US20060252980A1 - Methods and Apparatus for Securing and Tensioning a Urethral Sling to Pubic Bone - Google Patents

Abstract

Improved methods and apparatus to secure a urethral sling to pubic bone in a sub-urethral location to support the urethra and alleviate incontinence are disclosed. The urethral sling is preferably formed of a flexible sheet material extending between opposed first and second sling ends and bounded by opposed first and second sling sides. The urethral sling is selectively tensioned in a central portion intermediate the first and second sling ends and/or in one or both of end portions bracketing the central portion. In one embodiment, pre-positioned plicating lines in the central portion are selectively drawn and tied to slacken the central portion and tension the end portions. In further embodiments, bone anchor lines passed through locations displaced from the sling ends are drawn and fixed to tension the central portion between the displaced locations and slacken the end portions.

Description

RELATED APPLICATIONS
• This application claims priority to U.S. Provisional Application Ser. No. 60/677,456 filed May 4, 2005, the entire content of which is incorporated herein by reference.
FIELD OF THE INVENTION
• The present invention pertains to surgical procedures, kits, and implants to alleviate human incontinence, and particularly to improved methods and apparatus to secure a urethral sling to pubic bone in a sub-urethral location and tensioning the urethral sling to support the urethra and alleviate incontinence.
BACKGROUND OF THE INVENTION
• Incontinence is a condition characterized by involuntary loss of urine, beyond the individual'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'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. 6,406,480, 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, supra-pubic and pre-pubic exposures or pathways.
• The above-referenced '214 and '480 patents describe 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 anchors or screws fixed to the descending pubic rami is depicted inFIG. 12 of the above-referenced '214 patent.
• One minimally invasive surgical procedure that incorporates the teachings of the above-referenced '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 '214 patent. 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 anchors or 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 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'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 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 '214, '480, and '524 patents also disclose procedures for repairing a cystocele using retropubic and lateral pubic bone anchors. The surgery disclosed in the '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. These anchors may comprise 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. Other types of bone anchors are disclosed in the above-referenced '480 patent.
• 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 types described above and in the above-referenced '480 patent 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 are 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.
• 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.
• It would be desirable to simplify the process of and to reduce the amount of time that it takes to tension and secure the urethral mesh to the sutures extending from bone anchors of the types described above.
• 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 anchor 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 anchors.
• 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 the sutures in a manner that does not require untying and retying the sutures and is not compromised by trimming the suture length.
SUMMARY OF THE INVENTION
• 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. It will be understood that the inventive features and preferred embodiments may be applied in treating both male and female patients.
• In one aspect of the present invention, a urethral sling is preferably formed of a flexible sheet material extending between opposed first and second sling ends and bounded by opposed first and second sling sides. The urethral sling is provided with at least one pre-positioned, plicating line, e.g., a suture, having a plicating line length extending between first and second plicating line free ends. An intermediate portion of the plicating line is passed through the material of the urethral sling between at least first and second points disposed intermediate first and second sling ends. The intermediate portion of the pre-positioned, plicating line thus extends generally across a central portion of the urethral sling displaced from the first and second sling ends.
• In use, the urethral sling is affixed by any of the known techniques to the bone screws or anchors inserted into the pubic bones to extend laterally across and support the urethra, and testing for urethral resistance to leakage may be conducted. The plicating line free ends of the one or more pre-positioned plicating line may be gripped and drawn together to draw a fold or crease in the sling material (i.e., to plicate the sling material) in the central portion of the urethral sling, whereby the urethral sling material is drawn tight in first and second end portions bracketing the central portion. Thus, the urethral sling is tensioned by the tension of the plicating line against the urethra to increase urethral resistance to leakage. The resistance to leakage may be rechecked, and the plicating line free ends tied together to maintain the slack or fold or crease and resulting sling tension that provide an acceptable urethral resistance to leakage.
• In preferred embodiments, the length of plicating line may be passed through the material of the urethral sling at further points intermediate the first and second points. In addition, the plicating line free ends may be folded against one side of the urethral sling and held there to avoid entanglement during or interference with the procedure. The plicating line free ends are held in place by threading through additional suture pores until released for use.
• In further preferred embodiments, more than one plicating line is provided extending across the central portion of the urethral sling so that the urethral sling may be tensioned more precisely between the first and second sling sides. Unused plicating lines may be left in place or retracted from the urethral sling.
