US20100094079A1 - Method and Apparatus for Securing a Urethral Sling to Pubic Bone - Google Patents

Abstract

Surgical procedures, kits and implants for alleviating human incontinence, and particularly providing improved methods and apparatus to secure a urethral sling to pubic bone to support the urethra and alleviate incontinence are disclosed. Bone anchors are driven into pubic bones with elongated bone anchor sutures 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

• 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. 6,652,450 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 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 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 and depicted inFIGS. 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'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 '214 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. 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 '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.
• 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 '058, '273 and '041 patents, or any other form of bone fixation mechanism.
• 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 ofFIG. 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 inFIG. 2;
• FIG. 4 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 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 ofFIG. 4;
• FIG. 6 is a side view of the suture retainer ofFIG. 5;
• FIG. 7 is a top view of a dispenser coupled to the suture retainer ofFIGS. 5 and 6 to be employed in the fixation of the retainer to the sutures of the bone screw ofFIG. 4;
• FIG. 8 is a plan view in partial section of the bone screw ofFIG. 4 screwed into pubic bone and the suture retainer ofFIGS. 5-7 engaging the sutures and retaining the mesh of the urethral sling ofFIG. 3 proximate the pubic bone;
• FIG. 9 is a schematic illustration of the fixation of a urethral sling ofFIG. 3 with a plurality of bone screws ofFIG. 4 screwed into the right and left descending pubic rami and a like plurality of suture retainer ofFIGS. 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 ofFIG. 4;
• FIG. 11 is a top view of the suture retainer ofFIG. 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 ofFIG. 4;
• FIG. 13 is a schematic illustration of the fixation of a urethral sling ofFIG. 3 with a plurality of bone screws ofFIG. 4 screwed into the right and left descending pubic rami and suture retainers ofFIG. 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 ofFIG. 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 ofFIG. 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 ofFIG. 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 ofFIG. 4;
• FIG. 20 is a plan view in partial section of the bone screw ofFIG. 4 screwed into pubic bone and the suture retainer ofFIG. 18 orFIG. 19 engaging the sutures and retaining the mesh of the urethral sling ofFIG. 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 inFIG. 4; and
• FIG. 22 is a side view illustrating the application of the suture retainer ofFIG. 21 laterally between a barbed fixation element of a suture extending from a bone screw of the type depicted inFIG. 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.
• 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 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 theurethral sling30, which can correspond to the InteMesh™ Synthetic Surgical Mesh urethral sling, is depicted in greater detail inFIG. 3. In a preferred embodiment, theurethral sling30 is knitted into a mesh from a supple polyester yarn to have a plurality of sling openings comprising mesh pores40 bounded by yarn strands and may be 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.
• 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 thebulbocavemous muscle20. Lateral dissection is used to expose the corpora cavemosum22 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 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 sutures84,86,88,90,92,94 extend proximally from eachbone screw64,66,68,70,72,74, respectively. Onesuch bone screw64 with the pair of bone screw sutures84 extending from the screw head is depicted in the expanded view ofFIG. 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 screws64,66,68,70,72,74 are screwed fully into the bone so that the No. 1 Prolene sutures84,86,88,90,92,94, 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 suture of the respective suture pairs84,86,88,90,92,94 will be passed through mesh pores.
