Methods and apparatus for intraluminal placement of a bifurcated intraluminal graft

Abstract

Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft. In turn, a second introducer sheath and a second catheter assembly are provided contralaterally for introduction of a graft extension. Upon balloon-expansion, the graft extension is frictionally engaged with the contralateral leg of the aortic graft. A third catheter assembly including a second extension graft is provided for introduction of the extension graft and balloon-expansion thereof for frictional engagement with the ipsilateral leg of the graft.

1 - 24 . (canceled)  
   
   
       25 . An intraluminal prosthesis comprising: 
 a trouser graft having a trunk in an upstream direction and two legs diverging in a downstream direction from the trunk at a septum region, the trouser graft being formed of a graft body having an external surface and an internal surface;    one or more self-expanding wireforms connected to the trouser graft; and    at least one balloon-expandable wireform connected to the graft body at the trunk.    
   
   
       26 . The intraluminal graft of  claim 25  wherein a self-expanding wireform is connected to the trouser graft at the septum region.  
   
   
       27 . The intraluminal graft of  claim 26  wherein the self-expanding wireform is connected to the exterior of the trouser graft at the septum region.  
   
   
       28 . The intraluminal graft of  claim 27  wherein a self-expanding wireform is connected to the exterior of the trouser graft in each of the two legs.  
   
   
       29 . The intraluminal prosthesis of  claim 28  further including a lateral reinforcement wire coupled to at least one of the legs between the self-expanding wireform in the one leg and the self-expanding wireform at the septum region.  
   
   
       30 . The intraluminal prosthesis of  claim 29  wherein the lateral reinforcement wire is attached to the exterior of the graft body.  
   
   
       31 . The intraluminal prosthesis of  claim 30  wherein the self-expanding wireforms in the legs and at the septum region each have alternating peaks and valleys around their respective circumferences, and wherein the lateral reinforcement wire extends between a valley on the self-expanding wireform at the septum region and a peak on the self-expanding wireform in the one leg.  
   
   
       32 . The intraluminal prosthesis of  claim 26 , wherein the self-expanding wireform at the septum region has a radiopaque marker attached thereto.  
   
   
       33 . The intraluminal prosthesis of  claim 32 , wherein the radiopaque marker points to the location at the septum region where the two legs diverge.  
   
   
       34 . The intraluminal prosthesis of  claim 32 , wherein the self-expanding wireform at the septum region includes at least one crimp, and wherein the radiopaque marker is provided on the crimp.  
   
   
       35 . The intraluminal prosthesis of  claim 34 , wherein the radiopaque marker points to the location at the septum region where the two legs diverge.  
   
   
       36 . The intraluminal prosthesis of  claim 35 , wherein there are two crimps each having radiopaque markers thereon, and wherein both of the markers point to the location at the septum region where the two legs diverge.  
   
   
       37 . The intraluminal prosthesis of  claim 25 , wherein a balloon-expandable wireform is positioned at the upper edge of the trunk.  
   
   
       38 . The intraluminal graft of  claim 25  wherein a self-expanding wireform is connected to the trouser graft in each of the two legs.  
   
   
       39 . The intraluminal prosthesis of  claim 25 , further including a tubular extension connected to a downstream end of at least one of the two legs.  
   
   
       40 . The intraluminal prosthesis of  claim 39 , wherein the tubular extension includes balloon-expandable wireforms and is placed inside the downstream end of the leg in such a manner that the self-expanding wireform in the leg exerts a radially inward force on the balloon-expandable wireform in the associated tubular extension.  
   
   
       41 . The intraluminal prosthesis of  claim 40 , wherein the tubular extensions include tubular bodies, the balloon-expandable wireforms being woven through the tubular bodies and having crimps positioned external to the tubular bodies, the crimps being positioned to interlock with the self-expanding wireforms on each of the two legs of the trouser graft body.  
   
   
       42 . The intraluminal prosthesis of  claim 41 , wherein the tubular extensions include a plurality of the balloon-expandable wireforms generally evenly spaced therealong, each of the wireforms having the crimps positioned external to the tubular bodies so as to increase frictional contact with a surrounding body lumen.  
   
   
       43 . An intraluminal prosthesis comprising: 
 a trouser graft having a trunk in an upstream direction and two legs diverging in a downstream direction from the trunk at a septum region, the trouser graft being formed of a graft body having an external surface and an internal surface;    one or more self-expanding wireforms connected to the trouser graft, wherein one of the self-expanding wireform is connected to the trouser graft at the septum region and wherein the wireform at the septum has a radiopaque marker attached thereto; and    at least one balloon-expandable wireform connected to the graft body at the upper edge of the trunk.    
   
   
       44 . An intraluminal prosthesis comprising: 
 a trouser graft having a trunk in an upstream direction and two legs diverging in a downstream direction from the trunk at a septum region, the trouser graft being formed of a graft body having an external surface and an internal surface;    one or more self-expanding wireforms connected to the trouser graft, wherein one of the self-expanding wireform is connected to the trouser graft at the septum region and wherein a self-expanding wireform is connected to the trouser graft in each of the two legs; and    at least one balloon-expandable wireform connected to the graft body at the upper edge of the trunk.