Embolectomy catheters and methods for treating stroke and other small vessel thromboembolic disorders

• US 6,685,722 B1
• Filed: 11/10/1999
• Issued: 02/03/2004
• Est. Priority Date: 05/01/1998
• Status: Expired due to Term

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Microvention Incorporated (Terumo Corporation)
• Inventors: Rosenbluth, Robert F., Cox, Brian J., Monetti, Richard R., Green, George R. Jr., Chow, Sean L., Sternweiler, Thomas R.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/437,530
• Time in Patent Office: 1,546 Days
• Field of Search: 604/96-1-1, 604/11, 604/264, 604/266, 604/267, 604/268, 604/523-532, 606/1, 606/159, 606/167, 606/700, 606/713, 606/190-199, 600/201, 600/204, 600/207, 600/210
• US Class Current: 606/200
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• 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 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: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

Embolectomy catheters, rapid exchange microcatheters, systems and methods for removing clots or other obstructive matter (e.g., thrombus, thromboemboli, embolic fragments of atherosclerotic plaque, foreign objects, etc.) from blood vessels. This invention is particularly useable for percutaneous removal of thromboemboli or other obstructive matter from small blood vessels of the brain, during an evolving stroke or period of cerebral ischemia. In some embodiments, the embolectomy catheters of this invention are advanceable with or over a guidewire which has been pre-inserted through or around the clot. Also, in some embodiments, the embolectomy catheters include clot removal devices which are deployable from the catheter after the catheter has been advanced at least partially through the clot. The clot removal device may include a deployable wire nest that is designed to prevent a blood clot from passing therethrough. The delivery catheter may include telescoping inner and outer tubes, with the clot removal device being radially constrained by the outer tube. Retraction of the outer tube removes the constraint on the clot removal device and permits it to expand to its deployed configuration. An infusion guidewire is particularly useful in conjunction with the embolectomy catheter, and permits infusion of medicaments or visualization fluids distal to the clot.

Claims

1. An embolectomy catheter for removing a blood clot or other such obstructive matter from a blood vessel, the catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end, an inner tube, a distal tip attached to a distal end of the inner tube, and a guidewire lumen, a part of which extends longitudinally through the inner tube, the guidewire lumen being sized to receive a guidewire therein and being open on its distal end to permit the guidewire so received to project distally from the distal end of the catheter body;

a clot removal device having a distal end attached to the inner tube and a proximal end free to slide axially over the inner tube; and

,

an outer tube that is moveable between a distal position wherein it constrains the clot removal device in a collapsed state, and a proximal position wherein the clot removal device is substantially unconstrained and allowed to deploy to a radially expanded state;

wherein the distal tip defines a proximal mouth for receiving a short length of the outer tube, wherein the distal end of the outer tube is thereby prevented from catching on the clot as the catheter body passes therethrough.

2. The catheter of claim 1, wherein the catheter body and clot removal device, when in the collapsed state, are passable through the clot.

3. The catheter of claim 2, wherein the inner and outer tubes are relatively axially displaceable to cause the clot removal device to transition between the collapsed and expanded states.

4. The catheter of claim 3, wherein the inner and outer tubes coextend axially substantially the entire length of an insertion portion of the catheter body.

5. The catheter of claim 4, further including a handle attached to a proximal end of the insertion portion, and an actuator on the handle for proximally displacing the outer tube with respect to the inner tube.

6. The catheter of claim 5, further including an infusion port provided on the handle in fluid communication with an annular space defined between the inner and the outer tubes.

7. The catheter of claim 6, wherein the infusion port is mounted to a slide that is axially displaceable on the handle, and wherein the catheter body outer tube is attached to a distal end of the slide to receive fluid from the infusion port.

8. The catheter of claim 2, wherein the distal tip includes a tapered distal surface defining the distal end of the catheter body, the tapered distal surface facilitating passage of the catheter body through the clot.

