Methods and devices for lining a blood vessel and opening a narrowed region of a blood vessel

• US 6,712,842 B1
• Filed: 03/09/2000
• Issued: 03/30/2004
• Est. Priority Date: 10/12/1999
• Status: Expired due to Fees

• Current Assignee: Will Allan
• Original Assignee: Allan Will
• Inventors: Dieck, Martin S., Will, Allan R., Sutton, Douglas S., Gifford, Hanson S. III, Sepetka, Ivan, Chew, Sunmi, Deem, Mark E.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): BAXTER, JESSICA R
• Application Number:
  US09/522,316
• Time in Patent Office: 1,482 Days
• Field of Search: 623/1.13, 623/1.23, 623/1.36, 623/1.2, 604/506-509, 604/96.01, 606/108, 606/151-158, 606/198, 606/194
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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 2/958 Inflatable balloons for placing stents or 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A liner is advanced through a narrowed region in a vessel such as the internal carotid artery. The liner is advanced through the narrowed region in a collapsed position. A stent is then advanced through the liner and expanded to open the narrowed region. The liner may also have an anchor which expands an end of the liner before the stent is introduced.

Claims

1. A device for lining a vessel, comprising:

an expandable anchor movable from a collapsed shape to an expanded shape;

a liner attached to the anchor and extending from an end of the anchor;

an inner layer, the liner being mounted over the inner layer;

an outer layer extending over the liner and the anchor, the outer layer being retracted to expose the liner when the outer layer is moved proximally relative to the inner layer; and

a radiopaque coil extending beyond the distal end of the liner and the inner and outer layers, the radiopague coil also being positioned at least partially between the inner and outer layers.

2. The device of claim 1 wherein:

the outer layer holds the anchor in the collapsed position.

3. The device of claim 1 wherein:

the outer layer has a thickness of 0.0005-0.002 inch.

4. The device of claim 1 wherein:

the outer layer stretches over a tapered portion, the outer layer stretching as it passes over the tapered portion when the outer layer is moved proximally relative to the inner layer.

5. The device of claim 1 further comprising:

an inner element positioned beneath the liner and the anchor, the inner layer being attached to the inner element.

6. The device of claim 5, wherein:

the inner layer has a thickness of 0.0005-0.002 inch.

7. The device of claim 1 wherein:

the outer layer has a diameter of no more than 0.055 inch when in the collapsed position.

8. The device of claim 1 wherein:

the outer layer has a diameter of no more than 0.050 inch when in the collapsed position.

9. The device of claim 1 wherein:

the outer layer applies a compressive force to the liner to hold the liner in the collapsed position.

10. The device of claim 1 wherein:

the outer layer lies directly over the anchor and holds the anchor in the collapsed position, the outer layer being retracted by an outer element to expose the anchor and permit the anchor to move to the expanded position.

11. The device of claim 1 wherein:

the liner is collapsed by forming a number of folds.

12. The device of claim 1 wherein:

the liner is made of expanded PTFE.

13. The device of claim 1 wherein:

the inner and outer layers extend beyond a distal end of the liner, the outer layer tapering distally and being flexible enough to expand over the tapered section when the outer layer is retracted relative to the inner layer.

14. The device of claim 1 wherein:

the inner liner is attached to an inner element, the inner element engaging the anchor to hold the anchor when the outer layer is retracted relative to the inner layer.

15. The device of claim 14, wherein:

the inner element is spiral cut at a distal end.

16. The device of claim 15, wherein:

the inner element has a lumen for receiving a guidewire, the lumen having a diameter of 0.015-0.25 inch.

17. The device of claim 1 wherein:

the anchor has a length of less than 15 mm when collapsed.

18. A method of lining a vessel, comprising the steps of:

providing an expandable anchor, a liner, an inner layer, and an outer layer, the anchor and liner being movable from a collapsed shape to an expanded shape, the liner being attached to the anchor and extending from an end of the anchor, the outer layer being slidable relative to the inner layer, the outer layer extending over the liner and the anchor in the collapsed position, the radiopaque coil extending beyond the distal end of the liner and the inner and outer layers, the radiopaque coil being positioned at least partially between the inner and outer layers;

advancing a medical device to a treatment site;

retracting the outer layer to expose the liner and the anchor to permit the anchor to expand; and

advancing the medical device into the liner after the retracting step.

