Patent Publication Number: US-9888912-B2

Title: Collapsible tissue anchor device and method

Description:
PRIORITY 
     This application is a Continuation of U.S. patent application Ser. No. 12/468,754, filed May 19, 2009, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/054,202 filed on May 19, 2008, each of which is fully incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The invention relates to apparatus and methods for treating pelvic conditions by use of anchored pelvic implants, mesh or sutures to support pelvic tissue. The pelvic conditions include conditions of the female or male anatomy, and specifically include treatments of female or male urinary and fecal incontinence, and treatment of female vaginal prolapse conditions including enterocele, rectocele, cystocele, vault prolapse, and any of these conditions in combination. 
     BACKGROUND 
     Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (fecal and urinary) and pelvic tissue prolapse (e.g., female vaginal prolapse). Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vagina and introitus. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems. 
     In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times. 
     Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) occurs when the patient is physically stressed. 
     One cause of urinary incontinence is damage to the urethral sphincter. Other causes include the loss of support of the urethral 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, over-flowing incontinence, and fistulas. 
     The female&#39;s natural support system for the urethra is a hammock-like supportive layer composed of endopelvic fascia, the anterior vaginal wall, and the arcus tendineus. Weakening and elongation of the pubourethral ligaments and the arcus tendineus fascia pelvis, and weakening of the endopelvic 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 urinary incontinence. 
     In general, urinary continence is considered to be a function of urethral support and coaptation. For coaptation to successfully prevent or cure incontinence, 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 for the Correction of Stress Incontinence in Women, West. J. Surg., Obstetrics &amp; Gynecology, pp. 243-246, July-August 1959. 
     One alternative surgical 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 bladder neck or urethra. There are a variety of different sling procedures. 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 region 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 portion” or “tissue support portion”), and two extension portions bracketing the support portion, optionally a protective sheath or sheaths encasing at least the extension portions. Although complications associated with sling procedures are infrequent, they do occur. Complications include urethral obstruction, prolonged urinary retention, bladder perforations, damage to surrounding tissue, and sling erosion. 
     Other treatments involve implantation of a Kaufman Prosthesis, an artificial sphincter (such as the AMS-800 Urinary Control System available from American Medical Systems, Inc.), or a urethral sling procedure in which a urethral sling is inserted beneath the urethra and advanced to the retropubic space. Peripheral or extension portions of the elongated urethral sling are affixed to bone or body tissue at or near the retropubic space. A central support portion of the elongated urethral sling extends under the urethral or bladder neck to provide a platform that compresses the urethral sphincter, limits urethral distention and pelvic drop, and thereby improves coaptation. Similar attached slings or supports have been proposed for restoring proper positioning of pelvic organs, e.g., the vagina or bladder. 
     Elongated “self-fixating” slings have also been introduced for implantation in the body, to treat pelvic conditions such as prolapse and incontinence conditions. Self-fixating slings do not require the extension portions to be physically attached to tissue or bone. Rather, the slings rely upon tissue ingrowth into sling pores to stabilize the sling. See, for example, commonly assigned U.S. Pat. Nos. 6,382,214, 6,641,524, 6,652,450, and 6,911,003, and publications and patents cited therein. The implantation of these implants involves the use of right and left hand sling implantation tools that create transvaginal, transobturator, supra-pubic, or retro-pubic exposures or pathways. A delivery system for coupling the sling ends to ends of elongate insertion tools, to draw sling extension portions through tissue pathways, is also included. Needles of the right and left hand insertion tools described in the above-referenced 2005/0043580 patent publication have a curvature in a single plane and correspond more generally to the BioArc™ SP and SPARC™ single use sling implantation tools sold in a kit with an elongated urethral sling by American Medical Systems, Inc. 
     In some sling implantation kits, the needle portion has a proximal straight portion extending from the handle and a distal curved portion terminating in a needle end or tip. As described in the above-referenced &#39;003 patent, the kit may include more than one type of implantation tool (also, “insertion tool”). 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. from the vaginal incision toward a skin incision) procedure. Surgeons that prefer an approach dictated by the surgeon&#39;s dominant hand can select the procedure and the appropriate implantation tool. Alternately, universal implantation tools (e.g., right and left sling implantation tools each suitable for both an inside-out and an outside-in approach) may be provided. 
