Clot capture coil and method of using the same

• US 6,530,935 B2
• Filed: 10/12/1998
• Issued: 03/11/2003
• Est. Priority Date: 02/02/1996
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Wensel, Jeffrey P., Gobin, Y. Pierre
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/170,135
• Publication Number:
  US 20010031980A1
• Time in Patent Office: 1,611 Days
• Field of Search: 606/151, 606/198, 606/191, 606/200, 606/159, 606/127, 606/128
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A clot and foreign body removal device is described which comprises a catheter with at least one lumen. Located within the catheter is a clot capture coil that is connected to an insertion mandrel. In one embodiment, the clot capture coil is made out of a solid elastic or superelastic material which has shape memory, preferably nitinol. The elasticity or superelasticity of the coil allows it to be deformed within the catheter and to then reform its original coil configuration when the coil is moved outside of the catheter lumen. In another embodiment the coil is a biphasic coil which changes shape upon heating or passing an electric current. Once the coil configuration has been established, the coil can be used to ensnare and corkscrew a clot in a vessel. A clot is extracted from the vessel by moving the clot capture coil and catheter proximally until the clot can be removed or released into a different vessel that does not perfuse a critical organ. Foreign bodies are similarly captured by deploying the coil distal to the foreign body and moving the clot capture coil proximally until the foreign body is trapped within the coil. By removing the device from the body, the foreign material is also removed.

Claims

1. A clot capture coil device comprising:

(a) a catheter having proximal and distal ends and two lumens extending therethrough;

(b) two corresponding insertion mandrels, each having proximal and distal ends, wherein the distal end of each mandrel is slidable within its corresponding lumen of the catheter; and

(c) only a single coil formed of a coiled or double helix-shaped strand of solid shape memory material, said coil having proximal and distal ends, expanded and compressed forms, and a varying diameter along its length when in expanded form, wherein each end of the coil is connected to a different mandrel, said coil being slidably contained within the lumen of the catheter when in compressed form;

whereby distal movement of the mandrel relative to the catheter results in distal movement of the coil relative to the catheter, releases the coil from the lumen and allows the coil to expand into its expanded form, and whereby proximal movement of the mandrel relative to the catheter results in proximal movement of the coil relative to the catheter, and forces the coil into its compressed form within the lumen of the catheter.

2. A method of filtering thrombic material in a vessel, comprising the steps of:

(a) inserting a catheter having a least one lumen into the vessel;

(b) inserting into the lumen only a single coil formed of a coiled or double helix-shaped strand of solid, superelastic, shape memory material having a varying diameter along its length, the coil being connected at one of its ends to an insertion mandrel, whereby the coil deforms to an essentially straight configuration;

(c) advancing the coil distally out of the catheter to allow the superelastic shape memory coil to reform its natural coil configuration;

(d) allowing blood to flow through the coil to thereby trap thrombic material contained in the blood within the coil; and

(e) moving the thrombic material out of the vessel by moving the coil out of the vessel.

3. A method of removing an obstruction in a blood vessel comprising:

positioning an obstruction retriever within the lumen of a catheter, the obstruction retriever having an obstruction engaging portion extending from an insertion element, the obstruction engaging portion being an elongate element which extends from the insertion element to a free end, the obstruction engaging element having coils with varying diameters along the length of the obstruction engaging element, the obstruction engaging portion being movable between a collapsed position and an expanded position and being in the collapsed position when positioned in the lumen and being naturally biased toward the expanded position when positioned outside the lumen, wherein the lumen of the catheter is smaller than the expanded position of the obstruction engaging portion so that the lumen constrains and holds the obstruction engaging portion in the collapsed position;

advancing the catheter through an obstruction;

moving the obstruction engaging portion into engagement with the obstruction; and

thereafter removing the obstruction.

4. The method of claim 3 wherein the obstruction engaging portion is made of a superelastic material.

5. The method of claim 3 further comprising the step of introducing the catheter through another catheter to the obstruction.

6. The method of claim 5 further comprising:

loading the obstruction retriever into the catheter in a retrograde direction; and

thereafter introducing the catheter through the other catheter.

7. The method of claim 3 wherein the obstruction engaging element has a generally conical shape.

8. The method of claim 7 wherein the free end of the obstruction engaging element forms a tip of the conical shape.

9. The method of claim 3 wherein the providing step is carried out with the obstruction engaging element having a generally cylindrical portion.

10. The method of claim 3 wherein the catheter has only one lumen.

11. The method of claim 3 wherein the obstruction engaging element extends proximally from the insertion element to the free end when in the expanded condition.

12. The method of claim 3 wherein the obstruction engaging portion extends distally from the insertion element to the free end when in the expanded condition.

13. The method of claim 3, wherein the obstruction retriever has substantially only one filament which extends to the free end.

14. The method of claim 3, wherein:

the moving step is carried out by moving the obstruction engaging portion proximally into engagement with the obstruction.

