Device and method for use in transvaginal procedures to reduce recurrence of pelvic organ prolapse

Abstract

A device and method for use in transvaginal procedures involving the suturing in place of a permanent suture anchored to the obturator membranes at the posterior vaginal wall. An introducer assembly includes a hollow sheath and an introducer having a screw tip. The hollow sheath includes a knob with an anchor compartment. The introducer is selectively secured, axially and radially, relative to the sheath. A suture line is threaded along a channel of the introducer and through anchor holes of an anchor stored in the anchor compartment. After removal of the introducer from the sheath, a latch covering the anchor compartment is opened and the suture is pulled to draw the anchor out of the compartment, and through the sheath. The anchor may then be secured to an obturator membrane.

Description

DEVICE AND METHOD FOR USE IN TRANSVAGINAL PROCEDURES TO REDUCE RECURRENCE OF PELVIC ORGAN PROLAPSEFIELD

[0001] This disclosure relates generally to medical devices for use in procedures directed toward mitigating or preventing pelvic organ prolapse and, more specifically, to devices useful in transvaginal procedures involving the suturing in place of a permanent suture anchored to the obturator membranes at the posterior vaginal wall aiming to restore the genital size.BACKGROUND

[0002] Pelvic organ prolapse (POP) is a condition that occurs when the pelvic floor weakens or tears, causing the pelvic organs to fall downward into the vagina. Enlarged genital hiatus is associated with both the development and recurrence of POP, and each year over 225,000 women in the United States require surgery for POP. Up to 30% of these women will require reoperation for recurrent prolapse.

[0003] There are wide ranges of reconstructive pelvic surgery procedures to address anerior vaginal wall, posterior vaginal wall, as well as apical, prolapse. A preferred procedure to surgically repair anterior and apical POP is a Sacrocolpopexy, which is a mesh augmented repair, involving securing a surgical mesh to anterior and posterior portions of the vagina, which mesh is attached to the sacrum, restoring the vagina and other fallen organs to their proper place and suspending the top of the vagina or cervix in a normal position. Prolapse recurrence are susceptible after Sacrocolpopexy, particularly in women experiencing enlarged genital hiatus, who have a four-fold increase in operative failure. Vaughan MH, Siddiqui NY, Newcomb LK, et al. Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension. Obstet Gynecol. 2018 ; 131 (6):1137- 1144. Current procedures such as posterior repairs and perinoerrhaphies are frequently performed aiming to reduce the size of the genital hiatus, but the short term and long term results demonstrate the lack of effective and sustained restoration of the hiatus. Chen L, Schmidt P, DeLancey JO, Swenson CW. Analysis of long-term structural failure after native tissue prolapse surgery: a 3D stress MRI-based study. Int Urogynecol J. 2021 ; Chen L, Swenson CW, Xie B, Ashton-Miller JA, DeLancey JO. A new 3D stress MRI measurement strategy to quantify surgical correction of prolapse in three support systems. Neurourol Urodyn. 2021 ;40(8):1989-1998. There is an existing mesh sling that is inserted behind the urethra, vagina, and rectum to reduce the hiatus, but not in clinical use due to its meshbased technology.SUMMARY

[0004] A new, mesh-free device and surgical approach to restore genital hiatus and treat pelvic prolapse transvaginally is described herein. The device includes a suture that passes, bilaterally, through the posterior wall of the vagina and an anchor that secures the suture to a pelvic membrane (obturator membrane) at the posterior vaginal wall. In a minimally invasive surgical procedure using the device, the tissue between the vagina and rectum is lifted and the perineal body is drawn closer to the pubic bone, thereby reducing urogenital hiatus. Risk of recurrent prolapse is decreased because the anchored suture arrangement mimics the lifting support normally obtained by the pelvic floor muscles, achieving sustained hiatus size reduction.

