Endovascular graft

• US 6,395,019 B2
• Filed: 08/14/1998
• Issued: 05/28/2002
• Est. Priority Date: 02/09/1998
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Chobotov, Michael V.
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/133,978
• Publication Number:
  US 20010023369A1
• Time in Patent Office: 1,383 Days
• Field of Search: 606/1,108,191,194,198 623/1.1,1.23,1.25,1.37,1.35,1.36
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/945 hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

An endovascular graft which is configured to conform to the morphology of the vessel to be treated and which is made from an inflatable structure having a proximal end with a proximal inflatable cuff and a distal end with a distal inflatable cuff. At least one elongated inflatable channel is disposed between and in fluid communication with fluid tight chambers of the inflatable cuffs which may contain rupture discs therebetween which can be configured to rupture at different pressures. A thin flexible barrier disposed between the inflatable cuffs and the elongated inflatable channel of the frame so as to form a tubular structure defining a longitudinal channel to confine a flow of blood or other fluid therethrough. The graft may also have an expansion member attached to the proximal end of the graft which is preferably made of linked expandable rings of pseudoelastic shape memory alloy which is self expanding and prevents axial displacement of the graft once it is deployed.

Claims

1. An endovascular graft comprising:

a) a tubular structure having a first end portion and a second end portion;

b) an inflatable cuff permanently secured to the tubular structure adjacent the first end portion; and

c) a non-inflatable expansion member secured to and extending from the first end portion away from the tubular structure and configured to exert an outward radial force independent of the tubular structure.

2. The endovascular graft of claim 1 wherein the inflatable cuff is configured to sealingly engage an interior surface of a vessel wall.

3. The endovascular graft of claim 1 further comprising a neck portion at the first end portion having an inlet axis which forms an angle up to about 45 degrees with a longitudinal axis of the tubular structure.

4. The endovascular graft of claim 1 wherein the inflatable cuff is formed separately from the tubular structure and bonded thereto.

5. The endovascular graft of claim 1 wherein the inflatable cuff is integral with the tubular structure to form a monolithic structure.

6. The endovascular graft of claim 1 wherein the inflatable cuff is formed by bonding the edges of strips of material to the tubular structure.

7. The endovascular graft of claim 1 wherein the non-inflatable expansion member is self-expanding.

8. An endovascular graft comprising:

a) an inflatable frame structure having a proximal end and a distal end, with a proximal inflatable cuff disposed on the proximal end and at least one elongated inflatable channel in fluid communication with the proximal inflatable cuff;

b) a thin flexible layer member disposed between the proximal inflatable cuff, and the elongated inflatable channel of the frame to form a longitudinal channel; and

c) a non-inflatable expansion member disposed proximal of the proximal inflatable cuff, secured to the proximal end of the inflatable frame structure, extending away from the inflatable frame structure and configured to exert an outward radial force independent of the inflatable frame structure.

9. The endovascular graft of claim 8 wherein the non-inflatable expansion member is comprised of linked expandable rings.

10. The endovascular graft of claim 9 wherein the linked expandable rings are comprised of a pseudoelastic shape memory alloy.

11. The endovascular graft of claim 10 wherein the linked expandable rings further comprise outwardly directed protuberances.

12. The endovascular graft of claim 8 further comprising a rupture disc disposed between a fluid tight chamber of the proximal inflatable cuff and a fluid tight chamber of the elongated channel.

13. The endovascular graft of claim 8 wherein the thin flexible layer is disposed over, at least partially surrounds, and is secured to the inflatable frame structure.

14. The endovascular graft of claim 8 wherein the thin flexible layer is disposed within and secured to the inflatable frame structure.

15. The endovascular graft of claim 8 further comprising a proximal neck portion secured to the proximal end of the inflatable frame structure.

