vaginal prolapse conditions Including
enterocele, rectocele, cystooele, vault prolapse, and any of these conditions in combination. In particular, the present invention relates to a surgically implanted implants that support pelvic tissue and that are secured to pelvic tissue to provide that support.
BACKGROUND
Pelvic health for men and women Is a medical area of increasing importance, at
least in part duo to an aging population. Examples of common pelvic ailments include

incontinence (fecal and urinary) and pelvic tissue protapes (e.g., female vaginal prolapse). Urlnary Incontinence can further be classified as including different types, such as stress urinaiy incontinence (SUl), uige urinary incontinence, mixed urinaor incontinence, among others. Other pelvic floor disorders include cystocele rectocele, enterocelc, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vana and introitus. Pelvic disorders such as ftese can result from weakness or damege to normal pelvic support systems.
In its severest forms, Vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele h a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends Into the rectovaginal space. Vanal vault prolapse end enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times.
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 fbmale stress winnry incontinence (SUl) occurs when the patioit is physically stressed.
One cause of urinary incontinence Is damage to the urethral sphincter. Other causes include the loss of sufort of the uretitral sphincter, such as can occur in males after prostatectomy or following radiation treatment, or that can occur due to pelvic accidents and aging related deterioration of muscle and connective tissue supporting the urethra. Other causes of male incontinence include bladder instability overflowing incontinence, and fistulas.
The female's natural support system forthe urethrs is a hammock-like supportive layer composed of endopelvie ftscia, the anterior vaginal wall, and the arcus tendineus. Weakening and elongation of the pubourethral ligaments and the arcus tontheus fascia pelvis, and weakening of the endopelvie fascia and pubourethral prolapse of the anterior

vaginal wall, may have a role in the loss of pelvic support for the urethra and a low non-anatomic position that leads to urtnaiy incontinence..
In'geni&ral» urinary continence is considered to be a function of urethral support and coaptation. For coaptation to successfully prevent or cure ineontience, the urethra must be supported and stabilized in its normal anatomic position. A number: of surgical procedures ' and implantable medical devices have been developed over the years to provide urethral support and restore coaptation. Examples of such surgical instruments included Stamey needles, Raz needles, and Pereyra needles. See Stamey, Endoscopic Suspension of the Vesical Neck for Urinary Incontinence in Females, Ann. Surgery, pp. 465-471, October 1980; and Pereyra, A Simplified Surgical Procedure fbr the Correction of Stress Incontinence in Women, West. J. Sutg., Obstetrics & Gynecology, pp. 243-246, July-August 1959.
One altenoative surical procedure is a pubovaginal sling procedure. A pubovaginal sling procedure is a surgical method involving the placement of a sling to stabilize or support the bladdn neck or urethra. There are a variety of different sling proceduros. Descriptions of different sling procedures are found 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.
Some pubovaginal sling procedures extend a sling from the rectus fascia in the abdominal rogion to a position below the urethra and back again. The slings comprise a central portion that is adapted to support the urethra or a pelvic organ (i.e., a "support porUon" or "tissue support porticm"), and two extension portions bracketitig the support ' portion, optionally a protecdve sheath or sheaths encasing at least the extension pordons. Although complications associated with sling procedtms an inftequent Hheydo occur. Complications include urethral obstruction, prolonged urinary retention, bladder perforations, dantage to surrounding tissue, and sling erosion.

Other trsatments involve impiantation of a Kaufinan Prosthesis, an artificial spbincter (such as the AMS-800 Urinaiy Control System available from American Medical Systems, Inc.), or a uretibrel sling procedure in which a urefliral sling is inserted beneath the urethra and advanced to the retropubic space. Peripheml or extmsion portions of the elongated urethral sling are affixed to bone or body tissue at or near the retropubic space. A central support portton of the elongated urethral sling extends under the urethral or bladder neck to provide a platform tiiat contpresses the urethral sphincter, limits urethral distention and pelvic drop, and thereby improves coaptation. Similar attached slings or supports have been proposed for restoring proper positionnig of peMe organs, e.g., the vagnsi or bladder.
Elongated "sdf-fixatin' slings have alio been introduced ibr implantation in the body, to treat pelvic conditions such as prolapse Hid incontinence conditions. Selffixating slings, do not require the extension portions to be physically attached to tissue or bone. Rather, the slings rely upon tissue ingrovrih Into sling pores to stabilize the sling. See, ibr example, commonly assigned U.S. Patent Nos. 6,382,214,6,641,524,6,632/150, and 6,911,003, and publications and patents cited therein. The implantation of these implants involves the use of rigt and left hand sling implantation tools that create transvaginal, transobtucator, supra-pubic, or retro-publc exposures or pathways. A delivery system for coupling the sling ends to ends of elongate insertion tools, to draw sling extension pmtlons throu tissue pathways. Is also included. Needles of the right and left hand bisertion tools described in the abovera&ranced 2005/0043580 patent publication have a curvature ia a single plane and correspond more generally to the BioArc'M SP and SPARC single use sling implantation tools sold in a kit with an elongated urethral slfaig by American Medical Systems, Inc.
In some sling implantation kits, the needle portion has a proximal straight portion 5 extendfaig ihsn the handle and a distal curved portion terminating in a needle end or tip. As described in the above-relrenced '003 patent, the kit may include more than one type of

Implantation tool (also, insertion tool0 The kit may include one tool suitable for an outside-in (e.g. from the skin incision toward a vaginal incision) procedure and another that may be suitable for an inside-out (e.g. firom the vaginal incision toward a skin incision) procedure. Surgeons that prefer an approach dictated by fbe surgeon's dominant hand can select Ute procedure and Uie appropriate implantation tool. Alternately, universal implantation tools (e.ft., rit and left sling implantation tools each suitable fbr both an inside-o\it and an outslde-in approach) may be provided.
Optionally, a detachable protective sheath may encase some portion of an extension portion of a pelvic implant. Connectors rosy be attached to the ends of the extension portions for connecting with and end of an huertion tool. Generally speaking, the insertion tool ends are inserted axially into the connectorsj and the extension portions of the implant are drawn througji pathirays trailing the connectors and needles to draw a central support portion against the pelvic tissue (e.g., the urethra) to provide support. The connectors are drawn out through skin incisions and the implant and encasing sheath are severed atacent to file connecton.
Similfflr transobturator implantadon procedures ibr implanting a pelvic implant to support a pelvic organ, e.g., the vagina, restored in propn anatomic position, are described in commonly assigned U.S. Patent Applicatioo Publication Kos. 2005/0043 580 and 200S/0065395. Alternate implantation procedures text creating tissue patbwi exiting the skin lateral to the anus and implanting an implant extending between the skin incisions to support a pelvic organ, e.g., the vagina, restored in proper anatomic position, are described in commonly assigned U.S. Patent Application Publication Ko. 2004/00394S3 and in PCT Publication No. WO 03/096929. Various ways of atttushing a iileevo end and implant mesh extension to a self-fixating tip are detailed In the above-ifbrenced '450 patent, for example. 5 Further wfQrs of attaching extensions of an implant to an implantation tool are described in

us. Patent Publication 2004/0D87970. In each case extra incisions must be made in the patient's abdomen.
SUMMARY
The present patent applicatbn describes pelvic Implants and methods for treating pelvic conditions such as incontinence (various forms such as Ibcal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.) vaginal prolapse (including various ibrms such as entorocele, oystooele, rectocele, vault prolapse, etc.) among fathers. Embodiments of implants include a self-fixanring tip at a distil end of one cat more extension portions. The self-fpcatlng tip can be placed at and secured within internal tissue of the pelvic region to support the implant end extension and pelvic tissue ttiat is supported'by the implant. As an example, a self-fixating tip can be placed at tissue of the obturator foramen (this phrase reftoring to tissue that lies within or spans the obturator finamen, tbr example ihe obturator intemus muscle, the obturator membrane, or the obturator exteraus muscle). Other tissue of the pelvic region can also be locations useful for implanting a self-fixating tip. The seHfixatlng tips can be designed to engage a distal end of an insertion tool to allow the insertion tool to place the self-fixating tip at a desired tissue location by pushing.
Embodiments of self-fixating tips can be designed to provide desired function and performance in becoming positioned and maintaining position within tissue of the petvic region. For example, a self-fixating tip can be designed to provide desirably low input force, desirably high pullout force, and reduced trauma caused by passage of the self-fixating tip or an associated insertion tool. A self-fixating tip may also be designed to allow fbr removabiliQr in situations of necessity, witii reduced trauma to tissue, the self-fixathig tip can be designed to minimize removal ibrce and trauma hi instances that require removal. These ftinotlonal properties can result firom selecting size and shape features of a self-fixating tip, such as relatively reduced overall dimensions (lengti) or diameter) of the tip;

and size, shape, and number of lateral extensions.
Exemplary methods of using a self-fixating tip attached to an lmplant» when implanted by use of an elongate Insertion tool, allow a physician to obtain direct tactile palpation without relying Potential advantages related to the use of the certain of the cuirently-desoribed methods and devices can Include reduced overall trauma of a procedure due to one or more of. design of a self-fixtatingtip or insertion tool; reduced trauma caused by a self-fixating tip or associated Insertion tool, due to a reduced length of tissue passages (e.g., for posterior repairs reduced trauma based on the abiliiy to avoid tissue passages next to critical structure; and reduced trauma due to the abilhy to eliminate the need for local steb (external) incisions otherwise required for needle entry and exit sites-.
According to exemplary methods, a physician identifies tissue within the pelvic reon to which a self-fixating tip will be secured. An ins«tion tool and self-fixathig tip can be introduced throu| a medial incision to insert a permanent (plastic i.e., polypropylene or metaO or bioresorpable implant assembly that includes a self-fixating tip having one or multiple lateral extensions, to the target site.. This pirocedure can be puformed by use of a single (mediaO incision.
One'embodiment of implant is a urinary incontinence sling that includes a sling body» a first self-fixating tip (sometimes alternately referred to herein as an "anchof or

"anchor member") attached to a first end of the sling, and a second anchor member attached to a second end of the sling, wherein the sling is made of a single piece of mesh material.
The invention also contemplates a method of treating minary incontinence in male and female patients. The method include creatutg a single medial incision (a transvaginal incision or a perineal hicision) under the mid-urethra, dissecting a tissue patii on each side of the incision, passing a urinaiy incontinence sling through the incision whereby the urinary incontinence sling is suspended between the obturator intemus muscles and the sling body is positioned between the patient's urethra and vaginal wall (ibr a fbmale) to provide support to the urethra. Par males a perineal incision can be made to pass the sling fiirough the incision and suspend the sling in a manner comparable to the sling installed in the jmale patient anatomy. A procedure for treating male urinary incontinence may be peribrmed with or following a prostatectomy, or otherwise.
In addition to treating urinary incontinence, the invention also contemplates methods relating to otber types of pelvic floor rahrs. Currently, pelvic floor repah-s are surgically treated Qirough graft augmented repairs and with kit systems that use needles to deliver a graft through an incision on the anterior and posterior vaginal wall. These curreirt procedures address tissue, muscle and ligament weakness in the pelvic floor such as i«otooeles, ehteroceles, cystoceles, apical, and uterine descent.
The invention allows pelvic floor reconstruction procedures to become more minimally invasive and easier to use for all peMc floor surgeon groups. The invention relates to a tissue fixation anchoring system tihat can be applied to a variety of areas of the pelvic floor: anterior repahs, posterior repidrs, apical support, perineal body isupport (address levator hiatus opmings) fecal incontinence, hystereotomy repairs with vault support by means of graft augmentation with tissue anchors into several dUlbrent anatomical landmarics. These landmarks nuiy be the white Ibie, muscle, and fhscial layers, ligament structures (saerospinous, saorotuberous, cardinal, round, uterosacrals, perineal and rectal

ligaments, etc.) etc. The self-flxBting tip can be delivered to tissue in combination with a' sling, hammock, or suture thread, introduced with an elongate insertion tool directly to tissue.
-Another embodiment is a method of treating urinary inoontinenoe (e.g. SUO in a minimally invasive manner including itvfecting a local anesthetic; creating only one medial Ce;g., transvaginal) incision under the noid-utethra; providing a urinary incontinence stltig, the sling includmg a slfaig body and a first and second anchors operably attached to the sling body; inserting the first anchor throu the incision and securing the anchor into a desired location in the pelvic region; inserting the second andior through Hie incision and anchoring the second anchor at a desired location in the pelvic region; positioning the sling into a desired supporting position relative to the urethra; and closing the incision. Advantageously, the mtire procedure can be performed with a single incision, e.g., the transvaginal incision. There is no need for any extern incision of flie patient such as widi -other methods of installing a urethral sling.
Yet another embodiment is method of treating female urinary incontinence The present invention fiuthetmore Includes a method and apparatus for a urinaiy inoontfaience sling that is implanted through a single vaginal (or perineal for males) incision whereby the sling does not «clt through another sicin incision such as an abdominal or leg incision.
An aspect of the invention relates to a pelvic implant assembly that includes a support portion and an extension portion, and a self-fixating tip connected to the extension portion. The self-fixating tip includes a base comprlsbig a proximal base end and a distal

