Method for Attaching a Prosthesis to Soft Tissue

Abstract

A method of attaching a prosthesis to soft tissue is provided and includes providing a handheld fastener applier having a drive mechanism; and a fastener disposed at a distal end of the applier. The fastener includes a continuous helical coil, wherein the helical coil is constructed from a first material; and a cap secured to a proximal end of the helical coil, wherein the cap is constructed from a second material, and wherein the cap is non-rotatably and selectively connected to the drive mechanism. The fastener applier further includes a fastener driver coupled to the drive mechanism and engaging the cap, wherein the fastener driver rotates the fastener when the drive mechanism is actuated. The method further includes placing the distal end of the applier against a prosthesis; and manually powering the drive mechanism to actuate the fastener driver, and in turn, to rotate the fastener connected thereto.

We claim: 
     
         1 . A system comprising
 at least one tissue-piercing fastener having a sharpened distal tip for piercing and penetrating tissue,   a fastener attachment assembly sized and configured to be deployed from a remote access site to a targeted endovascular region, the fastener attachment assembly including
 an intraluminal directing device defining an access path and including a deflectable distal region, and 
 an intraluminal fastener applier separate from the intraluminal directing device and being sized and configured for introduction along the access path and including an actuated member that is selectively operable to generate an implantation force in an implantation force direction to implant the tissue-piercing fastener by causing the sharpened distal tip to pierce and penetrate the tissue in the targeted endovascular region, and 
 means associated with the fastener attachment assembly for applying a resolving force in a direction different than the implantation force direction within the targeted endovascular region to resolve at least a portion of the implantation force. 
   
     
     
         2 . A system according to  claim 1   wherein the means includes a stabilizing member carried by the intraluminal directing device and/or the intraluminal fastener applier.   
     
     
         3 . A system according to  claim 2   wherein the stabilizing member includes a strut assembly.   
     
     
         4 . A system according to  claim 2   wherein the stabilizing member includes a spring-loaded arm adapted for contact with tissue.   
     
     
         5 . A system according to  claim 2   wherein the stabilizing member includes an expandable member adapted for contact with tissue.   
     
     
         6 . A system according to  claim 2   wherein the stabilizing member includes a tissue grasping element.   
     
     
         7 . A system according to  claim 1   wherein the at least one tissue-piercing fastener comprises a helical fastener, and wherein the actuated member comprises a driven member for implanting a helical fastener.   
     
     
         8 . A system according to  claim 1   wherein the intraluminal fastener applier includes a catheter body that carries the actuated member, the catheter body having a column strength, and   wherein the means includes, at least in part, the column strength of the catheter body.   
     
     
         9 . A system according to  claim 1   wherein the intraluminal directing device has a column strength, and   wherein the means includes, at least in part, the column strength of the intraluminal directing device.