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

Claim 2

A graft device having a bifurcation for repairing an aortic aneurysm close to or involving the aortic bifurcation having an arterial wall in a patient, said device 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 having respectively first, second and third openings therein in communication with each other, expandable anchor means secured to said main body adjacent the first opening and additional expandable anchor means secured to said first leg adjacent the second opening.

Claim 3

A graft device as claimed in Claim 1 wherein said expandable anchor means and said additional expandable 00 anchor means are in the form of a spring attachment means, each oO.e having hook-like elements disposed outwardly therefrom adapted to came into engagement with the arterial wall of the patient.

Claim 4

A graft device as claimed in Claims 1 or 2 further including a lead line removably connected to said second leg. 25 4. A graft device as claimed in Claim 3 wherein oooo 0. said lead line includes a single line which is looped through said material forming said second leg and a knot formed in said pull line remote from said leg.

Claim 5

A graft device as claimed in Claim 4 further including a flexible tubular member extending over said pull line into a region in close proximity to said second 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 an aperture therein.

Claim 6

A graft device as in any one of the preceding claims, wherein said main body includes a plurality of Q \0 IIU'A(J( A )V VVJ6 -21 longitudinally spaced apart radiopaque marker means mounted thereon.

Claim 7

A graft device as in any one of the preceding claims, wherein a plurality of longitudinally spaced apart radiopaque markers are carried by each of said first and second tubular legs.

Claim 8

An endovascular graft suitable for residence in the vasculature of a patient for repairing an aortic aneurysm proximate the aortic bifurcation, comprising: a. support means having a bifurcation with a main body and first and second 10 tabular bodies for reinforcing the aortic bifurcation proximate the aneurysm to prevent rupture, said support means in fluid communication with the vasculature; b. a plurality of expandable anchoring means for attaching said support means to S the vasculature and for forming a substantially fluid-tight seal with the vasculature; and c. marker means for positioning said support means in the aortic bifurcation relative to the aneurysm so that said anchoring means may be affixed to healthy vasculature c. tissue on either side of said aneurysm.

Claim 9

An endovascular graft suitable for residence in the vasculature of a patient for repairing an aortic aneurysm proximate the aortic bifurcation, comprising: a. support means having a bifurcation with a main body and first and second 10 tabular bodies for reinforcing the aortic bifurcation proximate the aneurysm to prevent rupture, said support means in fluid communication with the vasculature; b. a plurality of expandable anchoring means for attaching said support means to S the vasculature and for forming a substantially fluid-tight seal with the vasculature; and c. marker means for positioning said support means in the aortic bifurcation relative to the aneurysm so that said anchoring means may be affixed to healthy vasculature c. tissue on either side of said aneurysm.

Claim 10

The endovascular graft of claim 8 wherein said marker means comprise a plurality of 20 aligned, spaced apart radiopaque markers attached to said support means so that the graft can 20 be properly located relative to the aneurysm and to allow correction of any twisting of said support means. An endovascular graft for attachment in a patient's vasculature for repairing an aortic aneurysm proximate to the aortic bifurcation, comprising: a. a main tubular body having a proximal end; b. first and second tubular members each having proximal ends and each joined to and in fluid communication with said main tubular body; c. expandable anchoring means for anchoring said main tubular body at its proximal end to the vasculature; d. means for anchoring each of said first and second tubular members at their respective distal ends to the vasculature, said anchoring means providing a substantially fluid- 80 9L I 1,51AI4M -22- tight seal between the vasculature and the graft so that there is fluid communication between the vasculature and said main tubular body and said first and second tubular members.

Claim 11

The endovascular graft of claim 10 wherein each of said anchoring means includes a self-expanding spring means having a plurality of hooks which forcibly engage the patient's vasculature when said spring means self-expands.

Claim 12

The endovascular graft of claim 11 wherein said spring means has a low-profile collapsed diameter permitting free movement in the vasculature and, after it self-expands, an expanded diameter that is substantially the same as or larger than the inside diameter of the patient's vasculature thereby creating a substantially fluid-tight seal.

Claim 13

The endovascular graft of any one of claims 10 through 12 wherein said first and second tubular members are of substantially the same length.

Claim 14

An endovascular graft for attachment in a patient's vasculature for repairing an aortic aneurysm proximate to the aortic bifurcation, comprising: o S S *SSS*S o* a. a main tubular body having a proximal end and extending proximally to the aortic bifurcation; b. first and second tubular members each having proximal ends and each joined to and in fluid communication with said main tubular body, said first tubular member extending distally into the first iliac artery and said second tubular member extending distally into the second iliac artery; c. means for anchoring said main tubular body at its proximal end to the vasculature; d. means for anchoring each of said first and second tubular members at their respective distal ends to the vascul.f,ure, said anchoring means providing a substantially fluid-tight seal between the vasculature and the graft so that there is fluid communication between the vasculature and said 15 main tubular body and said first and second tubular members. e 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 e* 20 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 tne 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. A method as in Claim *6Awherein 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. A method as in Claim -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 ar- 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, 25 inflating the balloon to urge the first named expandable spring o*ee 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. 17 A method as in Claim k* 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 15 removing the lead tube. l A method for positioning an endovascular graft suitable for residence in the vasculature of a patient for repairing an aortic aneurysm proximate the aortic bifurcation, the graft having a main tubular body and first and second tubular members joined thereto, the method comprising: inserting the graft into the femoral artery; locating the graft adjacent the aneurysm near the aortic bifurcation; 25 adjusting the position of the graft relative to tne aortic aneurysm; anchoring the proximal end of the main tubular member in healthy tissue on one side of the aortic aneurysm; positioning the first and second tubular members in respective first and second iliac arteries; anchoring the distal ends of the first and second tubular members to the respective first and second iliac arteries; and providing a substantially fluid-tight seal at each anchor point so that the graft is in fluid communication with the vasculature and iliac arteries. s The method of claim 34/ further comprising the step: ':\OI1R\C(1'\lr5-9213- 1S/t19 -26- visually inspecting a plurality of radiopaque markers located on the graft by using fluoroscopic means to determine if the graft is twisted or misaligned.

Claim 15

The method of claim 20, further comprising the step: realigning any twisted segments of the graft so that an unobstructed flow of fluid results.

Claim 16

A graft device having a bifurcation substantially as hereinbefore described with reference to the accompanying drawings.

Claim 17

A graft device having a bifurcation substantially as hereinbefore described with reference to the accompanying drawings.