9. The catheter of claim 1, wherein the outer tube is relatively retractable in the proximal direction with respect to the inner tube, the clot removal device residing in a region between the retracted outer tube and the distal tip when in the expanded state.

10. The catheter of claim 1, wherein the second end of the clot removal device is axially movable away from the first end to longitudinally stretch and radially constrict the device when the outer tube is in the retracted position.

11. The catheter of claim 10, wherein the clot removal device comprises a plurality of separate wires each attached at their distal ends to the inner tube and being looped about the inner tube at their proximal ends.

12. The catheter of claim 10, further including a sliding marker band disposed about the inner tube and configured to slide with the second end of the clot removal device to indicate the transition between retracted and extended positions.

13. The catheter of claim 12, further including a fixed marker band attached about the inner tube distally with respect to the clot removal device, the relative spacing between the fixed marker band and the sliding marker band indicating the transition between the retracted and extended positions.

14. The catheter of claim 1, wherein the catheter further comprises a handle and an insertion portion of the catheter body extending distally from handle, the insertion portion being defined by the inner tube and a co-axial outer tube extending substantially to the distal end of the catheter body.

15. The catheter of claim 14, wherein the insertion portion becomes more flexible in a distal direction from the handle.

16. The catheter of claim 15, wherein the catheter body has a size of between about 1-5 French at its distal end.

17. The catheter of claim 15, wherein both the inner and outer tubes become more flexible in a distal direction from the handle.

18. The catheter of claim 17, wherein both the inner and outer tubes include discrete segments that become more flexible in a distal direction from the handle.

19. The catheter of claim 18, wherein at least one of the inner and outer tubes includes a reinforced segment adjacent the handle.

20. The catheter of claim 14, further including an actuator on the handle for proximally displacing the outer tube with respect to the inner tube.

21. The catheter of claim 20, further including an infusion port provided on the handle in fluid communication with an annular space defined between the inner and outer tubes.

22. The catheter of claim 21, wherein the infusion port is mounted to a slide that is axially displaceable on the handle.

23. The catheter of claim 22, further including an inner hypotube extending substantially the length of the handle and attached at its distal end to the catheter body inner tube, and a guidewire introducer on a proximal end of the handle leading to the lumen of the inner hypotube, wherein the slide includes a throughbore receiving the hypotube.

24. The catheter of claim 23, wherein the infusion port is in fluid communication with the throughbore, and wherein the catheter body outertube is attached to a distal end of the slide co-axially with respect to the throughbore for receiving fluid from the infusion port.

25. The catheter of claim 1, wherein the clot removal device comprises a plurality of separate wires attached at their distal ends to the inner tube and looped about the inner tube at their proximal ends, the wires being spring biased to radially expand when unconstrained.

26. The catheter of claim 25, wherein the separate wires are helically wound about the inner tube, the spring-biased helical wires forming a radially expanded nest configuration upon their release from within the outer tube.

27. A system including the catheter of claim 1, and further including a guidewire received in the guidewire lumen and having a length sufficient to extend from the proximal end of the catheter body and project from the distal end.

28. The system of claim 27, wherein the guidewire is an infusion guidewire.

33. The catheter of claim 28, wherein the catheter body becomes more flexible in a direction from the proximal end to the distal end.

34. The catheter of claim 33, wherein the catheter body has a size of between about 1-5 French at its distal end.

35. The catheter of claim 33, wherein both the inner and outer tubes include discrete segments that become more flexible in a direction from the proximal end to the distal end.

36. The catheter of claim 35, wherein the inner tube is reinforced along its entire length, and includes a proximal reinforced segment and a distal reinforced segment, and wherein the proximal segment has reinforcement of higher density than in the distal segment.

37. The catheter of claim 33, wherein a portion of the outer tube that constrains the clot removal device in its collapsed configuration has a substantially lower column strength than a portion of the inner tube about which the clot removal device is mounted.

