MATERIAL REMOVAL DEVICE AND METHOD OF USE

• US 20110306995A1
• Filed: 06/14/2011
• Published: 12/15/2011
• Est. Priority Date: 06/14/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Moberg, John Robert
• Granted Patent: US 9,119,662 B2
• 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 2017/320791 with cutter extending outside the cutting window

Abstract

A catheter having a tubular body and a rotatable shaft disposed within a lumen of the tubular body. A cutting element is coupled to the rotatable shaft, the cutting element having a cutting edge, the cutting element and rotatable shaft being longitudinally moveable within the tubular body between a stored position in which the cutting element is positioned distal of a side opening and a cutting position in which the cutting element is contained within the lumen of the tubular body and longitudinally aligned with the side opening. The cutting element is configured to extend through the side opening and to cut material from the wall of a vessel at a treatment site as the catheter is pulled proximally through the treatment site. The catheter may optionally have a rotating distal tip with an abrasive surface. The catheter includes a collection chamber positioned proximally of the cutting window.

Claims

1. A catheter for removing material from a vascular lumen comprising:

a tubular body having proximal and distal ends and a wall defining a lumen, the wall having a side opening positioned proximal of the distal end of the tubular body;

a rotatable shaft disposed within the lumen of the tubular body;

a cutting element coupled to the rotatable shaft, the cutting element having a cutting edge, the cutting element and rotatable shaft being longitudinally moveable within the tubular body between a stored position in which the cutting element is positioned distal of the side opening and a cutting position in which the cutting element is contained within the lumen of the tubular body and longitudinally aligned with the side opening;

a cutting element exposure member, the cutting element exposure member being longitudinally moveable within the tubular body between a distal position and a proximal position, the cutting element exposure member being configured such that movement of the cutting element exposure member from the distal position to the proximal position when the cutting element is in the cutting position results in movement of the cutting element from the cutting position to an extended position in which a portion of the cutting edge is extended through the side opening beyond an outer diameter of the tubular body; and

a material collection chamber positioned within the tubular body at a location proximal of the side opening.

2. The catheter of claim 1 further comprising:

a rotatable tip connected to the distal end of the tubular body; and

a connector assembly for selectively coupling and uncoupling the rotatable tip from the rotatable shaft.

3. The catheter of claim 2 wherein the connector assembly comprises a first portion of the cutting element shaped to mechanically interlock with a second portion of the rotatable tip.

4. The catheter of claim 2 further comprising a guidewire lumen extending through the rotatable shaft, through the cutting element and through the rotating tip such that the catheter is configured as an over the wire catheter.

5. The catheter of claim 2 wherein the rotatable tip comprises an abrasive surface.

6. The catheter of claim 1 further comprising:

a handle attached at a proximal portion of the tubular body, the handle including a power source, a motor coupled to the rotatable shaft, and first and second control members, the first control member being coupled to the rotatable shaft, the second control member being coupled to the cutting element exposure member, the first control member being configured to move the cutting element between the stored position and the cutting position, the second control member being configured to move the cutting element exposure member between the distal position and the proximal position.

7. The catheter of claim 6 wherein the cutting element exposure member comprises a pull wire having distal and proximal ends and an arc shaped bushing connected at the distal end of the pull wire, the proximal end of the pull wire being connected to the second control member.

8. The catheter of claim 1 wherein the cutting element is longitudinally moveable within the tubular body to a material compression position located proximal of the side opening, the cutting element being configured to compress material in the material collection chamber when the cutting element is in the material compression position.

9. The catheter of claim 1 wherein the cutting element further comprises a side cutting blade configured to cut material which invaginates the side opening when the cutting element is in the cutting position.

10. The catheter of claim 9 wherein the cutting element is configured such that material from the vascular lumen is cut with the cutting edge when the cutting element is in the extended position and the catheter is moved proximally within the vascular lumen and material is cut with the side cutting blade when the cutting element is in the cutting position and the catheter is moved distally or proximally within the vascular lumen.

11. The catheter of claim 1 further comprising means to direct material removed from the vascular lumen proximally into the collection chamber.

