Graft deployment system

• US 8,034,100 B2
• Filed: 11/25/2003
• Issued: 10/11/2011
• Est. Priority Date: 03/11/1999
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Van Pham, Trinh, Van Pham, To, Shaolian, Samuel M., Madrid, Gilbert
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US10/722,367
• Publication Number:
  US 20040167618A1
• Time in Patent Office: 2,877 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.35, 623/1.23, 604/164.05, 606/108
• 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 2/954 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 2002/067 modular
• 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 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

A graft deployment system, comprises 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. A main vessel graft restraint comprising a first peelable cover for restrains a main vessel portion of a graft. In a bifurcated graft, a first branch vessel graft restraint restrains a first branch vessel portion of the graft. A second branch vessel graft restraint restrains a second branch vessel portion of the graft. The first peelable cover is coupled to a main branch release element and wherein each of the main vessel graft restraint, first branch vessel graft restraint, and the second branch vessel graft restraint are positioned within the catheter body in a graft loaded condition.

Claims

1. A bifurcation prosthesis 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 an atraumatic distal tip coupled to the inner core and positioned adjacent the distal end of the catheter body;

a self-expanding bifurcated graft comprising a main vessel portion, a first branch vessel portion, and a second branch vessel portion;

a main vessel graft restraint comprising a first peelable cover for restraining substantially the entire length of the main vessel portion of the bifurcated graft;

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

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

wherein;

the first peelable cover is coupled to a main branch release element;

each of the bifurcated graft, main vessel graft restraint, first branch vessel graft restraint, and the second branch vessel graft restraint are positioned within the catheter body in a graft loaded condition in an orientation such that the main vessel portion is positioned nearer to the distal end of the catheter body than either the first branch vessel portion or the second branch vessel portion; and

the first peelable cover is configured such that proximal retraction of the first peelable cover causes the first peelable cover to tear.

2. A deployment system as in claim 1, wherein the main branch release element comprises an elongate, flexible, axially moveable release element extending through the catheter.

3. A deployment system as in claim 1, wherein the first branch vessel graft restraint comprises a first tubular sleeve.

4. A deployment system as in claim 3, wherein the first tubular sleeve is coupled to the inner core.

5. A deployment system as in claim 1, wherein the first branch vessel graft restraint comprises a second peelable cover.

6. A deployment system as in claim 5, wherein the second peelable cover is attached to a first branch release element comprising an elongate, flexible, axially moveable release element also extending through the catheter.

7. A deployment system as in claim 1, wherein the second branch vessel graft restraint comprises a tubular sleeve.

8. A deployment system as in claim 7, wherein the tubular sleeve is attached to a second branch release element comprising an elongate, flexible, axially moveable release element.

9. A deployment system as in claim 8, wherein the catheter is configured to enter through a first percutaneous puncture site and the second branch release element is configured to exit through a second percutaneous puncture site.

10. The deployment system of claim 1, comprising a self-expanding wire support for deployment within the bifurcated graft, the wire support comprising a main component, a first branch component, and a second branch component, wherein:

the wire support is self-expandable along substantially the entire length thereof;

the main component of the wire support is configured to support substantially the entire length of the main vessel portion of the graft;

the first branch component of the wire support is configured to support substantially the entire length of the first branch vessel portion of the graft; and

the second branch component of the wire support is configured to support substantially the entire length of the first branch vessel portion of the graft.

11. The deployment system of claim 1, wherein the main branch release element extends proximally and is configured to withdraw the first peelable cover by proximal retraction of the main branch release element.

12. The deployment system of claim 1, wherein the main branch release element is connected to a proximal end portion of the first peelable cover and does not extend distally past the proximal end portion of the first peelable cover.

13. The deployment system of claim 1, wherein the first branch vessel graft restraint restrains substantially the entire length of the first branch vessel portion of the graft, and the second branch vessel graft restrains substantially the entire length of the second branch vessel portion of the graft.

