Atherectomy device for severe occlusions

• US 4,926,858 A
• Filed: 08/07/1989
• Issued: 05/22/1990
• Est. Priority Date: 05/30/1984
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Devices for Vascular Intervention, Inc.
• Inventors: Gifford, Hanson S. III, Simpson, John B., Brown, Peter S.
• Primary Examiner(s): Bennet, Henry A.
• Application Number:
  US07/391,636
• Time in Patent Office: 288 Days
• Field of Search: 128/304, 128/305, 128/305.1, 128/755, 128/303 R, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00845 of moving parts with respect to each other
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/22074 the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
• CPC Class Codes: A61B 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An atherectomy catheter for removal of plaque buildup from the walls of a blood vessel. The atherectomy catheter includes a cutter assembly disposed at the distal end of a flexible guide tube that may be inserted into a vessel and directed to the occlusion. A proximal actuator assembly is adapted to impart both rotary and axial movement to the cutter. The cutter assembly includes a cutter having a forwardly extending annular cutting surface. A guide wire with a flexible spring tip extends forward of the cutter for guiding the cutter as it travels axially through the artery. All of the removed atheroma materials are collected within the device and a retention member carried by the guide wire and positioned in front of the cutter forms a cap to retain the collected atheroma materials. In a disclosed embodiment, the retention member is expandable, and in one of the preferred embodiments, the retention member may be expanded to engage the vessel walls to anchor the device during the cutting stroke.

Claims

1. An atherectomy device for removal of material of an atheroma from a vascular vessel, said device comprising:

a flexible tubular member adapted to be inserted into the vessel and having proximal and distal extremities,

flexible drive means having proximal and distal extremities and disposed within said tubular member for rotational and axial movement therein, said drive means extending from the proximal to distal ends of the tubular member,

a cup-shaped cutter carried by the distal extremity of the flexible drive means, said cutter having a distally extending annular cutting surface and an interior collection chamber, and

means carried by the proximal extremity of the flexible tubular member and coupled to the flexible drive means for rotating the cutter independently of rotation of the tubular member and for axially extending and retracting the cutter independent of axial movement of the tubular member,

whereby said cutter is movable axially from a position fully received by the tubular member to an axially extended position wherein the cutting surface is spaced forwardly of the distal extremity of the tubular member so that the cutter is capable of engaging and severing the atheroma with the severed portions of the atheroma being received in the collection chamber.

2. An atherectomy device as in claim 1 wherein said drive means includes a tubular drive cable having a longitudinal passage therethrough.

3. An atherectomy device as in claim 2 wherein said guiding means includes a flexible guide wire mounted for axial movement within the drive cable passage.

4. An atherectomy device as in claim 3 together with retaining means carried by the guide wire for facilitating collection of materials removed from the atheroma by the cutter.

16. An atherectomy device as in claim 1 wherein the collection chamber is flexible.

18. An atherectomy device as in claim 1 wherein said tubular member includes a housing for receiving said cutter.

20. An atherectomy device as recited in claim 18 wherein said anchoring means includes an inflatable balloon.

21. An atherectomy device as recited in claim 20 wherein said flexible guiding wire has a lumen running axially therethrough to facilitate inflation of the balloon.

22. An atherectomy device as in claim 20 together with an expandable protective sheath that covers all portions of the balloon that contact the cutting edge.

23. An atherectomy device as in claim 22 wherein the protective sheath is formed of braided material.

5. An atherectomy device for removal of material of an atheroma from a vessel, said device comprising:

a flexible tubular member adapted to be inserted into the vessel and having proximal and distal extremities,

flexible drive means having proximal and distal extremities disposed within said tubular member for rotational and axial movement in the tubular member, said drive means being tubular and having a passage extending longitudinally therethrough,

a cup-shaped cutter carried by the distal extremity of the flexible drive means, said cutter having a distally extending annular cutting surface and an interior collection chamber,

means carried by the proximal extremity of the flexible tubular member and coupled to the flexible drive means for rotating the cutting device independent of rotation of the tubular member and for axially extending and retracting the cutter independent of axial movement of the tubular member,

a flexible guide wire mounted for axial movement in the passage in the drive means, said guide wire extending forward of the cutter, and

retaining means carried by the guide wire for facilitating collection of materials removed from the atheroma by the cutter.

6. An atherectomy device as in claim 5 wherein said retaining means includes an expandable member together with expansion means for expanding and contracting the expandable member in a radial direction between a first and a second position whereby in the first position the retaining means is collapsed to facilitate insertion of the device into the vessel.

7. An atherectomy device as in claim 6 wherein said expandable member includes a balloon for resisting slippage of the cutter as it cuts through the atheroma.

8. An atherectomy device as in claim 5 wherein the retaining means includes a rigid member having a collection cavity facing the cutter.

