Abstract:
Surgical procedures, kits and implants for alleviating human incontinence, and particularly providing improved methods and apparatus to secure a urethral sling ( 30 ) to pubic bone ( 24, 26 ) to support the urethra and alleviate incontinence are disclosed. Bone anchors ( 64 ) are driven into pubic bones with elongated bone anchor sutures ( 84 ) configured to be passed through openings of a urethral sling. Suture retainers are applied to the sutures to apply retentive force to the urethral sling to maintain the fixation of the urethral sling proximate to the pubic bone.

Description:
RELATED APPLICATIONS 
     This application is a continuation application of U.S. patent application Ser. No. 11/993,441, filed Dec. 9, 2009, which claims the benefit from International Application No. PCT/US2006/023956, having PCT Publication No. WO 2007/002071, which was filed on Jun. 20, 2006, which in turn claims priority under 35 USC §119(e) from U.S. Provisional Patent Application having Ser. No. 60/692,667, filed on Jun. 21, 2005, wherein these applications are incorporated herein by reference in their entireties. 
    
    
     BACKGROUND 
     Incontinence is a condition characterized by involuntary loss of urine, beyond the individual&#39;s control, that results in the loss or diminution of 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 or emotionally stressed. 
     One cause for this condition is damage to the urethral sphincter or 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 (a distal attachment to the pubic bone). Weakening and elongation of the pubourethral ligaments and the arcus tendineus fascia pelvis, weakening of the endopelvic fascia and pubourethral prolapse of the anterior vaginal wall, and their complex interaction with intraabdominal forces are all suspected to play a role in the loss of pelvic support for the urethra and subsequent hypermobility to an unnaturally low non-anatomic position, leading to urinary incontinence. 
     Females can also exhibit cystocele, a condition due to laxity of the pelvic floor wherein the bladder extrudes out and downwards causing SUI. The severity of this bladder collapse is rated between Grades one through four. In Grade four cystocele, the bladder extrudes out of the vaginal opening. The treatment of choice for this condition includes the reduction or closing of the pelvic floor opening from which the bladder descends using sutures. As noted below, other procedures involving implantation of a urethral sling are also gaining acceptance. 
     In general, 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. 
     The present application is directed to the treatment of SUI and chronic urinary incontinence due to inability of the urethral sphincter to close or remain closed as bladder fluid pressure builds. Currently, incontinence treatments of choice 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 in the retro pubic space. Peripheral portions of the elongated urethral sling are affixed to bone or body tissue, and a central 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. 
     Male and female urethral sling procedures are disclosed in commonly assigned U.S. Pat. Nos. 6,652,450 and 6,382,214, for example, and further female urethral sling procedures are described in commonly assigned U.S. Pat. No. 6,641,524, for example, and publications and patents cited therein. The implantation of certain urethral slings involves the use of delivery systems configured for and techniques that involve transvaginal, transobturator, suprapubic and pre-pubic exposures or pathways. 
     The above-referenced &#39;214 patent describes apparatus and methods for treatment of male incontinence and female cystocele repair in which a urethral sling material is positioned between the descending pubic rami of the pubic bone. In such an operation a “hammock-like” urethral sling material is sutured below the urethra in males, or below the posterior bladder wall in the case of cystocele in females. The urethral sling material may comprise synthetic material or cadaveric or autologous fascia and may or may not be absorbable over time. 
     In the male case, the urethral sling applies passive compression against the bulbar urethra. The compression, either by itself or in conjunction with urethral mobility, prevents urine leak during strain. If additional passive pressure is required on the urethra after surgery is completed, collagen or other bulky material can be injected with a tiny needle through the perineum, causing more pressure created by the bulky material on one side (the lower or caudal side) by the urethral sling, and on the other (the upper or superior) side compressing the urethra. An example of a urethral sling sutured to and extending between four bone screws fixed to the descending pubic rami is depicted in FIG. 12 of the above-referenced &#39;214 patent. 
     One minimally invasive surgical procedure that incorporates the teachings of the above-referenced &#39;214 patent to alleviate mild to moderate male SUI is performed employing the InVance™ Male Urethral Sling System for implanting the InteMesh™ Synthetic Surgical Mesh (both available from American Medical Systems, Inc.) in a manner generally described in the above-referenced &#39;214 patent and depicted in  FIGS. 1-3 . The InteMesh™ Synthetic Surgical Mesh is about 4 cm×7 cm and knitted from a supple polyester material coated with silicone, the knitted mesh having a pore size that allows for tissue ingrowth during chronic implantation. The InVance™ Male Urethral sling System includes four to six, typically, titanium bone screws and a disposable, battery powered, inserter or driver. Each bone screw has a distal self-tapping spiral thread and a length of No. 1 Prolene suture extending proximally from the bone screw. 
     In the implantation procedure, the patient is first placed in the lithotomy position and draped, and the surgical field is prepared. A 16 French Foley catheter, for example, is inserted into the urethra, the catheter balloon is inflated t to assist the surgeon in identifying the urethra during dissection, and the scrotum is elevated. A vertical incision is made over the midline in the perineum, and the skin and subcutaneous tissues are dissected free. The bulbocavernous muscle is then exposed, and dissection is carried out posteriorly to the area of the transverse perineum to completely free the bulbar urethra. Lateral dissection is used to expose the corpora cavernosum and the descending pubic rami. 
     The six titanium bone screws or anchors are then screwed, one at a time, into the inner portion of the descending pubic rami of the pubic bone using the battery-powered driver. The bone screws are screwed fully into the pubic bone so that the No. 1 Prolene sutures extend outward from each bone. The location of each bone screw and the order of bone screw insertion can be selected by the surgeon. In one approach, the first pair of bone screws is inserted just below the symphysis, the second pair is inserted just proximal to the level of the ischial tuberosity, and the third pair is inserted intermediate the first and second pair. 
     The InteMesh™ Synthetic Surgical Mesh is then applied against the array of bone screws bridging the lower surface of the bulbar urethra between the descending pubic rami to determine where the sutures will be passed through the mesh pores and tied off. The sutures extending from one of the descending pubic rami may be first passed though selected mesh pores and tied off employing several surgeon&#39;s suture knots. Tension is then applied to the other side or end of the urethral sling as it is drawn against the other pubic ramus to determine where the bone screw sutures should be passed through the mesh pores and tied off. 
     The determination of the appropriate tension may be accomplished using a cough test or Retrograde Perfusion Pressure (RPP) test. To perform a RPP test, the Foley catheter balloon is then deflated, and the Foley catheter is withdrawn and connected to a sterile saline perfusion line. A zero pressure state is obtained by lowering the bag to the level of the symphysis. The tip of the catheter is repositioned at the penoscrotal angle, and the urethral resistance to start of flow or leakage is recorded (by distance of the bag above the level of the symphysis). In patients under anesthesia suffering from sphincter incontinence, the urethral resistance is very low. Tension is then applied to the untied side of the urethral sling by advancing the end of the urethral sling along the sutures toward the bone screws so that the urethral sling bears against the bulbar urethra. The mesh urethral sling compresses the bulbar urethra as it is adjusted in tension to increase urethral resistance to withstand a pressure selected between 30 and 60 cm of water. The sutures are then tied to maintain the selected tension. 
     The Foley catheter is then advanced to the bladder (which should advance without difficulties), and the wound is irrigated with Bethadine solution and closed in layers. Subsequently, the Foley catheter is removed after 2 hours, and the patient can be discharged home on oral antibiotics and pain medication after completing a successful voiding trial. 