• The free ends of each suture of eachsuture 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 sutures of the suture 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 suture of eachsuture pair84,86,88 are sequentially grasped, drawn tight and tied together at least two times forming several surgeon's suture 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 sutures of the bone screw suture 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 sutures of bone suture pairs90,92,94 are drawn tight against the fabric ofurethral sling30 and tied off. The sutures of bone suture 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 sutured 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 knots made with the suture pairs84,86,88,90,92,94 are relatively bulky and can cause irritation of tissues. In accordance with the present invention, the procedure for securing theurethral sling30 to the descending pubic rami and tensioning theurethral sling30 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 theurethral sling30 of the type depicted inFIGS. 2 and 3 formed of a mesh withmesh pores40 as described above to the descendingpubic rami24,26 generally in at least certain of the locations of the bone screws64,66,68,70,72,74 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 descendingpubic rami24,26 or other pubic bone.
• In one embodiment of the present invention depicted inFIGS. 5-9, a disk-shapedsuture retainer100 is provided for each of the bone screws64,66,68,70,72,74 or a lesser or greater number of bone screws screwed into the descendingpubic rami24,26. Thebone screw64 is depicted, for example, inFIGS. 4 and 8 having the bonescrew suture pair84 comprisingsutures85 and87 extending therefrom. The cross-section area along the length of thesutures85 and87 is substantially uniform.
• Theretainer100 has a substantiallyplanar retainer body102 with retainer bores104 and108 extending through theretainer body102. The retainer bores104 and106 are sized to receive and frictionally engage thesutures85 and87 to inhibit slippage of thesutures85 and87 with respect to the respective retainer bores104 and106. The retainer bores104 and106 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 bores104 and106. Retainer notches orslots106 and110 extend from the retainer bores104 and106, respectively, to the circumference or edge of theretainer body102.
• Thesuture retainer100 is adapted to be applied against a portion of theurethral sling30 to retain the sling portion proximate the pubic bones. Thesuture retainer100 has a major surface area adapted to bear against theurethral sling30 that exceeds the cross-section area of the sling opening, e.g., themesh pore40. Thus, thesuture retainer100 is too large to be drawn through themesh pore40.
• Thesuture retainer100 is applied to extend across or laterally with respect to thesutures85 and87 such that thesutures85 and87 are first received in the respective retainer notches orslots106 and110 and then are compressed in cross-section area when inserted into the respective retainer bores104 and108, whereby the retainer bores104 and108 frictionally engage thesutures85 and87 with an engagement force that inhibits slippage along thesutures85 and87. The suture and retainer bore cross-section areas may be selected to enable axial advancement of thesuture retainer100 along thesutures85 and87 and into engagement with a portion of the urethral sling if necessary in tensioning thesling30.
• The lateral application of the suture retainer may be facilitated employing a retainer installation anddispensing tool120 depicted inFIG. 7. Thedispensing tool120 may be about the same thickness as thesuture retainer100 and includes a substantially C-shapedclamp126 terminating inclamp jaws122 and124 shaped to fit in a tool engaging feature of theretainer body102, e.g., a pair ofrecesses112 and114 in the edge of theretainer body102. Atab128 extends from the C-shapedclamp126 that is to be grasped by the surgeon between finger and thumb to position thesuture retainer notches106 and108 with respect to therespective sutures85 and87 as shown inFIG. 8. Thetab128 is advanced laterally to insert thesutures85 and87 in the retainer bores104 and108, respectively. Thetab128 may then be twisted to release theclamp jaws122 and124 from therecesses112 and114 of thesuture retainer100.
• Turning toFIG. 9, the application of sixsuch suture retainers100, designated144,146,148,150,152 and154, into engagement with portions of theurethral sling30 and with the suture pairs84,86,88,90,92, and94 of respective bone screws64,66,68,70,72, and74 is depicted. Thesuture retainers144,146,148,150,152 and154 are depicted displaced from the respective bone screws64,66,68,70,72, and74 for convenience of illustration. It will be understood that, in practice, thesuture retainers144,146,148,150,152 and154 may substantially overlie and obscure the respective bone screws64,66,68,70,72, and74.
• Thus, in use and referring toFIG. 9, the bone screws64,66, and68 may be screwed into the pubic bone of the descendingpubic ramus24, and the bone screws70,72, and74 may be screwed into the pubic bone of the descendingpubic ramus26. An end portion of theurethral sling30 alongsling end32 is applied against or proximate the descendingpubic ramus24, as the suture pairs84,86,88 are inserted through selected sling openings, e.g., mesh pores40 depicted inFIG. 3. A first set of threesuture retainers100 are applied as shown inFIG. 8 to the suture pairs84,86, and88 to retain theurethral sling30 proximate the descendingpubic ramus24.