[0005] A suture passer, in the form of a handle-mounted curved needle having an eye adjacent a distal end, is used to puncture a small hole on the obturator membrane, guide a suture through the thigh fascia, muscle, obturator membrane, along the pelvic sidewall, and into the perineum. The suture is then retrieved, on the perineal side, from the curved needle, and the suture passer is removed.

[0006] A separate introducer assembly can then be used to deliver an anchor to pass the thigh fascia and muscle and lay on the obturator membrane. The introducer assembly includes a sheath with an elongate tubular member having a distal end. The elongate tubular member has a knob-shaped end disposed at a proximal end, which knob-shaped end has a hollow channel therein in communication with an interior of the elongate tubular member. The knob-shaped end includes an anchor storage compartment, preferably with a latch provided over the anchor storage compartment, the latch being actuatable between a closed condition in which the anchor storage compartment is shielded and an open condition in which the anchor storage compartment is exposed.

[0007] A central trocar is received in, and slidably removable through, the interior of the elongate tubular member. The central trocar includes a screw tip, i.e. a threaded tip region, at a distal end thereof. The screw tip extends distally of a distal end of the elongate tubular member of the sheath when the central trocar is received in the sheath.

[0008] An anchor is removably received in the anchor storage compartment. The anchor may have an atraumatic geometry, such as an oval profile, a flat bottom, a domed upper surface, and at least two anchor holes extending through the anchor from the flat bottom to the domed upper surface. At least one suture line is threaded through two of the apertures of the anchor, which suture line extends along a portion of the domed upper surface between the two apertures through which the suture line is threaded.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 is a perspective view of an anchor introducer assembly of the present disclosure;

[0010] FIG. 2A is a perspective view of a central trocar removed from a hollow sheath of the anchor introducer assembly of FIG. 1 ;

[0011] FIG. 2B is a perspective view of the sheath of the anchor introducer assembly of FIG. 1 , without the central trocar of FIG. 2A;

[0012] FIG. 3A is an inferior anatomic view of the pelvic region of a female human in a supine position;

[0013] FIG. 3B is an inferior anatomic view similar to FIG. 3A, but illustrating the pelvic region in a condition of pelvic organ prolapse (POP);

[0014] FIG. 3C is a lateral anatomic view comparing an existing mesh sling, represented by an upper band secured behind the urethra, vagina, and rectum, to a mesh-free, bilaterally inserted suture and anchor assembly of the present disclosure, arranged to lift and directly close the urogenital hiatus;

[0015] FIG. 3D is a lateral anatomic view similar to FIG. 3C, with a portion of the pubic bones hidden for clarity;

[0016] FIG. 3E is a lateral anatomic view similar to FIG. 3D, with the pubic bone omitted for yet additional clarity;

[0017] FIG. 4A is an enlarged anatomic cross-section of a pelvic region in a condition of POP;

[0018] FIG. 4B is an enlarged anatomic cross-section similar to FIG. 4A, and an anchor introducer assembly of the present disclosure, with lengths of a suture extending from a central trocar of the introducer assembly into the vagina;

[0019] FIG. 4C is an enlarged anatomic cross-section illustrating the anchor assembly of the present disclosure, after twisting and advancing the central trocar using its screw tip to pierce through and dissect the muscle fascia and muscle tissue, until a depth stopper contacts the thigh fascia, indicative of the threaded tip of the central trocar reaching the obturator membrane;

[0020] FIG. 4D is an enlarged anatomic cross-section illustrating the position of an anchor deployed against the obturator membrane, using the anchor introducer assembly of the present disclosure;

[0021] FIG. 4E is an inferior anatomic illustration of a pelvic region in a condition of POP, and a bilateral insertion of a suture and anchor employing an anchor introducer assembly ofthe present disclosure, after deployment of a first anchor and prior to removal of the central trocar to deploy a second anchor;

[0022] FIG 4F is an inferior anatomic illustration of a pelvic region similar to FIG. 4E, after removal of the central trocar and after deployment of the second anchor;