12. The catheter of claim 1 wherein the cutting element comprises a proximally oriented cup shaped surface configured to direct material removed from the vascular lumen into the collection chamber.

13. The catheter of claim 1 further comprising means for preventing the rotatable shaft from blocking the side opening when the cutting element is in the extended position.

55. The catheter of claim 1 wherein the cutting element exposure member is selectively moveable to control the amount by which the cutting edge is extended through the side opening.

14. A catheter for removing material from a vascular lumen comprising:

a tubular body having proximal and distal ends and a wall defining a lumen, the wall having a side opening positioned proximal of the distal end of the tubular body;

a rotatable shaft disposed within the lumen of the tubular body;

a cutting element coupled to the rotatable shaft, the cutting element and rotatable shaft together forming a rotatable assembly, the cutting element having a cutting edge, the cutting element and rotatable shaft being moveable within the tubular body between a position in which the cutting element is contained within the lumen of the tubular body and an extended cutting position in which a portion of the cutting edge is extended through the side opening beyond an outer diameter of the tubular body;

a material collection chamber positioned within the tubular body at a location proximal of the side opening;

a rotatable tip connected to the distal end of the tubular body; and

a connector assembly for selectively coupling and uncoupling the rotatable tip from the rotatable assembly.

15. The catheter of claim 14 wherein the connector assembly comprises a first portion of the rotatable assembly and a second portion of the rotatable tip, the rotatable assembly being moveable within the tubular body between a proximal uncoupled position to a distal coupled position, the first and second portions being shaped to mechanically interlock when the rotatable assembly is in the distal coupled position.

16. The catheter of claim 15 wherein the first portion is not mechanically interlocked with the second portion when the rotatable assembly is in the proximal uncoupled position.

17. The catheter of claim 14 further comprising a guidewire lumen extending through the rotatable shaft, through the cutting element and through the rotating tip such that the catheter is configured as an over the wire catheter.

18. The catheter of claim 14 wherein the rotatable tip comprises an abrasive surface.

19. The catheter of claim 14 further comprising:

a handle attached at a proximal portion of the tubular body, the handle including a power source, a motor coupled to the rotatable shaft, and a first control member, the first control member being coupled to the rotatable shaft, the first control member being configured to move the rotatable assembly between the uncoupled position and the coupled position.

20. The catheter of claim 14 wherein the cutting element is moveable within the tubular body to a material compression position located proximal of the side opening, the cutting element being configured to compress material in the material collection chamber when the cutting element is in the material compression position.

21. The catheter of claim 14 wherein the cutting element further comprises a side cutting blade configured to cut material which invaginates the side opening when the cutting element is in the position in which the cutting element is contained within the lumen of the tubular body.

22. The catheter of claim 21 wherein the cutting element is configured such that material from the vascular lumen is cut with the cutting edge when the cutting element is in the extended position and the catheter is moved proximally within the vascular lumen and material is cut with the side cutting blade when the cutting element is in the position in which the cutting element is contained within the lumen of the tubular body and the catheter is moved distally or proximally within the vascular lumen.

23. The catheter of claim 14 further comprising means to direct material removed from the vascular lumen proximally into the collection chamber.

24. The catheter of claim 14 wherein the cutting element comprises a proximally oriented cup shaped surface configured to direct material removed from the vascular lumen into the collection chamber.

25. The catheter of claim 14 further comprising means for preventing the rotatable shaft from blocking the side opening when the cutting element is in the extended cutting position.

26. The catheter of claim 14 further comprising:

a cutting element exposure member, the cutting element exposure member being longitudinally moveable within the tubular body between a distal position and a proximal position, the cutting element exposure member being configured such that movement of the cutting element exposure member from the distal position to the proximal position when the cutting element is in the position in which the cutting element is contained within the lumen of the tubular body results in movement of the cutting element from the position within the lumen of the tubular body to the extended cutting position.

27. The catheter of claim 14 further comprising:

a handle attached at a proximal portion of the tubular body, the handle including a power source, a motor coupled to the rotatable shaft, and first and second control members, the first control member being coupled to the rotatable shaft, the second control member being coupled to the cutting element exposure member, the first control member being configured to move the rotatable assembly between the uncoupled position and the coupled position, the second control member being configured to move the cutting element exposure member between the distal position and the proximal position.