19. The method of claim 18 wherein:

the providing step is carried out with the outer layer holding the anchor and the liner in the collapsed position.

20. The method of claim 18 wherein:

the providing step is carried out with the outer layer having a thickness of 0.0005-0.002 inch.

21. The method of claim 18 wherein:

the providing step is carried out with the outer layer having a tapered portion when the anchor is in the collapsed position; and

the retracting step is carried out with the outer layer stretching over the tapered portion as it passes over the tapered portion.

22. The method of claim 21, wherein:

the providing step is carried out with the inner layer having a thickness of 0.0005-0.002 inch.

23. The method of claim 18 wherein:

the providing step is carried out with the outer layer having a diameter of no more than 0.050 inch when in the collapsed position.

24. The method of claim 18 wherein:

the providing step is carried out with the outer layer having a diameter of no more than 0.045 inch when in the collapsed position.

25. The method of claim 18 wherein:

the providing step is carried out with the outer layer lying directly over the anchor to hold the anchor in the collapsed position;

the retracting step being carried out so that the outer layer is retracted to expose the anchor and permit the anchor to expand.

26. The method of claim 18 wherein:

the providing step is carried out with the liner collapsed by forming a number of folds which are folded around one another.

27. The method of claim 18 wherein:

the providing step is carried out with the liner being made of expanded PTFE.

28. The method of claim 18, wherein:

the advancing step is carried out with the medical device being a medical device selected from the group consisting of a stent, an angioplasty balloon, a filter, a drug delivery device, and an atherectomy device.

29. The method of claim 18 wherein:

the providing step is carried out with the inner layer being attached to an inner element; and

the retracting step is carried out with the inner element contacting the anchor to hold the anchor in place while retracting the outer layer.

30. The method of claim 29, wherein:

the providing step is carried out with the inner element having a lumen for receiving a guidewire, the lumen having a diameter of 0.015-0.25 inch.

31. The method of claim 18 wherein:

the providing step is carried out with the outer layer attached to an outer element; and

the retracting step is carried out with the outer element being retracted with the outer layer.

32. The method of claim 18 wherein:

the providing step is carried out with the anchor having a length of less than 15 mm when collapsed.

33. A method of opening a narrowed region in a blood vessel, comprising the steps of:

providing a liner movable from a collapsed condition to an expanded condition;

advancing the liner to a narrowed region of a blood vessel with the liner in the collapsed position;

passing at least a portion of the liner through the narrowed region of the blood vessel in the collapsed position;

moving a stent into the liner after the passing step so that the stent is also positioned in the narrowed region of the blood vessel; and

expanding the stent after the moving step so that the stent expands the liner and opens the narrowed region of the vessel.

34. The method of claim 33, wherein:

the advancing and passing steps are carried out with the blood vessel being a vessel selected from the group comprising the internal carotid artery and saphenous vein graft.

35. The method of claim 33, further comprising the step of:

expanding at least part of the liner before expanding the stent.

36. A device for lining a vessel, comprising:

An expandable anchor movable from a collapsed shape to an expanded shape;

a liner attached to the anchor and extending from an end of the anchor;

an inner layer, the liner being mounted over the inner layer; and

an outer layer extending over the liner and the anchor, the outer layer being retracted to expose the liner when the outer layer is moved proximally relative to the inner layer, the outer layer stretching over a tapered portion, the outer layer stretching as it passes over the tapered portion when the outer layer is moved proximally relative to the inner layer;

wherein the inner layer is attached to an inner element, the inner element engaging the anchor to hold the anchor when the outer layer is retracted relative to the inner layer, the inner element being spiral cut at a distal end.

37. The device of claim 36 wherein:

the outer layer holds the anchor in the collapsed position.

38. The device of claim 36 wherein:

the outer layer has a thickness of 0.0005-0.002 inch.

39. The device of claim 36 further comprising:

an inner element positioned beneath the liner and the anchor, the inner layer being attached to the inner element.

40. The device of claim 39 wherein:

the inner layer has a thickness of 0.0005-0.002 inch.

