Delivery system and method for bifurcated endovascular graft

• US 6,761,733 B2
• Filed: 07/27/2001
• Issued: 07/13/2004
• Est. Priority Date: 04/11/2001
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Chobotov, Michael V., Glynn, Brian A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): SWEET, THOMAS
• Application Number:
  US09/917,371
• Publication Number:
  US 20020151953A1
• Time in Patent Office: 1,082 Days
• Field of Search: 623/1.11, 623/1.12, 606/108
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

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 delivery system for a bifurcated intracorporeal device comprising:

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

an elongate primary belt support member that is configured to be disposed within at least a portion of the bifurcated intracorporeal device;

at least one primary belt secured to the primary belt support member configured to be circumferentially disposed about the bifurcated intracorporeal device so to at least partially constrain the device;

a primary release member configured to engage and releasably secure the primary belt in a constraining configuration;

at least one elongate secondary belt support member disposed adjacent the elongate primary belt support member;

at least one secondary belt secured to the secondary belt support member and configured to be circumferentially disposed about the bifurcated intracorporeal device so to at least partially constrain the device; and

a secondary release member configured to engage and releasably secure the secondary belt in a constraining configuration.

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

3. The delivery system of claim 1 wherein the primary belt and the secondary belt each comprises a length of wire having a first end and a second end, with each of said first and second wire ends secured to the primary belt support members and secondary belt support member, respectively.

4. The delivery system of claim 3 wherein the wire comprises nickel titanium.

5. The delivery system of claim 1 wherein one or both of the primary belt and the secondary belt comprises first and second opposed ends and wherein the first opposed end has a different cross-sectional area than the second opposed end.

6. The delivery system of claim 5 wherein each of the first and second opposed ends forms an end loop.

7. The delivery system of claim 1 wherein the release members comprise release wires moveably disposed within opposed looped ends of the respective belts.

8. The delivery system of claim 1 wherein the belts in the constraining configuration form a planes that are substantially orthogonal to a longitudinal axis of the elongate shaft.

9. The delivery system of claim 1 wherein at least two belts are configured to be releasable by a single release member.

10. The delivery system of claim 1 comprising a plurality of primary release members wherein the proximal ends of at least two of the primary release members are color-coded.

11. The delivery system of claim 1 wherein the at least one primary belt comprises a plurality of primary belts and wherein the primary release member comprises a plurality of primary release members that releasably secure the plurality of primary belts, wherein proximal ends of the primary release members are in a linear spatial configuration at a proximal end of the delivery system that corresponds to a desired deployment sequence for the plurality of belts.

12. The delivery system of claim 11 wherein the plurality of primary release members comprise a distal primary release wire handle and a proximal primary release wire handle disposed in a nested configuration.

13. The delivery system of claim 1 wherein the primary release member comprises a branched release wire.

14. The delivery system of claim 1 further comprising a secondary belt support member housing secured to the primary belt support member wherein the secondary belt support member is configured to move axially within the housing and the housing and secondary belt support member are configured to prevent relative rotational movement therebetween.

15. A delivery system for a bifurcated graft comprising:

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

a portion having disposed thereon the bifurcated graft, the graft having a main body portion, an ipsilateral leg and a contralateral leg;

an elongate primary belt support member disposed adjacent the main body portion and the ipsilateral leg;

at least one primary belt secured to the primary belt support member and releasably disposed about a circumference of the bifurcated graft and which constrains at least a portion of the graft;

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

at least one secondary belt support member disposed adjacent the contralateral leg;

at least one secondary belt secured to the secondary belt support member and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft; and

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

16. The delivery system of claim 15 additionally comprising a first proximal self-expanding member secured to a proximal end of the contralateral leg and a second proximal self-expanding member secured to a proximal end of the ipsilateral leg, and wherein the legs have a different length and the first and second proximal self-expanding members are axially offset from each other when the graft is in a constrained state within the delivery system.

17. The delivery system of claim 15 additionally comprising a first proximal self-expanding member secured to a proximal end of the contralateral leg and a second proximal self-expanding member secured to a proximal end of the ipsilateral leg and wherein the legs have substantially the same length and one of the legs is axially compressed or folded such that the first and second proximal self-expanding members are axially offset from each other when the graft is in a restrained state within the delivery system.

