Woven intravascular devices and methods for making the same and apparatus for delivery of the same

• US 7,018,401 B1
• Filed: 02/01/2000
• Issued: 03/28/2006
• Est. Priority Date: 02/01/1999
• Status: Expired due to Term

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Hyodoh, Hideki, Wright, Kenneth C., Konya, Andras
• Primary Examiner(s): THALER, MICHAEL H
• Application Number:
  US09/496,243
• Time in Patent Office: 2,247 Days
• Field of Search: 606/188, 606/36, 606/200, 623/1.35, 623/1.1, 623/1.53, 623/1.22, 623/1.16, 623/1.15, 623/1.12, 623/1.13, 623/1.2
• US Class Current: 623/1.12
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/0006 : circular
• CPC Class Codes: A61F 2230/001 : Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D04C 3/48 : Auxiliary devices
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents

Abstract

Self-expandable, woven intravascular devices for use as stents (both straight and tapered), filters (both temporary and permanent) and occluders for insertion and implantation into a variety of anatomical structures. The devices may be formed from shape memory metals such as nitinol. The devices may also be formed from biodegradable materials. Delivery systems for the devices include two hollow tubes that operate coaxially. A device is secured to the tubes prior to the implantation and delivery of the device by securing one end of the device to the outside of the inner tube and by securing the other end of the device to the outside of the outer tube. The stents may be partially or completely covered by graft materials, but may also be bare. The devices may be formed from a single wire. The devices may be formed by either hand or machine weaving. The devices may be created by bending shape memory wires around tabs projecting from a template, and weaving the ends of the wires to create the body of the device such that the wires cross each other to form a plurality of angles, at least one of the angles being obtuse. The value of the obtuse angle may be increased by axially compressing the body.

Claims

1. A device comprising:

a plurality of shape memory wires woven together to form a body suitable for implantation into an anatomical structure, the body having first and second ends, the shape memory wires crossing each other to form a plurality of cells and a plurality of angles, at least one of the angles being obtuse, at least one of the cells being defined by only four sides, and both ends of at least one shape memory wire being located proximate one end of the body,

wherein the value of the at least one obtuse angle may be increased by axially compressing the body.

2. The device of claim 1, wherein the shape memory wires comprise nitinol.

3. The device of claim 1, wherein the shape memory wires comprise FePt, FePd or FeNiCoTi.

4. The device of claim 1, wherein the shape memory wires comprise FeNiC, FeMnSi or FeMnSiCrNi.

5. The device of claim 1, wherein the shape memory wires each have a diameter ranging in size from about 0.006 inches to about 0.012 inches.

6. The device of claim 1, wherein the plurality of shape memory wires includes at least 6 shape memory wires.

7. The device of claim 1, wherein the body has a tubular shape with a substantially uniform diameter.

8. The device of claim 1, wherein the body has a tapered shape with a diameter that decreases from one end of the body to the other end of the body.

9. The device of claim 1, wherein the body has a generally hourglass shape.

10. The device of claim 1, wherein the body is hand woven.

11. The device of claim 1, wherein the body is machine woven.

12. The device of claim 1, further comprising a graft material attached to the body.

13. The device of claim 12, wherein the graft material comprises woven polyester.

14. The device of claim 12, wherein the graft material comprises Dacron.

15. The device of claim 12, wherein the graft material comprises polyurethane.

16. The device of claim 12, wherein the graft material comprises PTFE.

17. The device of claim 12, wherein the graft material partially covers the body.

18. The device of claim 1, further comprising:

a first tube configured to accept a guide wire; and

a second tube configured to fit over the first tube.

19. The device of claim 18, wherein the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is secured to the second tube.

20. A device comprising:

a body suitable for implantation into an anatomical structure, the body having a first end, a second end and being defined by at least n shape memory wires, wherein n is greater than one, the n shape memory wires being arranged such that the body comprises a first portion, the first portion comprising a first woven portion and at least one strut, the shape memory wires of the first woven portion crossing each other to form a plurality of cells and a plurality of angles, at least one of the angles being obtuse, at least one of the cells being defined by only four sides, and both ends of at least one shape memory wire being located proximate one end of the body;

wherein the value of the at least one obtuse angle may be increased by axially compressing the body.

21. The device of claim 20, wherein the shape memory wires comprise nitinol.

22. The device of claim 20, wherein the shape memory wires comprise FePt, FePd or FeNiCoTi.

23. The device of claim 20, wherein the shape memory wires comprise FeNiC, FeMnSi or FeMnSiCrNi.

24. The device of claim 20, wherein the body further comprises a second portion adjacent the first portion, the second portion comprising a second woven portion, and the second portion having n+x shape memory wires, wherein x is at least one.

25. The device of claim 20, wherein the first portion comprises a first woven portion separated from a second woven portion by multiple first struts.

26. The device of claim 25, wherein the first portion has a generally domed shape.

27. The device of claim 25, wherein the first woven portion has a generally domed shape and the multiple first struts are bent slightly so as to increase the self-anchoring capability of the body in an anatomical structure.

28. The device of claim 25, wherein the first portion further comprises a third woven portion separated from the second woven portion by multiple second struts, and wherein the first and third woven portions have generally domed shapes.