9. An atherectomy device as in claim 5 wherein said retaining means allows blood to pass therethrough.

10. An atherectomy device as in claim 6 wherein the expandable member includes an expandable basket having first and second ends.

11. An atherectomy device as in claim 10 wherein the guide wire has a lumen extending therethrough and wherein the expansion means includes an expansion wire disposed within the guide wire lumen and mounted for axial movement relative to the guide wire for expanding and contracting the expandable basket.

12. An atherectomy device as in claim 10 wherein the basket includes a first end secured to the guide wire and a second end mounted for axial translation along the guide wire, the second basket end being adapted to communicate with the flexible drive means for expanding the basket radially.

13. An atherectomy device as in claim 10 wherein the basket is formed of a meshed material.

14. An atherectomy device as in claim 13 wherein the mesh is formed from braided strands.

15. An atherectomy device as in claim 14 wherein the braided strands are stainless steel and the basket is formed from in the range of 16 to 32 strands.

17. An atherectomy device as in claim 5 wherein the guide wire has a spring tip.

49. An atherectomy device as in claim 8, wherein the rigid member is cylindrical, tapered on the distal end facing away from the cutter, and includes a circular blade on the proximal end facing the cutter.

50. An atherectomy device as in claim 49, wherein, the cylindrical diameter is slightly less than that of the cutter.

51. An atherectomy device as in claim 50, wherein the cutter includes an interior collection chamber at its distal end facing the rigid member, whereby the rigid member can be drawn into said chamber to effect cutoff of severed atheroma.

19. An atherectomy device for removal of material of an atheroma from a vessel, said device comprising:

a flexible tubular member adapted to be inserted into the vessel and having proximal and distal extremities,

a flexible drive means disposed within the tubular member for rotational and axial movement therein.

a cup-shaped cutter carried by the flexible drive means, said cutter having a distally extending annular cutting surface and an interior collection chamber,

a flexible guiding wire extending forward of the cutter for guiding the cutter to travel axially within the vessel, and

anchoring means carried by the guide wire forward of the cutter for pressing radially to resist slippage by the cutter as it cuts through the atheroma.

24. An atherectomy device as recited in claim 19 together with actuator means for moving said cutter into abutting contact with said anchoring means for retaining the removed material within said device.

25. An atherectomy device as in claim 24 wherein said anchoring means includes an expandable member together with means for expanding the expandable member in a radial direction.

26. An atherectomy device as in claim 25 wherein the guiding wire has a lumen running axially therethrough and the expanding means includes an expansion wire disposed within said guiding wire and adapted for axial movement relative to and within the guiding wire for expanding and contracting the expandable member.

27. An atherectomy device as in claim 25 wherein the expandable member is formed of a braided material.

28. An atherectomy device as in claim 27 wherein the braided basket is formed form in the range of 10 and 50 wires.

29. An atherectomy device as in claim 27 wherein the braided basket is formed from in the range of 16 to 32 stainless steel wire.

30. An atherectomy device for removing material of an atheroma from a vessel, said device comprising:

a flexible tubular member adapted to be inserted into the vessel and having proximal and distal extremities,

a flexible drive means having proximal and distal extremities and disposed within said tubular member for rotational movement within the tubular member,

a tubular collection chamber secured to the distal extremity of the flexible drive means, said chamber having an open distal end and a substantially closed proximal end,

an annular cutting ring secured to the tubular collection chamber, whereby material severed by the ring can enter the collection chamber,

a sheath for receiving said cutting means such that at least a portion of the cutting edge is not exposed,

actuator means carried by the proximal extremity of the flexible tubular member and coupled to the flexible drive means for rotating the cutting device independent of rotation of the tubular member,

translating means for simultaneously moving said cutting means and said sheath relative to said tubular member,

flexible guiding means extending forward of the cutter for guiding the cutter to travel axially within the vessel, and

retention means carried by the guiding means forwardly of the cutting means for cooperating with the collection means to collect removed atheroma material within the atherectomy device.

31. An atherectomy device as in claim 30 wherein the cutting means further includes a collection chamber for retaining the removed atheroma material.

32. An atherectomy device as in claim 31 wherein the retention means includes a basket expandable in a radial direction, the basket formed to act as a cover for the collection chamber for retaining the severed atheroma materials.

33. An atheroma device for removal of material of an atheroma from a vessel, said device comprising:

a flexible tubular member adapted to be inserted into the vessel,

a flexible drive means disposed within the tubular member for rotational and axial movement therein,

a cup-shaped cutter carried by the flexible drive means, said cutter having a forwardly extending annular cutting surface and an interior collection chamber,

a flexible guiding wire extending forward of the cutter for guiding the cutter to travel axially within the vessel,

retention means carried by the guide wire forward of the cutter for collecting the removed atheroma material within the atherectomy device,

said retention means including an expandable member.