     Optionally, a detachable protective sheath may encase some portion of an extension portion of a pelvic implant. Connectors may be attached to the ends of the extension portions for connecting with and end of an insertion tool. Generally speaking, the insertion tool ends are inserted axially into the connectors, and the extension portions of the implant are drawn through pathways 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 adjacent to the connectors. 
     Similar transobturator implantation procedures for implanting a pelvic implant to support a pelvic organ, e.g., the vagina, restored in proper anatomic position, are described in commonly assigned U.S. Patent Application Publication Nos. 2005/0043580 and 2005/0065395. Alternate implantation procedures for creating tissue pathways 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 No. 2004/0039453 and in PCT Publication No. WO 03/096929. Various ways of attaching a sleeve end and implant mesh extension to a self-fixating tip are detailed in the above-referenced &#39;450 patent, for example. Further ways of attaching extensions of an implant to an implantation tool are described in U.S. Patent Publication 2004/0087970. In each case extra incisions must be made in the patient&#39;s abdomen. 
     SUMMARY OF THE INVENTION 
     The present patent application describes collapsible tissue anchor devices and methods for inserting into a tissue structure in a first non-collapsed configuration and then collapsing it into a second collapsed configuration. The disclosed tissue anchors may include a sleeve having an interior and a bolt or shank extending through it. The bolt or shank may include a head portion that engages an end of the sleeve. An end of the shank or the head portion itself may be exerted upon to apply a force to the sleeve causing it to move from a first generally tubular non-collapsed configuration to a second collapsed configuration. In the second collapsed configuration the sleeve has flanges that extend radially from the shank or bolt. The flanges act to prevent the anchor from being pulled out of the tissue. A sling, suture, mesh or the like may be coupled to a portion of the anchor to support tissue or an organ in order to treat incontinence, prolapse or any other conditions where a particular tissue or organ has moved from its typical anatomical location, thereby causing undesirable physiological symptoms. 
     The above summary of the invention is not intended to describe each illustrated embodiment or every implementation of the invention. The figures in the detailed description that follow more particularly exemplify these embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will be better understood when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: 
         FIG. 1  is a perspective view of a bolt anchor device and corresponding driving tool. 
         FIGS. 2-3  are perspective views of embodiments of a bolt anchor device. 
         FIGS. 4-5  are partial section views of a sleeve anchor device, with weakened wall portions, inserted through and collapsed within target body tissue. 
         FIG. 6  is a perspective view of a sleeve anchor device with living hinges. 
         FIG. 7  is a partial section view of a lock feature for the sleeve anchor device. 
         FIG. 8  is a partial cross section view of a collapsed anchor within target body tissue. 
         FIG. 9  is a side cross section view of a sleeve anchor device with living hinges, shown in a first deployment state and a partially collapsed state. 
         FIG. 10  is a side section view of the sleeve anchor device of  FIG. 9  anchored within target body tissue. 
         FIG. 11  is a side view of a sleeve for the sleeve anchor device, illustrating the position of the living hinges. 
         FIG. 12  is a view of the sleeve of  FIG. 11  in a collapsed or anchoring state. 
         FIG. 13  is a side view of a sleeve for the sleeve anchor device, illustrating the position of the living hinges. 
         FIG. 14  is a top view of the sleeve of  FIG. 13  in a collapsed or anchoring state. 
         FIGS. 15-16  are side section views of a sleeve anchor device and a relatively long shank in an initial deployment state and a collapsed state. 
         FIGS. 17-18  are side section views of a sleeve anchor device and a relatively short shank in an initial deployment state and a collapsed state. 
         FIGS. 19-20  are perspective views of a sleeve anchor device, having relatively short longitudinal slots, in an initial deployment state and a collapsed state. 
         FIGS. 21-22  are perspective views of a sleeve anchor device, having relatively long longitudinal slots, in an initial deployment state and a collapsed state. 
         FIGS. 23-26  are views of various embodiments of the shank for use in embodiments of the sleeve anchor device. 
         FIGS. 27-28  are views of a sleeve anchor device having multiple collapsing regions, in an initial deployment state and in a collapsed state anchoring the device in a target tissue location. 