29. The device of claim 20, further comprising a graft material attached to the body.

30. The device of claim 29, wherein the graft material comprises woven polyester.

31. The device of claim 29, wherein the graft material comprises Dacron.

32. The device of claim 29, wherein the graft material comprises polyurethane.

33. The device of claim 29, wherein the graft material comprises PTFE.

34. The device of claim 29, wherein the graft material partially covers the body.

35. The device of claim 20, further comprising:

a first tube configured to accept a guide wire; and

a second tube configured to fit over the first tube.

36. The device of claim 35, wherein the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is secured to the second tube.

37. An occluding system comprising:

a plurality of shape memory wires woven together to form a body useful for occluding an anatomical structure, the body having first and second ends, both ends of at least one shape memory wire being located proximate one end of the body, the shape memory wires crossing each other to form a plurality of cells and a plurality of angles, at least one of the angles being obtuse, and at least one of the cells being defined by only four sides;

wherein the value of the at least one obtuse angle may be increased by axially compressing the body.

38. A device comprising:

a body suitable for implantation into an anatomical structure, the body having a first end and a second end, wherein the body comprises a shape memory wire having a first segment and a second segment, the segments being separated by a bend in the wire located proximate one end of the body, the first segment and second segments being arranged to form loops and twisted segments such that at least two contiguous substantially closed loops are separated from another loop by a twisted segment.

39. A device comprising:

a body suitable for implantation into an anatomical structure, the body having two ends and comprising a shape memory wire having a first segment and a second segment, the segments being separated by a bend in the wire located proximate one end of the body, the segments being secured to each other in loop-defining locations, the segments also extending between the loop-defining locations in spaced relation to each other so as form at least two loops, at least one of the at least two loops having a compressed shape.

40. A device comprising:

a plurality of shape memory wires woven together to form a body suitable for implantation into an anatomical structure, the body having a first end, a second end, and an intersection of two shape memory wires crossed in non-interlocking fashion;

where both ends of at least one shape memory wire are located proximate one end of the body, and the two crossed wires form an obtuse angle that may be increased by axially compressing the body.

41. The device of claim 40, where the shape memory wires comprise nitinol.

42. The device of claim 40, where the shape memory wires comprise FePt, FePd or FeNiCoTi.

43. The device of claim 40, where the shape memory wires comprise FeNiC, FeMnSi or FeMnSiCrNi.

44. The device of claim 40, where the shape memory wires each have a diameter ranging in size from about 0.006 inches to about 0.012 inches.

45. The device of claim 40, where the plurality of shape memory wires includes at least 6 shape memory wires.

46. The device of claim 40, where the body has a tubular shape with a substantially uniform diameter.

47. The device of claim 40, where the body has a tapered shape with a diameter that decreases from one end of the body to the other end of the body.

48. The device of claim 40, where the body has a generally hourglass shape.

49. The device of claim 40, where the body is hand woven.

50. The device of claim 40, where the body is machine woven.

51. The device of claim 40, further comprising a graft material attached to the body.

52. The device of claim 51, where the graft material comprises woven polyester.

53. The device of claim 51, where the graft material comprises Dacron.

54. The device of claim 51, where the graft material comprises polyurethane.

55. The device of claim 51, where the graft material comprises PTFE.

56. The device of claim 51, where the graft material partially covers the body.

57. The device of claim 40, further comprising:

a first tube configured to accept a guide wire; and

a second tube configured to fit over the first tube.

58. The device of claim 57, where the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is secured to the second tube.

59. A device comprising:

a plurality of shape memory wires woven together to form a body suitable for implantation into an anatomical structure, the body having a first end, a second end, a middle, and an intersection of two shape memory wires crossed in non-interlocking fashion;

where both ends of at least one shape memory wire are located nearer one end of the body than the middle, and the two crossed wires form an obtuse angle that may be increased by axially compressing the body.

60. The device of claim 59, where the shape memory wires comprise nitinol.

61. The device of claim 59, where the shape memory wires comprise FePt, FePd or FeNiCoTi.

62. The device of claim 59, where the shape memory wires comprise FeNiC, FeMnSi or FeMnSiCrNi.

63. The device of claim 59, where the shape memory wires each have a diameter ranging in size from about 0.006 inches to about 0.012 inches.

64. The device of claim 59, where the plurality of shape memory wires includes at least 6 shape memory wires.

65. The device of claim 59, where the body has a tubular shape with a substantially uniform diameter.

66. The device of claim 59, where the body has a tapered shape with a diameter that decreases from one end of the body to the other end of the body.

67. The device of claim 59, where the body has a generally hourglass shape.

68. The device of claim 59, where the body is hand woven.

69. The device of claim 59, where the body is machine woven.

70. The device of claim 59, further comprising a graft material attached to the body.

71. The device of claim 70, where the graft material comprises woven polyester.

72. The device of claim 70, where the graft material comprises Dacron.

73. The device of claim 70, where the graft material comprises polyurethane.

74. The device of claim 70, where the graft material comprises PTFE.

75. The device of claim 70, where the graft material partially covers the body.

76. The device of claim 59, further comprising:

a first tube configured to accept a guide wire; and

a second tube configured to fit over the first tube.

77. The device of claim 76, where the second tube is placed over the first tube, one end of the body is secured to the first tube and the other end of the body is secured to the second tube.