18. The delivery system of claim 15 wherein the primary belt constrains a distal self-expanding member disposed at a distal end of the bifurcated graft main body portion.

19. The delivery system of claim 18 wherein the distal self-expanding member is a tubular stent.

20. The delivery system of claim 19 wherein the stent comprises a circumferential groove configured to accept at least a portion of the primary belt.

21. The delivery system of claim 15 wherein the primary belt and the secondary belt each comprises at least one length of wire having a first end and a second end and configured in a loop with each of said first and second wire ends secured to the primary belt support member and the secondary belt support member, respectively.

22. The delivery system of claim 21 wherein the wire comprises nickel titanium.

23. The delivery system of claim 15 wherein the primary belt and secondary belt comprise at least one length of wire having opposed end loops having differing diameters.

24. The delivery system of claim 15 wherein the release members comprise release wires moveably disposed within opposed looped ends of their respective belts.

25. The delivery system of claim 15 wherein the belts in the constraining configuration form planes that are substantially orthogonal to a longitudinal axis of the elongate shaft.

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

27. The delivery system of claim 15 wherein the primary belt support member comprises a guidewire tube.

28. The delivery system of claim 15 wherein the distal section further comprises an outer protective sheath disposed about the bifurcated graft while the bifurcated graft is in a constrained state.

29. A delivery system for a bifurcated graft having a main body portion, an ipsilateral leg, contralateral leg and a plurality of self-expanding members secured to the graft, comprising:

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

a portion configured to have disposed thereon the bifurcated graft;

a guidewire tube disposed within the main body portion and ipsilateral leg of the bifurcated graft;

a plurality of primary belts secured to the guidewire tube, the plurality of belts being adjacent the self-expanding members of the graft, the belts being circumferentially disposed about adjacent self-expanding members in a configuration that at least partially constrains the respective self-expanding members;

a primary release wire that engages and releasably secures at least one of the primary belts in a constraining configuration;

a secondary belt support member disposed within the contralateral leg of the bifurcated graft;

a secondary belt secured to the secondary belt support member adjacent self-expanding members of the graft, the belt being circumferentially disposed about an adjacent self-expanding member in a configuration that at least partially constrains the adjacent self-expanding member; and

a secondary release wire that engages and releasably secures the secondary belt in a constraining configuration.

30. A delivery system for a bifurcated intracorporeal device comprising:

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

an elongate primary constraint support means;

at least one primary constraint means secured to the primary constraint support means configured to be releasably disposed about a circumference of the bifurcated intracorporeal device so to at least partially constrain the device;

a primary release means configured to engage and releasably secure the primary constraint means in a constraining configuration;

at least one elongate secondary constraint support member disposed adjacent the elongate primary constraint support means;

at least one secondary constraint means secured to the secondary constraint support means configured to be circumferentially disposed about a bifurcated intracorporeal device so to at least partially constrain the device; and

a secondary release means configured to engage and releasably secure the secondary constraint means in a constraining configuration.

31. The delivery system of claim 30 wherein the primary constraint support means is an elongate tubular means and the bifurcated intracorporeal device is a bifurcated graft in a constrained state.

32. The delivery system of claim 30 wherein one or both of the primary constraint means and the secondary constraint means comprises first and second opposed ends and wherein the first opposed end has a different cross-sectional area than the second opposed end.

33. The delivery system of claim 30 wherein the constraint means in the constraining configuration form planes that are substantially orthogonal to a longitudinal axis of the elongate shaft means.

34. The delivery system of claim 30 wherein at least two of the constraint means are configured to be releasable by a single release means.

35. The delivery system of claim 30 comprising a plurality of primary release means wherein the proximal ends of at least two of the primary release means are color-coded.

36. The delivery system of claim 30 wherein the at least one primary release means comprises a plurality of primary release means and the at least one primary constraint means comprises a plurality of constraint means, wherein proximal ends of the plurality of primary release means are in a linear spatial configuration that corresponds to a desired deployment sequence for the plurality of constraint means.

