Debulking catheters and methods

• US 20030125757A1
• Filed: 11/04/2002
• Published: 07/03/2003
• Est. Priority Date: 12/20/2000
• Status: Abandoned Application

• Current Assignee: Foxhollow Technologies Incorporated (Medtronic Plc)
• Original Assignee: Foxhollow Technologies Incorporated (Medtronic Plc)
• Inventors: Corvi, Tim, Patel, Himanshu, Simpson, John B., Doud, Darren G., Venegas, Gautama B., Follmer, Brett, Willis, Eric
• Application Number:
  US10/288,559
• Publication Number:
  US 20030125757A1
• Time in Patent Office: Days
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft

Abstract

A debulking catheter comprising a tissue debulking assembly for removing material from a body lumen. Catheters of the present invention generally include a catheter body having proximal and distal portions and a tissue debulking assembly disposed at least partially within the distal portion. The tissue debulking assembly is radially movable to expose at least a portion of the assembly through a window on the catheter body to contact material in the body lumen. The catheter may then be moved to allow the tissue debulking assembly to remove all or a portion of the material. In exemplary embodiments, the distal portion of the catheter body is rotatably coupled to the proximal portion such that rotation or deflection of the distal portion, relative to the proximal portion, urges the window against material in the body lumen, exposes the tissue debulking assembly through the window, or both. In some embodiments, the flexible proximal portion includes a rigid distal portion to enhance positioning of the debulking assembly within the body lumen.

Claims

1. A debulking catheter for removing material from a body lumen, the catheter comprising:

a catheter body comprising a proximal portion and a distal portion, the distal portion comprising a window; and

a tissue debulking assembly disposed at least partially within the distal portion, wherein the tissue debulking assembly is radially movable to expose at least a portion of the assembly through the window to contact the material in the body lumen.

2. The catheter of claim 1, wherein the distal portion has an outer diameter of between about 0.1 cm and about 0.22 cm and the window has a length of between about 0.12 cm and about 0.25 cm.

3. The catheter of claim 1 wherein the tissue debulking assembly comprises a radio frequency electrode, a laser, or an ultrasound emitter.

4. The catheter of claim 1, wherein the tissue debulking assembly comprises a rotatable cutter.

5. The catheter of claim 4, wherein the rotatable cutter includes a beveled edge for contacting the material in the body lumen while preventing injury to the body lumen.

6. The catheter of claim 4, wherein the rotatable cutter includes a tungsten carbide cutting edge.

7. The catheter of claim 4, wherein the proximal portion and the distal portion define a channel having a longitudinal axis, the catheter further comprising a drive shaft positioned within the channel, wherein the drive shaft is attachable to a driver for rotating the cutter.

8. The catheter of claim 1, wherein the distal portion angularly deflects, relative to the proximal portion, to urge the window against the material in the body lumen.

9. The catheter of claim 8, further comprising:

a proximal guidewire lumen coupled with the proximal portion; and

a distal telescoping guidewire lumen coupled with the distal portion and extending within the proximal guidewire lumen to form a continuous guidewire lumen, wherein the distal telescoping guidewire lumen is movable in and out of the proximal guidewire lumen upon deflection of the distal portion of the catheter relative to the proximal portion.

10. The catheter of claim 9, wherein the distal guidewire lumen has a length of between about 5.0 cm and about 8.0 cm and the proximal guidewire lumen has a length of between about 10 cm and about 14 cm.

11. The catheter of claim 1, wherein the distal portion angularly deflects, relative to the proximal portion, to expose the portion of the tissue debulking assembly through the window to contact the material in the body lumen.

12. The catheter of claim 11, wherein the distal portion deflects in a direction opposite of the window about an axis that is substantially orthogonal to a longitudinal axis of the catheter body.

13. The catheter of claim 11, wherein the distal portion is coupled to the proximal portion with a joint, wherein movement of the tissue debulking assembly actuates deflection of the distal portion about the joint.

14. The catheter of claim 1, wherein radially moving the tissue debulking assembly though the window causes the distal portion to angularly deflect, relative to the proximal portion.

15. The catheter of claim 1, further comprising a ramp positioned on the distal portion opposite of the window, wherein proximal movement of the tissue debulking assembly over the ramp deflects the distal portion to radially move the tissue debulking assembly out of the window.

16. The catheter of claim 15, wherein the tissue debulking assembly further comprises a shuttle mechanism to lock the tissue debulking assembly in place when the distal portion is deflected.

17. The catheter of claim 16, wherein the shuttle mechanism is coupled with the proximal portion by means of a first joint and with the distal portion by means of a second joint, so that the shuttle mechanism is movable relative to the distal portion, the proximal portion or both.