base end, the proximal base end being connected to the extension portion. The base includes an intemai channel extending from the proximal base end at least partially along a length of the base toward the distal base end. The self-fixating tip ftirther includes a fixed lateral {tension extending firom the base.
In another aspects the invention rolates to a pelvic implant assombly tiiat inciudes a stipport pordon and an extension portion, with a self-fixating tip connected to the extension portion. The self-fixating tip includes a base comjrising jn'oximai base end and a distal base end, the proximal base end being connected to Another aspect of the invention Includes a combination (e.g., kit, system, etc.) of an hilant, as described herieim including one or more self-flxatbig t. The kit also includes one or more insertion tool use&l widi the implant.
In another aspect, the invention relates to a meUiod of treating a pelvic condition. The method includes providing an implant according to the current description; providing an insertion tool that includes a handle and a needle extending from the handle, the needle including a proximal end attached to the handle and a distal end, the distal end Includfaig a needle distal end that removably engages the self-fixating tip; engaging the needle distal end witii the self-fixating tip, inserting the needle distal end and tip throu] an incision in.a patioit; and inserting the self-fixating tip into tissue in the pelvic region.
In another aspect the invention relates to a method of treating a pelvic condition. The metiiod includes creating a single Incision tiirou the vaghia or perineal floor; dissecting tissue beneath tissue to be suppcnted; providing a pelvic implant according to the

present description; pawing the pelvic implant through the incision; and implanting the self-■ fixating tip at tissue of the pelvic region.
Yetmother aspect of the invention relates to a mettiod of treathig a pelvic condition. The method includes: creating only one incision under Ihe mid-urethra through the vagina or through the perineal floon providing an implant aocording to the present description; insetting a selfixating tip througjh the incision and anchoring the self-fixating tip within fibrous tissue; Inserting a second self-fixsting tip tiuvugh the incision and anchoring the self-fixating t within fibrous tissue; positioning the implant into a desired supporting position, relative to tissue of the pelvic region; and closing lh& incision.
BRIBF DESCRIPTION OP DRAWINGS
Other features and advantages of the present invention will be seen as the following description of particular embodiments progresses in GOtQunotioa with Ae drawings. Drawings are schematic and not to scale.
Figure 1 illustrates a side view of an embodiment of a self-fixating tip.
Figure 2 illustrates an end view of an embodiment of a self-fixating tip.
Figure 3 A illustrates an embodiment of a kit according to the invention, the kit including an implant and an insertion tool.
Figure 3B illustrates an embodiment of an implant according to the invention.
Figure 3C illustrates an embodiment of an Implant according to the invmtion.
I Figures 4 and 5 illustrate an embodiment of a self-fixating tip according to the
invention.
Figure 6 illustrates exemplary placement of elements of animplant according to the invention.
Figure 7 illuslarates an embodiment of a portion of an tanplant according to the f invention.

Figure 8 illustrates exflmplaty placement of elements of an implant according to the invention.
Figure 9 jllostrates exemplary placement of elements of an implant according to e invention.
Figures 10 and 11 illustrate features of an embodiment of an insertion tool according to the invention.
Figure 12A, 12B» 12C, 12D, and 12B, illustrate features of embodiments of insertion tools according to the invention.
Figure I3A and 13B, illustrate ftotures of an embodiment of an insertion toibl according to the invention.
Figure 14A, 14B, and 14C illustrate features of en embodiment of an insertion tool according to the invention.
Figure 1S illustrates an embodiment of a portion of an implant according to the inventiiKi.
Figure I6A illustrates an embodiment of a kit according to the invention, fiie kit includmg an implant and an insertion tool.
Figures I6B and 16C illustrate embodiments of implants according to the invention.
Figure 17 illustrates exemplaiy placement of elonents of an implant according to
the invention. '
) Figure IS illustrates an embodiment of a portion of an implant according to the
invention.
Figure 19 illustrates exemplaiy placement of elements of an implant accordingto the Invention.
Figures 2QA, 20B, 20C, and 20D illustrate an embodiment of a self-fixating tip S ' according to the invention.

Figures 21A and 21B illustrate an embodiniTOt of a portion of an implant according to the invention.
Figures 22A and 22B jllustrate an embodiment of a portion of an implant according to the invention.
Figures 23A and 23B illustrate an embodiment of a portion of an implant according to the invention.
The following descripUon is meant to be illustrative only tad not limiting. Other embodiments of this invention will be apparent to those of ordinary skill in the art in view of this description.
The present invention is directed to surgical instrunnents, assemblies, and implantable artioles for treating pelvic floor disorders such as feoal or urinary incontinence, including sttass urinaty incontinence (SUO prolapse, etc. According to various embodiment, a sutgicat implant can be used to treat a pelvic condition, including the • specific examples of hnplanting a sappozt member C'implanf'} to treat a condition such as vaginal vault prolapse or incontinence (male or lmale). Described are various features of surgical Implants, surreal toots, surgical systems, surgical kits, and surgical methods, useftii for installing implants. An implant can be implanted In a male or a fbmale to tr«»,t disorders such as urge Incontinence, mixed incontinence, overflow incontinence, fiinctional incontinence, ftcal incontinence, or for female con(Utions Including prolepse (e.g. vaginal or uterine), enteroceles (e.g. of the uterus), rectoceles, «ystbcele, and anatomic hypermobili.
An implant can inojude a tissue support portion (or 'support portion") tirnt can be used to support pelvic tissue such as the urethra (which includes the bladder neck), vaginal tissue, etc. During use. the tissue support portion is typically placed in contact wilii and attached to tissue to be supported, such as with a suture. An Implant can additionally include one or more extension portions (oflierwise known as "end" portions or "arms")

attached to the tissue support portion. Examples of pelvic implants are described in t!ie following exemplaiy documents: United States patent application serial number 10/834,943, inied April 30,2004; United States patent application serial number 10/306,179, filed November 27,2002; United States patent application serial number 11/347,063, filed Febniary 3,2006; United States patent application number \ 1/347,596, filed February 3, 2006; United States patent application serial number 11/347,553, Hied February 3,2006; United States patent application serial number 11/347,047, filed Februaiy 3,2006; United States patent application serial number 11/346,750, filed Februaiy 3,2006; United States patent application serial number 11/398368, filed April 5,2005; United States patent application serial number! 1/243,802, filed October 5,200S; United States patent application serial number 10/840,646, filed May 7,2004; and Intemationai patmt application number PCT/US2006/028828, having an International Filing Date of July 25, 2006; the entireties of each of these disclosures being inoorporated herein by refbrence.
An implant may include portions or sections titat are synflietic or of biological material (e.g.. porcine, cadaveric, etc.). Bxtension portions may be, e.g., a synthetic mesh such as a polypropylene mesh. The tissue support portion may be synthetic (e.g., a poiyproilene mesh) or biologic Examples of implant products that mi be similar to those useAil acooiding to the present description, hidude those sold commnclally by American Medical Systems, Inc., of Minnetonka NIN, tmder the trade names Apogee® and Perigee Bxemplaiy implants can include a tissue 8U{ort portion fbr placing in contact with tissue to be supported and one or more "extension portions, fhe tissue support portion being useful to support a specific type of pelvic tissue such as the urethra, bladder, or vaginal tissue (anterior, posterior, apical, etc.). The tissue support portion can be sized and shaped to contact tihie deshed tissue when installed, e.g., as a "slini m "hammock,' to comact and

support pelvic tissue. A tissue support portion that is located between two or more exteiuton or extension portions is sometimesrefemd to herein as a "central support portion" or a "support portion."
Extension portions are elongate pieces of material tliat extend irom the tissue . support portion and either are or can be connected to the tissue support portion, and are usefiil to attach to anatomical ibaturss in the pelvic region (e.g.» using a self-fixating tip) to fliereby provide support for the tiwue support portion and the supported tissue. One or muKiple (e.g., one two, or four) extension portions can extend fivm the tissue support portion as elongate "ends," "arms," or "extensions," useful to attach to tissue in the peivie region, such as by extending through a tissue path to an internal anchoring point as described herem.
An example of a particular type of pelvic implant is the type that includes' supportive portions inctudnig or consisting of a central support portion and eiOier two, ibur, or six elongate extension portions extending from the central support portion. An implant that has exactly two extension portions can be of the type useflil far treadng, e.g., urlnaiy incontinence, anterior vanal prolapse, posterior vaginal prolapse; an implant having four or six extenrion portions can be useful for treating combinations of these conditions. The term "supportive portions" refers to portions of an implant that function to support tissue after the implant has been implanted, and speeifically includes extension portions and tissue support portions, and does not include optional or appurtenant jfeatures of an implant such as a Sheath or self-flxattng tip or other type of connector for attaching the Implant to an insertion tool.
Types of exemplary implants that can be generally useftil as discussed herein can include those preylously and currently used in treating pelvic conditions, including those implants referred to as urethral "slmj strips," "mesh strips," "hammocks," among other tenns for pelvic implants. Examples of implants for treating incontinence, e.g., urethral

slings, can bs comprise a central support portion and two extension portions, and may take e fbnn of an integral mesh strip. An exemplaiy urethral sling can be an integral mesh strip with supportive portions consisting of or consisting essentialty of a central support portion and two extension portions. Examples of urethral slings for treating male urinary
4 «
incontinence can have a widened central support portion, as discussed, Ibr example, in
A8Stgnees copending United States patent application serial numbers 11/347,047 and
1 t/347,SS3. Other exemplary urethral sling implants are described in Assignee's copending
United States patent application serial numbers 10/306,179; 11/347,596; 11/346,750; among
others.
) Examples of implants for treating vaginal prolapse can comprise a central support
portion and from two to four to six extension portions, and may take the form of an integral piece ofmesh or multiple pieces ofmesh attached in a modular ftshion. See, e.g., Asslgnees copending United States patent applications serial numbers U/398,369; 10/834.943; 11/243,802; 10/840,646; PCT/2006/028828: among others.
Dimensions of an implant can be as desired and usefoi for any particular installation procedure, treatment, patient anatomy, and to support a specific tissue or type of tissue. Exemplary dimensions can be sufficient to allow the tissue support portion to contact tissue to be supported, and to allow extension portions to extend fiom the tissue sujqtort porticm to a desired anatomical location to allow the extension portion be secured to anatomy of the pelvic region to support the tissue support portion.
Dimensions of nttension portions according to the invention can allow the extension portion to reach between a tissue support portion placed to .support pelvic tissue (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 pelvic tissue. A distal end of an extension.pordon, according to embodiments of the Invention, can include a self-fbcaxintg tip that can be attached du«ctly to peWlc tissue such as pelvic musole» ligament, or tendon. The

iengUi of the extension portion, therefore, can be in a range that allows placement of a tissue support portion as desired to support pelvic tissue, while the self-fixating tip is installed in ■ pelvic tissue.
As described elsewhere herein, a length of an nttension portion can optionally be fixed (i.e,, the extension portion does not include any form of length-adjusting mechanism), as can a length of an implant spanning from opposite'self-fixating tips and including extension portions and a length or segment of tissue support portion. Alternate embodiments of implant's of the invention may include a4}u8tment or tensioning mechanisms that allow a physician to alter the length of an extension portion before, during, or after implantation. On -the other hand, a4}ustment and tensioning medianisms cein also be excluded ftom embodiments of implants of the invention by selecting the length pf «ctenslon portions and tissue support portions, and by adjusting for tensioning or pofliti As an example, implants for treating incontinence, prolapse, or a mixture of incontinencfe and prolapse, can include a pcntion useftil to support the uredira or bladder neck to addrass urinaiy Incontinence. For «tampte a urethral slhig is used exclusively to support the ursdira or bladder neck, and may be In the foim of a mesh strip that includes a support pcartion implanted below ttte urethra or bladder neck. Implants for prolapse, especidly antnrior prolapse, can also include and anterior portion usefol for supporting the ■ urethra or bladderneck in tiiB same fhshion. A prefoned distance biween distal ends of extension portions designed to support the urethra or bladder neck can be of a total length between distal 6nds (e.g., self-fucating tips) to allow the combined length of extension portions and tissue support portion to extend fiom a rlgt obturator foramen to a left obturator foramen, e.g., from one obturator intemus muscle to the other obturator intemus

muscle. This length is shown at figure 3C as length L2 between self-fixating tips 182 (the length including the length of both of the self-fixating tips) of anterior extension portions of prolapse imptant 180, and at figure 3B as length L2 between self-fixating tips 172 of urethr sling 170. Useilii lengths of extension portions are as desired, and are exemplified elsewhere in the present description.
According to embodiments of implants and methods, a fixed-length implant or implant portion (e.g., as exemplified in all of figures 3A, 3B, and 3C), including no length-adjusting mechanism, can lie phused with desired positioning and effect (e.g.. supportive force, approximation, or both) on pelvic tissue, by selective placement of seif
and depth of insertion, can be separately selected to result in a desired position of the implant, tension on Ifae implant, approximation of pelvic tissue, or supportive force applied to pelvic tissue to be supported by the Implant.
With regard to placement of a self-fixating tip at an obturator foramm, tissue of obturator foramen, meaning the obturator Intemns muscle, the obturator membrBne, and £he obturator extemus muscle, may have a combined thioknesB In the range from about 1 to about 2 centimeters. An obturator intemus muscle may have a thickness in the range firom 0.5. to 1 centimeter. These are rough approximations and thicknesses will depend, e.g., on anatomy of a particular patient. A self-fiTcating tip as described herein may be installed at any location (point of insertion) wiQiin tissue spanning an area of obtumtor foramen, and at any depth of penetration into tissue of the obturator fbramen, e.g., obturator intemus muscle. The self-fbcathig tip may be passed into the obturatpr intemus muscle, optionally into or through the obturator membrane, and optionally into the obturator extemus muscle. It may be preierred to avoid penetration of the obturator membrane.
A selflxating tip may enter tissue at an angle that is perpendicular to the tissue, or at an angle that may be as much as 30 degrees, 45 degrees, or possibly more, fiom perpendicular. If the self-ftxating tip mters at an angle non-perpendicular to ftie tissue, the self-fixating tip mity elTectlvely extend through an amount of tissue that is greater tiian the thickness of the tissue measured at a perpendicular lengfli or depth.
The abliily to select point of inserdon and deptit of penetration of a self-fixating tip into a tissue is a feature of exemplary self-fixating tips and their methods of use, according to the invention, that allows a surgeon to select a location of an implant, to select an amount of tension placed on an installed implant, to place a desired amount of supportive fbrce on a suppoited pelvic tissue, or combinations of tiirae. With this ftature, embodiments of the ; invention may avoid the need for a separate lengtb-adjustmemt or tensioning mechanism, and onbodiments of implants according to the invention can optionally exclude any sort of