     The above-referenced &#39;214 and &#39;524 patents also disclose procedures for repairing a cystocele using retropubic and lateral pubic bone anchors. The surgery disclosed in the &#39;214 patent is indicated for patients with grade four cystocele and urethral hypermobility. The procedure repairs the central defect, the lateral defect, approximates the cardinal ligaments to the midline, and creates a urethral sling of the urethra. 
     After preparation and draping, a Foley catheter is inserted in the bladder. Once the catheter is in place, a “goal post” incision is made. The vertical bars of the goal post extend laterally from the distal urethra to the horizontal bar that is made just proximal to the bladder neck. The vertical bars reach the vaginal cuff. 
     After creation of the goal post incision, the vaginal wall is dissected free to expose the perivesical fascia laterally and the cardinal ligaments posteriorly. A figure eight 2-0 absorbable suture is applied to approximate the cardinal ligament to the midline without tying it. If an enterocele sac is encountered, it should be repaired at this stage. 
     The retropubic space is then entered over the periurethral fascia at the level of the vertical bars of the incision, and the urethropelvic ligaments are exposed. Two fascial anchors (the upper pair) are inserted into the tissue of the suprapubic area. Each of these anchors comprises a bone screw having a distal self-tapping screw thread of the type described above with a No. 1 Prolene suture attached to the proximal end of the bone screw. 
     In an alternative embodiment, at this stage of the procedure, the retropubic space is not open and two bone anchors or screws of the type described above are applied to the inner surfaces of the symphisis using a right angle drill. 
     After application of the first set of anchors, a second pair of bone anchors or screws of the type described above are applied to the inner surface of the descending pubic rami of the symphysis. 
     Once the four bone screws are in place, the bladder prolapse is reduced using a moist sponge over a right angle retractor. Alternatively, a Dexon mesh is applied and left in place. The lower pair of Prolene sutures is then used to incorporate the perivesical fascia and the cardinal ligaments area. Interrupted 2-0 absorbable sutures are used to approximate the perivesical fascia to the midline over the Dexon mesh. 
     A variation on this procedure is set forth in commonly assigned, U.S. Patent Application Publication No 2002/0183762 to provide urethral support and coaptation employing the InFast™ Ultra Transvaginal Urethral sling System for implanting a urethral sling selected from among the InteXen™ Porcine Dermal Matrix or the InteDerm™ Allograft Dermal Matrix or the InteLata™ Allograft Fascia Lata (all available from American Medical Systems, Inc.). The selected urethral sling is intended to be cut to size and in a T-shape to fit between the bone screws and to be attached thereto as described above. The InFast™ Ultra Female Urethral sling System includes four, typically, titanium bone screws and a disposable, battery powered, inserter that positively engages the bone screw to drive it into bone. In this system, a length of No. 1 Prolene suture is passed through a metal ring extending proximally from the bone screw, and the ends of the suture are joined to needles adapted to be passed through the urethral sling. A distal end of a drive shaft of the battery-powered inserter engages the bone screws, and the drive shaft is shaped to enable orientation of the screw threads toward the posterior aspect of the pubic bone. Other types of bone anchors that include a penetrating tip, a shaft, and a suture threaded through the shaft and that are adapted to be inserted into bone are disclosed in commonly assigned U.S. Pat. Nos. 6,635,058 and 6,746,455. 
     The tensioning of the selected urethral sling is accomplished in this procedure as the suture needles are passed through the urethral sling, and the urethral sling is pressed against the bone surface. The suture needles are severed, and the suture ends are tied together. The tied suture knot is slid upward and posteriorly (behind the bone) to ensure juxtaposition of the sling end to the bone surface. 
     The above-described bone screws are intended to be driven into the bone until completely embedded with the suture extending out of the self-tapped bore in the bone. 
     Thus, in the above-described procedures, the urethral sling in maintained in place, and sling tension is adjusted and applied through the tied sutures. The procedure of initially tensioning and tying the sutures takes an undue amount of the surgical time, up to 15-25 minutes as observed in some instances employing the InVance™ Male Urethral Sling System for implanting the InteMesh™ Synthetic Surgical Mesh. Moreover, it is sometimes difficult to achieve the tension in the urethral sling that is sufficient to constrict the urethral sphincter to provide urethral resistance to leakage at the selected water bag height, e.g. at 60 cm. 
     If the resulting sling tension is not adequate, it may be necessary to untie the tied sutures to readjust tension including possibly repositioning the bone screw in the pubic bone or the sutures extending through the urethral sling. Tying, untying and retying the suture knots consumes further time. Thus, it would be desirable to simplify the process of and to reduce the amount of time that it takes to detach, adjust tension, and reattach the urethral mesh to the sutures extending from bone screws. 
     Moreover, the sutures may have been trimmed at the knot following an earlier tying. Applying tension through and retying the trimmed sutures may be difficult to accomplish. Therefore, it would be desirable to simplify the process of tensioning and retying the sutures in a manner that is not compromised by trimming the suture length. 
     In addition, redundant knots are often tied to increase reliability of the suture knot, and the size of the knots so formed can irritate adjacent enervated tissue, causing discomfort to the patient. Consequently, it would be desirable to minimize the physical size of suture fixation of the urethral sling to the bone anchors or screws. 
     Various types of bone anchors that include a penetrating tip, a shaft, and a head and are adapted to be inserted into bone are disclosed in commonly assigned U.S. Pat. Nos. 6,328,744, 6,387,041, 6,544,273, 6,730,110, and 6,843,796. In certain embodiments disclosed in the &#39;041 patent, for example, the head extends at an angle to the shaft axis, and may comprise laterally extending arms or may comprise a circular plate, a sphere or a half-sphere. In use, the tip is advanced through the sling so that the sling bears against the shaft and is maintained there by the head. 
     The preferred embodiments of the present invention incorporate a number of inventive features that address the above-described problems that may be combined as illustrated by the preferred embodiments or advantageously separately employed. 
     SUMMARY 
     The kits, tools, and/or components of the preferred embodiments of the present invention may be employed to affix a sling to a bone or bones, in particular, a urethral sling to pubic bones. The urethral sling may be of any type having opposed sling sides and extending between a first sling end adapted to be coupled to a first pubic bone and a second sling end adapted to be coupled to a second pubic bone to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence. The urethral sling may be formed of material having sling openings extending through it at least in portions adjacent the first and second sling ends. In the case that the urethral sling is formed of a mesh having mesh pores for tissue ingrowth, mesh pores may be selected to function as sling openings. Alternatively, the urethral sling may be formed of a material capable of being perforated in the surgical procedure to form sling openings extending through it at least in portions adjacent the first and second sling ends. 
     The kits, tools and/or components of the preferred embodiments of the present invention include bone anchors adapted to be attached to bone, e.g., pubic bone, with elongated sutures extending from the bone anchor bodies. The sutures extending proximally from the anchor bodies are adapted to be threaded through sling openings in any of the manners described above. Suture retainers are adapted to engage the sutures to apply retentive forces against the urethral sling to retain portions of the urethral sling proximate the pubic bones. Sling tension testing may proceed and repositioning may occur until satisfactory sling tension is achieved. 