56. The catheter of claim 26 wherein the cutting element exposure member is selectively moveable to control the amount by which the cutting edge is extended through the side opening.

28. A method of removing material from a treatment site within a vascular lumen with a catheter having a tubular body, the tubular body having proximal and distal ends and a wall defining a lumen, the wall having a side opening positioned proximal of the distal end of the tubular body, a rotatable shaft disposed within the lumen of the tubular body and a cutting element coupled to the rotatable shaft, the cutting element having a cutting edge, the proximal end of the tubular body being connected to a control handle, the distal end of the tubular body being connected to a rotatable cutting tip, the method comprising:

advancing the tubular body through the vascular lumen until the rotatable cutting tip is proximal to the treatment site;

rotating the rotatable tip while advancing the tubular body distally across the treatment site to position the side opening at a location within or distal to the treatment site;

moving the cutting element from a position within the tubular body to an extended cutting position in which a portion of the cutting edge extends through the side opening beyond an outer diameter of the tubular body; and

withdrawing the tubular body proximally through the vascular lumen with the cutting element in the extended cutting position to move the cutting edge across the treatment site to cut material from the treatment site.

29. The method of claim 28 wherein the catheter includes a connector assembly for selectively coupling and uncoupling the rotatable cutting tip from the rotatable shaft and wherein rotating the rotatable tip comprises rotating the rotatable shaft while the rotatable cutting tip is coupled to the rotatable shaft.

30. The method of claim 29 wherein the step of withdrawing the tubular body proximally with the cutting tip in the extended cutting position is performed while the rotatable cutting tip is uncoupled from the rotatable shaft.

31. The method of claim 28 wherein the catheter includes a material collection chamber within the tubular body proximal of the side opening and wherein the method further includes moving the cutting element within the tubular body to a position proximal of the side opening to compress cut material within the material collection chamber.

32. The method of claim 28 wherein the step of moving the cutting element to an extended cutting position comprises:

moving the cutting element proximally within the tubular body from a stored position distal of the side opening to a cutting position in which the cutting element is contained within the lumen of the tubular body and longitudinally aligned with the side opening; and

moving the cutting element radially outwardly from the cutting position to the extended cutting position.

33. The method of claim 28 wherein the catheter includes a guidewire lumen which extends through the rotatable shaft, through the cutting element and through the rotatable cutting tip and wherein the step of advancing the tubular body through the vascular lumen comprises advancing the tubular body over a guidewire inserted within the guidewire lumen.

34. The method of claim 28 wherein the handle of the catheter includes first and second control members and wherein the step of moving the cutting element to an extended cutting position comprises:

manipulating the first control member to move the cutting element proximally within the tubular body from a stored position distal of the side opening to a cutting position in which the cutting element is contained within the lumen of the tubular body and longitudinally aligned with the side opening; and

manipulating the second control member to move the cutting element radially outwardly from the cutting position to the extended cutting position.

35. The method of claim 28 wherein the cutting element has a second cutting edge, the method further comprising:

advancing the tubular body distally through the vascular lumen with the cutting element in the extended cutting position to move the second cutting edge across the treatment site to cut material from the treatment site.

36. The method of claim 35 wherein the step of advancing the tubular body distally through the vascular lumen with the cutting element in the extended cutting position is performed after the step of withdrawing the tubular body proximally through the vascular lumen with the cutting element in the extended cutting position.

37. The method of claim 28 further comprising rotating the tubular body about a longitudinal axis of the tubular body to reorient the position of the cutting element within the treatment site.

