Intraluminal grafting system

• US 6,221,102 B1
• Filed: 06/07/1995
• Issued: 04/24/2001
• Est. Priority Date: 12/09/1983
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Baker, Steven G., Quiachon, Dinah B., Piplani, Alec A., Sterman, Wesley D., Williams, Ronald G.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US08/485,481
• Time in Patent Office: 2,148 Days
• Field of Search: 623/1, 623/11, 623/12, 623/1.13, 623/1.36, 606/191, 606/194, 606/198, 606/108
• US Class Current: 623/1.36
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30451 soldered or brazed or welded
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An intraluminal grafting system having a delivery catheter comprising a flexible elongate tubular member having proximal and distal extremities and a capsule mounted on the distal extremity of the tubular member and including a graft disposed within the capsule. The graft is comprised of a tubular body configured to be secured to a blood vessel by a self expanding attachment system. The attachment system comprises a generally sinusoidal wire frame having apices which extend longitudinally outward from the end of the tubular body apices which are secured within the tubular body. Both the protruding apices and the base apices are formed with helices which bias the attachment system radially outward. The attachment system further includes a plurality of lumen piercing members that are oriented in a responsive relationship to the radially outward bias of the attachment system. Furthermore, the graft may be configured with a plurality of synthetic fiber tufts secured to the outer surface of the tubular body to facilitate sealing the graft within the vessel. The graft may also include a plurality of crimps formed in the tubular body of the graft.

Claims

1. A system for intraluminally attaching a graft within a vessel, said system comprising:

a generally sinusoidal wire frame configured to be affixed to the graft and to exert an outwardly directed bias, said wire frame having a plurality of alternatively oriented apices, each of said plurality of alternatively oriented apices having a helical configuration; and

a plurality of lumen piercing members affixed to said wire frame.

2. A system for intraluminally attaching a graft within a vessel, said system comprising:

a generally sinusoidal wire frame configured to be affixed to the graft and to exert an outwardly directed bias, said wire frame having a plurality of alternatively oriented apices, each of said plurality of alternatively oriented apices having a helical configuration; and

a plurality of V-shaped anchoring members cooperating with said wire frame, each of said plurality of V-shaped members having an apex with a helical configuration and ends bent radially outward from said wire frame to form hooks.

3. An intraluminal graft for repairing a vessel having a wall, comprising:

a tubular body;

a generally sinusoidal wire frame affixed to the graft and configured to exert an outwardly directed bias, said wire frame having a plurality of alternatively oriented apices, each of said plurality of alternatively oriented apices having a helical configuration;

a plurality of V-shaped anchoring members cooperating with said wire frame, each of said plurality of V-shaped members having an apex with a helical configuration and ends bent radially outward from said wire frame to form hooks; and

a plurality of fibrous tufts affixed to said tubular body, said plurality of fibrous tufts configured to be positioned between the wall of the vessel and the tubular body to limit fluid flow between the wall and the tubular body.

4. An intraluminal graft for repairing a lumen, comprising:

a tubular body;

a generally sinusoidal wire frame affixed to the graft and configured to exert an outwardly directed bias, said wire frame having a plurality of alternatively oriented apices, each of said plurality of alternatively oriented apices having a helical configuration;

a plurality of V-shaped anchoring members cooperating with said wire frame, each of said plurality of V-shaped members having an apex with a helical configuration and ends bent radially outward from said wire frame to form hooks; and

a plurality of crimps formed in said tubular body.

5. An attachment system for securing a graft to a blood vessel, the attachment system comprising:

a sinusoidal wire frame having a plurality of apices, said apices being configured with a helical coil spring operating to exert an outwardly directed bias on the wire frame; and

a plurality of lumen penetrating members cooperating with said wire frame and responsive to the outwardly directed bias of the same.

6. The attachment system of claim 5, wherein said wire frame has a first terminal end and a second terminal end, said first terminal end being affixed to said second terminal end to provide a continuous wire frame.