15. The method of claim 14, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

16. The method of claim 3, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

17. The method of claim 3, wherein the obstruction engaging element has a helical shape.

18. A method of removing an obstruction in a blood vessel comprising:

positioning an obstruction retriever within the lumen of a catheter, the obstruction retriever having an obstruction engaging portion extending from an insertion element, the obstruction engaging portion being an elongate element which extends from the insertion element to a free end, the obstruction retriever having substantially only one filament which extends to the free end, the obstruction engaging portion being movable between a collapsed position and an expanded position and being in the collapsed position when positioned in the lumen and being naturally biased toward the expanded position when positioned outside the lumen;

advancing the catheter through an obstruction;

moving the obstruction engaging portion into engagement with the obstruction; and

thereafter removing the obstruction.

19. The method of claim 18 wherein the obstruction engaging portion is made of a superelastic material.

20. The method of claim 18 further comprising the step of introducing the catheter through another catheter to the obstruction.

21. The method of claim 18 further comprising:

loading the obstruction retriever into the catheter in a retrograde direction; and

thereafter introducing the catheter through the other catheter.

22. The method of claim 18 wherein the obstruction engaging element has a generally conical shape.

23. The method of claim 22 wherein the free end of the obstruction engaging element forms a tip of the conical shape.

24. The method of claim 18 wherein the providing step is carried out with the obstruction engaging element having a generally cylindrical portion.

25. The method of claim 18 wherein the catheter has only one lumen.

26. The method of claim 18 wherein the obstruction engaging element extends proximally from the insertion element to the free end when in the expanded condition.

27. The method of claim 18 wherein the obstruction engaging portion extends distally from the insertion element to the free end when in the expanded condition.

28. The method of claim 18, wherein:

the moving step is carried out by moving the obstruction engaging portion proximally into engagement with the obstruction.

29. The method of claim 28, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

30. The method of claim 18, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

31. The method of claim 18 wherein the obstruction engaging element has a helical shape.

32. The method of claim 18 wherein the obstruction engaging element has coils having varying diameters along the length of the obstruction engaging element.

33. A method of removing an obstruction in a blood vessel comprising:

positioning an obstruction retriever within the lumen of a catheter, the obstruction retriever having an obstruction engaging portion extending from an insertion element, the obstruction engaging portion being an elongate element which extends from the insertion element to a free end, the obstruction engaging portion being movable between a collapsed position and an expanded position and being in the collapsed position when positioned in the lumen and being naturally biased toward the expanded position when positioned outside the lumen;

advancing the catheter through an obstruction, the obstruction engaging element having a helical shape;

moving the obstruction engaging portion into engagement with the obstruction; and

thereafter removing the obstruction.

34. The method of claim 33 wherein the obstruction engaging portion is made of a superelastic material.

35. The method of claim 33 further comprising the step of introducing the catheter through another catheter to the obstruction.

36. The method of claim 35 further comprising:

loading the obstruction retriever into the catheter in a retrograde direction; and

thereafter introducing the catheter through the other catheter.

37. The method of claim 33 wherein the obstruction engaging element has a generally conical shape.

38. The method of claim 37 wherein the free end of the obstruction engaging element forms a tip of the conical shape.

39. The method of claim 33 wherein the providing step is carried out with the obstruction engaging element having a generally cylindrical portion.

40. The method of claim 33 wherein the catheter has only one lumen.

41. The method of claim 33 wherein the obstruction engaging element extends proximally from the insertion element to the free end when in the expanded condition.

42. The method of claim 33 wherein the obstruction engaging portion extends distally from the insertion element to the free end when in the expanded condition.

43. The method of claim 33, wherein the obstruction retriever has substantially only one filament which extends to the free end.

44. The method of claim 33, wherein:

the moving step is carried out by moving the obstruction engaging portion proximally into engagement with the obstruction.

45. The method of claim 44, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

46. The method of claim 33, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

47. The method of claim 33 wherein the obstruction engaging element has coils having varying diameters along the length of the obstruction engaging element.

48. A method of removing an obstruction in a blood vessel comprising:

positioning an obstruction retriever within the lumen of a catheter, the obstruction retriever having an obstruction engaging portion extending from an insertion element, the obstruction engaging portion being an elongate element which extends from the insertion element to a free end, the obstruction engaging portion being movable between a collapsed position and an expanded position and being in the collapsed position when positioned in the lumen and being naturally biased toward the expanded position when positioned outside the lumen, the obstruction engaging element having coils with varying diameters along the length of the obstruction engaging element;

advancing the catheter through an obstruction;

moving the obstruction engaging portion into engagement with the obstruction; and

thereafter removing the obstruction.

49. The method of claim 48 wherein the obstruction engaging portion is made of a superelastic material.

50. The method of claim 48 further comprising the step of introducing the catheter through another catheter to the obstruction.

51. The method of claim 50 further comprising:

loading the obstruction retriever into the catheter in a retrograde direction; and

thereafter introducing the catheter through the other catheter.

52. The method of claim 48 wherein the obstruction engaging element has a generally conical shape.

53. The method of claim 48 wherein the free end of the obstruction engaging element forms a tip of the conical shape.

54. The method of claim 48 wherein the providing step is carried out with the obstruction engaging element having a generally cylindrical portion.