     In one aspect of the present invention, the retainers comprise retainer bodies having at least one retainer bore therethrough sized to receive and frictionally engage one or more suture to inhibit slippage of the suture(s) with respect to the retainer bore, whereby a surface of the suture retainers is adapted to be applied against portions of the urethral sling to retain the sling portions proximate the pubic bones. The suture retainers have surface areas adapted to bear against the sling that exceed the cross-section areas of the sling openings. 
     The bone anchors that are attached to the pubic bones may comprise one or more suture extending to a suture free end, the suture(s) adapted to be extended through sling openings so that portions of the sling are applied proximate the pubic bones. Certain embodiments of suture retainers are adapted to be applied to each suture(s) extending through the sling openings of the urethral sling. Other embodiments of suture retainers are adapted to be applied to a plurality of suture(s) extending from a plurality of bone anchors through a plurality of sling openings of the urethral sling. 
     In certain embodiments, the suture(s) extending from each bone anchor has a substantially constant cross-section area through substantially the entire length of the suture. In alternative embodiments, the suture(s) extending from each bone anchor is configured to positively engage the urethral sling and/or a suture retainer. The retainer bore cross-section area is selected to be somewhat smaller than the suture cross-section area where the suture extends through the retainer bore, whereby the retainer bore frictionally engages the suture with an engagement force that inhibits slippage along the suture. 
     In exemplary preferred embodiments, the suture retainer body is shaped having a laterally extending slot extending to or providing the retainer bore. In use, each bone anchor suture is extended through a laterally extending slot into a retainer bore of the suture retainer. The retainer may be advanced along the suture into engagement with a portion of the urethral sling (if necessary) by applying sufficient force to overcome the frictional engagement force. 
     In other exemplary preferred embodiments, a slot is not provided to enable lateral insertion of the suture into the retainer bore. Each suture is inserted through a retainer bore, and the suture retainer is advanced along the suture(s) into engagement with a portion of the urethral sling by applying sufficient force to overcome the frictional engagement force. The suture retainer may be resilient, having retainer bore(s) sized and shaped to be expanded when advanced over the suture as the suture retainer is advanced toward the bone anchor and to resist retraction over the suture away from the bone anchor. 
     In further exemplary preferred embodiments, the bone anchor suture is not uniform in cross-section area along its length. The suture is shaped along at least a portion of the suture length with at least one suture fixation element that extends outward to abut or engage the suture retainer to maintain it against the urethral sling and inhibit slippage. In use, the suture body between fixation elements may be inserted laterally through a slot and into a retainer bore of a suture retainer, whereby the suture retainer is disposed between the sling and the fixation element. 
     In another preferred embodiment, the suture retainer and fixation element(s) are complementary in shape so that the suture retainer may be applied over the free end of the bone anchor suture(s) and advanced toward the urethral sling over one or a plurality of suture fixation elements. The suture retainer is applied against a portion of the urethral sling and maintained in position by a suture fixation element abutting the suture retainer. For example, the suture retainer may be resilient and have a retainer bore sized and shaped to be expanded when advanced over the outwardly extending fixation elements as the suture retainer is advanced toward the bone anchor. The contraction of the retainer bore engages the suture to inhibit retraction of the suture retainer over the suture away from the bone anchor. 
     In a still further aspect of the present invention, a tool is employed to apply the suture retainer to the suture(s) to press and entrap the urethral sling material against the pubic bone. 
     Advantageously, procedures for attaching the urethral sling to bone anchors or anchors are simplified to shorten the surgical time, the tensioning and fixation are made more reliable, and the resulting suture knots are reduced in size or eliminated. 
     In use for retaining a urethral sling against body tissue proximate the urethra, a first plurality of bone anchors are affixed to a first pubic bone and a second plurality of bone anchors are affixed to a second pubic bone. The bone anchor sutures of the first plurality of bone anchors are passed through the sling openings along a first end of the urethral sling. A suture retainer having a plurality of retainer bores or a plurality of suture retainers are applied to the sutures of the first plurality of bone anchors to engage and retain the first end of the urethral sling proximate the first pubic bone. The urethral sling is tensioned as the second plurality bone anchor sutures are drawn through sling openings along the second end of the sling. A suture retainer having a plurality of retainer bores or a plurality of suture retainers are applied to the sutures of the second plurality of bone anchors to engage and retain the second end of the urethral sling proximate the second pubic bone. The urethral sling is thereby entrapped engaged and tensioned between the pubic bones and the suture retainers. The suture retainers may be released so that the urethral sling may be quickly detached and reattached to change sling tension as tension testing dictates. 
     Advantageously, the end portions of the sutures proximate the suture retainers may be trimmed or tied off and trimmed after adequate tension is achieved and with fewer knots to reduce suturing time and the final exposed suture bulk. 
     Bone anchors usable in the practice of the present invention may comprise bone screws having spiral thread bone fixation mechanisms adapted to be screwed into bone or tapered, pointed, bone tack bone fixation mechanisms adapted to be advanced into bone, as disclosed for example in the above-referenced, commonly assigned &#39;058, &#39;273 and &#39;041 patents, or any other form of bone fixation mechanism. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other advantages and features of the present invention will be more readily understood from the following detailed description of the preferred embodiments thereof, when considered in conjunction with the drawings, in which like reference numerals indicate identical structures throughout the several views, and wherein: 
         FIG. 1  is a schematic illustration of the fixation of bone anchors, e.g., bone screws, to descending pubic rami with sutures extending from the bone screws in accordance with the prior art; 
         FIG. 2  is a schematic illustration of the fixation of a urethral sling to the bone screws of  FIG. 1  with the sutures extending from the bone screws in accordance with the prior art; 
         FIG. 3  is an enlarged plan view of a prior art urethral sling formed of a mesh and adapted to be attached to the descending pubic rami as shown in  FIG. 2 ; 
         FIG. 4  is an expanded side view of a bone anchor, particularly a bone screw of the type employed in  FIGS. 1 and 2 , with a pair of bone screw sutures extending from the screw head; 
         FIG. 5  is a top view of a first embodiment of a suture retainer employable with the suture pair of the bone screw of  FIG. 4 ; 
         FIG. 6  is a side view of the suture retainer of  FIG. 5 ; 
         FIG. 7  is a top view of a dispenser coupled to the suture retainer of  FIGS. 5 and 6  to be employed in the fixation of the retainer to the sutures of the bone screw of  FIG. 4 ; 
         FIG. 8  is a plan view in partial section of the bone screw of  FIG. 4  screwed into pubic bone and the suture retainer of  FIGS. 5-7  engaging the sutures and retaining the mesh of the urethral sling of  FIG. 3  proximate the pubic bone; 
         FIG. 9  is a schematic illustration of the fixation of a urethral sling of  FIG. 3  with a plurality of bone screws of  FIG. 4  screwed into the right and left descending pubic rami and a like plurality of suture retainer of  FIGS. 5-7  engaging the sutures and retaining the mesh of the urethral sling proximate the pubic bone; 
         FIG. 10  is a side view of a further embodiment of a suture retainer employable with a plurality of suture pairs extending from a plurality of bone screws of  FIG. 4 ; 
         FIG. 11  is a top view of the suture retainer of  FIG. 10 ; 
         FIG. 12  is a top view of a still further embodiment of a suture retainer employable with a plurality of suture pairs extending from a plurality of bone screws of  FIG. 4 ; 
         FIG. 13  is a schematic illustration of the fixation of a urethral sling of  FIG. 3  with a plurality of bone screws of  FIG. 4  screwed into the right and left descending pubic rami and suture retainers of  FIG. 12  engaging the sutures and retaining the mesh of the urethral sling proximate the pubic bone; 
         FIG. 14  is an expanded side view of a bone anchor, particularly a bone screw, with a bone screw suture extending from the screw head shaped with periodic conical or barbed fixation elements; 
         FIG. 15  is a side view illustrating the passage of the bone screw suture of the bone screw of  FIG. 14  affixed to a descending pubic ramus through a mesh pore of the urethral sling and tensioning the urethral sling by progressively drawing barbed fixation elements through a mesh pore as a portion of the urethral sling is advanced toward the pubic bone surface; 
         FIG. 16  is a side view illustrating the advancement of the portion of the urethral sling is proximate the pubic bone surface and the positioning of a further embodiment of a suture retainer over the free end of the bone screw suture; 
         FIG. 17  is a side view illustrating the advancement of the suture retainer of  FIG. 16  over the barbed fixation elements of the suture and against the urethral sling proximate the pubic bone surface thereby engaging the suture and retaining the mesh of the urethral sling proximate the pubic bone; 
         FIG. 18  is a top view of a further embodiment of a suture retainer employable with the suture pair of the bone screw of  FIG. 4 ; 
         FIG. 19  is a top view of a further embodiment of a suture retainer employable with the suture pair of a plurality of the bone screws of  FIG. 4 ; 
         FIG. 20  is a plan view in partial section of the bone screw of  FIG. 4  screwed into pubic bone and the suture retainer of  FIG. 18  or  FIG. 19  engaging the sutures and retaining the mesh of the urethral sling of  FIG. 3  proximate the pubic bone; 
         FIG. 21  is a top view of a further embodiment of a suture retainer employable with a single suture extending from a bone screw of the type depicted in  FIG. 4 ; and 
         FIG. 22  is a side view illustrating the application of the suture retainer of  FIG. 21  laterally between a barbed fixation element of a suture extending from a bone screw of the type depicted in  FIG. 4  and against the urethral sling proximate the pubic bone surface thereby engaging the suture and retaining the mesh of the urethral sling proximate the pubic bone. 