length-acyustment feature or tensiontcustment feature; these ftatures include the use of separate implant pieces Uiat can be secured t(t}ier as desired to select a ierigUi of an extension portion or length of an implant, the use of sutures to acust a length of an extension portion or implant, afustable mechanica) SbBteaen, or other cinching or
«
mechanical tneclianisms that allow a surgeon to increase or decrease a iengOi of an extension portion or implant either before, durbg, or after implantation.
An example of this advantageous fisature of the invention can be described with respect to placement of a uretiirel sling with self-fixating tips placed at oiosing obturator ibramen. White this example is in terms of selfflxating tips of a urethral sling placed at tissue of the obturator foitnnen, alternately, instead of a urethral slirig, the same method and advantage can be applied to implantation of other supportive bnplants such as an anterior portion of an implant to treat prolapse, to support the urethra or vanal tissue, or both, to treat a condition of Vaginal prolse, uredval incontinence, or combined vaginal prolapse and urinaty incontinence. As othn' alternate methods an extraision portion may be placed at a pelvic tissue other than the obturator foramen, such as at a different muscle, or at a ligament or tendon e.g., the arcus tendineus, sacrospinous ligament, uterosacral ligament, levator ani, etc.. A tendon or ligament may have a depth less than a depth of a muscle tissue, in which case a surgeon may still select a point of entry, if not a depth of penetration, to place an implant (e.g., of fixed lengfii) In a manner that can control location, tension, or supportive force, as stated.
According to fliis wcemplaiy advantageous technique, a physician (e.g., surgeon) is able place an implant between locations at opposite tissues of the obturator foramm to ■ position the implant to support the urethra, without the need fbr an a(ustment feature designed into the implant. The surgeon inserts a first self-fixating tip in tissue of one obturator foramen, preferably hi the obturator intranus muscle, at a desired position (i' point of entty relative to the total area of the obturator foramen) and a desired depth. The

obturator intsmus muscle has enough depth to allow the self-fixating tip to be piaced at a varied of depots within the thickness of the muscle. For example, the self-ftxating tip may be inserted to any depth at which the lateral extensions are able to resist movement back in a direction opposite of the direction of inserticm, such as by penetrating a selected depth into the obturator intemus muscle. The self-fixating tip mtr be inserted in a direction perpendicular to the muscle or at an angle (resulting in a greater efftotive depth witiiin whidi a self-fixating tip mi be penetrated). The second self-fixating tip located on the opposite extension portion of the implant can be inserted into tissue of the opposite obturator foramen preferably the obturator intemi» musol6» and the position or tension or both of the implant below the urethra, or the amount of support, approximation, or both, of the urethra provided by the sling» etc., can be selected, controlled, or adjusted by the depth and placement of the self-fixating tips witiiin the tissue of the opposite obturator fbramen. Because these exemplary embodiments of implants and their extension portions do not require either a length-adjusting or a tension-adjusting mechanism, these embodiments of implants of the invmtion can include a fixed ieng;th of implant material separatmg two opposing self-fixating tips. A "fbced" length of material can mean that the implant does not faiclude a Iengtti-«
The length of a urethral sling or «n anterior portion of an implant, between distal ends of extension portions, can be suflfioient to place opposing self-fixating tips at positions and depths of tissue of the obturator foramen, prefbrably without penetrating Out obturator membrane, with the implant reaching between the opposing obturator ibramen while supporting the urethra. Exemploiy lengths of an implant or implant portion for extension betow the urethra, between opposing obturator fbramen, from distal end to distal end of the extensions while laying fiat, can be in the range Irom about 6 to 15 centimeters, e.g., firom 7. to 10 centimeters or from S to 9 centimeteis or about 8.5 centimeters. (Lengths LI and L2 of figures 3B and 3C can be wiQiin these ranges.) The lengths are for male and female urethral slings, and are for anterior portions of implants for treating female prolapse or combined female prolapse and Incontinence, which include an anterior portion diat has a length between ends of anterior extensions portions within these same ranges.
A width of the extension portion-can be as desired, such as within the range from about 1 to 1.5 centimeters.
An extension portion of an implant of the invention can include a self-fbcating tip at an end of the extension portion tiiat is distial 1h)m a tissue support portion. The self-fixating tip in general can be a structure connected to a distal end of an extenirion portion and that can be implanted into tissue In a manner that will maintain the position of the self-fixating tip and the attached imptant Exempiaiy selfixating tips can also'be designed to engage an end of an insertion tool (e.g., elongate needle, elongate tube, etc.) ao the insertion tool can be used to push the self-fixating tip through tissue for implantation. The self-fixating tip may engage the insertion tool at an internal channel of Ae self-fbcating tip, at an external location such as at the base, or at a lateral extension, as desired.
A self-fixating tip can be made out of any usefbl matisnial, generally including i materials that can be molded or formed to a desired structure and connected to or attached to an end of an extension portion of an implant Usefbl materials can include plastics such as

polyethylene, polypropylene, and ofiier thennoplastic or thermofoimable materials, as well as metals, ceramios, and other types of biocompatible and optionally bioabsorbable or bioresorbable materials, Bxemplaiy bioabsorbable materials include, e.g., polyglycolic aoid CPGA), polylactide (PLA). copolymers of PQA and PLA,
A self- Factors tiiat can be balanced in designing a self-fixating tip as described include insertion force and pullout force, the insertion force being preferably reduced or minimized while a pullout force allows removal of the self-fixating tip only when desired by a surgeon during an implantation procedure. Concurrently, the self-fixating tip design can attempt to minimize the amount of potential trauma caused to tissue by inserting or, when necessary,
) removing, a selfixatmg tip. A desired combination of these foctors can be achieved liy selecting size, shape, and oOier structural features of the self-fixating tip and the elements of the self-fixating tip such as the base and lateral extensions.
Anotlier foctor tiiat can balance the above performance properties of a self-fixating tip con be the number of latmal extensions. A self-fixating tip can have from one to a large
5 number of lateral extensions, but it has been found that a self-fixating tip can fbnction well witii a small number of fixed lateral extensions suoh.a8 two or four lateral extensions. To

provide desired dimensions of a self-fljcating tip, such as reduced overall length, embodiments of self-fixating tips include lateral extensions located at liie same position along the longitudinal dimension (length) of the base between the pr(»cimal base end and the distal base end. A salf-fixatiiig tip tint includes exactly two lateral extensions, for example, can be located opposite of each other along a length of a base, to provide desired insertion and pullout fbrces, especially by Implanting the two Mteral extensions to be oriented in fibrous tissue wiA the direction of the lateral extensions being not parallel to the tissue fibers, for example being perpendicular to the fibers (or across the grain"). Also, a relatively low number of lateral extensions, such as two, can desirably reduce the amount of trauma when, as may become necessary at the discretion of a surgeon durbg implantation, a self-fixating tip must be withdrawn from tissue after placement
Another feature of a self-fixatbig tip according to the present invention can be sizes of the base, lateral extensions, or both, to allow the self-fixating tip to be inserted into tissue at a selected depth. As an example, a iateral extension that will be placed into muscle tissue can have a length dimension (measured along a longitudinal axis of the base) that allows the self-fixating tip to be insetted Into the tissue at any selected depth along the thickness of the tissue. This can mean that the length dimension of the lateral extension Is shorter than the total deptii of the muscle tissue.
A base of a self-fixating tip can be of any desired size, shape, aind dimonsion (e.g,, length, diameter, widtii). A diameter of a
be sufScient to allow placement of B dsBired numbw of,lat«Bl extensions around the perimeter of the base.
Exemplaiy self-fixating tips discussed lierein include a oylindrioal base or tapered cylindrical base, with a hollow or solid interior. Other shapes for a base may also be useftil. such as blodks having iBquare or rectangular forms when viewed in cross section along a longitudhial axis extending from a proximal base end to a distal base end. For those types of self-fixa(ting ttpSj dimensions of a square or rectangular cross section can be of a range similar to the diameter of a cylindrical base such as firom about 2 to about S millimeters in eifter dimension when viewed in cross section.
As an «caraple of a specific range of a length of a iself-fixating tiip, lengths (measured ftom the proximal base end to flie distal base end along a longitudinal axis of the self-fixating tip) in the range ftom 0.4 to 1.0 centimeter, e.g., fi-om 0.4 to O.B centimeters, or fifom 0.4 to 0.7 centimeters, iiave been fcnind to be usefiii. These ranges are speciflcaily -useful for self-fixating tips that can te inserted into muscle of the obturator intetnus, because the relatively short length can allow the self-fixating tip to be inserted Into the muscle tissue a desired depA, i.e., over a range of deptlis, optionally without penetrating the obturator membrane; the selfixating tip can be of a lengfii dimension that is less flian the thicicness of the muscle, sq the self-fixating tip can be inswted a desired distance into the muscle.
According to exemplaiy 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 of an implant. The base extends firom the proximal base end to the distal iNue end and can optionally faiclude an internal channel extending •Stom the proximal base f end at least partially alon a length of the base toward the distal base end. The optional Internal channel can be designed to biteract with (i.e., engage) 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. /
Alternate embodiments of self-fixating tips do not require and can exctude'an internal channel for engaging an insertion tool. These altnate embodiments m be solid, with no internal channel, and may engage an insertion tool, If desired, l any alternate forni of engagement, such as, for example, by use of an insertion tool ttiat contacts the self-fixating tip at an external location such as by grasping the base (on a side or at the face of the proximal base end) or by contacting a lateral extension.
Embodiments of self-flxating tips also include one w more lateral extension extending laterally (e.g., radially) ftwa the base, such as from a lopotion between the proximal end and the distal end, ftom a location a) the distal base end, or from a locati Bxemplary lBt««l extensions can be rigid or "Hxed" relative to the base so the lateral extension does not substantially move or deflect during or afier implantation. For example, a fixed lateral extenBi A lateral extension can have a threci-dimenslonal fonn that results in a balance of the performance fkctors discussed herein, including insertion force, puUout force, and

reduced trauma caused to tissae during insertion or in the event of a need to remove the self-
fixating tip during an imptantation procedure. A lateral extension can include a three-
dimensional form referred to as an extension body itofined as the lateral extension material
between a leading edge, a trailing edge, and a boundaiy at which the lateral extension
connects to a base; away firom the boundary of the lateral extension and the base, the far
lateral edge of a lateral extension may include a point of connection of the trailing edge and
the leading edge, or another segment or connection may connect the leading edgp with the
trailing edge away jHrom their respective connections to the base. The "leading edge means
the boundaiy of dte lateral extension on the side of the lateral extension toward the base
distal end, whidi is also the edge that leads the lateral extension body and contacts tissue first as the self-fixating tip is inserted into tissue by pudiing. The "trailing edge' tpeans the boundaiy of the lateral extension on the aide of the lateral extension toward the base proximal ea.6, which is also the edge that trails behind the lateral nctension body and passes through or contacts tissue last when the self-fixating tip is inserted into tissue by pushing. The lateral extension body can exhibit a thickness or diicloiess profile as desired, such as a uniibrm thickness or a varied thickness across the octended area of the body. For example, embodiments of implants may include a leading edge of a low profile, e.g., reduced thickness or even sharpened, to allow for reduced insertion force. According to these embodiments, Ais thickness of the lateral extension h6dy can reduce gradually or taper
I fhim a central portion of the body (away from edges) in the direction of a leading edge. A leading edge, being of a reduced thickness to reduce insertion fbrce, may optionally in addition exhibit a forni that extends in a direction back toward the trailing edge, i.e., a 'swept-back" leading edge, to further reduce insertion force. The shape of the leading edge may be linear or arcuate, and if arcuate Toey be convex or concave. Optionally the leading
» edge may take an arcuate convex padi that sweeps back to meet the trailing edge at a single

