Neuro thrombectomy catheter

• US 6,482,217 B1
• Filed: 09/07/2000
• Issued: 11/19/2002
• Est. Priority Date: 04/10/1998
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Endicor Medical, Inc. (Medtronic Plc)
• Inventors: Pintor, Rafael, Heitzmann, Harold Alexander, Culbert, Bradley Steven, Stambaugh, Bruce D.
• Primary Examiner(s): Chaudhuri, Olik
• Assistant Examiner(s): Trinh, (Vikki) Hoa B.
• Application Number:
  US09/656,635
• Time in Patent Office: 803 Days
• Field of Search: 606/1, 606/108, 606/159, 606/170, 606/171, 606/180, 600/562-568, 151/040.5, 151/041.4, 151/041.5, 151/041.6, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means

Abstract

An elongate tubular body extends between a rotatable cutter and a control. The cutter is connected to the control with a rotatable element. A vacuum is applied through an annular passage defined between the tubular body and the rotatable element. The tubular body has a sufficiently small outside diameter and sufficient kink resistance and pushability to navigate through the internal carotid artery and at least into the M3 segment of the middle cerebral artery.

Claims

1. A rotational neuro thrombectomy catheter, comprising:

an elongate flexible tubular body, having a proximal end and a distal end, the tubular body having a distal segment with an outside diameter small enough to access the M1 segment of the middle cerebral artery and sufficiently kink-resistant to enable rotation of a rotatable tip therein;

a rotatable element extending through the body;

a rotatable tip at the distal end of the body and connected to the rotatable element;

a control on the proximal end of the body;

at least one radially inwardly extending stationary cutting member on the tubular body; and

at least one radially outwardly extending flange on the rotatable tip for cooperating with the stationary cutting member to cut material drawn into the tubular body.

2. A rotational medical device as in claim 1, wherein the outside diameter of the distal segment of the tubular body is small enough to access the M2 segment of the middle cerebral artery.

3. A rotational medical device as in claim 2, wherein the outside diameter of the distal segment of the tubular body is small enough to access the M3 segment of the middle cerebral artery.

4. A rotational medical device as in claim 1, comprising two radially outwardly extending flanges on the tip.

5. A rotational medical device as in claim 1, comprising two stationary cutting members on the tubular body.

6. A rotational medical device as in claim 1, further comprising an annular recess in the tubular body for rotatably receiving the radially outwardly extending flange.

7. A rotational medical device as in claim 1, wherein the rotatable tip has a diameter within the range of from about 0.020 inches to about 0.092 inches.

8. A rotational medical device as in claim 1, wherein the rotatable tip has an axial length within the range of from about 0.030 inches to about 0.120 inches.

9. A rotational medical device as in claim 1, wherein the distal end of the rotatable tip is approximately axially aligned with the distal end of the tubular body.

10. A rotational medical device as in claim 1, wherein the distal end of the rotatable tip extends beyond the distal end of the tubular body.

11. A rotational medical device as in claim 1, wherein the rotatable tip is recessed within the tubular body.

12. A rotational medical device as in claim 1, wherein the rotatable element comprises a torque tube.

13. A rotational medical device as in claim 1, wherein the torque tube comprises a layer of braided wire.

14. A rotational medical device as in claim 1, wherein the torque tube comprises a layer of coiled wire.

15. A rotational medical device as in claim 14, wherein the coiled wire comprises metal.

16. A rotational medical device as in claim 14, wherein the coiled wire comprises a polymer.

17. A rotational medical device as in claim 1, comprising a central guidewire lumen extending throughout the length of the rotational medical device.

18. A rotational medical device as in claim 1, comprising a monorail guidewire lumen extending throughout the length of the rotational medical device.

19. A rotational medical device as in claim 5, wherein the rotatable tip further comprises a radially inwardly extending annular recess.

20. A method of removing material from the middle cerebral artery, comprising the steps of:

providing an elongate, flexible, tubular body, having a proximal end and a distal end, a rotatable tip at the distal end of the tubular body, and at least one stationary cutting member on the tubular body which cooperates with at least one flange on the rotatable tip;

advancing the distal end of the tubular body transluminally through the internal carotid artery at least as distal as the M1 segment of the middle cerebral artery;

rotating the rotatable tip; and

drawing portions of material from the middle cerebral artery proximally past the rotatable tip so that the material is cut by the action of the flange rotating past the stationary member.

21. A method as in claim 20, wherein the advancing step comprises moving the distal end of the tubular body transluminally through the internal carotid artery at least as distal as the M2 segment of the middle cerebral artery.

