Graft deployment system

• US 20040167618A1
• Filed: 11/25/2003
• Published: 08/26/2004
• Est. Priority Date: 03/11/1999
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Shaolian, Samuel M., Madrid, Gilbert, Pham, To Van, Pham, Trinh Van
• Granted Patent: US 8,034,100 B2
• Time in Patent Office: Days
• 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 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;

a main vessel graft restraint comprising a first peelable cover for restraining a main vessel portion of a bifurcated 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 restaining a second branch vessel portion of the graft;

wherein 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.

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. 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 bifurcated prosthesis having a main body section with proximal and distal ends, and first and second branch sections at the proximal end of the main body section, wherein 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 also held in a radially compressed within a second tubular cover.

11. The deployment system of claim 10, 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.

12. The deployment system of claim 10, wherein the first tubular cover is a peelable cover.

13. The deployment system of claim 10, wherein a distal end of the outer sheath includes an RO marker.

14. The deployment system of claim 13, wherein the RO marker comprises a band of RO material.

15. The deployment system of claim 10, further including means for marking a distal end of the outer sheath with RO material.

16. A method for deploying a bifurcated endoluminal prosthesis at the junction of a main vessel and first and second branch vessels, comprising the steps of:

providing a deployment system containing a prosthesis having a main body section and first and second proximally extending branch sections;

introducing the deployment system into the first branch vessel at a first access site;

advancing the deployment system distally through at least a portion of the first branch vessel and into the main vessel;

releasing the second branch section of the prosthesis by proximally retracting an outer sheath of the deployment system;

expanding the main body section of the prosthesis from a radially compressed state within the deployment system to a radially expanded state within the main vessel by removing a first peelable sheath from the main branch section;

expanding the second branch section within the second branch vessel by proximally retracting a second branch release wire.

17. The method of claim 16, wherein the second branch release wire is proximally retracted through a second access site.

18. The method of claim 16, further including the step of expanding the first branch section within the first branch vessel by proximally retracting an inner core of the deployment system.

19. The method of claim 16, further including the step of expanding the first branch section within the first branch vessel by removing a second peelable sheath from the first branch section.

20. The method claim 19, wherein the second peelable sheath is removed by proximally retracting a first branch release wire.

21. The method of claim 16, wherein the main vessel is an aorta and the first and second branch vessels are ipsilateral and contralateral iliac arteries.

22. The method of claim 16, wherein the second branch section comprises a self-expandable wire support.

23. The method claim 16, wherein the first peelable sheath is removed by proximally retracting a main branch release wire through the first access site.

24. A straight tube 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;

a first graft restraint comprising a first peelable cover for restraining at least a first portion of a straight tube graft;

wherein the first peelable cover is coupled to a first release element and wherein the first graft restraint is positioned within the catheter body in a graft loaded position.

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

26. A deployment system as in claim 24, wherein the deployment system further comprises a second graft restraint comprising a second peelable cover for restraining a second portion of the straight tube graft.

27. A deployment system as in claim 26, wherein the second peelable cover is attached to a second release element comprising an elongate, flexible, axially moveable release element extending through the catheter.

28. A method for deploying a straight tube endoluminal prosthesis, comprising the steps of:

providing a deployment system containing a straight tube prosthesis including a distal section and a proximal section;

introducing the deployment system into a vessel at an access site;

advancing the deployment system distally through the vessel;

proximally retracting an outer sheath of the deployment system to expose the prosthesis;

expanding at least a portion of the prosthesis from a radially compressed state within the deployment system to a radially expanded state within the vessel by proximately retracting a first release element so as to tear a peelable cover;

30. The method of claim 31, further comprising the step of expanding a proximal portion of the prosthesis from a radially compressed state within the deployment system to a radially expanded state within the vessel by proximately retracting a second release element so as to tear a second peelable cover.

29. The method of claim 30, wherein the step of expanding at least a portion of the prosthesis includes expanding the distal portion of the prosthesis.