Methods and Apparatus for Securing and Tensioning a Urethral Sling to Pubic Bone

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.

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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 6 , wherein the line fixation element is coupled to the anchor line.  
   
   
       8 . The bone anchor of  claim 6 , wherein the line fixation element is integrally formed as an enlargement of the anchor line.  
   
   
       9 . The bone anchor of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 18 , wherein the anchor lines are formed of suture material.  
   
   
       21 . The kit of  claim 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 of  claim 22 , wherein the line fixation element is coupled to the anchor line.  
   
   
       24 . The kit of  claim 22 , wherein the line fixation element is integrally formed as an enlargement of the anchor line.  
   
   
       25 . The kit of  claim 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 of  claim 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 of  claim 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 of  claim 22 , wherein the anchor lines are formed of suture material.  
   
   
       29 . The kit of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 43 , wherein the fixation elements are spherical shaped.  
   
   
       47 . The method of  claim 43 , wherein the fixation elements are barb shaped.