lateral extension point away ftom the base. E.£., see the exemplary self-fixating tip illustrated at figure 1.
The direction and shape of the trailing edge of a lateral extension, as the edge extends away from the base (e.g., when viewed as in figure 1), may be linear or arcuate, and if arcuate may be convex or concave relative to the lateral extension body. A trailing edge can be as desired, such as arouatCj straight, convex, flat linear, rounded, tapered, sharp, blunt, etc. Optionally a trailing edge can exhibit a thickness (a thictoness dimensifm is illustrated, e.g,, at figure 2) to produce increased puttout fbrce, yet that does not result in undue trauma in the event that a self-fixating tip must be removed from tissue after insertion.
Viewing the trailing edge along the longitudinal axis of the ttase and looking at the proximal base end (as in figure 2), a trailing edge can exhibit an area tihat Includes a width (w, tite distance the trailing edge extends laterally awiE from the base) and a thickness (t, the distance perpendicular to the widdi and the longitudinal axis of the self-fixating tip). An exemplary width (w, in figure 2) of the trailing edge can be, e.g., in the range from 0.5 to 3 millimeters.
An exemplaty thickness at a trailing edge nuQr be the same as a thickness at an interior or central portion of the lateral extension (away from &e leading and trailing edgesX or a thickness at a trailing edge may be a maximum thickness of tite entire lateral extension, meaning fbr example that the thickness increases from a narrow thickness at the leading edge and widens gradually to a maximum thickness at the trailbtg edge A thickness of a trailing edge can be, e.g., in the range from 02 to 2 millimeters, e.g., from 0.5 to' 1.S millimeters.
Based on the above-recited exemplary thickness and width dimensions, a surface area of a trailing edge may be, e.g., ttom the range from 0.25 to 5 square milllmeten, e.g., iivm 0.S to 4, or fhnn 1 to 3 square milllmeten. The surface area of ifae trailing edge may

be concave, convex, rounded, tapered (symmetrically or toward one or the other surikces of the lateral extension), etc. A flat surflkoe may be preforred, to provide increased or maximum puUout force Ibr preventing removal of the self-fixating tip after implantation.
A lateral extension can also include a third dimension tiiat can be refbrred to as a "length" dimension (shown as "L" at figure 1). A length can be measured at a location where the lateral extension meets or extends flrom the base. This length dimension can become smaller as the lateral extension extends ttcm the base. An exemplaiy length of a lateral extension at the location of the lateral extension meeting the base can be, e.g., from 0.5 to 5 millimeters, sued) as from 1 to 4 millimeters or from 1.S to 3.5 millimeters.
In the specific example of a self-flxathig tip for insertion to tissue of the obturator foramen, an exemplary length of a lateral exteatslon can be a length diat is less than the total diickness of obturator Ibramen tissue 0e the combined thickness of obturator intemus muscle, obturator membrane, and obturator extemus muscle); a length of a lateral extension intended to be inserted into the obturator intemus muscle can be a length that is a portion of the diickness of the obturator intemus, e.g., less than 1 centimeter, such as less than 0.S centimeter.
As noted, a setf-fixating tip can include multiple lateral extensions at multiple locations, either at difibrent positions along a length of a base, at difbrsnt locations around • a perimeter of a base, or both. With self-fixating tips of reduced dimensions (to achieve functionality as described), a self-fixating tip may prefbrably include all lateral extensions originating ttom tite same position along a length of a base, e.g., a single set of lateral extensions can be arrenged around a perim»r of a base, each extending in a different direction but from the same portion of lengdv between the proximal base end and the distal base end. See, e.g., figures 1.3A, 3B, 3C, 4, and S.
A self-fixating tip can be connected to an extension portion of an implant in any frtthlon, diieotfy by any attachment mechanism, or indirectly such as through an attachment

strocture such as a suture. A connection can be based on a meohanical structure, by adhesive, by a connecting suture, or by an integral connection such as by injection molding or "insert" molding (also, ov(Rmolding as described U.S. Publication No. 2006-0260618-At, incorporated herein 1 reference. According to that description a fiiennoplastic or thermosetting polymer material can be insert molded or iiyection molded at an end of a mesh extension portion'of an implant e.g., directly to the mesh. By this method, a molded polymer can fbrm a self-fixating tip at an end of an extension portion. The self fixating tip can be as described herem, fbr example, including lateral extensions and an internal channel.
. A single example of a self-fixating tip, for puiposes of non-limiting illustration and explanation, is at figure 1. Figure I shows self-fixatlngtip 10, induduig base 12 (for attachment to an implant extension end), proximal base end 14, distal base end 16, ivltsmal channel 18, and two lateral extensions 20 located on outer surfiKs and on opposite sides of base 12. Tip 10 can be prepared fixnf a biocompatible material, prefbrably a biocompatible material such as a biocompatible polymer, whi may optionally be bioresorbable or bioabsorbable. Exemplaiy self-ftxatingtip 10 as illustrated includes internal channel 18 (optional according to the invention) which Is an opening within base 12 extending fitom proximal end 14 toward distal end 16 along at least a portion of &e total longitudinal lengtti of base 12. Internal channel 18 is capable of receiving a distal end of an elongate needle of an insertion tool to allow tip 10 to be pushed into position wldiin pelvic tissue during an implant installation procedure. Lateral extensions 20 include leading edge 24 and trailing edge 26. Leading edge 24 orinates at base 12 and extends «wtv fixm base 12 along an arcuate pathway sweeping back toward proximal base end 14, meeting trailing edge 26 at point 28. Leading edge 24 can pirefbrably include a reduced thlclmess or a shaip or sharpened edge. TJrailing edge 26 is shown to be relatively strait but could alternately be arcuate, concave, or crnivex. Trailing edge 26 has a flat surface area. Trailing edge 26 is

also shown to sweep slitty back in a proximal direction, although it could alternately extend straight away teotn (iA. perpendicular to) base 12 or extend away fiom base 12 in a direction that includes a fbnvard component, i.e., a directional component in the direction of distal base end 16.
Referring now to figure 2, self-fixating tip 10 is viewed in a direction looking at imudmal base end (surfe) 14 along a longitudinal axis of base 12. In this view, surfoce areas of lateral extensions 20 are shown as flat surfaces of api»x»cimate1y the area of thickness (t) by width (w. Also visible in figure 2 is interior surface 22 of internal diannel 18 of base 12. Surfhce 22 fiinctions to orient self-fixating tip 10 in a desired rotational orientation retative to a distal end of a needle of an insertion tool; the distal end of the needle can be provided with a flat surface that is complementary to surface 22. As will \se appreciated, sorfe 22 does not need to be a flat surilue but could be any other type of surfece or protrusion such as a rounded surlbce, angled surface, key structure, edge, or other feature that can orient a self-fixating tip rotationally relative to a distal end of an insertion needle.
An insertion tool can be used to install the implant Various types of insertion tools
are known, and these types of tools and modifications thereof can be used according to this
description to .install an implant. Examples of useful tools include those types of tools that
generally includes a thin elongate needle that attaches to a handle; a handle attached to one
end (a proximal end) of the needle; and a distal end of flie needle adapted to engage a self-
fixating tip that allows the needle to push the self-fixating through a tissue passage and
insert liie self-fixating tip within tissue of the pelvic region. This class of tool can be used
with a self-fixatJngtip ttiat hicludes an internal channel designed to be engaged by a distal
end of an insertion tool. OQier general types of insertion tools will also be usefiil, but may
rngfigfi a self-fixating tip in a manner that does not involve an intmnal channel of a self-
fixating tip. These al — —'

base end of a self-fixating tip In tlie absrace of an internal cliannel extending fixm the proximal base end toward the distal base end, sach as by grasping an external surlce of tlie base. An alternate insertion tool may contact or grasp a side of the base, a lateral extension, Exemplaty insertion tools for treatment of incontinence and vaginal prolapse are described, e.g., in United States patent application serial numbers 10/834,943,10/306,179; 11/347,553; 11/398,368; 10/840.646; PCT application number 2006/028828; and PCT application number 2006/0260618; among others. Tools described in those patent documents are designed for placement of an implant in a pelvic region fbr the treatment of prolapse, male or fbmale incontinence, etc. The tools of the above-refbuenced patent documents may be curved in two or tiwee dtanensions, and may include, fbr example, a helical portion in three dimensions for placing an tension portion of en implant through a tissue path tiut passes from a region of the urethra, throu an obturator foramen, to an external incision in the groin or inner thigih area. Other described hisertion tools include a two-dimensional elcmgate needle that allows a user to place an extension portion of an implant through an external incision in the perirectel or coccyx region of the lower back and buttoclc area.
Bxemplaiy insertion tools ibr use according to the invention can be similar to or can include features of took described in the above-referenced patent documents. For use according to methods described herein, those insertion tools nwy be modified to allow the insertion tool to be used to placet a self-fixating tip at tissue wittiin the pelvic region tiirough . a tissue path that does not extend to an extnnal incision, The insertion tool can be designed, shaped, and sized, to include an elongate inserter or needle that may be straight or tiiat may, " be curved in two or three dimensions, tiiat can be inserted through a vaginal incision (fbr

female anatomy) or through a perineal incision (for male anatomy), and to extend from tiiiat incision to a pelvic tissue location for placement of a self-fixating tlpi
Some previous insertion tools are designed to reach through a vaginal or perineal incision, through an internal tissue path and to .then extend through a second external incision, e.g., at the huier groin, thijgh, abdominal area, or perirectal region. As ojosed to those types of insertion tools, exemplary insertion tools for use according to fflnbodiments of presently described meUiods con be sized and shaped to place a self-fixating tip at an internal location of the pelvic region, and do not need to be sufficiently long to extend from a vaginal or perirectal incision to an external incision. The length can be only sufficient to reach from a vaginal or perirectal incision to an obturator foramen, for example. Alternately, the length may be only sufficient to reach from a vaginal or pireotal incision to a different muscle or tissue, such as a levator anl, eocgeous muscle, iliococcygeous muscle, arcus tendinous, saerospinous ligamntt, etc., to place a self-fixating tip at one of those tissues.
According to prefbrred methods of the invention, a self-fixating tip may be placed into pelvic tissue that is a fibrous tissue such la musde ligament, or tendon, with specific examples including the arcus tendineus, the obturator intemus muscle, the levator ani, and the saerospinous ligament. Preferably, an elongate portion (e.g., elongate inserter, elongate needle etc.) of an insertion tool can include an engagement sur&ce for contacting a self-ilxating tip, the'engagement surface being fai the Ibim of any one of an internal diannel or an external surftioe, channel, extension, or otiter structure, A complementaiy surflice of a self-flxsting tip (ititemally or at an exterior surface such but not necessarily the base), can be designed to place tip at an orientation so that lateral extensions of a self-fixating tip (Le., the extended or "widOi" direction of lateral extsitsions) are implanted within the fibrous tissue at an orientation that places the lateml extensions in a direcdon ttiat is non-parallel to the fibms of the fibrous tissue, e.g., that is at an angle of at least 45 degrees to the dhection of

the fibers such as at an angle in the range fircsn SO to 130 degrees, or fVom 60 to 120 degrees or ihim 70 to 110 degrees, preferably perpendicular to the fibers. In certain embodiments of Ihe methods and devices of the invttition, placing lateral extensions in such a non-parallel orientation can increase pullout force. In these embodiments, exemplaiy self-fixating tips can include only two lateral extensions located on opposite sides of a base.
.As a specific example of the above concept of designing an insertion tool and self-fixating tip to place lateral extensions at a non-parallel orientation to fibrous tissue, this can be done for a urethral sling implant that will include a self-fixating tip placed at the obturator foramen, e.g., wtUiin 0\e obturator intemus muscle. Using a female anatomy as an example, an insertion tool and self-fixating tip can be designed to orient two lateral «ctensions of a self-fixating tip at an angle perpendicular to fibers of the obturator intemus muscle when the needle and tip are inserted trough a transvaginal incision and a tissue path leading to the obturator Intemus muscle. Based on ttiat tissue padi, and the direction of fibers of the obturator intemus muscle, it has been fbund that an insertion tool that includes a curve (in two dimensions) tiiat allows the distal end to be located at the obturator interoua muscle when the needle is inserted through a vaginal incision and that orients lateral extensions relatively perpendicular to (e.g., at an angle in the range finom 75 to 105 degrees, such as from 80 to 100 degrees) a plane defined ty the curve, will also cause the lateral extensions to enter Aie obturator Intemus muscle at an orientation that is substantially perpmdicular to the fibers of the muscle.
Orientatt
surffaoe of a self-fixatiDg tip such as a surfluse of the base on the proximal baae end, on the outer sur&ce of the bass, or a lateral extension, may provide the desired orientation. The surfaces can be complementary, and may include flat, curved, circular sem{circutar, rounded, "keyed," or o&erwise opposing sur&oes that allow a surfiuse of sellMlxating lip to provide desired engagement with the insertion tool. According to certain embodiments, an internal channel of a self-fixattng tip can fit over a length of a distal end of a needle of an insntion tool with a single or alternate fi x«d radial orientations relative to an axis of an insertion too).'
Thus, an example of a combination of insertion tool and self-fixating tip'according to tiiis description can include tn elongate curved needle, hollow tube, or othor "elongate inserter,' curved in two dlmenaions, and a self-fixating tip; the distal end of the needle, tube, or inserter, and fbe self-fixating tip, include comptementaiy engaging surfaces that can cause tile self-fixating tip to be oriented at the distal end of the needle, tube, or inserter so that latwal extensions are oriented to be peipendicular (90 degrees, or more broadly, at an angle in the range iirom 80 to 100 degrees) to a plane defined by the two-dimensional curve.
The elongate inserter (e.g Implants as described can be usefUl for treating male and female conditions of the pelvic area. Examples of specific pelvic floor disordns are fecal and urinaiy incontinence such as.stress urinaiy incontinencd (SUI) in bofii men and women, and prolapse conditions ' In wofften. The implant can be designed for a specific application with a sl29e, shape, and number of extension portions designed to support a specific type of pelvic tissue.