[0023] FIG. 4G is an inferior anatomic illustration of the pelvic region of FIGS. 4E and 4F, after tension is applied to the free suture ends and the connective tissue approaches the posterior vaginal wall at a desired proximity to the obturator membrane;

[0024] FIG. 5 illustrates a curved needle suture passer;

[0025] FIG. 6 is a cross-sectional view illustrating a smooth eye of the curved needle suture passer;

[0026] FIG. 7 illustrates another view of the curved needle suture passer of FIG. 5;

[0027] FIG. 8 is an enlarged side view of a tip of the curved needle suture passer of FIGs. 5 and 7;

[0028] FIG. 9 is an enlarged perspective view of the tip and eye of the curved needle suture passer of FIGs. 5-8;

[0029] FIG. 10 is an elevation view of an anchor introducer assembly of the present disclosure;

[0030] FIG. 11 is a proximal perspective view of the anchor introducer assembly of FIG. 10;

[0031] FIG. 12 is a distal perspective view of the anchor introducer assembly of FIG. 10;

[0032] FIG. 13 is a top (proximal end) view of the anchor introducer assembly of FIG. 10;

[0033] FIG. 14 is another distal perspective view of the anchor introducer assembly ofFIG. 10, with a marker that is securable to one of the graduations on an exterior of a hollow sheath of the introducer assembly;

[0034] FIG. 15 is a distal perspective view of an introducer of the introducer assembly, after having been removed through an interior of the hollow sheath;

[0035] FIG. 16 is a distal perspective view of the hollow sheath of the introducer assembly;

[0036] FIG. 17 is a cross-sectional view of the introducer assembly, taken along lines 17- 17 of FIG. 14, with an anchor received in an anchor storage compartment of a proximal knob end of the sheath, and a latch covering the anchor storage compartment;

[0037] FIG. 18 is a perspective view of the anchor received in the anchor storage compartment of the proximal knob end of the sheath of the introducer assembly of the present disclosure;

[0038] FIG. 19 is a right side view of the anchor of FIG. 18, a left side view being a mirror image thereof;

[0039] FIG. 20 is a front elevation view of the anchor of FIG. 18, a rear elevation view being a mirror image thereof;

[0040] FIG. 21 is a top view of the anchor of FIG. 18;

[0041] FIG. 22 is a bottom view of the anchor of FIG. 18;

[0042] FIG. 23 is a cross-sectional view of the anchor of FIG. 18, taken along lines 23-23 of FIG. 21 ;

[0043] FIG. 24 is a cross-sectional view of the anchor of FIG. 18, taken along lines 24-24 of FIG. 21 ;

[0044] FIG. 25 is a proximal exploded perspective view of the anchor introducer assembly and anchor;

[0045] FIG. 26 is a proximal perspective view of the hollow sheath of the anchor introducer assembly, including an interior aperture in which a sheath engaging tang of the central trocar is selectively received for preventing rotation between the sheath and the center trocar;

[0046] FIG. 27 is a perspective, broken-away view of a proximal end of the central trocar, including a sheath-engaging tang for preventing rotation between the sheath and the central trocar;

[0047] FIG. 28 is a distal perspective view of the central trocar, illustrating an axially- extending sheath-receiving groove thereof;

[0048] FIG. 29 is a cross-sectional view of the anchor introducer assembly similar to FIG. 17, but with a suture threaded along the axially-extending sheath-receiving groove thereof and through an anchor received in the anchor storage compartment in the proximal knob end of the sheath, and one end of the suture threaded through the eye of the curved needle introducer;

[0049] FIG. 30 is another cross-sectional view of the introducer assembly, similar to FIG. 17, and including a suture threaded along the axially-extending sheath-groove of the central trocar and through the anchor received in the anchor storage compartment of the sheath;

[0050] FIG. 31 is a perspective view, broken away, illustrating the central trocar being withdrawn from the hollow sheath; and