7. The attachment system of claim 6, wherein said first terminal end is welded to said second terminal end.

8. The attachment system of claim 6, wherein said first terminal end extends from a first terminal helix and said second terminal end extends from a second terminal helix and said first terminal end is welded to said second terminal end equidistance between said first terminal helix and said second terminal helix.

9. The attachment system of claim 5, wherein said plurality of lumen penetrating members include a generally longitudinally extending arm having a first end and a second end and outwardly protruding hooks extending radially outward from said first end of said arm.

10. The attachment system of claim 9, wherein said outwardly protruding hooks terminate with a sharpened conical tip.

11. The attachment system of claim 9, wherein said outwardly protruding hooks terminate with a duck bill tip.

12. The attachment system of claim 9, wherein said longitudinally extending arms protrude longitudinally beyond at least one of said helical coil springs.

13. The attachment system of claim 5, wherein said wire frame includes a plurality of struts, each of said struts connecting one of said plurality of apices to another of said plurality of apices.

14. The attachment system of claim 13, wherein said lumen penetrating members are individually affixed to one of said struts.

15. The attachment system of claim 14, wherein said lumen penetrating members are individually welded to said struts.

16. The attachment system of claim 15, wherein said lumen penetrating members are welded equidistant between said one of said plurality of apices and said another of said plurality of apices.

17. The attachment system of claim 5, wherein said apices include a first set of apices longitudinally displaced from a second set of apices.

18. The attachment system of claim 17, wherein said first set of apices are all longitudinally aligned.

19. The attachment system of claim 17, wherein said first set of apices are positioned in a longitudinally staggered configuration.

20. The attachment system of claim 17, wherein said second set of apices are all longitudinally aligned.

21. The attachment system of claim 17, wherein said second set of apices are positioned in a longitudinally staggered configuration.

22. The attachment system of claim 5, wherein said lumen penetrating members include first and second generally longitudinally extending arms, said arms protruding longitudinally beyond at least one of said apices and terminating as radially outwardly protruding hooks.

23. The attachment system of claim 22, wherein said apices of said lumen penetrating members is configured with a helical coil.

24. The attachment system of claim 22, wherein said first longitudinally extending arm extends outward at an acute angle from said second longitudinally extending arm.

25. The attachment system of claim 6, wherein said first and second terminal ends are formed with eyelets.

26. The attachment system of claim 25, wherein said first terminal end is configured to overlap said second terminal end.

27. The attachment system of claim 25, wherein said first terminal end extends from a first terminal helix and said second terminal end extends from a second terminal helix, said first terminal end is configured to overlap said second terminal helix and said second terminal end is configured to overlap said first terminal helix.

28. The attachment system of claim 6, wherein said first and second terminal ends are configured with longitudinally extending arms which terminate as radially outward protruding hooks.

63. The attachment system of claim 5, wherein the lumen penetrating members are V-shaped having first and second arms.

64. The attachment system of claim 5, wherein the lumen penetrating members have a radially outward protruding hook at the end of each said arm.

29. An attachment system for securing a graft to a blood vessel, the attachment system comprising:

a first and a second sinusoidal wire frames, each of said wire frames having a pair of terminal ends and further having a plurality of apices, said apices configured with helical coil springs, said first and second wire frames cooperating to exert an outwardly directed bias;

a plurality of first longitudinally extending arms, each said arm formed at one of said terminal ends of said first wire frame and configured as radially outwardly protruding hooks; and

a plurality of second longitudinally extending arms, each said arm formed at one of said terminal ends of said second wire frame and configured as radially outwardly protruding hooks.

30. The attachment system of claim 29, further having terminal helices formed at the respective terminal ends of each said first and second wire frames and wherein said first wire frame is joined to said second wire frame such that said terminal helices formed at said terminal ends of said first wire frame overlap the terminal helices formed at said terminal ends of said second wire frame and each of said first plurality of longitudinally extending arms are individually twisted around a portion of said second wire frame and each of said second plurality of longitudinally extending arms are individually twisted around a portion of said first wire frame.

65. The attachment system of claim 29, wherein said hooks terminate with a sharpened conical tip.

66. The attachment system of claim 29, wherein said hooks terminate with a duck bill tip.

67. The attachment system of claim 29, wherein said longitudinally extending arms protrude longitudinally beyond at least one of said helical coil springs.

