Abstract:
An adjustable single-incision sling system, includes a tissue support portion, a first tissue anchor, and a second tissue anchor. The first tissue anchor connects to the tissue support portion via a first arm, which spaces the first tissue anchor from the tissue support portion a fixed first distance. The second tissue anchor connects to the tissue support portion via a second arm, which has a free end passing through the second tissue anchor spacing the second tissue anchor from the tissue support portion a variable second distance, such that movement of the free end with respect to the second tissue anchor decreases the second distance.

Description:
[0001]    This application is a continuation of U.S. patent application Ser. No. 13/524,408, filed Jun. 15, 2012, now U.S. Pat. No. 8,574,149, which is a continuation of U.S. patent application Ser. No. 12/269,749, filed Nov. 12, 2008, now U.S. Pat. No. 8,206,280, which claims the benefit of priority to U.S. Provisional Application Nos. 60/987,469, filed Nov. 13, 2007, titled “Implant with Adjustability Feature;” 61/015,741, filed Dec. 21, 2007, titled “Tissue Anchor Insertion Device;” 61/020,231 filed Jan. 10, 2008, titled “Continuous Knit Tubular Mesh Implant;” 61/025,461 filed Feb. 1, 2008, titled “Adjustable Tissue Support Member;” and 61/102,147, filed Oct. 2, 2008, titled “Adjustable Tissue Support Member,” the disclosures of which are all incorporated herein by reference in their entirety. 
     
    
       [0002]    Female urinary incontinence is commonly treated by a sling suspension procedure. Generally, sling suspension procedures involve the placement of a sling member beneath a patient&#39;s urethra. The sling member is suitably implanted in the patient&#39;s tissue with an introducer needle, which helps draw the sling into position. 
         [0003]    Slings have been made of numerous materials, synthetic and natural, and are generally in the form of a mesh. A traditional sling procedure involves placing a strip of implant material (natural tissue, synthetic mesh, or a combination of the two) under the urethra and securing it to the rectus fascia or other portions of the patient&#39;s anatomy with sutures to hold the implant in position during the healing process. 
         [0004]    Improved techniques have been developed that speed the implant process by reducing the number of incisions made and by altering the pathways by which the implant is introduced into the body. These improvements, which employ specialized instrumentation, help to reduce operative time and have made the procedure less invasive. The improved techniques generally require that an implant be joined to an introducer needle. The implant is then inserted into, and pulled through, the body. Subsequently, the implant is detached from the introducer needle. 
         [0005]    Such procedures may require long needle passes and substantial tissue dissection, such as in the case of a retropubic or suprapubic procedure. Long needle passes increase the likelihood of an unintended perforation of a body structure (e.g., the bladder). In addition, the procedures typically require not only at least one vaginal incision, but also two external incisions at the locus of the obturator foramina in the case of a transobturator approach, and above the pubic bone in the retro- and suprapubic approaches. 
         [0006]    Such procedures often use instrumentation that lacks an adjustability feature. A mesh sling has to exert an appropriate amount of tension on the urethra. Excessive tension can result in kinking of the urethra and/or undue tissue erosion, whereas insufficient tension can result in an ineffective sling. It might be desirable to be able to adjust the tension of the sling after both ends of the sling have been anchored in tissue, but before the tension is fixed and surgery is concluded. In addition, it could be desirable to provide bi-directional adjustment and not just adjustment in a single direction. Features that further the achievement of at least one of the foregoing goals could be desirable. 
         [0007]    In view of the above, it would be beneficial to have a minimally invasive sling suitable for treating various conditions, such as incontinence, for example fecal and urinary incontinence, such as female urinary incontinence. According to various embodiments, each end of the implanted minimally invasive sling terminates in a tissue anchor. The length of the sling (and the tension exerted by the sling on the urethra) is configured for adjustment once at least one of the tissue anchors has been implanted. 
       SUMMARY 
       [0008]    According to one embodiment, there is disclosed herein a tissue support system comprising an implantable tissue support member, wherein the implantable tissue support member comprises a tissue support portion having a length and a width, a first arm disposed at one end of the tissue support portion, and a second arm disposed at an opposite end of the tissue support portion, a first tissue anchor connected to the first arm, and a second tissue anchor connected to the second arm, wherein the second tissue anchor is slideable along a length of said second arm. 
