Implantable prosthesis

Abstract

A graft system for intraluminal delivery in a vessel in need of repair comprising a graft, anchoring means, and a strippable sheath around at least part of the graft. A preferred anchoring means is a balloon-expandable stent. Also included in the invention is a method of using the device to treat a body lumen. The strippable sheath is removable by pulling on a drawstring to remove it which permits expansion of the graft. The positioning of the device may then be adjusted prior to stent dilation. A preferred embodiment of the invention includes a bifurcated graft system for intraluminal delivery in an aortic aneurysm comprising a bifurcated graft having a distal region and two legs, an expandable stent disposed in part of the distal region, and a strippable crocheted sheath around the distal region and one of the two legs. The strippable crocheted sheath is removable by untying it to permit expansion of the graft after initial placement within the aneurysm.

What is claimed:  
     
         1 . A system for endoluminal delivery and emplacement of a prosthesis in a body lumen, comprising: 
 a tubular graft having a central axis, a first radially compressed configuration for endoluminal delivery, and a second radially expanded configuration;    radial expansion means for expanding the graft to its radially expanded configuration; and    a strippable sheath surrounding at least part of the graft in the first configuration thereof, the strippable sheath being removable to permit expansion of the graft.    
     
     
         2 . The system of  claim 1  further comprising anchoring means for anchoring said tubular graft in said body lumen.  
     
     
         3 . The system of  claim 1  further comprising a drawstring extending from the strippable sheath, wherein retraction of the drawstring results in the removal of said sheath.  
     
     
         4 . The system of  claim 3  wherein said strippable sheath is crocheted and retraction of said drawstring results in the untying and removal of said sheath.  
     
     
         5 . The system of  claim 1  wherein the graft includes a bifurcation.  
     
     
         6 . The system of  claim 5  wherein said graft includes an unbifurcated tubular distal section on one side thereof and two tubular distal sections on the other side thereof.  
     
     
         7 . The system of  claim 6  wherein the strippable sheath extends around the unbifurcated distal section and only one of the bifurcated distal sections of the graft.  
     
     
         8 . The system of  claim 6  wherein the strippable sheath extends around only the unbifurcated distal section.  
     
     
         9 . The system of  claim 1  wherein the radial expansion means is an inflatable balloon.  
     
     
         10 . The system of  claim 2  wherein the anchoring means is a stent.  
     
     
         11 . The system of  claim 10  wherein the stent is disposed at only one end of the graft.  
     
     
         12 . The system of  claim 1  for use in repairing an aortic aneurysm, wherein: 
 the graft is a bifurcated graft having a distal aortic region and two distal iliac legs;  
 a balloon expandable stent is disposed in the distal aortic region; and  
 the strippable sheath is a crocheted strippable sheath which extends around the distal region and only one of the two distal legs.  
 
     
     
         13 . A system for endoluminal delivery and emplacement of a prosthesis in a body lumen, comprising: 
 a tubular graft;    a tubular stent disposed in at least part of the graft, the stent and graft having a common central axis, a first radially compressed configuration for endoluminal delivery and a second radially expanded configuration;    radial expansion means for expanding the stent and graft to the radially expanded configurations thereof;    a strippable sheath surrounding at least part of the graft in the first configuration thereof, the strippable crocheted sheath being removable to permit expansion of the graft and stent; and    a drawstring extending from the strippable sheath, wherein retraction of the drawstring results in the untying of said sheath.    
     
     
         14 . The system of  claim 13  further comprising anchoring means for anchoring said tubular graft in said body lumen.  
     
     
         15 . The system of  claim 13  wherein said strippable sheath is crocheted and retraction of said drawstring results in the untying and removal of said sheath.  
     
     
         16 . The system of  claim 13  wherein the graft includes a bifurcation.  
     
     
         17 . The system of  claim 16  wherein said graft includes an unbifurcated tubular distal section on one side thereof and two tubular distal sections on the other side thereof.  
     
     
         18 . The system of  claim 17  wherein the strippable sheath extends around the unbifurcated distal section and only one of the bifurcated distal sections of the graft.  
     
     
         19 . The system of  claim 17  wherein the strippable sheath extends around only the unbifurcated distal section.  
     
     
         20 . The system of  claim 13  wherein the radial expansion means is an inflatable balloon.  
     
     
         21 . The system of  claim 14  wherein the anchoring means is a stent.  
     
     
         22 . The system of  claim 21  wherein the stent is disposed at only one end of the graft.  
     