• The other sling end34 of theurethral sling30 is then drawn across the urethra toward the descendingpubic ramus26, and the suture pairs90,92,94 are inserted through selected sling openings, e.g., mesh pores40 depicted inFIG. 3, in an end portion of theurethral sling30 alongsling end34. A second set of threesuture retainers100 are applied as shown inFIG. 8 to the suture pairs90,92, and94 to retain theurethral sling30 proximate the descendingpubic ramus26 and to thereby tension the portion of theurethral sling30 extending across the urethral region.
• An RPP test may be conducted, and one or more of thesuture retainers144,146,148,150,152 and154 may be adjusted along the length of the respective suture pairs84,86,88,90,92, and94 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 pairs84,86,88,90,92, and94 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 theurethral sling30. Thus, first and second suture retainers may be provided that are adapted to be applied to the suture pairs84,86, and88 and to the suture pairs90,92 and94, respectively, or to any number of suture pairs extending from bone anchors inserted into the descendingpubic rami24 and26.
• A first embodiment of an exemplary “multiple suture”retainer160 is depicted inFIGS. 10 and 11 that may constitute or resemble a plurality of thesuture retainers100 joined together in an elongated array. Onesuch suture retainer160 would be applied along theurethral sling end32 to engage the suture pairs84,86 and88, and afurther suture retainer160 would be applied along theurethral sling end34 to engage the suture pairs90,92,94.
• Thus, each elongatedsuture retainer body162 is generally rectangular having a major surface adapted to be pressed against a portion of theurethral sling30 adjacent theurethral sling end32 or34. A series of retainer slots and bores164,166,168,170,172, and174 are formed extending from one side of and through thesuture retainer body162.
• 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 bores164,166,168,170,172, and174 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 bores164,166,168,170,172, and174 may be formed insuture retainer body162 arrayed along substantially the entire length of thesuture retainer body162. In such an embodiment, the surgeon may select the most suitably spaced apart slot and bore pairs to receive each suture pair.
• Thesuture retainer body162 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 thesuture retainer body162 to an appropriate size and shape leaving only two pair of the depicted slots and bores164,166,168,170,172, and174 to accommodate two pair of sutures.
• A further embodiment of amultiple suture retainer200 is depicted in
• FIGS. 12 and 13. Themultiple suture retainer200 is formed of aretainer cover202 and aretainer base210 that are fitted together to entrap a number of sutures or suture pairs within suture slots and/or bores when theretainer cover202 is fitted to theretainer base210. Theretainer cover202 may be separate from the retainer base, as depicted inFIG. 12, or attached, e.g., by a living hinge, joining mutual ends or sides, for example. In either case, theretainer cover202 is to be applied into engagement with or moved from an open to a closed position with theretainer base210 to entrap and hold sutures placed through the suture slots and/or bores, and thesuture retainer200 formed of theretainer cover202 andbase210 bears against a portion of theurethral sling30 to hold it in place in proximity to a pubic bone.
• A pair of snap recesses216 and218 are formed in the opposite ends, for example, of theretainer body214. Thecover body204 is shaped and dimensioned to fit over and against theretainer body214. A pair of snap-incatches206 and208 are formed in the ends of thecover body204 that are adapted to be received in the respective snap-inrecesses216 and218 in the ends of theretainer body214.
• In the particular illustrated embodiment ofmultiple suture retainer200, a series of slots and/orsuture engaging bores220,222,224,226,228, and230 extend into and across one major surface of the substantiallyrectangular retainer body214 of theretainer base210. Each pair ofsuture engaging bores220,222,224,226,228, and230 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 ofsuture engaging bores220,222,224,226,228, and230 are schematically illustrated and may take any suitable form. It will also be understood that a greater number of suture engaging bores than the depictedsuture engaging bores220,222,224,226,228, and230 may be formed insuture retainer body210 arrayed along substantially the entire length of thesuture retainer body210. 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 toFIG. 