Neuro thrombectomy catheter

• US 7,842,055 B2
• Filed: 07/21/2006
• Issued: 11/30/2010
• Est. Priority Date: 04/10/1998
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: ev3 Endovascular, Inc. (Medtronic Plc)
• Inventors: Pintor, Rafael, Heitzmann, Harold Alexander, Stambaugh, Bruce D., Culbert, Bradley Steven
• Primary Examiner(s): Nguyen; Anhtuan T.
• Assistant Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US11/490,620
• Publication Number:
  US 20060259052A1
• Time in Patent Office: 1,593 Days
• Field of Search: 600/564, 600/565, 600/566, 600/567, 600/568, 604/22, 604/96, 604/7, 604/101, 604/19, 604107-107, 604/171, 604/264, 606/159, 606/167, 606/170, 606/180, 606/194, 128/898
• 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 arteries such as the internal carotid artery.

Claims

1. A method of removing tissue from the vasculature of a brain, the method comprising:

introducing a neuro thrombectomy catheter into a patient, the neuro thrombectomy catheter comprising an elongate, flexible tubular body having a proximal end and a distal end, the catheter comprising sufficient flexibility to traverse a vessel radius of curvature of about 5 mm or greater, the catheter further comprising a rotatable distal cutting tip positioned within a first lumen of the tubular body that, when rotated within a vessel of a patient, does not contact a wall of the vessel, wherein the neuro thrombectomy catheter comprises a guidewire lumen non-coaxial with the first lumen, the guidewire lumen having a distal guidewire port and a proximal guidewire port spaced distally apart from the proximal end of the tubular body, and the neuro thrombectomy catheter is introduced into the vasculature of the brain of the patient by advancing the guidewire lumen over a guidewire extending throughout the length of the tubular body and having a diameter of less than about 0.02 inches, wherein the distal guidewire port is distal to a distal opening of the first lumen and is positioned on a distal advance segment for enhancing the trackability of the neuro thrombectomy catheter;

advancing the distal end of the tubular body into the vasculature of the brain to a location proximate the tissue to be removed;

rotating the distal cutting tip to remove tissue from the patient without the distal cutting tip contacting the wall of the vessel in which the distal cutting tip is located; and

drawing tissue into the first lumen of the tubular body to remove the tissue from vasculature of the brain.

2. The method of claim 1, wherein the distal end of the tubular body is advanced into at least one of the M1, M2, and M3 segments of the middle cerebral artery.

3. The method of claim 1, wherein the distal end of the tubular body is advanced into the right or left vertebral artery.

4. The method of claim 1, wherein the distal end of the tubular body is advanced into the basilar artery.

5. The method of claim 1, wherein the distal end of the tubular body is advanced into the right or left posterior cerebral artery.

6. The method of claim 1, wherein the distal end of the tubular body is advanced into the right or left posterior communicating artery.

7. The method of claim 1, further comprising severing the tissue from the vasculature of the brain by rotating the distal cutting tip without the distal cutting tip contacting the vasculature wall when the tissue is severed.

8. The method of claim 7, wherein the tissue is drawn into the tubular body prior to being severed by the distal cutting tip.

9. The method of claim 7, wherein the tissue is severed by cooperation of a cutting surface on the distal cutting tip and a stationary cutting member located on the tubular body.

10. The method of claim 1, further comprising infusing fluid into the vasculature prior to rotating the distal cutting tip of the catheter.

11. The method of claim 10, wherein the fluid that is infused into the vasculature is thrombolytic.

12. The method of claim 10, wherein rotating the distal cutting tip of the catheter macerates the tissue to be removed.

13. The method of claim 1, wherein the proximal guidewire port is spaced proximally from the distal guidewire port by a distance within the range of from about 10 cm to 155 cm.

14. The method of claim 1, wherein the distal advance segment has an outside diameter of less than roughly 1 mm.

15. The method of claim 1, wherein the distal advance segment has an axial length of between 1 mm and 6 mm.

16. The method of claim 1, wherein the proximal guidewire port has an angled opening.

17. The method of claim 1, wherein the rotatable distal cutter tip is at least partially exposed externally outside the tubular body by way of a distal opening of the flexible tubular body, the distal opening having an axial length.

18. The method of claim 17, wherein the distal opening is angled.

19. The method of claim 17, wherein the distal opening has an axial length of between 0.5 mm and 3 mm.

20. The method of claim 17, wherein the cutting tip is axially moveable out of the distal opening.

21. The method of claim 1, wherein tissue is drawn into the first lumen by aspiration.

22. The method of claim 1, wherein introducing the neuro thrombectomy catheter comprises advancing the guidewire lumen over the guidewire that is encircled within the guidewire lumen between the proximal and distal guidewire ports, and that extends alongside the tubular body throughout the length of the tubular body proximal to the proximal guidewire port.

23. A method of removing tissue from the vasculature of a brain, the method comprising:

introducing a neuro thrombectomy catheter into the vasculature of the brain of a patient, wherein the neuro thrombectomy catheter comprises an elongate, flexible tubular body having a proximal end and a distal end, a first lumen, and a guidewire lumen comprising a distal guidewire port and a proximal guidewire port spaced distally apart from the proximal end of the tubular body, the guidewire lumen non-coaxial with the first lumen, wherein the neuro thrombectomy catheter is introduced into the vasculature of the brain of the patient by advancing the guidewire lumen over a guidewire extending throughout the length of the tubular body and having a diameter of less than about 0.02 inches;

cutting tissue from the vasculature of the brain of the patient, said cutting being performed by rotating a distal tip located within the first lumen of the tubular body to separate tissue from the vasculature while advancing said distal tip along the vasculature, wherein the distal tip, when rotating, is prevented from contacting the vessel wall; and

drawing tissue once cut into the first lumen of the tubular body to remove tissue from vasculature of the brain.