[0051] FIG. 32 is a proximal perspective view, broken away, illustrating the latch associated with the anchor storage compartment being open to permit drawing of the anchor through the hollow sheath upon application of axial force to the suture.DETAILED DESCRIPTION

[0052] FIG. 3A illustrates a normal pelvic region of an adult female, in which the perineal membranes, PM, connected through a normal perineal body (PB), are closely spaced to one another. By comparison, FIG. 3B illustrates a pelvic region of an adult female in a condition of pelvic organ prolapse (POP) with enlarged genital hiatus (GH), in which a wide gap exists between the perineal membranes (PM) transversely (displacement of the pair of black dots from their relative position in FIG. 3A versus FIG. 3B illustrates the perineal membrane separation in enlarged genital hiatus) and the genital hiatus GH is stretched in anterior and posterior direction due to the injury to the levator ani muscle. Existing native tissue posterior repair restores the GH by reducing the transverse perineal membrane separation. Surgical options to restore the anterior-posterior diameter of the GH are limited. One existing surgical approach to restore the GH following POP utilizes a mesh sling under the rectum, and draws the perineal body anteriorly closer to the pubic bone, to correct the transverse perineal separation. While such methodologies attempt to restore the GH anterior-posterior diameter, its mesh reinforcement follows the direction of puborectalis muscle and are at angle with the GH plane. There has not been an efficient and reliable device, system, or method to reduce the anterior-posterior diameter of the hiatus. The proposed new mesh-free device implant sutures follow the pubococcygeus muscle direction anchoring to the obturator membrane, which directly reinforce the compromised pubococcygeus muscle and restores the GH.

[0053] FIGs. 3C, 3D, and 3E provide an anatomical representation of a pelvic region in a POP condition, with an upper band illustrating a position of a mesh sling MS of a conventional surgical approach following the direction of the puborectalis muscle to restoring the pelvic floor opening, and a lower pair of lines representing anchored sutures AS secured in place in a manner, and using devices, of the present disclosure, following the direction of the pubococcygeus muscle, aimed at closing the genital hiatus and retaining the closure. The existing approach, represented by the upper band, can constrict the pelvic floor at different levels, but does not directly close the genital hiatus GH.

[0054] Turning to FIGs. 4A-32, steps involved in a procedure for surgically inserting and anchoring sutures AS to the obturator membranes for restoration of the perineal body, anddevices for performing such steps, are illustrated. Following a groin incision lateral to the clitoris in the labio-crural fold, and blunt dissection to the level of the thigh fascia, a suture is introduced via a suture passer 10 having a curved needle 12, with an eye 14. As illustrated in the cross-sectional view of FIG. 6, the eye 14 of the suture passer has a smooth profile which allows the suture to move smoothly. An end of the suture AS is retrieved at a vaginal side, and the needle introducer 10 is removed. An anchor introducer assembly 16, including a sheath 18 and a central trocar 20 removably secured within the sheath 18, is used to penetrate the thigh fascia. The central trocar 20 is provided with a sharp-edged threaded distal tip region. The sharp-edged threaded distal tip region of the central trocar 20, also referred to herein as a screw tip 22, is exposed distally of the sheath 18 when the central trocar 20 is secured in the sheath 18.

[0055] The sheath 18 is hollow and is preferably provided with graduations 24 along its exterior. A stopper S, such as a pinch-grip depth stopper S (see FIG. 14), is movable along the exterior of the sheath 18. The depth stopper S may be secured and locked using a spring or leveled clam mechanism in any of the graduations 24, and indicia adjacent each of the graduations provides a depth indication indicative of sheath insertion depth. In use, a surgeon measures the depth to the muscle fascia, indicating the depth to which the screw tip 22 of the central trocar 20 is to be inserted so as to position the suture AS at a desired level within the pelvic region near, but without penetrating, the obturator membrane OM. The depth stopper S is then moved along the sheath 18 until it rests in the graduation 24 corresponding to the desired depth of insertion of the screw tip 22. The anchor introducer assembly 16 is then twisted, resulting in the screw tip 22 penetrating through the thigh fascia, until the depth stopper S is flush with the thigh fascia, indicating the screw tip 22 is inserted to the desired depth.