29. An embolectomy catheter for removing a blood clot or other such obstructive matter from a blood vessel, the catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end, an inner tube, and an outer tube terminating just short of a distal end of the catheter body;

a clot removal device having a distal end attached to the inner tube and a proximal end free to slide axially over the inner tube, the clot removal device being initially collapsed and constrained in its collapsed configuration by a portion of the outer tube;

a distal tip of the catheter body located on the inner tube and adapted to pass through a blood clot to be removed, the distal tip having a proximal mouth;

wherein the outer tube that extends distally within the proximal mouth of the distal tip prior to being retracted and is proximally movable to remove the constraint on the clot removal device, allowing axial displacement of the proximal end of the clot removal device toward the distal end to expand the clot removal device from a second, longitudinally stretched and radially constricted, state passable through the clot, to a first, deployed state.

30. The catheter of claim 29, wherein the inner tube is reinforced along its entire length.

31. The catheter of claim 30, wherein the inner tube is more flexible at its distal end than at its proximal end.

32. The catheter of claim 31, wherein the inner tube includes a proximal reinforced segment and a distal reinforced segment, and wherein the proximal segment has reinforcement of higher density than in the distal segment.

38. The catheter of claim 29, further including a handle attached to a proximal end of an insertion portion of the catheter body, and an actuator on the handle for displacing the outer tube with respect to the inner tube.

39. The catheter of claim 38, further including an infusion port provided on the handle in fluid communication with an annular space defined between the inner and outer tubes.

40. The catheter of claim 39, wherein the infusion port is mounted to a slide that is axially displaceable on the handle.

41. The catheter of claim 38, further including a slide that is axially displaceable on the handle and an inner hypotube extending substantially the length of the handle and attached at its distal end to the catheter body inner tube, and a guidewire introducer on a proximal end of the handle leading to the lumen of the inner hypotube, wherein the slide includes a throughbore receiving the hypotube.

42. The catheter of claim 29, further including a sliding marker band disposed about the inner tube and configured to slide with the proximal end of the clot removal device to indicate the transition between the first and second states.

43. The catheter of claim 29, wherein the inner tube defines a guidewire lumen sized to receive a guidewire therein, the guidewire lumen being open on its distal end to permit the guidewire so received to project distally from the distal end of the catheter body, and further including a guidewire received in the guidewire lumen and having a length sufficient to extend from the proximal end of the catheter body and project from the distal end.

44. The system of claim 43, wherein the guidewire is an infusion guidewire.

45. An embolectomy catheter for removing a blood clot or other such obstructive matter from a blood vessel, the catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end, an inner tube, and an outer tube terminating just short of a distal end of the catheter body, the catheter body becoming more flexible in a direction from the proximal end to the distal end;

a clot removal device having a distal end attached to the inner tube and a proximal end free to slide axially over the inner tube, the clot removal device being initially collapsed and constrained in its collapsed configuration by a portion of the outer tube;

a distal tip of the catheter body located on the inner tube and adapted to pass through a blood clot to be removed;

wherein the outer tube is proximally movable to remove the constraint on the clot removal device, allowing axial displacement of the proximal end of the clot removal device toward the distal end to expand the clot removal device from a second, longitudinally stretched and radially constricted, state passable through the clot, to a first, deployed state; and

wherein a portion of the outer tube that constrains the clot removal device in its collapsed configuration has a substantially lower column strength than a portion of the inner tube about which the clot removal device is mounted.

46. The catheter of claim 45, wherein the outer tube extends distally within a proximal mouth of the distal tip prior to being retracted.

47. The catheter of claim 45, wherein the inner tube is reinforced along its entire length.

48. The catheter of claim 47, wherein the inner tube is more flexible at its distal end than at its proximal end.

49. The catheter of claim 48, wherein the inner tube includes a proximal reinforced segment and a distal reinforced segment, and wherein the proximal segment has reinforcement of higher density than in the distal segment.

50. The catheter of claim 45, wherein the catheter body has a size of between about 1-5 French at its distal end.

51. The catheter of claim 45, wherein both the inner and outer tubes include discrete segments that become more flexible in a direction from the proximal end to the distal end.