According to an aspect of the invention, an implant can include one or multiple self-fixating tips at one or multiple ends of extension portions and an implantation method oan include placing the self-fixating tip or tips within tissue in the pelvic reon to support the implant as the implant supports a e of pelvic tissue. The tissue can be a fibrous tissue audi as a muscle (e.g., of the obturator foremen, obturator internus, obturator extemus, levator ani, cooigeous, iliococgeous), ligament (e.g., aacrospinoua ligament), tendon (arcus tendinous), etc.. Also preferably, but not as a reqpuirement of fhe invention, a self-fixating tip can be oriented in a fibrous tissue to cause a mor dimension (referred to herein as the widdi) of a lateral extension to be oriented in a direction that is not parallel to the direction of the fibers.
To control the placement and degree of support of the implant relative to a tissue to be supported by the implant, fhe self-fixating tip can be inserted at a desired point of entiy relative to the total area of tite tissue, and, Ibr tissues of sufRdlent thickness or depth, the self-fixating tip can be insetted to a selected depth.
A single example of a method according to the Invention is a method of treating urinary incontinence by surgical implantation of a urediral sling (e.g., a singly integral, optionally uniform, woven polymeric mesh strip, with two self-fixating tips, one on each end) through a vaginal (for female anatomy) or perineal (ibr male anatomy) incision, along a tissue path tiiat extends ihm a region of the urethra to the obturator foramen. These methods c advantageously involve only a single incision (a vaginal incision in a fbmale or a perineal incision in a male) and can exclude the need fbr any additional incision. An elongate urethral sling is attached at tissue of the opposing obturator foramen by self-fixating tips at opposing distal ends of the utvthral slii widi the sling positioned to pass below the urethra to support the unva.
An exemplary metiiod of installing a male urethral sling can include a step of preating a perineal (e.g., medial) incision at the external male perineum and creating

opposing tissue paths from the medial incision, below the urethra to the patient's left and
right obturator foramen, and installing a urernt sling that includes extension portions with
self-fixating tips for placement at tissue of the obturator foramen, e.g., the obturator intemus
muscle. Preferably, the 8Blfxatlng tip can include lateral extensions (e.g., two, of the same
size and shape and form, extending in opposite directions irom opposite sides of the base).
Whoi installed, lateral extensions can be oriented in a direction that is non-parallel to, e.g.,
substantially perpendicular to, fibers of the obturator intemus muscle. The urethral sling
may be placed using one or more insertion tools as described, by installing extension
portions of the sling between the incision and the obturator fbramen, with tihie middle
(support) portion of the sling positioned below the urethra. The extension portions may be
pushed through the tissue path at the lead of an insertion tool that engages the self-fixating
tip and maintains the self-fixating tip in an orientation to enter the obturator intemus muscle
with lateral extensicHis non-paiallel to the muscle fibers. The fixed oriratation Is
maintained, and rotation is presented, also, during insertion and passage through tissue. The
tissue support portion (central portion) of the urethral sling may be placed as desired to
support the ureUua, optionally with approximation, compression, or a combination of
approximation and compression. A4justment of the implant pan be performed based on flie
location (point of entiy) and depfli of insertion of the self-fixating tips at tissue of fte
opposing obturator foramen. The slit may be placed below the bulbospongiosus muscle or
below the corpus spongiosum, as desned, The sting may optionally include a widened
central support portion tiiat is placed t» contact the eoipus spongiosum, and the support
portion and sling are used to approximate the urethra to improve continence, e.g., without
the need fir compression of the uretiua. See, e.g., United States patent application serial
numbers 11/347,553 ud 11/347,047. /
An embodimeat of a kit according to the invention, including an insertion tool and an Implant, is shown at figure 3A. bicontinence slbg 100 can beinstalled to help maintain

continence by supporting the urothra during times of increased abdominal pressure. The present invention also includes methods of implanting Iho sling 100. Sling 100 can be implanted through a single incision in the vaginal Avail for females, or perineal floor for males, and attached to Referring to figure 3A, sling 100 may include a first anchor (i.e., "self-fixatmg tip") 120, a second andior 122, a first anchoring arm 124, a second anchoring ann 126, and a Sling body ('central support poition" or "tissue support portion" 128). As illustrated, sling body 128 msy be suspended between first anchoring arm 124 and second anchoring arm 126 and may be operably attached to a first end of each 124A, I26A. Second end 124B, 126B of each anchoring arm 124,126 is attached to corresponding anchor 120,122. The overall dimensions of the sling 100 may be 6-15 cm in length, in flie range from 6 to 10,8 to 10,10 to IS, 10 to 12, or 12to IS centimeters in length, and \-2 cm, morepreforably 1-I.S cm. In width (at the arms). The total length dimension between anchors should be at least sufficient to extend fiom an obturator intemus muscle on one side of the urethra and into an obturator intemus muscle on the cosite side of flie urethra. Self-fixating tips 120 and 122

include a base, optional internal channel (not shown), and four lateral extensions, and the design is to allow self-fixating tips 120 and 122 to be implanted securely within tissue of the obturator ibramen.
Figure 3 A includes a perspective view of one implant embodiment of the present invention, and the invention is not limited to the piartioular embodiment shown. It is • understood that a large number of diffiarent sizes, shapes, and dimensions of implant (e.g., slings) will be suitable according to different embodiments of metiiods and bnplants described herein. In one embodiment the sling body 128 and anchoring arms 124,126 ere all substantially one piece (i., "integrated") and may be of unifonn width and thickness. In such an embodiment the sling may appear as one continuous ribbon or tape. In further emnbodiments, sling 110 may be an assembly of two or more pieces, e.g., different pieces of mesh or combinations of mesh and a biologic material.
Sltng body 128 may be mado by being woven, knitted, sprayed, or punched from a blank. In ono aspect of the invention, sling body 128 may include one or more woven, knitted, or inter-linked filaments or fibors that form multiple fiber junctions. The flber junctions may be ibrmed via weavingi knitting, braiding, or through other techniques, including combinations thereof. In addition, the size of the resultant openings or pores of the mesh may be sufficient to allow tissue in-growth and fixation within surrounding tissue.
The material used to make the sling body 128, anms 124 and 126, and anchors 120 and 122, may include a varied of different plastics or other materials that are strong but conducive to being used in the body, such as, but not limited to, polypropylene, cellulose, polyvinyl, silicone, polytetrafluoroethylene, polygalactin. Silastic, carbon-fiber, polyediylene, nylon, polyester (e.g. dacron) PLLA, acetols, EPTFB and PGA. Sling body 128, arms 124 and 126. and anchors 120 and 122, each may independently be any of resorbable, absorbable or non-absorbabie; optionally, some portions may be absorbable and other portions may be non-absorbable. In further embodiments the material used to make

the sling body 128 may include a non-synthetic material or a synthetic and non-synthetic blend of materials. In addition, it taay be preferable tint the sling body 128 be relatively elastic. In other embodiments the sling may be relatively inelastic.
Some example of commercially available materials may include MarlM . (potyptopylene) available from Bard of Covington, RI, Prolene' polypropylene) and Mersilene (polyethylene terephfhalate) Hemia Mesh available from Bthicon, of New Jersey, Gore-TeX™ (eqpanded polytetrafluoroediyiene) available ftom W. L. Oore and associates Phoenix, Arizona, and the polypropylene sling available hi the SPARC" sling system, available flrom American Medical Systems, Inc. of Minnetonka, Minnesota. Commercial examples of absorbable materials include Dexon™ Oaolygiycolic acid) available ftom Davis and Oeck of Danbury, Conneoticut, and Vieiyl'" available firom Bthicon.
First and second arms 124,126 may likewise be made by weaving, knitting at in toy of the other ways previously discussed in refteence to sling body 128. First and second arras 124,125 may be made of the same or different materia! as sling body 128 and may include the same or different physical characteristics, such as, for example, reabsoibabllity. In one embodiment, first and second anchoring arms 124,126 may be a weave Oiat results in a stronger or densw material than the'wenwe used to make Uie sling body 128 so as to support more weight over a given surface area. In one embodiment the arms 124,126 may not be woven. In fiulher tanbodiments, sting body 128 and the ftest and second arms 124, 126 may be made of one continuous weave structure of the same or different weave densities.
Figures 3B and 3C illustrate alternate embodiments of implants of the invention. Figure 3B shows urethral sling (mesh strip) 17Q for supporting a male or fale urethm by placement of self-fixating tips 172 at tissue of the obturator foramen. Length LI can be, e.g., about 8.5 centimeters. Figure 3C illustrates implant 180 fbr treating vaginal prolapse. Self'fixating tips 182 are at ends of anterior extension portions 183» which are each

connected at their opposite ends to an anterior portion of tissue support portion 184. Posterior or central extension portions 185 are connected at one end to central portion of support portion 184, and include self-fixating tips 186 at the opposite ends. Self-fixating tips 186 may be placed at tissue of the central or posterior pelvic region such as a muscle, i tendon, or ligament, B.g., a muscle of the obturator foramen, levator ani, coccygeous, iljoeoccgeous; sacrospinous ligament; arcus tendinous. As illustrated, central portion 184 can be a biologic material but could alternately be a mesh or other syntilietic material. Extension portions 183 and 185 are illustrated to be of synthetic mesh.
As illustrated in figure 3A, first and second anchors 120,122 of an implant can be substantially identical, and, as illustrated, can be described with refbrence to anchor 120. Anchors 120,122 may also be known as anchor members, fixation members, self-fixatdng tips, oriiuteners. In one embodiment, referring also to figures 4 and S, anchor 120 may include a body (or "base") 130 with a first (distal) end 132 and a second (proximal) end 134. A number of fixation brings (or "lateral extensions") 136 may be attached to body 130 at some point or along a length between first end 132 and second end 134. In the embodiment illustrated, anchor 120 includes fbur fixation wings 136 spaced evenly about a perimeter of bocfy 130. In alternate embodiments, anchor 120 may include a greater or lesser number of fixation wings 136, positioned in any desired pattern around the body 130. Fixation wings 136 may also be referred to as or may include barbs, extensions, fls, tines, spikes, teeth, or pins.
Fixation wings 136 may be as described elsewhere in the present description, and may accoiding to certain embodiments be in the form of relatively thin (a thickness in the range of mtlllmeten or less) wing-lypo structures that extend generally peipendicularly fam the surfiKse of body 130. Fixation wings 136 may extend away from body 130 to fonn a smoothly angled surfiice 138. Surftoe (or "edge) 138 may extend fiurfher fhm body 130 when traveling fom first end 132 toward second end 134 in a continuous or other angular.

curved, arcuate, concave, convex, or other pattern. The form of surfoce (or "edge") 138 can be one that allows Ibr anchor 120 to be implanted through tissue in an implantation direction with reduced or minimal damage to the tissue, and reduced or minimal insertion force. Fixation wings 136 may furflier include tip 140. Tip 140 miry be a barbed-litce structure at the tail end of sloping surftce 138. Tip 140 may allow fbr anchor 120 to resist being withdrawn ftom a desired andtoring position. Tip 140 may forni a pointed tip 140 or may form a more rounded tip. In either case, tip 140 provides anchor 120 wiA a structure dtat helps to bind anchor 120 in a desired position in a pelvic tissue. As will be fbrther discussed, anchors such as andiors 120,122 are dedgned ibr anchoring an implant to tissue rather than bone.
In alternate embodiments, fixatJon wing 136 may take other forms such as a barb, spike, (optionally fixed) etc., that can effectuate the implantation of anchors 120,122 in the desired location. In addition, body 130 of anchor 120 may include barbs and spikes hi addition to the fixation wing 136. Fixation wings 136 of figures 4 and S are fixed, meaning not substantiatly moveable between different positions. Alternate embodiments of self-fixating tips (e.g., "anchors'), such as anchors 120, taay include fixation wings (or "lateral extensions") 136 that are moveable, e.g., ftat are nctended or depleted to an extended position from body 130 after anchor 120 is in the desired position, or that will otherwise move or deflect during or after inserdon into tissue.
Embodiments of implants such as a sling 100 may further include a protective sleeve 150, as shown in figure 3A. Sleeve 150 may be a protective sheath that is placed over sling 100 or an extension portion (126) befbre implantation, to assist with-implantation. Some slings 100 may \» sufficiently robust to be inseitsd without a protective sleeve 150. However, in those situations wherein sling 100 requires additional structural integrity, or includes structural characteristics that may damige the tissue of the patient during passage therethrough, sleeve 150 may provide support for the implant protection Ibr the tissue, or

both. Sleeve 150 covering mesh of sling 100 may be designed to minimize risk of contamination and to reduce abrasive "slidinn' of sling 100 through tissue of a patient. Sleeve ISO may be particularly desirable when sling 100 is elastic, as sleeve 150 assists in introducii sling 100 within tissue and avoids damage to material of sling 100. After sling 100 is inlanted, sleeve I SO is removed and discarded.
Preferaibly, protective sleeve 1 SO is constructed of a material that allows for visual examination of sling 100 and that affords convenient passage of sling 100 throrugh tissue of the patient. In a prefeiTBd embodiment, sleeve ISO is made of polyetiiiylene. Other materials including, widiout limitation, polyproilene nylon, polyester, or Teflon may also be used to construct sleeve ISO. Sleeve 1 SO should also conveniently separate ftotn sling 100 after sling 100 is fanplanted, without materially changing the position or shape of slhig
loo!
In one embodiment, sleeve ISO may comprise two elongate, separable seoflons, that substantially fbrm one continuous covering over anchor aims 124,126 and optionally body 128 and andiors 120,122. Optionally, portions of two sleeves 150 on opposite arms may detachably and telescopioally overlap near the middle portion of the sling. Optionally, sleeve 150 may be slit or perfOTated or ofiierwise toeakable (e.g. lontudinally or p«pendicular to the lonjtudinal axis) to afford convenient separation of the separable secdons into siEwrated pieces that can be removed tma a patioit after Implantation of an
«
anchor.
Optionally, according to various implant embodiments, a material that finins any portion of a sling 100 may include one or more substances incorporated into the material or coated onto the material of the sling. Bxamples of substances may include, witiiout limitation, drugs, hcmnones, antibiotics, antimicrobial substfinoes, dyes, silicone elastomers, I polyurethanes, radiopaque filaments or substances, position or length indicators, anti¬bacterial substances, chemicals or sgents, including any combinations thereof. A substance

