Method and apparatus for intraluminally implanting an endovascular aortic graft

• US 6,432,131 B1
• Filed: 08/20/1999
• Issued: 08/13/2002
• Est. Priority Date: 01/31/1995
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Ravenscroft, Adrian C.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/378,268
• Time in Patent Office: 1,089 Days
• Field of Search: 623/1.1, 623/1-3-, 623/1.36, 623/1.39, 623/1.44, 623/1.46, 623/1.49
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

An intraluminal prosthesis for intraluminal repair of body conduits, especially aortic aneurysms, is disclosed. The prosthesis includes a generally tubular, flexible graft (20) having a proximal open end (30) and at least one distal open end (31) terminating in a hem (33). A stent (21) can be disposed within the proximal open end (30) and is adapted to be attached to the body conduit (1). The hem (33) is inverted within the graft so that it is disposed as a cuff (34) within the graft. The hem (33) is arranged so that upon withdrawing the distal open end (31) from inside the cuff (34), the cuff will unfold and follow the distal open end to expose it to receive another stent for attachment to the body conduit (12) for intraluminal implantation of the graft. Preferably the hem is folded a second time within the cuff to form a second cuff (35) within the graft. The stents are preferably formed of a plexus of wires adapted to expand from a first narrow diameter to a second diameter to engage the body conduit. Also disclosed is a method of intraluminal implantation of the graft.

Claims

1. An intraluminal prosthesis for intraluminal repair of a proximal location within a body lumen from a distal location outside said body lumen, said prosthesis comprising:

a generally tubular, flexible graft having a proximal portion with a proximal open end having a first diameter and at least one leg having a distal open end having a second diameter smaller than said first diameter, wherein said at least one leg has a first distal portion adapted to be inverted proximally during introduction to the body lumen and to be extended distally when fully deployed; and

at least one stent disposed within and attached to said graft for anchoring said graft within said body lumen.

2. The prosthesis of claim 1, wherein the material of said graft is selected from the group consisting of:

polyester, polytetrafluoroethylene, and porous polyethylene urethane.

3. The prosthesis of claim 2, wherein said graft is coated with a coating.

4. The prosthesis of claim 3, wherein said material is polytetrafluoroethylene and said coating is polyester.

5. The prosthesis of claim 1, wherein said at least one leg is axially stretchable.

6. The prosthesis of claim 1, wherein said at least one leg comprises a plurality of legs wherein the lengths of said legs are equal.

7. The prosthesis of claim 1, wherein said at least one leg comprises a plurality of legs wherein the lengths of said legs are initially equal, but at least one leg is axially stretchable to a longer length.

8. The prosthesis of claim 1, wherein said first distal portion of said leg has a length adequate to be grasped by a catheter and intraluminally extended distally.

9. The prosthesis of claim 1, wherein said at least one leg has a second distal portion adapted to be inverted distally from said first distal portion.

10. The prosthesis of claim 1, wherein said at least one leg is tapered along the length toward the distal open end.

11. The prosthesis of claim 1, wherein said first distal portion has a diameter at its distal end equal to said second diameter, and an axial portion of said leg proximal said first distal portion has a diameter larger than said second diameter and smaller than said first diameter.

12. The prosthesis of claim 11, wherein the axial portion of said leg comprises a tapered diameter from said first diameter to said second diameter.

13. The prosthesis of claim 1, wherein:

said at least one leg has a second distal portion adapted to be inverted distally from said first distal portion, said second distal portion having a diameter equal to said second diameter and first distal portion having a third diameter greater than said second diameter; and

said at least one leg has an axial portion proximal said first distal portion having a fourth diameter greater than said third diameter and smaller than said first diameter.

14. The prosthesis of claim 13, wherein the axial portion of said leg proximal said first distal portion comprises a tapered diameter from said first diameter to said third diameter.

15. The prosthesis of claim 14, wherein said at least one leg comprises two legs.

16. The prosthesis of claim 15, wherein only one of said two legs is adapted to be inverted.

17. The prosthesis of claim 1, wherein said at least one stent comprises:

a first stent disposed within and attached to at least said first distal portion of said at least one leg including at said distal open end,

a second stent disposed within and attached to at least said proximal portion of said graft including at said proximal open end.

18. The prosthesis of claim 17, wherein said first stent protrudes distally from said distal open end and said second stent protrudes proximally from said proximal open end.

19. The prosthesis of claim 17, wherein said at least one leg comprises two legs, said first stent is disposed in one of said legs, and said at least one stent further comprises a third stent disposed in and attached to another of said legs.

20. The prosthesis of claim 1, wherein said at least one stent comprises a single, integral stent extending from said proximal open end to said distal open end of said graft.

21. The prosthesis of claim 20, wherein said stent protrudes proximally from said proximal open end and distally from said distal open end of said graft.

22. The prosthesis of claim 1, wherein said at least one stent is expandable from a first narrow diameter to a second wider diameter and comprises one of:

a plexus of wires adapted for expansion by an internal force, a self-expandable plexus of wires, or polymeric expandable structural members.

23. The prosthesis of claim 22 further comprising a polymeric composition in at least said first distal portion, said polymeric composition adapted to harden when expanded and activated by heat.

24. An intraluminal prosthesis for intraluminal repair of a proximal location within a body lumen from a distal location outside said body lumen, said prosthesis comprising:

a generally tubular, flexible graft having a proximal portion with a proximal open end and at least one leg having a distal open end and a first distal portion adapted to be inverted proximally and radially inwardly; and

at least one stent disposed within and attached to said graft for anchoring said graft within said body lumen.

25. The prosthesis of claim 24, wherein said at least one leg has a second distal portion adapted to be inverted distally and radially inwardly from said first distal portion.

26. A method of implanting a prosthesis for intraluminal repair of a proximal location within a body lumen from a distal location outside said body lumen, wherein said prosthesis comprises:

(a) a generally tubular, flexible graft having a proximal open end and at least one leg having a distal open end and a distal portion adapted to be inverted proximally and radially inwardly, with a polymeric composition in at least said distal portion, said polymeric composition adapted to harden when expanded and activated by heat; and

(b) at least one stent disposed within and attached to said graft for anchoring said graft within said body lumen, the method comprising;

inserting said prosthesis into said body lumen in said proximal location and expanding said at least one stent to anchor at least said proximal open end of said graft to said body lumen;

intraluminally engaging and withdrawing said distal portion, thereby extending said at least one leg distally; and

expanding and heating at least said distal portion to harden said polymeric composition and anchor said leg within said body lumen.

27. A method of intraluminally implanting a graft within an aorta, said method comprising:

intraluminally inserting in an iliac artery branching from said aorta a generally tubular, flexible graft with a proximal portion with a proximal open end and at least one leg having a distal open end and a first distal portion adapted to be inverted proximally and radially inwardly and with at least one stent disposed within and attached to said graft;

locating the proximal open end of said graft in a predetermined position within said aorta;

expanding said at least one stent at said proximal end to anchor the proximal open end of said graft within said aorta;

causing said distal portion of said leg to protrude distally from said proximal portion into an iliac artery; and

expanding said at least one stent at said distal end to anchor the distal open end of said graft within said iliac artery thereby implanting said graft.