• In a further aspect of the present invention usable separately or together with the above-described aspect of the invention, anchor fixation lines extending from each bone anchor are employed alone or in conjunction with line retainers to affix an implantable medical device in the patient's body. Each bone anchor comprises a bone anchor body having a bone fixation end and an elongated bone anchor line affixed at one line end to the bone anchor body and extending to an anchor line free end.
• In one variation, the anchor line comprises at least one line fixation element shaped to be fitted with the device fixation element to affix the medical device to the bone anchor. In other variations, the anchor lines comprise a plurality of line fixation elements spaces along the anchor line length to be selectively fitted to the device fixation element.
• In the context of implanting a urethral sling formed of a mesh fabric, the device fixation element comprises a selected mesh pore. In this aspect of the invention, each bone anchor line is inserted through the sling material at a location of the urethral sling displaced from a sling end and the site where the bone anchor is affixed into the pubic bone. Generally speaking, the bone anchor line or line pair extends from each bone anchor affixed to one pubic bone toward a bone anchor affixed to the other pubic bone and is passed through the sling material at the displaced location. In preferred embodiments, the bone anchor lines are in this way extended across first and second end portions of the urethral sling and passed through the sling material at the displaced locations, whereby the central portion of the urethral sling is bounded by the displaced locations. The bone anchor lines are selectively tensioned and fixed at the displaced locations to slacken and possibly induce a fold or crease or plication in the first and/or second end portions and tension the central portion.
• In one preferred embodiment, a line retainer is provided that can be selectively advanced over the bone anchor line extending through the mesh and against the urethral sling to maintain the tension. In preferred embodiments, the line retainer is resilient and has a retainer bore sized and shaped to be expanded to pass over the bone anchor line (including any outwardly extending line fixation elements) as the retainer is advanced toward the bone anchor and that resists retraction over the bone anchor away from the bone anchor. Retainer-dispensing tools may be provided that facilitate application of the retainers over the anchor lines.
• After adequate tension is achieved with or without use of line retainers, the anchor lines may be tied off with fewer or smaller knots to reduce suturing time, and the final exposed line trimmed.
• It will be understood that the present invention may be practiced employing any suitable bone anchor line and bone anchors of any of the types known in the prior art, including those disclosed in the above-referenced '480 patent.
• Advantageously, the procedure for attaching the urethral sling to bone anchors is simplified to shorten the surgical time, the tensioning and fixation are made more reliable, and any line knots that are employed are reduced in size.
• This summary of the invention has been presented here simply to point out some of the ways that the invention overcomes difficulties presented in the prior art and to distinguish the invention from the prior art and is not intended to operate in any manner as a limitation on the interpretation of claims that are presented initially in the patent application and that are ultimately granted.
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 or screws to descending pubic rami with lines extending from the bone screws;
• FIG. 2 is a schematic illustration of the fixation of a urethral sling to the bone screws with the lines extending from the bone screws in accordance with the prior art resulting in insufficient tensioning in certain instances;
• FIG. 3 is a plan view of an embodiment of a urethral sling in accordance with the present invention with one or more pre-positioned plicating line extending across the urethral sling;
• FIG. 4 is a side view of the urethral sling ofFIG. 3;
• FIG. 5 is an expanded side view of a bone anchor, particularly a bone screw of the type employed inFIGS. 1 and 2, with a pair of bone screw lines extending from the screw body;
• FIG. 6 is a schematic illustration of the urethral sling fixed to the bone screws with the plicating line(s) of the urethral sling ofFIG. 3 drawn and tied to form a fold or crease in the urethral sling to adjust tension and obtain satisfactory urethral resistance;
• FIG. 7 is a plan view of an embodiment of a line button adapted to be applied over the lines extending from the bone screw ofFIG. 5;
• FIG. 8 is a plan view of a further embodiment of a line button adapted to be applied over the lines extending from the bone screw ofFIG. 5;
• FIG. 9 is a side view in partial cross-section illustrating the passage of bone screw lines of a bone screw affixed to a descending pubic ramus through a mesh pore of the urethral sling and tensioning the urethral sling by drawing a line button ofFIG. 7 or8 over the lines and against the urethral sling;
• FIG. 10 is a schematic illustration of the urethral sling fixed to the bone screws with the bone screw lines drawn through the line buttons to form folds or creases in the urethral sling to adjust tension and obtain satisfactory urethral resistance;
• FIG. 11 is an expanded side view of a bone anchor, particularly a bone screw, with a bone screw line extending from the screw body shaped with periodic spherical fixation elements;
• FIG. 12 is a side view illustrating the passage of the bone screw line of the bone screw ofFIG. 11 affixed to a descending pubic ramus through a mesh pore of the urethral sling and tensioning the urethral sling by progressively drawing spherical fixation elements through a mesh pore to bear against the urethral sling;
• FIG. 13 is an expanded side view of a bone anchor, particularly a bone screw, with a bone screw line extending from the screw body shaped with periodic barbed fixation elements; and
• FIG. 14 is a side view illustrating the passage of the bone screw line of the bone screw ofFIG. 13 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 to bear against the urethral sling.
• It will be understood that the drawing figures are not necessarily to scale.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
• 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 tensioning urethral slings fixed to pubic bones. 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. The urethral sling may be formed of any biocompatible flexible sheet material known in the art with or without pores or openings through the sheet material.