     
    
    
     It will be understood that the drawing figures are not necessarily to scale. 
     DETAILED DESCRIPTION 
     In the following detailed description, references are made to illustrative embodiments of methods and apparatus for carrying out the invention. It is understood that other embodiments can be utilized without departing from the scope of the invention. Preferred methods and apparatus are described for affixing urethral slings fixed to pubic bones, particularly the descending pubic rami. 
     It will be understood that the term “urethral sling” encompasses any type of sling, tape, hammock or the like that supports and or/applies compression to the urethra. One exemplary form of urethral sling is illustrated in the figures and described below in use of the kits, tools, and/or components of the preferred embodiments of the present invention that is formed of a mesh having mesh pores that facilitate tissue ingrowth. As noted above, the urethral sling may be formed of any biocompatible flexible sheet material known in the art with or without pores or sling openings through the sheet material. 
     Furthermore, while the bone anchor embodiments are illustrated and described having an anchor body bearing a bone fixation mechanism comprising a spiral thread adapted to be screwed into bone, it will be understood that the principles of the present invention are applicable to other forms of bone anchors. 
     Referring to  FIGS. 1 and 2 , the male anatomy in the pelvic region  10  is depicted schematically to illustrate how a urethral sling  30  is affixed to the right and left descending pubic rami  24  and  26  to extend across and support the male urethra  12  in the manner described above, for example, in the procedure employing the InVance™ Male Urethral Sling System for implanting the InteMesh™ Synthetic Surgical Mesh urethral sling. 
     An embodiment of the urethral sling  30 , which can correspond to the InteMesh™ Synthetic Surgical Mesh urethral sling, is depicted in greater detail in  FIG. 3 . In a preferred embodiment, the urethral sling  30  is knitted into a mesh from a supple polyester yarn to have a plurality of sling openings comprising mesh pores  40  bounded by yarn strands and may be coated with medical grade silicone rubber. The knitted mesh pores  40  have a pore size that allows for tissue ingrowth therethrough during chronic implantation. The urethral sling  30  extends end-to-end between first and second sling ends  32  and  34  and side-to-side between first and second sling sides  36  and  38 . 
     Returning to  FIGS. 1 and 2 , as noted above, the surgical field is prepared after the patient, placed in the dorsal lithotomy position and draped. The scrotum  14  and penis  16  are elevated, a vertical incision is made over the midline in the perineum of the skin and subcutaneous tissues (not shown) are dissected to the side to expose the bulbocavernous muscle  20 . Lateral dissection is used to expose the corpora cavernosum  22  and the surfaces of the descending pubic rami  24  and  26 . 
     As shown in  FIG. 1 , the illustrated fixation of the surgical urethral sling  30  is effected employing six titanium bone screws  64 ,  66 ,  68 ,  70 ,  72 ,  74  sequentially driven by a disposable, battery powered, inserter or driver (not shown). Each bone screw  64 ,  66 ,  68 ,  70 ,  72 ,  74  has a distal self-tapping spiral thread adapted to be screwed into bone when the screw tip is applied to the bone surface and the driver is powered. A pair of No. 1 Prolene sutures  84 ,  86 ,  88 ,  90 ,  92 ,  94  extend proximally from each bone screw  64 ,  66 ,  68 ,  70 ,  72 ,  74 , respectively. One such bone screw  64  with the pair of bone screw sutures  84  extending from the screw head is depicted in the expanded view of  FIG. 4 . Typically, the pair of bone screw sutures is crimped at one end into a bore of the bone screw and extends about 30 cm to bone screw suture free ends. The bone screw suture free ends can be joined as by use of ultrasonic welding to ease in handling and use of a bone screw fixation tool. The surgeon may choose to pass the joined suture free ends through a selected mesh pore, tie a knot or knots, and then trim the sutures. Or, the surgeon may first trim the sutures, separately pass the severed suture free ends through a common or separate mesh pores, tie a knot or series of knots, and again trim the suture free ends. 
     The bone screws  64 ,  66 ,  68 ,  70 ,  72 ,  74  are screwed fully into the bone so that the No. 1 Prolene sutures  84 ,  86 ,  88 ,  90 ,  92 ,  94 , respectively, extend outward of the descending pubic rami  24  and  26  as shown in  FIG. 1 . The surgeon can select the location of each bone screw  64 ,  66 ,  68 ,  70 ,  72 ,  74  and the order of insertion. In one approach depicted in  FIG. 1 , a first pair of bone screws  64 ,  70  is inserted just below the symphysis, the second pair  66 ,  72  is inserted proximal to the level of the ischial tuberosity, and the third pair  68 ,  76  is inserted intermediate the first and second pair. 
     The urethral sling  30  is then applied against the array of bone screws  64 ,  66 ,  68 ,  70 ,  72 ,  74  bridging the lower surface of the bulbar urethra  20  between the descending pubic rami  24  and  26  to determine where each suture of the respective suture pairs  84 ,  86 ,  88 ,  90 ,  92 ,  94  will be passed through mesh pores. 
     The free ends of each suture of each suture pair  84 ,  86 ,  88 ,  90 ,  92 ,  94  are sequentially grasped, passed through separate mesh pores and drawn tight and tied together against the mesh of the urethral sling  30 . 