16. The endovascular graft of claim 15 wherein the proximal neck portion tapers proximally to a reduced diameter.

17. The endovascular graft of claim 15 wherein the proximal neck portion tapers proximally to an increased diameter.

18. The endovascular graft of claim 8 further comprising a distal neck portion.

19. The endovascular graft of claim 18 wherein the distal neck portion tapers distally to a reduced diameter.

20. The endovascular graft of claim 18 wherein the distal neck portion tapers distally to an increased diameter.

21. The endovascular graft of claim 17 further comprising a distal neck portion that tapers distally to a increased diameter.

22. The endovascular graft of claim 15 wherein the proximal neck portion further comprises a proximal inlet axis which forms an inlet axis angle with a longitudinal axis of the endovascular graft of up to about 50 degrees.

23. The endovascular graft of claim 22 wherein the inlet axis angle is about 20 to about 30 degrees.

24. The endovascular graft of claim 8 wherein the non-inflatable expansion member is secured to the proximal end of the inflatable frame structure and has an inlet axis which forms an angle with respect to a longitudinal axis of the endovascular graft of up to about 40 degrees.

25. The endovascular graft of claim 8 wherein the non-inflatable expansion member is self-expanding.

26. An endovascular graft comprising:

a) a tubular main body portion with a distal end, a proximal end, a proximal inflatable cuff disposed on the proximal end, a non-inflatable expansion member which is disposed proximally of the proximal inflatable cuff, secured to the proximal end extending away from the tubular main body portion and configured to exert an outward radial force independent of the tubular main body portion, at least one elongated inflatable channel in fluid communication with the proximal inflatable cuff, and a thin flexible layer disposed between the proximal inflatable cuff and elongated inflatable channel so as to form a conduit to confine a flow of fluid therethrough;

b) a first bifurcated tubular portion having a distal end and a proximal end which is secured to the distal end of the tubular main body portion, and having a conduit therein extending from the proximal end to the distal end, said conduit in fluid communication with the conduit of the tubular main body portion; and

c) a second bifurcated tubular portion having a distal end and a proximal end which is secured to the distal end of the tubular main body portion, and having a conduit therein extending from the proximal end to the distal end, said conduit in fluid communication with the conduit of the tubular main body portion.

27. The endovascular graft of claim 26 wherein the non-inflatable expansion member is comprised of linked expandable rings.

28. The endovascular graft of claim 27 wherein the linked expandable rings are comprised of a pseudoelastic shape memory alloy.

29. The endovascular graft of claim 28 wherein the linked expandable rings further comprise outwardly directed protuberances.

30. The endovascular graft of claim 26 wherein a rupture disc is disposed between a fluid tight chamber of the proximal inflatable cuff and a fluid tight chamber of the elongate inflatable channel.

31. The endovascular graft of claim 30 wherein the first bifurcated tubular portion further comprises an elongated inflatable channel in fluid communication with the elongated inflatable channel of the tubular main body portion and the second bifurcated tubular portion further comprises an elongated inflatable channel in fluid communication with the elongated inflatable channel of the tubular main body portion.

32. The endovascular graft of claim 31 further comprising a rupture disc disposed between the fluid tight chamber of the elongated inflatable channel of the tubular main body portion and a fluid tight chamber of the elongated inflatable channel of the first bifurcated tubular portion.

33. The endovascular graft of claim 32 further comprising a rupture disc disposed between the fluid tight chamber of the elongated inflatable channel of the tubular main body portion and a fluid tight chamber of the elongated inflatable channel of the second bifurcated tubular portion.

34. The endovascular graft of claim 33 wherein the rupture discs have different burst thresholds to facilitate sequential deployment of the graft.

35. The endovascular graft of claim 26 further comprising a proximal neck portion disposed on the proximal end of the tubular main body portion.

36. The endovascular graft of claim 35 wherein the proximal neck portion tapers proximally to a reduced diameter.

37. The endovascular graft of claim 35 wherein the proximal neck portion tapers proximally to an increased diameter.

38. The endovascular graft of claim 26 wherein the proximal end of the tubular main body portion further comprises a proximal inlet axis which forms an inlet axis angle with respect to a longitudinal axis of the main body portion of up to about 50 degrees.