41. The device of claim 36 wherein:

the outer layer has a diameter of no more than 0.055 inch when in the collapsed position.

42. The device of claim 36 wherein:

the outer layer has a diameter of no more than 0.050 inch when in the collapsed position.

43. The device of claim 36 wherein:

the outer layer applies a compressive force to the liner to hold the liner in the collapsed position.

44. The device of claim 36 wherein:

the outer layer lies directly over the anchor and holds the anchor in the collapsed position, the outer layer being retracted by an outer element to expose the anchor and permit the anchor to move to the expanded position.

45. The device of claim 36 wherein:

the liner is collapsed by forming a number of folds.

46. The device of claim 36 wherein:

the liner is made of expanded PTFE.

47. The device of claim 36 further comprising:

radiopaque coil extending beyond the distal end of the liner and being positioned at least partially between the inner and outer layers.

48. The device of claim 47, wherein:

the radiopaque coil extends beyond the distal end of the inner and outer layers.

49. The device of claim 36, wherein:

the inner and outer layers extend beyond a distal end of the liner, the outer layer tapering distally and being flexible enough to expand over the tapered section when the outer layer is retracted relative to the inner layer.

50. The device of claim 36, wherein:

the inner element has a lumen for receiving a guidewire, the lumen having a diameter of 0.015-0.25 inch.

51. The device of claim 36, wherein:

the anchor has a length of less than 15 mm when collapsed.

52. A device for lining a vessel, comprising:

an expandable anchor movable from a collapsed shape to an expanded shape;

a liner attached to the anchor and extending from an end of the anchor;

an inner layer, the liner being mounted over the inner layer; and

an outer layer extending over the liner and the anchor, the outer layer being retracted to expose the liner when the outer layer is moved proximally relative to the inner layer, the inner and outer layers extending beyond a distal end of the liner, the outer layer tapering distally and being flexible enough to expand over the tapered section when the outer layer is retracted relative to the inner layer;

wherein the inner layer is attached to an inner element, the inner element engaging the anchor to hold the anchor when the outer layer is retracted relative to the inner layer, the inner element being spiral cut at a distal end.

53. The device of claim 52, wherein:

the outer layer holds the anchor in the collapsed position.

54. The device of claim 52, wherein:

the outer layer has a thickness of 0.0005-0.002 inch.

55. The device of claim 52, wherein:

the outer layer stretches over a tapered portion, the outer layer stretching as it passes over the tapered portion when the outer layer is moved proximally relative to the inner layer.

56. The device of claim 52, further comprising:

an inner element positioned beneath the liner and the anchor, the inner layer being attached to the inner element.

57. The device of claim 56, wherein:

the inner layer has a thickness of 0.0005-0.002 inch.

58. The device of claim 52, wherein:

the outer layer has a diameter of no more than 0.055 inch when in the collapsed position.

59. The device of claim 52, wherein:

the outer layer has a diameter of no more than 0.050 inch when in the collapsed position.

60. The device of claim 52, wherein:

the outer layer applies a compressive force to the liner to hold the liner in the collapsed position.

61. The device of claim 52, wherein:

the outer layer lies directly over the anchor and holds the anchor in the collapsed position, the outer layer being retracted by an outer element to expose the anchor and permit the anchor to move to the expanded position.

62. The device of claim 52, wherein:

the liner is collapsed by forming a number of folds.

63. The device of claim 52, wherein:

the liner is made of expanded PTFE.

64. The device of claim 52, further comprising:

a radiopaque coil extending beyond the distal end of the liner and being positioned at least partially between the inner and outer layers.

65. The device of claim 64, wherein:

the radiopaque coil extends beyond the distal end of the inner and outer layers.

66. The device of claim 52, wherein:

the inner element has a lumen for receiving a guidewire, the lumen having a diameter of 0.015-0.25 inch.

67. The device of claim 52, wherein:

the anchor has a length of less than 15 mm when collapsed.

68. A device for lining a vessel, comprising:

an expandable anchor movable from a collapsed shape to an expanded shape;

a liner attached to the anchor and extending from an end of the anchor;

an inner layer, the liner being mounted over the inner layer;

an outer layer extending over the liner and the anchor, the outer layer being retracted to expose the liner when the outer layer is moved proximally relative to the inner layer; and

an inner element attached to the inner layer, the inner element engaging the anchor to hold the anchor when the outer layer is retracted relative to the inner layer, the inner element being spiral cut at a distal end.