52. The catheter of claim 51, wherein the inner tube is reinforced along its entire length, and includes a proximal reinforced segment and a distal reinforced segment, and wherein the proximal segment has reinforcement of higher density than in the distal segment.

53. The catheter of claim 45, further including a handle attached to a proximal end of the insertion portion, and an actuator on the handle for proximally displacing the outer tube with respect to the inner tube.

54. The catheter of claim 53, further including an infusion port provided on the handle in fluid communication with an annular space defined between the inner and outer tubes.

55. The catheter of claim 54, wherein the infusion port is mounted to a slide that is axially displaceable on the handle.

56. The catheter of claim 53, further including a slide that is axially displaceable on the handle and an inner hypotube extending substantially the length of the handle and attached at its distal end to the catheter body inner tube, and a guidewire introducer on a proximal end of the handle leading to the lumen of the inner hypotube, wherein the slide includes a throughbore receiving the hypotube.

57. The catheter of claim 45, wherein the clot removal device has a proximal end and a distal end, the distal end being attached to the inner tube and the proximal end being free to slide axially over the inner tube, the proximal end of the clot removal device being axially displaced away from the distal end within the outer tube to longitudinally stretch and radially constrict the device in a second state prior to its deployment to the first state, the clot removal device in the second state being passable through the clot.

58. The catheter of claim 57, further including a sliding marker band disposed about the inner tube and configured to slide with the proximal end of the clot removal device to indicate the transition between the first and second states.

59. A system including the catheter of claim 45, wherein the inner tube defines a guidewire lumen sized to receive a guidewire therein, the guidewire lumen being open on its distal end to permit the guidewire so received to project distally from the distal end of the catheter body, and further including a guidewire received in the guidewire lumen and having a length sufficient to extend from the proximal end of the catheter body and project from the distal end.

60. The system of claim 59, wherein the guidewire is an infusion guidewire.

61. An embolectomy catheter for removing a blood clot or other such obstructive matter from a blood vessel, the catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end, an inner tube, and a guidewire lumen a part of which extends longitudinally through the inner tube, the guidewire lumen being sized to receive a guidewire therein and being open on its distal end to permit the guidewire so received to project distally from the distal end of the catheter body;

a clot removal device having a distal end attached to the inner tube and a proximal end free to slide axially over the inner tube;

an outer tube that is moveable between a distal position wherein it constrains the clot removal device in a collapsed state, and a proximal position wherein the clot removal device is substantially unconstrained and allowed to deploy to its radially expanded state;

a handle and an insertion portion of the catheter body extending distally from handle, the insertion portion being defined by the inner tube and a co-axial outer tube extending substantially to the distal end of the catheter body, the clot removal device being radially constricted about the inner tube in a second state prior to its deployment to the first state, the catheter body and clot removal device in the second state being passable through the clot, wherein the inner and outer tubes are relatively axially displaceable to cause the clot removal device to transition between the first and second states;

an actuator on the handle for proximally displacing the outer tube with respect to the inner tube

an infusion port mounted to a slide that is axially displaceable on the handle, the infusion port being in fluid communication with an annular space defined between the inner and outer tubes;

an inner hypotube extending substantially the length of the handle and attached at its distal end to the catheter body inner tube; and

a guidewire introducer on a proximal end of the handle leading to the lumen of the inner hypotube, wherein the slide includes a throughbore receiving the hypotube.

62. The catheter of claim 61, wherein the catheter body and clot removal device, when in the collapsed state, are passable through the clot.

63. The catheter of claim 62, wherein the inner and outer tubes are relatively axially displaceable to cause the clot removal device to transition between the collapsed and expanded states.

64. The catheter of claim 63, wherein the inner and outer tubes coextend axially substantially the entire length of an insertion portion of the catheter body.

65. The catheter of claim 62, wherein the distal tip includes a tapered distal surface defining the distal end of the catheter body, the tapered distal surface facilitating passage of the catheter body through the clot.