         FIG. 29  is a partial side section view of an engagement or locking feature for the sleeve anchor device of  FIG. 28 . 
         FIG. 30  is a side section view of a sleeve anchor device having opposing end cap members and an engageable push rod. 
         FIG. 31  is a partial section view of an end cap member and an end portion of the push rod of  FIG. 30 . 
     
    
    
     The preceding description of the drawings is provided for example purposes only and should not be considered limiting. The following detailed description is provided for more detailed examples of the invention. Other embodiments not disclosed or directly discussed are also considered to be within the scope and spirit of the invention. It is not the intention of the inventor to limit the scope of the invention by describing one or more example embodiments. 
     DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS 
     The invention may be embodied in these and other specific forms without departing from the spirit or attributes thereof, and it is therefore desired that the embodiments be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention. 
     Referring generally to  FIGS. 1-31 , various embodiments of the present invention are depicted showing soft tissue anchor devices. The anchor devices  10  can be advanced through soft tissue  12  that is positioned so that at least a limited space is available, or can be created, on both sides of the tissue (e.g., sacrospinous ligmanet, obturator internus muscle, etc.). As such, various anchor embodiments can extend through the tissue, with a first portion of the anchor provided on a first side of the tissue and a second portion of the anchor provided on a second side of the tissue. This configuration creates an anchor site adapted to secure or support implants, slings, mesh, and the like. The anchor devices described herein can be deployed and positioned within the pelvic region of a patent via a catheter or other delivery tool. 
     In the embodiments of  FIGS. 1-3 , the anchor comprises a bolt device or anchor  20  having a bolt  22 , a tube or sleeve  24 , and one or more washers  26  threadably engaged with the bolt  22 . In  FIG. 1 , the bolt  22  is generally elongate and extends through the cylindrical tube  24  such that a first washer  26   a  is provided proximate a first end of the bolt  22  having a bolt head  23 , and a second washer  26   b  is provided proximate a second end of the bolt  22 . Further, the cylindrical tube  24  can include a plurality of longitudinal slots  28  defined therein. The slots  28  provide regions or lengths of weakness in the body of the cylindrical tube  24  that are vulnerable to longitudinal compression. As a result, while the tube  24  is generally elongate in its neutral or initial deployment state, a certain level of compression force on the tube  24  from the torque of turning the extending bolt  22  causes the tube  24  to collapse on itself along the weakened slot  28  regions. At the completion of the collapse, the previously elongate tube  24  is compressed to define a plurality of radially extending flanges  30 . 
     A driver tool  25  can be utilized to deploy the bolt device  20  to and through the body tissue  12 . Such a driver or actuator  25  can be manually and/or electrically powered and operated. The driver tool  25  may include a sleeve  25   a  having an open distal end  25   b  for receiving the bolt head  23 . The end of the sleeve  25   a  may include one or more engagement members  25   c  that engage washer  26   a . The engagement members  25   c  may comprise posts, shafts or rods that mate with openings or holes in washer  26   a . In one embodiment, washer  26   a  can include engagement apertures or features  27  adapted to receive a portion of the driver tool  25  such that the driver tool rotates the bolt  22  while keeping the washer  26   a  and concomitantly the tube  24  from rotating. By keeping the tube  24  and washer  26   a  stationary while rotating the bolt  22  a physician is able to collapse the tube  24  without needing any external forces against an outer surface of the tube  24  or without needing tissue engagement members or structures extending away from an outer surface of the tube  24  to engage surrounding tissue. Alternatively, a catheter, or other known delivery device can be used to deploy the bolt device  20  to the target tissue, wherein the actuator can then be used to drive the bolt device  20  through the tissue and into the securing configuration of a tissue anchor. 
     Various structures and techniques are envisioned for penetrating the tissue for positioning of the bolt device  20  through the tissue. For instance, the leading end of the bolt distal the bolt head  23  can include one or more angled members to aid in penetration through the tissue. In another embodiment of the invention either end or both ends of the bolt device  20  may be generally pointed to aid in delivery of the bolt device  20  to a particular tissue location. Alternatively, a drilling tool can be employed to bore through the tissue prior to insertion of the bolt device  20 . 
