DUAL CONCENTRIC GUIDEWIRE AND METHODS OF BIFURCATED GRAFT DEPLOYMENT

• US 20080172122A1
• Filed: 01/12/2007
• Published: 07/17/2008
• Est. Priority Date: 01/12/2007
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Pham, Trinh V., Mayberry, Kevin J., Gray, Brian C.
• Granted Patent: US 8,523,931 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• 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:

a deployment catheter for deploying an endoluminal vascular prosthesis having at least a main graft portion and a first branch graft portion, said deployment catheter having distal and proximal ends and a lumen extending therethrough;

a hollow guidewire slidably positioned within said deployment catheter;

said hollow guidewire coupled with a branch graft restraint member configured to releasably constrain the first branch graft portion; and

an inner core member slidably positionable within said hollow guidewire;

said inner core member having a length such that the proximal and distal ends of said inner core member extend beyond the proximal and distal ends of the hollow guide wire.

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 2, wherein the branch graft restraint member comprises a tubular sheath mounted to an outerwall of the hollow guidewire.

4. The deployment system of claim 2, wherein the branch graft restraint member comprises a pull wire configured to be coiled around the branch graft portion a plurality of times.

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

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

7. The deployment system of claim 6, 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

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

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

10. A method of deploying an endoluminal vascular prosthesis in a patient'"'"'s artery comprising:

positioning a hollow guidewire sheath across a bifurcation in a patient'"'"'s artery and in a contralateral branch of said patient'"'"'s artery, said hollow guidewire sheath having distal and proximal ends and a lumen extending therethrough, said distal end of said hollow guidewire sheath slidably inserted into a deployment catheter, said proximal end of said hollow guidewire assembly extending from said contralateral branch outside said patient;

advancing said deployment catheter over through an iliac branch of said patient'"'"'s artery;

applying traction to the proximal end of said hollow guidewire sheath to remove slack from said hollow guidewire sheath;

positioning said deployment catheter at said bifurcation in said patient'"'"'s artery;

deploying a main graft segment from said deployment catheter;

advancing said inner core wire distally through said lumen of said hollow guidewire sheath such that the inner core wire extends beyond the distal end of said hollow guidewire sheath and beyond the distal end of said main graft segment;

proximally retracting said hollow guidewire sheath;

withdrawing said hollow guidewire sheath from said patient'"'"'s artery; and

withdrawing said deployment catheter from said patient'"'"'s artery, leaving the inner core wire in place through the main graft segment.

11. The method of claim 10, wherein said distal end of said hollow guidewire sheath comprises a branch graft restraint mechanism configured to releasably restrain a branch graft portion and wherein proximally retracting said hollow guidewire sheath comprises releasing said branch graft restraint mechanism.

12. The method of claim 10, wherein the branch graft restraint mechanism comprises a tubular sheath mounted to the hollow guidewire sheath and configured to constrain a branch graft portion and wherein proximally retracting the hollow guidewire sheath comprises proximally retracting the tubular sheath from the branch graft portion.

13. The method of claim 10 further comprising advancing a dilation catheter over the inner core wire to the main graft portion.

14. The method of claim 10, further comprising:

advancing a tubular exchange sleeve over the inner core wire, said tubular exchange sleeve having a larger inner diameter than said hollow guidewire sheath;

withdrawing said inner core wire through said exchange sleeve; and

advancing a guidewire through said exchange sleeve, said guidewire having a larger cross-sectional diameter than a cross-sectional diameter of said inner core wire.

15. A concentric guidewire assembly kit comprising:

a hollow guidewire sheath having a lumen with an inner diameter extending therethrough, said hollow guidewire sheath having a first length;

a core wire having a diameter smaller than said inner diameter of said hollow guidewire sheath and a second length, wherein said second length is substantially longer than said first length.

16. The guidewire assembly kit of claim 15, wherein said second length is at least twice as long as said first length.

17. The guidewire assembly kit of claim 15, wherein said first length is between about 120-140 cm and wherein said second length is between about 180-300 cm.

18. The guidewire assembly kit of claim 15, wherein said core wire has a diameter of between about 0.014 to about 0.020 inches.

19. The guidewire assembly kit of claim 15, wherein said hollow guidewire sheath further comprises a branch graft restraint mechanism positioned on a distal end of said hollow guidewire sheath.

20. The guidewire assembly kit of claim 15, wherein said branch graft restraint mechanism comprises a tubular sheath mounted on an outerwall of said hollow guidewire sheath.