Delivery system and method for endovascular graft

• US 20020151956A1
• Filed: 04/11/2001
• Published: 10/17/2002
• Est. Priority Date: 04/11/2001
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Chobotov, Michael V., Glynn, Brian A.
• Granted Patent: US 6,733,521 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

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.

Claims

1. A delivery system for an expandable intracorporeal device comprising:

an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising;

a portion having disposed thereon the expandable intracorporeal device;

an elongate belt support member disposed adjacent a portion of the expandable intracorporeal device;

a belt secured to the belt support member and circumferentially disposed about the expandable intracorporeal device and which constrains at least a portion of the expandable intracorporeal device; and

a release member which releasably secures the belt in the constraining configuration.

2. The delivery system of claim 1 wherein the belt constrains a self-expanding portion of the expandable intracorporeal device.

3. The delivery system of claim 2 wherein the self-expanding portion is a tubular stent.

4. The delivery system of claim 3 wherein the stent comprises a cicumferential groove configured to accept at least a portion of the belt.

5. The delivery system of claim 1 wherein the belt support member is an elongate tubular member and the expandable intracorporeal member is an endovascular graft in a constrained state.

6. The delivery system of claim 1 wherein the belt comprises at least one length of wire having a first end and a second end.

7. The delivery system of claim 6 wherein the at least one length of wire is configured in at least one loop with each of said first and second wire ends secured to the belt support member.

8. The delivery system of claim 6 wherein the wire comprises a shape memory alloy.

9. The delivery system of claim 8 wherein the wire comprises nickel titanium.

10. The delivery system of claim 1 wherein the release member comprises a release wire releasably secured to at least one end of the belt.

11. The delivery system of claim 10 wherein the release wire is moveably disposed within opposed looped ends of the belt.

12. The delivery system of claim 1 wherein the belt in the constraining configuration forms a plane which is substantially orthogonal to a longitudinal axis of the elongate shaft.

13. The delivery system of claim 1 wherein a plurality of belts are secured to various axial positions on the belt support member and circumferentially disposed about the expandable intracorporeal device and have a configuration that constrains the expandable intracorporeal device, and

at least one release member that releasably secures the belts in the constraining configuration.

14. The delivery system of claim 13 wherein the number of belts is three.

15. The delivery system of claim 13 wherein at least two belts are configured to be releasable by the same release member.

16. The delivery system of claim 13 wherein all the belts are configured to be releasable by the same release member.

17. The delivery system of claim 15 wherein the order in which the at least two belts are released is determined by the axial position of the at least two belts and the direction of movement of the at least one release member.

18. The delivery system of claim 17 wherein the at least one release member comprises a release wire moveably disposed within opposed looped ends of each belt and wherein the delivery system is configured such that a distal-most belt will be released first when a distal end of the release wire is retracted in a proximal direction so as to move past the looped ends of the distal-most belt, and belts located more proximally are released sequentially thereafter as the distal end of the release wire passes the respective looped ends thereof.

20. The delivery system of claim 19 wherein the belt support member comprises a guidewire tube.

21. The delivery system of claim 19 wherein the belt comprises nickel titanium.

22. The delivery system of claim 19 wherein the endovascular graft comprises a plurality of self-expanding members and wherein a plurality of belts are secured to various axial positions on the belt support member adjacent the plurality of self-expanding members, and circumferentially disposed about the self-expanding members and having a configuration which constrains the self-expanding members.

23. The delivery system of claim 22 wherein the release wire is moveably disposed within opposed looped ends of the belts and configured such that a distal-most belt will be released first when a distal end of the release wire is retracted in a proximal direction so as to move past the looped ends of the distal most belt, and belts located more proximally in an axial direction are released sequentially thereafter as the distal end of the release wire passes the respective looped ends thereof.

24. The delivery system of claim 22 wherein the distal section of the delivery system comprises at least two release wires configured to release different belts.

25. The delivery system of claim 19 wherein the distal section further comprises an outer protective sheath disposed about the endovascular graft while the graft is in a constrained state, the belts being in their constraining configuration and at least a portion of the release wire being disposed at the belts.

28. The method of claim 27 wherein the delivery system further comprises an outer protective sheath disposed about the endovascular graft in a constrained state, the belt in its constraining configuration and at least a portion of the release wire disposed at the belt, and further comprising retracting the outer protective sheath from the endovascular graft while the graft is in a constrained configuration prior to activating the release member.

29. The method of claim 28 wherein the outer protective sheath comprises an outer tubular member and is retracted in a proximal direction while the graft is in a constrained configuration prior to activating the release member.

19. A delivery system for an endovascular graft with a flexible tubular body portion and at least one self-expanding member secured to the flexible tubular body portion, comprising:

an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising;

a portion having disposed thereon the self-expanding endovascular graft;

an elongate belt support member disposed adjacent the self-expanding member of the endovascular graft;

a belt secured to the belt support member adjacent the self-expanding member and circumferentially disposed about the self-expanding member and which has a configuration which constrains the self-expanding member; and

a release wire releasably securing ends of the belt in the constraining configuration.

