Endovascular graft having bifurcation and apparatus and method for deploying the same

Abstract

Graft having a bifurcation for repairing an aneurysm in the vicinity of an aortic bifurcation in a patient comprising a main tubular body and first and second tubular legs joined to said main body in a bifurcation. The main body and the legs are formed of a flexible surgically implantable material. The main body and each of the first and second legs having an opening therein in communication with the other openings. Expandable spring attachments are secured to the main body adjacent the opening in the main body. An additional expandable spring attachment is secured to one of said legs adjacent the opening in said one leg.

1 . A graft having a bifurcation for repairing an aortic aneurysm close to or involving the aortic bifurcation in a patient comprising a main tubular body and first and second tubular legs joined to said main body in a bifurcation, said main body and said legs being formed of a flexible surgically implantable material, said main body and said first and second legs each having an opening therein in communication with the other openings, expandable anchor means secured to the main body adjacent the opening in the main body and additional expandable anchor means secured to one of said legs adjacent the opening in said one leg.  
     
     
         2 . A graft as in  claim 1  wherein said expandable anchor means and said additional expandable anchor means are in the forming spring attachment means, each having hook-like elements disposed outwardly therefrom adapted to come into engagement with the arterial wall of the patient.  
     
     
         3 . A graft as in  claim 1  together with a lead line removably connected to the other of said legs.  
     
     
         4 . A graft as in  claim 3  wherein said lead line includes a single line which is looped through said material forming said other leg and a knot formed in said pull line remote from said leg.  
     
     
         5 . A graft as in  claim 4  together with the flexible tubular member extending over said pull line into a region in close proximity to the other leg, means carried by said tubular member engaging said knot to prevent said tubular member from accidentally being removed from said pull line, said flexible tubular member having cutout therein.  
     
     
         6 . In a major deployment device, a capsule catheter and a balloon catheter, said capsule catheter comprising a flexible elongate tubular member having proximal and distal extremities, a flexible capsule mounted on the distal extremity of the flexible elongate tubular member, said capsule having an open end, a graft disposed within the capsule, said balloon catheter comprising a flexible elongate tubular member having proximal and distal extremities, balloon secured to the distal extremity of the flexible elongated tubular member of the balloon catheter, said flexible elongated tubular member of the balloon catheter extending through the graft and through the capsule in which the graft is disposed and through the flexible elongated tubular member secured to the capsule, retention means carried by the flexible elongated tubular member of the balloon catheter and engaging the graft, a control mechanism having a handle adapted to be grasped by a human hand and having first and second parts movable relative to each other, means for securing the flexible elongate tubular member of the capsule catheter to the first part, said flexible elongate tubular member of the balloon catheter extending through said first part and through said control mechanism and means carried by the control mechanism for causing movement of the first part with respect to the second part to thereby permit the capsule to be withdrawn from over the graft and permitting the retention means to retain the graft in a position so that it is ejected from the capsule as the first part is moved relative to the second part.  
     
     
         7 . A device as in  claim 6  wherein said graft has expandable anchor means capable of moving outwardly as soon as the expandable anchor means clears the capsule.  
     
     
         8 . A device as in  claim 6  wherein said means for causing relative movement between the first and second parts includes a rack and pinion.  
     
     
         9 . A device as in  claim 6  wherein said control mechanism includes means for preventing longitudinal movement of the flexible elongate tubular member of the balloon catheter relative to the control mechanism.  
     
     
         10 . A device as in  claim 9  wherein said control mechanism includes means for operating on said means for preventing longitudinal movement of the flexible elongate tubular member of the balloon catheter to permit longitudinal movement of the flexible elongate tubular member of the balloon catheter relative to the control mechanism.  
     
     
         11 . A device as in  claim 6  wherein said graft is in the form of a main body and first and second legs adjoining the main body and extending away from the main body to provide a bifurcation, one of said legs being folded over and lying generally parallel to the main body when the graft is disposed within the capsule.  
     
     
         12 . A device as in  claim 11  together with a lead tube connected to the folded-over leg and extending out of said capsule.  
     
     
         13 . A device as in  claim 12  together with a single pull line secured to said leg and extending through said leg and having its free ends knotted together, said lead tube extending over the pull line into the vicinity of said capsule and means formed in the tube engaging the knot to prevent the lead tube from being pulled off of the pull line.  
     