• For convenience of illustration of the aspects of the present invention, the preferred embodiments simply depict the bone anchors as bone screws. It will be understood that the present invention may be practiced employing bone anchors of any of the types known in the prior art, e.g., those disclosed in the above-referenced '480 patent.
• For convenience of illustration of the aspects of the present invention, the preferred embodiments are described in the context of implantation of a urethral sling in a male patient. It will be understood that the present invention is not so limited and may also be practiced in the implantation of urethral slings in female patients.
• It will be understood that the fixation lines and plicating lines disclosed herein may be but are not necessarily formed of lengths of suture.
• Referring toFIGS. 1 and 2, the male anatomy in thepelvic region10 is depicted schematically to illustrate how aurethral sling30 is affixed to the right and left descendingpubic rami24 and26 to extend across and support themale urethra12 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 an improvedurethral sling30 of the present invention, which can be implemented in the InteMesh™ Synthetic Surgical Mesh urethral sling, is depicted in greater detail inFIGS. 3 and 4. In a preferred embodiment, theurethral sling30 is knitted from a supple polyester yarn to have a plurality of sling or mesh pores40 and is coated with medical grade silicone rubber. The knitted mesh pores40 have a pore size that allows for tissue ingrowth therethrough during chronic implantation. Theurethral sling30 extends end-to-end between first and second sling ends32 and34 and side-to-side between first and second sling sides36 and38. At least oneplicating line50 having a line length extending between first and second line free ends52 and54 is fitted through mesh pores40. Anintermediate line portion56 is passed through two or more mesh pores40 to extend the line length betweenpoints58 and60 across theurethral sling30 intermediate the first and second sling ends32 and34 and either parallel to or at an angle to the first and second sling sides36 and38.
• In preferred embodiments, theintermediate portion56 ofplicating line50 may be passed throughfurther pores40 of theurethral sling30 at points intermediate the first andsecond points58 and60. The line free ends52 and54 may be folded against one side of theurethral sling34 and held there by passing them through additional pores as shown inFIG. 4. The line free ends52 and54 are released from the
• Additional plicating lines50′ and50″, for example, are depicted inFIG. 3 passing through the mesh pores40 in the manner described above providing an exemplary illustration of a further preferred embodiment of aurethral sling30.
• Returning toFIGS. 1 and 2, as noted above, the surgical field is prepared after the patient, placed in the dorsal lithotomy position and draped. Thescrotum14 andpenis16 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 thebulbocavernous muscle20. Lateral dissection is used to expose the corpora cavernosum22 and the surfaces of the descendingpubic rami24 and26.
• As shown inFIG. 1, the illustrated fixation of the surgicalurethral sling30 is effected employing six titanium bone screws64,66,68,70,72,74 sequentially driven by a disposable, battery powered, inserter or driver (not shown). Eachbone screw64,66,68,70,72,74 has an anchor or screw body with 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. 1Prolene suture lines84,86,88,90,92,94 extend proximally from eachbone screw64,66,68,70,72,74, respectively. Onesuch bone screw64 with the pair ofbone screw lines84 extending from the screw body is depicted in the expanded view ofFIG. 5. Typically, the pair of bone screw lines is crimped at one end into a bore of the bone screw and extends about 30 cm to bone screw line free ends. The bone screw line 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 line free ends through a selected mesh pore, tie a knot or knots, and then trim the lines. Or, the surgeon may first trim the lines, separately pass the severed line free ends through a common or separate mesh pores, tie a knot or series of knots, and again trim the line free ends.
• The bone screws64,66,68,70,72,74 are screwed fully into the bone of the so that the No. 1Prolene lines84,86,88,90,92,94, respectively, extend outward of the descendingpubic rami24 and26 as shown inFIG. 1. The surgeon can select the location of eachbone screw64,66,68,70,72,74 and the order of insertion. In one approach depicted inFIG. 1, a first pair of bone screws64,70 is inserted just below the symphysis, thesecond pair66,72 is inserted proximal to the level of the ischial tuberosity, and thethird pair68,76 is inserted intermediate the first and second pair.
• Theurethral sling30 is then applied against the array of bone screws64,66,68,70,72,74 bridging the lower surface of thebulbar urethra20 between the descendingpubic rami24 and26 to determine where each line of the respective line pairs84,86,88,90,92,94 will be passed through mesh pores.
• The free ends of each line of eachline pair84,86,88,90,92,94 are sequentially grasped, passed through separate mesh pores and drawn tight and tied together against the mesh of theurethral sling30.
• The lines of the line pairs84,86,88 extending from the descendingpubic ramus24 may be first passed though selected mesh pores adjacent thefirst sling end32. The first slingfree end32 is then pressed against the descendingpubic ramus24. The free ends of each line of eachline pair84,86,88 are sequentially grasped, drawn tight and tied together at least two times forming several surgeon's line knots against the mesh of theurethral sling30 firmly holding the sling first end against the descendingpubic ramus24.
• Tension is then applied to thesecond sling end34 of theurethral sling30 as it is drawn against the secondpubic ramus26 to determine where the lines of the bone screw line pairs90,92,94 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 lines of bone line pairs90,92,94 are drawn tight against the fabric ofurethral sling30 and tied off. The lines of bone line pairs90,92,94 may be retracted from the initially selectedpores40 and reinserted inother pores40 in the process of optimizing the tension. In this way, theurethral sling30 is eventually lined to all of the bone anchors or screws64,66,68,70,72,74 inserted into the descendingpubic rami24 and26 to extend laterally across and support thebulbar urethra20. An intermediate portion of theurethral sling30 extends between the bone screws64,66,68 and the bone screws70,72, and74.