     To facilitate anchoring within the tissue, the leading edge of the bolt device  20 , including the washer  26   b , may be inserted through the tissue for positioning on the second side of the tissue. The driver tool may then engage the bolt head  23  and engagement apertures  27 . Actuation of the driver tool drives washer  26   a  and washer  26   b  toward each other, which in turn provides an increasing level of compression force on the tube  24 . As the compression forces increases with continued turning of the driver tool, the tube  24  begins to buckle due to the compromised structure created by the slots  28 . As such, the tube  24  completely buckles to transform at least a portion of the tube  24  from its initial elongated deployment configuration to a compressed anchoring configuration. In the compressed anchoring configuration, the buckled tube  24  defines a plurality of flanges  30  extending radially from a central axis of the bolt  22  such that the body tissue is positioned intermediate washer  26   b  and the extended flanges  30 , providing an anchor in the tissue. Further adjustments, e.g., loosening or tightening, can be made to the bolt head  23  via the driver tool  25  to stabilize and secure the anchor  20 . 
     The bolt anchor  20  and its respective components can be constructed of known compatible metal or plastic materials. In addition, known support structures or devices, such as mesh, sutures and slings, can be selectively attached to one or more portions of the anchor  20 , including the bolt head  23  or washer  26   a , to provide a tissue anchor site for the support structures or devices. Any sutures or slings now known or to be developed can be connected to a portion of the bolt anchor  20 . Additionally, multiple bolt anchors  20  may be used to suspend a suture or sling to support tissue or an organ. 
     Alternative embodiments of the bolt anchor  20  are depicted in  FIGS. 2-3 . The embodiment of  FIG. 2  shows a bolt anchor  20  in its compressed state or configuration, with the anchor  20  having a single washer  26  threadably engaged with the bolt  22  proximate the bolt head  23 . The embodiment of  FIG. 3  includes a plurality of loop-shaped flanges  30 . Components and structures of the bolt anchor  20  can take on a myriad of alternative shapes, sizes and configurations without deviating from the spirit and scope of the present invention. 
     In another embodiment, as shown in  FIGS. 4-5 , the anchor  20  comprises a shank device  40  including an elongate sleeve  42  having a lumen  43  therethrough, and a shank  44  extendable through at least a portion of the lumen  43 . The shank  44  includes a head portion  45  sized generally larger than the lumen  43  of the elongate sleeve  42 . Further, the elongate sleeve  42  generally includes a plurality of compromised or weakened wall portions  46 . The wall portions  46  can be formed or otherwise defined in the wall of the sleeve  42  with notches, scoring, folding, bending, decreased wall thickness, and the like. 
     In use, the sleeve  42  and shank head  45  are inserted through the tissue  12  to the second side of the tissue  12   b  such that at least a trailing end  42   a  of the sleeve  42  is positioned on the first side  12   a  of the tissue  12 . The shank head  45  can be angled to aid in tissue penetration. Alternatively, a drilling or deployment tool can be employed to penetrate the tissue  12  to facilitate insertion of the anchor  20 . After insertion of the shank head  45  and sleeve  42  through the tissue  12 , the shank  44  and corresponding shank head  45  may be pulled back toward the tissue  12  to exert a compression force on the wall of the sleeve  42 . This compression force causes the weakened wall portions  46  to bend or fold, causing the sleeve  42  to fold onto itself at the weakened wall portions  46  to form the anchor flanges  48  ( FIG. 5 ). Various locking structures, configurations and techniques can be employed to aid in retaining the anchor  40  in the tissue  12 , including any of the various locking features disclosed herein. For instance,  FIGS. 15-18  illustrate a tabbed locking feature that can be implemented with the anchor  40 . In certain embodiments, where continuous tension is applied to the suture  15  or shank  44 , it may not be necessary to provide locking features. 