13, the bone screws64,66, and68 may be screwed into the pubic bone of the descendingpubic ramus24, and the bone screws70,72, and74 may be screwed into the pubic bone of the descendingpubic ramus26. An end portion of theurethral sling30 alongsling end32 is applied against or proximate the descendingpubic ramus24, as the suture pairs84,86,88 are inserted through selected sling openings, e.g., mesh pores40 depicted inFIG. 3. Thesuture retainer base210 of afirst suture retainer200 is applied against theurethral sling30 along theedge32 and aligned with the suture pairs84,86,88 to dispose thesuture pair84 in slots and/orsuture engaging bores220 and222, thesuture pair86 in slots and/orsuture engaging bores224 and226, and thesuture pair88 in slots and/orsuture engaging bores228, and230. Theretainer cover202 is closed against or snapped onto theretainer base210 to capture the suture pairs84,86 and88.
• The other sling end34 of theurethral sling30 is then drawn across the urethra toward the descendingpubic ramus26, and the suture pairs90,92,94 are inserted through selected sling openings, e.g., mesh pores40 depicted inFIG. 3 in an end portion of theurethral sling30 alongsling end34. Thesuture retainer base210 of asecond suture retainer200 is applied against theurethral sling30 along theedge34 and aligned with the suture pairs90,92,94 to dispose thesuture pair90 in slots and/orsuture engaging bores220 and222, thesuture pair92 in slots and/orsuture engaging bores224 and226, and thesuture pair94 in slots and/orsuture engaging bores228, and230. Tension may be applied to the free ends of the suture pairs90,92 and94 to draw theretainer base210 against the portion of theurethral sling30 and thereby tension the portion of theurethral sling30 extending across the urethral region. Theretainer cover202 is closed against or snapped onto theretainer base210 to capture the suture pairs90,92 and94.
• An RPP test may be conducted, and theretainer cover202 of either or both the first and second “multiple suture”retainers200 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 pairs84,86,88,90,92, and94 may be tied and/or trimmed as the surgeon prefers.
• A substantially similar process is employed to dispose first and secondmultiple suture retainers160 into engagement with the suture pairs84,86,88 and90,92,94 and against portions of theurethral sling30 adjacent sling ends32 and34 to tension and hold the portions of theurethral sling30 proximate the descendingpubic rami24 and26.
• It will be understood that the above-describedsuture retainers100,160,200 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 ofsuture retainers100,160,200 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 inFIGS. 14-17, abone screw64 of the type described above is adapted to be screwed into the descendingpubic ramus24 or26, and abone screw suture250 having asuture body252 extends from a suture end attached to thebone screw64 to a suturefree end254. Thesuture body252 is shaped with a series ofsuture fixation elements258 projecting outward from the diameter of thesuture body252. Suchsuture fixation elements258 may take any suitable form, e.g., cylindrical, spherical or the depicted generally conical shape. Thesuture fixation elements258 are separated apart alongsuture body254 by a distance that accommodates at least the thickness ofurethral sling30 and preferably the thickness of theurethral sling30 and the thickness or length of a suture retainer that bears against theurethral sling30. It will be understood that the depictedbone screw suture250 may be provided with only onesuture fixation element258 suitably spaced from thebone screw64 to receive and inhibit retraction of the suture retainer and/or theurethral sling30 away from the descendingpubic ramus24 or26 and toward the suturefree end254. Thesuture fixation element258 that is in contact with thesling30 and/or a suture retainer inhibits retraction of the suture retainer and/or theurethral sling30 toward the suturefree end254.
• Generally speaking, thesuture fixation elements258 are sized in maximum cross-section area to the selected sling opening, e.g.,mesh pore40, such that thesuture fixation elements258 can be barely passed through the sling opening. Thus, it is preferable that thesuture fixation elements258 have a relatively gradual ramp shape increasing in cross-section area from thesuture body252 to the maximum cross-section area closer to thebone screw64. The ramp shape provides a sling opening expansion surface as thesling30 is advanced from right to left over it as shown inFIG. 15. The ramp shape terminates with an abrupt transition back to the cross-section area of thesuture body252 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 thesuture fixation elements258 is simply one way of satisfying this preferred characteristic.