• The testing for urethral resistance may reveal that tension applied by the intermediate portion of theurethral sling30 to theurethra12 is insufficient to halt leakage despite the attempts to optimize urethral resistance. This deficiency and the preceding urethral resistance optimization tests and efforts may be advantageously minimized by taking the further steps of freeing the line free ends52 and54 of the plicating line(s)50,50′,50″ from the retained position shown in solid lines inFIG. 4 toward one another as shown in broken lines inFIG. 4 and tying them together with one or more surgeon's knot.
• More particularly, the plicating line free ends52 and54 may be gripped and drawn together after being freed from retention to shorten the distance between the first and second points, thereby shortening a dimension of theurethral sling30 and tensioning it against the urethra12 to increase urethral resistance to leakage. The resistance to leakage may be rechecked, and the plicating line free ends52 and54 tied together to maintain the shortened dimension and tension that provides an acceptable urethral resistance to leakage. The knotted plicating line free ends52,54 of each of the plicating lines50,50′,50″ are shown overlying the mesh of theurethral sling30 inFIG. 4. As also shown inFIG. 6, a mesh fold is created in the central portion as theurethral sling30 is tensioned by the tied together, plicating line free ends52,54.
• In this way, thepre-positioned plicating lines50,50′50″ slacken or draw a fold or crease in the sling material in the central portion of theurethral sling30, whereby the urethral sling material is drawn tight in first and second end portions bracketing the central portion. Thus, theurethral sling30 is tensioned by the tension of the plicating lines50,50′,50″ against the urethra to increase urethral resistance to leakage. The resistance to leakage may be rechecked, and the plicating line free ends tied together to maintain the slack or fold or crease and resulting sling tension that provide an acceptable urethral resistance to leakage.
• Unused plicating lines amonglines50,50′,50″ may be left in place or withdrawn from the mesh pores40 of theurethral sling30 and disposed of.
• The tensioning of a urethral sling, e.g., the InteMesh™ Synthetic Surgical Mesh urethral sling or the above-describedurethral sling30 can be enhanced in a further way. For convenience, theurethral sling30 will be employed in describing the following embodiments, but it understood that the plicating lines50,50′,50″ may be absent or may be employed in the manner described above to augment tensioning of theurethral sling30.
• In these embodiments, each bone screw (or other bone anchor) line is inserted through a selectedmesh pore40 in a portion or at a location of theurethral sling30 displaced from the site where the bone screw is screwed into the descending pubic ramus and intermediate the sling first and second ends32 and34. Theurethral sling30 is urged toward each bone screw screwed into the descending pubic ramus to slacken or form a fold or crease in the end portion of theurethral sling30 between the bone screw and the selectedmesh pore40 that tensions the central portion of theurethral sling30. In the following description of this aspect of the invention, it will be understood that either or both of the end portions of theurethral sling30 can be made slack or have a fold or crease induced therein.
• Thus, in the embodiment of this aspect of the invention illustrated inFIGS. 7-10, the bone screws64,66,68 are screwed into the descendingpubic ramus24 and the bone screws,70,72,74 are screwed into the descendingpubic ramus26 in the manner depicted inFIG. 1 and described above. The bone line pairs84,86,88,90,92,94 (or a single line) extend from therespective bone screw64,66,68,70,72,74 as also shown inFIG. 1.
• In accordance with this embodiment, a line retainer, e.g., one of theline button100 depicted inFIG. 7 or theline button110 depicted inFIG. 8, is provided for fixation of eachbone line pair84,86,88,90,92,94 extending through a selectedmesh pore40. Theline buttons100 and110 have a thickness and lateral dimension, e.g., the major and minor diameters of the ellipse shapedline button100 and the diameter of thecircular line button110 that are suitable for implantation at the site and cannot be passed through amesh pore40 at the elastic limits of the yarn forming theurethral sling30. It will be understood that the line retainers may have any shape and size suitable for the purposes of applying retaining force against a portion of theurethral sling30 and resisting passage through amesh pore40.
• Theline buttons100 and110 are formed with centrally locatedbutton apertures102 and112, respectively, that are sized and shaped to receive and frictionally engage a bone screw line pair (or single line) as shown inFIGS. 9 and 10. Thebutton aperture102,112 is shaped to allow a bone screw line to be inserted through it so that theline button100,110 may be advanced over the line pair toward the portion of theurethral sling30 surrounding a selectedmesh pore40 that the line pair extends through as shown inFIG. 9 to apply force thereto. Thebutton aperture102,112 is also shaped to maintain the applied force by resisting retraction of theline button100,110 along the line pair in the direction away from thebone screw64 depicted inFIG. 9. Exemplary button aperture shapes are depicted inFIGS. 7 and 8 that form a pair of resilient flaps separated by a aperture that is smaller than the diameters of the bone screw lines (or line). The passage of the line pair84 (or single line) widens the aperture and displaces the flaps away from thebone screw64 as shown inFIG. 9 to resist slippage.
• Theline buttons100 and110 are preferably formed of a biocompatible material suitable for chronic implantation and having a resilience enabling the widening of the aperture between the flaps as depicted inFIG. 9 but resisting slippage. It will be understood that thebutton apertures102 and112 may take any other shape and size that allows advancement in one direction and resists retraction in the opposite direction.
• In use, the lines of the line pairs84,86,88 extending from the descendingpubic ramus24 may be each first passed though a selectedadjacent mesh pore40 adjacent thefirst sling end32. The first slingfree end32 is then pressed against the descendingpubic ramus24. The free ends of each line of each line pairs84,86,88 are sequentially grasped, drawn laterally toward the descendingpubic ramus26 and extended through a moreremote mesh pore40, whereby an edge portion of the urethral sling is disposed between the adjacent and remote mesh pores40. In each case, aline button100 or110 is then applied over each of the line pairs84,86,88 and advanced sufficiently toward the respective bone screws64,66,68 to stay in place.
