Bifurcated graft deployment systems and methods

• US 8,357,192 B2
• Filed: 03/11/2011
• Issued: 01/22/2013
• 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:
  US13/046,541
• Publication Number:
  US 20110224772A1
• Time in Patent Office: 683 Days
• Field of Search: 606/108, 623/1.1, 623/1.11, 623/1.12, 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
• 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. An endoluminal vascular prosthesis deployment catheter for deploying an endoluminal vascular prosthesis having at least a main branch and a first branch, comprising:

a flexible catheter body that supports the prosthesis in a pre-deployment state and comprises an outer sheath with a proximal and distal end, an inner core that extends through the outer sheath and is axially moveable with respect to the outer sheath, and a distal tip that is positioned adjacent the distal end of the outer sheath and is coupled to the inner core;

a main branch restraint that surrounds and constrains at least the main branch, the main branch restraint having a first end portion, a second end portion, and an intermediate portion positioned between the first and second end portions;

a first branch restraint that comprises a tubular member configured to releasably constrain the first branch; and

a withdrawal element that is coupled with the main branch restraint and the first branch restraint;

wherein;

the withdrawal element is coupled with the main branch restraint and the first branch restraint such that withdrawal of the withdrawal element withdraws the main branch restraint and the first branch restraint;

the main branch restraint is coupled with the withdrawal element at a first position on the withdrawal element relative to a distal end of the withdrawal element;

the first branch restraint is coupled with the withdrawal element at a second position on the withdrawal element relative to the distal end of the withdrawal element; and

the first position is spaced apart along the length of the withdrawal element from the second position, the first position being further away from the distal end of the withdrawal element than the second position.

2. The deployment of claim 1, further comprising a release wire extending through a plurality of perforations formed in the main branch restraint and configured to tear portions of the main branch restraint between the perforations to deploy the main branch when the release wire is proximally retracted.

3. The deployment catheter of claim 2, wherein the release wire is routed through the perforations such that withdrawal of the release wire releases a proximal portion or an intermediate portion of the main branch restraint before releasing a distal portion of the first restraint, the proximal portion of the main branch restraint being downstream of the distal portion of the first restraint.

4. The deployment catheter of claim 1, further comprising a guidewire lumen extending through the inner core of the deployment catheter.

5. The deployment catheter of claim 1, wherein the main branch restraint defines a first end portion and a second end portion, and the release wire is routed through the perforations such that an end of the release wire is positioned between the first end portion and the second end portion of the main branch restraint.

6. The deployment catheter of claim 1, wherein the main branch restraint comprises a score line between at least some of the perforations.

7. The deployment catheter of claim 1, wherein the main branch restraint comprises a slit between at least some of the perforations.

8. The deployment catheter of claim 1, wherein the withdrawal element comprises a hollow guidewire.

9. The deployment catheter of claim 8, wherein the deployment catheter further comprises an inner core wire slidably positionable within the hollow guidewire.

10. The deployment catheter of claim 1, comprising a first tab coupled with the withdrawal element at the first position, the first tab being configured to engage the main branch restraint when the first tab abuts a constricted portion of the main branch restraint.

11. The deployment catheter of claim 10, comprising a second tab coupled with the withdrawal element at the second position, the second tab being configured to engage the first branch restraint when the second tab abuts a constricted portion of the first branch restraint.

12. The deployment system of claim 1, further comprising a second branch restraint constraining a second branch portion of the endoluminal prosthesis.

13. The deployment catheter of claim 1, wherein in use the deployment system comprising the main branch restraint is advanced through a first access site and the main branch restraint is removed through a second access site that is different than the first access site.

14. The deployment system of claim 1, wherein the inner core is configured to support at least the main branch of the prosthesis.

15. The deployment system of claim 1, wherein the first position is spaced apart from the second position by at least a distance equal to a length of the main branch restraint.

16. An endoluminal vascular prosthesis deployment catheter for deploying an endoluminal vascular prosthesis having at least a main branch and a first branch, comprising:

a flexible catheter body that supports the prosthesis in a pre-deployment state and comprises an outer sheath with a proximal and distal end, an inner core that extends through the outer sheath and is axially moveable with respect to the outer sheath, and a distal tip that is positioned adjacent the distal end of the outer sheath and is coupled to the inner core;

a main branch restraint that surrounds and constrains at least the main branch, the main branch restraint having a first end portion, a second end portion, and an intermediate portion positioned between the first and second end portions;

a first branch restraint that comprises a tubular member configured to releasably constrain the first branch; and

a withdrawal element that is coupled with the main branch restraint and the first branch restraint such that withdrawal of the withdrawal element withdraws the main branch restraint and the first branch restraint;

wherein;

at least a distal portion of the withdrawal element is positioned between the inner core and the outer sheath when the catheter is in a pre-deployment state; and

the withdrawal element has a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions;

the deployment catheter is configured such that the intermediate portion of the withdrawal element is positioned within the outer sheath and the proximal portion of the withdrawal element extends past the distal end of the outer sheath when the deployment catheter is in a pre-deployment state; and

the inner core is positioned within the outer sheath along the entire length of the outer sheath when the deployment catheter is in a pre-deployment state.

17. The deployment of claim 16, further comprising a release wire extending through a plurality of perforations formed in the main branch restraint and configured to tear portions of the main branch restraint between the perforations to deploy the main branch when the release wire is proximally retracted.

18. The deployment system of claim 16, wherein the withdrawal element comprises a hollow guidewire.

19. The deployment system of claim 16, wherein the deployment catheter further comprises an inner core wire slidably positionable within the hollow guidewire.