• Consistent with the above-described methods, a plurality of bone screws, exemplified by thebone screw64 ofFIGS. 14-17, are affixed to the descendingpubic rami24 and26. First, thesuture250 of each bone screw affixed to the descendingpubic ramus24 is inserted through a selected sling opening, e.g., amesh pore40 along a first end portion of theurethral sling30 alongsling end32, and the first end portion is advanced over thesutures250 against or proximate the descendingpubic ramus24. Preferably, a suture retainer is then interposed over or onto the bonescrew suture body252 to bear against theurethral sling30 to retain it in position. Then, thesuture250 of each bone screw affixed to the descendingpubic ramus26 is inserted through a selected sling opening, e.g., amesh pore40 along a first end portion of theurethral sling30 alongsling end34, and the first end portion is advanced over thesutures250 against or proximate the descendingpubic ramus26. Preferably, a suture retainer is then interposed over or onto the bonescrew suture body252 to bear against theurethral sling30 to retain it in position. Any of the above-describedsuture retainers100,160 and200 may be interposed between the sling contact surface and thesling30 by laterally passing thesuture body252 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 therespective sutures250 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 ends254 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 alternativeexemplary suture retainer270 is depicted inFIG. 16 that is advanced over the suturefree end254 and toward theurethral sling30 over the suture fixation elements until thesuture retainer270 contacts theurethral sling30. Thesuture retainer270 is axially advanced into a retention position over thesuture250 and is configured to interlock with thesuture fixation element258 contacting theurethral sling30 to bear againsturethral sling30 and to be maintained in the retention position.
• Thesuture retainer270 has a generally annular, “cup-shaped”retainer body272 defining and surrounding a central retainer bore274 and having a body length equal to or exceeding the distance between adjacentsuture fixation elements258. Theretainer body272 extends between a minimum diameter orcross-section retainer end276 that is adapted to be applied against asuture fixation element258 and a maximum diameter orcross-section retainer end282 that is adapted to be applied against theurethral sling30 as shown inFIG. 17. Theretainer body272 is relatively thin walled and defines aretainer bore274 extending between the retainer ends276 and282 that conforms with the shape of the suture fixation element, particularly the generally conical shape ofsuture fixation element258. It will be understood that the maximum diameter orcross-section retainer end282 may have any suitable diameter and may include an annular flat portion extending transversely to the axis of theretainer body272.
• Preferably, a plurality ofresilient flaps278 are provided betweenslots280 through theretainer body272. Theresilient flaps278 extend from the minimum diameter orcross-section retainer end276 toward the maximum diameter orcross-section retainer end282 to a diameter of the generallyconical bore274 corresponding generally to the maximum diameter ofretainer end282. Thus, theresilient flaps278 are flexed outward to enable advancement of thesuture retainer270 over eachsuture fixation element258. Theresilient flaps278 return to their resting shape with theretainer end276 disposed against the abrupt sling contact surface end of an adjacentsuture fixation element258 when theretainer end282 is applied against theurethral sling30 as shown inFIG. 17.
• It will be noted that theretainer270 may also be modified to be applied over a constant diameter suture or suture pair, e.g., thesuture pair84 ofbone screw64 ofFIG. 4, by suitably dimensioning thebore274 to provide a frictional fit with the suture ofsuture pair84. In this regard, the single and “multiple suture”retainers300 and310 depicted inFIGS. 18-20 are especially configured for over-the-suture application to thesutures85 and87 of thesuture pair84 ofFIG. 4.
• Thesingle suture retainer300 depicted inFIGS. 18 and 20 is formed of a generally planar circular or rectangular or oblong retainer body302 having two retainer bores306 and308 extending through the retainer body302 (or one retainer bore for both sutures or a single suture). The retainer bores306 and308 are smaller in cross-section area than the suture body cross-section area to provide an interference friction fit. The retainer bores306 and308 are preferably be bounded by resilient flaps that extend slightly out of the plane of the retainer body302 created by slits similar to theflaps278 andslits280 of thesuture retainer270. For example, the retainer bores306 and308 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 bores306,308,320,322,324,326,328,330 extend through theretainer body304,312 and are dimensioned and shaped to enable axial advancement of theretainers300 and310 over the suture into engagement with a portion of theurethral sling30 and to resist axial retraction of theretainers300 and310 from engagement with the portion of theurethral sling30.