24. The method of claim 23, wherein the rotating distal tip is rotated within the tubular body to prevent the rotating distal tip from contacting the vessel wall.

25. The method of claim 23, wherein the tissue is separated from the vasculature by being severed between a portion of the rotating distal tip and a portion of the tubular body.

26. The method of claim 23, wherein the tissue is separated from the vasculature by macerating the tissue during or after delivery of a thrombolytic drug.

27. The method of claim 26, wherein the thrombolytic drug is infused through an aspiration channel extending through a portion of the first lumen of the tubular body.

28. The method of claim 23, wherein the tissue is drawn into the tubular body by applying a vacuum to an aspiration channel extending through at least a portion of the first lumen of the tubular body.

29. The method of claim 23, wherein introducing the neuro thrombectomy catheter comprises advancing the guidewire lumen over the guidewire that is encircled within the guidewire lumen between the proximal and distal guidewire ports, and that extends alongside the tubular body throughout the length of the tubular body proximal to the proximal guidewire port.

30. A method of removing thrombi from the brain, the method comprising:

endovascularly introducing a neuro thrombectomy catheter of at least 165 cm length through a femoral artery puncture site to a target vessel within the vasculature of the brain, wherein the neuro thrombectomy catheter comprises an elongate, flexible tubular body, the neuro thrombectomy catheter having a rotatable cutting member located within a first lumen of the catheter at a distal portion thereof, wherein the neuro thrombectomy catheter comprises a guidewire lumen separate from and non-coaxial with the first lumen, the guidewire lumen having a distal guidewire port and a proximal guidewire port spaced distally apart from a proximal end of the tubular body, and the neuro thrombectomy catheter is introduced into the vasculature of the brain of the patient by advancing the guidewire lumen over a guidewire extending throughout the length of the tubular body and having a diameter of less than about 0.02 inches;

infusing a drug through the first lumen into the target vessel proximate the thrombi;

applying rotational energy to the rotatable cutting member to separate the thrombi from the target vessel wall without the rotatable cutting member engaging a wall of the target vessel; and

applying a vacuum to a proximal end of the catheter to aspirate the thrombi from the target vessel through the first lumen after applying rotational energy to the rotatable cutting member.

31. The method of claim 30, wherein a thrombolytic drug is infused prior to applying rotational energy to the rotatable member.

32. The method of claim 30, wherein rotation of the rotatable cutting member occurs within first lumen of the thrombectomy catheter to prevent the rotatable cutting member from engaging the wall of the target vessel.

33. The method of claim 30, wherein the thrombectomy catheter is introduced into at least one of the M1, M2, and M3 segments of the middle cerebral artery.

34. The method of claim 30, wherein the distal end of the tubular body is advanced into the right or left vertebral artery.

35. The method of claim 30, wherein the distal end of the tubular body is advanced into the basilar artery.

36. The method of claim 30, wherein the distal end of the tubular body is advanced into the right or left posterior cerebral artery.

37. The method of claim 30, wherein the distal end of the tubular body is advanced into the right or left posterior communicating artery.

38. The method of claim 30, wherein introducing the neuro thrombectomy catheter comprises advancing the guidewire lumen over the guidewire that is encircled within the guidewire lumen between the proximal and distal guidewire ports, and that extends alongside the tubular body throughout the length of the tubular body proximal to the proximal guidewire port.

39. A method of removing tissue from the vasculature of a brain, the method comprising:

introducing a neuro thrombectomy catheter into a patient, the neuro thrombectomy catheter comprising an elongate, flexible tubular body having a proximal end and a distal end, the catheter comprising sufficient flexibility to traverse a vessel radius of curvature of about 5 mm or greater, the catheter further comprising a cutter positioned within a first lumen of the tubular body, wherein the neuro thrombectomy catheter comprises a guidewire lumen separate from the first lumen, the guidewire lumen having a distal guidewire port and a proximal guidewire port spaced distally apart from the proximal end of the tubular body, and the neuro thrombectomy catheter is introduced into the vasculature of the brain of the patient by advancing the guidewire lumen over a guidewire extending throughout the length of the tubular body and having a diameter of less than about 0.02 inches, such that guidewire lumen encircles the guidewire distal to the proximal guidewire port but does not encircle the guidewire proximal to the proximal guidewire port;

advancing the distal end of the tubular body into the vasculature of the brain to a location proximate the tissue to be removed;

using the cutter to remove tissue from the patient; and

drawing tissue into the first lumen of the tubular body to remove the tissue from vasculature of the brain.

40. The method of claim 39, wherein using the cutter to remove tissue from the patient comprises actuating the cutter.

41. The method of claim 39, wherein using the cutter to remove tissue from the patient comprises rotating the cutter.

42. The method of claim 39, wherein the tissue is drawn into the tubular body prior to using the cutter.

43. The method of claim 39, further comprising infusing fluid into the vasculature prior to using the cutter.

44. The method of claim 39, comprising cutting tissue while advancing the distal end along the vasculature.

45. The method of claim 39, wherein the proximal guidewire port is spaced proximally from the distal guidewire port by a distance within the range of from about 10 cm to 155 cm.

46. The method of claim 39, wherein the distal guidewire port is distal to a distal opening of the first lumen and is positioned on a distal advance segment for enhancing the trackability of the neuro thrombectomy catheter.

47. The method of claim 39, wherein the cutting tip is axially moveable out of the distal opening.