     
         23 . The system of  claim 13  for use in repairing an aortic aneurysm, wherein: 
 the graft is a bifurcated graft having a distal aortic region and two distal iliac legs;  
 a balloon expandable stent is disposed in the distal aortic region; and  
 the strippable sheath is a crocheted strippable sheath which extends around the distal region and only one of the two distal legs.  
 
     
     
         24 . A bifurcated graft system for intraluminal delivery in an aortic aneurysm in need of repair comprising: 
 a bifurcated graft having a distal region and two legs;    an expandable stent disposed in part of said distal region;    a strippable sheath around said distal region and one of said two legs, the strippable sheath being removable to permit expansion of the graft and stent; and    a drawstring extending from said strippable crocheted sheath, wherein retraction of said drawstring results in the removal of said sheath.    
     
     
         25 . An aortic graft system for intraluminal delivery to repair an abdominal aortic aneurysm in an aorta having two iliac arteries associated therewith at an aortic bifurcation, comprising: 
 a graft having a first end and an intermediate region disposed adjacent said first end, the graft being self expandable from a reduced profile for insertion into the aorta to an expanded profile;    means for securing the first end of the graft to the aorta, the securing means having a first diameter which permits intraluminal delivery of the securing means into the aorta and the securing means having a second, expanded diameter, to secure the first end of the graft to the aorta;    radial expansion means for expanding securing means and graft to the radially expanded configurations thereof;    a strippable sheath covering at least part of said graft, the strippable sheath maintaining the graft in the reduced profile; and    at least one drawstring extending from the strippable sheath, the drawstring being retractable to permit removal of the strippable sheath and subsequent expansion of the graft from its reduced profile to its expanded profile.    
     
     
         26 . The graft system of  claim 25  wherein said securing means includes a balloon expandable stent.  
     
     
         27 . A method of inserting a graft system to repair a vessel in need of repair comprising the steps of: 
 inserting a catheter from a vessel access location into a vessel to a deployment location in need of repair, the catheter having a graft system disposed thereon, the graft system comprising: 
 a centrally disposed push wire surrounded by a graft;  
 anchoring means for anchoring said tubular graft in said vessel;  
 a strippable sheath around at least part of the graft, the strippable sheath being removable to permit expansion of the graft; and  
 a drawstring extending from the strippable sheath to the access location, wherein retraction of the drawstring results in the removal of the sheath;  
   retracting the drawstring to cause removal of the strippable sheath to allow expansion of the graft;    anchoring the graft within the vessel; and    removing the catheter.    
     
     
         28 . The method of  claim 27  wherein the anchoring means comprises a balloon expandable stent and said anchoring step comprises inflating a balloon disposed on the catheter to expand said balloon expandable stent.  
     
     
         29 . The method of  claim 27  wherein the strippable sheath is a crocheted sheath.  
     
     
         30 . The method of  claim 27  wherein the vessel in need of repair is a bifurcated vessel, the graft is bifurcated having a distal region and two distal legs, and the strippable sheath extends around the distal region and only one of the two distal legs.  
     
     
         31 . The method of  claim 30  wherein said vessel in need of repair is an aortic aneurysm.  
     
     
         32 . The method of  claim 27  wherein said inserting step is through one iliac artery, further comprising the step of: 
 before said retracting step, pulling the leg not covered by the strippable crocheted sheath into the iliac artery not used to insert the catheter.  
 
     
     
         33 . A method of inserting a graft system to repair a vessel in need of repair comprising the steps of: 
 inserting a catheter from a vessel access location into a vessel to a deployment location in need of repair, the catheter having a graft system disposed thereon, the graft system comprising: 
 a centrally disposed push wire surrounded by a graft;  
 an expandable stent disposed in at least part of the graft;  
 a strippable crocheted sheath around at least part of the graft, the strippable crocheted sheath being removable to permit expansion of the graft and stent; and  
 a drawstring extending from the strippable crocheted sheath to the access location, wherein retraction of the drawstring results in the untying and removal of the sheath;  
   retracting the drawstring to cause untying and removal of the strippable crocheted sheath to allow expansion of the graft;    expanding the stent to anchor the stent and the graft within the vessel; and    removing the catheter.    
     
     
         34 . The method of  claim 33  wherein the stent is a balloon expandable stent and said expanding step comprises inflating a balloon disposed on said catheter.  
     
     
         35 . The method of  claim 33  wherein the vessel in need of repair is an aortic aneurysm, the graft is bifurcated having a distal region and two distal legs, and the strippable crocheted sheath extends around the distal region and only one of the two distal legs.  
     
     
         36 . The method of  claim 35  wherein said inserting step is through one iliac artery, further comprising the step of: 
 before said retracting step, pulling the leg not covered by the strippable crocheted sheath into the iliac artery not used to insert the catheter.