     The sutures of the suture pairs  84 ,  86 ,  88  extending from the descending pubic ramus  24  may be first passed though selected mesh pores adjacent the first sling end  32 . The first sling free end  32  is then pressed against the descending pubic ramus  24 . The free ends of each suture of each suture pair  84 ,  86 ,  88  are sequentially grasped, drawn tight and tied together at least two times forming several surgeon&#39;s suture knots against the mesh of the urethral sling  30  firmly holding the sling first end against the descending pubic ramus  24 . 
     Tension is then applied to the second sling end  34  of the urethral sling  30  as it is drawn against the second pubic ramus  26  to determine where the sutures of the bone screw suture pairs  90 ,  92 ,  94  should be passed through mesh pores and tied off in the manner described above. Testing for urethral resistance to leakage may be conducted employing the techniques and instruments described above as the sutures of bone suture pairs  90 ,  92 ,  94  are drawn tight against the fabric of urethral sling  30  and tied off. The sutures of bone suture pairs  90 ,  92 ,  94  may be retracted from the initially selected pores  40  and reinserted in other pores  40  in the process of optimizing the tension. In this way, the urethral sling  30  is eventually sutured to all of the bone anchors or screws  64 ,  66 ,  68 ,  70 ,  72 ,  74  inserted into the descending pubic rami  24  and  26  to extend laterally across and support the bulbar urethra  20 . An intermediate portion of the urethral sling  30  extends between the bone screws  64 ,  66 ,  68  and the bone screws  70 ,  72 , and  74 . 
     The knots made with the suture pairs  84 ,  86 ,  88 ,  90 ,  92 ,  94  are relatively bulky and can cause irritation of tissues. In accordance with the present invention, the procedure for securing the urethral sling  30  to the descending pubic rami and tensioning the urethral sling  30  is simplified, the fastening elements are less bulky than the prevailing use of suture knots, and suture knots are eliminated in some embodiments. 
     The present invention may be practiced employing a variety of bone anchors. The illustrated form of bone anchor is a self-tapping bone screw that can be manually screwed into bone with a screwdriver or screwed into bone with a motor driven, battery powered screwdriver of the type described above. In each embodiment, the bone screw head or body is configured to mate with a screwdriver tip to be rotated and screwed into a pubic bone, typically the descending pubic ramus. 
     For convenience, the following embodiments are described in the context of attaching the urethral sling  30  of the type depicted in  FIGS. 2 and 3  formed of a mesh with mesh pores  40  as described above to the descending pubic rami  24 ,  26  generally in at least certain of the locations of the bone screws  64 ,  66 ,  68 ,  70 ,  72 ,  74  or in additional locations. However, the described embodiments and techniques and their equivalents may be employed to advantageously attach any suitable urethral sling not having mesh pores but having other pre-formed sling openings extending through it or that can be perforated to make sling openings during surgery to the descending pubic rami  24 ,  26  or other pubic bone. 
     In one embodiment of the present invention depicted in  FIGS. 5-9 , a disk-shaped suture retainer  100  is provided for each of the bone screws  64 ,  66 ,  68 ,  70 ,  72 ,  74  or a lesser or greater number of bone screws screwed into the descending pubic rami  24 ,  26 . The bone screw  64  is depicted, for example, in  FIGS. 4 and 8  having the bone screw suture pair  84  comprising sutures  85  and  87  extending therefrom. The cross-section area along the length of the sutures  85  and  87  is substantially uniform. 
     The retainer  100  has a substantially planar retainer body  102  with retainer bores  104  and  108  extending through the retainer body  102 . The retainer bores  104  and  108  are sized to receive and frictionally engage the sutures  85  and  87  to inhibit slippage of the sutures  85  and  87  with respect to the respective retainer bores  104  and  108 . The retainer bores  104  and  108  have bore cross-section areas related to and somewhat smaller than the suture cross-section areas to enable frictional engagement of the sutures received within the retainer bores  104  and  108 . Retainer notches or slots  106  and  110  extend from the retainer bores  104  and  108 , respectively, to the circumference or edge of the retainer body  102 . 
     The suture retainer  100  is adapted to be applied against a portion of the urethral sling  30  to retain the sling portion proximate the pubic bones. The suture retainer  100  has a major surface area adapted to bear against the urethral sling  30  that exceeds the cross-section area of the sling opening, e.g., the mesh pore  40 . Thus, the suture retainer  100  is too large to be drawn through the mesh pore  40 . 
     The suture retainer  100  is applied to extend across or laterally with respect to the sutures  85  and  87  such that the sutures  85  and  87  are first received in the respective retainer notches or slots  106  and  110  and then are compressed in cross-section area when inserted into the respective retainer bores  104  and  108 , whereby the retainer bores  104  and  108  frictionally engage the sutures  85  and  87  with an engagement force that inhibits slippage along the sutures  85  and  87 . The suture and retainer bore cross-section areas may be selected to enable axial advancement of the suture retainer  100  along the sutures  85  and  87  and into engagement with a portion of the urethral sling if necessary in tensioning the sling  30 . 
     The lateral application of the suture retainer may be facilitated employing a retainer installation and dispensing tool  120  depicted in  FIG. 7 . The dispensing tool  120  may be about the same thickness as the suture retainer  100  and includes a substantially C-shaped clamp  126  terminating in clamp jaws  122  and  124  shaped to fit in a tool engaging feature of the retainer body  102 , e.g., a pair of recesses  112  and  114  in the edge of the retainer body  102 . A tab  128  extends from the C-shaped clamp  126  that is to be grasped by the surgeon between finger and thumb to position the suture retainer notches  106  and  108  with respect to the respective sutures  85  and  87  as shown in  FIG. 8 . The tab  128  is advanced laterally to insert the sutures  85  and  87  in the retainer bores  104  and  108 , respectively. The tab  128  may then be twisted to release the clamp jaws  122  and  124  from the recesses  112  and  114  of the suture retainer  100 . 
     Turning to  FIG. 9 , the application of six such suture retainers  100 , designated  144 ,  146 ,  148 ,  150 ,  152  and  154 , into engagement with portions of the urethral sling  30  and with the suture pairs  84 ,  86 ,  88 ,  90 ,  92 , and  94  of respective bone screws  64 ,  66 ,  68 ,  70 ,  72 , and  74  is depicted. The suture retainers  144 ,  146 ,  148 ,  150 ,  152  and  154  are depicted displaced from the respective bone screws  64 ,  66 ,  68 ,  70 ,  72 , and  74  for convenience of illustration. It will be understood that, in practice, the suture retainers  144 ,  146 ,  148 ,  150 ,  152  and  154  may substantially overlie and obscure the respective bone screws  64 ,  66 ,  68 ,  70 ,  72 , and  74 . 
     Thus, in use and referring to  FIG. 9 , the bone screws  64 ,  66 , and  68  may be screwed into the pubic bone of the descending pubic ramus  24 , and the bone screws  70 ,  72 , and  74  may be screwed into the pubic bone of the descending pubic ramus  26 . An end portion of the urethral sling  30  along sling end  32  is applied against or proximate the descending pubic ramus  24 , as the suture pairs  84 ,  86 ,  88  are inserted through selected sling openings, e.g., mesh pores  40  depicted in  FIG. 3 . A first set of three suture retainers  100  are applied as shown in  FIG. 8  to the suture pairs  84 ,  86 , and  88  to retain the urethral sling  30  proximate the descending pubic ramus  24 . 