         [0009]    According to another embodiment, there is disclosed herein a tissue support system comprising an implantable tissue support member, wherein the implantable tissue support member comprises a tissue support portion having a first end and a second end, a first arm having a first end and a second end, wherein the first end is joined to the first end of the tissue support portion, a second arm having a first end and a second end, wherein the first end is joined to the second end of the tissue support portion, a first tissue anchor fixed to the second end of the first arm, and a second tissue anchor having an aperture therein, wherein the aperture is configured to at least partially enclose a portion of the second arm. 
         [0010]    According to yet another embodiment, there is disclosed herein a method for providing support to body tissue, comprising making an incision in the vaginal wall, inserting an introducer needle having a first tissue anchor at the distal end thereof into the incision in the direction of the obturator membrane, wherein the first introducer needle is connected to an implant, ejecting the first tissue anchor from the introducer needle, withdrawing the introducer needle from the incision, and inserting a second tissue anchor in the distal end thereof wherein the second tissue anchor is connected to an implant, re-inserting the introducer needle into the incision in the direction of the contra-lateral obturator membrane, ejecting the second tissue anchor from the introducer needle, and applying traction to the implant until the desired amount of tissue support is obtained. 
         [0011]    According to another embodiment, there is disclosed herein a medical device configured for implantation in tissue, comprising a lumen formed from a flexible material, at least one tissue anchor having at least one aperture therein, said at least one aperture configured to receive said lumen formed from a flexible material, and an anchor stop disposed in said lumen, wherein said anchor stop is configured to resist movement when urged in one direction within said lumen. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The disclosed embodiments can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. 
           [0013]      FIG. 1  illustrates one aspect of a tissue support system in accordance with the present disclosure. 
           [0014]      FIG. 2  illustrates an aspect of an implantable tissue support member and an introducer needle. 
           [0015]      FIG. 3  illustrates a tissue anchor being released from an introducer needle. 
           [0016]      FIG. 4  illustrates a stylet being urged into a lumen. 
           [0017]      FIG. 5  illustrates a view of a tissue support member. 
           [0018]      FIG. 6  illustrates an exploded view of a tissue support member. 
           [0019]      FIG. 7  illustrates a view of one aspect of a tissue support member. 
           [0020]      FIG. 8  illustrates an exploded view of an introducer needle. 
           [0021]      FIGS. 9A-9B  illustrate cut-away views of exemplary tissue anchors. 
           [0022]      FIG. 10  illustrates an embodiment of a tissue support system. 
           [0023]      FIG. 11  illustrates cut-away views of exemplary tissue anchors. 
           [0024]      FIGS. 12A-12B  illustrate bottom and side views of an exemplary tissue anchor. 
       
    
    
     DESCRIPTION 
       [0025]    The following description should be read with reference to the drawings. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. 
         [0026]      FIG. 1  illustrates a tissue support system  10  according to various aspects of the present disclosure. The system includes an implantable tissue support member  100 , a stylet  185 , and an introducer needle  200 . The tissue support member comprises a tissue support portion  130  having ends  132  and  134  connected to arms  120  and  160 , and orienting indicia  140 . The arm  129  has ends  121  and  122 , and arm  160  has ends  162  and  164 . 
         [0027]    The orienting indicator  140  can comprise, by way of non-limiting example, a dyed centerline, or a colored thread woven into the center portion of the implant. According to one embodiment, the indicator is colored midline indicator in the form of a blue polypropylene thread woven through the middle of tissue support portion  130 . 
         [0028]    The implantable support member  100  further comprises a first tissue anchor  110 , and a second tissue anchor  150 . Tissue anchor  150  is configured to be connected to, but moveable along (i.e., slidably attached to), a length of arm  160 . According to one embodiment, tissue anchor  150  slides along a length of arm  160 . According to various embodiments, tissue anchor  150  has an aperture therein, through which arm  160  is received. According to certain embodiments, anchor  110  is fixed to end  121  of arm  120 . According to another embodiment, anchor  110  is configured to be connected to, but moveable along, a length of arm  120 . 
         [0029]    According to one embodiment, tissue support portion  130  is a flat, single layer of mesh, and arms  120  and  160  are tubular mesh constructs. The tubular knit pattern allows for bi-directional adjustability of the implant once the tissue anchors  110  and  150  are in place. The arms are joined to the support feature via any suitable means, including by stitching, adhesive, sonic welding, and heat-staking. According to one embodiment, each of the arms is sewn to the tissue support portion  130  using the same type and size of polypropylene fiber from which the tissue support portion  130  and arms  120  and  160  are constructed. 