or material may be used to enhance treatment efifeets, reduce potential sling rejection 1 the body, reduce the chances of tissue erosion, allow or enhance visualization or location monitoring, indicate proper sling orientation, resist inftction, In one embodiment of a method of tfie invention, an implant such as sling 100 (or an anterior portion of anotlier type of implant, e.g., to treat jxrolapse or a ocmtbination of prolapse and incontinence) may be introduced using en 'inside-ouf approadi to place the implant below the urefiira with ends at tissue of the two opposite olsturator fbramofi, through an incision at the vagina or perineum. The precise, final location of an implant (e.g.» sling . 100) will depend on a variety of Actors including the particular surgical procedure performed, and any preconditions of the patient such as soar tissue or previous surgeries. For example, it may be prefbrred to place an implant such as sling 100 in close pr(»cimity to, but not in contact with, a mid portion of the otedira to treat incontinence. Alternately, an implant such as sling 100 may be placed near the bladder neck. The present invention is particularly suitabie fbr placing a sling 100 or an anterior portion of a larger implant tiiat may also treat prolapse, in a titerapeutically efiictive position fbr treating any one or a ■ combination of pelvic conditions.
For a typical procedure fiv treating any pelvic condition, a patient may be first placed under local, spinal, or general anesthesia. According to exemplaiy metiiods of treathig a fbmale condition of incontinence Ce.g., a small, medial, transvaginal indslon foe treating fbmale urinaty incontinence) is made in the upper wall of the vagina under the mld-urettira. For implantation of a sling 100 to treat incontinence in a male, a perineal incision may be made instead. The incision should be lange enou for the smgeon to place sling 100 through the incision using selected instruments. A desbvd amount of tisaue m«y optionally be dissected on each side, fbr placement of sling 100. In one embodiment the tissue may be dissected approximately I -2 centimeters in each direction awi fkom the

urethra and tfward opposing locations for anchors (or "self-fixating tips") 120 (e.g., at tissue of the obturator foramen). The dissection of tissue may be as much or as Itthe as desired, including none. The first anchor 120 is then placed through the incision and directed toward tbe.desired anchoring position (e, tissue of the obturator fisramen).
As previously discussed, a sling 100 or a portion of an implant may be positioned inside a sleeve 150 before the implant is inserted through the incision. In alternate embodiments, sleeve ISO may not be used or necessaiy, depwiding on surgeon preference. In one embodiment sleeve 150 or a deliveiy tool can cover the woven portion but not anchors 12( 122, during implantation. In o&er embodiments sleeve 150 or a detivery tool may also cover anchors 120,122. As described herein, embodiments of the'invention can Involve the use of various types of delivery tools to prevent an extenslcm portion of an implant from contacting tissue of a tissue path during insertion of the extension portion through a tissue path.
In an exemplary embodiment, anchor 120 can be placed through the incision and into tiasiie of the obturator foramen (e.g., the obturator intemus muscle, the obturator membrane, or the obturator external muscle). Anchor 120 may be driven to tiia desired position by the surgieon's finger or by using an insertion toot such as introducnr 160.
Introducer 160 (see figure 3 A) may be any type of insertion tool Aat can engage anchor 120 to drive anchor 120 through and into pelvic tissue of a desii«d location. Such an
I introducer 160 may include a durable biocompatible, curved or straig|it needle portion 162, made, e.g., of stainless steel, titanium, Nitinol, polymers, plastics, or other individual or combinations of materials. Hatulle 161 is attached at a proximal end of needle portion 162, and distal and 164 of needle portion 162 is designed to engage self-fixating tips 120 and 122, e.g., by being sized and shaped to fit within m interior i Introducer 160 should have sufficient structural integrity to position anchor 120 as desired. Introducer 160 may mate with or engage anchor 120 by any manner, including fitting within

an internal channel of a bodfy or base of anchor 120, alternately on an external portito of a body or base of an anchor 120, or by interacting with fixation wings 136. Anchor 120,122 may be situated inside or outside of sleevci ISO and introducer 160,
Once a ifirst anchor 120 is placed into a desired position, a second anchor 122 may be inserted through the same incision and placed in a desired position on an opposite side of the patient As widi the first anchor 120, the second andlior 122 may be positioned witih or without the assistance of an introducer 160 and may be placed, e.g., into tissue of the obturator foramen (obturator intexnus muscle, obturator membrane, obturator nctemus muscle). Sling body 128 may be properly oriented into the desired position In relation to the uredira. It raay be desirable to ensure liiat the sling 100 is not twisted during implantation. Positioning of implant 100 can be accomplished 1 selecting the point of entiy and depth of each anchor 120,122.
Figure 6 Illustrates an example of a therapeutically effective position for a urtherai sling audi as Implant 100 (or, alternately, an anterior portion of an implant for treating prolapse such as implant 180 illustrsted in figure 3C). Other positions of an implant or sling are also contemplated herein, such as positions tot treating prolapse, which could alternately or additionally place extension portions and self-flxatingtips tiirough relatively more posterior tissue patiis leading to posterior tissue of the pelvic region for placement of the self-fixflting tips. The precise anatomical position of an implant can depend on a variety of fyfUon Including the typt and degree of anatomical damage, location of stgnifloant scar tissue, and whether the jnvcedure is combined with other procedures. Typically, an implant sudi as a urethral sling (e.g., sling 100) etm be placed mid-urethra, without tension, but in position to support the mid-urethra. Alternately, the sling could be placed to ewpport the bladder neck and/brUV Junction. Implants for use to treat prolapse can be positioned at the middle or posterior vagina, or vaginal vault, bnplants for treating fecal incontinence can be

placed in the posterior portion of the pelvic region to support tissue fbr treating fecal Incontinence.
Sling tmision may be austed by a tension member sucli as a tensioning suture disclosed for wcample, in U.S. Published Patent 6,652,450. The tensioning suture may be constructed from a permanetnt or abBorbable (i.e., bioresorbable or bioabsorbable) material. In still ftirther embodiments, an implant such as sling 100 can be introduced witi) a desired amount of tension in a number of different ways, such as those discussed elsewhere in the present dcBcription tiiat involve selected positioning of self-fixating tips.
A sleeve, 150, if present, may be removed after implantation of an impl«it such as . sling 100 and before the atustment of tension by a tenoAoa member such as a tensioning ' suture. Once Ihe implant is positionied and optionalV tensioned or ajustedt the incision may l}& closed.
Another embodiment of the present invention may include a Icit that includes an implant (eg., a sling such as sling 100, or any othra- implant as discussed hereinX optionally including a sleeve 1 SO, and an insertion tool siich as introducer 160. (See figure 3.) The sling 100 may or may not include bioabaorable portions or portions that induce tissue in-growtli. The kit may include one or more insertion tools, which can include any features of insertion tools of the present description, and optionally and preferably can be designed to engage self-fixating tips of an implant
As iitustFBted in figure 7, another embodinMnt of an implant according to the invention, implant 40, comprising mesh 41, can include anchors 42 in the finrm of anchoring fins (or "lateral CKtensions") that extend directly from locations toward the end of mesh 41. Placing fins 42 directly to mesh eliminates a discrete andior base or anchor body while still increasing the anchoring Ibroe (pullout fbrce) of a mesh ann. The fins 42 can be of a design deso-ibed herdn (e.g., of described dimensions, materials, etc.) to improve pullout force, reduce trauma, allow ibr a desirable insertion force, etc, and rosy be molded separately and

attached directly to the mesh using rivets, ultrasottic welding, injection molding, or may be woven into the mesh; fins 42 may also be attached to a connecting member MCtending between fins 42 and connecting to mesh 4% to provide additions] support between fins 42 and additional structural integrity between fins 42 and mesh 42. Pins 42 may be designed to provide anchoring at a specific anatomical level (on a membrane or fmcia, for example) or for anchoring generally into soft tissue (muscle or fht).
As illustrated bi figure 8, another «nbodiment an implant, and self-fixating tip, can be as shown. Self-fixating tip (anchors) 51 is attached at an end of mesh extension portion 50, by any of a varied of attachment mechanisms such as by it\jection molding anchor 51 over an extension portion end. Anchor 51, as illastrated, includes (optional) intamal channel 52 for receiving an end of an insertion tool, and multiple lateral extensions S4 designed to maintain the position of anchor 51 within tissue, Latearai extensions 54 are in two opposite rows along the length of the base of anchor 51, on opposite sides of the base. Lateral extensions 54 can therefore be placed in an orientation tiiat is nonparallel to fibers of fibrous tissue such as a muscle of the obturator fbtamen. To allow placement and positioning of the implant as desired, anchor 51 can be dimoisioned, including its length, to be placed at a desired depth within a muscle tissue such as, e.g., the obturator intemus (the muscle in figure 8 is shown in side view to illustrate the depth or fiiickness dimension of the muscle; fhe direction of muscle fibers is not illustrated in figure 8) or obturator extemus. Lateral extensions 54 can also be dimensioned as described hwein, to provide for one or more of desirable insertion force, pullout fbrce, and reduced trauma.
As illustrated in figure 9, another embodiment of an implant mi include anchor 60 placed at a distance along a lengtib of an extension portion 62, optionally in a manner that allows extension portion 62 to move relative to andior 60, e.g., to allow adyustment. In the illustration, anciior 60 has passed completely dirough the obturator intemus muscle (o. int.), punctured the obturator membrane (o. membrane), and has been inserted within the

obturator extemus musole (o. ext). Anchor 60 may be placed at a predetermined distance ftom the end of a mesh extension portion 62 such that a distal portion of me 64 also is located beyond anchor 60. The distal pmrtion of mash 64 may provide greater Initial anchoring and may allow for greater tissue in-growtiii to occur. As illustrated, anchor 60 may be a plastic or other biocompatible (optionally bIoresortable) material that ia positioned and secured over the top of extension portion 62. Extension portion 62 passes through a bore that extends intematly along the longitudinal dimension (length) ofaaohor 62 and that is sized and shaped sucli tiiat the position of andior 60 can be moveable or secured relative to the extension portion v Anchor 60 can be positioned and then secured to extension portion 62, e.g., by clamping andior 60 around extension portion 62 or otherwise passing anchoring ann 62 trough the bore until a desired anchor position is reached and then securing nichor 60 into position relative to «aens)on portion 62 by use of any deshable and useful securing mechanism. In the embodiment illustrated at figure 9, anchor 62 causes mesh of 6Xtensi In Airther embodiments, othn instruments, anchors, and insertion devices, as illustrated herein, may be incorporated or used with devices and methods of the present description, separately or in any combination. Various instruments and devices may aid in the insertion or retention of an implant. The devices may also be usefiil separately or widi alternate methods or implants, as will be appreciated.
Figures lOthrougih 14 illustrate delivery toots for assisting in insertion of an i extension portion of an implant Referring to figure 10, delivoTy tool (or "insertion tool") 200 includes handle 202 connected to holIfw elongate inserter 204. Hollow elongate

inserter 204 is an example of an'inserter that oan be used to insert an extension portion througli tissue, with reduced contact between the extension portion and the tissue. For implant extensions that do not include a sheath or other removable covering (e.g., because the sheath can be difficult to remove in the absence of an external incision, as relates to exemplaiy metiiods of the present description) an insMlion tool such as tool 200 can be used to reduce contact between implant and tissue, during implantation. Elongate hollow inserter 204 includes an elongate slotted tube 207 eiitendlng from handle 202 to distal end 206. An opening for inserting an implant extension portion, slot 210, extnids along the length of tube 207, and also (optionatiy, and as illustrated) into handle 202 as slot 212. Internal bore 208 «Ktend8 the lengdt of tube 207 to form a hollow interior of tube 207 (bore 20S). An extension portion of an implant can be inserted into slot 210 (and 212), to be contained by tube 207 within bore 208, Ibr implantation. Tube 207 can act to encapsulate or otherwise protect the extension portion as the extension portion is pushed through tissue (using tool 200). Distal end 206 may be open (as illustrated), closed, or sized to receive a self-fixating tip. For example, distal end 206 can engi a self-fixeting tip by contacting a complementary surlkce, optionally in a desired orientation. Once an extension portion is pushed into tissue of &e patient, using tool 200, the extension portion can be removed from tool 200 by exiting tube 207 through slot 210. Tube 207 is shown to be straight, but may optionally be curved as deshed to roach a desired tissue location.
Optionally, aiother insertion tool such as an elongate needle may be placed within bore 208. The second tool may include an end that engage a self-fixating tip to push the tip through bort 208 and into tissue of the pelvic region. Afier the self-fixating tip is located within tissue as desii, the second tool may disengi the tip and be removed firom bore 208 of tube 207, and tool 200 can be removed ftom the tissue path.
Referring now to figure 11, shown is an end, cross section view of elongate hollow inserter tool 200 looking in the direction froth distal end 206 toward handle 202, figure 11

