Atherectomy devices and methods

• US 20090234378A1
• Filed: 10/22/2008
• Published: 09/17/2009
• Est. Priority Date: 10/22/2007
• Status: Active Grant

• Current Assignee: Atheromed, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Atheromed, Inc. (Koninklijke Philips N.V.)
• Inventors: To, John T., Danek, Christopher James, Escudero, Paul Q.
• Granted Patent: US 8,070,762 B2
• Time in Patent Office: Days
• US Class Current: 606/180
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2017/22048 Balloons
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and method relate to removal of the occluding material from the blood vessels as well as other body lumens.

Claims

1. A rotary tissue removal device for removing material from body lumens, the device comprising:

a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy;

a housing located at the distal end of the catheter, the housing having at least one opening;

a cutter rotatably located within the housing and having a plurality of fluted cutting edges located on both a near fluted cutting portion and a far fluted cutting portion, where the near fluted cutting portion and the far fluted cutting portion are spaced along an axis of the cutter and the far fluted cutting portion has fewer fluted cutting edges than the near fluted cutting portion, where on rotation of the cutter the fluted cutting edges remove material from the body lumen; and

a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

2. The device of claim 1, where the torque shaft includes an exterior surface having a raised portion helically located thereon such that upon rotation, the raised portion conveys materials in a proximal direction.

3. The device of claim 1, where the far cutting portion comprises two far fluted cutting edges symmetrically located about the axis, and where the near cutting portion comprises four near fluted cutting edges symmetrically located about the axis.

4. The device of claim 1, where the at least one opening comprises a plurality of openings, where the cutter is located within the housing such that upon rotation of the cutter the fluted cutting edges cut material through the openings in the housing.

5. The device of claim 4, where the openings are sufficiently large to expose a portion of the fluted cutting edges located on both the near and far fluted cutting portions.

6. The device of claim 1, where the housing comprising a cylindrical housing having an open front face, where an edge of a sidewall of the cylindrical housing comprises a front cutting surface, and where the cutter rotates within the cylindrical housing.

7. The device of claim 6, where the front cutting surface is beveled.

8. The device of claim 6, where the cylindrical housing is fixed relative to the cutter.

9. The device of claim 6, where the cylindrical housing rotates with the cutter.

10. The device of claim 1, further comprising a sweep sheath located within the catheter lumen and exterior to the rotatable torque shaft, the sweep sheath being rotatable and axially moveable within the catheter, the sweep sheath also having a pre-set curved segment at a distal end thereof such that when the pre-set curve curved segment is in the flexible distal portion of the catheter, the cutter deflects.

11. The device of claim 10, where the sweep sheath is rotatable relative to the catheter such that upon rotation, the cutter sweeps in an arc having a radius greater than a radius of the cutter.

12. A rotary tissue removal device for removing material from body lumens, the device comprising:

a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy;

a housing located at the distal end of the catheter body, the housing having at least one opening;

a cutter having being rotatably located within the housing and rotatable about an axis, and having a first plurality of cutting edges extending helically along the entire cutter, and a second plurality of cutting edges extending helically only along a portion of the cutter, where on rotation of the cutter the fluted cutting edges remove material from the body lumen through the opening in the housing and drive the cut material in a proximal direction; and

a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

13. The device of claim 12, where the torque shaft includes an exterior surface having a raised portion helically located thereon such that upon rotation, the raised portion conveys materials in a proximal direction.

14. The device of claim 12, where the first plurality of cutting edges comprises two cutting edges, and where second plurality of cutting edges comprises four cutting edges.

15. The device of claim 14, where the first plurality of cutting edges are symmetrically located about the axis of the cutter, and where second plurality of cutting edges are symmetrically located about the axis of the cutting assembly.

16. The device of claim 12, where the at least one opening in the housing comprises a plurality of openings in a sidewall of the housing, where the cutter is located within the housing such that upon rotation of the cutter at least the first plurality of cutting edges cuts material through the openings in the housing.

17. The device of claim 16, where the openings are sufficiently large to expose a portion of both the first and second plurality of fluted cutting edges.

18. The device of claim 12, where the housing comprising a cylindrical housing having an open front face, where an edge of a sidewall of the housing comprises a front cutting surface, and where the cutter rotates within the cylindrical housing.

19. The device of claim 18, where the front cutting surface is beveled.

20. The device of claim 18, where the cylindrical housing is fixed relative to the cutter.

21. The device of claim 18, where the cylindrical housing rotates with the cutter.

22. The device of claim 12, further comprising a sweep sheath located within the catheter lumen and exterior to the rotatable torque shaft, the sweep sheath being rotatable and axially moveable within the catheter body, the sweep sheath also having a pre-set curved segment at a distal end thereof such that when the pre-set curve curved segment is in the flexible distal portion of the catheter, the cutter deflects.

23. The device of claim 22, where the sweep sheath is rotatable relative to the catheter such that upon rotation, the cutter sweeps in an arc having a radius greater than a radius of the cutter.

24. A rotary tissue removal device for removing material from body lumens, the device comprising:

a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy;

a housing located at the distal end of the catheter, the housing having at least one opening on a sidewall of the housing;

a cutter having being rotatably located within the housing and rotatable about an axis, and having a first plurality of cutting edges extending helically along the entire cutter, and a second plurality of cutting edges extending helically only along a portion of the cutter, where on rotation of the cutter the cutting edges remove material from the body lumen through the opening in the housing; and

a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

25. The device of claim 24, where the second plurality of cutting edges does not extend to a distal end of the cutting assembly.

26. The device of claim 24, where the first and second plurality of cutting edges are fluted cutting edges.

27. The device of claim 24, where the first plurality of cutting edges are symmetrically located about the axis of the cutter.