68. The attachment system of claim 29, wherein said first sinusoidal wire frame has first terminal apices adjacent said first longitudinally extending arms and said second sinusoidal wire frame has second terminal apices adjacent said second sinusoidal wire frame, said first terminal apices are configured to overlap said second terminal apices.

31. An intraluminal graft for repairing a blood vessel comprising:

a graft body having a plurality of ends;

an attachment system affixed to each said end, each said attachment system further comprising a first and a second sinusoidal wire frame having a plurality of apices, said apices configured with a helical coil spring, each said wire frame cooperating to exert an outwardly directed bias against said graft body, each of said first and second wire frames having a pair of terminal ends; and

a plurality of first longitudinally extending arms, each said arm formed at one of said terminal ends of said first wire frame and configured as radially outwardly protruding hooks; and

a plurality of second longitudinally extending arms, each said arm formed at one of said terminal ends of said second wire frame and configured as radially outwardly protruding hooks.

32. The graft of claim 31, wherein each of said first and second longitudinally extending arms protrude longitudinally beyond one of said ends of said graft body.

33. The graft of claim 31, wherein each of said plurality of apices include base apices and longitudinally protruding apices, said base apices are affixed to said graft longitudinally inward from said ends.

34. The graft of claim 31, wherein each of said plurality of apices include base apices and longitudinally protruding apices and said base apices are affixed near one of said ends of said graft body.

35. The graft of claim 31, wherein said graft includes tufts sewn to said graft body near said ends.

36. The graft of claim 35, wherein said tufts are sewn in a cross stitch pattern around an outside surface of said graft body.

37. The graft of claim 36, wherein said tufts are sewn to said graft body longitudinally inward from where said attachment system is affixed to said graft body.

69. The attachment system of claim 31, wherein said hooks terminate with a sharpened conical tip.

70. The attachment system of claim 31, wherein said hooks terminate with a duck bill tip.

71. The attachment system of claim 31, wherein said longitudinally extending arms protrude longitudinally beyond at least one of said helical coil springs.

72. The attachment system of claim 31, wherein said first sinusoidal wire frame has a first terminal apices adjacent said first longitudinally extending arms and said second sinusoidal wire frame has second terminal apices adjacent said second longitudinally extending arm, said first terminal apices are configured to overlap said second terminal apices.

38. A graft for repairing a blood vessel, the graft comprising:

a graft body having first and second ends;

a first and a second sinusoidal wire frame, said first frame secured to said first end of said graft body, said second frame secured to said second end of said graft body, said first and second wire frames having a plurality of apices, each of said apices being configured with a helical coil spring operating to exert an outwardly directed bias against the inside wall of said graft body; and

a plurality of lumen penetrating members, said lumen penetrating members cooperating with at least one of said first and second wire frames and responsive to said outwardly directed bias thereof.

39. The graft of claim 38, wherein each said first and second wire frames have a first end and a second end, said first end being affixed to said second end to provide a continuous wire frame.

40. The graft of claim 39, wherein said first end of each said first and second wire frames overlaps said respective second end.

41. The graft of claim 38, further including tufts secured to an outside surface of said graft body.

42. The graft of claim 41, wherein said tufts are secured to said graft body longitudinally inward from where said first and second wire frames are affixed to said graft body.

43. The graft of claim 41, wherein said tufts are sewn in a cross stitch pattern.

44. The graft of claim 41, wherein said tufts are made of dacron wool.

45. The graft of claim 41, wherein said first and second wire frames include struts connecting one of said helices to another of said helices and said tufts are secured to said body generally between said struts.

46. The graft of claim 38, wherein said graft includes laterally extending pleats.

47. The graft of claim 46, wherein said pleats are located longitudinally inward from where said first and second wire frames are secured to said graft body.

48. The graft of claim 38, wherein said first and second wire frames are configured to be sewn to an inside wall of said graft body.

49. The graft of claim 48, wherein a portion of said first wire frame protrudes longitudinally past said first end of said graft body, and a portion of said second wire frame protrudes longitudinally past said second end of said graft body.

