Transvaginal suture spacer devices and methods of use

Abstract

The present invention relates to suture spacers and methods for their use. More particularly, the present invention relates to devices which permit a surgeon to create a consistent amount of suture slack in a suture line when tying sutures under very tight space constraints including procedures such as bladder neck stabilization and treatment of hypermobility or intrinsic sphincter deficiency. Further, the present invention relates to methods of tying sutures using the disclosed devices in such procedures.

What is claimed is:  
     
         1 . A suture spacer, comprising: 
 a first member having a proximal end, a distal end, and a surface contacting side for contacting a surface from which one or more sutures emanate;    a second member having a proximal end, a distal end, a surface contacting side for contacting a surface from which one or more sutures emanate, a knot formation side on which a knot is formed, and a knot formation site being located on said knot formation side; and    a border disposed between said first and second members such that said border, and said distal ends of said first and second members define a suture receiving site for releasably receiving one or more sutures.    
     
     
         2 . The suture spacer of    claim 1   , wherein said suture spacer has dimensions which are suitable for use in transvaginal surgical procedures.  
     
     
         3 . The suture spacer of    claim 1   , further comprising a suture retaining ridge disposed generally perpendicular to and adjacent to said knot formation site of said second member.  
     
     
         4 . The suture spacer of    claim 1   , wherein said first and second members are movable with respect to each other to facilitate insertion of one or more sutures into said suture receiving site.  
     
     
         5 . The suture spacer of    claim 1   , further comprising a protuberance extending from said distal end of said first member and a protuberance extending from said distal end of said second member, wherein said protuberance of said first member and said protuberance of said second member define a distal end of said suture receiving site.  
     
     
         6 . The suture spacer of    claim 5   , wherein said protuberance of said first member contacts said protuberance of said second member.  
     
     
         7 . The suture spacer of    claim 5   , wherein said protuberances of said first and second members are substantially rigid.  
     
     
         8 . The suture spacer of    claim 5   , wherein said protuberances of said first and second members are substantially flexible.  
     
     
         9 . The suture spacer of    claim 1   , further comprising a limiting protuberance for limiting movement of said first and second members with respect to each other, said limiting protuberance being disposed between said first member and said second member.  
     
     
         10 . The suture spacer of    claim 1   , wherein said proximal end of said first member and said proximal end of said second member comprise handles.  
     
     
         11 . A suture spacer, comprising: 
 a first member having a proximal end and a distal end, said distal end also having a surface contacting side for contacting a surface from which one or more sutures emanate and a knot formation side located generally opposite to said surface contacting side;    a second member having a proximal end and a distal end, said distal end also having a surface contacting side for contacting a surface from which one or more sutures emanate and a knot formation side located generally opposite to said surface contacting side; and    a border disposed between said first and second members, wherein said border, and said distal ends of said first and second members define a suture receiving site for releasably receiving one or more sutures, and wherein a distance between said surface contacting sides and said knot formation sides of said first and second members defines a preselected amount of suture slack between a surface from which one or more sutures emanate and a suture knot.    
     
     
         12 . The suture spacer of    claim 11   , wherein said suture spacer has dimensions which are suitable for use in transvaginal surgical procedures.  
     
     
         13 . The suture spacer of    claim 11   , further comprising a pivot disposed between said first and second members.  
     
     
         14 . A suture spacer, comprising: 
 a body having a surface contacting end for contacting a surface from which one or more sutures emanate, a knot formation end at which a suture knot is formed, and a suture receiving lumen extending from said surface contacting end to said knot formation end, said body also having a slot extending parallel to a longitudinal axis of said body, said slot being in fluid communication with said suture receiving lumen, said slot also being adapted to releasably retain a suture within said suture receiving lumen, wherein a distance from said surface contacting end to said knot formation end of said body and back again defines a preselected amount of slack in said suture when said suture spacer is used to form said suture knot.    
     
     
         15 . The suture spacer of    claim 14   , wherein said suture spacer has dimensions which are suitable for use in transvaginal surgical procedures.  
     
     
         16 . The suture spacer of    claim 14   , wherein said body is a cylinder.  
     
     
         17 . The suture spacer of    claim 14   , further comprising a forceps tang on an external surface of said body.  
     
     
         18 . The suture spacer of    claim 14   , wherein said suture receiving lumen is disposed centrally in said body.  
     
     
         19 . The suture spacer of    claim 14   , wherein said suture receiving lumen is disposed off-center in said body.  
     
     
         20 . The suture spacer of    claim 14   , wherein said body is substantially rigid.  
     
     
         21 . The suture spacer of    claim 14   , wherein said body is substantially flexible.  
     
     
         22 . The suture spacer of    claim 14   , wherein the portions of said body adjacent to said slot are flexible.  
     
     
         23 . The suture spacer of    claim 21   , wherein said preselected amount of slack in said suture is defined by a distance from said surface contacting end to said knot formation end and back again when said body is compressed.  
     
     
         24 . A suture spacer, comprising: 
 an elongate body having a surface contacting side for contacting a surface from which one or more sutures emanate, a knot formation side adjacent to which a suture knot is formed, and one or more suture receiving sites extending between said surface contacting side and said knot formation side, said one or more suture receiving sites being positioned to facilitate removal of said suture spacer after formation of said suture knot, wherein a distance from said surface contacting side to said knot formation side and back again defines a preselected amount of suture slack.    
     