     As illustrated in  FIGS. 6-14 , various hinging anchor devices  50  generally include a main sleeve body portion  52  having an interior  54 , and a shank  56  having a head portion  58 . The main body portion  52  includes a plurality of adjacent longitudinal body sections  60  defined by separated longitudinal grooves or slots  61  in the body portion  52 , with each of the sections  60  further including a living hinge  62 . The living hinges  62  can be provided in the body sections  60  by predefined bends, scores, creases, pleats, folds, crimps, decreased wall thickness, and the like. Grooves or slots  61  of varying length, spacing, size and number can be included in the main body portion  52  to predefine the area of the main body portion  52  that is collapsible. 
     The embodiment of  FIGS. 7 and 9  further include a locking feature  64  within the interior  54  of the body portion  52 . The locking feature  64  can include one or more tabs  66  extending into the interior  54 . The tabs  66  are sized and shaped to mate with a corresponding end  68  (e.g., angled) of the shank  56  to lock the shank  56  in place within the body portion  52 . In the embodiment of  FIGS. 9-10 , a washer or flange  53  can also be included at the end of the body portion  52  distal the shank head  58  to aid in retaining the anchor  50  within the tissue for those applications where the suture  15  is not continuously exerting a pulling force on the shank  56  or body portion  52 . While a suture  15  is shown in the figures for connection with the anchor  50 , other devices and structures, such as support mesh and slings, can be connected with the anchor  50  as well. 
     Like the embodiments of  FIGS. 4-5 , the hinging anchor  50  embodiment is inserted through the tissue  12  with the leading end including the shank head  58 . In this elongate deployment state A ( FIG. 9 ), a substantial portion of the body sections  60 , including the living hinges  62 , is disposed on the second side  12   b  of the tissue  12 . The shank  56  is then pulled back toward the tissue  12  to exert a compression force on the body portion  52  that causes the body sections  60  to bend at the living hinges  62 . This intermediate or partially collapsed state B for the main body portion  52  is illustrated in  FIGS. 6 and 9 . As a result of continued compression, the body sections  60  on the second tissue side  12   b  ultimately expand out to form extending flanges  70  to anchor the device  50  in place within the tissue  12 . Again, washer  53  ( FIGS. 9-10 ), locking feature  64  ( FIGS. 7 and 9 ) and/or other structures or techniques can be employed to retain the anchor device  50  in its position within the body tissue  12 . 
       FIGS. 11-14  illustrate various embodiments of the anchor device  50 , wherein modifications in the positioning of the living hinges  62  results in extending flanges  70  of varying angles and designs. 
     Referring to  FIGS. 15-22 , embodiments of the present invention employing slotted sleeves and shanks are depicted to illustrate the anchors in use, and alternative configurations for the shank and slot lengths. Any of these configurations can be employed, in whole or in part, with any of the anchor embodiments described or depicted herein. For instance, the shank  90  shown in  FIGS. 15-16  can extend substantially the entire length of the collapsible sleeve  94  to create a travel distance for the shank  90  to the point of containment within the locking feature  96 . This shorter travel distance, in turn, results in a reduced compression state for the sleeve  94  ( FIG. 16 ). In contrast, a greater compression state is achieved with the embodiment of  FIGS. 17-18 , where the length of the shank  90  is substantially shorter than the length of the sleeve  94  to create a greater travel distance for the shank  90  to the locking feature  96 .  FIGS. 15-16  also show an embodiment of the shank head  92  angled to assist in penetrating body tissue during deployment. 
       FIGS. 19-21  illustrate embodiments of the anchor device with alternative slot  98  lengths along the collapsible sleeve  97 . Relatively short slots  98  ( FIGS. 19-20 ) in the sleeve  97  results in shorter extending flanges  99  in a fully collapsed state ( FIG. 20 ). In contrast, relatively long slots  98  ( FIGS. 21-22 ) results in longer extending flanges  99  in the fully collapsed state. Similarly, shorter slots  98  dictate a shorter travel distance for the shank  90  to actuate complete collapse of the sleeve  97 , while longer slots  98  dictate a longer travel distance for the shank  90  to actuate complete collapse. 