         [0030]    According to another embodiment, tissue support portion  130  and arms  120  and  160  are constructed from a unitary tubular member having a single lumen running longitudinally therethrough. In such an embodiment, the diameter of the arms transition at  162  and  122  to form the tissue support portion  130 . According to this embodiment, there is no joint at  162  or  122 . According to various embodiments, the tubular mesh is smooth, providing a slight “ratcheting” effect during adjustment to give tactile feedback to the user. 
         [0031]    Tubular mesh implants can be prepared by a number of known methods. For example, the tubular mesh can be manufactured by circular knitting, either single-ended or double-ended for added strength to provide a stable knit, uniform cross section, and smooth profile. The mesh can be manufactured by weft knitting via a “glove” style knitting machine to make smooth chain link stitches, which can allow diameter variation over a given length. According to another embodiment, the tubular mesh is a double warp knit, providing a high strength, multi-end knit using two flat mesh warp knits that are joined on the sides to make a tube mesh. According to another embodiment, the tubular mesh is made from a flat knitting machine, such as a Shimatronic® flat knitting machine sold by Shima Seiki Mfg., Ltd. of Wakayama, JP. 
         [0032]    The mesh portions of implant  100  can have a single-strand or double-strand construction. According to certain embodiments, the tissue support portion  130  is a flat mesh comprising a knitted, open porosity, monofilament, polypropylene mesh strip. The open porosity of the mesh design and large pore sizes allow for macrophage penetration and the creation of an inert scaffold for tissue ingrowth to create a permanent support for the urethra. The pore sizes can be of any suitable diameter to allow tissue ingrowth. The tissue support portion  130  of implant  100  can have smaller pores ranging in diameter from 0.4 mm to 1.1 mm, for example 0.5 mm to 1.0 mm, such as 0.6 to 0.9 mm. The mesh can additionally have larger pores ranging in diameter from 0.8 mm to 1.3 mm, for example 1.0 mm to 1.2 mm. 
         [0033]    According to one embodiment, the mesh is a polypropylene knit made from a small diameter fiber to create a soft and pliable material. According to various embodiments, the mesh is constructed so as to avoid, or at least minimize, curling of the implant upon application of a tensile force in the lengthwise direction. According to one embodiment, the mesh implant is a single-knit, double-stranded construction. The fibers can be of any suitable diameter. For example, the fibers can have a diameter ranging from 0.0015″ to 0.100″, for example 0.002″, 0.0025″, 0.003″ or 0.004″. 
         [0034]    The implants disclosed herein can be constructed from different types of mesh. One suitable non-limiting example is a knitted polypropylene monofilament mesh fabric, such as BARD MESH from C. R. Bard, Inc. Other materials include SOFT TISSUE PATCH (microporous ePTFE—available from W.L. Gore &amp; Associates, Inc.); SURGIPRO (available from US Surgical, Inc.); TRELEX (available from Meadox Medical); PROLENE and MERSILENE (available from Ethicon, Inc.); and other mesh materials (e.g., available from Atrium Medical Corporation). It is also contemplated that the mesh fabric may be formed from multifilament yarns and that any suitable method, such as knitting, weaving, braiding, molding, and the like, may be employed to form the prosthetic mesh material. The mesh may also be constructed from absorbable materials, such as polylactic acid. According to various embodiments, the mesh implants disclosed herein are manufactured via a knitting machine, such as a computerized Jacquard flat knitting machine. 
         [0035]    The implants disclosed herein can include, or be constructed entirely from, a natural material. For example, the natural material can be disposed over at least one surface of the tissue support members disclosed herein. The natural material can be any suitable material including, but not limited to, biologically derived materials, such as cadaveric (human) or xenograft tissue (particularly of porcine or bovine origin)—for example dermis processed to make an acellular collagen scaffold or intestinal submucosa or other biological material and/or bioengineered materials. Collagen materials can be obtained from various sources, such as that available from Cook Biomedical, Inc. under the name COOK SURGISIS soft tissue graft. In one embodiment, the natural material comprises a cross-linked porcine dermal collagen material, such as COLLAMEND surgical implant from Davol (R.I.). Other suitable bioengineered materials may be employed as the present disclosure is not limited in this respect. 