• In use, the bone screws64,66, and68 may be screwed into the pubic bone of the descendingpubic ramus24, and the bone screws70,72, and74 may be screwed into the pubic bone of the descendingpubic ramus26 as described above with respect toFIGS. 2 and 9. An end portion of theurethral sling30 alongsling end32 is applied against or proximate the descendingpubic ramus24, as the suture pairs84,86,88 are inserted through selected sling openings, e.g., mesh pores40 depicted inFIG. 3. A first set of threesuture retainers300 are applied as shown inFIG. 20 to the suture pairs84,86, and88 to retain theurethral sling30 proximate the descendingpubic ramus24.
• The other sling end34 of theurethral sling30 is then drawn across the urethra toward the descendingpubic ramus26, and the suture pairs90,92,94 are inserted through selected sling openings, e.g., mesh pores40 depicted inFIG. 3, in an end portion of theurethral sling30 alongsling end34. A second set of threesuture retainers300 are applied as shown inFIG. 20 to the suture pairs90,92, and94 to retain theurethral sling30 proximate the descendingpubic ramus26 and to thereby tension the portion of theurethral sling30 extending across the urethral region.
• An RPP test may be conducted, and one or more of thesuture retainers300 may be adjusted along the length of the respective suture pairs84,86,88,90,92, and94 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 pairs84,86,88,90,92, and94 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”retainer310 is depicted inFIGS. 19 and 20 that may constitute or resemble a plurality of thesuture retainers300 joined together end-to-end in an elongated array and may be employed instead of a plurality ofsuture retainers300. Onesuch suture retainer310 would be applied along theurethral sling end32 to engage the suture pairs84,86 and88, and afurther suture retainer310 would be applied along theurethral sling end34 to engage the suture pairs90,92,94 in the manner ofsuture retainers160 and200 as described above with respect toFIG. 13. Thesutures85 and87 ofsuture pair84 may be passed through thebores320 and322, respectively, of afirst suture retainer310. Similarly, the sutures of the suture pairs86 and88 may be passed through thebores324,326 and328,330 of thefirst suture retainer310. The sutures ofsuture pair90 may be passed through the retainer bores320,322, the sutures ofsuture pair92 may be passed through the retainer bores324,326, and the sutures ofsuture pair90 may be passed through the retainer bores328,330 of asecond suture retainer310.
• Again, it will be understood that the “multiple suture”suture retainer310 may be formed with a greater number of spaced apart retainer bores like retainer bore320, 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 thesuture retainers310 may be adjusted along the length of the respective suture pairs84,86,88, and suture pairs90,92,94 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 pairs84,86,88,90,92, and94 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, thesuture retainers100,160 and200 may also be employed in conjunction with a shaped suture or sutures like shapedsuture250 depicted inFIGS. 14-17 having at least one enlargedsuture fixation element258 engaging thesuture retainers100,160 and200 against portions of the urethral sling. The selectedsuture retainer100,160 or200 would be applied laterally to thesuture body252 between the enlarged end of thesuture fixation element258 and theurethral sling30 to effect fixation in the manner of thesuture retainer270 as described above. The enlarged suture fixation element thereby enhances the fixation of thesuture retainers100,160 and200 with the suture pairs84,86,88,90,92 and94 shown inFIGS. 9 and 13.
• In this regard, a furthersingle suture retainer340 is depictedFIGS. 21 and 22 in cooperative relation with asingle suture350 having a singlesuture fixation element358 disposed along thesuture body352 displaced from the suturefree end354 adjacent to the suture attached end with thebone screw64. Thesuture fixation element358 may or may not have a generally conical shape because thesuture retainer340 is applied laterally to thesuture body352 between the enlarged end of thesuture fixation element358 and theurethral sling30 to effect fixation in the manner of thesuture retainer270 as described above but need not be applied over-the-suture as described above.
• Thesuture retainer340 is configured with a generally circular and substantially planarsuture retainer body342 having single retainer bore344 open to the circumference of theretainer body342 by aslit346. 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 thesuture retainer160. In either case, the steps described above are followed to apply thesuture retainer340 laterally to frictionally engage thesuture body352 within the retainer bore344 with theretainer body342 interposed between theurethral sling30 and thesuture fixation element358 as shown inFIG. 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.