[0056] The sheath 18 of the anchor introducer assembly 16 is provided with a knob 26 at a proximal end. The knob 26 includes an anchor storage compartment 28 therein. A latch 30 is actuatable between a first, closed condition in which the anchor storage compartment 28 is shielded, and an open condition exposing the anchor storage compartment 28. An anchor 32 is received in the anchor storage compartment 28, and may only be withdrawn from the anchor storage compartment 28 when the latch 30 is open. The anchor 32 preferably has two or more anchor holes 34 therein to thread suture lines through the anchor 32. While the anchor 32 may take on several geometric configurations, one preferred configuration of the anchor 32 is a generally oblong shape, with a convex upper surface, a rounded side edge about a perimeter, a generally flat bottom surface, and the anchor holes 34 equally spaced from an apex of the upper surface. The convex contour of the upper surface of the anchor facilitates atraumatic movement of the anchor 32 to a desired position,such as at the obturator membrane OM. Rounded ends of the anchor holes 34 allow the anchor 32 to serve in a pulley-like manner, so suture line threaded through the anchor holes 34 and along the rounded upper surface of the anchor 32 between the anchor holes 34, can lay smoothly along contacted surfaces of the anchor without snagging or catching.

[0057] As illustrated in FIG. 4D, the deployed anchor 32 is positioned against the obturator membrane OM, as the stability of the obturator membrane is optimal for accommodating the stresses imparted by the anchor to adjacent tissue. If the anchor were secured, for example, to the muscle fascia or within the muscle, the anchor would be more susceptible to migration during patient movement.

[0058] The sheath 18 includes an axially-extending inner rib 36, and the central trocar 20 has an axially-extending channel 38 that accommodates the axially-extending inner rib 36 of the sheath 18, as well as a suture line. The interface of the axially-extending inner rib 36 and axially-extending channel 38 serves to rotationally fix the sheath 18 and the central trocar 20 relative to one another. The axially-extending channel 38 may terminate at a distal end of the screw tip 22, or preferably, just proximally of the threads of the screw tip 22.

[0059] The sheath 18 also includes an interior aperture 40, preferably within the knob 26 of the sheath 18. The interior aperture 40 may be in the form of a generally rectangular window that selectively receives a sheath-engaging tang 42 of the central trocar 20. When the center trocar-sheath engaging tang 42 is positioned within the center trocar-sheath latch window 40, the central trocar 20 of the introducer assembly 16 is secured axially relative to the sheath 18.

[0060] The central trocar 20 includes a lever handle 44, engageable by a thumb or finger of a surgeon. A directional arrow 46 may be provided on a proximal end 48 of the lever handle 46, which points in a direction opposite to the center trocar sheath-engaging tang 42. The directional arrow 46 may be raised and / or printed on the proximal end 48. When the lever handle 44 is urged in the direction of the directional arrow 46, the center trocar sheathengaging tang 42 is released from the center trocar -sheath latch window40 of the sheath 18, and the central trocar 20 can then be slid through the sheath 18, while maintaining the position of the sheath 18 in the thigh fascia.

[0061] Once the central trocar 20 is slid out of the sheath 18, the latch 30 on the knob 26 is opened, and the suture line is pulled to draw the anchor 32 out of the anchor storage compartment 28 and through the sheath 18, until the anchor 32 is firmly seated and laying flat on the obturator membrane. The suture is then threaded into the connective tissue in the vaginal incision just above the hymenal ring. The process is then repeated on the contralateral side. Once one end of the suture is anchored in the connective tissue on bothsides, the free end of the suture is grasped with a hemostat, an introital sizing obturator (not shown) is then placed in the vagina, tension is applied to the free suture ends until the connective tissue approaches the posterior vaginal wall at a desired proximity to the obturator membrane, and the free end of each of the sutures are affixed to the vaginal tissue.

