Implant Deployment Apparatus

Abstract

A delivery system including a restraining member maintains a collapsed implant in its collapsed state for delivery through a small passageway to a desired site in a mammalian body. Once the implant is positioned at the desired site, the restraining member is released so that the stent may expand or be expanded to its expanded state. In a preferred embodiment, the restraining member comprises a sheet of material that surrounds at least a portion of the collapsed stent. Portions of the restraining member are releasably coupled to one another with a low profile thread-like member or suture.

1 . An endoluminal implant device for implanting within a body lumen having a natural lumen diameter, the device comprising:
 a tubular graft member made of expanded polytetrafluoroethylene, wherein the graft member has a proximal end for positioning in an upstream location of the body lumen and a distal end for positioning in a downstream location of the body lumen;   a stent member attached to the proximal end of the graft member, wherein the stent member is self-expanding from a collapsed configuration to an expanded configuration, wherein a diameter of the stent member in the expanded configuration is larger than the natural lumen diameter of the body lumen, and wherein the stent member comprises:
 a wire undulating around the graft member, the undulating wire defining proximal apexes and distal apexes, and 
 a plurality of anchors disposed around the undulating wire, wherein each anchor protrudes from the wire away from the graft member and in a direction toward the distal apexes, and is disposed between the proximal apexes and the distal apexes along the longitudinal axis of the graft member. 
   
     
     
         2 . The device of  claim 1 , wherein the each anchor comprises a wire having an open end bent out and away from the graft member. 
     
     
         3 . The device of  claim 1 , wherein the each anchor comprises two wires having open ends bent out and away from the graft member. 
     
     
         4 . The device of  claim 1 , wherein the each anchor comprises a U-shaped wire. 
     
     
         5 . The device of  claim 1 , wherein the anchors of the plurality of anchors are disposed in an evenly spaced pattern around the circumference of the graft member. 
     
     
         6 . The device of  claim 1 , wherein the proximal apexes of the undulating wire project angularly outward from the remaining portions of the undulating wire and from the longitudinal axis of the graft member. 
     
     
         7 . The device of  claim 1 , wherein the graft member comprises an inside face and an outside face, wherein the stent member is disposed over the outside face of the graft member, and wherein the device further comprises a tape member disposed over the stent member, the tape member bonded to the graft member through openings in the undulating wire of the stent member. 
     
     
         8 . The device of  claim 7 , wherein the tape member comprises fluorinated ethylene-propylene coated expanded polytetrafluoroethylene. 
     
     
         9 . The device of  claim 1 , wherein the wire undulates around the graft member in a helical pattern. 
     
     
         10 . The device of  claim 1 , wherein the wire undulates around the graft member in a single turn to form a ring. 
     
     
         11 . The device of  claim 1 , wherein the undulating wire comprises an upstream turn and a downstream turn around the graft member, and wherein the each anchor extends from the upstream turn and under a proximal apex of the downstream turn, and protrudes away from the graft member downstream of the proximal apex. 
     
     
         12 . The device of  claim 11 , wherein the upstream turn comprises extended struts formed adjacent to each anchor and extending under the downstream turn. 
     
     
         13 . The device of  claim 1 , further comprising a restraining member in which the device is constrained in a collapsed state for deployment within the body lumen. 
     
     
         14 . The device of  claim 13 , wherein the restraining member comprises a pull line that releases the restraining member to allow the device to expand. 
     
     
         15 . The device of  claim 1 , wherein the stent member has an expansion ratio of approximately 5:1. 
     
     
         16 . The device of  claim 1 , wherein the each anchor extends from a proximal apex of the undulating wire. 
     
     
         17 . The device of  claim 1 , further comprising an outer graft member made of expanded polytetrafluoroethylene, wherein the stent member is sandwiched between the tubular graft member and the outer graft member to attach the stent member to the proximal end of the tubular graft member. 
     