37. A delivery system for a bifurcated graft comprising:

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

a portion having disposed thereon the bifurcated graft, the graft having a main body portion, an ipsilateral leg and a contralateral leg;

an elongate primary constraint support means disposed within the main body portion and ipsilateral leg;

at least one primary constraint means secured to the primary constraint support means and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft;

a primary release means which releasably secures the primary constraint means in the constraining configuration;

at least one secondary constraint support means disposed adjacent the contralateral leg;

at least one secondary constraint means secured to the secondary constraint support means and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft; and

a secondary release means which releasably secures the secondary constraint means in the constraining configuration.

38. The delivery system of claim 37 wherein the primary constraint means constrains a distal self-expanding member disposed at a distal end of the bifurcated graft main body portion.

39. The delivery system of claim 37 wherein the constraint means in the constraining configuration form planes that are substantially orthogonal to a longitudinal axis of the elongate shaft means.

40. A delivery system for a bifurcated graft having a main body portion, an ipsilateral leg, contralateral leg and a plurality of self-expanding members secured to the graft, comprising:

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

a portion configured to have disposed thereon the bifurcated graft;

a guidewire tube means disposed within the main body portion and ipsilateral leg of the bifurcated graft;

a plurality of primary constraint means secured to the guidewire tube means and adjacent respective self-expanding members of the graft, the primary constraint means being circumferentially disposed about the adjacent self-expanding members in a configuration that at least partially constrains the respective self-expanding members;

a primary release means that engages and releasably secures at least one of the primary constraint means in a constraining configuration;

a secondary constraint support means disposed within the contralateral leg of the bifurcated graft;

a secondary constraint means secured to the secondary constraint support means adjacent respective self-expanding members of the graft, the secondary constraint means being circumferentially disposed about the adjacent self-expanding members in a configuration that at least partially constrains the adjacent self-expanding members; and

a secondary release means that engages and releasably secures the secondary constraint means in a constraining configuration.

41. A delivery system for a bifurcated intracorporeal device comprising:

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

an elongate primary belt support member;

at least one primary belt secured to the primary belt support member configured to be circumferentially disposed about the bifurcated intracorporeal device so to at least partially constrain the device;

a primary release member configured to engage and releasably secure the primary belt in a constraining configuration;

at least one elongate secondary belt support member disposed adjacent the elongate primary belt support member;

at least one secondary belt secured to the secondary belt support member configured to be circumferentially disposed about the bifurcated intracorporeal device so to at least partially constrain the device; and

a secondary release member configured to engage and releasably secure the secondary belt in a constraining configuration,

wherein the primary belt and the secondary belt each comprises a length of wire having a first end and a second end with each of said first and second wire ends secured to the primary belt support member and secondary belt support member, respectively.

42. The delivery system of claim 41 wherein one or both of the primary belt and the secondary belt comprises first and second opposed ends.

43. The delivery system of claim 42 wherein each of the first and second opposed ends forms an end loop.

44. The delivery system of claim 41 wherein the wire comprises nickel titanium.

45. The delivery system of claim 41 wherein the release members comprise release wires moveably disposed within opposed looped ends of the respective belts.

46. The delivery system of claim 41 wherein the belts in the constraining configuration form planes that are substantially orthogonal to a longitudinal axis of the elongate shaft.

47. The delivery system of claim 41 wherein at least two belts are configured to be releasable by a single release member.

48. The delivery system of claim 41 comprising a plurality of primary release members wherein the proximal ends of at least two of the primary release members are color-coded.

49. The delivery system of claim 41 wherein proximal ends of the primary and secondary release members are in a linear spatial configuration at a proximal end of the delivery system that corresponds to a desired deployment sequence for the primary belt(s) and secondary belt(s).

50. The delivery system of claim 49 wherein the primary and secondary release members comprise release wire handles that are disposed in a nested configuration.

51. The delivery system of claim 41 wherein the at least one primary belt and the at least one secondary belt are configured to be circumferentially disposed about self expanding members on the bifurcated intracorporeal device.

52. A delivery system for a bifurcated graft comprising:

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

a portion having disposed thereon the bifurcated graft, the graft having a main body portion, an ipsilateral leg and a contralateral leg, a self-expanding tubular stent disposed at a distal end of the bifurcated graft main body portion;

an elongate primary belt support member disposed adjacent the main body portion and ipsilateral leg;

at least one primary belt secured to the primary belt support member and circumferentially disposed about the self-expanding tubular stent;

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

at least one secondary belt support member disposed adjacent the contralateral leg;

at least one secondary belt secured to the secondary belt support member and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft; and

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

53. The delivery system of claim 52 wherein one or both of the primary belt and the secondary belt comprises first and second opposed ends.

