Single puncture bifurcation graft deployment system

• US 8,167,925 B2
• Filed: 03/25/2010
• Issued: 05/01/2012
• Est. Priority Date: 03/11/1999
• Status: Expired due to Fees

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Shaolian, Samuel M., Madrid, Gilbert, Pham, To Van, Pham, Trinh Van, Nguyen, Thanh Van
• Primary Examiner(s): Bui, Vy Q.
• Application Number:
  US12/732,095
• Publication Number:
  US 20100179638A1
• Time in Patent Office: 768 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/1.35, 606/108, 606/194, 606/195, 606/198
• US Class Current: 623/1.11
• 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 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

The present invention relates to the endoluminal repair of abdominal aortic aneurysms at the aortic and iliac bifurcation. In particular, a deployment system and graft are disclosed for deploying the bifurcated graft within both iliac branches, as well as the aortic trunk, from a single vascular access.

Claims

1. A graft deployment system, comprising:

an elongate, flexible catheter body, having a proximal end and a distal end;

a main vessel graft restraint for restraining a main vessel portion of a graft;

a first branch vessel graft restraint for restraining a first branch vessel portion of the graft; and

a second branch vessel graft restraint for restraining a second branch vessel portion of the graft;

wherein;

the main vessel graft restraint, the first branch vessel graft restraint, and the second branch vessel restraint are arranged in a Y-configuration that is advanced through a first puncture site in a patient'"'"'s vasculature; and

the deployment system is configured such that the main vessel graft restraint, the first branch vessel graft restraint, and the second branch vessel graft restraint are connected to a portion of said graft deployment system to be withdrawn with the graft deployment system through the first puncture site after deployment of the main vessel graft portion of the graft, the first branch vessel portion of the graft, and the second branch vessel portion of the graft.

2. The deployment system of claim 1, wherein the second vessel graft restraint comprises a water-soluble bioadhesive.

3. The deployment system of claim 2, wherein the water-soluble bioadhesive comprises compounds in the polyglycolic acid family.

4. The deployment system of claim 1, wherein the main vessel graft restraint is perforated along at least a portion of a length thereof.

5. The deployment system of claim 1, wherein at least one of the main vessel graft restraint, the first branch vessel graft restraint, and the second branch vessel graft restraint is perforated along at least a portion of a length thereof.

6. The deployment system of claim 1, wherein said graft is a bifurcated graft.

7. The deployment system of claim 1, further comprising an outer sheath, an inner core that is axially moveable with respect to the outer sheath, and a distal tip coupled to the inner core.

8. The deployment system of claim 1, wherein the first and second branch vessel graft restraints are separate restraints.

9. The deployment system of claim 1, wherein the graft comprises a self-expanding support structure positioned inside the main vessel portion of the graft, the first branch vessel portion of the graft, and the second branch vessel portion of the graft.

10. The deployment system of claim 1, wherein a length of the first branch vessel portion of the graft is approximately the same as a length of the second branch vessel portion of the graft.

11. The deployment system of claim 1, wherein the deployment system is configured such that the first branch vessel graft restraint is configured to be removed from the first branch vessel portion of the graft after the first branch vessel portion of the graft is inserted into the first branch vessel, and the second branch vessel graft restraint is configured to be removed from the second branch vessel portion of the graft after the second branch vessel portion of the graft is inserted into the second branch vessel.

12. The deployment system of claim 1, wherein the first branch vessel graft restraint covers only the first branch vessel portion of the graft and the second branch vessel graft restraint restrains only the second branch vessel portion of the graft.

13. The deployment system of claim 1, wherein the first puncture site is in a first branch vessel, the first branch vessel portion of the graft is deployable in the first branch vessel by removal of the first branch vessel graft restraint, and the second branch vessel portion of the graft is deployable in a second branch vessel by removal of the second branch vessel graft restraint, which restrains only the second branch vessel portion of the graft.

14. The deployment system of claim 1, wherein a portion of the graft deployment system containing the graft is configured to be introduced through the first puncture site and, after deployment of the main vessel graft portion of the graft, the first branch vessel portion of the graft, and the second branch vessel portion of the graft have been deployed, the portion of the graft deployment system that had contained the graft prior to deployment is withdrawn from the first puncture site.

15. A graft deployment system, comprising:

an elongate, flexible catheter body, having a proximal end and a distal end and comprising an outer sheath and an inner core that is axially moveable with respect to the outer sheath and a distal tip positioned adjacent the distal end of the catheter body;

a graft having a main vessel portion, a first branch vessel portion, and a second branch vessel portion; and

a restraint system configured to restrain the main vessel portion, the first branch vessel portion, and the second branch vessel portion;

wherein;

the deployment system is configured to be inserted through a first puncture site in a first branch vessel of a patient'"'"'s vasculature;

the restraint system comprises a second branch vessel restraint configured to restrain only the second branch vessel portion that is positionable in the second branch vessel; and

the restraint system is configured to be completely withdrawn through the first puncture site in the first branch vessel after deployment of the main vessel portion, the first branch vessel portion, and the second branch vessel portion.

16. The deployment system of claim 15, wherein the graft is a bifurcated graft.

17. The deployment system of claim 15, wherein the restraint system comprises at least one peelable sheath.

18. The deployment system of claim 15, wherein the restraint system comprises at least one perforated sheath.

19. The deployment system of claim 15, comprising a peelable tubular sheath to restrain the main vessel portion of the graft.

20. The deployment system of claim 15, comprising a first peelable tubular sheath to restrain the main vessel portion of the graft and a second peelable tubular sheath to restrain at least the second branch vessel portion of the graft.

21. The deployment system of claim 15, wherein at least the portion of the restraint system restraining the main vessel portion and the second branch vessel portion of the graft is perforated.

22. The deployment system of claim 15, wherein at least a portion of the restraint system is coupled to the inner core.

23. The deployment system of claim 15, wherein the distal tip is coupled to the inner core.