shows, tool 200 from this end view, with implant 214 (e.g., mesh extension portion) shown partially within bore 20B and partially extending out through slot 2} 0. Figure 11 illustrates that a mesh strip Ce.g.» extension portion also in an end cross-section view) may be inserted and removed from bore 218 through slot 210, prior to implanting a mesh strip (B.g.» 214) into a tissue path; once the mesh strip is placed, tool 200 can be mnoved ftom the mesh strip also by passing the mesh strip (214) through slot 210.
Optionally, a tool such ai tool 200, designed to include a hollow interior for containing an extension portion of an implant, particularly useftil for implanting kn extension portion that does not include a protective sheadi, can additionally include a cover that can open or close an elongate opening such as slot 210. Referring to figure 12A, ' delivery tool 220 bioludes an outer slotted tube 222 connected to handle 224. An inner slotted tube 226 (see ftgures 2C and 2D), oontrblted by handle 228. is contained concentrically wittiin an internal bore of outer slotted tube 222. lnn«- slotted tube 226 and outer slotted tube 222 each includes handles 228 and 224, respectively. Each slotted tube. 222,226 includes an internal bore to produce a hollow interior, and each tube includes a longitudinal slot (230,232, respectively) running the entire length of each tube 222 and 226. The slotted tubes and internal bores can preferably be conoenljlc to allow slots 230,232 to be aligned t manipulation of handles 224 and 228. See flgres 12B and 12D, which show that when slots 230 and 232 are aligned, an extension portion (not shown) can be inserted through both aligned slots, into the intenial space of interior tube 226. As shown in Hgure 12C, slots 230 and 232 can then be moved relative to each other to close or cover outer slot 230 by rotating the interior tube into position behind outer slot 230.
With further exemplaiy detail of this insertion tool embodiment, inno tube 226 may be sized and shaped such that bjn«: tube 226 is rotatably enclosed by outer tube 222. As illustrated, inner tube 226 may be lonsr than outiar tube 222 such that handle 228 of inner tube 226 is accessible. During placement; an extension portion (e.g., mesh strip) can be

enclosed inside of inner tube 226, which is positioned inside of outer tube 222, and the handles 224 and 228 can be oriented relative to each other such that slots 230 and 232 are not aligned. See figure 12C. As illustrated, an andior (self-fixating tip) 234 projects firom the distal end of the inner tube 226, but in alternate embodiments inner tube 226 may instead enclose an anchor 234 during placement. Once delivery tool 220 lias been inserted into the desired position, inner tube 226 and outer tube 222 are rotated relative to each other such that slots 230 and 232 are aligned and an extension portion contained within inner tube 226 can be slid out through aligned slots 230 and 232.
Outer tube 222 and inner tube 226 of tool 220 are shown to be straight, but may be curved if desired, e,g., by selecdoii of a flexlbl e material fbr inner tube 226. Also, a difTerent closing mechanism could he used to close outer slot 230, such as an inner or outer cover of a snuiller dlmmsion relative to the itiustrated inner tube 226. For example, figure 12E shows an example of an outer tube 222 and an inner cover 223, which is of a reduced size compared to inner tube 226 in temts of arolength. Inner cover 223 functions in a manner similar to inner tube 226, by being moveable (according to arrows shown in figure 12B) betweot a position tiiat covers slot 230 and a position that does not cover slot 230 of outer tube 222. Mesh 22S is Illustrated also in figure 12E.
Another embodiment of an insertion tool (or 'delivery tool") is illustrated at figure 13 A. This type of tool can also be particularly uaefbl to allow delivery of an extension
) portion, of an implant duough a tissue path to a tissue site, the extension portion not including a protective sheath, and the tissue padi not leading to an external incision. In general, this type of insertion tool allows delivety at an internal tissue location, of an extension portion that does not include a sheath by delivering the extension portion (e.g., inserting a self-fixathig tip at internal tissueX then breaking pieces of the insertion tool away
I flrom
Tool 250 BS illustreted in figure 13A includes handle 260, elongate body 254 extending distaily along a length ftom handle 260. Body 2S4 includes fitst and second peel lines (or, "separation lines" or "break lines") 258,259 along a longitudinal length (peel line 259 is shown as dashed line 2S9 because peel line 259 is located on the fo- side of body 254). Peel lines 258,259 may be a tear line or break line, or other separable engagement along which two separate pieces of elongate boi 254 c As illustrated, two separate pieces (253 and 255) of body 254 are of substantially equal and complementaty sizes, i.e., each constitute half of body 254, to produce at hollow, elongate, cylindrical body fm pieces 253 and 255 when 6ssembled, with an open interior fbr locating an extension portion of an implant; illustrated pieces 253,255, are substantially . . opposite sides (halves) of body 254 that are designed allow body 254 to break apart and separate into two sections along its length, for removal of separated pieces 253,255, after implantation of the extension portion. Handle 260 can be removed fhmi &e proximal end of body 254 to allow pieces 253,255 to be dls-assembled, Handle 260 m be integral (as illustrated), or may likewise separate into two pieces. As in the previous dellveiy tools, body 254, Men assembled, includes a bore therethrough that encapsulates or encloses an extension pordon of an implant (e.g., a urMbral sling) during placnnent Moreovn; an anchor (252) may or may not extend fSrom a distal end of the boy 254 during placement. Once dellvny tool 250 is in position, handle 260 is sepuated into two sectimis C253,255) and body 254 is witiidrawn and simultaneously peeled, leaving an extension portion in the desired position.
■ An insertion tool according to tlie invention can optionally inolude a mechanism by which a self-fixating tip can be securely and releesable engaged with a distal end of an

insertion tool such that a self-fixating tip can ie selectively secured to the distal end mechanicaily, then released; this contrasts with, for example, a simple slidable engagement that invol'ves only a distal end of an insertion tool engaging a surftce (e,g.» inner channel) of a self-fixating tip in the absence of any securing meohaniam. With a releasable engBgetnent. a setf-flxating tip can be removed fhun the distal end by releasing ftie engagement (e.g., mechanical engagement) by movement of an actuator at Ihe proximal end of the insertion tool, such as at the handle.
For Bxanle, an internal channel (or external surfiuse) of a self-fixoilng tip base can include an engaging aurfiice designed to engage a mechanism at the distal tip (i.e., distal end) of an insertion tool white the self-ftxat!i% tip is placed at, on, or ov«r the distal end of the insertion tool. As an example, an internal or external surfbce of a self-fixating tip can include a depression, ring, edge, or ledge, tliat can be rounded, angular, etc. A mechanical detent such as a pin, ball, spring, deflector, or other surfhee or extension located at the distal end of the insertion tool can be moved, deflected, or wctended relative to the distal end of the Insnlion tool to contact a surfeoe of the setf-flxating tip, such as the depression, ring, edge, or ledge, etc., to securely and releasably hold the self-fixating tip at the distal end of the insertion tool and prevent removal of the tip ftom the distal end, until removal is desired. The detent (extended, moved, or deflected surface, spring, deflector, phi, or ball, etc) can be cause to extend from the distal end of the insertion tool by actuating a trigger or other mecduttiism located at the handle of the insertbn tool. 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 &e tip to become loose. The insertion tool can then be removed firom the tissue patit, and the self-fixating tip can remain in a desned implanted iooatic»i. An fficample of such tool is illustrated that figures 14A, 14B, and 14C.

Figures 14A through 14C illustrate a lever-activated delivery tool 270 that includes a lever that oan activate and de-activate a detent at distal end 274 of tool 270, the detent being capable of retaining self-fixating tip 272 at distal end 274 during an implantation procedure, and releasing tip 272 as desired upon placement. Lever 282 controls the detent which may be, e.g., a mechanical enjgement mechanism that all(nvs deliveiy tool 270 to securely engage and releassbly diB«ngage anchor 272 IVom distal end 274.
In more detail, tool 270 includes handle 280, having lever 282 operabiy positioned (hingecQ on handle 280. Elongate hollow tube 276 extends disIy fttan handle 280 and includes bore 278 fheretitrough, firom handle 280 to distal end 274. Push rod 284 is fitted through bore 278. Andbor 272 is fitted into or onto distal end 274 of tube 276. A mesh sling or extension portion (not shown) of an implant can be attached to selfxating tip 272; an extension portion or mesh sling may be attached directly to anchor 272 such that the extension portion or mesh sling drags along the ovtslde of tube 276 during insertion through a tissue path, bi alternate embodiments a sling or extension parti During insertion, when delivery tool 270 and tip 272 have been placed in a desired position, lever 282 may be moved to cause push rod 284 to move through bore 278. At
i distal end 274, movement of push rod 284 causes release of a detent that allows tip 272 to be easily released ttoai distal end 274.
Any releasable engagement and detent mechanism that is capable of holding a self-fixating tip at a distal end of an insertion tool may be usefbl aocoiding to the present description. As will be appreciated, a number of diJBferent structures, medianisms, collars,
i locking arms, or other mechanicai features may be integrated into an insertion tool suob as tool 270 to effectuate holding and release of an anchor during implantation. A detent or

other releasable attachment between a distal end of an insertion too] and a self-fixating tip may operate on principles of a friction fit, a snap fit, a twist connection, a rotating connection, a moveable engagement, or any other structure of method Icnown to those in the mechanical engagement, holding, and release arts. The engagement may conCact any portion of a self-fExating tip, such as an internal bore of a base, en external surfiice of a base, a lateral extension, etc. Figure I4C shows details of a single embodiment of a usefiil mechanical detent mechanism; this example is not limiting and other types of engagement mechanisms can be used instead.
RiefeiTing now to figure 14B, self-ilxating tip 272 is located at distal end 274 of tool 270. Self-fixating tip 272 includes internal channel 275, base 273, proximal end 290, distal end 292, and lateral extensions 294. Distal end 274 of insertion tool 270 includes tube 276, bore 278, and push rod 284. The ftr distal end of push rod 284 mctends to a location witiitn internal channel 275 of self-fixating tip 272. At that portion of push rod 2SS is connected a collar 286 and an enlarged tip 288; in this exemplary illustration, collar 286 can be moveable relative to pushrod 284, and enlarged tip 288 can be stationaiy relative to pushrod . 284.
Wittiin internal channel 275 of self-fixating tip 272, connected to internal channel 275, are mechanical idetents, "arms' or springs 296, biased to contact push rod 285. As will be appreoiate4 movement of collsis 286 distally will cause collar 286 to engage springs 296, causing springs 296 to be pushed away from contacting pushrod 285 and creating an aperture tiuit will allow enlaiged tip 288 to be moved proximally through opened springs 296. Collars 286 are moved away ftom pushrod 285 a sufficient distance to create an opening between springs 296 large enough for enlarged tip 288 to pass ttirougfa the opening while moving in a proximal direction, therelr releasing self-fixating tip 272 fhim distal end '
Figure IS illustrates an embodiment of a method of connecting an end of mesli ' extension portion 302 to a self-fixating.tip 304. Reftrring to f!gure 1S» self-fixating tip 304 includes base 306, lateral extensions 30B» and internal chaimel 310. Ribs 312 are located toward proximal end'314 of tip 306.' Ribs 312 are ridges or bumps or extensions on the outtt- sufboe of tip 306, and (as Illustrated) extend around a fUll circumference of base 302. (Ribs 312 are not required to be continuous around the circumference of base 302, but could be intermittent or interrupted. Mesh extension portion 302 contacts proximal end 314 around the exterior surface of base 306. According to this embodiment of a self-fixating tip, ridges 312 allow mesh 302 to be connected to tip 304 by a suture or other mechanical
I
I fostening device wrapped around mesh 302, placed about base 306, the suture or fastener being wrapped around l»se 306 at a location between ribs 312.
bi anothnr embodiment of an implant according to the invention an implant fir treating a pelvic condition such as incontinence, prblapse, or a combined condition of incontinence and prolapse, m be Assembled fixtm sepsrate pieces, e.g., as a modular
i assembly of parts, which can be advantageous for reasons including flexibility in placement of the different pieces and in sizing of an assembled modular implant. Figures 16 and 17 illustrate implant 320 that inchides two suppcnt portions 322, each including a self-fbcating tip 324 (as described herein). Also illustrated is an ins«rtion tool 326 (as described herein) that can be usefiil in combination with implant 320, e.g., in the famt of a kit. Implant 320
) can be placed as two different sections and then connected together at a desired position and tension to form a single implant fiom the combined pieces. Each of the two portions of implant 320 may be placed with any insertion tool such as tool 326, or any alternate insertion tool described herein. Once each sling section 322 is placed, sling sections 322 may be attached at their connecting ends 321 by use of any flastening mechanism, such as by
$ clips, sutures, or other methods known to those in the art or developed in the ftiture.