• The procedure is then repeated to route the bone line pairs90,92 and94 through adjacent and remote mesh pores40 and to loosely apply aline button100 or110 over each of the line pairs90,92,94 and advanced sufficiently toward the respective bone screws70,72,74 to stay in place. Theline buttons100 or110 over each of the bone line pairs84,86,88,90,92,94 are then selectively and sequentially advanced toward the respective bone screws64,66,68,70,72,74 to tension theurethral sling30 intermediate the threeline buttons100 or110 proximate the descendingpubic ramus24 and the threeline buttons100 or110 proximate the descendingpubic ramus26. Testing for urethral resistance to leakage may be undertaken as described above to judge the sufficiency of the tensioning.
• The application of theline buttons100 or110 and the tensioning of theurethral sling30 are schematically depicted inFIG. 10. For convenience, the selectedline buttons100 or110 applied over thebone screw lines84,86,88,90,92,94 are numbered respectively as144,146,148,150,152,154. The tensioning process may induce creases or folds132 and134 in the end portions of theurethral sling30 adjacent the respective sling ends32 and34 and on either side of the tensioned intermediate portion of theurethral sling30 as shown inFIG. 10. It will be understood that the free ends of the line pairs84,86,88,90,92,94 (or single lines) can be tied together or otherwise knotted with surgical knots over theline buttons144,146,148,150,152,154 if it is considered desirable to do so.
• A still further embodiment of the invention for applying tension to theurethral sling30 in the manner depicted inFIG. 10 is illustrated inFIGS. 11 and 12.FIG. 11 illustrates a bone anchor, particularly abone screw64, with abone screw line114 extending from the screw body. Thebone screw line114 is shaped like a key chain having periodic, enlarged, substantially sphericalline fixation elements118 separated by reduceddiameter link portions116. Theline fixation elements118 may be attached to or formed integrally with thebone screw line114. It will be understood that in this embodiment, thebone screw lines84,86,88,90,92,94 of each of the bone screws64,66,68,70,72,74 are shaped as exemplarybone screw line114.
• FIG. 12 illustrates theexemplary bone screw64 ofFIG. 11 affixed to a descendingpubic ramus24,26, and the passage of thebone screw line114 through aremote mesh pore40 of theurethral sling30. Theurethral sling30 is tensioned by progressively drawingspherical fixation elements118 through theremote mesh pore40 to advance theremote mesh pore40 and surrounding portion of theurethral sling30 toward thebone screw64. Thus, the process described above with respect to the embodiment ofFIGS. 7-10 is followed to tension the intermediate portion of the urethral sling and to induce the folds orcreases132 and134 depicted inFIG. 10.
• The tensioning of the intermediate portion of theurethral sling30 should elongate theremote pores40 that bear against thespherical fixation elements118 so that the possibility of slippage by retraction of thespherical fixation elements118 through theremote pores40 is minimized. It will also be understood that aline button100,110 having a suitably sized and shapedbutton aperture102,112 may be supplied to fit over thespherical fixation elements118 and rest in a reduceddiameter link portion116 to bear against the portion of the urethral sling surrounding theremote mesh pore40 to reinforce the fixation and tensioning of theurethral sling30.
• Yet another embodiment of the invention for applying tension to theurethral sling30 in the manner depicted inFIG. 10 is illustrated inFIGS. 13 and 14.FIG. 13 illustrates a bone anchor, particularly abone screw64, with abone screw line124 extending from the screw body. Thebone screw line124 is shaped to have periodic, enlarged,barbs128 separated by reduceddiameter link portions126. The barb-shapedline fixation elements128 may be attached to or formed integrally with thebone screw line124. It will be understood that in this embodiment, thebone screw lines84,86,88,90,92,94 of each of the bone screws64,66,68,70,72,74 are shaped as exemplarybone screw line124.
• FIG. 14 illustrates theexemplary bone screw64 ofFIG. 13 affixed to a descendingpubic ramus24,26, and the passage of thebone screw line124 through aremote mesh pore40 of theurethral sling30. Theurethral sling30 is tensioned by progressively drawingbarbs128 through theremote mesh pore40 to advance theremote mesh pore40 and surrounding portion of theurethral sling30 toward thebone screw64. Thus, the process described above with respect to the embodiment ofFIGS. 7-10 is followed to tension the intermediate portion of the urethral sling and to induce the folds orcreases132 and134 depicted inFIG. 10.
• Thebarbs128 are relatively resilient and may spread to resist slippage of the tensionedurethral sling30. It will also be understood that aline button100,110 having a suitably sized and shapedbutton aperture102,112 may be supplied to fit over thebarbs128 and rest in a reduceddiameter link portion126 to bear against the portion of theurethral sling30 surrounding theremote mesh pore40 to reinforce the fixation and tensioning of theurethral sling30
• FIG. 14 is a side view illustrating the passage of the bone screw line of the bone screw ofFIG. 13 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 to bear against the urethral sling.
• Various combinations of the above-described aspects of the invention may be made. For example, a line retainer, e.g., aline button100,110 ofFIGS. 7 and 8 could be passed over the plicating line free ends52 and54 in lieu of the knots depicted inFIG. 6 to maintain the tension induced in the central portion of theurethral sling30.
• All patents and publications referenced herein are hereby incorporated by reference in their entireties.
• It will be understood that certain of the above-described structures, functions and operations of the above-described preferred embodiments are not necessary to practice the present invention and are included in the description simply for completeness of an exemplary embodiment or embodiments. It will also be understood that there may be other structures, functions and operations ancillary to the typical surgical procedures that are not disclosed and are not necessary to the practice of the present invention.
• In addition, it will be understood that specifically described structures, functions and operations set forth in the above-referenced patents can be practiced in conjunction with the present invention, but they are not essential to its practice.
• It is therefore to be understood, that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described without actually departing from the spirit and scope of the present invention.