22. A method as in claim 21, wherein the advancing step comprises moving the distal end of the tubular body transluminally through the internal carotid artery at least as distal as the M3 segment of the middle cerebral artery.

23. A method as in claim 20, wherein the drawing step is accomplished by applying vacuum to the proximal end of the tubular body.

24. A method as in claim 20, wherein the advancing step comprises advancing the tubular body along a guidewire.

25. A method as in claim 20, wherein the advancing step comprises advancing the tubular body through a percutaneous access site.

26. A method as in claim 20, further comprising the step of infusing fluid through a flush port on the proximal end of the tubular body.

27. A method as in claim 20, wherein the advancing step is accomplished by applying axial distal pressure on the tubular body, and further comprising the step of reducing the amount of axial distal pressure in response to feedback indicating a change in the load on the rotatable tip.

28. A method as in claim 23, wherein the applying a vacuum step is initiated prior to commencing rotation of the rotatable tip.

29. A method of removing material from a patient, comprising:

providing an elongate flexible tubular body, having a proximal end, a distal end, and at least two radially inwardly extending stationary cutting members near the distal end, a rotatable distal tip carried by the distal end of the tubular body, the tip having at least two radially outwardly extending flanges, and a control on the proximal end of the tubular body, the tubular body having a diameter of no more than about 1.3 mm over a distal portion of the catheter having a length of at least about 25 cm;

advancing the distal tip of the tubular body into the vasculature of the brain to the material to be removed;

manipulating the control to activate a vacuum through the tubular body;

commencing rotation of the rotatable tip to remove material from the patient; and

shearing the material between the flanges and the stationary cutting members.

30. A rotational neuro thrombectomy catheter, comprising:

an elongate flexible tubular body, having a proximal end and a distal end, the tubular body having a distal segment with an outside diameter small enough to access the M1 segment of the middle cerebral artery and sufficiently kink-resistant to enable rotation of a rotatable tip therein;

a rotatable element extending through the body;

a rotatable tip at the distal end of the body and connected to the rotatable element;

a control on the proximal end of the body;

at least one radially inwardly extending stationary cutting member on the tubular body; and

two radially outwardly extending flanges on the rotatable tip for cooperating with the stationary cutting member to cut material drawn into the tubular body.

31. A rotational medical device as in claim 30, wherein the outside diameter of the distal segment of the tubular body is small enough to access the M2 segment of the middle cerebral artery.

32. A rotational medical device as in claim 31, wherein the outside diameter of the distal segment of the tubular body is small enough to access the M3 segment of the middle cerebral artery.

33. A rotational medical device as in claim 30, comprising two stationary cutting members on the tubular body.

34. A rotational medical device as in claim 30, further comprising an annular recess in the tubular body for rotatably receiving the radially outwardly extending flange.

35. A rotational medical device as in claim 30, wherein the rotatable tip has a diameter within the range of from about 0.020 inches to about 0.092 inches.

36. A rotational medical device as in claim 30, wherein the rotatable tip has an axial length within the range of from about 0.030 inches to about 0.120 inches.

37. A rotational medical device as in claim 30, wherein the distal end of the rotatable tip is approximately axially aligned with the distal end of the tubular body.

38. A rotational medical device as in claim 30, wherein the distal end of the rotatable tip extends beyond the distal end of the tubular body.

39. A rotational medical device as in claim 30, wherein the rotatable tip is recessed within the tubular body.

40. A rotational medical device as in claim 30, wherein the rotatable element comprises a torque tube.

41. A rotational medical device as in claim 30, wherein the torque tube comprises a layer of braided wire.

42. A rotational medical device as in claim 30, wherein the torque tube comprises a layer of coiled wire.

43. A rotational medical device as in claim 42, wherein the coiled wire comprises metal.

44. A rotational medical device as in claim 42, wherein the coiled wire comprises a polymer.

45. A rotational medical device as in claim 30, comprising a central guidewire lumen extending throughout the length of the rotational medical device.

46. A rotational medical device as in claim 30, comprising a monorail guidewire lumen extending throughout the length of the rotational medical device.

47. A rotational medical device as in claim 33, wherein the rotatable tip further comprises a radially inwardly extending annular recess.

48. A rotational neuro thrombectomy catheter, comprising:

an elongate flexible tubular body, having a proximal end and a distal end, the tubular body having a distal segment with an outside diameter small enough to access the M1 segment of the middle cerebral artery and sufficiently kink-resistant to enable rotation of a rotatable tip therein;

a rotatable element extending through the body;

a rotatable tip at the distal end of the body and connected to the rotatable element;

a control on the proximal end of the body;

two radially inwardly extending stationary cutting members on the tubular body; and

at least one radially outwardly extending flange on the rotatable tip for cooperating with the stationary cutting member to cut material drawn into the tubular body.