66. The catheter of claim 65, wherein the distal tip defines a proximal mouth for receiving a short length of the outer tube, wherein the distal end of the outer tube is thereby prevented from catching on the clot as the catheter body passes therethrough.

67. The catheter of claim 61, wherein the outer tube is relatively retractable in the proximal direction with respect to the inner tube, the clot removal device residing in a region between the retracted outer tube and the distal tip when in the expanded state.

68. The catheter of claim 61, wherein the second end of the clot removal device is axially movable away from the first end to longitudinally stretch and radially constrict the device when the outer tube is in the retracted position.

69. The catheter of claim 68, wherein the clot removal device comprises a plurality of separate wires each attached at their distal ends to the inner tube and being looped about the inner tube at their proximal ends.

70. The catheter of claim 68, further including a sliding marker band disposed about the inner tube and configured to slide with the second end of the clot removal device to indicate the transition between retracted and extended positions.

71. The catheter of claim 70, further including a fixed marker band attached about the inner tube distally with respect to the clot removal device, the relative spacing between the fixed marker band and the sliding marker band indicating the transition between the retracted and extended positions.

72. The catheter of claim 61, wherein the insertion portion becomes more flexible in a distal direction from the handle.

73. The catheter of claim 72, wherein the catheter body has a size of between about 1-5 French at its distal end.

74. The catheter of claim 72, wherein both the inner and outer tubes become more flexible in a distal direction from the handle.

75. The catheter of claim 74, wherein both the inner and outer tubes include discrete segments that become more flexible in a distal direction from the handle.

76. The catheter of claim 75, wherein at least one of the inner and outer tubes includes a reinforced segment adjacent the handle.

77. The catheter of claim 61, wherein the infusion port is in fluid communication with the throughbore, and wherein the catheter body outertube is attached to a distal end of the slide co-axially with respect to the throughbore for receiving fluid from the infusion port.

78. The catheter of claim 61, wherein the clot removal device comprises a plurality of separate wires attached at their distal ends to the inner tube and looped about the inner tube at their proximal ends, the wires being spring biased to radially expand when unconstrained.

79. The catheter of claim 78, wherein the separate wires are helically wound about the inner tube, the spring-biased helical wires forming a radially expanded nest configuration upon their release from within the outer tube.

80. A system including the catheter of claim 61, and further including a guidewire received in the guidewire lumen and having a length sufficient to extend from the proximal end of the catheter body and project from the distal end.

81. The system of claim 80, wherein the guidewire is an infusion guidewire.

82. An embolectomy catheter for removing a blood clot or other such obstructive matter from a blood vessel, the catheter comprising:

an elongate flexible catheter body having a proximal end, a distal end, an inner tube, and a guidewire lumen a part of which extends longitudinally through the inner tube, the guidewire lumen being sized to receive a guidewire therein and being open on its distal end to permit the guidewire so received to project distally from the distal end of the catheter body;

a clot removal device having a distal end attached to the inner tube and a proximal end free to slide axially over the inner tube, the clot removal device comprising a plurality of separate wires attached at their distal ends to the inner tube and looped about the inner tube at their proximal ends, the wires being spring biased to radially expand when unconstrained; and

,

an outer tube that is moveable between a distal position wherein it constrains the clot removal device in a collapsed state, and a proximal position wherein the clot removal device is substantially unconstrained and allowed to deploy to its radially expanded state.

83. The catheter of claim 82, wherein the catheter body and clot removal device, when in the collapsed state, are passable through the clot.

84. The catheter of claim 83, wherein the inner and outer tubes are relatively axially displaceable to cause the clot removal device to transition between the collapsed and expanded states.

85. The catheter of claim 84, wherein the inner and outer tubes extend co-axially substantially the entire length of an insertion portion of the catheter body.

86. The catheter of claim 85, further including a handle attached to a proximal end of the insertion portion, and an actuator on the handle for proximally displacing the outer tube with respect to the inner tube.