Claims (47)

1. A urethral sling comprising;

a flexible sheet material extending between opposed first and second sling ends adapted to be fixed to bone and bounded by opposed first and second sling sides; and

at least one pre-positioned, plicating line having a plicating line length extending between first and second plicating line free ends and passed through the flexible sheet material at first and second points displaced from the respective first and second sling free ends such that an intermediate portion of the plicating line extends across a central portion of the urethral sling intermediate first and second end portions of the urethral sling, whereby after the first and second sling ends are attached to bone, the plicating line free ends are adapted to be drawn together to induce tension in the first and second end portions and apply tension across the central portion of the urethral sling.

2. The urethral sling ofclaim 1, wherein a plurality of plicating lines are passed through the flexible sheet material at first and second points in substantially side-by-side relation between the first and second sling sides.

3. The urethral sling ofclaim 2, wherein the free ends of each plicating line are passed through the sheet material at temporary retention points to hold the free ends against the flexible sheet material.

4. The urethral sling ofclaim 1, wherein the free ends of the plicating line are passed through the sheet material at temporary retention points to hold the free ends against the flexible sheet material.

5. The urethral sling ofclaim 1, wherein the plicating line is formed of suture material.

6. A bone anchor adapted to be affixed to bone of a patient's body and to be coupled to an implantable medical device having at least one device fixation element, the bone anchor comprising:

a bone anchor body having a bone fixation end; and

an elongated bone anchor line affixed at one line end to the bone anchor body and extending to an anchor line free end, and wherein:

the bone anchor line comprises at least one line fixation element shaped to be fitted with the device fixation element to affix the medical device to the bone anchor.

7. The bone anchor ofclaim 6, wherein the line fixation element is coupled to the anchor line.

8. The bone anchor ofclaim 6, wherein the line fixation element is integrally formed as an enlargement of the anchor line.

9. The bone anchor ofclaim 6, wherein the bone anchor body is a bone screw having a fixation end shaped as a screw thread adapted to be screwed into bone.

10. The bone anchor ofclaim 6, wherein the implantable medical device is a fabric mesh having mesh pores, and the line fixation device is shaped to be fitted through an expandable mesh pore to bear against the mesh around the mesh pore, the mesh pore thereby operable as the device fixation element.

11. The bone anchor ofclaim 10, wherein the line fixation element is substantially spherical shaped and dimensioned to expand the mesh pore as the spherical shaped line element is fitted through the mesh pore.

12. The bone anchor ofclaim 10, wherein the line fixation element is barb shaped and dimensioned to expand the mesh pore as the barb shaped line element is fitted through the mesh pore

13. The bone anchor ofclaim 10, wherein a plurality of line fixation elements are spaced along at least a portion of the line length of the anchor line whereby a selected line fixation element can be fitted through the mesh pore.

14. The bone anchor ofclaim 6, wherein the line fixation element is substantially spherical shaped, and the device fixation element comprises an opening in the medical device dimensioned to enable passage of the line fixation element therethrough.

15. The bone anchor ofclaim 6, wherein the line fixation element is substantially barb shaped, and the device fixation element comprises an opening in the medical device dimensioned to enable passage of the line fixation element therethrough.

16. The bone anchor ofclaim 6, wherein a plurality of line fixation elements are spaced along at least a portion of the line length of the anchor line whereby a selected line fixation element can be fitted with a device fixation element.