Claims (29)

1. A surgical kit comprising:

a urethral sling 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 (26) to fix the urethral sling in a sub-urethral location to support the urethra and alleviate incontinence, the urethral sling having or capable of having a sling opening formed through the sling adjacent the first and second sling ends;

at least one bone anchor having a bone fixation mechanism adapted to be affixed to pubic bone and an elongated anchor suture adapted to be passed through a urethral sling opening to enable advancement of the urethral sling over the suture body and toward a pubic bone after the bone anchor is affixed to the pubic bone; and

at least one suture retainer having a retainer body (102;162;204,214;272;304;312;342) and a retainer bore through the retainer body, the retainer bore sized and shaped to receive and engage the suture adjacent the urethral sling to apply retentive force through the retainer body against the urethral sling to retain a portion of the urethral sling proximate the pubic bone.

2. The surgical kit ofclaim 1, wherein:

the suture has a suture cross-section area; and

the retainer bore has a bore cross-section area related to the suture cross-section area sufficiently to enable frictional engagement of the suture received within the retainer bore.

3. The surgical kit ofclaim 2, wherein the suture cross-section area is substantially constant through the suture length.

4. The surgical kit ofclaim 3, wherein the retainer body further comprises at least one slot extending from a retainer body edge to a retainer bore dimensioned to enable lateral advancement of the retainer with respect to the suture to pass the suture through the slot into the retainer bore and to dispose the retainer into engagement with a portion of the sling.

5. (canceled)

6. The surgical kit ofclaim 3, wherein the retainer bore extends through the retainer body and is dimensioned to enable axial advancement of the retainer over the suture into engagement with a portion of the urethral sling.

7. (canceled)

8. The surgical kit ofclaim 3, wherein a plurality of retainer bores extend through the retainer body and are dimensioned to enable axial advancement of the retainer over a like plurality of sutures extending from a plurality of bone anchors and through the retainer bores into engagement with a portion of the urethral sling.

9. The surgical kit ofclaim 8, wherein the retainer bores are shaped to enable axial advancement of the retainers over the sutures into engagement with a portion of the urethral sling and to resist axial retraction of the retainer from engagement with the portion of the urethral sling.

10. The surgical kit ofclaim 1, wherein the suture has a variable suture cross-section area and comprises a suture body extending from the suture anchor to a suture free end having at least one retention element along the suture body.

11. The surgical kit ofclaim 10, wherein the retainer body further comprises a slot extending from a retainer body edge to a retainer bore dimensioned to enable lateral advancement of the retainer with respect to the suture to pass the suture through the slot into the retainer bore and to dispose the retainer into engagement with and between a retention element and a portion of the sling.

12. The surgical kit ofclaim 10, wherein the retainer bore extends through the retainer body and is dimensioned to enable axial advancement of the retainer over the suture into engagement with a portion of the urethral sling.

13. The surgical kit ofclaim 10, wherein the suture retainer has a retainer body that extends from a first body end to a second body end, the retainer bore extends from a first bore diameter at the first body end sufficient to receive a retention element to a second bore diameter at the second body end smaller than the first bore diameter, the retainer body expandable at the second body end to expand the second bore diameter to pass the retention element through the retainer bore.

14. The surgical kit ofclaim 13, wherein the retention element is shaped to expand the second bore diameter as the retainer body is advanced over the retention element and to allow contraction of the second bore diameter upon passage of the retainer body over the retention element.

15. The surgical kit ofclaim 1, wherein:

the retainer body further comprises a slot extending from a retainer body edge to a retainer bore dimensioned to enable lateral advancement of the retainer with respect to the suture to pass the suture through the slot into the retainer bore and to dispose the retainer into engagement with a portion of the sling, and a tool engaging feature and further comprising:

a retainer installation and dispensing tool comprising a clamp adapted to engage the tool engaging feature of the retainer body, and a tab that may be gripped to laterally insert the sutures through the slots and into the retainer bores.