18. The catheter of claim 1, wherein the tissue debulking assembly is movable between a first position and a second position, wherein the tissue debulking assembly in the first position closes the window.

19. The catheter of claim 18, wherein the movable tissue debulking assembly in the second position extends beyond an outer diameter of the distal portion of the catheter body.

20. The catheter of claim 19, wherein the movable tissue debulking assembly in the second position extends beyond the outer diameter of the distal portion by between about 0.025 mm and about 0.64 mm.

21. The catheter of claim 19, wherein the tissue debulking assembly in the second position moves a longitudinal axis of the tissue debulking assembly to an angled position relative to the longitudinal axis of the distal portion and moves out of the window beyond the outer diameter of the distal portion.

22. The catheter of claim 19, wherein the tissue debulking assembly in the second position moves a longitudinal axis of the assembly to an offset parallel position relative to the longitudinal axis of the distal portion and moves out of the window beyond the outer diameter of the distal portion.

23. The catheter of claim 1, wherein the proximal portion further comprises at least one rigid portion disposed near a distal end of the proximal portion for helping to urge the tissue debulking assembly into the material in the body lumen.

24. The catheter of claim 23, wherein the rigid portion comprises a curvature.

25. The catheter of claim 23, wherein the rigid portion comprises a length of the proximal portion of the catheter body in which a first side of the proximal portion is less rigid than a second side, wherein the first and second sides are disposed opposite one another across a cross section of the rigid portion so that tension applied to the proximal portion in the proximal direction causes the catheter body to deflect in the direction of the first side.

26. The catheter of claim 25, wherein the second side is disposed opposite the side of the window so that tension applied to the proximal portion in the proximal direction causes the window to be urged into contact with the material in the body lumen.

27. The catheter of claim 1, further comprising a flexible distal tip coupled to the distal portion, wherein at least one of the distal tip and distal portion comprise a collection chamber.

28. The catheter of claim 27, wherein the collection chamber is at least partially translucent and the distal portion adjacent the window is radiopaque.

29. The catheter of claim 27, wherein the distal tip comprises the collection chamber, and the distal tip and the distal portion have complementary interlocking components for attaching with one another.

30. The catheter of claim 27, further comprising:

a proximal guidewire lumen coupled with the proximal portion; and

a distal guidewire lumen coupled with at least one of the distal tip and the distal portion, wherein the proximal and distal guidewire lumens allow passage of a guidewire therethrough.

31. The catheter of claim 30, wherein the distal guidewire lumen has a length of between about 2.0 cm and about 3.0 cm and the proximal guidewire lumen has a length of between about 10 cm and about 14 cm.

32. The catheter of claim 30, wherein a portion of the distal guidewire lumen is movable relative to the catheter body.

33. A rapid exchange debulking catheter for removing material from a body lumen, the catheter comprising:

an elongate catheter body comprising an articulable distal portion coupled to a proximal portion;

a tissue debulking assembly coupled to the articulable distal portion for removing the material from the body lumen;

a proximal guidewire lumen coupled to the proximal portion; and

a distal telescoping guidewire lumen at least partially coupled with the distal portion and extending within the proximal guidewire lumen to form a continuous guidewire lumen.

34. The rapid exchange debulking catheter of claim 33, further comprising a flexible distal tip coupled to the distal portion, wherein at least one of the distal tip and distal portion comprise a collection chamber.

35. The rapid exchange debulking catheter of claim 34, wherein the collection chamber is at least partially translucent and the distal portion adjacent the window is radiopaque.

36. The rapid exchange debulking catheter of claim 34, wherein the distal tip comprises the collection chamber, and the distal tip and the distal portion have complementary interlocking components for attaching with one another.

37. The rapid exchange debulking catheter of claim 34, wherein the distal guidewire lumen is attached to the flexible distal tip and wherein a portion of the distal guidewire lumen adjacent the debulking assembly is movable relative to the catheter body.

38. The rapid exchange debulking catheter of claim 33 wherein the elongate catheter body comprises an inner lumen that extends through the proximal portion and the distal portion, wherein the tissue debulking assembly is positioned within the inner lumen.

39. The rapid exchange debulking catheter of claim 38 wherein the proximal guidewire lumen and a portion of the distal guidewire lumen are attached to an outer surface of the inner lumen.

40. The rapid exchange debulking catheter of claim 39 wherein a portion of the distal guidewire lumen is movable relative to the catheter body.

41. The rapid exchange debulking catheter of claim 40 wherein the unattached portion is positioned adjacent the debulking assembly.

42. The rapid exchange debulking catheter of claim 33 wherein the distal guidewire lumen has a length of between about 5.0 cm and about 8.0 cm and the proximal guidewire lumen has a length of between about 10 cm and about 14 cm.