17. The urethral sling ofclaim 6, wherein the anchor line is formed of suture material.

18. A kit for implanting a urethral sling to extend between descending pubic rami and across and supporting the urethra, the kit comprising:

a urethral sling comprising a flexible sheet material extending between opposed first and second sling ends adapted to be fixed to bone and bounded by opposed first and second sling sides;

a plurality of bone anchors each comprising an anchor body having a bone fixation end and an elongated bone anchor line affixed at one line end to the anchor body and extending to an anchor line free end, the bone anchors adapted to be affixed, spaced from one another, into the bone of the descending pubic rami, and the bone anchor lines adapted to be extended through the material of the urethral sling at selected locations displaced from the first and second sling ends; and

a plurality of bone anchor line retainers having a retainer bore for receiving a bone anchor line, the retainer bore sized and shaped to be expanded to pass over the bone anchor line as the retainer is advanced toward the bone anchor and that resists retraction over the bone anchor away from the bone anchor,

whereby the anchor line retainers may be selectively advanced toward the first descending pubic rami to induce and retain slack in end portions of the urethral sling between the sling ends and the anchor line retainers and tension in a central portion of the urethral sling disposed between the bone anchor line retainers and applied against the urethra.

19. The kit ofclaim 18, wherein the retainer bore comprises a pair of resilient flaps shaped to form an aperture dimensioned with respect to the bone anchor line such that the passage of the bone anchor line through the aperture widens the aperture and displaces the flaps to resist slippage of the bone anchor line through the aperture.

20. The kit ofclaim 18, wherein the anchor lines are formed of suture material.

21. The kit ofclaim 18, wherein the bone anchor body is a bone screw having a fixation end shaped as a screw thread adapted to be screwed into bone.

22. A kit for implanting a urethral sling to extend between descending pubic rami and across and supporting the urethra comprising:

a urethral sling comprising a flexible sheet material having pores therethrough extending between opposed first and second sling ends adapted to be fixed to bone and bounded by opposed first and second sling sides; and

a plurality of bone anchors each comprising an anchor body having a bone fixation end and an elongated bone anchor line affixed at one line end to the bone anchor and extending to an anchor line free end, the bone anchors adapted to be affixed, spaced from one another, into the bone of the descending pubic rami, and the bone anchor line free ends adapted to be extended through the pores of the urethral sling at selected pore locations displaced from the first and second sling ends to induce tension in a central portion of the urethral sling,

wherein the bone anchor lines comprise at least one line fixation element that extends outward of the bone anchor line that expands pore size during advancement through the pore and bears against the material of the urethral sling and provides resistance to retraction of the fixation element through the pore.

23. The kit ofclaim 22, wherein the line fixation element is coupled to the anchor line.

24. The kit ofclaim 22, wherein the line fixation element is integrally formed as an enlargement of the anchor line.

25. The kit ofclaim 22, wherein the line fixation element is substantially spherical shaped and dimensioned to expand the pore as the spherical shaped line element is fitted through the pore.

26. The kit ofclaim 22, wherein the line fixation element is barb shaped and dimensioned to expand the pore as the barb shaped line element is fitted through the pore.

27. The kit ofclaim 22, wherein a plurality of line fixation elements are spaced along at least a portion of the line length of the anchor line, whereby a selected line fixation element can be fitted through the pore.

28. The kit ofclaim 22, wherein the anchor lines are formed of suture material.

29. The kit ofclaim 22, wherein the bone anchor body is a bone screw having a fixation end shaped as a screw thread adapted to be screwed into bone.

30. The kit ofclaim 22, further comprising:

a plurality of bone anchor line retainers having a retainer bore for receiving a bone anchor line, the retainer bore sized and shaped to be expanded to pass over the bone anchor line as the retainer is advanced toward the bone anchor and that resists retraction over the bone anchor away from the bone anchor,

whereby the anchor line retainers may be selectively advanced toward the first descending pubic rami to induce and retain slack in end portions of the urethral sling between the sling ends and the anchor line retainers and tension in a central portion of the urethral sling disposed between the bone anchor line retainers and applied against the urethra.

31. The kit ofclaim 30, wherein the retainer bore comprises a pair of resilient flaps shaped to form an aperture dimensioned with respect to the bone anchor line such that the passage of the bone anchor line through the aperture widens the aperture and displaces the flaps to resist slippage of the bone anchor line through the aperture.

32. The kit ofclaim 30, wherein the anchor line retainer is adapted to be placed between the retainer element and against the material of the urethral sling to block passage of the retainer element through the pore.

33. A method of implanting a urethral sling to extend between descending pubic rami and across and supporting the urethral comprising:

providing a urethral sling comprising:

a flexible sheet material extending between opposed first and second sling ends adapted to be fixed to bone and bounded by opposed first and second sling sides; and

at least one pre-positioned, plicating line having a plicating line length extending between first and second plicating line free ends and passed through the flexible sheet material at first and second points displaced from the respective first and second sling free ends such that an intermediate portion of the plicating line extends across a central portion of the urethral sling intermediate first and second end portions of the urethral sling;

surgically affixing the first and second sling ends to the descending pubic rami to extend across the urethra;

drawing the plicating line free ends together to induce tension in the first and second end portions and apply tension across the central portion of the urethral sling; and

tying the plicating line free ends.

