Steerable endovascular graft delivery system

• US 7,553,323 B1
• Filed: 01/08/2004
• Issued: 06/30/2009
• Est. Priority Date: 01/08/2004
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Rapoza, Richard, Perez, Juan I., Lemere, Mark
• Primary Examiner(s): Stewart; Alvin J
• Application Number:
  US10/755,209
• Time in Patent Office: 2,000 Days
• Field of Search: 623/1.23, 623/1.11, 623/1.13, 606/108, 606191-195
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/9505 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

Abstract

The present invention embodies delivery systems and methods for delivering medical repair devices that allow the flexibility of the delivery system to be varied and allow the delivery system to be steered and directed in a particular direction.

Claims

1. A system for repair of vasculature, comprising:

an elongate member having a superior portion and an inferior portion and at least one lumen therethrough, the superior portion having a superior tip with reduced diameter;

a repair device mounted near the superior portion of the elongate member and having means for anchoring the repair device in vasculature;

a jacket coaxially disposed about the elongate member; and

means for varying the flexibility of the elongate member, the means extending to the superior tip of the elongate member and including structure providing a particular point along the elongate member with alternatively a first flexibility and a second flexibility; and

means for releasably attaching the jacket to the elongate member such that relative movement is precluded.

2. The system of claim 1, wherein the means for varying flexibility comprises a hypotube slidably disposed within the elongate member such that the hypotube may be moved longitudinally relative to the elongate member.

3. The system of claim 2, wherein the slidable hypotube may be advanced into the superior portion of the elongate member such that the hypotube is inside the reduced diameter superior tip.

4. The system of claim 2, the inferior portion of the elongate member further comprising means for limiting the advancement and retraction of the slidable hypotube in the elongate member.

5. The system of claim 2, further comprising means for releasably attaching the slidable hypotube to the elongate member such that relative movement is precluded.

6. The system of claim 1, further comprising a hypotube fixedly attached to the superior portion elongate member.

7. The system of claim 6, wherein the means for varying flexibility comprises areas of the fixed hypotube having reduced outside diameter.

8. The system of claim 1, wherein the repair device is releasably attached to the elongate member by a release wire.

9. The system of claim 1, further comprising an inflatable balloon near the superior portion.

10. The system of claim 9, wherein the inflatable balloon is under the repair device.

11. The system of claim 1, wherein the elongate member comprises a tri-lumen.

12. The system of claim 1, further comprising a stop ring attached to the elongate member adjacent the repair device anchoring means.

13. The system of claim 1, further comprising a jacket guard attached to the elongate member distal the reduced diameter superior tip.

14. The system of claim 1, comprising a molded superior portion permanently affixed to the elongate member, the molded superior portion having a reduced diameter tip, a stop ring adjacent the repair device anchoring means, a jacket guard distal the reduced diameter tip and a tube.

15. A system for repair of vasculature, comprising:

an elongate member having a superior portion and an inferior portion and at least one lumen therethrough, the superior portion having a superior tip with reduced diameter;

a repair device mounted near the superior portion of the elongate member and having means for anchoring the repair device in vasculature;

a jacket coaxially disposed about the elongate member; and

a hypotube slidably disposed within the elongate member, the hypotube extending to the superior tip of the elongate member such that moving the hypotube relative to the elongate member varies the flexibility of the elongate member and provides a particular point along, the elongate member with alternatively a first flexibility and a second flexibility and

wherein the elongate member comprises a second hypotube fixedly attached to the superior portion.

16. A system for repair of vasculature, comprising:

an elongate member having a superior portion and an inferior portion and at least one lumen therethrough, the superior portion comprising a molded tip with an SST tube inserted therein, the SST tube having a superior end with a reduced diameter tip and an inferior portion having a stop ring and jacket guard;

a first hypotube permanently attached to the inferior portion of the SST tube;

a repair device releasably attached near the superior portion of the elongate member by a release wire and having means for anchoring the repair device in vasculature;

a jacket coaxially disposed about the elongate member; and

a second hypotube slidably disposed within the first hypotube, the second hypotube extending into the SST tube reduced diameter tip and attached to a slider mechanism at the inferior portion of the elongate member such that the second hypotube may be moved longitudinally relative to the elongate member.

17. A system for repair of vasculature, comprising:

an inner member having a superior portion and an inferior portion and at least one lumen therethrough, the superior portion of the inner member being highly flexible;

a repair device mounted at the superior portion of the inner member and having means for anchoring the repair device in vasculature;

at least one steering ring coaxially attached at the superior portion of the inner member distal the repair device anchoring means, the at least one steering ring having a center aperture therethrough;

a plurality of steering wires attached to the at least one steering ring such that manipulating the steering wires causes the superior portion of the inner member to bend;

an outer member having a superior portion and an inferior portion and coaxially disposed over at least a portion of the inner member;

means for manipulating the steering wires; and

a jacket coaxially disposed about the inner member- and outer member, the jacket having a superior end and an inferior end.

18. The system of claim 17, wherein the at least one steering ring is attached to the inner member with an adhesive.

19. The system of claim 17, wherein areas of increased diameter on the inner member preclude longitudinal movement of the at least one steering ring.