14. The deployment system of claim 1, wherein the first peelable cover comprises a peel start point.

15. The deployment system of claim 14, wherein the first peelable cover comprises at least one of a slit, a perforation, and a v-shaped cut.

16. The deployment system of claim 1, wherein the first peelable cover comprises at least one of a perforation line, a slit, a crease, and a recess extending axially along at least a portion thereof to facilitate tearing of the first peelable cover.

17. A deployment system for deploying a bifurcated prosthesis at the junction of a main vessel and first and second branch vessels, comprising:

a delivery catheter having an inner core, an outer sheath and a distal tip that is coupled to the inner core, the inner core being slidably engaged within the outer sheath; and

a self-expanding bifurcated prosthesis having a main body section with proximal and distal ends and being self-expandable along a substantial portion of the length thereof, and first and second branch sections at the proximal end of the main body section, each being self-expandable along a substantial portion of the length thereof;

wherein;

at least a portion of the main body section is held in a radially compressed state by a first peelable cover, the first branch section is held in a radially compressed state within a first tubular cover, and the second branch section is held in a radially compressed state within a second tubular cover;

the main body section is deployable by proximally retracting the first peelable cover;

the first peelable cover is configured such that proximal retraction of the first peelable cover causes the first peelable cover to tear; and

the compressed bifurcated prosthesis is positioned within the outer sheath such that the distal end of the bifurcated prosthesis is positioned nearer to the distal tip of the delivery catheter.

18. The deployment system of claim 17, wherein the bifurcated prosthesis further comprises an expansion spring having an apex and first and second leg portions, wherein the leg portions are connected to respective first and second branch sections.

19. The deployment system of claim 17, wherein the first tubular cover is a peelable cover.

20. The deployment system of claim 17, wherein a distal end of the outer sheath includes an RO marker.

21. The deployment system of claim 20, wherein the RO marker comprises a band of RO material.

22. The deployment system of claim 17, further including means for marking a distal end of the outer sheath with RO material.

23. A bifurcation prosthesis 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 an atraumatic distal tip coupled to the inner core and positioned adjacent the distal end of the catheter body;

a self-expanding bifurcated graft comprising a main vessel portion, a first branch vessel portion, and a second branch vessel portion;

a main vessel graft restraint comprising a first peelable cover for restraining substantially the entire length of the main vessel portion of the bifurcated graft;

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

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

wherein;

the first peelable cover is coupled to a main branch release element;

each of the bifurcated graft, main vessel graft restraint, first branch vessel graft restraint, and the second branch vessel graft restraint are positioned within the catheter body in a graft loaded condition in an orientation such that the main vessel portion is positioned nearer to the distal end of the catheter body than either the first branch vessel portion or the second branch vessel portion; and

the deployment system is configured such that proximal retraction of the main branch release element in an axial direction causes the first peelable cover to tear.

24. A deployment system as in claim 23, wherein the main branch release element comprises an elongate, flexible, axially moveable release element extending through the catheter.

25. A deployment system as in claim 23, wherein the first branch vessel graft restraint comprises a first tubular sleeve.

26. A deployment system as in claim 25, wherein the first tubular sleeve is coupled to the inner core.

27. A deployment system as in claim 23, wherein the first branch vessel graft restraint comprises a second peelable cover.

28. A deployment system as in claim 27, wherein the second peelable cover is attached to a first branch release element comprising an elongate, flexible, axially moveable release element also extending through the catheter.

29. A deployment system as in claim 23, wherein the second branch vessel graft restraint comprises a tubular sleeve.

30. A deployment system as in claim 29, wherein the tubular sleeve is attached to a second branch release element comprising an elongate, flexible, axially moveable release element.

31. A deployment system as in claim 30, wherein the catheter is configured to enter through a first percutaneous puncture site and the second branch release element is configured to exit through a second percutaneous puncture site.