Single puncture bifurcation graft deployment system

• US 20040138735A1
• Filed: 10/21/2003
• Published: 07/15/2004
• Est. Priority Date: 03/11/1999
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Gilbert Madrid, Samuel M. Shaolian, Thanh V. Nguyen, To Van Pham, Trinh Van Pham
• Inventors: Shaolian, Samuel M., Madrid, Gilbert, Nguyen, Thanh Van, Pham, To Van, Pham, Trinh Van
• Granted Patent: US 7,691,135 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 2002/072 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/005 using adhesives
• 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

The present invention relates to the endoluminal repair of abdominal aortic aneurysms at the aortic and iliac bifurcation. In particular, a deployment system and graft are disclosed for deploying the bifurcated graft within both iliac branches, as well as the aortic trunk, from a single vascular access.

Claims

1. 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 an 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;

proximally retracting the deployment system to position the second branch section within the second branch vessel;

expanding the first branch section of the prosthesis from a radially compressed state within the deployment system to a radially expanded state within the first branch vessel by activating a first release element 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 activating a second release element of the deployment system;

expanding the second branch section within the second branch vessel; and

retracting the deployment system proximally through said access site and out of the patient'"'"'s body.

2. The method of claim 1, wherein the main vessel is an aorta and the first and second branch vessels are ipsilateral and contralateral iliac arteries.

3. The method of claim 1, wherein the second branch section comprises a wire support formed from a memory metal alloy.

4. The method of claim 3, wherein the second branch section is expanded by heating the wire support.

5. The method of claim 1, wherein the step of expanding the second branch section is accomplished by removing a peelable sheath from the second branch portion.

6. The method of claim 1, wherein the second branch section comprises a self-expandable wire support.

7. The method claim 5, wherein the peelable sheath is removed by proximally retracting a release wire.

8. The method of claim 1, wherein the second branch section comprises a self-expandable wire support, the second branch section being restrained in a radially compressed state by a biodegradable adhesive.

9. The method of claim 1, wherein the step of expanding the second branch is accomplished by distally advancing a tubular sheath.

10. A method for deploying a bifurcated endoluminal prosthesis at a junction of an aorta and ipsilateral and contralateral iliac arteries in a patient'"'"'s body, comprising the steps of:

advancing a deployment system distally through at least a portion of the ipsilateral iliac artery and into the aorta, the deployment system containing a prosthesis having a main body section and ipsilateral and contralateral limb sections, wherein the sections of the prosthesis are held in a radially compressed state in the deployment system, and wherein at least the main body and ipsilateral limb of the prosthesis are adapted to self-expand upon release from the deployment system;

retracting an outer sheath proximally to expose the contralateral limb of the prosthesis, wherein the contralateral limb inclines laterally away from the deployment system;

positioning the contralateral limb within the contralateral iliac artery by proximally retracting the deployment system;

deploying the self-expanding ipsilateral limb of the prosthesis within the ipsilateral iliac artery by proximally retracting a middle core of the deployment system;

deploying the self-expanding main body section of the prosthesis within the aorta by distally advancing an inner core of the deployment system;

deploying the second branch section within the second branch vessel; and

retracting the deployment system proximally through a central lumen in the main body and ipsilateral limb sections of the prosthesis and out of the patient'"'"'s body.

11. A method as in claim 10, wherein the deploying the second branch section step is accomplished by removing a tubular restraining sheath from around the second branch section.

12. A method as in claim 11, wherein the removing step comprises tearing the restraining sheath.

13. A method as in claim 11, wherein the removing step comprises axially displacing the restraining sheath from the second branch section.

17. A method as in claim 12, wherein the deploying step comprises expanding a second portion of the graft by applying an electrical current thereto.

14. A method of implanting a bifurcation graft, comprising the steps of:

providing a bifurcation graft having a trunk portion and first and second branch portions, the graft mounted on a delivery catheter such that the first and second branch portions are substantially parallel;

introducing the graft into a vessel through a vascular access site;

transluminally advancing the graft to a bifurcation where a trunk vessel branches into first and second branch vessels;

manipulating the catheter to position the graft such that the trunk portion is in the trunk vessel, the first branch portion is in the first branch vessel and the second branch portion is in the second branch vessel;

deploying the graft from the catheter at the bifurcation; and

removing the catheter from the vessel through the access site;

wherein access to the graft during the manipulating and deploying steps is accomplished solely through the vascular access site.

15. A method as in claim 14, wherein the deploying step comprises permitting at least a first portion of the graft to self expand.

16. A method as in claim 15, wherein the deploying step comprises removing a tubular restraint from the first portion to permit it to self expand.

18. A method as in claim 16, wherein the removing step comprises tearing the restraint.