METHOD OF DELIVERING ADVANCED ENDOVASCULAR GRAFT

• US 20100016943A1
• Filed: 09/25/2009
• Published: 01/21/2010
• Est. Priority Date: 12/20/2001
• Status: Abandoned Application

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Chobotov, Michael V.
• Application Number:
  US12/566,808
• Publication Number:
  US 20100016943A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• 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: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• 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 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes

Abstract

A flexible low profile delivery system for delivery of an expandable intracorporeal device, specifically, an endovascular graft, which has at least one belt circumferentially disposed about the device in a constraining configuration. The belt is released by a release member, such as a release wire, by retracting the wire from looped ends of the belt. Multiple belts can be used and can be released sequentially so as to control the order of release and placement of the endovascular graft. An outer protective sheath may be disposed about the endovascular graft while in a constrained state which must first be retracted or otherwise removed prior to release of the graft from a constrained state. The delivery system can be configured for delivery over a guiding device such as a guidewire. The delivery system can also be configured for delivery of bifurcated intracorporeal devices.

Claims

1. A method of treating a patient'"'"'s vasculature, comprising:

delivering an endovascular graft in a constrained state to a target location within a patient'"'"'s vasculature with a delivery system, the endovascular graft including a tubular graft body section and a distal self-expanding member disposed distally of the graft body section and the endovascular graft being disposed within an outer tubular member of the delivery system;

retracting a distal section of the outer tubular member of the delivery system from the constrained endovascular graft;

repositioning the endovascular graft by manipulation of a proximal portion of the delivery system; and

deploying the distal self-expanding member of the graft by manipulation of a handle disposed on the proximal portion of the delivery system such that the distal self-expanding member engages tissue of the patient'"'"'s vasculature in which the graft is deployed and prevents axial migration of the graft due to blood flow within the patient'"'"'s vasculature.

2. The method of claim 1 wherein deployment of the distal self-expanding member comprises release of a constraint disposed about the distal self-expanding member.

3. The method of claim 1 wherein delivering the endovascular graft to a treatment site within the patient'"'"'s body with a delivery system comprises advancing the delivery system over a guidewire.

4. The method of claim 1 further comprising using fluoroscopic imaging to visualize and reposition the endovascular graft.

5. The method of claim 4 wherein using fluoroscopic imaging to visualize and reposition the endovascular graft further comprises fluoroscopic imaging of at least one radiopaque marker secured to the delivery system.

6. The method of claim 4 wherein using fluoroscopic imaging to visualize and reposition the endovascular graft further comprises fluoroscopic imaging of at least one radiopaque marker secured to the endovascular graft.

7. The method of claim 1 wherein the distal self-expanding member comprises one or more barbs disposed on struts of the distal self-expanding member and further comprising deploying the barbs such that the one or more barbs engage tissue of the patient'"'"'s vasculature in which the graft is deployed and prevent axial migration of the graft due to blood flow within the patient'"'"'s vasculature.

8. The method of claim 7 wherein the one or more barbs of the distal self-expanding member comprise barbs which are integrally formed with respective struts of the distal self-expanding member.

9. A method of treating a patient'"'"'s vasculature, comprising:

delivering an endovascular graft in a constrained state to a treatment site within a patient'"'"'s body with a delivery system, the endovascular graft including a tubular graft body section and a distal self-expanding member disposed distally of a second self-expanding member and the tubular graft body section;

deploying the second self-expanding member of the endovascular graft by manipulation of a handle disposed on a proximal portion of the delivery system;

repositioning the endovascular graft by manipulation of a proximal portion of the delivery system; and

deploying the distal self-expanding member of the graft by manipulation of a handle disposed on the proximal portion of the delivery system such that the distal self-expanding member engages tissue of the patient'"'"'s vasculature in which the graft is deployed and prevents axial migration of the graft due to blood flow within the patient'"'"'s vasculature.

10. The method of claim 9 wherein deployment of the distal self-expanding member comprises release of a constraint disposed about the distal self-expanding member.

11. The method of claim 9 wherein delivering the endovascular graft to a treatment site within the patient'"'"'s body with a delivery system comprises advancing the delivery system over a guidewire.

12. The method of claim 9 further comprising using fluoroscopic imaging to visualize and reposition the endovascular graft.

13. The method of claim 12 wherein using fluoroscopic imaging to visualize and reposition the endovascular graft further comprises fluoroscopic imaging of at least one radiopaque marker secured to the delivery system.

14. The method of claim 12 wherein using fluoroscopic imaging to visualize and reposition the endovascular graft further comprises fluoroscopic imaging of at least one radiopaque marker secured to the endovascular graft.