38. A method of removing material from a treatment site within a vascular lumen with a catheter having a tubular body, the tubular body having proximal and distal ends and a wall defining a lumen, the wall having a side opening positioned proximal of the distal end of the tubular body, a rotatable shaft disposed within the lumen of the tubular body and a cutting element coupled to the rotatable shaft, the cutting element having first and second cutting edges, the proximal end of the tubular body being connected to a control handle, the method comprising:

advancing the tubular body through the vascular lumen until the side opening is proximal to the treatment site;

moving the cutting element from a position within the tubular body to an extended cutting position in which a portion of the first and second cutting edges extend through the side opening beyond an outer diameter of the tubular body;

advancing the tubular body distally through the vascular lumen with the cutting element in the extended cutting position to move the first cutting edge across the treatment site to cut material from the treatment site; and

withdrawing the tubular body proximally through the vascular lumen with the cutting element in the extended cutting position to move the second cutting edge across the treatment site to cut material from the treatment site.

39. The method of claim 38 wherein the step of withdrawing the tubular body proximally through the vascular lumen with the cutting element in the extended cutting position is performed after the step of advancing the tubular body distally through the vascular lumen with the cutting element in the extended cutting position.

40. The method of claim 38 further comprising rotating the tubular body about a longitudinal axis of the tubular body to reorient the position of the cutting element within the treatment site.

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

a tubular body having proximal and distal ends and a wall defining a lumen, the tubular body having a first opening at the distal end and a second opening through the wall proximal of the distal end;

a first cutting element positioned at the distal end of the tubular body and configured to cut material from the vessel through the first opening as the catheter is moved distally through the vessel; and

a second cutting element positioned proximally of the first cutting element and configured to remove material from the vessel through the second opening as the catheter is moved proximally through the vessel.

42. The catheter of claim 41 further comprising:

a rotatable shaft disposed within the lumen of the tubular body, the second cutting element being coupled to the rotatable shaft, the second cutting element and rotatable shaft together forming a rotatable assembly.

43. The catheter of claim 42 wherein the second cutting element includes a cutting edge, the second cutting element and rotatable shaft being moveable within the tubular body between a position in which the second cutting element is contained within the lumen of the tubular body and an extended cutting position in which a portion of the cutting edge is extended through the second opening beyond an outer diameter of the tubular body.

44. The catheter of claim 42 wherein the first cutting element comprises an abrasive rotatable tip.

45. The catheter of claim 44 further comprising:

a connector assembly for selectively coupling and uncoupling the rotatable tip from the rotatable assembly.

46. The catheter of claim 43 wherein the second cutting element further comprises a side cutting blade configured to cut material which invaginates the second opening when the second cutting element is in the position in which the second cutting element is contained within the lumen of the tubular body.

47. The catheter of claim 41 further comprising:

a material collection chamber positioned within the tubular body at a location proximal of the second opening.

48. A catheter for removing material from a vascular lumen comprising:

a tubular body having proximal and distal ends and a wall defining a lumen, the tubular body having a first opening at the distal end and a second opening through the wall proximal of the distal end;

a first cutting element positioned at the distal end of the tubular body and configured to cut material from the vessel through the first opening as the catheter is moved distally through the vessel;

a second cutting element positioned proximally of the first cutting element and configured to remove material from the vessel through the second opening as the catheter is moved proximally through the vessel; and

a third cutting element configured to remove material from the vascular lumen through the second opening when the catheter is stationary within the vessel.

49. The catheter of claim 48 further comprising:

a rotatable shaft disposed within the lumen of the tubular body, the second cutting element being coupled to the rotatable shaft, the second cutting element and rotatable shaft together forming a rotatable assembly.

50. The catheter of claim 49 wherein the second cutting element includes a cutting edge, the second cutting element and rotatable shaft being moveable within the tubular body between a position in which the second cutting element is contained within the lumen of the tubular body and an extended cutting position in which a portion of the cutting edge is extended through the second opening beyond an outer diameter of the tubular body.

51. The catheter of claim 49 wherein the first cutting element comprises an abrasive rotatable tip.

52. The catheter of claim 51 further comprising:

a connector assembly for selectively coupling and uncoupling the rotatable tip from the rotatable assembly.

53. The catheter of claim 50 wherein the third cutting element comprises a side cutting blade attached to the second cutting element configured to cut material which invaginates the second opening when the second cutting element is in the position in which the second cutting element is contained within the lumen of the tubular body.

54. The catheter of claim 48 further comprising:

a material collection chamber positioned within the tubular body at a location proximal of the second opening.