50. The graft of claim 38, wherein said lumen penetrating members include first and second generally longitudinally extending arms projecting from a helical coil formed at an apex of said lumen penetrating members and terminating in radially outwardly protruding hooks.

51. The graft of claim 50, wherein said lumen penetrating members are sewn to an inside wall of said graft body.

52. The graft of claim 50, wherein said lumen penetrating members are mounted to said graft body by passing said first and second arms through a wall of said graft body to thereby position said apex of said lumen penetrating member on an outside of said graft body and at least a portion of said first and second arms inside said graft body.

53. The graft of claim 52, wherein tufts are affixed to said apices of said lumen penetrating member.

54. The graft of claim 50, wherein said plurality of apices of said first and second wire frames include base apices and said lumen penetrating members are mounted to said graft body such that said apices of said lumen penetrating members is positioned longitudinally along said graft body between at least one of said ends of said graft body and where at least one of said base apices is positioned along said graft body, said helical coils of said wire frames having a diameter greater than said helical coils of said lumen penetrating members.

55. The graft of claim 38, wherein each of said wire frames have a first terminal end and a second terminal end, said first and second terminal ends being formed with first and second terminal eyelets, respectively.

56. The graft of claim 55, wherein said first terminal end is configured to overlap said second terminal end.

57. The graft of claim 55, wherein said first terminal ends are configured to overlap one of said second terminal eyelets and said second terminal ends are configured to overlap one of said first terminal eyelets.

58. The graft of claim 38 wherein said graft body includes a plurality of laterally extending pleats.

59. The graft of claim 58, wherein said pleats cover less than half of the length of said graft body.

60. An intraluminal graft for repairing a blood vessel, the graft comprising:

a graft body having an inner surface and an outer surface;

a sinusoidal wire frame having a plurality of apices and a plurality of struts, each of said struts connecting one of said apices to another of said apices, said apices and struts operating to exert an outwardly directed bias against the inner surface of said graft body; and

a plurality of tufts that are discrete from the fabric of the graft body and are selectively affixed to said outer surface of said graft body.

61. The graft of claim 60, wherein each of said tufts are positioned longitudinally along said outer surface of said graft body inward from where said wire frame is positioned longitudinally along said body.

62. The graft of claim 60, wherein said tufts are affixed to said outside surface of said graft body generally between said struts.

73. An attachment system for securing a graft to a blood vessel, the attachment system comprising:

a first and a second sinusoidal wire frames, said wire frames having a pair of terminal ends and further having a plurality of apices, said first and second wire frames cooperate to exert an outwardly directed bias;

a plurality of first longitudinally extending arms formed at one of said terminal ends of said first wire frame and configured as radially outwardly protruding hooks; and

a plurality of second longitudinally extending arms, each said arm formed at one of said terminal ends of said second wire frame and configured as radially outwardly protruding hooks.

74. The attachment system of claim 73, further having terminal apices formed adjacent the respective terminal ends of each said first and second wire frames and wherein said first wire frame is joined to said second wire frame such that said terminal apices formed adjacent said terminal ends of said first wire frame overlap the terminal apices formed adjacent said terminal ends of said second wire frame and each of said first plurality of longitudinally extending arms are individually twisted around a portion of said second wire frame and each of said second plurality of longitudinally extending arms are individually twisted around a portion of said first wire frame.

75. The attachment system of claim 73, wherein said hooks terminate with a sharpened conical tip.

76. The attachment system of claim 73, wherein said hooks terminate with a duck bill tip.

77. The attachment system of claim 73, wherein said plurality of apices are defined by helical coil springs and said longitudinally extending arms protrude longitudinally beyond at least one of said helical coil springs.

78. The attachment system of claim 73, wherein said first sinusoidal wire frame has a first terminal apices adjacent said first longitudinally extending arms and said second sinusoidal wire frame has second terminal apices adjacent said second longitudinally extending arms, said first terminal apices are configured to overlap said second terminal apices.

