Bifurcated graft deployment systems and methods

• US 8,764,812 B2
• Filed: 01/18/2013
• Issued: 07/01/2014
• Est. Priority Date: 04/11/2008
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Mayberry, Kevin, Pham, Trinh, Schreck, Stefan G.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US13/745,682
• Publication Number:
  US 20130138200A1
• Time in Patent Office: 529 Days
• Field of Search: 604/528, 600/585, 623/1.1, 623/1.13, 623/1.15, 623/1.16, 623/1.17, 623/1.18, 623/1.19, 623/1.2, 623/1.22, 623/1.23, 623/1.28, 623/1.29, 623/1.3, 623/1.31, 623/1.35, 606/108
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/97 the outer sleeve being splittable
• 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 2002/9511 the retaining means being filaments or wires

Abstract

A method for deploying an endoluminal vascular prosthesis using a deployment catheter that has at least a main graft portion and a first branch graft portion. The deployment catheter preferably comprises an elongate, flexible catheter body having a proximal end and a distal end, and an outer sheath and an inner core that is axially moveable with respect to the outer sheath. The catheter preferably comprises a main graft restraint that has a main graft release mechanism comprising a main graft sheath and a suture threaded through a plurality of the openings in the main graft sheath. The catheter further comprises at least one branch graft restraint comprising at least one branch graft release mechanism.

Claims

1. A method of deploying a bifurcated prosthesis in a patient'"'"'s vasculature, comprising:

supporting the bifurcated prosthesis with a deployment catheter;

advancing at least a distal end portion of the deployment catheter and the prosthesis through a first access site in a first vessel in the patient'"'"'s vasculature to a bifurcation region of the patient'"'"'s vasculature;

positioning a main body portion of the bifurcated prosthesis in a main vessel;

positioning a first branch portion of the bifurcated prosthesis in a first branch vessel, a diameter of the first branch portion being smaller than a diameter of the main body portion;

positioning a second branch portion of the bifurcated prosthesis in a second branch vessel, wherein the first and second branch vessels branch off the main vessel, a diameter of the second branch portion being smaller than the diameter of the main body portion;

releasing a main body portion of the bifurcated prosthesis from a main body restraint so that the main body portion of the bifurcated prosthesis expands in the main vessel; and

withdrawing the main body restraint from the patient'"'"'s vasculature through a second access site in a second vessel, wherein the second access site is at a different location than the first access site.

2. The method of claim 1, comprising advancing the main body restraint into the patient'"'"'s vasculature through the first access site.

3. The method of claim 1, comprising releasably restraining the first branch portion of the prosthesis with a first branch restraint and releasably restraining the second branch portion of the prosthesis with a second branch restraint.

4. The method of claim 3, comprising withdrawing the first branch restraint from the patient'"'"'s vasculature through the first access site in the first branch vessel and withdrawing the second branch restraint from the patient'"'"'s vasculature through the second access site in the second branch vessel.

5. The method of claim 1, wherein supporting the bifurcated prosthesis with the deployment catheter comprises supporting the bifurcated prosthesis on an outside surface of a portion of an inner core, the deployment catheter further comprising an outer sheath extending over at least a portion of the inner core and being axially advanceable relative to the inner core, the outer sheath being configured to surround the prosthesis until the outer sheath is proximally retracted.

6. The method of claim 1, comprising opening at least a portion of the main body restraint by retracting a release wire attached to the main body restraint.

7. The method of claim 1, further comprising opening at least a portion of the main body restraint by retracting a release wire configured to tear one or more portions of the main body restraint when the release wire is proximally retracted.

8. The method of claim 1, wherein withdrawing the main body restraint from the patient'"'"'s vasculature through the second access site in the second vessel comprises retracting a retraction wire coupled with the main body restraint through the second access site.

9. The method of claim 8, wherein the retraction wire is a hollow retraction wire and wherein the method of deploying the bifurcated prosthesis in the patient'"'"'s vasculature further comprises positioning an inner wire within the hollow retraction wire.

10. The method of claim 9, further comprising generally maintaining a position of the inner wire in the patient'"'"'s vasculature while retracting the retraction wire.

11. The method of claim 1, comprising withdrawing a second branch restraint from the patient'"'"'s vasculature through the second access site in the second vessel by retracting a retraction wire through the second access site, the retraction wire being configured to engage and withdraw the second branch restraint as the retraction wire is withdrawn.

12. The method of claim 1, wherein the first access site is an opening in one iliac artery, establishing it as the ipsilateral iliac artery, and the second access site is an opening in the contralateral iliac artery.

13. The method of claim 1, wherein the main vessel is the abdominal aorta, and wherein the first branch vessel and the second branch vessel are common iliac arteries.

14. A method of deploying a prosthesis in a patient'"'"'s vasculature, comprising:

supporting the prosthesis with a deployment catheter;

advancing at least a distal end portion of the deployment catheter and the prosthesis through a first access site in a first vessel in the patient'"'"'s vasculature to a target vessel of the patient'"'"'s vasculature, a diameter of the first vessel being smaller than a diameter of the target vessel;

releasing the prosthesis from a restraint so that at least a portion of the prosthesis self-expands in the target vessel; and

withdrawing the restraint from the patient'"'"'s vasculature through a second access site in a second vessel, wherein the second access site is at a different location than the first access site, a diameter of the second vessel being smaller than the diameter of the target vessel.

15. The method of claim 14, comprising advancing the restraint into the patient'"'"'s vasculature through the first access site.

16. The method of claim 14, comprising releasably restraining a first branch portion of the prosthesis with a first branch restraint and releasably restraining a second branch portion of the prosthesis with a second branch restraint, the prosthesis being a branched or bifurcated prosthesis.

17. The method of claim 15, comprising withdrawing the second branch restraint from the patient'"'"'s vasculature through the second access site in the second vessel.

18. The method of claim 14, comprising tearing open at least a portion of the restraint by retracting a release wire attached to or coupled with a portion of the restraint.

19. The method of claim 14, further comprising opening at least a portion of the restraint by retracting a release wire attached to the restraint through the first access site.

20. The method of claim 14, wherein withdrawing the restraint from the patient'"'"'s vasculature through the second access site in the second vessel comprises retracting a retraction wire coupled with the restraint through the second access site and wherein the retraction wire is a hollow retraction wire and wherein the method of deploying the prosthesis in the patient'"'"'s vasculature further comprises positioning an inner wire within the hollow retraction wire.

21. The method of claim 14, wherein the first access site is an opening in one iliac artery establishing it as the ipsilateral iliac artery, and the second access site is an opening in the contralateral iliac artery.

22. The method of claim 14, wherein the main vessel is the abdominal aorta, and wherein the first vessel and the second vessel are common iliac arteries.