Methods for Making a Supported Graft

Abstract

A device includes a tubular substrate and a support member. The support member includes a component that is elastically deformable and elastically recoverable. The support member wraps around and adheres to an abluminal surface of the tubular substrate. The device is adapted for use in an anatomical conduit. For example, the device may be adapted for bypassing an anatomical conduit, for creating an arteriovenous shunt, or as a support structure for maintaining an opening in an anatomical conduit.

What is claimed is: 
     
         1 . A device, comprising:
 a tubular substrate having an abluminal surface; and   a support member comprising a component that is elastically deformable and elastically recoverable, wherein the support member wraps around and adheres to the abluminal surface;   the device being adapted for use in an anatomical conduit.   
     
     
         2 . The device of  claim 1 , wherein the support member wraps circumferentially around and adheres to the abluminal surface. 
     
     
         3 . The device of  claim 1 , wherein the component comprises one or more of shape memory alloys, biocompatible spring steels, biocompatible spring metal alloys, or carbon fiber ma-terials. 
     
     
         4 . The device of  claim 3 , wherein shape memory alloys comprise nickel-titanium alloys. 
     
     
         5 . The device of  claim 3 , wherein shape memory alloys comprise an alloy with a pre-set austenite configuration that has substantially the same diameter as the substrate. 
     
     
         6 . The device of  claim 1 , wherein a polymeric cover surrounds the support member and connects to the abluminal surface. 
     
     
         7 . The device of  claim 6  wherein the polymeric cover comprises any one or any combination of polytetrafluoro-ethylenes, polyurethanes, polyethylenes, polypropylenes, polyamides, polyimides, polyesters, polypropylenes, polyfluoroethylenes, silicones, fluorinated polyolefins, fluori-nated ethylene/propylene copolymers, perfluoroalkoxy fluo-rocarbons, ethylene/tetra-fluoroethylene copolymers, or polyvinylpyrolidones. 
     
     
         8 . The device of  claim 1 , wherein the substrate further comprises a biocompatible material comprising any one or any combination of expanded polytetrafluoroethylenes, polyethylenes, polyethylene terepthalates, polyurethanes, or collagens. 
     
     
         9 . A device comprising a helical component, comprising:
 a support member comprising a component that is elastically deformable and elastically recoverable; and   an expanded polytetrafluoroethylene film member joined to the support member, wherein overlapping film-member portions of adjacent windings bond to one another;   the device being adapted for use in an anatomical conduit.   
     
     
         10 . The device of  claim 9 , wherein a polytetrafluoroethylene film member joins to the expanded polytetrafluoroethylene film member to embed the support member. 
     
     
         11 . The device of  claim 10 , wherein the joint comprises an adhesive interlayer. 
     
     
         12 . The device of  claim 10 , wherein the polytetrafluoroethylene film member comprises expanded polytetrafluoroethylene. 
     
     
         13 . The device of  claim 9 , wherein a bonding agent joins the support member to the film member. 
     
     
         14 . The device of  claim 13 , wherein the bonding agent comprises any one or any combination of polytetrafluoroethylenes, polyurethanes, polyethylenes, polypropylenes, polyamides, polyimides, polyesters, polyfluoroethylenes, silicones, fluorinated polyolefins, fluorinated ethylene/propylene copolymers, perfluoroalkoxy fluorocarbons, ethylene/tetrafluoroethylene copolymers, or polyvinylpyrolidones. 
     
     
         15 . The device of  claim 13 , wherein the bonding agent joins the support member to an abluminal surface of a polytetrafluoroethylene tubular substrate. 
     
     
         16 . The device of  claim 13 , wherein the bonding agent clads the support member. 
     
     
         17 . A device comprising an expanded polytetrafluoroethylene tubular substrate having an abluminal surface and a support member comprising a shape memory alloy, wherein the support member adheres to and helically winds around the abluminal surface. 
     
     
         18 . The device of  claim 17 , wherein the shape memory alloy comprises a nickel-titanium alloy. 
     
     
         19 . The device of  claim 18 , wherein the nickel-titanium alloy comprises an alloy consisting essentially of about 50 atomic percent of nickel and about 50 atomic percent of titanium. 
     
     
         20 . The device of  claim 17 , wherein the shape memory alloy has a pre-set austenite configuration that in turn has a diameter substantially equal to the substrate diameter. 
     
     
         21 . The device of  claim 17 , wherein a polymeric covering surrounds the support member and joins to the abluminal surface. 
     
     
         22 . The device of  claim 21 , wherein the polymeric covering comprises any one or any combination of polytetrafluoro-ethylenes, polyurethanes, polyethylenes, polypropylenes, polyamides, polyimides, polyesters, polyfluoroethylenes, silicones, fluorinated polyolefins, fluorinated ethylene/propylene copolymers, perfluoroalkoxy fluorocarbons, ethylene/tetrafluoroethylene copolymers, and polyvinylpyrolidones. 
     
     
         23 . A method comprising wrapping a support member comprising a shape memory alloy about and in bonded contact with an abluminal surface of a seamless expanded polytetrafluoroethylene tubular member. 
     
     
         24 . The method of  claim 23 , further comprising a step of providing the support member with a concentric covering comprising a material bondingly compatible with the tubular member. 
     
     
         25 . The method of  claim 24 , wherein the step of providing the support member with a covering further comprises a step of selecting a covering material comprising any one or any combination of polytetrafluoroethylenes, polyurethanes, polyethylenes, polypropylenes, polyamides, polyimides, poly-ester, polyfluoroethylenes, silicones, fluorinated polyolefin, fluorinated ethylene/propylene copolymers, perfluoroalkoxy fluorocarbons, ethylene/tetrafluoroethylene copolymers, and polyvinylpyrrolidone. 
     
     
         26 . The method of  claim 25 , wherein the step of providing the support member with a covering further comprises a step of co-extruding the support member with a polytetrafluoroethylene covering. 
     
     
         27 . The method of  claim 26 , further comprising:
 forming an assembly by helically wrapping a polytetrafluoroethylene tape around the tubular substrate and the support member co-extruded with the polytetrafluoroethylene covering, and along a longitudinal extent of the tubular substrate, wherein the tubular substrate is radially and longitudinally secured; and   heating the assembly above the crystalline melt point of polytetrafluoroethylene long enough to bond the covering to the substrate.   
     
     
         28 . The method of  claim 25 , further comprising heating the abluminal surface and the support member to a temperature above the bondingly compatible material's melt point long enough to bond the support member to the abluminal surface. 
     
     
         29 . The use of a device constructed using the method of  claim 26  for restoring an opening in an anatomical conduit. 
     
     
         30 . The use of a device made with the method of  claim 24  for creating a transluminal intrahepatic portosystemic shunt. 
     
     
         31 . The use of the device of  claim 1  for bypassing an anatomical conduit. 
     
     
         32 . The use of the device of  claim 1  for creating an arteriovenous shunt. 
     
     
         33 . The use of the device of  claim 1  as a support structure for maintaining an opening in an anatomical conduit.