Invertible bifurcated stent/graft and method of deployment

• US 5,904,713 A
• Filed: 07/14/1997
• Issued: 05/18/1999
• Est. Priority Date: 07/14/1997
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation), Datascope Corporation (Getinge AB)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Leschinsky, Boris
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/892,410
• Time in Patent Office: 673 Days
• Field of Search: 623/1, 623/11, 623/12
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels

Abstract

A single-piece bifurcated graft for insertion into the femoral artery and further into the aorta with approximately one half of the graft inverted inside out after positioning within the artery. There is no central section like other bifurcated grafts. Instead, two bifurcated sections are joined at the top. Upon introduction, the graft is attached to the aortic wall in the middle section, the vicinity of the renal arteries, and the inversion process takes place. This process allows deployment of the second half of the graft into its final inverted position. While stents are located only at the openings of the graft, additional stents may be deployed inside the graft if necessary.

Claims

1. A graft device comprising a first tubular leg and a second tubular leg each having a top end and a bottom end the top end, of the first leg and the bottom end of the second leg are partially connected along a septum, the first leg and the second leg are substantially parallel, the second leg is capable of inversion, upon deployment the second leg is inverted and the first leg and the second leg are substantially parallel and are side by side and the length of the graft device extends substantially from the septum to the bottom end of the first leg or substantially from the septum to the top of the second leg.

2. The graft device as claimed in claim 1 further comprising fixation means for fixing the top end and the bottom end of the first leg and the second leg within a vessel.

3. The graft device as claimed in claim 1 further comprising stents for fixing the top end and the bottom end of the first leg and the second leg within a vessel.

4. The graft device as claimed in claim 1 wherein the first leg and the second leg each have a D-shape cross sectional area comprising a flat portion and a curved portion and wherein the septum is flat, upon inversion of the second leg the first leg and the second leg together have a substantially round cross section and assume the cross sectional shape of the vessel.

5. The graft device as claimed in claim 1 wherein the first leg and the second leg each have a D-shape cross sectional area comprising a flat portion and a curved portion and wherein the septum is flat, upon inversion of the second leg the first leg and the second leg together have a substantially round cross section and assume the cross sectional shape of the vessel, and wherein the first leg and the second leg are tapered such that the cross sectional area of the bottom end of the first leg is smaller than that of the top end of the first leg and the cross sectional area of the top end of the second leg is smaller than that of the bottom end of the second leg.

6. A graft device for insertion into a bifurcated vessel comprising a first tubular leg and a second tubular leg each having a top end and a bottom end, and fixation devices for fixing the top end and the bottom end of the first leg and the second leg within the vessel, the top end of the first leg and the bottom end of the second leg are partially connected along a flat septum, the first leg and the second leg are substantially parallel and do not communicate, the second leg is capable of inversion, upon inversion of the second leg the first leg and the second leg are substantially parallel and are side by side, the first leg and the second leg each have a D-shape cross sectional area comprising a flat portion and a curved portion, upon inversion of the second leg the first leg and the second leg together have a substantially round cross section and assume the cross sectional shape of the vessel, the first leg and the second leg are tapered such that the cross sectional area of the bottom end of the first leg is smaller than that of the top end of the first leg and the cross sectional area of the top end of the second leg is smaller than that of the bottom end of the second leg.

7. A method for bridging a bifurcated aneurysm in a blood vessel with a graft device comprising a first tubular leg and a second tubular leg each having a top end and a bottom end, and fixation means for fixing the top end and the bottom end of the first leg and the second leg within the vessel, the top end of the first leg and the bottom end of the second leg are partially connected along a flat septum, the first leg and the second leg are substantially parallel, the second leg is capable of inversion, upon inversion of the second leg the first leg and the second leg are substantially parallel and are side by side and the length of the graft device extends substantially from the septum to the bottom end of the first leg or substantially from the septum to the top end of the second leg, comprising the steps of:

(a) percutaneously inserting the graft device into a first leg of the bifurcated blood vessel;

(b) deploying fixation means at the bottom end and the top end of the fist leg which is downstream of the second leg;

(c) inverting the second leg of the graft device;

(d) deploying the fixation means in the bottom end and the top end of the inverted second leg.

8. The method for bridging a bifurcated aneurysm in a blood vessel as claimed in claim 7 wherein the fixation means comprises stents.