Atherectomy catheter having axially-disposed cutting edge

• US 5,242,460 A
• Filed: 10/25/1990
• Issued: 09/07/1993
• Est. Priority Date: 10/25/1990
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Devices for Vascular Intervention, Inc. (Eli Lilly and Company)
• Inventors: Baim, Donald S., Plaia, Mark E., Mueller, Richard P., Kermode, James R., Klein, Enrique J.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US07/604,036
• Time in Patent Office: 1,048 Days
• Field of Search: 604/22, 128/750, 128/751, 128/752, 128/753, 128/754, 128/755, 606/159, 606/170, 606/180
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter

Abstract

Atherectomy catheters are described having a cylindrical cutting head rotatably mounted at the distal end of a catheter body. The head has an axially elongated aperture and an open interior. A severing means is disposed adjacent the elongated aperture such that atheromatous material invaginated by the head is severed and diverted into the interior of the head. A preferred embodiment has the elongated aperture helically-disposed about the central axis of the cylindrical head and a cutting means formed integrally along the periphery of the aperture. Another preferred embodiment has the cylindrical head provided with a tapered distal end that extends distally from a housing for the head and incorporates an extension of the elongated aperture.

Claims

1. An atherectomy catheter comprising:

a catheter body having a proximal end and a distal end;

a cylindrical cutting head rotatably mounted at the distal end of the catheter body, said cylindrical head having a cylindrical wall surrounding an open interior and an axially elongated aperture in said wall, said wall having a surface area excluding said aperture which is substantially greater than the area defined by said aperture, said aperture being helically disposed about a central axis of the cylindrical cutting head and subtending less than a complete turn thereabout;

means within the catheter body for rotating the cylindrical head; and

means disposed adjacent the elongated aperture of the cylindrical head for severing atheromatous material and diverting severed material into the interior of said head as the head is rotated.

2. A catheter as in claim 1, wherein the cylindrical cutting head is tapered at its distal end and wherein said tapered distal end extends out from the distal end of the catheter body.

3. A catheter as in claim 2, wherein the axially elongated aperture extends to near the tapered distal end of the head.

4. A catheter as in claim 1, wherein the means for severing and diverting comprises a cutting edge which forms at least a portion of a trailing edge of the aperture as the cylindrical cutting head is rotated.

5. A catheter as in claim 4, wherein the means for severing and diverting further comprises a lip which is inclined radially inward along at least a portion of a leading edge of the aperture.

6. An atherectomy catheter comprising:

a catheter body having a proximal end and a distal end;

a housing attached to the distal end of the catheter body, said housing having a single axially-aligned elongated opening;

a cylindrical cutting head rotatably mounted in the housing, said head having a cylindrical wall surrounding an open interior and an axially elongated aperture in said wall, said wall having a surface area excluding said aperture which is substantially greater than the area defined by said aperture;

means within the catheter body for rotating the cylindrical head;

means disposed adjacent the elongated aperture of the cylindrical head for severing atheromatous material and diverting severed material into the interior of said head as the head is rotated; and

means on the housing of urging the housing in the direction of the opening when the catheter is in a blood vessel.

7. A catheter as in claim 6, wherein the urging means comprises an inflatable balloon mounted externally on the housing and disposed generally opposite the elongated opening.

8. A catheter as in claim 6, wherein the cylindrical cutting head is tapered at its distal end and wherein said tapered distal end extends out from an opening in the distal end of the housing.

9. A catheter as in claim 8, wherein the axially elongated aperture extends to near the tapered distal end of the head.

10. A catheter as in claim 6, wherein the means for severing and diverting comprises a cutting edge which forms at least a portion of a trailing edge of the aperture as the cylindrical cutting head is rotated.

11. A catheter as in claim 10, wherein the means for severing and diverting further comprises a lip which is inclined radially inward along at least a portion of a leading edge of the aperture.

12. A catheter as in claim 6, wherein the elongated aperture is helically-disposed about a central axis of the head.

13. A catheter as in claim 12, wherein the helical aperture subtends less than a complete turn about the cylindrical cutting head.

14. A catheter as in claim 12, wherein the helical aperture subtends at least one complete turn about the cylindrical cutting head.

15. A catheter as in claim 6, further comprising means for withdrawing severed atheromatous material from the interior and through the forward distal end of the cylindrical cutting head.

16. A catheter as in claim 15, wherein the means for withdrawing severed atheromatous material comprises a spool which is slidably disposed within the interior of the cylindrical cutting head.

