Dual concentric guidewire and methods of bifurcated graft deployment

• US 8,523,931 B2
• Filed: 01/12/2007
• Issued: 09/03/2013
• Est. Priority Date: 01/12/2007
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Mayberry, Kevin J., Pham, Trinh V., Gray, Brian C.
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US11/623,022
• Publication Number:
  US 20080172122A1
• Time in Patent Office: 2,426 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/1.13, 623/1.16, 623/1.35, 606/108, 606/198, 606/200, 600/585
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61M 2025/09075 having a core without a coil possibly combined with a sheath
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09025 with sliding mandrils

Abstract

A guidewire assembly for use in deploying a bifurcated endoluminal vascular prosthesis that has a main graft portion and at least a first branch graft portion The guidewire assembly include a hollow guidewire sheath having a restraint mechanism, such as a tubular sheath, for constraining a branch graft portion of the vascular prosthesis and an inner core wire that is slidably insertable into a central lumen of the hollow guidewire sheath. In use, the guidewire assembly may be used with a deployment catheter to deploy the bifurcated vascular prosthesis and leave the inner core wire in position in the patient'"'"'s aorta, extending through the main graft portion of the vascular prosthesis.

Claims

1. A self-expandable endoluminal vascular prosthesis deployment system, comprising:

an endoluminal vascular prosthesis having at least a main graft portion having a lumen therethrough and a first branch graft portion having a lumen therethrough;

a deployment catheter having a catheter body for deploying the endoluminal vascular prosthesis, said deployment catheter having a central tubular core having a guidewire lumen extending therethrough, and distal and proximal ends, wherein said first branch graft portion is constrained within a branch graft restraint member comprising a tubular sheath prior to deployment;

a contralateral guidewire extending through the first branch graft portion and the branch graft restraint member in a predeployment state; and

an inner core member slidably positionable within said contralateral guidewire;

wherein;

said contralateral guidewire comprises a hollow guidewire securely connected to said branch graft restraint member such that movement of the hollow guidewire and branch graft restraint member connected thereto away from the main graft portion simultaneously moves the branch graft restraint member away from the main graft portion and releases said first branch graft portion from said branch graft restraint member;

the hollow guidewire comprises a distal end portion that extends through the lumen of the first branch graft portion and substantially into the lumen of the main graft portion in a predeployment state; and

the hollow guidewire has a substantially uniform cross-sectional size and shape along an entire the length thereof, and has a proximal end portion that is advanceable through a patient'"'"'s vasculature.

2. The deployment system of claim 1, wherein the branch graft restraint member is located near the distal end of the hollow guidewire.

3. The deployment system of claim 1, wherein the tubular sheath is mounted to an outer wall of the hollow guidewire.

4. The deployment system of claim 1, wherein the inner core member is substantially longer than the hollow guidewire.

5. The deployment system of claim 4, wherein the inner core member has a length between about 2-3 times greater than a length of the hollow guidewire.

6. The deployment system of claim 5, wherein the hollow guidewire has a length of between about 120-140 cm and the inner core member has a length of between about 240-300 cm.

7. The deployment system of claim 1, wherein the hollow guidewire comprises a reinforced tubular member.

8. The deployment system of claim 7, wherein the hollow guidewire comprises a composite tubular member comprising a polyimide tube over a wire coil wrapped around the polyimide tube.

9. The deployment system of claim 1, wherein the distal end portion of the hollow guidewire is supported within a tubular member of the deployment catheter in a pre-deployment state and the remainder of the length of the hollow guidewire is positioned outside the tubular member in the pre-deployment state.

10. The deployment system of claim 1, wherein the deployment catheter further comprises a tubular member having proximal and distal end portions, and the hollow guidewire does not extend through the entire tubular member such that only the distal end portion of the tubular member surrounds the hollow guidewire when the deployment catheter is in a pre-deployment state.

11. The deployment system of claim 1, wherein:

the deployment catheter further comprises a tubular member projecting from a proximal portion of the deployment catheter;

the tubular member is moveable between a first position wherein a distal end portion of the tubular member axially surrounds at least a portion of the first branch graft portion of the prosthesis and a second position wherein a distal end portion of the tubular member is proximal to a proximal end portion of the first branch graft portion of the prosthesis; and

when the tubular member is in the second position, proximal movement of the hollow guidewire will result in proximal movement of the branch graft restraint member.

12. The deployment system of claim 11, wherein the hollow guidewire does not pass through a proximal end portion of the tubular member.

13. The deployment system of claim 1, wherein the hollow guidewire is independently moveable relative to the catheter body.

14. The deployment system of claim 1, wherein only a distal portion of the hollow guidewire is positioned within the deployment catheter and wherein a proximal and an intermediate portion of the hollow guidewire are moveable relative to the deployment catheter.

15. A self-expandable endoluminal vascular prosthesis deployment system, comprising:

an endoluminal vascular prosthesis having at least a main graft portion having a lumen therethrough and a first branch graft portion having a lumen therethrough;

a deployment catheter having a catheter body for deploying the endoluminal vascular prosthesis, said deployment catheter having a central tubular core having a guidewire lumen extending therethrough, and distal and proximal ends, wherein said first branch graft portion is constrained within a branch graft restraint member comprising a tubular sheath prior to deployment;

a contralateral guidewire extending through the first branch graft portion and the branch graft restraint tubular sheath in a predeployment state; and

an inner core member slidably positionable within said contralateral guidewire;

wherein;

said contralateral guidewire comprises a hollow guidewire securely connected to said branch graft restraint member such that movement of the hollow guidewire and branch graft restraint connected thereto away from the main graft portion simultaneously moves the branch graft restraint member away from the main graft portion and releases said branch graft from said branch graft restraint member;

the hollow guidewire comprises a distal end portion that extends through the lumen of the first branch graft portion and substantially into the lumen of the main graft portion in a predeployment state; and

a proximal end portion of the hollow guidewire is sized and configured to be advanceable through a first puncture site in the body and withdrawn through a second puncture site.

16. The deployment system of claim 15, wherein the tubular sheath is mounted to an outer wall of the hollow guidewire.

17. The deployment system of claim 15, wherein the inner core member has a length between about 2-3 times greater than a length of the hollow guidewire.

18. The deployment system of claim 15, wherein the hollow guidewire comprises a composite tubular member comprising a polyimide tube over a wire coil wrapped around the polyimide tube.

19. The deployment system of claim 15, wherein the distal end portion of the hollow guidewire is supported within a tubular member of the deployment catheter in a pre-deployment state and the remainder of the length of the hollow guidewire is positioned outside the tubular member in the pre-deployment state.

20. The deployment system of claim 15, wherein the deployment catheter further comprises a tubular member having proximal and distal end portions, and the hollow guidewire does not extend through the entire tubular member such that only the distal end portion of the tubular member surrounds the hollow guidewire when the deployment catheter is in a pre-deployment state.

21. The deployment system of claim 15, wherein:

the deployment catheter further comprises a tubular member projecting from a proximal portion of the deployment catheter;

the tubular member is moveable between a first position wherein a distal end portion of the tubular member axially surrounds at least a portion of the first branch graft portion of the prosthesis and a second position wherein a distal end portion of the tubular member is proximal to a proximal end portion of the first branch graft portion of the prosthesis; and

when the tubular member is in the second position, proximal movement of the hollow guidewire will result in proximal movement of the branch graft restraint member.

22. The deployment system of claim 21, wherein the hollow guidewire does not pass through the proximal end portion of the tubular member.