Surgical articles and methods for treating urinary incontinence

Abstract

Described are devices, implants and kits for treating incontinence in a male or female. In particular an assembly comprising a multi-piece implant comprising a support portion piece ( 82 ) and two extension portion pieces ( 84 ) adjustably connected to the support portion piece, and an adjusting tool ( 92 ) to allow adjustment of extension portion pieces relative to the support portion piece, is described.

What is claimed is: 
     
         1 . An assembly for treating urinary incontinence, the assembly comprising a multi-piece implant comprising a support portion piece and two extension portion pieces, and an adjusting tool, wherein
 the support portion piece comprising a tissue support portion sized and shaped for placement to support a urethra, and   the extension portion pieces each comprise a proximal end, a distal end, and a tissue fastener,   the first extension portion piece is adjustably connected to the support portion piece at a first adjustable connection,   the second extension portion piece is adjustably connected to the support portion piece at a second adjustable connection, and   the adjusting tool comprises two adjusting surfaces, the two adjusting surfaces being capable of simultaneously engaging the support portion piece to allow adjustment of a position of the extension portion piece relative to the support portion piece at the first adjustable connection, and adjustment of a position of the second extension portion piece relative to the support portion piece at the second adjustable connection.   
     
     
         2 . An assembly according to  claim 1  wherein each of the two adjusting surfaces is adjacent to a slot or aperture adapted to engage the extension portion piece. 
     
     
         3 . An assembly according to  claim 1  wherein the adjusting tool comprises a shaft and a yoke, the two adjusting surfaces are located at the yoke, and the yoke is stationary relative to the shaft. 
     
     
         4 . An assembly according to  claim 1  wherein the adjusting tool comprises a shaft and a yoke, the two adjusting surfaces are located at the yoke, and the yoke can be moved relative to a length of the shaft. 
     
     
         5 . An implant according to  claim 1  wherein the adjustable connection comprises an aperture through which the extension portion piece extends to adjustably connect the extension portion piece to the support portion piece. 
     
     
         6 . An implant according to  claim 1  wherein the adjustable connection comprises a grommet. 
     
     
         7 . An implant according to  claim 1  wherein the extension portion piece comprises a tissue fastener. 
     
     
         8 . An implant according to  claim 1  wherein the implant comprises supportive portions consisting of the tissue support portion and two extension portions. 
     
     
         9 . A method of treating urinary incontinence in a patient, the method comprising:
 providing an assembly according to  claim 1 ,   creating a medial incision in the patient,   dissecting from the medial incision to tissue below a urethra,   placing the tissue support portion to contact tissue to support the urethra,   placing a distal end of the first extension portion in a tissue path extending toward a first obturator foramen of the patient,   placing a distal end of the second extension portion in a tissue path extending toward a second obturator foramen of the patient,   connecting the first extension portion piece with the support portion piece at the first adjustable connection,   connecting the second extension portion piece with the support portion piece at the second adjustable connection,   engaging the adjusting tool with the support portion piece, and   adjusting a position of the support portion piece relative to first and second extension portion pieces.   
     
     
         10 . A method according to  claim 9 , wherein
 the implant comprises a left-side extension portion piece connected to the support portion piece at an adjustable connection at a left end of the support portion piece to form a left extension portion, and the method comprises extending the left extension portion to engage supportive tissue at a left side of the patient, and   the implant comprises a right-side extension portion piece connected to the support portion piece at an adjustable connection at a right end of the support portion piece to form a right extension portion, and the method comprises extending the right extension portion to engage supportive tissue at a right side of the patient.   
     
     
         11 . A method according to  claim 9  wherein the patient is a male patient, the method comprising
 exposing bulbospongiosus muscle, 
 dissecting bulbospongiosus muscle to expose corpus spongiosum, and 
 placing the tissue support portion to contact the corpus spongiosum. 
 
     
     
         12 . A method according to  claim 9 ,
 wherein the adjusting tool comprises a shaft and a yoke, the two adjusting surfaces are located at the yoke, the yoke can be moved relative to a length of the shaft, and the method comprises moving the yoke relative to the shaft.   
     
     
         13 . An implant for treating urinary incontinence, the implant comprising
 a tissue support portion sized and shaped for placement to support a urethra, and   two extension portions, each extension portion extending from an end of the tissue support portion, and   a tissue fastener at each extension portion,   wherein each extension portion comprises an adjustable length between the tissue support portion and the tissue fastener.   
     
     
         14 . An implant according to  claim 13  wherein each of the two extension portions comprises a suture, and the tissue fastener is a self-fixating tip adjustably connected to the suture. 
     
     
         15 . A method of treating urinary incontinence in a patient, the method comprising:
 providing an implant according to  claim 13 ,   creating a medial incision in the patient,   dissecting from the medial incision to tissue below a urethra,   placing the tissue support portion to support the urethra,   placing the tissue fastener at the first extension portion in a tissue path extending toward a first obturator foramen of the patient,   placing the tissue fastener at the second extension portion in a tissue path extending toward a second obturator foramen of the patient, and   adjusting the adjustable length between the tissue support portion and the tissue fastener.   
     
     
         16 . An assembly for treating urinary incontinence in a patient, the assembly comprising an implant comprising a tissue support portion and two extension portions, and an insertion tool, wherein the insertion tool comprises a small-diameter needle having a diameter of less than 0.09 inch, a radius of curvature at a tip at one end of the needle that is less than 0.015 inch, and a length to extend between a medial incision in the patient, and a lateral incision in a patient adjacent to an obturator foramen. 
     
     
         17 . A method of treating urinary incontinence, the method comprising:
 providing an assembly according to  claim 16 ,   creating a medial incision in the patient,   dissecting from the medial incision to tissue below a urethra,   placing the tissue support portion to support the urethra,   attaching the extension portion to the small diameter needle,   using the small-diameter needle, passing the extension portion between the medial incision and an external location adjacent to an obturator foramen, the needle and extension portion passing through an obturator foramen.   
     
     
         18 . A method according to  claim 17  comprising initially inserting an end of the small-diameter needle at a medial incision, advancing the small-diameter needle toward an obturator foramen and through the obturator foramen, then advancing the small diameter needle through an exit point at external skin tissue adjacent to the obturator foramen. 
     
     
         19 . A method according to  claim 17  comprising
 initially inserting an end of the small-diameter needle at an entry point at external skin tissue adjacent to the obturator foramen, 
 advancing the small-diameter needle toward an obturator foramen and through the obturator foramen, 
 then advancing a leading end of the small-diameter needle to the medial incision, 
 then engaging an extension portion with the leading end of the small-diameter needle, and 
 retracting the small diameter needle to place the extension portion at a tissue path extending between the medial incision and the entry point. 
 
     
     
         20 . A urethra-positioning tool comprising an elongate shaft capable of being inserted through a meatus and into a urethra to adjust a positioning of the urethra.