34. The method ofclaim 33, wherein:

the providing step comprises providing a plurality of plicating lines passed through the flexible sheet material at first and second points in substantially side-by-side relation between the first and second sling sides; and

the drawing step comprises drawing one or more of the plicating line free ends together to induce tension in the first and second end portions and apply tension across the central portion of the urethral sling.

35. The method ofclaim 34, wherein:

the providing step comprises affixing the free ends of each plicating line through the sheet material at temporary retention points to hold the free ends against the flexible sheet material; and

the drawing step comprises releasing the free ends of each plicating line from the sheet material at the temporary retention points.

36. The method ofclaim 33, wherein:

the providing step comprises affixing the free ends of each plicating line through the sheet material at temporary retention points to hold the free ends against the flexible sheet material; and

the drawing step comprises releasing the free ends of each plicating line from the sheet material at the temporary retention points.

37. A method of implanting a urethral sling to extend between descending pubic rami and across and supporting the urethral comprising:

providing a urethral sling comprising a flexible sheet material extending between opposed first and second sling ends adapted to be fixed to bone and bounded by opposed first and second sling sides;

providing bone anchors having a bone fixation end and an elongated bone anchor line affixed at one line end to the bone anchor and extending to an anchor line free end;

affixing bone anchors, spaced from one another, into the bone of the descending pubic rami;

attaching the sling first end to the bone anchors affixed to a first one of the descending pubic rami;

attaching the sling second end to the bone anchors affixed to a second one of the descending pubic rami; and

tensioning a central portion of the urethral sling by inducing a slack in the flexible fabric of the urethral sling in a first edge portion between the central portion and the first sling edge.

38. The method ofclaim 37, wherein the tensioning step further comprises inducing a slack in the flexible fabric of the urethral sling in a second edge portion between the central portion and the second sling edge.

39. A method of implanting a urethral sling to extend between descending pubic rami and across and supporting the urethral comprising:

providing a urethral sling comprising a flexible sheet material extending between opposed first and second sling ends adapted to be fixed to bone and bounded by opposed first and second sling sides;

providing a plurality of bone anchors having a bone fixation end and an elongated bone anchor line affixed at one line end to the bone anchor and extending to an anchor line free end;

affixing the provided bone anchors, spaced from one another, into the bone of the descending pubic rami;

extending the anchor line free ends extending from the bone anchors affixed to the one descending pubic ramus through the flexible sheet material of the urethral sling at a selected locations displaced from the sling first end, whereby a first edge portion of the urethral sling is defined between the selected locations and the sling first end;

extending the anchor line free ends extending from the bone anchors affixed to the other descending pubic ramus through the flexible sheet material of the urethral sling at a selected locations displaced from the sling second end, whereby a second edge portion of the urethral sling is defined between the selected locations and the sling second end;

selectively drawing the anchor line free ends extending from the bone anchors affixed to the first descending pubic rami toward the first descending pubic rami to induce slack in the first end portion of the urethral sling and tension in the central portion of the urethral sling applied against the urethra; and

fixing the drawn anchor line free ends with respect to the sling material to retain the induced slack in the first end portion of the urethral sling and tension in the central portion of the urethral sling applied against the urethra.

40. The method ofclaim 39, further comprising:

selectively drawing the anchor line free ends extending from the bone anchors affixed to the first descending pubic rami toward the second descending pubic rami to induce slack in the second end portion of the urethral sling and tension in the central portion of the urethral sling applied against the urethra; and

fixing the drawn anchor line free ends with respect to the sling material to retain the induced slack in the second end portion of the urethral sling and tension in the central portion of the urethral sling applied against the urethra.

41. The method ofclaim 40, further comprising:

providing a plurality of bone anchor line retainers; and

the fixing step further comprises attaching the anchor line retainers to the anchor lines and against the urethral sling.

42. The method ofclaim 40, further comprising:

providing a plurality of bone anchor line retainers having a retainer bore sized and shaped to be expanded to pass over the bone anchor line as the retainer is advanced toward the bone anchor and that resists retraction over the bone anchor away from the bone anchor;

the fixing step further comprises fitting the anchor lines through the retainer bores and advancing the anchor line retainers over the anchor lines and against the urethral sling.

43. The method ofclaim 39, wherein the bone anchor line is provided with a plurality of line fixation elements periodically spaced along at least a portion of the line length between the line free end and the line attached end, the line fixation elements extending outward to engage the urethral sling to maintain the tension.

44. The method ofclaim 43, further comprising:

providing a plurality of bone anchor line retainers; and

the fixing step further comprises attaching the anchor line retainers to the anchor lines between line fixation elements and against the urethral sling.

45. The method ofclaim 43, further comprising:

providing a plurality of bone anchor line retainers having a retainer bore sized and shaped to be expanded to pass over the bone anchor line as the retainer is advanced toward the bone anchor and that resists retraction over the bone anchor away from the bone anchor;

the fixing step further comprises fitting the anchor lines through the retainer bores and advancing the anchor line retainers over the anchor lines and against the urethral sling.

46. The method ofclaim 43, wherein the fixation elements are spherical shaped.

47. The method ofclaim 43, wherein the fixation elements are barb shaped.

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