         [0036]    The arms  120  and  160  can have any width sufficient for the implant&#39;s intended purpose. For example, the arms can have a width ranging from 0.5 to 5.0 mm, including 1 mm to 5 mm, for example 2.0 mm to 4 mm, or 2.5 mm to 3.5 mm. The arms can have a length ranging from 10 mm to 100 mm, for example 20 mm to 60 mm, including 30 mm to 50 mm. According to various embodiments, tissue support portion  130  has a length ranging from about 30 mm to about 100 mm, for example about 40 mm to about 80 mm, including 65 mm. The support portion  130  can have any width sufficient to provide support to a body tissue. According to various embodiments, the width can range from 5 mm to 20 mm, for example 7 mm to 15 mm, including 10 mm to 14 mm. According to one embodiment, the width of tissue support portion  130  ranges from 5 mm to 15 mm, for example 10 mm to 12 mm. According to various embodiments, arms  120  and  160  have the same length, or substantially the same length. According to another embodiment, arms  120  and  160  have different lengths. For example, arm  120  is 5 mm to 20 mm long, for example 80 mm to 15 mm long, and arm  160  is 80 mm to 200 mm, for example 100 mm to 150 mm in length. 
         [0037]    According to various embodiments, a tissue anchor can be fixed, either directly or indirectly (i.e., via a connector) to one or both of arms  120  and  160 . Any anchor suitable for anchoring an implant to tissue, such as soft tissue, for example muscle tissue, a ligament, a tendon, or a membrane, such as the transobturator membrane, will suffice. The anchor may be fixed to the arms via any suitable means, including mechanically, by adhesive, friction fit, ultrasonic welding, solvent bonding, and heat staking. 
         [0038]    According to various embodiments, a first tissue anchor  110  is configured to move freely along a length of arm  120 , and a second anchor  150  is also configured to move freely along a length of arm  160 . Once the anchors are implanted and the desired tension is obtained, both anchors can be fixed in position to arms  120  and  160 . According to another embodiment, a first tissue anchor  110  is permanently fixed to the terminal end  121  of arm  120 , and a second anchor  150  is configured to move freely along a length of arm  160 . This facilitates the adjustment feature of the implant, such that once the first anchor and then the second anchor are implanted, the tension exerted on the urethra by the sling is adjusted by manipulating arm  160  in either direction relative to the anchor  150 . The manipulation is via gripping feature  180 , disposed at end  164  of arm  160 . Once the desired tension is reached, the arm  160  is fixed in position to the anchor. 
         [0039]    According to one embodiment, at least one of the tissue anchors, such as tissue anchor  150 , contains an aperture that is normal to the longitudinal axis of the anchor. This is illustrated in  FIGS. 9A-9B  and  FIG. 11 .  FIG. 9A  illustrates anchor  150   a  having barbs  151   a , and aperture  152   a  configured to receive mesh arm  160 . The aperture  151   a  and mesh arm  160  are respectively sized so that movement of arm  160  therethrough is restricted. The degree of restriction will depend on the fit between the arm and the edges of the aperture. According to one embodiment, the arm  160  and aperture  152   a  are relatively sized so that a slippage resistance in an amount of force ranging from 4 ounces to 6 pounds, for example 2 to 6 pounds, or 1 to 2 pounds, is required to pull 1 cm of the arm through the anchor aperture.  FIG. 9B  illustrates tissue anchor  150   b  having a triangularly-shaped aperture  152   b . Arm  160  is received in aperture  152   b , and exemplary feature  153   b  (the distal end of aperture  152   b ) assists in resisting movement of the arm. Additional exemplary tissue anchors are illustrated in  FIG. 11 . 
         [0040]      FIG. 12A  illustrates a bottom view of an exemplary tissue anchor  150  according to the present disclosure. According to one embodiment, the tissue anchor has a longitudinal axis defined by a lumen. According to one embodiment, the lumen is configured to receive a pin that can pierce, and thereby anchor into position, arm  160 .  FIG. 12B  illustrates a side view of tissue anchor  150 . 
