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.

What is claimed is:  
     
         1 . An intraluminal prosthesis comprising: 
 a trouser graft having a trunk and two trunk legs diverging in a downstream direction from the trunk at a septum region, wherein the trouser graft is attachable at its upstream end to an aorta;    wherein the trouser graft is of a specified length and at least a first trunk leg is of a specified length so that upon attachment of the trouser graft to the aorta the septum region and the first trunk leg are locatable upstream from the aortic bifurcation;    wherein the trunk comprises a first trunk diameter at its upstream end conformable to the diameter of the aorta where it will be attached and a second trunk diameter at its downstream end which is different from the first trunk diameter and wherein each trunk leg has a trunk leg diameter; and    a tubular extension overlappingly connectable to a downstream end of the first trunk leg, at least a portion of the tubular extension having a tubular extension diameter conformable to the first trunk leg diameter to provide a consistent interface therewith.    
     
     
         2 . The intraluminal prosthesis of  claim 1  wherein the first trunk diameter is greater than the second trunk diameter and the trunk steps down between its upstream and downstream ends.  
     
     
         3 . The intraluminal prosthesis of  claim 1  wherein the first trunk diameter is greater than the second trunk diameter and the trunk tapers at least along a portion of its length between its upstream and downstream ends.  
     
     
         4 . The intraluminal prosthesis of  claim 1  wherein the first trunk diameter is less than the second trunk diameter and the trunk steps up between its upstream and downstream ends.  
     
     
         5 . The intraluminal prosthesis of  claim 1  wherein the first trunk diameter is less than the second trunk diameter and the trunk tapers at least along a portion of its length between its upstream and downstream ends.  
     
     
         6 . The intraluminal prosthesis of  claim 1  wherein the tubular extension diameter is substantially uniform throughout its length.  
     
     
         7 . The intraluminal prosthesis of  claim 1  wherein the tubular extension has a first tubular extension diameter at an upstream end which is conformable to the trunk leg diameter to provide a consistent interface therewith and a second tubular extension diameter at a downstream end which is conformable to the diameter of a vessel to which it will be attached.  
     
     
         8 . The intraluminal prosthesis of  claim 7  wherein the first tubular extension diameter is greater than the second tubular extension diameter and the tubular extension steps down between the upstream and downstream ends.  
     
     
         9 . The intraluminal prosthesis of  claim 7  wherein the first tubular extension diameter is greater than the second tubular extension diameter and the tubular extension tapers at least along a portion of its length between the upstream and downstream ends.  
     
     
         10 . The intraluminal prosthesis of  claim 7  wherein the first tubular extension diameter is less than the second tubular extension diameter and the tubular extension steps up between the upstream and downstream ends.  
     
     
         11 . The intraluminal prosthesis of  claim 7  wherein the first tubular extension diameter is less than the second tubular extension diameter and the tubular extension tapers at least along a portion of its length between the upstream and downstream ends.  
     
     
         12 . The intraluminal prosthesis of  claim 1  wherein the two trunk legs are circular in cross-section and the combined diameters of their respective trunk leg diameters is equal to the second trunk diameter.  
     
     
         13 . The intraluminal prosthesis of  claim 12  wherein the second trunk diameter is 26 mm and the trunk leg diameter of each trunk leg is 13 mm.  
     
     
         14 . The intraluminal prosthesis of  claim 1  wherein the trouser graft further comprises one or more expandable wireforms at its upstream end attachable to an aorta.  
     
     
         15 . An intraluminal prosthesis comprising: 
 a trouser graft having a trunk and two trunk legs diverging in a downstream direction from the trunk at a septum region, wherein the trouser graft is formed of a graft body having an external surface and an internal surface and comprises one or more expandable wireforms at its upstream end attachable to an aorta;    wherein the trouser graft is of a specified length so that upon attachment of the trouser graft to the aorta the septum region is locatable upstream from an aortic bifurcation and at least a first trunk leg is of a specified length so that upon attachment of the trouser graft to the aorta the first trunk leg is locatable upstream from the aortic bifurcation;    wherein the trunk has a circular cross-section and comprises a first trunk diameter at its upstream end conformable to the diameter of the aorta to which it will be attached and a second trunk diameter at its downstream end which is different from the first trunk diameter and wherein each trunk leg has a trunk leg diameter; and    a tubular extension overlappingly connectable to a downstream end of the first trunk leg, the tubular extension having a first tubular extension diameter at an upstream end which is conformable to the trunk leg diameter to provide a consistent interface therewith and a second tubular extension diameter at a downstream end which is conformable to the diameter of a vessel to which it will be attached.    
     