39. The endovascular graft of claim 38 wherein the inlet axis angle is about 20 to about 30 degrees.

40. The endovascular graft of claim 26 wherein the expansion member further comprises a proximal inlet axis which forms an inlet axis angle with respect to a longitudinal axis of the endovascular graft of about 20 to about 30 degrees.

41. The endovascular graft of claim 26 further comprising elongated battens disposed upon the graft.

42. The endovascular graft of claim 41 wherein the battens are comprised of metal or plastic.

43. The endovascular graft of claim 26 wherein the non-inflatable expansion member is self-expanding.

44. A method of deploying an endovascular graft comprising:

a) providing an inflatable endovascular graft comprising;

a tubular body member having a proximal end and a distal end;

a proximal inflatable cuff disposed on the proximal end of the tubular body member; and

a non-inflatable expansion member disposed proximally of the proximal inflatable cuff, secured to the proximal end of the tubular member extending away from the tubular body member and configured to exert an outward radial force independent of the tubular body member;

b) positioning the graft in a desired location within a body channel of a patient;

c) allowing the non-inflatable expansion member to expand to conform to a morphology of the body channel; and

d) inflating the proximal inflatable cuff to form a seal against the body channel.

45. The method of claim 44 wherein inflation of the proximal inflatable cuff of the graft causes the graft and proximal inflatable cuff to conform to a morphology of the body channel surrounding the graft.

46. The method of claim 44 wherein the endovascular graft is positioned by percutaneous delivery.

47. The method of claim 44 wherein the non-inflatable expansion member is allowed to expand by extruding the graft from a constraining tubular delivery catheter.

48. The method of claim 44 wherein the endovascular graft further comprises a plurality of inflatable fluid tight chambers which are separated by rupture discs that are configured to burst at varying pressure thresholds such that the graft is sequentially inflated.

49. The method of claim 44 wherein the proximal inflatable cuff is inflated by injecting a pressurized material through an inflation catheter and into an injection port which is in fluid communication with a fluid tight chamber within the proximal inflatable cuff.

50. The method of claim 49 further comprising disconnecting the inflation catheter from the injection port by applying inflation pressure sufficient to trigger a disconnect mechanism.

51. An endovascular graft comprising:

a) an inflatable frame structure comprising;

a main body portion having

a proximal end with a proximal inflatable cuff disposed thereon,

a distal end with a distal inflatable cuff disposed thereon,

at least one elongated inflatable channel disposed between and in fluid communication with the proximal inflatable cuff and the distal inflatable cuff,

a first bifurcated portion having

a proximal end which is connected to the distal end of the main body portion,

a proximal inflatable cuff disposed on the proximal end,

a distal end with a distal inflatable cuff disposed thereon,

at least one elongated inflatable channel disposed between and in fluid communication with the proximal inflatable cuff and the distal inflatable cuff,

a second bifurcated portion having

a proximal end which is connected to the distal end of the main body portion,

a proximal inflatable cuff disposed on the proximal end,

a distal end with a distal inflatable cuff disposed thereon, and

at least one elongated inflatable channel disposed between and in fluid communication with the proximal inflatable cuff and the distal inflatable cuff; and

b) a thin flexible layer member disposed between the proximal inflatable cuff, the distal inflatable cuff and the elongated inflatable channel of the main body portion, first bifurcated portion and second bifurcated portion in order to form a bifurcated tubular structure having a longitudinal channel to confine a flow of blood therethrough at each of said portions.

52. An endovascular graft comprising:

a) a tubular structure having a proximal end portion and a distal end portion;

b) an inflatable cuff disposed on the proximal end portion; and

c) a non-inflatable expansion member disposed proximal of the inflatable cuff, secured to the graft extending away from the tubular structure and configured to exert an outward radial force independent of the tubular structure.

53. The endovascular graft of claim 52 wherein the non-inflatable expansion member is secured to the inflatable cuff.

54. The endovascular graft of claim 52 further comprising a proximal neck portion wherein the non-inflatable expansion member is secured to the proximal neck portion.

55. The endovascular graft of claim 52 wherein the non-inflatable expansion member is self-expanding.