34. An atherectomy device as in claim 33 wherein the collection chamber is flexible.

35. An atheroma device for removal of material of an atheroma from a vessel, said device comprising:

a flexible tubular member,

a tubular flexible drive means disposed within said tubular member for rotational movement in the tubular member,

a cup-shaped cutter carried by the distal extremity of the flexible drive means, the cutter having a forwardly extending annular cutting surface and an interior collection chamber,

a flexible guide wire disposed within the drive means and mounted for axial movement therein, said guide wire extending beyond the distal extremity of the cutter, and being rotationally decoupled therefrom,

a retention means carried by the guide wire distally to the cutter for facilitating collection of materials removed from the atheroma by the cutter, and

means for translating the cutter and the retention means relative to each other.

36. An atherectomy device as in claim 35 wherein the retention means includes a rigid member having a smaller diameter than the cutter.

37. An atherectomy device as in claim 36 wherein the rigid member has a collection cavity extending from its proximal extremity for retaining materials removed from the atheroma by the cutter.

38. An atherectomy device as in claim 35 wherein the cutting surface is a rigid ring and the collection chamber is flexible and secured proximally of the ring.

39. A method for removing at least a portion of an atheroma from a blood vessel, the method comprising the steps of:

advancing a guide wire into the vessel to a position so that at least a portion of an expandable member carried by the guide wire is positioned distally to the portion of the atheroma to be removed;

advancing a cutter over the guide wire through the atheroma towards the expandable member for removing a portion of the atheroma;

expanding the expandable member within the vessel in the radial direction; and

bringing the cutter into contact with the expanded expandable, whereby the atheroma is severed.

40. A method as in claim 39 wherein the steps are repeated to remove additional portions of the atheroma until sufficient portions of the atheroma are removed to provide a relatively good flow passage in the vessel through the atheroma.

41. A method as in claim 39 wherein the cutter is rotated relative to the atheroma while the cutter is being advanced.

42. A method as in claim 41 together with the step of egressing the cutter from the housing while it is being advanced.

43. A method as in claim 41 wherein the expanding step occurs before the cutting step and the expandable member is adapted to resist slippage of the cutter as it cuts through the atheroma.

44. A method for removing at least a portion of an atheroma from a blood vessel, the method comprising the steps of:

advancing a guide wire into the vessel to a position in the vicinity of the atheroma to be removed;

advancing a cup-shaped cutter over the guide wire into the vessel to a position proximal to the portion of the atheroma to be removed, said cutter having an annular cutting surface and an interior collection chamber; and

simultaneously rotating and advancing the cutter, the advancement causing the cutter to egress from the housing, whereby the atheroma is severed and the severed portions of atheroma are collected in the collection chamber.

45. A method as in claim 44 wherein the guide wire carries a retention means distally to the cutter, together with the step of drawing the retention means into abutment with the cutter to entrap the severed portions of atheroma therein.

46. A method as in claim 45 together with the step of expanding the retention means.

47. In a method for removing at least a portion of an atheroma from a vessel using an atherectomy device having a flexible tubular member, a cutter carried by the distal extremity of a flexible tubular drive means disposed within the tubular member and mounted for rotational movement therein, a flexible guide wire passing axially through the tubular drive means and adapted for axial movement therein, the guide wire carrying a retention means near its distal extremity, the method comprising the steps of:

inserting the guide wire and retention means into the vessel;

advancing the retention means within the vessel to a desired position proximal to the atheroma materials to be removed;

guiding the cutter to a position within the vessel that is a selected distance proximal to the retention means;

rotating the cutter while simultaneously advancing the retention means and the cutter through the atheroma for removing a portion of the atheroma while maintaining the fixed spacing;

collecting the removed portions of atheroma;

drawing the retaining means into abutment with the cutter for retention of the collected atheroma materials within the atherectomy device; and

withdrawing the cutter and retention means carrying the collected portions of atheroma from the vessel.

48. In a method for removing at least a portion of an atheroma from a vessel using an atherectomy device having a flexible tubular member, a cutter carried by the distal extremity of a flexible tubular drive means disposed within the tubular member and mounted for rotational movement therein, a flexible guide wire passing axially through the tubular drive means and adapted for axial movement therein, the guide wire carrying an expandable member near its distal extremity, the method comprising the steps of:

inserting the guide wire and expandable member into the vessel;

advancing the expandable member within the vessel to a first desired position relative to the atheroma materials to be removed;

guiding the cutter to a second desired position within the vessel that is proximal to the atheroma materials to be removed;

expanding the expandable member to anchor the atherectomy device at a position distal to the cutting assembly;

simultaneously rotating and advancing the cutter to remove a portion of the atheroma;

collecting the removed portions of atheroma;

drawing the expandable member into abutment with the cutter for retaining the collected atheroma materials within the atherectomy device; and

withdrawing the collected portions of atheroma from the vessel.