87. The catheter of claim 86, further including an infusion port provided on the handle in fluid communication with an annular space defined between the inner and outer tubes.

88. The catheter of claim 87, wherein the infusion port is mounted to a slide that is axially displaceable on the handle, and wherein the catheter body outer tube is attached to a distal end of the slide to receive fluid from the infusion port.

89. The catheter of claim 83, further including a distal tip attached to a distal end of the inner tube, the distal tip having a tapered distal surface defining the distal end of the catheter body, the tapered distal surface facilitating passage of the catheter body through the clot.

90. The catheter of claim 89, wherein the distal tip defines a proximal mouth for receiving a short length of the outer tube, wherein the distal end of the outer tube is thereby prevented from catching on the clot as the catheter body passes therethrough.

91. The catheter of claim 90, wherein the outer tube is relatively retractable in the proximal direction with respect to the inner tube, the clot removal device residing in a region between the retracted outer tube and the distal tip when in the expanded state.

92. The catheter of claim 82, wherein the proximal end of the clot removal device is axially movable away from the distal end to longitudinally stretch and radially constrict the device when the outer tube is in the retracted position.

93. The catheter of claim 92, further including a sliding marker band disposed about the inner tube and configured to slide with the proximal end of the clot removal device to indicate the transition between retracted and extended positions.

94. The catheter of claim 93, further including a fixed marker band attached about the inner tube distally with respect to the clot removal device, the relative spacing between the fixed marker band and the sliding marker band indicating the transition between the retracted and extended positions.

95. The catheter of claim 82, wherein the catheter further comprises a handle and an insertion portion of the catheter body extending distally from handle, the insertion portion being defined by the inner tube and the outer tube is substantially coaxial with the inner tube and extending substantially to the distal end of the catheter body.

96. The catheter of claim 95, wherein the insertion portion becomes more flexible in a distal direction from the handle.

97. The catheter of claim 96, wherein the catheter body has a size of between about 1-5 French at its distal end.

98. The catheter of claim 96, wherein both the inner and outer tubes become more flexible in a distal direction from the handle.

99. The catheter of claim 98, wherein both the inner and outer tubes include discrete segments that become more flexible in a distal direction from the handle.

100. The catheter of claim 99, wherein at least one of the inner and outer tubes includes a reinforced segment adjacent the handle.

101. The catheter of claim 95, further including an actuator on the handle for proximally displacing the outer tube with respect to the inner tube.

102. The catheter of claim 101, further including an infusion port provided on the handle in fluid communication with an annular space defined between the inner and outer tubes.

103. The catheter of claim 102, wherein the infusion port is mounted to a slide that is axially displaceable on the handle.

104. The catheter of claim 103, further including an inner hypotube extending substantially the length of the handle and attached at its distal end to the catheter body inner tube, and a guidewire introducer on a proximal end of the handle leading to the lumen of the inner hypotube, wherein the slide includes a throughbore receiving the hypotube.

105. The catheter of claim 104, wherein the infusion port is in fluid communication with the throughbore, and wherein the catheter body outer tube is attached to a distal end of the slide co-axially with respect to the throughbore for receiving fluid from the infusion port.

106. The catheter of claim 82, further including a sliding marker band disposed about the inner tube and configured to slide with the proximal end of the clot removal device to indicate the transition between the first and second states.

107. The catheter of claim 106, further including a fixed marker band attached about the inner tube distally with respect to the clot removal device, the relative spacing between the fixed marker band and the sliding marker band indicating the transition between the first and second states.

108. The catheter of claim 82, wherein the separate wires are helically wound about the inner tube, the spring-biased helical wires forming a radially expanded nest configuration upon their release from within the outer tube.

109. A system including the catheter of claim 82, and further including a guidewire received in the guidewire lumen and having a length sufficient to extend from the proximal end of the catheter body and project from the distal end.

110. The system of claim 109, wherein the guidewire is an infusion guidewire.