49. A rotational medical device as in claim 48, wherein the outside diameter of the distal segment of the tubular body is small enough to access the M2 segment of the middle cerebral artery.

50. A rotational medical device as in claim 49, wherein the outside diameter of the distal segment of the tubular body is small enough to access the M3 segment of the middle cerebral artery.

51. A rotational medical device as in claim 48, comprising two radially outwardly extending flanges on the tip.

52. A rotational medical device as in claim 48, further comprising an annular recess in the tubular body for rotatably receiving the radially outwardly extending flange.

53. A rotational medical device as in claim 48, wherein the rotatable tip has a diameter within the range of from about 0.020 inches to about 0.092 inches.

54. A rotational medical device as in claim 48, wherein the rotatable tip has an axial length within the range of from about 0.030 inches to about 0.120 inches.

55. A rotational medical device as in claim 48, wherein the distal end of the rotatable tip is approximately axially aligned with the distal end of the tubular body.

56. A rotational medical device as in claim 48, wherein the distal end of the rotatable tip extends beyond the distal end of the tubular body.

57. A rotational medical device as in claim 48, wherein the rotatable tip is recessed within the tubular body.

58. A rotational medical device as in claim 48, wherein the rotatable element comprises a torque tube.

59. A rotational medical device as in claim 48, wherein the torque tube comprises a layer of braided wire.

60. A rotational medical device as in claim 48, wherein the torque tube comprises a layer of coiled wire.

61. A rotational medical device as in claim 60, wherein the coiled wire comprises metal.

62. A rotational medical device as in claim 60, wherein the coiled wire comprises a polymer.

63. A rotational medical device as in claim 48, comprising a central guidewire lumen extending throughout the length of the rotational medical device.

64. A rotational medical device as in claim 48, comprising a monorail guidewire lumen extending throughout the length of the rotational medical device.

65. A rotational medical device as in claim 48, wherein the rotatable tip further comprises a radially inwardly extending annular recess.

66. A rotational neuro thrombectomy catheter, comprising:

an elongate flexible tubular body, having a proximal end and a distal end, the tubular body having a distal segment with an outside diameter small enough to access the M1 segment of the middle cerebral artery and sufficiently kink-resistant to enable rotation of a rotatable tip therein;

a rotatable element extending through the body;

a rotatable tip at the distal end of the body and connected to the rotatable element;

a control on the proximal end of the body;

at least one radially inwardly extending stationary cutting member on the tubular body;

at least one radially outwardly extending flange on the rotatable tip for cooperating with the stationary cutting member to cut material drawn into the tubular body; and

an annular recess in the tubular body for rotatably receiving the radially outwardly extending flange.

67. A rotational medical device as in claim 66, wherein the outside diameter of the distal segment of the tubular body is small enough to access the M2 segment of the middle cerebral artery.

68. A rotational medical device as in claim 67, wherein the outside diameter of the distal segment of the tubular body is small enough to access the M3 segment of the middle cerebral artery.

69. A rotational medical device as in claim 66, comprising two radially outwardly extending flanges on the tip.

70. A rotational medical device as in claim 66, comprising two stationary cutting members on the tubular body.

71. A rotational medical device as in claim 66, wherein the rotatable tip has a diameter within the range of from about 0.020 inches to about 0.092 inches.

72. A rotational medical device as in claim 66, wherein the rotatable tip has an axial length within the range of from about 0.030 inches to about 0.120 inches.

73. A rotational medical device as in claim 66, wherein the distal end of the rotatable tip is approximately axially aligned with the distal end of the tubular body.

74. A rotational medical device as in claim 66, wherein the distal end of the rotatable tip extends beyond the distal end of the tubular body.

75. A rotational medical device as in claim 66, wherein the rotatable tip is recessed within the tubular body.

76. A rotational medical device as in claim 66, wherein the rotatable element comprises a torque tube.

77. A rotational medical device as in claim 66, wherein the torque tube comprises a layer of braided wire.

78. A rotational medical device as in claim 66, wherein the torque tube comprises a layer of coiled wire.

79. A rotational medical device as in claim 78, wherein the coiled wire comprises metal.

80. A rotational medical device as in claim 78, wherein the coiled wire comprises a polymer.

81. A rotational medical device as in claim 66, comprising a central guidewire lumen extending throughout the length of the rotational medical device.

82. A rotational medical device as in claim 66, comprising a monorail guidewire lumen extending throughout the length of the rotational medical device.

83. A rotational medical device as in claim 70, wherein the rotatable tip further comprises a radially inwardly extending annular recess.