55. The method of claim 48 wherein the catheter has only one lumen.

56. The method of claim 48 wherein the obstruction engaging element extends proximally from the insertion element to the free end when in the expanded condition.

57. The method of claim 48 wherein the obstruction engaging portion extends distally from the insertion element to the free end when in the expanded condition.

58. The method of claim 48, wherein the obstruction retriever has substantially only one filament which extends to the free end.

59. The method of claim 48, wherein:

the moving step is carried out by moving the obstruction engaging portion proximally into engagement with the obstruction.

60. The method of claim 59, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

61. The method of claim 48, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

62. The method of claim 48 wherein the obstruction engaging element has a helical shape.

63. A method of removing an obstruction in a blood vessel comprising:

positioning an obstruction retriever within the lumen of a catheter, the obstruction retriever having an obstruction engaging portion extending from an insertion element, the obstruction engaging portion being an elongate element which extends from the insertion element to a free end, the obstruction retriever having substantially only one filament which extends to the free end, the obstruction engaging portion being movable between a collapsed position and an expanded position and being in the collapsed position when positioned in the lumen and being naturally biased toward the expanded position when positioned outside the lumen, wherein the lumen of the catheter is smaller than the expanded position of the obstruction engaging portion so that the lumen constrains and holds the obstruction engaging portion in the collapsed position;

advancing the catheter through an obstruction;

moving the obstruction engaging portion into engagement with the obstruction; and

thereafter removing the obstruction.

64. The method of claim 63 wherein the obstruction engaging portion is made of a superelastic material.

65. The method of claim 63 further comprising the step of introducing the catheter through another catheter to the obstruction.

66. The method of claim 65 further comprising:

loading the obstruction retriever into the catheter in a retrograde direction; and

thereafter introducing the catheter through the other catheter.

67. The method of claim 63 wherein the obstruction engaging element has a generally conical shape.

68. The method of claim 67 wherein the free end of the obstruction engaging element forms a tip of the conical shape.

69. The method of claim 63 wherein the providing step is carried out with the obstruction engaging element having a generally cylindrical portion.

70. The method of claim 63 wherein the catheter has only one lumen.

71. The method of claim 63 wherein the obstruction engaging element extends proximally from the insertion element to the free end when in the expanded condition.

72. The method of claim 63 wherein the obstruction engaging portion extends distally from the insertion element to the free end when in the expanded condition.

73. The method of claim 63, wherein:

the moving step is carried out by moving the obstruction engaging portion proximally into engagement with the obstruction.

74. The method of claim 73, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

75. The method of claim 63, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

76. The method of claim 63 wherein the obstruction engaging element has a helical shape.

77. The method of claim 63 wherein the obstruction engaging element has coils having varying diameters along the length of the obstruction engaging element.

78. A method of removing an obstruction in a blood vessel comprising:

positioning an obstruction retriever within the lumen of a catheter, the obstruction retriever having an obstruction engaging portion extending from an insertion element, the obstruction engaging portion being an elongate element which extends from the insertion element to a free end, the obstruction engaging element having a helical shape, the obstruction engaging portion being movable between a collapsed position and an expanded position and being in the collapsed position when positioned in the lumen and being naturally biased toward the expanded position when positioned outside the lumen, wherein the lumen of the catheter is smaller than the expanded position of the obstruction engaging portion so that the lumen constrains and holds the obstruction engaging portion in the collapsed position;

advancing the catheter through an obstruction;

moving the obstruction engaging portion into engagement with the obstruction; and

thereafter removing the obstruction.

79. The method of claim 78 wherein the obstruction engaging portion is made of a superelastic material.

80. The method of claim 78 further comprising the step of introducing the catheter through another catheter to the obstruction.

81. The method of claim 80 further comprising:

loading the obstruction retriever into the catheter in a retrograde direction; and

thereafter introducing the catheter through the other catheter.

82. The method of claim 78 wherein the obstruction engaging element has a generally conical shape.

83. The method of claim 82 wherein the free end of the obstruction engaging element forms a tip of the conical shape.

84. The method of claim 78 wherein the providing step is carried out with the obstruction engaging element having a generally cylindrical portion.

85. The method of claim 78 wherein the catheter has only one lumen.

86. The method of claim 78 wherein the obstruction engaging element extends proximally from the insertion element to the free end when in the expanded condition.

87. The method of claim 78 wherein the obstruction engaging portion extends distally from the insertion element to the free end when in the expanded condition.

88. The method of claim 78, wherein the obstruction retriever has substantially only one filament which extends to the free end.

89. The method of claim 78, wherein:

the moving step is carried out by moving the obstruction engaging portion proximally into engagement with the obstruction.

90. The method of claim 89, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

91. The method of claim 78, wherein:

the moving step is carried out by rotating the obstruction engaging portion.

92. The method of claim 78 wherein the obstruction engaging element has coils having varying diameters along the length of the obstruction engaging element.