17. A method for removing atheromatous material from a vascular lumen comprising:

introducing the distal end of a catheter into the vascular lumen adjacent the atheromatous material;

rotating a cylindrical cutting head mounted at the distal end of the catheter, said head having a cylindrical wall surrounding an open interior, an axially elongated aperture in said wall, said wall having a surface area excluding said aperture which is substantially greater than the area defined by said aperture, and means for severing adjacent the aperture, whereby atheromatous material is severed and diverted into the interior of the head;

displacing the cylindrical cutting head laterally as it is being rotated, whereby atheromatous material on the side of the catheter may be removed; and

withdrawing the distal end of the catheter from the vascular lumen while the severed material remains captured within the walls of the cylindrical cutting head.

18. A method as in claim 17, wherein the cylindrical cutting head is rotated relative to the catheter.

19. A method as in claim 17, further comprising axially advancing the catheter within the lumen as the cylindrical cutting head is being rotated, wherein the means for severing includes a forwardly disposed cutting edge and whereby atheromatous material in front of the catheter may be removed.

20. A method as in claim 17, further comprising axially advancing the cylindrical cutting head relative to the catheter as the cutting head is being rotated, wherein the means for severing includes a forwardly disposed cutting edge and whereby atheromatous material in front of the catheter may be removed.

21. A method as in claim 17, wherein the entire catheter is rotated together with the rotating cylindrical cutting head.

22. A method as in claim 17, wherein the means for severing is shielded within a housing while the catheter is being introduced to or withdrawn from the vascular lumen.

23. A method as in claim 17, wherein the catheter is axially stationary with the vascular lumen and the means for severing includes a rearwardly disposed cutting edge, whereby the catheter experiences a distal thrust.

24. An atherectomy catheter comprising:

a catheter body having a proximal end and a distal end;

a housing attached to the distal end of the catheter body, said housing having a distal opening and a single axially-aligned elongated opening;

a cylindrical cutting head rotatably mounted in the housing, said head having a cylindrical wall surrounding an open interior and an axially elongated aperture in said wall, said wall having a surface area excluding said aperture which is substantially greater than the area defined by said aperture, said head having a tapered distal end which extends through the distal opening of the housing with the aperture extending to near the tapered distal end of the head;

means within the catheter body for rotating the cylindrical head; and

means disposed adjacent the elongated aperture of the cylindrical head for severing atheromatous material and diverting severed material into the interior of said head as the head is rotated.

25. A catheter as in claim 24, further comprising an inflatable balloon mounted externally on the housing and disposed generally opposite the elongated opening.

26. A catheter as in claim 24, wherein the means for severing and diverting comprises a cutting edge which forms at least a portion of a trailing edge of the aperture as the cylindrical cutting head is rotated.

27. A catheter as in claim 24, wherein the means for severing and diverting further comprises a lip which is inclined radially inward along at least a portion of a leading edge of the aperture.

28. A catheter as in claim 24, wherein the elongated aperture is helically disposed about a central axis of the head.

29. A catheter as in claim 28, wherein the helical aperture subtends less than a complete turn about the cylindrical cutting head.

30. A catheter as in claim 28, wherein the helical aperture subtends least one complete turn about the cylindrical cutting head.

31. A catheter as in claim 24, further comprising means for withdrawing severed atheromatous material from the interior and through the forward distal end of the cylindrical cutting head.

32. A catheter as in claim 31, wherein the means for withdrawing severed atheromatous material comprises a spool which is slidably disposed within the interior of the cylindrical cutting head.

33. An atherectomy catheter comprising:

a catheter body having a proximal end and a distal end;

a housing attached to the distal end of the catheter body, said housing having a single axially-aligned elongated opening;

a cylindrical cutting head rotatably mounted in the housing, said head having a cylindrical wall surrounding an open interior and an axially elongated helical aperture in said wall, said wall having a surface area excluding said aperture which is substantially greater than the area defined by said aperture, said aperture subtending less than a complete turn about the cylindrical cutting head;

means within the catheter body for rotating the cylindrical head;

means disposed adjacent the elongated aperture of the cylindrical head for severing atheromatous material and diverting severed material into the interior of said head as the head is rotated.

34. A catheter as in claim 33, further comprising an inflatable balloon mounted externally on the housing and disposed generally opposite the elongated opening.

35. A catheter as in claim 33, wherein the cylindrical cutting head is tapered at its distal end and wherein said tapered distal end extends out from an opening in the distal end of the housing.