     The other sling end  34  of the urethral sling  30  is then drawn across the urethra toward the descending pubic ramus  26 , and the suture pairs  90 ,  92 ,  94  are inserted through selected sling openings, e.g., mesh pores  40  depicted in  FIG. 3 , in an end portion of the urethral sling  30  along sling end  34 . A second set of three suture retainers  100  are applied as shown in  FIG. 8  to the suture pairs  90 ,  92 , and  94  to retain the urethral sling  30  proximate the descending pubic ramus  26  and to thereby tension the portion of the urethral sling  30  extending across the urethral region. 
     An RPP test may be conducted, and one or more of the suture retainers  144 ,  146 ,  148 ,  150 ,  152  and  154  may be adjusted along the length of the respective suture pairs  84 ,  86 ,  88 ,  90 ,  92 , and  94  to adjust the sling tension if the test results are not satisfactory. The above-described steps may be repeated until the RPP test results are satisfactory. Finally, the free ends of the suture pairs  84 ,  86 ,  88 ,  90 ,  92 , and  94  may be trimmed and left untied or first tied with a simple small size knot and then trimmed at the discretion of the surgeon. 
     Other embodiments of “multiple suture” retainers are adapted to be applied to a plurality of suture(s) extending through a plurality of openings of the urethral sling  30 . Thus, first and second suture retainers may be provided that are adapted to be applied to the suture pairs  84 ,  86 , and  88  and to the suture pairs  90 ,  92  and  94 , respectively, or to any number of suture pairs extending from bone anchors inserted into the descending pubic rami  24  and  26 . 
     A first embodiment of an exemplary “multiple suture” retainer  160  is depicted in  FIGS. 10 and 11  that may constitute or resemble a plurality of the suture retainers  100  joined together in an elongated array. One such suture retainer  160  would be applied along the urethral sling end  32  to engage the suture pairs  84 ,  86  and  88 , and a further suture retainer  160  would be applied along the urethral sling end  34  to engage the suture pairs  90 ,  92 ,  94 . 
     Thus, each elongated suture retainer body  162  is generally rectangular having a major surface adapted to be pressed against a portion of the urethral sling  30  adjacent the urethral sling end  32  or  34 . A series of retainer slots and bores  164 ,  166 ,  168 ,  170 ,  172 , and  174  are formed extending from one side of and through the suture retainer body  162 . 
     In use, each pair of retainer slots and bores receives and engages a respective pair of bone screw sutures. Again, the bores are sized to receive and frictionally engage the sutures passed laterally through the slots. It will be understood that the series of slots and bores  164 ,  166 ,  168 ,  170 ,  172 , and  174  are schematically illustrated and may take any suitable form. It will also be understood that a greater number of slots and bores than the depicted slots and bores  164 ,  166 ,  168 ,  170 ,  172 , and  174  may be formed in suture retainer body  162  arrayed along substantially the entire length of the suture retainer body  162 . In such an embodiment, the surgeon may select the most suitably spaced apart slot and bore pairs to receive each suture pair. 
     The suture retainer body  162  is formed of a biocompatible plastic material that may be thin enough to be trimmed with shears by the surgeon to an overall size and shape accommodating the particular patient. For example, only two bone anchors or screws may be required to be placed in each pubic bone in certain instances, and the surgeon may trim the suture retainer body  162  to an appropriate size and shape leaving only two pair of the depicted slots and bores  164 ,  166 ,  168 ,  170 ,  172 , and  174  to accommodate two pair of sutures. 
     A further embodiment of a multiple suture retainer  200  is depicted in  FIGS. 12 and 13 . The multiple suture retainer  200  is formed of a retainer cover  202  and a retainer base  210  that are fitted together to entrap a number of sutures or suture pairs within suture slots and/or bores when the retainer cover  202  is fitted to the retainer base  210 . The retainer cover  202  may be separate from the retainer base, as depicted in  FIG. 12 , or attached, e.g., by a living hinge, joining mutual ends or sides, for example. In either case, the retainer cover  202  is to be applied into engagement with or moved from an open to a closed position with the retainer base  210  to entrap and hold sutures placed through the suture slots and/or bores, and the suture retainer  200  formed of the retainer cover  202  and base  210  bears against a portion of the urethral sling  30  to hold it in place in proximity to a pubic bone. 
     A pair of snap recesses  216  and  218  are formed in the opposite ends, for example, of the retainer body  214 . The cover body  204  is shaped and dimensioned to fit over and against the retainer body  214 . A pair of snap-in catches  206  and  208  are formed in the ends of the cover body  204  that are adapted to be received in the respective snap-in recesses  216  and  218  in the ends of the retainer body  214 . 
     In the particular illustrated embodiment of multiple suture retainer  200 , a series of slots and/or suture engaging bores  220 ,  222 ,  224 ,  226 ,  228 , and  230  extend into and across one major surface of the substantially rectangular retainer body  214  of the retainer base  210 . Each pair of suture engaging bores  220 ,  222 ,  224 ,  226 ,  228 , and  230  would receive a respective pair of bone screw sutures. Again, the bores are sized to receive and frictionally engage the sutures passed laterally through the slots. It will be understood that the series of suture engaging bores  220 ,  222 ,  224 ,  226 ,  228 , and  230  are schematically illustrated and may take any suitable form. It will also be understood that a greater number of suture engaging bores than the depicted suture engaging bores  220 ,  222 ,  224 ,  226 ,  228 , and  230  may be formed in suture retainer body  210  arrayed along substantially the entire length of the suture retainer body  210 . In such an embodiment, the surgeon may select the most suitably spaced apart slot and/or bore pairs to receive each suture pair. 
     Thus, in use and referring to  FIG. 13 , the bone screws  64 ,  66 , and  68  may be screwed into the pubic bone of the descending pubic ramus  24 , and the bone screws  70 ,  72 , and  74  may be screwed into the pubic bone of the descending pubic ramus  26 . An end portion of the urethral sling  30  along sling end  32  is applied against or proximate the descending pubic ramus  24 , as the suture pairs  84 ,  86 ,  88  are inserted through selected sling openings, e.g., mesh pores  40  depicted in  FIG. 3 . The suture retainer base  210  of a first suture retainer  200  is applied against the urethral sling  30  along the edge  32  and aligned with the suture pairs  84 ,  86 ,  88  to dispose the suture pair  84  in slots and/or suture engaging bores  220  and  222 , the suture pair  86  in slots and/or suture engaging bores  224  and  226 , and the suture pair  88  in slots and/or suture engaging bores  228 , and  230 . The retainer cover  202  is closed against or snapped onto the retainer base  210  to capture the suture pairs  84 ,  86  and  88 . 
     The other sling end  34  of the urethral sling  30  is then drawn across the urethra toward the descending pubic ramus  26 , and the suture pairs  90 ,  92 ,  94  are inserted through selected sling openings, e.g., mesh pores  40  depicted in  FIG. 3  in an end portion of the urethral sling  30  along sling end  34 . The suture retainer base  210  of a second suture retainer  200  is applied against the urethral sling  30  along the edge  34  and aligned with the suture pairs  90 ,  92 ,  94  to dispose the suture pair  90  in slots and/or suture engaging bores  220  and  222 , the suture pair  92  in slots and/or suture engaging bores  224  and  226 , and the suture pair  94  in slots and/or suture engaging bores  228 , and  230 . Tension may be applied to the free ends of the suture pairs  90 ,  92  and  94  to draw the retainer base  210  against the portion of the urethral sling  30  and thereby tension the portion of the urethral sling  30  extending across the urethral region. The retainer cover  202  is closed against or snapped onto the retainer base  210  to capture the suture pairs  90 ,  92  and  94 . 