54. The delivery system of claim 53 wherein each of the first and second opposed ends forms an end loop.

55. The delivery system of claim 52 wherein the release members comprise nickel titanium.

56. The delivery system of claim 52 wherein the release members comprise release wires moveably disposed within opposed looped ends of the respective belts.

57. The delivery system of claim 52 wherein the belts in the constraining configuration form planes that are substantially orthogonal to a longitudinal axis of the elongate shaft.

58. The delivery system of claim 52 wherein at least two belts are configured to be releasable by a single release member.

59. The delivery system of claim 52 comprising a plurality of primary release members wherein the proximal ends of at least two of the primary release members are color-coded.

60. The delivery system of claim 52 wherein the at least one primary belt comprises a plurality of primary belts and wherein the primary release member comprises a plurality of primary release members that releasably secure the plurality of primary belts, wherein proximal ends of the primary release members are in a linear spatial configuration at a proximal end of the delivery system that corresponds to a desired deployment sequence for the plurality of belts.

61. The delivery system of claim 60 wherein the plurality of primary release members comprise a distal primary release wire handle and a proximal primary release wire handle disposed in a nested configuration.

62. The delivery system of claim 52 additionally comprising a first proximal self-expending member secured to a proximal end of the contralateral leg and a second proximal self-expanding member secured to a proximal end of the ipsilateral leg, and wherein the legs have a different length and the first and second proximal self-expanding members are axially offset from each other when the graft is in a constrained state within the delivery system.

63. The delivery system of claim 52 additionally comprising a first proximal self-expanding member secured to a proximal end of the contralateral leg and a second proximal self-expanding member secured to a proximal end of the ipsilateral leg, and wherein the legs have substantially the same length and one of the legs is axially compressed or folded such that the first and second proximal self-expanding members are axially offset from each other when the graft is in a constrained state within the delivery system.

64. The delivery system of claim 52 wherein the stent comprises a circumferential groove configured to accept at least a portion of the primary belt.

65. The delivery system of claim 52 wherein the bifurcated graft is inflatable, wherein the delivery system further comprises an inflation lumen that is releasably coupleable to the bifurcated graft.

66. A delivery system for a bifurcated graft comprising:

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

a portion having disposed thereon the bifurcated graft, the graft having a main body portion, an ipsilateral leg and a contralateral leg;

an elongate primary belt support member disposed adjacent the main body portion and ipsilateral leg;

at least one primary belt secured to the primary belt support member and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft;

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

at least one secondary belt support member disposed adjacent the contralateral leg;

at least one secondary belt secured to the secondary belt support member and circumferentially disposed about the bifurcated graft and which constrains at least a portion of the graft; and

a secondary release member which releasably secures the secondary belt in the constraining configuration,

wherein the primary belt and the secondary belt comprise at least one length of wire having a first end and a second end and configured in a loop with each of said first and second wire ends secured to the primary belt support member and secondary belt support member, respectively.

67. The delivery system of claim 66 wherein the length of wires have opposed end loops having differing diameters.

68. The delivery system of claim 66 wherein the wire comprises nickel titanium.

69. The delivery system of claim 66 wherein the release members comprise release wires moveably disposed within opposed looped ends of their respective belts.

70. The delivery system of claim 66 wherein the belts in the constraining configuration form planes that are substantially orthogonal to a longitudinal axis of the elongate shaft.

71. The delivery system of claim 66 wherein at least two primary belts are configured to be releasable by the same release member.

72. The delivery system of claim 66 wherein the primary belt support member comprises a guidewire tube.

73. The delivery system of claim 72 wherein the distal section further comprises an outer protective sheath disposed about the endovascular graft while the graft is in a constrained state.

74. The delivery system of claim 66 wherein proximal ends of the primary and secondary release members are in a linear spatial configuration at a proximal end of the delivery system that corresponds to a desired deployment sequence for the primary belt(s) and secondary belt(s).

75. The delivery system of claim 74 wherein the primary and secondary release members comprise release wire handles that are disposed in a nested configuration.