         [0041]      FIG. 10  illustrates another embodiment in accordance with the present disclosure. A tissue support portion  130  is disposed underneath urethra  310  to assist in managing the flow of urine from bladder  300 . Anchors  110   a  and  150   a  having barbs  111   a  and  151   a , respectively, are anchored in the two obturator membranes  330   a  and  330   b , respectively. A first adjustment suture  410  is attached to arm  160  at location  412 . The distal end of first adjustment suture  410  is attached to tab  414 . A second adjustment suture  416  is attached to tissue support portion  130  at location  418 . The distal end of adjustment suture  416  is attached to tab  420 . Both adjustment sutures  416  and  410  are configured to be disposed outside vaginal incision  320 . According to various embodiments, and like the tissue anchors and the tissue support system, the adjustment sutures can be bioabsorbable. 
         [0042]    Once the anchors  110   a  and  151   a  are securely anchored in the two obturator membranes, the surgeon may adjust the amount of tension exerted by tissue support portion  130  on urethra  310 . According to one embodiment, the tension may be decreased by pulling suture  416  via tab  420 . Alternatively, tension may be increased by pulling on suture  410  via tab  414 . According to various embodiments, the adjustment sutures  410  and  416  may be differently colored to aid in identification. According to one embodiment, tabs  414  and  420  are differently shaped, differently colored, and/or marked to aid in distinguishing one suture from the other. According to another embodiment, sutures  410  and  416  are each in the form of a loop (not shown) that freely passes through respective points  412  and  418 . That way, when the loops are cut following final tensioning of the implant, the entire length of suture is removed from the body. 
         [0043]    According to various embodiments, immediately after the implant is tensioned, sutured  410  and  416  are cut and removed, and incision  320  is sutured closed. According to another embodiment, the implant is initially tensioned, and the incision is temporarily sutured and/or packed. The patient returns to the surgeon after 12 to 72 hours, and the patient&#39;s degree of continence or retention is reviewed. A final adjustment is made to the implant via tabs  414  and/or  420 , the sutures  410  and  416  are cut and removed, and incision  320  is sutured closed. 
         [0044]    The tissue anchors disclosed herein may be constructed from any biocompatible material, including stainless steel, polypropylene, and absorbable materials, including but not limited to polylactic acid, polyglactin, and polyglycolic acid, or other materials commonly used in absorbable surgical materials. According to various embodiments, the anchors disclosed herein can be of any dimension suitable to withstand particular pulling forces. The anchors can range in length from, for example, 5 mm to 20 mm, for example 10 mm to 15 mm, such as 10.1, 10.2, 10.3, 10.4, or 10.5 mm. The anchors have a thickness ranging from 1 mm to 5 mm, for example 2 mm to 3 mm thick. The anchors have a base of approximately 2.5 mm, for example 2.2 mm to 2.3 mm. 
         [0045]    With reference to  FIG. 1 , the tissue support system  10  may further include stylet  185 . Stylet  185  is configured for insertion into gripping feature  180 , and then into the lumen  166  of arm  160 . Stylet  185  includes a shaft  190  having a proximal end  194  and distal end  192 , gripping feature  196 , and a distal end  198 . Stylet  185  can range in length from, for example, 12 cm to 25 cm, including 18 cm to 22 cm, such as 21 cm. 
         [0046]    The tissue support system may further comprise introducer needle  200  having a handle  210 , shaft  220 , collet  240  configured to releasably secure a tissue anchor, and manually operable actuator  230 . The actuator  230  is configured to secure a tissue anchor to the collet  240  when in position  231  ( FIG. 2 ), and release the tissue anchor when moved to position  232  ( FIG. 3 ). The illustrated introducer needle  200  has a curved shaft  220 , where the curve is in substantially the same plane as the handle. With reference to  FIG. 2 , shaft  220  can have a length  213  ranging from 3 cm to 7 cm, such as 4 cm to 6 cm, for example 5 cm. Shaft  220  can have a length  214  ranging from 3.5 cm to 5.5 cm, for example 4 cm to 5 cm, and 4.5 cm. According to various embodiments, shaft  220  is sized and shaped so that it snugly rotates around the ischiopubic ramus when an anchor is inserted in the region of the obturator foramen. According to another embodiment, the shaft has a helical shape. According to this embodiment, the system may be provided to a clinician with two helically-shaped needles, one for each side of a patient&#39;s anatomy. 