     An RPP test may be conducted, and the retainer cover  202  of either or both the first and second “multiple suture” retainers  200  removed to adjust the suture pairs and closed to entrap the suture pairs if the test results are not satisfactory. The above-described steps may be repeated until the RPP test results are satisfactory. Then, the free ends of the suture pairs  84 ,  86 ,  88 ,  90 ,  92 , and  94  may be tied and/or trimmed as the surgeon prefers. 
     A substantially similar process is employed to dispose first and second multiple suture retainers  160  into engagement with the suture pairs  84 ,  86 ,  88  and  90 ,  92 ,  94  and against portions of the urethral sling  30  adjacent sling ends  32  and  34  to tension and hold the portions of the urethral sling  30  proximate the descending pubic rami  24  and  26 . 
     It will be understood that the above-described suture retainers  100 ,  160 ,  200  may be employed with bone anchors, e.g., bone screws, having only one suture extending from the bone anchor by simply placing the suture through a selected suture slot and/or bore of suture retainers  100 ,  160 ,  200  or providing a single or fewer slots and/or suture engaging bores in similar suture retainers. 
     Moreover, it will be understood that the single suture or the sutures of a suture pair extending from a bone anchor may be especially configured to enhance frictional engagement with the urethral sling and/or the suture retainer. In such further exemplary preferred embodiments, the bone screw suture is shaped along at least a portion of the suture length between the suture free end and the suture attached end with at least one suture fixation element that extends outward to engage the urethral sling or a suture retainer interposed between the urethral sling and the suture fixation elements to maintain fixation and inhibit slippage. The suture fixation elements may take any suitable form and one suture fixation element may be provided at a suitable distance from the suture attached end or a plurality of such suture elements may be disposed at suitable intervals along the length of the suture. 
     In one preferred embodiment depicted in  FIGS. 14-17 , a bone screw  64  of the type described above is adapted to be screwed into the descending pubic ramus  24  or  26 , and a bone screw suture  250  having a suture body  252  extends from a suture end attached to the bone screw  64  to a suture free end  254 . The suture body  252  is shaped with a series of suture fixation elements  258  projecting outward from the diameter of the suture body  252 . Such suture fixation elements  258  may take any suitable form, e.g., cylindrical, spherical or the depicted generally conical shape. The suture fixation elements  258  are separated apart along suture body  254  by a distance that accommodates at least the thickness of urethral sling  30  and preferably the thickness of the urethral sling  30  and the thickness or length of a suture retainer that bears against the urethral sling  30 . It will be understood that the depicted bone screw suture  250  may be provided with only one suture fixation element  258  suitably spaced from the bone screw  64  to receive and inhibit retraction of the suture retainer and/or the urethral sling  30  away from the descending pubic ramus  24  or  26  and toward the suture free end  254 . The suture fixation element  258  that is in contact with the sling  30  and/or a suture retainer inhibits retraction of the suture retainer and/or the urethral sling  30  toward the suture free end  254 . 
     Generally speaking, the suture fixation elements  258  are sized in maximum cross-section area to the selected sling opening, e.g., mesh pore  40 , such that the suture fixation elements  258  can be barely passed through the sling opening. Thus, it is preferable that the suture fixation elements  258  have a relatively gradual ramp shape increasing in cross-section area from the suture body  252  to the maximum cross-section area closer to the bone screw  64 . The ramp shape provides a sling opening expansion surface as the sling  30  is advanced from right to left over it as shown in  FIG. 15 . The ramp shape terminates with an abrupt transition back to the cross-section area of the suture body  252  to present a sling contact surface. The sling contact surface having a surface area exceeding the sling opening area is thereby provided to bear against the sling mesh or body to enhance retention of the sling. The depicted generally conical or arrowhead shape of the suture fixation elements  258  is simply one way of satisfying this preferred characteristic. 
     Consistent with the above-described methods, a plurality of bone screws, exemplified by the bone screw  64  of  FIGS. 14-17 , are affixed to the descending pubic rami  24  and  26 . First, the suture  250  of each bone screw affixed to the descending pubic ramus  24  is inserted through a selected sling opening, e.g., a mesh pore  40  along a first end portion of the urethral sling  30  along sling end  32 , and the first end portion is advanced over the sutures  250  against or proximate the descending pubic ramus  24 . Preferably, a suture retainer is then interposed over or onto the bone screw suture body  252  to bear against the urethral sling  30  to retain it in position. Then, the suture  250  of each bone screw affixed to the descending pubic ramus  26  is inserted through a selected sling opening, e.g., a mesh pore  40  along a first end portion of the urethral sling  30  along sling end  34 , and the first end portion is advanced over the sutures  250  against or proximate the descending pubic ramus  26 . Preferably, a suture retainer is then interposed over or onto the bone screw suture body  252  to bear against the urethral sling  30  to retain it in position. Any of the above-described suture retainers  100 ,  160  and  200  may be interposed between the sling contact surface and the sling  30  by laterally passing the suture body  252  through a selected slot and into a suture retainer bore of the selected suture retainer. 
     An RPP test may be conducted, and one or more of the suture retainers may be adjusted along the length of the respective sutures  250  to adjust the sling tension if the test results are not satisfactory. The above-described steps may be repeated until the RPP test results are satisfactory. Finally, the suture free ends  254  may be trimmed and left untied or first tied with a simple small size knot and then trimmed at the discretion of the surgeon. 
     An alternative exemplary suture retainer  270  is depicted in  FIG. 16  that is advanced over the suture free end  254  and toward the urethral sling  30  over the suture fixation elements until the suture retainer  270  contacts the urethral sling  30 . The suture retainer  270  is axially advanced into a retention position over the suture  250  and is configured to interlock with the suture fixation element  258  contacting the urethral sling  30  to bear against urethral sling  30  and to be maintained in the retention position. 
     The suture retainer  270  has a generally annular, “cup-shaped” retainer body  272  defining and surrounding a central retainer bore  274  and having a body length equal to or exceeding the distance between adjacent suture fixation elements  258 . The retainer body  272  extends between a minimum diameter or cross-section retainer end  276  that is adapted to be applied against a suture fixation element  258  and a maximum diameter or cross-section retainer end  282  that is adapted to be applied against the urethral sling  30  as shown in  FIG. 17 . The retainer body  272  is relatively thin walled and defines a retainer bore  274  extending between the retainer ends  276  and  282  that conforms with the shape of the suture fixation element, particularly the generally conical shape of suture fixation element  258 . It will be understood that the maximum diameter or cross-section retainer end  282  may have any suitable diameter and may include an annular flat portion extending transversely to the axis of the retainer body  272 . 
     Preferably, a plurality of resilient flaps  278  are provided between slots  280  through the retainer body  272 . The resilient flaps  278  extend from the minimum diameter or cross-section retainer end  276  toward the maximum diameter or cross-section retainer end  282  to a diameter of the generally conical bore  274  corresponding generally to the maximum diameter of retainer end  282 . Thus, the resilient flaps  278  are flexed outward to enable advancement of the suture retainer  270  over each suture fixation element  258 . The resilient flaps  278  return to their resting shape with the retainer end  276  disposed against the abrupt sling contact surface end of an adjacent suture fixation element  258  when the retainer end  282  is applied against the urethral sling  30  as shown in  FIG. 17 . 
