Balloon-tipped, multi-lumen catheter for endoluminal repair of endoluminal leaks in aortic or aorto-iliac endoluminal grafts

• US 7,105,031 B2
• Filed: 04/26/2002
• Issued: 09/12/2006
• Est. Priority Date: 04/26/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Letort, Michel
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): WEBB, SARAH K
• Application Number:
  US10/133,102
• Publication Number:
  US 20030204236A1
• Time in Patent Office: 1,600 Days
• Field of Search: 604/103.02, 604/103.07, 604/103.08, 604/508, 604/96.01, 606/194, 606/108, 128/898, 623 111- 154, 623/903
• US Class Current: 604/194
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

An endoluminal graft repair device includes a multi-lumen catheter with a balloon coupled to a distal end portion of the catheter. A portion of the outer surface of the balloon is designed and configured to define a repair cavity. A repair cavity lumen of the catheter is coupled to and in fluid communication with the repair cavity. The catheter and balloon are inserted into an artery system, advanced and positioned interluminally through percutaneous procedures so that the repair cavity is positioned to substantially align with the location of an endoluminal leak in an endoluminal graft used to treat aortic aneurysmal disease. The balloon is inflated by injecting an inflation fluid through an inflation lumen of the catheter into the balloon to fix the position of the repair cavity substantially adjacent the location of the endoluminal leak. A repair agent is conveyed to the repair cavity through the repair cavity lumen. The repair agent is contained by the repair cavity, solidifies in situ, and forms a patch on the endoluminal graft at the location of the endoluminal leak. After removal of the catheter, the repair agent patch remains on the endoluminal graft to repair the endoluminal leak.

Claims

1. A method of repairing an endoluminal leak through a tubular graft comprising:

forming, inside said tubular graft, a repair cavity about said endoluminal leak so that said endoluminal leak is isolated from blood flow,

wherein a perimeter edge of said repair cavity contacts an inner wall of said tubular graft to define a surface area on said inner wall;

said inner wall has an inner wall circumference; and

said surface area extends circumferentially around said inner wall less than said inner wall circumference so that said repair cavity does not extend circumferentially around said inner wall of said graft;

verifying said repair cavity is positioned about said endoluminal leak by injecting a test fluid into said repair cavity and determining whether said test fluid leaks through said graft;

verifying a seal about said perimeter edge of said repair cavity by determining whether said test fluid leaks into a lumen containing said graft;

rinsing said repair cavity after said verifying operations are successful; and

injecting, after said rinsing said repair cavity, a repair agent into said repair cavity to seal said endoluminal leak thereby repairing said endoluminal leak.

2. A method of repairing an endoluminal leak through a graft comprising:

positioning an outer balloon surface repair cavity portion of a balloon adjacent to a location of said endoluminal leak through said graft, wherein said outer balloon surface repair cavity portion extends between an outer perimeter edge of repair cavity portion and an inner perimeter edge of said repair cavity and further wherein said outer perimeter edge extends less than a circumference of an outer balloon surface of said balloon;

inflating said balloon,

wherein said outer balloon surface repair cavity portion defines a repair cavity about said endoluminal leak so that upon said repair cavity being properly positioned, said outer perimeter edge of repair cavity portion contacts said graft about said endoluminal leak to seal said repair cavity, and said endoluminal leak is isolated from blood flow; and

said outer balloon surface, not including said repair cavity portion, extending in a longitudinal direction of said graft and substantially parallel to an inner wall of said graft, circumferentially contacts said inner wall of said graft along a complete extent of said outer balloon surface, extending in said longitudinal direction of said graft and substantially parallel to an inner wall of said graft, to seal a lumen containing said graft and to provide a stable work platform for repairing said endoluminal leak;

rinsing said repair cavity; and

injecting a repair agent into said repair cavity to seal said endoluminal leak thereby repairing said endoluminal leak.

3. The method of claim 2 wherein said positioning further comprises:

positioning said outer balloon surface repair cavity portion axially adjacent to said location of said endoluminal leak.

4. The method of claim 2 wherein said positioning further comprises:

positioning said outer balloon surface repair cavity portion rotationally adjacent to said location of said endoluminal leak.

5. The method of claim 3 wherein said positioning further comprises:

positioning said outer balloon surface repair cavity portion rotationally adjacent to said location of said endoluminal leak.

6. The method of claim 2 further comprising:

verifying, following said inflating, that an inflation cavity of said balloon is fluidtight.

7. The method of claim 2 further comprising:

injecting a test fluid into said repair cavity prior to said injecting said repair agent.

8. The method of claim 7 further comprising:

verifying that said positioning is correct by verifying a leak of said test fluid through said graft; and

verifying said seal by determining whether there is a leak of said test fluid into a lumen containing said graft.

9. The method of claim 2 further comprising:

verifying said repairing of said endoluminal leak.