[0062] While certain preferred embodiments are described herein, it will be understood that variations may be made that are still within the scope of the appended claims.

Claims

What is claimed is:1 . A set of instruments for penetrating a thigh fascia to a predetermined depth and suturing an anchor in tissue without penetrating a membrane spaced from the fascia, comprising: a suture passer including a handle; and a curved needle extending from a distal end of the handle with an eye to hold the suture, the handle having an elongate main handle body with a proximal end and a distal end that is curved to a specified shape allowing for the needle passage through the thigh fascia, muscle, obturator membrane, and into the perineum of a patient; an anchor introducer assembly including a sheath including an elongate tubular member having a distal end, and a knob-shaped end disposed at a proximal end of the elongate tubular member, the knob having a hollow channel therein in communication with an interior of the elongate tubular member, the knob further including an anchor storage compartment therein and a latch actuatable between a closed condition in which the anchor storage compartment is shielded and an open condition in which the anchor storage compartment is exposed, a central trocar received in, and slidably removable from, the interior of the elongate tubular member, the central trocar including a threaded tip region at a distal end thereof, the threaded tip region extending distally of a distal end of the elongate tubular member of the sheath when the central trocar is received therein, the threaded tip region including a tip about which one or more threads are provided, and an anchor removably received in the anchor storage compartment, the anchor having an oval profile, the anchor having a flat bottom, a domed upper surface, at least two apertures extending through the anchor from the flat bottom to the domed upper surface, and at least one suture line threaded through two of the apertures and extending along a portion of the domed upper surface between the two apertures through which the suture line is threaded.

2. The set of instruments of claim 1 , wherein the sheath of the introducer assembly includes a notch in an inner wall thereof, and the central trocar includes a locking tab that, when received in the notch, locks the central trocar into engagement with the sheath.

3. The set of instruments of claim 2, the central trocar further including a release tab that projects proximally of a proximal end of the sheath when the central trocar is received in the sheath, the release tab being actuatable in a direction normal to a main longitudinal axis of the central trocar, wherein application of force to the release tab in the direction normal to the longitudinal axis of the central trocar withdraws the locking tab from the notch, enabling removal of the central trocar from the sheath.

4. The set of instruments of claim 3, the release tab being connected to the rest of the central trocar by a living hinge to allow the trocar to be removed from the sheath.

5. The set of instruments of any of claims 1-4, the central trocar provided with an axially-extending groove along its length, and the sheath including an elongate axially- extending internal rib received in the axially-extending groove of the central trocar when the central trocar is received in the sheath.

6. The set of instruments of claim 5, and a portion of the suture line being received in the axially-extending groove.

7. The set of instruments of claim 1 , the sheath including a plurality of graduation indicators along an exterior thereof and a pinch-grip depth stopper engageable with each of the plurality of graduation indicators, the pinch-grip depth stopper being positionable along the sheath at one of the graduation indicators corresponding to a predetermined depth of insertion of the central trocar , the predetermined depth selected as a depth that prevents perforation of the obturator upon insertion of the threaded tip region of the central trocar.