     
         14 . A device as in  claim 13  wherein said lead tube is provided with a cutout proximal of the knot.  
     
     
         15 . In a minor deployment device, a capsule catheter and a balloon catheter, said capsule catheter comprising a flexible elongated tubular element having proximal and distal extremities, a capsule secured to the distal extremity, a fitting provided on the proximal extremity, the balloon catheter comprising a flexible elongate tubular element having proximal and distal extremities, a balloon carried by the distal extremity, the balloon being disposed distally of the capsule and having the flexible elongate tubular member of the balloon catheter extending through the capsule and through the flexible elongate tubular member of the capsule catheter and a fitting mounted on the proximal extremity of the flexible elongate tubular member of the balloon catheter for inflating and deflating the balloon, said flexible elongate tubular member of the catheter having retention means provided thereon and disposed within the capsule, and an expandable spring attachment means disposed within the capsule and being in engagement with the retention means.  
     
     
         16 . A minor deployment device as in  claim 15  together with a guide wire extending through the balloon catheter.  
     
     
         17 . In a method for deploying a graft having bifurcation with a main body and first and second legs for deployment across an aortic bifurcation of a patient to repair an aneurysm close to or involving the aortic bifurcation and the associated first and second iliac arteries, folding the second leg of the graft so it lies substantially parallel to the main body of the graft to provide a folded-over second leg, introducing the graft with the folded-over second leg through the first iliac artery until the graft is disposed proximal of the bifurcation, securing the proximal extremity of the graft with the first leg of the graft being disposed in the first iliac artery, pulling down the folded-over second leg into the second iliac artery, securing the distal extremity of the first leg in the first iliac artery and thereafter securing the second leg of the graft in the second iliac artery.  
     
     
         18 . A method as in  claim 17  wherein said folded-over leg is provided with a lead tube, the steps of using the lead tube to pull the folded-over second leg into the second iliac artery.  
     
     
         19 . A method as in  claim 18  wherein the graft is provided with an opening in the main body and an opening in each of the legs together with expandable spring attachment means secured to the graft in the vicinity of the opening in the main body and additional expandable spring attachment means secured to the first leg of the graft adjacent the opening of the leg, together with a capsule catheter having a flexible elongate tubular member with proximal and distal extremities and with a capsule mounted on the distal extremity and having an open end, together with a balloon catheter having an inflatable balloon, and a deployment device with a supplemental expandable spring attachment disposed therein, said graft being disposed in said capsule so that the first named and additional expandable spring attachment means are disposed within the capsule, the steps of introducing the capsule into the arterial vessel of the patient so that the distal extremity of the capsule is disposed proximal to the aortic bifurcation and proximal of the proximal extremity of the aneurysm, withdrawing the capsule while retaining the graft therein stationary to cause the expandable spring attachment means in the vicinity of the opening in the main body to be ejected from the capsule to permit the expandable spring attachment means to expand, retracting the balloon catheter so that the balloon is disposed in the first named expandable spring attachment means, inflating the balloon to urge the first named expandable spring attachment means into engagement with the wall of the aorta, further withdrawing the capsule so that the folded over second leg clears the capsule, pulling down the folded-over second leg into the second iliac artery, still further withdrawing the capsule until the additional spring attachment means carried by the first leg of the graft clears the capsule and is permitted to expand, deflating the balloon of the balloon catheter, bringing the deflated balloon into the additional expandable spring attachment means, expanding the balloon to urge the additional expandable spring attachment means into engagement with the wall of the first iliac artery, using a deployment device to introduce supplemental expandable spring attachment means into the second iliac artery and into the second leg of the graft, urging the supplemental expandable spring attachment means out of the deployment device and permitting the supplemental expandable spring attachment means to expand into engagement with the graft and into the wall of the second iliac artery and removing the capsule catheter and the balloon catheter.  
     
     
         20 . A method as in  claim 19  together with an additional balloon catheter, and including the steps of advancing the additional balloon catheter into the supplemental expandable spring attachment means, expanding the balloon into engagement with the supplemental spring attachment means to urge the supplemental spring attachment means into engagement with the second leg of the graft and the wall of the second iliac artery, removing the additional balloon catheter and removing the lead tube.