15. The method of claim 9 wherein the distal self-expanding member comprises one or more barbs disposed on struts of the distal self-expanding member and further comprising deploying the barbs such that the one or more barbs engage tissue of the patient'"'"'s vasculature in which the graft is deployed and prevent axial migration of the graft due to blood flow within the patient'"'"'s vasculature.

16. The method of claim 15 wherein the one or more barbs of the distal self-expanding member comprise barbs which are integrally formed with respective struts of the distal self-expanding member.

17. An endovascular graft delivery system configured to deliver an endovascular graft to a target location within a patient'"'"'s vasculature and deploy the endovascular graft at the target location, comprising:

an endovascular graft including a tubular graft body section and a distal self-expanding member which is disposed distally of a second self-expanding member and the graft body section;

an elongate shaft having a proximal section and a distal section;

a first handle disposed on a proximal portion of the delivery catheter and configured to deploy the distal self-expanding member; and

a second handle disposed on the proximal portion of the delivery catheter and configured to deploy the second self-expanding member.

18. The endovascular graft delivery system of claim 17 further comprising an outer tubular member configured to cover the endovascular graft in a constrained state during delivery to a target location within the patient'"'"'s vasculature and configured to be retracted proximally to expose the endovascular graft.

19. The endovascular graft delivery system of claim 17 wherein the elongate shaft of the delivery system further comprises a guidewire lumen.

20. The endovascular graft delivery system of claim 17 further comprises a radiopaque marker imagable by fluoroscopy.

21. The endovascular graft delivery system of claim 17 wherein the distal self-expanding member comprises one or more barbs disposed on struts of the first distal self-expanding member.

22. The endovascular graft delivery system of claim 21 wherein the one or more barbs of the distal self-expanding member comprise barbs which are integrally formed with respective struts of the distal self-expanding member.

23. An endovascular graft delivery system configured to deliver an endovascular graft in a constrained state to a target location within a patient'"'"'s vasculature and deploy the endovascular graft at the target location, comprising:

an endovascular graft including a tubular graft body section and a distal self-expanding member which is disposed distally of a second self-expanding member and the graft body section;

an elongate shaft having a proximal section and a distal section;

an outer tubular member disposed over the constrained graft configured to cover the endovascular graft in a constrained state during delivery to the target location within the patient'"'"'s vasculature and configured to be retracted proximally to expose the endovascular graft; and

a first handle disposed on a proximal portion of the delivery catheter and configured to deploy the distal self-expanding member.

24. The endovascular graft delivery system of claim 23 wherein the elongate shaft of the delivery system further comprises a guidewire lumen.

25. The endovascular graft delivery system of claim 23 further comprises a radiopaque marker imagable by fluoroscopy.

26. The endovascular graft delivery system of claim 23 wherein the distal self-expanding member comprises one or more barbs disposed on struts of the first distal self-expanding member.

27. The endovascular graft delivery system of claim 26 wherein the one or more barbs of the distal self-expanding member comprise barbs which are integrally formed with respective struts of the distal self-expanding member.

28. A method of treating a patient'"'"'s vasculature, comprising:

delivering an endovascular graft in a constrained state to a target location within a patient'"'"'s vasculature with a delivery system;

partially deploying the endovascular graft by manipulation of a handle on a proximal portion of the delivery system;

repositioning the endovascular graft within the patient'"'"'s vasculature by manipulation of a proximal portion of the delivery system; and

deploying a self-expanding member of the endovascular graft by manipulation of a handle disposed on the proximal portion of the delivery system such that the self-expanding member engages tissue of the patient'"'"'s vasculature and prevents axial migration of the graft due to blood flow.

29. The method of claim 28 wherein a self-expanding member of the endovascular graft comprises one or more barbs and deploying the self-expanding member comprises engaging tissue of the patient'"'"'s vasculature with the one or more barbs to prevent axial migration of the graft due to blood flow.

30. An endovascular graft delivery system configured to deliver an endovascular graft to a target location within a patient'"'"'s vasculature and deploy the endovascular graft at the target location, comprising:

an endovascular graft including a graft body section and a distal self-expanding member which is disposed distally of the graft body section;

an elongate shaft having a proximal section and a distal section;

a handle disposed on a proximal portion of the delivery system configured to partially deploy the endovascular graft upon actuation of the handle; and

a handle disposed on the proximal portion of the delivery system configured to deploy the self-expanding member of the endovascular graft.

31. The delivery system of claim 30 wherein the self-expanding member of the endovascular graft comprises one or more barbs configured to engage tissue of the patient'"'"'s vasculature in a deployed state to prevent axial migration of the graft due to blood flow.