     
         25 . The suture spacer of    claim 24   , wherein said suture spacer has dimensions which are suitable for use in transvaginal surgical procedures.  
     
     
         26 . The suture spacer of    claim 24   , wherein said elongate body is substantially rigid  
     
     
         27 . The suture spacer of    claim 24   , wherein said elongate body is substantially flexible.  
     
     
         28 . The suture spacer of    claim 24   , wherein said elongate body has a longitudinal axis and said suture receiving sites extend substantially perpendicular to said longitudinal axis.  
     
     
         29 . A suture spacer, comprising: 
 a body having a surface contacting side for contacting a surface from which one or more sutures emanate and a knot formation side adjacent to which a suture knot is tied; and    an engagement member, said engagement member comprising an engagement body and at least one securing portion, said at least one securing portion being movable between a first position in which said at least one securing portion and said surface contacting side engage said surface from which one or more sutures emanate and a second position in which said at least one securing portion releases said surface from which one or more sutures emanate.    
     
     
         30 . The suture spacer of    claim 29   , further comprising a knot formation site on said knot formation side of said body.  
     
     
         31 . The suture spacer of    claim 29   , further comprising a knot formation site on said engagement body.  
     
     
         32 . The suture spacer of    claim 29   , wherein said suture spacer has dimensions which are suitable for use in transvaginal surgical procedures.  
     
     
         33 . The suture spacer of    claim 29   , further comprising a connector disposed between said surface contacting side of said body and said knot formation side of said body.  
     
     
         34 . The suture spacer of    claim 29   , wherein said engagement member comprises two securing portions.  
     
     
         35 . The suture spacer of    claim 29   , wherein said at least one securing portion is positioned above and generally parallel to said surface contacting side of said body when said engagement member is in said first position.  
     
     
         36 . The suture spacer of    claim 29   , wherein said engagement member is flexible.  
     
     
         37 . The suture spacer of    claim 29   , wherein said engagement member moves from said first position to said second position in response to application of a compressive force.  
     
     
         38 . The suture spacer of    claim 29   , wherein said engagement member further comprises a suture groove adapted to releasably retain a suture.  
     
     
         39 . A suture spacer, comprising: 
 a shaft having a proximal end and a distal end;    a connector having a proximal end and a distal end, said proximal end of said connector being connected to said distal end of said shaft; and    a slack defining member connected to said distal end of said connector, said slack defining member having a surface contacting side for contacting a surface from which one or more sutures emanate and a knot formation side adjacent to which a suture knot is formed, said knot formation side being disposed generally opposite to said surface contacting side, wherein a preselected amount of suture slack is defined by a distance from said surface contacting side to said knot formation side and back again.    
     
     
         40 . The suture spacer of    claim 39   , wherein said suture spacer has dimensions which are suitable for use in transvaginal surgical procedures.  
     
     
         41 . The suture spacer of    claim 39   , wherein said slack defining member is substantially spherical in cross-section.  
     
     
         42 . A method for producing a preselected amount of slack in a suture, comprising the steps of: 
 transvaginally contacting a surface from which one or more sutures emanate with a suture spacer, said suture spacer comprising a surface contacting side for contacting the surface from which one or more sutures emanate, said suture spacer also comprising a knot formation side located generally opposite to said surface contacting side, said suture spacer further comprising a suture receiving site for releasably receiving said one or more sutures;    inserting said one or more sutures emanating from the surface into said suture receiving site;    tying a knot in said one or more sutures, said knot being tied generally adjacent to said knot formation side; and    removing said suture spacer to produce the preselected amount of slack in said suture.    
     
     
         43 . The method of    claim 42   , wherein said step of transvaginally contacting a surface comprises contacting a sling.  
     
     
         44 . The method of    claim 43   , further comprising the step of positioning the sling between a urethra and an upper vaginal wall.  
     
     
         45 . A method for producing a preselected amount of slack in a suture, comprising the steps of: 
 contacting a surface from which one or more sutures emanate with a suture spacer so that said suture spacer lies between the sutures, said suture spacer comprising a shaft having a proximal end and a distal end, said suture spacer also comprising a connector having a proximal end and a distal end, said proximal end of said connector being connected to said distal end of said shaft,    said suture spacer further comprising a slack defining member connected to said distal end of said connector, said slack defining member having a surface contacting side for contacting the surface from which one or more sutures emanate and a knot formation side generally adjacent to which a suture knot is formed, said knot formation side being disposed generally opposite to said surface contacting side, wherein a preselected amount of suture slack is defined by a distance from said surface contacting side to said knot formation side and back again;    tying a knot in said suture, said knot being tied generally adjacent to said knot formation side; and    removing said suture spacer to produce the preselected amount of slack in said suture.    
     
     
         46 . The method of    claim 45   , wherein said step of contacting a surface comprises contacting a sling.  
     
     
         47 . The method of    claim 46   , further comprising the step of positioning the sling between a urethra and an upper vaginal wall.