28. The device of claim 24, where the second plurality of cutting edges are symmetrically located about the axis of the cutter.

29. The device of claim 24, where the torque shaft includes an exterior surface having a raised portion helically located thereon such that upon rotation, the raised portion conveys materials in a proximal direction.

30. The device of claim 24, where the far cutting portion comprises two far fluted cutting edges symmetrically located about the axis, and where the near cutting portion comprises four near fluted cutting edges symmetrically located about the axis.

31. The device of claim 24, where the at least one opening on the sidewall of the housing comprises a plurality of openings such that upon rotation of the cutter the first and second fluted cutting edges cut material through the openings in the housing.

32. The device of claim 24, where the openings are sufficiently large to expose a portion of the fluted cutting edges located on both the near and far fluted cutting portions.

33. The device of claim 24, further comprising a sweep sheath located within the catheter lumen and exterior to the rotatable torque shaft, the sweep sheath being rotatable and axially moveable within the catheter, the sweep sheath also having a pre-set curved segment at a distal end thereof such that when the pre-set curve curved segment is in the flexible distal portion of the catheter, the cutter deflects.

34. The device of claim 33, where the sweep sheath is rotatable relative to the catheter body such that upon rotation, the cutter sweeps in an arc having a radius greater than a radius of the cutter.

35. The device of claim 24, further comprising a guidewire lumen extending through the torque shaft and extending through the cutter.

36. The device of claim 24, further comprising a tapered member located on a front surface of the housing, the tapered member having a passage in fluid communication with the guidewire lumen and terminating at a guidewire opening at a distal end of the tapered member, such that as the tapered member advances through material in the body lumen, the tapered member dilates material away into the opening in the sidewall of the housing.

37. A vascular device for separating and removing material from vessels and for use with a guidewire, the device comprising:

a catheter body;

a rotatable cutter having at least one cutting surface and a guidewire lumen extending therethrough;

a housing containing the rotatable cutter having at least one cutting surface and having a plurality of openings located about a sidewall of the housing, where the cutter is configured to rotate within the housing about an axis of the cutter, where movement between the housing opening and the cutting surface removes material located therebetween;

a dilator member having a passage extending therethrough and in fluid communication with the guidewire lumen, the conical dilator extending distally from a front of the housing, where the dilator member comprises a tapered shape having a smaller diameter surface at a distal tip and a larger diameter surface adjacent to the front of the housing, such that as the dilator member advances through material in the vessel, dilator member dilates material away from the guidewire and into the plurality of openings in the housing; and

a shaft extending through the catheter body and coupled to the cutter, the shaft having a proximal end adapted to couple to a first rotating mechanism.

38. The device of claim 37, where the conical surface comprises a smooth surface to minimize interference of the conical surface against material when the housing is rotated or moved in an angular motion.

39. The device of claim 37, where the at least one cutting surface of the cutter includes a first plurality of cutting edges extending helically along the entire cutter, and a second plurality of cutting edges extending helically only along a portion of the cutter.

40. The device of claim 39, where the second plurality of cutting edges does not extend to a distal end of the cutter.

41. The device of claim 39, where each of the first plurality of cutting edges is symmetrically located about the axis.

42. The device of claim 39, where each of the second plurality of cutting edges is symmetrically located about the axis.

43. The device of claim 39, where the first and second plurality of cutting edges are fluted cutting edges.

44. The device of claim 39, where the at least one opening on the sidewall of the housing comprises a plurality of openings such that upon rotation of the cutter at least the first cutting edges cut material through the openings in the housing.

45. The device of claim 44, where the openings are sufficiently large to expose a portion of the first and second plurality of cutting edges.

46. The device of claim 37, where the torque shaft includes an exterior surface having a raised portion helically located thereon such that upon rotation, the raised portion conveys materials in a proximal direction.

47. The device of claim 46, further comprising a sweep sheath located within the catheter lumen and exterior to the rotatable torque shaft, the sweep sheath being rotatable and axially moveable within the catheter, the sweep sheath also having a pre-set curved segment at a distal end thereof such that when the pre-set curve curved segment is in the flexible distal portion of the catheter, the cutter deflects.

49. The device of claim 37, further comprising a guidewire lumen extending through the torque shaft and extending through the cutter and housing.

48. The device of claim 48, where the sweep sheath is rotatable relative to the catheter body such that upon rotation, the cutter sweeps in an arc having a radius greater than a radius of the cutter.

50. A method for debulking occlusive material within a totally or partially occluded blood vessel, the method comprising:

positioning a guidewire adjacent to the occlusive material in the blood vessel;

feeding a debulking device on the guidewire to the occlusive material, the debulking device having a cutter, where the cutter includes a housing having a plurality of openings located about the housing and containing a rotatable cutter configured to cut the occlusive material through the openings, where the debulking device further includes a conical dilator tip located at a front of the housing;

rotating the rotatable cutter;

dilating the occlusive material away from the guidewire and towards an opening in the housing by inserting the conical tip into the occlusive material; and

debulking the occlusive material after dilating the occlusive material by cutting the occlusive material with the rotatable cutter through the opening in the housing.

51. The method of claim 50, further comprising deflecting the debulking device relative to an axis of the vessel and

rotating the debulking device while rotating the rotatable cutter to form a second opening in the body lumen where the second is larger than the first opening.

52. The method of claim 50, where deflecting the debulking device relative to an axis of the vessel comprises advancing a pre-curved sweep sheath distally within the debulking device.

53. The method of claim 50, where a distal portion of the debulking device includes at least one fluid port coupled to a fluid source, and further comprising delivering fluid through the fluid port.

54. The method of claim 53, where delivering fluid comprises delivering a drug through the fluid port.

55. The method of claim 50, further comprising providing a helical conveyor member within the debulking device and transporting the debris material out of the body via the helical conveyor member.