       FIGS. 23-26  illustrate potential embodiments for the shank member capable of implementation with various anchors of the present invention. The shank  100  of  FIG. 23  can comprise a central shaft portion  102  extending between a head portion  106  and a travel end  104  adapted to traverse the interior of the collapsible sleeve. The head portion  106  can be rounded, or angled (e.g., FIGS.  15 - 16 ) to facilitate tissue penetration during deployment. The travel end  104  in this embodiment can be angled and rigid (e.g., generally solid) to promote engagement of the travel end  104  within a locking feature of the anchor (e.g., feature  96  of  FIG. 16 ). Alternatively, the shanks  110 ,  120  of  FIGS. 24 and 26  can include flexible, or otherwise deformable or malleable, travel ends  114 ,  124 . In the embodiment of  FIG. 24 , the flexible travel end  114  extends from the shaft  112 , distal the head portion  116 , and is configured with a generally open or hollow interior ( FIG. 25 ). As such, the flexible travel end  114  is capable of selectively deforming within the collapsible sleeve and upon engagement with locking features, washers, and other structures or components associated with the disclosed anchor devices. Similarly, the flexible travel end  124  of shank  120  in the embodiment of  FIG. 26  includes a plurality of angled members  125  adapted for selective deformability during travel and engagement. The flexible travel end  124  is positioned on an end of the shaft  122 , distal the head portion  126 . 
     As illustrated in  FIGS. 27-29 , embodiments of the present invention can include a collapsible sleeve  130  having multiple slotted portions  132 ,  134  longitudinally spaced from one another. As such, collapsible sleeve  130  includes two distinct collapsible regions separated by an intermediate body portion  136 . The sleeve  130 , in its initial elongate deployment state ( FIG. 27 ), is inserted or penetrated through body tissue  12  such that the slots  132  of the first collapsible region are positioned on a second tissue side  12   b , with the slots  134  of the second collapsible region positioned on the first second tissue side  12   a . Upon deployment, the shank  138  is pulled back, whereby the head portion  140  engages the sleeve  130  to apply a compression force on the sleeve  130 . To facilitate corresponding compression force on the compression slots  134  residing on first tissue side  12   a , an end cap  142  can be provided and adapted for engagement with travel end  138   a  of the shank  138 . Travel end  138   a  can include indexing teeth  139  spaced and configured to provide stepped or incremental engagement with corresponding structures or features in the end cap  142 . Other connection features and techniques are envisioned to selectively couple the shank  138 , or the travel end  138   a , with the second compression region having slots  134  defined therein. 
     As illustrated in  FIGS. 30-31 , an anchor device  150  of the present invention can include a sleeve portion  152 , a first cap member  154  and a second cap member  156 , with the cap members  154 ,  156  being insertable within respective ends of the sleeve  152 . Cap member  154  includes a head portion  158  abuttable against an outside portion of the sleeve  152 , such that an interior cap portion  160  extends into the lumen of the sleeve  152 . The interior cap portion  160  can further include a recess or bore  161  extending a distance therein. Cap member  156  includes a head portion  162  abuttable against an outside portion of the sleeve  152 , with an interior cap portion  160  extending into the lumen of the sleeve  152 . The interior portion  160  of cap member  154  can include teeth  160   a , or other engagement features, for interfacing and locking into corresponding features provided with the interior cap portion  164  of cap member  156 . The cap member  156  can include a bore  163  in alignable communication with the interior of the sleeve and the recess  161  in cap member  154 . 
     An engagement or push rod  166  is sized and shaped for insertion through the bore  163  of cap member  156 , through the sleeve  152  and into the recess  161  of cap member  154 , as shown in  FIG. 30 . The recess  161  can be configured and shaped to receive a leading end of the push rod  166 , as shown in  FIG. 31 . Once it is positioned within the recess  161 , the push rod  166  can be turned into a locking position, press fit, or otherwise engaged with the cap member  154  via the recess  161 . Upon engagement, the push rod  166  can be pulled which, in turn, pulls cap member  154  against the sleeve  152  to exert a compression force on the sleeve  152  between the two cap members  154 ,  156 . The various weakened wall and hinging features described herein for various embodiments can be included along a length or portion of the sleeve  152  to facilitate collapse of the sleeve  152 . As with the other embodiments, this collapse provides an anchoring device within the body tissue  12  that can be connected with sutures, slings, mesh and like devices. 
     The invention described and depicted herein may be embodied in these and other specific forms without departing from the spirit or attributes thereof, and it is therefore desired that the embodiments be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.