     
         16 . A method of implanting a modular intraluminal prosthesis while providing for a consistent interface between the modular components of the prosthesis comprising the following steps: 
 determining a main vessel diameter and a branch vessel diameter;    providing a bifurcated graft comprising a first trunk diameter at an upstream end which will conform to the main vessel diameter and a second trunk diameter at a downstream end which is different from the first trunk diameter, the bifurcated graft further comprising two trunk legs diverging in a downstream direction from the trunk at a septum region, each trunk leg having a standardized trunk leg diameter;    endoluminally delivering the bifurcated graft to an implantation site and expanding the bifurcated graft so that the upstream end of the bifurcated graft is in contact with the main vessel;    providing a tubular extension with at least a portion of the tubular extension having a standardized tubular extension diameter which will conform to the standardized trunk leg diameter;    endoluminally delivering the tubular extension into position to overlappingly fit into a downstream end of one of the two trunk legs; and    expanding the tubular extension so that the portion of the tubular extension having the standardized tubular extension diameter overlappingly connects to the downstream end of the one of the two trunk legs to provide a consistent interface therewith.    
     
     
         17 . The method of  claim 16  wherein the step of expanding the tubular extension further comprises expanding the tubular extension with a balloon catheter.  
     
     
         18 . The method of  claim 16  wherein the bifurcated graft provided has a first trunk diameter which is greater than the second trunk diameter and the trunk steps down between the upstream and downstream ends.  
     
     
         19 . The method of  claim 16  wherein the bifurcated graft provided has a first trunk diameter which is greater than the second trunk diameter and the trunk tapers at least along a portion of its length between the upstream and downstream ends.  
     
     
         20 . The method of  claim 16  wherein the bifurcated graft provided has a first trunk diameter which is less than the second trunk diameter and the trunk steps up between the upstream and downstream ends.  
     
     
         21 . The method of  claim 16  wherein the bifurcated graft provided has a first trunk diameter which is less than the second trunk diameter and the trunk tapers at least along a portion of its length between the upstream and downstream ends.  
     
     
         22 . The method of  claim 16:   wherein the step of providing a tubular extension further comprises providing a tubular extension having a first tubular extension diameter at a first end which will conform to the standardized trunk leg diameter and a second tubular extension diameter at a second end which will conform to the branch vessel diameter; and    wherein the step of expanding the tubular extension further comprises expanding the tubular extension so that the first end of the tubular extension overlappingly connects to the downstream end of the one of the two trunk legs and the second end of the tubular extension is in contact with the branch vessel.    
     
     
         23 . The method of  claim 22  wherein the step of expanding the tubular extension comprises expanding the tubular extension with a balloon catheter.  
     
     
         24 . A method of implanting a modular intraluminal prosthesis while providing for a consistent interface between the modular components of the prosthesis comprising the following steps: 
 determining a main vessel diameter and a branch vessel diameter;    providing a bifurcated graft comprising a first trunk diameter at an upstream end which will conform to the main vessel diameter and a second trunk diameter at a downstream end which is different from the first trunk diameter, the bifurcated graft further comprising two trunk legs diverging in a downstream direction from the trunk at a septum region, each trunk leg having a standardized trunk leg diameter and at least a first trunk leg being of a specified length;    endoluminally delivering the bifurcated graft to an implantation site and expanding the bifurcated graft so that the upstream end of the bifurcated graft is in contact with the main vessel while the septum region and the first trunk leg of the bifurcated graft are located upstream from a bifurcation of the main vessel into the branch vessel;    providing a tubular extension having a first standardized tubular extension diameter at a first end which will conform to the standardized trunk leg diameter and a second tubular extension diameter at a second end which will conform to the branch vessel diameter;    endoluminally delivering the tubular extension to an implantation site and expanding the tubular extension such that the first end of the tubular extension with the standardized tubular extension diameter overlappingly connects to the downstream end of the first trunk leg with the standardized trunk leg diameter and the second end of the tubular extension is in contact with the branch vessel.