Figure 17 show implant 320 after implantation. Bach tip 324 is secured within pelvic tissue, such as obturator intemus muscle 330, and mesh portions 322 extend through tissue patiiB to meet at connecting ends 321 below urelhra 328, wheste connecting ends 321 can be attached together white a desired amount of tcmslon is placed on urethra 328. Obturator membrane 332 and obturator extemus muscle 334 are also shown.
Anottter example of a multi-piece e.g., modular fanplant is shown at figure I6B. Implant 360 includes two support portions 364, each including a self-fixatmg tip 362 (as described herein j. Each support portion 364 includes a connecting end 366, which includes a non-pnrpendicular cU such as a slanted cut (as illustrated). The use of a nan-perpendicular (e.g., slanted) cut can result in a reduced ainount of overlapping material underneath a urefluti upon implantation of pordons 364 and connection together of connecting ends 366. A reduced amount of implant material (e.g., mesh) present below the urethra can reduce the bulk of the supportive material below the ureQira and can reduce the chance of «: AnothfflT example of a multi-piece, e.g. modular, implant is shown at figure 16C. Implant 370 bicludes two support portions 378, each including a self-fixating.tip 372 (as described herein). Eadh support portion 378 Includes a proximal portion 376 and distal portion 374. Proximal portion 376 is the portion of the implant material Oiat will be located below the urethra upon implantation, and distal portion 374 connects proximal portion 376 to self-fixating tip 372. According to ftis embodiment of the invention, proximal portion 376 is made of support material that is of a density (mass per volume) that is less tiian the density of distal portion 374. The use of a reduced density material' fbr proximal portions

376, which can be connected below the urethra, cut can result in a reduced amount of overlapping material underneath a urethra upon implantation of portions 378 and connection together of proximal portions 376. A reduced amount of implant material »
and then connected together at a desired position and tension to fonm a single implant from combined portions 378. Once each sling portion 378 is placed sling portions 378 may be attached at their proximal portions 376 biy use of any fastening mechanism, such as l dips, sutures, or oth«' methods known to those in the art or developed in the future.
' In a l\irther embodiment of an implant shown at figure 18, an implant may include an anchor 340, mesh extension portion 344, and break-away plastic sheaith 346. PerforaticMis 348 are located on sheath 346 at a position near anchor 340. A brealcable connection such as perforations 348 allows sheath 346 to be removed, B.g., brolcen or torn away ftom, the peribrated connection new anchdr 340 after anchor 340 is implanted into pelvic tissue. The size and amount of perforations 348 can be selected to cause sheath 346 to break at perforations 348 instead of moving uicfaor 340 wheaa sheath 346 is pulled.
Alternately or in addition to perforations 348, an elongate wire, needle, striiig, or other connection (not shown), can extend iirom the location of perforations 348 to a location available to a physician durit implantation, so that the connection can cause sheath 346 to be broken near anchor 340 as desired. According to one specific example of this design, a needle with bend or a T-shaped tip may be situated within sheath 346 and positioned next to a perfomted or otherwise weakened section of the sheath, e.g., near self-fixating tip 340. Wlten anchor 340 has been implanted at a desired position within tissue, the needle may be Spun, turned, or otherwise moved or manipulated to break sheath 346 at a location near. anchor 340 and release sheath 346 from anchor 340. In forther embodiments the needle and sheath 346 may be integrally formed so that when the needle is twisted or pulled, the end of

346 sheath twists relative to anchor 340 and the torque force tevaks sheath 346 near anchor 340.
Embodiments of Implants oan also allow fn a4tusting the position or tension of an implant after implantation. ,An example is shown at figure 19. Urethral sling 350 Includes anchors 352 and 353 placed at opposing obturator intemus muscles 354. Obturator membrane 356 and obturator extemus muscle 358 are also shown. Implant SSO'Can be affixed using fhtt anchor 3S2, which is fixed to one end of implant 350, and Is adjustably attethed to anchor 353 on the other end. Anchors 352 and 353 may be self-fixadng tips as described. However, anchor 353 includes a loop or slot 355 through which and 351 of • implant 350 can be aiustably located, thm secured into place upon positioning or adlustment. Implant end 351 is passed fbrough aperture 355 of anchor 353 and is drawn bacic along a tissue insertion path to achieve desired positionfoig and t«isioning of implant 350 relative to urethra 360. When the desired amount of tension is achieved on implant 350, or supportive f(»ce on uredva 360, end 351 of implant 350, dmwn through aperture 355, may be fastened or otherwise coupled or locked by a clip, or by any other means, to implant 350, to secure the position of implant 350.
Another example of a usefUl self-fixating tip according to the present description, is illustrated at figures 20A through 20D. Self-fixating tip 400 includes base 402, proximal base end 406, distal base end 408, and internal channel 404. Extending Ihim base 402 are lateral extensions 410, which extend laterally and in a direction that includes a component toward proximal base end 406. Lateral extensions 410 can be sufficiently rigid to be fixed, to not deflect upon inserdoh throu tissue, or may be capable of deflecting in a proximal dh«ction if desired. Lateral extensions 410 are shown to exhibit a fliidmess tiiat slightily less than a thickness of base 402
An alternate embodiment of an implant portion is illustrated at figures 21A and 21B. Implant portion 420 includes mesh 422 and self-fixating tip 424 (including one or more feattpes as described herein), contained by hollow elongate inserter 430. Seif-fixating tip 424 includes moveable section 428, and two optional sutures 426, one attached to each moveable section 428. During use« self-fixatii tip 424 can be insetted into pelvic tissue 432, as shown at figure 2IB. Inserter 430 can be withdrawn. Optionally, moveable sections 428 can be biased to extend away Irom each other, optionally away from a base of self-. fixating tip 424, upon removal of inserter 430. Alternately, or in addition, optional sutures 426 can be pulled to cause moveable sections 428 to move laterally and away firom each other, optionally away lirom a base of self-fixating tip 424, to extend into tissue 432 and secure self-fixating tip within tissue 432.
Another- alternate embodiment of an implant portion is illustrated at figures 22A and 22B. Implant portion 400 includes mesh 442 and self-fixating tip 448 (including one or more features as described herein). Inserter tool 444 is shown in a position engaging self-fixating tip 448. Self-fixating tip 448 includes three moveable sections 4S0, each section including three lateral extrastons 4S2. During use, self-fixating tip 448 can be inserted into pelvic tissue and moveable sections 450 can be expanded to increase the size of self-flxatmg tip 448 within the tissue. Optionally, moveable sections 4S0 can be biased to extend away fhm each other, e.g., upon removal of an inserter (not shown). Alternately, or in addition, moveable sections 450 can be cause to extend laterally away from each other, as desired, such a by use of a push-rod or other mechanism (not sliown) contained Iqr Insoler tool 444, that can be actuated fhm a proximal end of the Insertw tooL
Another alternate «nbodiment of an implant portion is illustrated at figures 23A and 23B. Implant portion 460 includes mesh 462, plastic protective sheath 464, and self-fbcating tip 468 (including one or more ftatures as described herein, Including lateral extensions 470). Tool 472 is shown in a position that places a'T" end at a location near self-fixating

tip 468; an opposite end of tool 472 ts located at a position that is accessible to a physician during an implantation procedure. During use, seif-'fixating tip 468 can be inserted into pelvic tissue as described herein. Tool 472 can be twisted, turned, or moved, or removed from the location with "T near selffixating tip 468, and such movement will cause sheath 464 to tear, break, or otherwise separate, at a location near self-fuMting Up 468, so that sheath 464 can be removed.
Although embodiments of the present invention have been described with reference to the treatment of female urinary continence, it should be appreciated that many of these embodiments would also be suitable to repair a variety of pelvic conditions in both males and females. For example, embodiments of the present invention would be suitable for a variety of pelvic floor repairs and/or treatments, including pelvic organ prolapse repair, levator hiatus repair, fecal incontinence treatment, perineal body support and hysterectomy support.
Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Aceordihgly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.


AMSOlll/IN
1. A pelvic implant assembly comprising
a support portion and an extension portion,
a self-fixating tip connected to the extension portion, the self-fixating tip comprising
a base comprising a proximal base end and a distal base end, the proximal base end being connected to the extension portion,
the base comprising an internal channel extending from the proximal base end at least partially along a length of the base toward the distal base end,
a fixed lateral extension extending from the base.
2. A pelvic implant assembly comprising
a support portion and an extension portion, and
a self-fixating tip connected to the extension portion, the self-fixating tip comprising
a base comprising proximal base end and a distal base end, the proximal base end being connected to the extension portion,
a fixed lateral extension extending from the base, the lateral extension comprises a lateral extension body comprising boundaries that include a leading edge, a trailing edge, and a length at which the lateral extension meets the base, wherein the trailing edge has a thickness greater than the leading edge.
3. An implant according to any of claims 1 through 2 wherein the self-fixating tip has a length measured from the proximal base end to the distal base end, in the range from 0.4 to 1.0 centimeter.
4. An implant according to any of claims 1 through 3 wherein the self-fixating tip includes two or more lateral extensions, all lateral extensions extending in a different direction from locations that are at the same length-wise position of the base.

5. An implant according to any of claims 1 through 4 wherein the self-fixating tip includes exactly two lateral extensions.
6. An implant according to any of claims 1 through 5 wherein a lateral extension comprises a fixed leading edge that extends away from the base and proximally to meet a trailing edge at a pointed lateral extension tip.
7. An implant according to any of claims 1 through 6 wherein a lateral extension comprises a lateral extension body comprising a leading edge and a trailing edge, wherein the thickness of the lateral extension body tapers from a greater thickness at a central portion of the body to a reduced thickness at the leading edge.
8. An implant according to any of claims 1 through 7 wherein a lateral extension comprises a trailing edge that includes a portion having a thickness in the range from 0.2 to 1.5 millimeters.
9. An implant according to any of claims 1 through 8 wherein a lateral extension includes dimensions comprising
a width dimension extending from the base, in the range from 0.5 to 3 millimeters, and
a thickness dimension in the range from 0.2 to 1.5 millimeter.
10. An implant according to any of claims 1 through 9 comprising a self-fixating tip including a length dimension where the lateral extension meets the base, in the range from 0.5 to 5 millimeters.
11. An implant according to claim any of claims 1 through 10 wherein a lateral extension has a length dimension, measured where the lateral extension meets the base, in the range from I to 4 millimeters, and the length dimension of the lateral extension becomes smaller as the lateral extension extends further from the base.
12. In combination, an implant according to any of claims 1 through 11 or 15 through 18, and an insertion tool, the insertion tool comprising a handle and a needle extending from the handle,

the needle comprising a proximal end attached to the handle and a distal end, the distal end comprising a tip that engages the self-fixating tip.
13. The combination of claim 12 wherein
the insertion tool comprises a curved needle portion and a distal end capable of engaging the self-fixating tip to allow the self-fixating tip to be inserted into tissue by pushing the self-fixating tip using the insertion tool, and
when the needle distal end is engaged with the self-fixating tip, the self-fixating tip maintains an orientation relative to the insertion tool with lateral extensions aligned for implantation into fibrous tissue so the lateral extensions penetrate the fibrous tissue in an orientation that is non-parallel to the direction of fibers of the fibrous tissue.
14. The combination of claim 13 wherein the self-fixating tip maintains an orientation relative to the tool so the extensions are aligned at an angle in the range from 70 to 100 degrees relative to fibers of obturator internus muscle tissue when the self-fixating tip is inserted into the tissue by extending the elongate needle through a vaginal incision in a female or a perineal incision in a male.
15. An implant according to any of claims 1 through 10, wherein
the implant is a urethral sling comprising a mesh strip and two self-fixating tips, one self-fixating tip at each end of the mesh strip.
16. An implant according to claim 15 wherein the sling has a length in the range from 6 to 10 centimeters.
17. An implant according to any of claims 1 through 10, for treating posterior vaginal prolapse, wherein
the implant comprises a tissue support portion, two posterior extension portions, and a self-fixating tip at a distal end of each posterior extension portion, and
with the tissue support portion placed at posterior vaginal tissue, the self-fixating tips can be placed at tissue of the sacrospinous ligament.

18. An implant according to any of claims 1 through 10, for treating anterior vaginal prolapse, wherein
the implant comprises
a tissue support portion,
two anterior extension portions, with two anterior self-fixating tips, one anterior self-fixating tip at a distal end of each anterior extension portion, and
two posterior extension portions, with two posterior self-fixating tips, one posterior self-fixating tip at a distal end of each posterior extension portion, and
with the tissue support portion placed at vaginal tissue, each anterior self-fixating tip can be placed at an obturator foramen, and each posterior self-fixating tip can be placed at tissue of a sacrospinous ligament.


Documents:

http://ipindiaonline.gov.in/patentsearch/GrantedSearch/viewdoc.aspx?id=OKLO3DvpLv4Wi2UOSQMABQ==&loc=egcICQiyoj82NGgGrC5ChA==


Patent Number 272603
Indian Patent Application Number 4234/CHENP/2008
PG Journal Number 16/2016
Publication Date 15-Apr-2016
Grant Date 12-Apr-2016
Date of Filing 11-Aug-2008
Name of Patentee AMS RESEARCH CORPORATION
Applicant Address 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
Inventors:
# Inventor's Name Inventor's Address
1 OTTE, JOHN, F; 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
2 KHAMIS, CHAOUKI, A; 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
3 LUND, ROBERT, E; 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
4 KALETA, RICHARD , C; 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
5 OGDAHL, JASON, W; 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
6 DAHDAH, MONA, N; 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
7 CHAPMAN, KELLY, ANN, 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
8 ROLL, JESSICA, L; 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
9 MONTPETIT, KAREN, PILNEY, 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
10 WOLD, JELICA, D; 10700 BREN ROAD WEST, MINNETONKA, MINNESOTA 55343
PCT International Classification Number A61B17/04
PCT International Application Number PCT/US07/4015
PCT International Filing date 2007-02-16
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 60/805,040 2006-06-16 U.S.A.
2 60/775,039 2006-02-16 U.S.A.
3 60/804,353 2006-06-09 U.S.A.
4 60/806,073 2006-06-28 U.S.A.