System and method for endoluminal grafting of bifurcated or branched vessels

• US 5,984,955 A
• Filed: 09/11/1997
• Issued: 11/16/1999
• Est. Priority Date: 09/11/1997
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Wisselink, Willem
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US08/927,439
• Time in Patent Office: 796 Days
• Field of Search: 623/1, 623/12
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels

Abstract

A system and method for endoluminal grafting of a main anatomical conduit (e.g., the aorta) and various branch conduits (e.g., side branch vessels such as the carotid, innominate, subclavian, intercostal, superior mesenteric, celiac, or renal arteries-or furcations such as the iliac arteries) which emanate from the main anatomical conduit. The grafting system generally comprises i) a primary graft having at least one opening therein and ii) at least one branch graft which is passable through the opening of the primary graft and into the branch conduit(s) such that the proximal end of each branch graft is in substantially fluid-tight sealing contact with the primary graft. Also disclosed is a specific system and method for grafting a bifurcated anatomical conduit (e.g., the aorto-iliac bifurcation) though only a single access opening (puncture site or incision) and a new balloon-anchorable guidewire system which is useable in the performance of such grafting of bifurcated anatomical conduits and numerous other medical procedures.

Claims

1. A system for endoluminal grafting of an anatomical conduit having at least one branch anatomical conduit emanating therefrom, said system comprising:

a) a tubular primary graft for deployment in the anatomical conduit;

i) said primary graft having first and second ends and a lumen extending longitudinally therethrough;

ii) a branch graft opening formed at a first location in the primary graft;

iii) a first connector member formed adjacent the branch graft opening; and

,

iii) a primary graft anchoring component operative to hold at least the first and second ends of the primary graft in substantially abutting contact with the anatomical conduit at locations on either side of said branch anatomical conduit, said primary graft anchoring component being thereby operative to hold the primary graft in a substantially fixed position within the lumen of the anatomical conduit such that its branch graft opening is substantially aligned with said branch anatomical conduit; and

,

b) a tubular branch graft for deployment into the branch anatomical conduit;

i) said branch graft having a proximal end, a distal end, and a lumen extending longitudinally therethrough, and said branch graft being advanceable distal-end-first through the branch graft opening and into the branch anatomical conduit;

ii) a second connector member being associated with the proximal end of the branch graft, said second connector member being configured to automatically frictionally engage said first connector as the proximal end of the branch graft is brought into approximation with the branch craft opening of the primary graft, said automatic frictional engagement of the second connector to the first connector being operative to form a connection between the proximal end of the branch graft and the primary graft.

2. The system of claim 1 wherein said primary graft is formed at least partially of woven polyester.

3. The system of claim 1 wherein said primary graft is formed at least partially of expanded polytetrafluoroethylene.

4. The system of claim 1 wherein the branch graft opening is formed in the side of the primary graft.

5. The system of claim 1 wherein a bifurcation is formed at one end of the primary graft, and said branch graft opening is formed in one side of that bifurcation.

6. The system of claim 5 wherein the primary graft further comprises a pliable tubular graft extension which extends from the side of the bifurcation which is opposite the side in which the branch graft opening is formed.

7. The system of claim 1 wherein the first connector member comprises an annular groove formed at least part way around the branch graft opening in the primary graft.

8. The system of claim 1 wherein the primary graft anchoring component is selected from the group of graft anchoring apparatus and substances consisting of:

at least one radially expandable stent which is separate from the primary graft;

at least one radially expandable stent which is integrated into the primary graft;

at least one radially expandable frame which is separate from the primary graft;

at least one radially expandable frame which is incorporated into the primary graft;

at least one projection which protrudes at least partially through the wall of the anatomical conduit;

an adhesive;

at least one suture; and

,

at least one staple.

9. The system of claim 1 wherein the branch graft portion of said system further comprises:

iii) a branch graft anchoring component for holding at least the distal end of the branch graft in contact with the wall of the branch anatomical conduit.

10. The system of claim 9 wherein the branch graft anchoring component is selected from the group of graft anchoring apparatus and substances consisting of:

at least one radially expandable stent which is separate from the first pliable tube;

at least one radially expandable stent which is integrated into the first pliable tube;

at least one radially expandable frame which is separate from the first pliable tube;

at least one radially expandable frame which is incorporated into the first pliable tube;

at least one projection which protrudes at least partially through the wall of the

anatomical conduit;

an adhesive;

at least one suture; and

,

at least one staple.

11. The system of claim 1 wherein said branch graft is formed at least partially of woven polyester.

12. The system of claim 1 wherein said branch graft is formed at least partially of expanded polytetrafluoroethylene.

13. The system of claim 1 wherein the second connector on the branch graft is configured to frictionally engage the first connector of the primary graft, as the branch graft is advanced out of the branch graft opening of the primary graft.

14. The system of claim 13 wherein the first connector on the primary graft is an annular groove, and the second connector on the branch graft is an annular ridge which is sized and configured to seat within and frictionally engage said annular groove.

15. The system of claim 14 wherein at least a portion of the branch graft is tapered such that its distal end is smaller in diameter than its proximal end.

16. The system of claim 15 wherein a portion of the branch graft, adjacent its proximal end, is frustoconical in configuration.

17. The system of claim 16 wherein the first connector member is formed on the proximal end of the frustoconical segment of the branch graft.