43. The rapid exchange debulking catheter of claim 33 further comprising a guidewire that extends through the continuous guidewire lumen.

44. The rapid exchange debulking catheter of claim 43 wherein the guidewire enters a proximal port of the proximal guidewire lumen, runs through the continuous guidewire lumen, and exits a distal port of the distal guidewire lumen.

45. The rapid exchange debulking catheter of claim 33 wherein the elongate catheter body comprises a central axis that runs through the proximal portion and the articulable distal portion, wherein the articulable distal portion is deflectable off of the central axis relative to the proximal portion.

46. A method of removing material from a body lumen, the method comprising:

delivering a catheter comprising a tissue debulking assembly coupled with a drive shaft to a target site in the body lumen;

moving the drive shaft to expose the tissue debulking assembly and deflect a distal portion of the catheter relative to a proximal portion of the catheter.

47. A method as in claim 46, wherein moving the drive shaft comprises actuating a single input device.

48. A method as in claim 47, wherein the tissue debulking assembly comprises a rotatable cutter.

49. A method as in claim 48, wherein actuating the single input device further comprises rotating the tissue debulking assembly.

50. A method as in claim 48, wherein the rotatable cutter includes a beveled edge for contacting the material in the body lumen while preventing injury to the body lumen.

51. A method as in claim 48, wherein the rotatable cutter includes a tungsten carbide cutting edge.

52. A method as in claim 48, wherein the proximal portion and the distal portion define a channel having a longitudinal axis, the drive shaft positioned within the channel, wherein the drive shaft is attachable to a driver for rotating the cutter.

53. A method as in claim 46, wherein the distal portion has an outer diameter of between about 0.1 cm and about 0.22 cm and the window has a length of between about 0.12 cm and about 0.25 cm.

54. A method as in claim 46, wherein the tissue debulking assembly comprises a radio frequency electrode, a laser, or an ultrasound emitter.

55. A method as in claim 46, wherein moving the drive shaft to deflect the distal portion urges a window on the catheter against material in the body lumen.

56. A method as in claim 46, wherein moving the drive shaft deflects the distal portion in a direction opposite of a window on the catheter about an axis that is substantially orthogonal to a longitudinal axis of the catheter body.

57. A method as in claim 46, wherein moving the drive shaft actuates deflection of the distal portion about a joint.

58. A method as in claim 57, wherein moving the drive shaft further comprises moving the tissue debulking assembly over a ramp in the catheter to deflect the distal portion and to expose the tissue debulking assembly out of a window to contact material in the body lumen.

59. A method as in claim 58, wherein moving the drive shaft further comprises locking the tissue debulking assembly in place via a shuttle mechanism when the distal portion is deflected.

60. A method as in claim 59, wherein the shuttle mechanism is coupled with the proximal portion by means of a first joint and with the distal portion by means of a second joint, so that the shuttle mechanism is movable relative to the distal portion, the proximal portion or both.

61. A method as in claim 46, wherein the tissue debulking assembly is movable between a first position and a second position, wherein the tissue debulking assembly in the first position closes a window on the catheter.

62. A method as in claim 61, wherein the movable tissue debulking assembly in the second position extends beyond an outer diameter of the distal portion of the catheter body.

63. A method as in claim 62, wherein the movable tissue debulking assembly in the second position extends beyond the outer diameter of the distal portion by between about 0.025 mm and about 0.64 mm.

64. A method as in claim 62, wherein the tissue debulking assembly in the second position moves a longitudinal axis of the tissue debulking assembly to an angled position relative to a longitudinal axis of the distal portion and the tissue debulking assembly moves out of the window beyond the outer diameter of the distal portion.

65. A method as in claim 62, wherein the tissue debulking assembly in the second position moves a longitudinal axis of the assembly to an offset parallel position relative to a longitudinal axis of the distal portion and moves out of the window beyond the outer diameter of the distal portion.

66. A method as in claim 46, further comprising using at least one rigid portion disposed near a distal end of the proximal portion to urge the tissue debulking assembly into material in the body lumen.

67. A method as in claim 66, wherein the rigid portion comprises a curvature in the proximal portion of the catheter body, near the distal end of the proximal portion.

68. A method as in claim 66, wherein the rigid portion comprises a length of the proximal portion of the catheter body in which a first side of the proximal portion is less rigid than a second side, wherein the first and second sides are disposed opposite one another across a cross section of the rigid portion so that tension applied to the proximal portion in the proximal direction causes the catheter body to deflect in the direction of the first side.

69. A method as in claim 68, wherein the second side is disposed opposite the side of a window on the catheter so that tension applied to the proximal portion in the proximal direction causes the window to be urged into contact with the material in the body lumen.