Method and Apparatus for Securing a Urethral Sling to Pubic Bone

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.

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 of  claim 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 of  claim 2 , wherein the suture cross-section area is substantially constant through the suture length. 
   
   
       4 . The surgical kit of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 19 , wherein the suture cross-section area is substantially constant through the suture length. 
   
   
       21 . The method of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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.