Stent-graft with proximal and distal attachment, delivery catheter and methods of making same

Abstract

A metallic or pseudometallic covered stent in which the stent component and the cover component are each fabricated of biocompatible metallic or pseudometallic materials, in which the cover and the stent are joined by at least one juncture at each of a proximal and distal end of the stent and the cover. A method of joining the stent and the cover is also disclosed.

What is claimed is: 
     
         1 . An implantable covered-stent, comprising:
 a) a self-expanding stent having structural members and a length defined between a most proximal vertex and a most distal vertex of the structural members, at least one enlarged member projecting from at least one of the most proximal vertex or the most distal vertex, wherein each of the at least one enlarged members has a substantially planar surface and a width greater than the width of any structural member of the stent, and at least one fenestration is disposed between the most proximal vertex and the most distal vertex; and   b) a metal cover member having a proximal end region, a distal end region, wall surfaces and a plurality of openings passing through the wall surfaces, wherein each of the plurality of openings has an open surface area less than an open surface area of the at least one fenestration;
 wherein the metal cover at least partially occludes the at least one fenestration to form the implantable covered-stent. 
   
     
     
         2 . The implantable covered-stent of  claim 1 , wherein the stent and the metal cover have compatible degrees of foreshortening. 
     
     
         3 . The implantable covered-stent of  claim 1 , wherein the stent and the metal cover are each composed of at least one material selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, zirconium-titanium-tantalum alloys, nickel-titanium alloys, cobalt-chromium alloys, and stainless steel. 
     
     
         4 . The implantable covered-stent of  claim 1 , wherein the proximal end region of the metal cover is joined by a thermal method in a first join to the at least one enlarged member. 
     
     
         5 . The implantable covered-stent of  claim 4 , wherein the distal end region of the metal cover is joined by a thermal method in a second join to the at least one enlarged member. 
     
     
         6 . The implantable covered-stent of  claim 5 , wherein the first join and the second join further comprise welds. 
     
     
         7 . The implantable covered-stent of  claim 6 , wherein the welds are passivated. 
     
     
         8 . The implantable covered-stent of  claim 1 , wherein the stent and the metal cover member are formed of the same biocompatible metal. 
     
     
         9 . The implantable covered-stent of  claim 1 , wherein the stent has a transition temperature less than body temperature. 
     
     
         10 . The implantable covered-stent of  claim 9 , wherein the metal cover has a transition temperature between about 60 to 100 degrees Centigrade. 
     
     
         11 . The implantable covered-stent of  claim 10 , wherein the at least one enlarged member of the stent flares at room temperature. 
     
     
         12 . The implantable covered-stent of  claim 1 , further comprising a constant outer diameter catheter sheath and a guidewire sheath. 
     
     
         13 . The implantable covered-stent of  claim 1 , said covered-stent further comprising a tapered catheter sheath and a guidewire sheath. 
     
     
         14 . The implantable covered-stent of  claim 1 , further comprising an outer diameter catheter sheath, a pusher member, a guidewire shaft, and an atraumatic tip, wherein the implantable covered-stent is partially contained within the catheter sheath, the guidewire shaft is coaxially coupled through a central lumen of the pusher member and a central lumen of the implantable covered-stent to the atraumatic tip, the atraumatic tip is affixed to a distal end of the guidewire shaft, and the atraumatic tip abuts with a distal end of the catheter sheath thereby enclosing the implantable covered-stent within the catheter sheath. 
     
     
         15 . The implantable covered-stent of  claim 1 , wherein the at least one enlarged member includes a generally quadrilateral shape in the X-Y axis of the luminal surface of the stent cover. 
     
     
         16 . The implantable covered-stent of  claim 1 , wherein the stent and the metal cover member are formed of a dissimilar biocompatible metal. 
     
     
         17 . An implantable covered-stent, comprising:
 a) a self-expanding stent having structural members and a length defined between a most proximal vertex and a most distal vertex of the structural members, at least one enlarged proximal member projecting proximally from the most proximal vertex and at least one enlarged distal member projecting distally from the most distal vertex, wherein each of the enlarged proximal and distal members has a substantially planar surface and a width greater than the width of any structural member of the stent, and at least one fenestration is disposed between the at least one enlarged proximal member and the at least one enlarged distal member; and   b) a metal cover member having a proximal end region, a distal end region, wall surfaces and a plurality of openings passing through the wall surfaces, wherein each of the plurality of openings has an open surface area less than an open surface area of the at least one fenestration;
 wherein the metal cover at least partially occludes the at least one fenestration to form the implantable covered-stent. 
   
     
     
         18 . The implantable covered-stent of  claim 17 , wherein the proximal end region of said metal cover is joined by a thermal method including a first interlayer material in a first join to the at least one enlarged proximal member. 
     
     
         19 . The implantable covered-stent of  claim 18 , wherein the distal end region of the metal cover is joined by a thermal method including a second interlayer material in a second join to the at least one enlarged distal member 
     
     
         20 . The implantable covered-stent of  claim 17 , wherein the stent and the metal cover member are formed of a dissimilar metal.