20. The system of claim 17, the at least one steering ring comprising eyelets about the circumference.

21. The system of claim 17, wherein the steering wires extend distally from the at least one steering ring between the inner member and the outer member.

22. The system of claim 21, the outer member further comprising at least one lumen through which the steering wires extend the at least one lumen exiting the outer member distal the inferior end of the jacket.

23. The system of claim 17, wherein the manipulating means is located on the inferior portion of the outer member.

24. The system of claim 17, wherein the manipulating means is located on the inferior portion of the inner member.

25. The system of claim 24, wherein the outer member can be moved longitudinally relative to the inner member.

26. The system of claim 17, wherein the manipulating means comprises a plurality of steering controllers, each steering controller adapted to manipulate at least two steering wires such that the superior portion of the inner member bends in both the horizontal and vertical planes.

27. The system of claim 17, wherein the manipulating means is adapted to preclude manipulation of the plurality of steering wires in the absence of an external force applied to the steering means.

28. The system of claim 17, wherein the at least one steering ring comprises a flat proximal side and a convex distal side.

29. The system of claim 17, the outer member further comprising a base at the superior portion, the base having a concave proximal side, a center aperture therethrough and a plurality of apertures about the circumference, the concave side abutting the convex side of the at least one steering ring such that the convex side of the at least one steering ring oscillates about the concave side of the base when the steering wires are manipulated.

30. The system of claim 17, wherein the at least one steering ring is located distal the repair device.

31. The system of claim 17, wherein the at least one steering ring is located adjacent the repair device anchoring means.

32. The system of claim 31, wherein the outer member extends longitudinally between the repair device and the at least one steering ring and plurality of steering wires and the superior portion of the outer member is adjacent the repair device anchoring means.

33. The system of claim 31, further comprising a shield between the repair device and the at least one steering ring and plurality of steering wires.

34. The system of claim 33, wherein the shield is formed of flexible shrink tubing.

35. The system of claim 17, comprising a plurality of steering rings.

36. The system of claim 35, wherein the most proximal steering ring has the plurality of steering wires attached thereto and the distal steering rings have apertures about the circumference.

37. The system of claim 35, wherein the plurality of steering rings have a flat proximal side and a convex distal side, the convex side of each steering ring abutting the flat side of the next adjacent steering ring such that the plurality of steering rings move in unison when the steering wires are manipulated.

38. The system of claim 35, further comprising a plurality of steering guides between adjacent steering rings such that the plurality of steering rings move in unison when the steering wires are manipulated.

39. The system of claim 17, wherein the steering wires are formed of Nitinol and are about 0.012 to about 0.020 inches thick.

40. A system for repair of vasculature, comprising:

an inner member having a superior portion and an inferior portion with at least one lumen therethrough, the superior portion of the inner member being highly flexible;

a repair device mounted at the superior portion of the inner member and having means for anchoring the repair device in vasculature;

a plurality of steering rings coaxially attached to the inner member distal the repair device anchoring means, the most proximal steering ring having a plurality of steering wires attached thereto;

means for causing the plurality of steering rings to bend in unison when the steering wires are manipulated such that manipulating the steering wires causes the superior portion of the inner member to bend in both the horizontal and vertical planes;

an outer member coaxially disposed over at least a portion of the inner member;

means for manipulating the steering wires; and

a jacket coaxially disposed about the inner member and outer member.

41. A system for repair of vasculature, comprising:

an inner member having a superior portion and an inferior portion with at least one lumen therethrough, the superior portion having a superior tip with reduced diameter;

a repair device mounted at the superior portion of the inner member and having means for anchoring the repair device in vasculature;

means for varying the flexibility of the inner member, the means extending to the reduced diameter superior tip of the inner member;

at least one steering ring coaxially attached to the inner member distal the repair device anchoring means and having a plurality of steering wires attached thereto such that manipulating the steering wires causes the superior portion of the inner member to bend;

an outer member coaxially disposed over at least a portion of the inner member;

means for manipulating the steering wires; and

a jacket coaxially disposed about the inner member and outer member.

42. The system of claim 41, wherein the means for varying flexibility comprises a hypotube slidably disposed within the inner member such that the hypotube may be moved longitudinally relative to the inner member.

43. The system of claim 41, further comprising a hypotube fixedly attached to the superior portion of the inner member and wherein the means for varying flexibility comprises areas of the hypotube having reduced outside diameter.

44. A method of repairing vasculature, comprising:

providing a catheter having an inner member coaxially disposed within an outer member, the superior portion of the inner member being highly flexible and having a repair device mounted thereon, the repair device having means for anchoring in vasculature, at least one steering ring coaxially attached to the inner member, the at least one steering ring having a plurality of steering wires attached thereto, and means for manipulating the steering wires such that manipulating the steering wires causes the superior portion of the inner member to bend;

advancing the catheter in vasculature such that the anchoring means of the repair device is adjacent a repair site;

manipulating the steering wires to position the anchoring means of the repair device;

deploying the anchoring means of the repair device.

45. The method of claim 44, the inner member having the means for varying the flexibility of the inner member disposed therein and comprising retracting the variable flexibility means such that the inner member is highly flexible.