36. A catheter as in claim 35, wherein the axially elongated aperture extends to near the tapered distal end of the head.

37. A catheter as in claim 33, wherein the means for severing and diverting comprises a cutting edge which forms at least a portion of a trailing edge of the aperture as the cylindrical cutting head is rotated.

38. A catheter as in claim 37, wherein the means for severing and diverting further comprises a lip which is inclined radially inward along at least a portion of a leading edge of the aperture.

39. A catheter as in claim 33, further comprising means for withdrawing severed atheromatous material from the interior and through the forward distal end of the cylindrical cutting head.

40. A catheter as in claim 39, wherein the means for withdrawing severed atheromatous material comprises a spool which is slidably disposed within the interior of the cylindrical cutting head.

41. A method for removing atheromatous material from a vascular lumen comprising:

introducing the distal end of a catheter into the vascular lumen adjacent the atheromatous material;

rotating a cylindrical cutting head mounted at the distal end of the catheter, said head having a cylindrical wall surrounding an open interior, an axially elongated aperture which is helically disposed in said wall and subtends less than one complete turn about the cylindrical head, said wall having a surface area excluding said aperture which is substantially greater than the area defined by said aperture, and means for severing adjacent the aperture, whereby atheromatous material is severed, diverted into the interior of the head and captured therein by said walls; and

withdrawing the distal end of the catheter from the vascular lumen while the severed material remains within the cylindrical cutting head.

42. A method as in claim 41, wherein the cylindrical cutting head is rotated relative to the catheter.

43. A method as in claim 41, further comprising axially advancing the catheter within the lumen as the cylindrical cutting head is being rotated, wherein the means for severing includes a forwardly disposed cutting edge and whereby atheromatous material in front of the catheter may be removed.

44. A method as in claim 41, further comprising axially advancing the cylindrical cutting head relative to the catheter as the cutting head is being rotated, wherein the means for severing includes a forwardly disposed cutting edge and whereby atheromatous material in front of the catheter may be removed.

45. A method as in claim 41, further comprising displacing the cylindrical cutting head laterally as it is being rotated, whereby atheromatous material on the side of the catheter may be removed.

46. A method as in claim 41, wherein the entire catheter is rotated together with the rotating cylindrical cutting head.

47. A method as in claim 41, wherein the means for severing is shielded within a housing while the catheter is being introduced to or withdrawn from the vascular lumen.

48. A method as in claim 41, wherein the catheter is axially stationary with the vascular lumen and the means for severing includes a rearwardly disposed cutting edge, whereby the catheter experiences a distal thrust.

54. A method as in claim 45, wherein the entire catheter is rotated together with the rotating cylindrical cutting head.

55. A method as in claim 45, wherein the catheter is axially stationary with the vascular lumen and the means for severing includes a rearwardly disposed cutting edge, whereby the catheter experiences a distal thrust.

49. A method for removing atheromatous material from a vascular lumen comprising:

introducing into the vascular lumen the distal end of a catheter comprising a housing having a single axially-aligned elongate opening at said distal end, a cylindrical cutting head mounted within the housing, said head having a cylindrical wall surrounding an open interior, an axially elongated aperture in said wall, said wall having a surface area excluding said aperture which is substantially greater than the area defined by said aperture, and means for severing adjacent the aperture, wherein the cylindrical cutting head is rotationally positioned within the housing so that the severing means is not exposed through the housing opening while the distal end is being introduced;

rotating the cylindrical cutting head after the housing has been positioned adjacent a region of atheroma, whereby atheromatous material is severed, diverted into the interior of the head and captured therein by said walls; and

withdrawing the distal end of the catheter from the vascular lumen while the severed material remains within the cylindrical cutting head.

50. A method as in claim 49, wherein the cylindrical cutting head is rotated relative to the catheter.

51. A method as in claim 49, further comprising axially advancing the catheter within the lumen as the cylindrical cutting head is being rotated, wherein the means for severing includes a forwardly disposed cutting edge and whereby atheromatous material in front of the catheter may be removed.

52. A method as in claim 49, further comprising axially advancing the cylindrical cutting head relative to the catheter as the cutting head is being rotated, wherein the means for severing includes a forwardly disposed cutting edge and whereby atheromatous material in front of the catheter may be removed.

53. A method as in claim 49, further comprising displacing the cylindrical cutting head laterally as it is being rotated, whereby atheromatous material on the side of the catheter may be removed.