8. The set of instruments of claim 7, the pinch-grip depth stopper received in one of the graduation indicators.

9. A method of transvaginal surgical intervention for treatment of pelvic organ prolapse (POP), comprising, on either side of a sagittal plane:making a groin incision through skin of a female patient having a POP condition, the groin incision being lateral to the clitoris in the labio-crural fold; bluntly dissecting to a level of thigh fascia; passing a suture through a needle eye of a suture passer; passing the suture passer from the groin incision, thigh fascia, thigh muscle, through an obtrurator membrane and into a vaginal incision near a perineal body; retrieving the suture in the vaginal wound from the needle eye of the suture passer and clamping the suture; removing the suture passer; measuring a depth from the skin at the groin incision to the muscle facia; securing a pinch-grip depth stopper at a location corresponding to one of a plurality of graduations along a sheath surrounding a central trocar of an anchor introducer assembly, the location of the graduation at which the pinch-grip depth stopper is secured being a distance from a tip of a threaded tip region at a distal end of the central trocar corresponding to the depth from the skin at the groin incision to the muscle fascia, the threaded tip region extending distally of a distal end of the elongate tubular member of the sheath; penetrating the thigh fascia by twisting the threaded tip region at the distal end of the central trocar of the anchor introducer assembly, until the pinch-grip depth stopper contacts the skin at the groin incision; withdrawing the central trocar from the sheath; pulling the suture in the vaginal incision until an anchor associated with the sheath of the anchor introducer assembly and secured to the anchor delivers the anchor to the obturator membrane; fixing the suture at the perineal tissue; and manipulating the suture to adjust to a desired hiatal diameter.

10. The method of claim 9, and in passing the suture through the needle eye of the suture passer, running the suture along a smooth transition from a shaft of the suture passer into the needle eye.11 . The method of claim 9, and in pulling the suture in the vaginal incision, withdrawing the anchor associated with the sheath of the anchor introducer assembly from an anchor storage compartment disposed at a proximal end of the sheath.

12. The method of claim 11 , and prior to withdrawing the anchor from the anchor storage compartment, actuating a latch from a closed condition in which the anchor storage compartment is shielded to an open condition in which the anchor storage compartment is exposed.

13. The method of claim 9, and prior to withdrawing the central trocar from the sheath, displacing a locking tab of the central trocar from a notch in an inner wall of the sheath of the introducer assembly.

14. The method of claim 13, and in displacing the locking tab from the notch, actuating a release tab projecting proximally of a proximal end of the sheath in a direction normal to a main longitudinal axis of the central trocar.

15. A method for preparing a set of instruments for penetrating a thigh fascia to a predetermined depth and suturing an anchor in tissue without penetrating a membrane spaced from the fascia, comprising: providing a suture passer including a handle; and a curved needle extending from a distal end of the handle with an eye to hold the suture, the handle having an elongate main handle body with a proximal end and a distal end that is curved to a specified shape allowing for the needle passage through the thigh fascia, muscle, obturator membrane, and into the perineum of a patient; assembling an anchor introducer assembly by: providing a sheath including an elongate tubular member having a distal end, and a knob-shaped end disposed at a proximal end of the elongate tubular member, the knob having a hollow channel therein in communication with an interior of the elongate tubular member, the knob further including an anchor storage compartment therein and alatch actuatable between a closed condition in which the anchor storage compartment is shielded and an open condition in which the anchor storage compartment is exposed, inserting a central trocar into the interior of the elongate tubular member, the central trocar including a threaded tip region at a distal end thereof and a groove, until the threaded tip region extends distally of a distal end of the elongate tubular member of the sheath, threading at least one suture line through two apertures of an anchor having an oval profile, the anchor having a flat bottom, a domed upper surface, at least two apertures extending through the anchor from the flat bottom to the domed upper surface; inserting the anchor within the anchor storage compartment; and closing the latch.

16. The method of claim 15, the central trocar including an axially-extending groove along its length, and the sheath including an elongate axially-extending internal rib, and in inserting the central trocar into the interior of the elongate tubular member, inserting the central trocar in such a manner that the axially-extending internal rib of the sheath is received in the axially-extending groove of the central trocar.

17. The method of claim 15, and prior to inserting the central trocar into the sheath, threading a portion of the suture lines in the axially-extending groove.

18. The method of claim 15, and in inserting a central trocar into the interior of the elongate tubular member, aligning the central trocar relative to the sheath such that a locking tab of the central trocar is received in a notch in an inner wall of the sheath of the anchor introducer assembly to provide secure engagement of the central trocar and the sheath.

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