Prosthetic graft and method for aneurysm repair

• US 5,800,521 A
• Filed: 11/14/1996
• Issued: 09/01/1998
• Est. Priority Date: 11/09/1994
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Inventors: Orth, Geoffrey A.
• Primary Examiner(s): Clarke, Robert A.
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/749,082
• Time in Patent Office: 656 Days
• Field of Search: 623/1, 623/11, 623/12, 623/66, 606/108, 606/153, 606/155, 606/156, 606/158, 606/191-195, 606/198, 606/200, 128/898
• US Class Current: 623/1.23
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30172 T-shaped
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

This invention provides a method and graft system for aneurysm repair comprising a prosthetic graft with means to draw a distal extremity of the graft over a portion of an expandable anchoring member. Prior to deployment, the graft and the anchoring member do not overlap to reduce the outer diameter of the delivery system. Preferably, the drawing means comprises pull strands connected to the distal extremity of the graft so that the distal extremity of the graft may be pulled over a proximal portion of the anchoring member. Subsequent expansion of the anchoring member seals the overlapped graft against the vessel wall to minimize blood flow-by and secures the graft in the vessel. Securing means may be advanced up each pull strand to abut the anchoring member and further secure the graft to the anchoring member.

The graft may also comprise means to guide a second expandable anchoring member to the proximal end of the graft. Preferably, the guiding means comprise guide strands connected to a proximal extremity of the graft. The anchoring member can then be advanced up the guide strands until the graft overlaps the second anchoring member. Expansion of the second anchoring member secures the proximal end of the graft.

Claims

1. A graft delivery system comprising:

a) an elongated catheter with proximal and distal ends and a means for expanding an expandable anchoring member on a distal portion of the catheter;

b) an expandable anchoring member with proximal and distal ends mounted on the means for expanding;

c) an aortic graft in a radially compressed state with proximal and distal ends and mounted on the catheter proximally adjacent to, and non-overlapping the proximal end of, the anchoring member; and

d) drawing means secured to the distal end of the graft and configured to pull the distal end of the graft to overlap the proximal end of the anchoring member.

2. The graft delivery system of claim 1 wherein the catheter further comprises a lumen with an opening at the distal end and extending to the proximal end and the drawing means comprises at least one pull strand extending from the distal end of the graft through the opening at the distal end of the catheter to the proximal end of the catheter.

3. The graft delivery system of claim 2 wherein the pull strand is laced through the anchoring member.

4. The graft delivery system of claim 1 wherein the means for expanding an anchoring member comprises an inflatable member.

5. The graft delivery system of claim 4 including an inflation lumen extending through the catheter in fluid communication with the interior of the inflatable member.

6. The graft delivery system of claim 1 wherein the system has an outer diameter of less than about 7 mm.

7. The graft delivery system of claim 1 wherein the anchoring member comprises a stent.

8. The graft delivery system of claim 1 wherein the graft further comprises guiding means extending from the proximal end of the graft.

9. The graft delivery system of claim 8 wherein the guiding means comprise at least one guiding strand.

10. A graft delivery system comprising:

a) an elongated catheter with proximal and distal ends;

b) a self-expanding anchoring member with proximal and distal ends mounted on a distal portion of the catheter;

c) an aortic graft in a radially compressed state with proximal and distal ends and mounted on the catheter proximally adjacent to, and non-overlapping the proximal end of, the anchoring member; and

d) drawing means secured to the distal end of the graft and configured to pull the distal end of the graft to overlap the proximal end of the anchoring member.

11. The graft delivery system of claim 10 wherein the catheter further comprises a lumen with an opening at the distal end and extending to the proximal end and the drawing means comprise pull strands extending from the distal end of the graft through the opening at the distal end of the catheter to the proximal end of the catheter.

12. The graft delivery system of claim 11 wherein the pull strands are laced through the anchoring member.

13. The graft delivery system of claim 10 wherein the self-expanding anchoring member is formed from shape-memory material.

14. The graft delivery system of claim 13 wherein the anchoring member is formed from a NiTi alloy.

15. The graft delivery system of claim 10 wherein the graft further comprises guiding means extending from the proximal end of the graft.

16. The graft delivery system of claim 15 wherein the guiding means comprise at least one guiding strand.

17. A method for repairing a portion of a patient'"'"'s vasculature comprising the steps of:

a) providing a catheter assembly having;

1) an elongated catheter with proximal and distal ends and a means for expanding an expandable anchoring member on a distal portion of the catheter,

2) an expandable anchoring member with proximal and distal ends mounted on the expanding means,

3) an aortic graft in a radially compressed state with proximal and distal ends and mounted on the catheter proximally adjacent to, and non-overlapping the proximal end of, the anchoring member, and

4) drawing means secured to the distal end of the graft and configured to pull the distal end of the graft to overlap the proximal end of the anchoring member; and

b) advancing the catheter assembly with the graft to the desired location in the patient'"'"'s vasculature;

c) operating the drawing means to pull the distal end of the graft to overlap the proximal end of the anchoring member; and

d) expanding the anchoring member to expand and anchor the graft within the patient'"'"'s vasculature.

18. The method for repairing a portion of a patient'"'"'s vasculature of claim 17 further comprising the step of attaching securing means on drawing means abutting the anchoring means to anchor the graft.

19. The method for repairing a portion of a patient'"'"'s vasculature of claim 17 wherein the graft further comprises guiding means and further comprising the steps of:

a) lacing the guiding means through a second anchoring member;

b) advancing the second anchoring member along the guiding means through the patient'"'"'s vasculature until the second anchoring member is at least adjacent to the proximal end of the graft; and

c) expanding the second anchoring member to anchor the proximal end of the graft.

20. A method for repairing a portion of a patient'"'"'s vasculature comprising the steps of:

a) providing a catheter assembly having;

1) an elongated catheter with proximal and distal ends,

2) a self-expanding anchoring member with proximal and distal ends mounted on a distal portion of the catheter,

3) an aortic graft in a radially compressed state with proximal and distal ends and mounted on the catheter proximally adjacent to, and non-overlapping the proximal end of, the anchoring member, and

4) drawing means secured to the distal end of the graft and configured to pull the distal end of the graft to overlap the proximal end of the anchoring member; and

b) advancing the catheter assembly with the graft to the desired location in the patient'"'"'s vasculature;

c) operating the drawing means to pull the distal end of the graft to overlap the proximal end of the anchoring member; and

d) allowing the self-expanding anchoring member to expand and anchor the graft within the patient'"'"'s vasculature.

21. The method for repairing a portion of a patient'"'"'s vasculature of claim 20 further comprising the step of attaching securing means on drawing means abutting the anchoring means to anchor the graft.

22. The method for repairing a portion of a patient'"'"'s vasculature of claim 20 wherein the graft further comprises guiding means and further comprising the steps of:

a) lacing the guiding means through a second anchoring member;

b) advancing the second anchoring member along the guiding means through the patient'"'"'s vasculature until it is at least adjacent to the proximal end of the graft; and

c) expanding the second anchoring member to anchor the proximal end of the graft.