Delivery catheter and graft for aneurysm repair

• US 5,769,887 A
• Filed: 01/17/1997
• Issued: 06/23/1998
• 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., Cannon, James M Jr., Brown, Peter S.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/785,198
• Time in Patent Office: 522 Days
• Field of Search: 623/1, 623/12, 606/194, 606/195, 606/198
• US Class Current: 623/1.23
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/30172 T-shaped
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0052 T-shaped

Abstract

This invention provides a graft delivery system and methods for its use comprising a prosthetic graft secured to an expandable anchoring member, such as a stent, by a butt-joint attachment means to minimize the system'"'"'s profile. The delivery system employs a catheter with a relatively small diameter shaft for flexibility and a relatively large diameter delivery base for supporting expansion of the anchoring member. The butt-joint attachment means comprises any means suitable to secure the graft to the anchoring member when deployed within the patient'"'"'s vasculature and allows the anchoring member and graft to expand during deployment. In a preferred embodiment, the delivery system is configured so that the expansion of the anchoring member pulls the distal end of the graft over the proximal end of the anchoring member and the final expansion of the anchoring member seals the distal end of the graft between the proximal end of the anchoring member and the vessel. One preferred method of use is to deploy a second anchoring member coaxially within the already deployed first anchoring member and graft assembly, overlapping at least the distal end of the graft in order to further secure the graft and minimize flow by.

Claims

1. A graft delivery system comprising:

a) a catheter having an elongated shaft and a delivery base on a distal portion of the elongated shaft;

b) a graft having proximal and distal ends, the graft mounted in a compressed state on the elongated shaft;

c) an anchoring member mounted on the delivery base and having proximal and distal ends, first and second expanding portions and attachment means, the second expanding portion disposed between the first expanding portion and the proximal end of the anchoring member, the attachment means coupling the graft to the first expanding portion so that expansion of the first expanding portion causes the attachment means to pull the distal end of the graft over the second expanding portion; and

d) means on the delivery base for expanding the anchoring member.

2. The graft delivery system of claim 1 wherein the attachment means comprises a plurality of staples radially disposed around the anchoring member having means for engaging the graft.

3. The graft delivery system of claim 2 wherein the means for engaging the graft comprise hooks or T-bars.

4. The graft delivery system of claim 1 wherein the first expanding portion comprises a plurality of sinusoidal circular expanding members.

5. The graft delivery system of claim 1 wherein the anchoring member is configured so that the distal end expands before the proximal end.

6. The graft delivery system of claim 1 wherein the means for expanding the anchoring member expands the distal end of the anchoring member before the proximal end.

7. The graft delivery system of claim 1 wherein the means for expanding comprises an inflatable balloon, and an inflation lumen extending through the elongated shaft in fluid communication with the interior of the inflatable balloon and the inflation lumen.

8. The graft delivery system of claim 1 wherein the diameter of the delivery base is from about 1.1 to about 4.0 times greater than the diameter of the elongated shaft.

9. A kit for deploying a graft to repair a portion of a patient'"'"'s aorta comprising:

a) a delivery catheter comprising a catheter having an elongated shaft, a delivery base on a distal portion of the elongated shaft and means for deploying the graft within the aorta;

b) an aortic graft having proximal and distal ends and configured to be disposed about the elongated shaft when in a compressed state; and

c) an anchoring member configured to be disposed on the delivery base, the anchoring member having proximal and distal ends, first and second expanding portions and attachment means, the second expanding portion disposed between the first expanding portion and the proximal end of the anchoring member, the attachment means configured to couple the aortic graft to the first expanding portion so that expansion of the first expanding portion causes the attachment means to pull the distal end of the aortic graft over the second expanding portion.

10. The kit of claim 9 wherein the deploying means comprises an inflatable balloon and an inflation lumen extending through the elongated shaft in fluid communication with the interior of the inflatable balloon and the inflation lumen.

11. The kit of claim 9 wherein the elongated shaft has a first outer diameter and the delivery base has a second outer diameter larger than the first outer diameter, the second outer being from about 1.1 to about 4.0 times greater than the diameter of the first outer diameter.

12. The kit of claim 9 wherein the attachment means comprises a plurality of staples radially disposed around the anchoring member having means for engaging the graft.

13. The kit of claim 12 wherein the means for engaging the graft comprise hooks or T-bars.

14. The kit of claim 9 wherein the first expanding portion comprises a sinusoidal circular expanding member.