16. A method of securing a urethral sling to pubic bone in a sub-urethral location to support the urethra and alleviate incontinence comprising:

affixing a plurality of bone screws having exposed elongated bone screw sutures into pubic bones on either side of the urethra;

passing the bone screw sutures through urethral sling openings; and

applying suture retainers to the bone screw sutures to apply retentive forces against the urethral sling to retain portions of the urethral sling proximate the pubic bone.

17. A method of securing a urethral sling to pubic bone in a sub-urethral location to support the urethra and alleviate incontinence comprising:

providing a urethral sling 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 having or capable of having a sling opening formed through the sling adjacent the first and second sling ends;

affixing a plurality of bone anchors having exposed elongated anchor sutures into the first and second pubic bones on either side of the urethra;

passing the anchor sutures extending from the first pubic bone through urethral sling openings proximate the first sling end;

engaging each anchor suture extending from the first pubic bone with a retainer bore of a suture retainer having a retainer body to dispose the retainer body in contact with a portion of the urethral sling;

passing the anchor sutures extending from the second pubic bone through urethral sling openings proximate the second sling end;

engaging each anchor suture extending from the second pubic bone with a retainer bore of a suture retainer having a retainer body to dispose the retainer body in contact with a portion of the urethral sling;

tensioning the urethral sling between the first and second one or more suture retainers.

18. The method ofclaim 17, wherein the retainer bores are sized and shaped to receive and engage the sutures adjacent the urethral sling to apply retentive force through the retainer body against the urethral sling to retain a portion of the urethral sling proximate the pubic bone.

19. The method ofclaim 18, wherein:

the suture has a suture cross-section area; and

the retainer bore has a bore cross-section area related to the suture cross-section area sufficiently to enable frictional engagement of the suture received within the retainer bore.

20. The method ofclaim 19, wherein the suture cross-section area is substantially constant through the suture length.

21. The method ofclaim 20, wherein the retainer body further comprises a slot extending from a retainer body edge to a retainer bore dimensioned to enable lateral advancement of the retainer with respect to the suture to pass the suture through the slot into the retainer bore and to dispose the retainer into engagement with a portion of the sling.

22. The method ofclaim 20, wherein the retainer bore extends through the retainer body and is dimensioned to enable axial advancement of the retainer over the suture into engagement with a portion of the urethral sling.

23. The method ofclaim 22, wherein the retainer bore is shaped to enable axial advancement of the retainer over the suture into engagement with a portion of the urethral sling and to resist axial retraction of the retainer from engagement with the portion of the urethral sling.

24. The method ofclaim 17, wherein the suture has a variable suture cross-section area and comprises a suture body extending from the suture anchor to a suture free end having at least one retention element along the suture body.

25. The method ofclaim 22, wherein the retainer body further comprises a slot extending from a retainer body edge to a retainer bore dimensioned to enable lateral advancement of the retainer with respect to the suture to pass the suture through the slot into the retainer bore and to dispose the retainer into engagement with and between a retention element and a portion of the sling.

26. The method ofclaim 22, wherein the retainer bore extends through the retainer body and is dimensioned to enable axial advancement of the retainer over the suture into engagement with a portion of the urethral sling.

27. The method ofclaim 22, wherein the suture retainer has a retainer body that extends from a first body end to a second body end, the retainer bore extends from a first bore diameter at the first body end sufficient to receive a retention element to a second bore diameter at the second body end smaller than the first bore diameter, the retainer body expandable at the second body end to expand the second bore diameter to pass the retention element through the retainer bore.

28. The method ofclaim 27, wherein the retention element is shaped to expand the second bore diameter as the retainer body is advanced over the retention element and to allow contraction of the second bore diameter upon passage of the retainer body over the retention element.

29. The method ofclaim 17, wherein:

the retainer body further comprises a slot extending from a retainer body edge to a retainer bore dimensioned to enable lateral advancement of the retainer with respect to the suture to pass the suture through the slot into the retainer bore and to dispose the retainer into engagement with a portion of the sling, and a tool engaging feature; and further comprising:

a retainer installation and dispensing tool comprising a clamp adapted to engage the tool engaging feature of the retainer body, and a tab that may be gripped to laterally insert the sutures through the slots and into the retainer bores.

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