     
         18 . An endoluminal implant device for implanting within a body lumen having a natural lumen diameter, the device comprising:
 a tubular graft member made of expanded polytetrafluoroethylene, wherein the graft member has a proximal end for positioning in an upstream location of the body lumen and a distal end for positioning in a downstream location of the body lumen;   a stent wire attached to the proximal end of the graft member,
 wherein the stent wire undulates around the graft member and defines proximal apexes and distal apexes, 
 wherein the stent wire is self-expanding from a collapsed configuration to an expanded configuration, and 
 wherein a diameter of the stent wire in the expanded configuration is larger than the natural lumen diameter of the body lumen; and 
   a plurality of anchor wires disposed around the undulating stent wire, wherein each anchor wire protrudes away from the graft member at a location between the proximal apexes and the distal apexes along the longitudinal axis of the graft member, and in a direction toward the distal apexes.   
     
     
         19 . The device of  claim 18 , wherein the each anchor wire is attached to a proximal apex of the undulating stent wire. 
     
     
         20 . The device of  claim 18 , wherein the each anchor wire extends from a proximal apex of the undulating stent wire. 
     
     
         21 . The device of  claim 18 , wherein the each anchor wire is an integral portion of the undulating stent wire. 
     
     
         22 . The device of  claim 18 , wherein the each anchor wire comprises two open ends bent out and away from the graft member. 
     
     
         23 . The device of  claim 18 , wherein in an expanded configuration, a diameter of the undulating wire at the proximal ends is larger than a diameter of the undulating wire at the distal ends. 
     
     
         24 . A method for manufacturing an endoluminal implant device for implanting within a body lumen having a natural lumen diameter, the method comprising:
 forming a tubular graft member from expanded polytetrafluoroethylene, wherein the graft member has a proximal end for positioning in an upstream location of the body lumen and a distal end for positioning in a downstream location of the body lumen;   forming a stent wire that wraps in a generally cylindrical configuration to define an interior area and an exterior area, and undulates to define proximal apexes, distal apexes, and openings between the distal and proximal apexes,
 wherein the stent wire is self-expanding from a collapsed configuration to an expanded configuration, and 
 wherein a diameter of the stent wire in the expanded configuration is larger than the natural lumen diameter of the body lumen; 
   forming a plurality of anchor wires disposed around the undulating stent wire, wherein each anchor wire protrudes away from the interior area at a location between the proximal apexes and the distal apexes along the longitudinal axis defined by the cylindrical configuration, and in a direction toward the distal apexes;   placing the tubular graft member on a mandrel;   placing the stent wire over the tubular graft member;   placing an outer graft member, made from expanded polytetrafluoroethylene, around the stent wire such that the outer graft member is exposed to the tubular graft member through the openings in the stent wire;   heating the outer graft member and the tubular graft member to adhere the outer graft member to the tubular graft member through the openings in the stent wire, thereby forming the implant device; and   removing the mandrel from inside the tubular graft member.   
     
     
         25 . The method of  claim 24 , further comprising
 collapsing the implant device;   placing the collapsed implant device inside a restraining member that constrains the implant device in a collapsed state; and   attaching a coupling member to the restraining member, wherein the coupling member is configured to release the collapsed implant device from the restraining member to allow the implant device to expand to an expanded state.   
     
     
         26 . An endoluminal implant device for implanting within a body lumen having a natural lumen diameter, the device comprising:
 a tubular graft member made of expanded polytetrafluoroethylene, wherein the tubular graft member has a proximal end for positioning in an upstream location of the body lumen and a distal end for positioning in a downstream location of the body lumen;   a stent member attached to the proximal end of the tubular graft member,
 wherein the stent member wraps in a generally cylindrical configuration around the tubular graft member, 
 wherein the stent member is self-expanding from a collapsed configuration to an expanded configuration, and 
 wherein a diameter of the stent member in the expanded configuration is larger than the natural lumen diameter of the body lumen; and 
   a plurality of anchors attached to the stent member, wherein each anchor protrudes away from the tubular graft member and in a direction toward the distal end of the tubular graft member.   
     
     
         27 . The device of  claim 26 , further comprising an outer graft member made of expanded polytetrafluoroethylene, wherein the stent member is sandwiched between the tubular graft member and the outer graft member, and wherein the outer graft member and the tubular graft member are attached to each other through openings in the stent member, to attach the stent member to the proximal end of the tubular graft member.