         [0047]      FIGS. 1-6  illustrate locking member  170  disposed in lumen  166  in accordance with the present disclosure. According to various embodiments, the locking member  170  is constructed from polypropylene. The locking member  170  can have any size suitable for its intended purpose. By way of non-limiting example, the locking member has a diameter ranging from 1 mm to 2 mm, for example 1.2 mm to 1.8 mm, a width ranging from 1.5 mm to 2.5 mm, and a length ranging from 2.5 mm to 5.5 mm, for example 4.5 mm. 
         [0048]    With reference to  FIG. 4 , the locking member  170  is configured to be initially disposed within the lumen  166  of arm  160  at a location proximal to grasping feature  180 . After anchor  150  is set in a desired tissue location, arm  160  is fixed in position relative to the locking feature until it abuts anchor  150 . The sliding can be accomplished by insertion of flexible stylet  185  through lumen  182  in grasping feature  185 , which lumen is in fluid communication with lumen  166  in arm  160 . The distal end  198  of stylet  185  contacts locking member  170 , and urges the locking member in the direction of anchor  150 . Movement of the locking member in the reverse direction, i.e., towards end  164  of arm  160 , is arrested by the prongs  172 . When the anchor stop is urged towards the end  164 , the prongs  170  will tend to anchor into the mesh, thus arresting further movement. 
         [0049]      FIG. 5  illustrates another view of the implantable tissue support member  100 .  FIG. 6  illustrates a partially exploded view of the tissue support member.  FIG. 7  illustrates one embodiment of the fixation of anchor  110  to arm  120 . End  121  of arm  120  is inserted into aperture  112  of anchor  110 . Plug  111  is then inserted into lumen  166  and aperture  112 , thereby providing a friction fit between the plug  112 , the arm  120 , and anchor  110 . 
         [0050]    The tissue support system in accordance with the present disclosure can be used to restore correct support to various types of tissue. For example, the system can be used to treat female and male urinary incontinence, for example stress incontinence. The system can be used to treat fecal incontinence. In addition, the system can be used for pelvic floor repair, such as pelvic organ prolapse, by fixing a tissue support portion to ligament and/or muscle for anterior, posterior, and apical vaginal vault repair. 
         [0051]    According to one embodiment, the tissue support system disclosed herein comprises a urethral sling. According to one embodiment, a procedure for implanting the urethral sling generally comprises making a mid-urethral incision and dissecting the vaginal tissue out laterally in the direction of the superior-medial aspect of the obturator foramen. The ends of the sling are then passed through the obturator internus muscle/obturator membrane using an introducer device. According to one embodiment, two exit incisions are made in the groin to allow for exteriorization of the introducer needle and sling ends. These exit incisions allow for adjustment of the sling tension under the urethra using the free arms of the mesh at the exit incisions. According to another embodiment of the present disclosure, the urethral sling does not require any exit incisions because mesh adjustment can be done at the vaginal incision. 
         [0052]    The following illustrates one way in which a tissue support system in accordance with the present disclosure may be used to treat female urinary incontinence. The patient is placed in a dorsal lithotomy position with hips in flexion at approximately 90 degrees and the buttocks even with the edge of the table. Standard operative preparation of the surgical site is completed, and the bladder is emptied with a Foley catheter. The mid-urethra is identified by first locating the external urethral meatus and then the bladder neck by identifying the Foley catheter bulb. 
         [0053]    Hydro-dissection is performed by injecting a solution (e.g., 1% lidocaine with epinephrine) at the midline between the vaginal wall and urethra, thereby creating a urethro-vaginal space. Additional hydro-dissection can be performed by injecting solution laterally towards the cephalad aspect of the ischiopubic ramus in order to better identify the lateral sulci. Allis clamps are placed at the level of the mid-urethra on the anterior vaginal wall. 
         [0054]    A small (approximately 1.5 cm) incision is made in the anterior vaginal wall beginning approximately 1 cm under the urethral meatus. The depth of the incision may extend into the vaginal muscularis. The urethra is gently freed from the anterior vaginal wall. Next, dissection is made using scissors (e.g., Metzenbaum scissors) laterally in a 45 degree angle until the tip of the scissors makes contact with the medial-cephalad aspect of the ischiopubic ramus (approximately 1-2 cm). This procedure is then repeated on the contralateral side. 
         [0055]    The introducer needle  200  is loaded with anchor  110 , as shown in  FIG. 2 . The introducer is then inserted into the vaginal dissection laterally through one of the dissected planes toward the cephalad aspect of the ischiopubic ramus. The introducer  200  is angled towards the superior-medial aspect of the obturator foramen. Once the fixed anchor is behind the ischiopubic ramus, anchor  110  is pushed into the tissue until it is slightly beyond the ramus. 