     It will be noted that the retainer  270  may also be modified to be applied over a constant diameter suture or suture pair, e.g., the suture pair  84  of bone screw  64  of  FIG. 4 , by suitably dimensioning the bore  274  to provide a frictional fit with the suture of suture pair  84 . In this regard, the single and “multiple suture” retainers  300  and  310  depicted in  FIGS. 18-20  are especially configured for over-the-suture application to the sutures  85  and  87  of the suture pair  84  of  FIG. 4 . 
     The single suture retainer  300  depicted in  FIGS. 18 and 20  is formed of a generally planar circular or rectangular or oblong retainer body  302  having two retainer bores  306  and  308  extending through the retainer body  302  (or one retainer bore for both sutures or a single suture). The retainer bores  306  and  308  are smaller in cross-section area than the suture body cross-section area to provide an interference friction fit. The retainer bores  306  and  308  are preferably be bounded by resilient flaps that extend slightly out of the plane of the retainer body  302  created by slits similar to the flaps  278  and slits  280  of the suture retainer  270 . For example, the retainer bores  306  and  308  are elongated and bounded by H-shape slits, although other bore and slit shapes, e.g., a starburst or radial slits from a circular bore, could be used. In this way, the retainer bores  306 ,  308 ,  320 ,  322 ,  324 ,  326 ,  328 ,  330  extend through the retainer body  304 ,  312  and are dimensioned and shaped to enable axial advancement of the retainers  300  and  310  over the suture into engagement with a portion of the urethral sling  30  and to resist axial retraction of the retainers  300  and  310  from engagement with the portion of the urethral sling  30 . 
     In use, the bone screws  64 ,  66 , and  68  may be screwed into the pubic bone of the descending pubic ramus  24 , and the bone screws  70 ,  72 , and  74  may be screwed into the pubic bone of the descending pubic ramus  26  as described above with respect to  FIGS. 2 and 9 . An end portion of the urethral sling  30  along sling end  32  is applied against or proximate the descending pubic ramus  24 , as the suture pairs  84 ,  86 ,  88  are inserted through selected sling openings, e.g., mesh pores  40  depicted in  FIG. 3 . A first set of three suture retainers  300  are applied as shown in  FIG. 20  to the suture pairs  84 ,  86 , and  88  to retain, the urethral sling  30  proximate the descending pubic ramus  24 . 
     The other sling end  34  of the urethral sling  30  is then drawn across the urethra toward the descending pubic ramus  26 , and the suture pairs  90 ,  92 ,  94  are inserted through selected sling openings, e.g., mesh pores  40  depicted in  FIG. 3 , in an end portion of the urethral sling  30  along sling end  34 . A second set of three suture retainers  300  are applied as shown in  FIG. 20  to the suture pairs  90 ,  92 , and  94  to retain the urethral sling  30  proximate the descending pubic ramus  26  and to thereby tension the portion of the urethral sling  30  extending across the urethral region. 
     An RPP test may be conducted, and one or more of the suture retainers  300  may be adjusted along the length of the respective suture pairs  84 ,  86 ,  88 ,  90 ,  92 , and  94  to adjust the sling tension if the test results are not satisfactory. The above-described steps may be repeated until the RPP test results are satisfactory. Finally, the free ends of the suture pairs  84 ,  86 ,  88 ,  90 ,  92 , and  94  may be trimmed and left untied or first tied with a simple small size knot and then trimmed at the discretion of the surgeon. 
     An embodiment of an exemplary, slitted bore “multiple suture” retainer  310  is depicted in  FIGS. 19 and 20  that may constitute or resemble a plurality of the suture retainers  300  joined together end-to-end in an elongated array and may be employed instead of a plurality of suture retainers  300 . One such suture retainer  310  would be applied along the urethral sling end  32  to engage the suture pairs  84 ,  86  and  88 , and a further suture retainer  310  would be applied along the urethral sling end  34  to engage the suture pairs  90 ,  92 ,  94  in the manner of suture retainers  160  and  200  as described above with respect to  FIG. 13 . The sutures  85  and  87  of suture pair  84  may be passed through the bores  320  and  322 , respectively, of a first suture retainer  310 . Similarly, the sutures of the suture pairs  86  and  88  may be passed through the bores  324 ,  326  and  328 ,  330  of the first suture retainer  310 . The sutures of suture pair  90  may be passed through the retainer bores  320 ,  322 , the sutures of suture pair  92  may be passed through the retainer bores  324 ,  326 , and the sutures of suture pair  90  may be passed through the retainer bores  328 ,  330  of a second suture retainer  310 . 
     Again, it will be understood that the “multiple suture” suture retainer  310  may be formed with a greater number of spaced apart retainer bores like retainer bore  320 , and the surgeon may select the retainer bores to receive the sutures of the suture pairs of the bone screws that are screwed into the pubic bones. 
     An RPP test may be conducted, and one or more of the suture retainers  310  may be adjusted along the length of the respective suture pairs  84 ,  86 ,  88 , and suture pairs  90 ,  92 ,  94  to adjust the sling tension if the test results are not satisfactory. The above-described steps may be repeated until the RPP test results are satisfactory. Finally, the free ends of the suture pairs  84 ,  86 ,  88 ,  90 ,  92 , and  94  may be trimmed and left untied or first tied with a simple small size knot and then trimmed at the discretion of the surgeon. 
     As noted above, the suture retainers  100 ,  160  and  200  may also be employed in conjunction with a shaped suture or sutures like shaped suture  250  depicted in  FIGS. 14-17  having at least one enlarged suture fixation element  258  engaging the suture retainers  100 ,  160  and  200  against portions of the urethral sling. The selected suture retainer  100 ,  160  or  200  would be applied laterally to the suture body  252  between the enlarged end of the suture fixation element  258  and the urethral sling  30  to effect fixation in the manner of the suture retainer  270  as described above. The enlarged suture fixation element thereby enhances the fixation of the suture retainers  100 ,  160  and  200  with the suture pairs  84 ,  86 ,  88 ,  90 ,  92  and  94  shown in  FIGS. 9 and 13 . 
     In this regard, a further single suture retainer  340  is depicted  FIGS. 21 and 22  in cooperative relation with a single suture  350  having a single suture fixation element  358  disposed along the suture body  352  displaced from the suture free end  354  adjacent to the suture attached end with the bone screw  64 . The suture fixation element  358  may or may not have a generally conical shape because the suture retainer  340  is applied laterally to the suture body  352  between the enlarged end of the suture fixation element  358  and the urethral sling  30  to effect fixation in the manner of the suture retainer  270  as described above but need not be applied over-the-suture as described above. 
     The suture retainer  340  is configured with a generally circular and substantially planar suture retainer body  342  having single retainer bore  344  open to the circumference of the retainer body  342  by a slit  346 . It will be understood that a multiple suture retainer may alternatively be provided having an elongated substantially planar retainer body with a plurality of such bores and slits formed therein either regularly spaced apart or grouped in the manner of the suture retainer  160 . In either case, the steps described above are followed to apply the suture retainer  340  laterally to frictionally engage the suture body  352  within the retainer bore  344  with the retainer body  342  interposed between the urethral sling  30  and the suture fixation element  358  as shown in  FIG. 22 . 
     Thus, in certain exemplary preferred embodiments, the bone screw sutures are extended through laterally extending slots into bores of the suture retainer into engagement with a portion of the urethral sling. In other exemplary preferred embodiments, the suture retainer is applied over the free ends and along bone screw sutures into engagement with a portion of the urethral sling.