69. The device of claim 68, wherein:

the outer layer holds the anchor in the collapsed position.

70. The device of claim 68, wherein:

the outer layer has a thickness of 0.0005-0.002 inch.

71. The device of claim 68, wherein:

the outer layer stretches over a tapered portion, the outer layer stretching as it passes over the tapered portion when the outer layer is moved proximally relative to the inner layer.

72. The device of claim 68, wherein:

the inner layer has a thickness of 0.0005-0.002 inch.

73. The device of claim 68, wherein:

the outer layer has a diameter of no more than 0.055 inch when in the collapsed position.

74. The device of claim 68, wherein:

the outer layer has a diameter of no more than 0.050 inch when in the collapsed position.

75. The device of claim 68, wherein:

the outer layer applies a compressive force to the liner to hold the liner in the collapsed position.

76. The device of claim 68, wherein:

the outer layer lies directly over the anchor and holds the anchor in the collapsed position, the outer layer being retracted by an outer element to expose the anchor and permit the anchor to move to the expanded position.

77. The device of claim 68, wherein:

the liner is collapsed by forming a number of folds.

78. The device of claim 68, wherein:

the liner is made of expanded PTFE.

79. The device of claim 68, further comprising:

a radiopaque coil extending beyond the distal end of the liner and being positioned at least partially between the inner and outer layers.

80. The device of claim 79, wherein:

the radiopaque coil extends beyond the distal end of the inner and outer layers.

81. The device of claim 68, wherein:

the inner and outer layers extend beyond a distal end of the liner, the outer layer tapering distally and being flexible enough to expand over the tapered section when the outer layer is retracted relative to the inner layer.

82. The device of claim 68, wherein:

the inner element has a lumen for receiving a guidewire, the lumen having a diameter of 0.015-0.25 inch.

83. The device of claim 68, wherein:

the anchor has a length of less than 15 mm when collapsed.

84. A device for lining a vessel, comprising:

an expandable anchor movable from a collapsed shape to an expanded shape;

a liner attached to the anchor and extending from an end of the anchor;

an inner layer, the liner being mounted over the inner layer;

an outer layer extending over the liner and the anchor, the outer layer being retracted to expose the liner when the outer layer is moved proximally relative to the inner layer; and

a radiopaque coil extending beyond the distal end of the liner and also being positioned at least partially between the inner and outer layers,

wherein the inner liner is attached to an inner element, the inner element engaging the anchor to hold the anchor when the outer layer is retracted relative to the inner layer, the inner element being spiral cut at a distal end.

85. The device of claim 84, wherein:

the inner element has a lumen for receiving a guidewire, the lumen having a diameter of 0.015-0.25 inch.

86. A device for lining a vessel, comprising:

an expandable anchor movable from a collapsed shape to an expanded shape;

a liner attached to the anchor and extending from an end of the anchor;

an inner layer, the liner being mounted over the inner layer;

an outer layer extending over the liner and the anchor, the outer layer being retracted to expose the liner when the outer layer is moved proximally relative to the inner layer, the outer layer stretching over a tapered portion, the outer layer stretching as it passes over the tapered portion when the outer layer is moved proximally relative to the inner layer; and

a radiopaque coil extending beyond the distal end of the liner and being positioned at least partially between the inner and outer layers.

87. The device of claim 86, wherein:

the radiopaque coil extends beyond the distal end of the inner and outer layers.

88. A device for lining a vessel, comprising:

an expandable anchor movable from a collapsed shape to an expanded shape;

a liner attached to the anchor and extending from an end of the anchor;

an inner layer, the liner being mounted over the inner layer, the inner element being spiral cut at a distal end; and

an outer layer extending over the liner and the anchor, the outer layer being retracted to expose the liner when the outer layer is moved proximally relative to the inner layer, the inner and outer layers extending beyond a distal end of the liner, the outer layer tapering distally and being flexible enough to expand over the tapered section when the outer layer is retracted relative to the inner layer.