         [0056]    The handle  210  is pivoted to insert the anchor  110  through the obturator internus muscle/membrane at the superior-medial aspect of the obturator foramen, such that the orienting indicia  140  is at or slightly past the midurethra (about 0.5 cm) in the direction of insertion. A distinctive pop may be heard, indicating perforation of the muscle/membrane. The anchor  110  is released by pushing the actuator  230  forward from position  231  to position  232  in the introducer handle  210 . The introducer is then gently retracted by reversing through the insertion path. 
         [0057]    After anchor  110  is released from collet  240 , gentle traction is applied to the sub-urethral sling to confirm secure fixation in the tissue. 
         [0058]    Next, adjustable anchor  150  is loaded into the introducer and secured by retracting the manual actuator  230  on the handle  210  from position  232  to position  231 . A slight “click” may be felt or heard, confirming secure loading. At this point in the procedure, care is taken to ensure the implant is not twisted. 
         [0059]    Next, it may be desirable to confirm at least 4 cm of adjustable mesh between the tissue support portion  130  and the anchor  150  prior to insertion. 
         [0060]    The anchor  150  is inserted in the contralateral dissection plane, and the introducer needle  200  is oriented towards the superior-medial aspect of the obturator foramen. Anchor  150  is pushed into the tissue slightly beyond the ischiopubic ramus, and handle  210  is pivoted to insert anchor  150  through the obturator internus muscle/membrane in the superior-medial aspect of the obturator foramen. 
         [0061]    Anchor  150  is released from collet  240  by pushing the actuator  230  from position  231  to position  232  in the introducer handle  210 . Introducer needle  200  is retracted by reversing through the insertion path. After anchor  150  is released, gentle traction is applied on the tissue support system  100  to confirm secure fixation in the tissue. 
         [0062]    Grasping feature  180  is gently pulled to adjust the tension exerted by the tissue support portion  130  on the urethra. To aid in adjustment, a finger is inserted vaginally to stabilize anchor  150  at the obturator internus muscle. The sling can also be loosened by using gentle counter-traction on the tissue support portion  130  on the side closest to anchor  150 . A thin, blunt instrument (such as a hemostat) between the urethra and the sub-urethral sling may be used as a spacer to aid in setting the appropriate tension. A cough or créde test can also be employed to achieve the appropriate tension. The orienting indicia  140  should be visible at the midline, no more than 1 cm away from the urethra in either direction. 
         [0063]    Once proper tensioning is achieved, stylet  185  is inserted into lumen  182  of gripping feature  180 . The stylet  185  is inserted into lumen  166  to urge locking member  170  into place at anchor  150 . When properly seated, the stylet  185  will bow, signifying that the locking member  170  is in the proper location and the tissue support member has been secured. Once anchor  150  is locked into position, additional tightening can be achieved using the gripping feature  180 . 
         [0064]    Stylet  185  is removed after final securement of the tissue support member  100 . According to one embodiment, arm  160  is cut between anchor  150  and end  164 . The vaginal incision is then closed using suture. According to various embodiments, the incision is temporarily closed and packed around arm  160 . This would allow the clinician to post-operatively modify the amount tension exerted by the implant on the urethra. Once desired degree of tension is obtained and confirmed, the anchor  150  can optionally be fixed to arm  160 , and the remaining material can be cut and, in the case wherein the implant is constructed of non-bioabsorbable material, be removed from the body. 
         [0065]    According to various embodiments, a sheath can enclose at least a portion of the tissue support member disclosed herein to facilitate their passage into tissue. In such an embodiment, the tissue support member, or at least the support portion thereof, is sandwiched between two sheaths. The sheath sides are suitably made out of a material with a low coefficient of friction, such as polytetrafluoroethylene (PTFE). According to another embodiment, the tissue support member is implanted without a sheath. 
         [0066]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for describing particular embodiments only and is not intended to be limiting of the invention. As used in the description of the invention and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. All publications, patent applications, patents, and other references mentioned herein are expressly incorporated by reference in their entirety. 
         [0067]    Also, unless otherwise indicated, all numbers expressing quantities of physical parameters and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches. 
         [0068]    Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Numerical ranges given throughout this specification will include every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.