26. A delivery system for an endovascular graft with a flexible tubular body portion and a plurality of self-expanding members secured to the tubular body portion, comprising:

an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising;

a portion having disposed thereon a self-expanding endovascular graft;

an elongate guidewire tube disposed within the endovascular graft with the endovascular graft being in a constrained state;

a plurality of shape memory wire belts secured to the guidewire tube adjacent the respective self-expanding members, the belts being circumferentially disposed about the respective self-expanding members and which have a configuration that constrains the respective self-expanding members;

a first release wire that releasably secures ends of the belts disposed about the self-expanding members at the distal end of the endovascular graft in the constraining configuration; and

a second release wire that releasably secures ends of the belts disposed about the self-expanding members at the proximal end of the endovascular graft in the constraining configuration.

27. A method for deploying an expandable intracorporeal device within a patient'"'"'s body comprising:

a) providing a delivery system for an expandable intracorporeal device including;

an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising;

an elongate belt support member disposed adjacent a portion of the expandable intracorporeal device,

a belt secured to the belt support member and circumferentially disposed about the expandable intracorporeal device and which has a configuration which constrains the expandable intracorporeal device, and

a release member which releasably secures the belt in the constraining configuration;

b) introducing the distal end of the delivery system into the patient'"'"'s body;

c) advancing the delivery system to a desired site within the patient'"'"'s body; and

d) activating the release member to release the belt from the constraining configuration.

30. A method for deploying within a patient'"'"'s body an endovascular graft having with a flexible tubular body portion and a plurality of self-expanding members secured to the tubular body portion, comprising:

a) providing a delivery system for an expandable intracorporeal device including;

an elongate shaft having a proximal section and a distal section with the distal section of the elongate shaft comprising;

an elongate guidewire tube disposed within the endovascular graft, the graft being in a constrained state,

a plurality of shape memory wire belts secured to the guidewire tube adjacent the respective self-expanding members, the belts being circumferentially disposed about the respective self-expanding members and which have a configuration that constrains the respective self-expanding members,

a first release wire that releasably secures ends of the belts disposed about the self-expanding members at the proximal end of the endovascular graft in the constraining configuration, and

a second release wire that releasably secures ends of the belts disposed about the self-expanding members at the distal end of the endovascular graft in the constraining configuration;

b) introducing the distal end of the delivery system into the patient'"'"'s body;

c) advancing the delivery system to a desired site within the patient'"'"'s body; and

d) activating the release wires to release the belts from the constraining configuration.

31. The method of claim 30 wherein the delivery system further comprises an outer protective sheath disposed about the endovascular graft in a constrained state, the belt in its constraining configuration and at least a portion of the release wires disposed at the belt, and further comprising retracting the outer protective sheath from the endovascular graft while the graft is in a constrained configuration prior to activating the release wires.

32. A delivery system for an expandable intracorporeal device comprising:

an elongate shaft having a proximal section and a distal section with the distal section comprising;

an elongate belt support member disposed adjacent a portion of the distal portion configured to receive an expandable intracorporeal device;

at least one belt secured to the belt support member and which is configured to be circumferentially disposed about the expandable intracorporeal device to constrain the expandable intracorporeal device; and

a release member which releasably secures the belt in the constraining configuration.

33. The delivery system of claim 32 wherein the belt support member is an elongate tubular member and the expandable intracorporeal member is an endovascular graft in a constrained state.

34. The delivery system of claim 32 wherein the belt comprises at least one length of wire having a first end and a second end.

35. The delivery system of claim 34 wherein the at least one length of wire is configured in at least one loop with each of said first and second wire ends secured to the belt support member.

36. The delivery system of claim 34 wherein the wire comprises a shape memory alloy.

37. The delivery system of claim 36 wherein the wire comprises nickel titanium.

38. The delivery system of claim 32 wherein the release member comprises a release wire releasably secured to loop ends of the belt.

39. The delivery system of claim 38 wherein the release wire is moveably disposed within opposed looped ends of the belt.

40. The delivery system of claim 32 wherein the belt in the constraining configuration forms a plane which is substantially orthogonal to a longitudinal axis of the elongate shaft.

41. The delivery system of claim 32 wherein the delivery system comprises a plurality of belts.

42. The delivery system of claim 41 wherein at least two belts are configured to be releasable by the same release member.

43. The delivery system of claim 41 wherein all the belts are configured to be releasable by the same release member.

44. The delivery system of claim 42 wherein the order in which the at least two belts are released is determined by the axial position of the at least two belts and the direction of movement of the at least one release member.

45. The delivery system of claim 44 wherein the at least one release member comprises a release wire moveably disposed within at least one end of each belt and wherein the delivery system is configured such that a distal-most belt will be released first when a distal end of the release wire is retracted in a proximal direction so as to move past the at least one end of the distal-most belt, and belts located more proximally are released sequentially thereafter as the distal end of the release wire passes the respective ends thereof.

46. The delivery system of claim 41 further comprising a plurality of release members wherein at least a portion of the proximal end of at least two of the release members are different colors.

47. The delivery system of claim 46 wherein the release members comprise release wire handles secured to proximal ends of release wires and at least a portion of at least two of the release wire handles are of different colors.

48. The delivery system of claim 41 further comprising a plurality of release members wherein proximal ends of the release members are in a linear spatial configuration at a proximal end of the delivery system that corresponds to a desired deployment order for the plurality of belts.

49. The delivery system of claim 41 wherein the release member comprises a branched release wire.