79. An intraluminal graft for repairing a blood vessel comprising:

a graft body having a plurality of ends;

an attachment system affixed to each end, said attachment system further comprising a first and a second sinusoidal wire frame having a plurality of apices, each said wire frame cooperating to exert an outwardly directed bias against said graft body, each of said first and second wire frames having a pair of terminal ends; and

a plurality of first longitudinally extending arms, each said arm formed at one of said terminal ends of said first wire frame and configured as radially outwardly protruding hooks; and

a plurality of second longitudinally extending arms, each said arm formed at one of said terminal ends of said second wire frame and configured as radially outwardly protruding hooks.

80. The graft of claim 79, wherein each of said first and second longitudinally extending arms protrude longitudinally beyond one of said ends of said graft body.

81. The graft of claim 79, wherein each of said plurality of apices include base apices and longitudinally protruding apices, said base apices are affixed to said graft longitudinally inward from said ends.

82. The graft of claim 79, wherein each of said plurality of apices include base apices and longitudinally protruding apices and said base apices are affixed near one of said ends of said graft body.

83. The graft of claim 79, wherein said graft includes tufts sewn to said graft body near said ends.

84. The graft of claim 83, wherein said tufts are sewn in a cross stitch pattern around an outside surface of said graft body.

85. The graft of claim 84, wherein said tufts are sewn to said graft body longitudinally inward from where said attachment system is affixed to said graft body.

86. The attachment system of claim 79, wherein each of said hooks terminate with a sharpened conical tip.

87. The attachment system of claim 79, wherein each of said hooks terminate with a duck bill tip.

88. The attachment system of claim 79, wherein said plurality of apices are defined by helical coil springs and each of said longitudinally extending arms protrude longitudinally beyond at least one of said helical coil springs.

89. The attachment system of claim 79, wherein said first sinusoidal wire frame has a first terminal apices adjacent said first longitudinally extending arms and said second sinusoidal wire frame has second terminal apices adjacent said first longitudinally extending arms and said first terminal apices are configured to overlap said second terminal apices.

90. An attachment system for securing a graft to a blood vessel, the attachment system comprising:

a sinusoidal wire frame having a plurality of apices operating to exert an outwardly directed bias on the wire frame; and

a plurality of V-shaped lumen penetrating members cooperating with said wire frame and responsive to the outwardly directed bias of the same.

91. The attachment system of claim 90, wherein said wire frame has a first terminal end and a second terminal end, said first terminal end being affixed to said second terminal end to provide a continuous wire frame.

92. The attachment system of claim 91, wherein said first terminal end is welded to said second terminal end.

93. The attachment system of claim 91, wherein said first terminal end extends from a first terminal apex and said second terminal end extends from a second terminal apex and said first terminal end is welded to said second terminal end equidistance between said first terminal apex and said second terminal apex.

94. The attachment system of claim 90, wherein said plurality of V-shaped lumen penetrating members include radially outwardly protruding hooks extending therefrom.

95. The attachment system of claim 94, wherein said outwardly protruding hooks terminate with a sharpened conical tip.

96. The attachment system of claim 94, wherein said outwardly protruding hooks terminate with a duck bill tip.

97. The attachment system of claim 96, wherein said longitudinally extending arms protrude longitudinally beyond at least one of said helical coil springs.

98. The attachment system of claim 90, wherein said apices include a first set of apices longitudinally displaced from a second set of apices.

99. The attachment system of claim 98, wherein said first set of apices are all longitudinally aligned.

100. The attachment system of claim 98, wherein said first set of apices are positioned in a longitudinally staggered configuration.

101. The attachment system of claim 98, wherein said second set of apices are all longitudinally aligned.

102. The attachment system of claim 98, wherein said second set of apices are positioned in a longitudinally staggered configuration.

103. The attachment system of claim 91, wherein said first and second terminal ends are formed with eyelets.

104. The attachment system of claim 103, wherein said first terminal end is configured to overlap said second terminal end.

105. The attachment system of claim 103, wherein said first terminal end extends from a first terminal apex and said second terminal end extends from a second terminal apex, said first terminal end is configured to overlap said second terminal apex and said second terminal end is configured to overlap said first terminal apex.