DIRECTIONAL ROTATIONAL ATHERECTOMY DEVICE WITH OFFSET SPINNING ABRASIVE ELEMENT

• US 20100121361A1
• Filed: 05/14/2009
• Published: 05/13/2010
• Est. Priority Date: 06/05/2008
• Status: Active Grant

• Current Assignee: Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Franchino, David C., Plowe, Charles A., Cambronne, Matthew D., Rivers, Jody, Piippo, Cassandra A., Darley, Jesse C., Kohler, Robert E.
• Granted Patent: US 9,101,387 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 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: Y10T 29/49863 with prestressing of part

Abstract

The invention provides a rotational atherectomy system, device and method comprising a flexible, elongated, rotatable drive shaft with a pre-curved abrasive section disposed within a catheter that deforms the abrasive section to a substantially straight profile and, when the abrasive section is moved distally out of the catheter, the abrasive section resumes its pre-curved profile. Directional ablation is achieved by rotation of the drive shaft along its pre-curved axis as the abrasive section is urged against a portion of the lumen wall.

Claims

1. A directional rotational atherectomy device for directional ablation of target tissue in an artery having a given diameter, comprising:

a catheter having an outer diameter less than the diameter of the artery and a lumen therethrough;

a flexible elongated, rotatable drive shaft advanceable within the catheter lumen, the drive shaft comprising wire turns, a pre-curved section having a curvilinear profile and a distal section operatively connected to a bearing, the curvilinear pre-curved section further comprising at least one abrasive section operatively connected thereto and more than one axis of rotation, wherein the pre-curved section is deformable to a substantially straightened profile when received within the catheter'"'"'s lumen.

2. The rotational atherectomy device of claim 1, the pre-curved section further comprising a height and a length.

3. The rotational atherectomy device of claim 1, wherein the pre-curved section further comprises at least one radiused section.

4. The rotational atherectomy device of claim 1, wherein the pre-curved section further comprises two radiused sections.

5. The rotational atherectomy device of claim 1, wherein the pre-curved section further comprises a peak.

6. The rotational atherectomy device of claim 5, wherein the abrasive section is at least partly disposed on the peak.

7. The rotational atherectomy device of claim 2, wherein the pre-curved section comprises a leading section, a distal section, and a peak therebetween, and wherein at least one abrasive section is operatively connected to the leading section, the distal section and/or the peak therebetween.

8. The rotational atherectomy device of claim 4, further comprising the two radiused sections each comprising a curvature, and wherein the curvatures of the two radiused sections are substantially equal.

9. The rotational atherectomy device of claim 4, further comprising the two radiused sections each comprising a curvature, and wherein the curvatures of the two radiused sections are not substantially equal.

10. The rotational atherectomy device of claim 1, wherein the drive shaft comprises a distal end and wherein pre-curved section is disposed proximate the distal end of the drive shaft.

11. The rotational atherectomy device of claim 7, wherein the at least one abrasive section comprises an abrasive coating on the wire turns of pre-curved section.

12. The rotational atherectomy device of claim 7, wherein the at least one abrasive section comprises an eccentric enlarged section of the drive shaft with an abrasive coating on at least a portion of the wire turns of pre-curved section.

13. The rotational atherectomy device of claim 7, wherein the at least one abrasive section comprises a concentric enlarged section of the drive shaft with an abrasive coating on at least a portion of the wire turns of pre-curved section.

14. The rotational atherectomy device of claim 7, wherein the at least one abrasive section comprises an eccentric abrasive crown operatively connected to the pre-curved section.

15. The rotational atherectomy device of claim 7, wherein the at least one abrasive section comprises a concentric abrasive crown operatively connected to the pre-curved section.

16. The high-speed rotational atherectomy device of claim 7, wherein the at least one abrasive section comprises an abrasive burr operatively connected to the pre-curved section.

17. The rotational atherectomy device of claim 1, further comprising the pre-curved section having a curvilinear profile when not advanced over guide wire.

18. The rotational atherectomy device of claim 1, further comprising the pre-curved section being formed of a shape memory alloy.

19. The rotational atherectomy device of claim 1, further comprising the pre-curved section being formed of Nitinol.

20. The rotational atherectomy device of claim 1, further comprising the pre-curved section being adapted to a certain curvilinear profile.

21. The rotational atherectomy device of claim 20, further comprising the pre-curved section being dynamically adaptable to a plurality of curvilinear profiles.

22. The rotational atherectomy device of claim 1, wherein the drive shaft is capable of rotating in two opposing directions and wherein the at least one abrasive section ablates less in one rotational direction and ablates more in the opposing rotational direction.

23. The rotational atherectomy device of claim 22, wherein the at least one abrasive section further comprises a grinding element on one side and a cutting element on an opposing side, wherein the drive shaft is capable of rotation in two directions and wherein rotation in one direction engages the grinding element with target tissue and rotation in the other direction engages the cutting element with target tissue.

24. The high-speed rotational atherectomy system of claim 18, further comprising:

a fluid supply line operatively connected to the catheter; and

a

biocompatible solution that is of a controlled temperature, wherein the biocompatible solution is urged through fluid supply line and into the catheter to provide operator control over the shape of the curvilinear profile.

25. A directional rotational atherectomy device for directional ablation of target tissue in a lumen having a given diameter, comprising:

a flexible elongated, rotatable drive shaft advanceable within the lumen, the drive shaft comprising wire turns, a pre-curved section having a curvilinear profile and a distal section operatively connected to a bearing, the curvilinear pre-curved section further comprising at least one abrasive section operatively connected thereto and more than one axis of rotation, wherein the pre-curved section is deformable by straightening deformation.

26. The directional rotational atherectomy device of claim 25, wherein the straightening deformation comprises mechanical deformation.

27. The directional rotational device of claim 25, wherein the pre-curved section comprises a shape memory alloy and the straightening deformation comprises cooling the pre-curved section.

28. The directional rotational device of claim 26, further comprising operator control over the curvilinear profile of the pre-curved section.

29. The directional rotation device of claim 25, further comprising operator control over the curvilinear profile of the pre-curved section and wherein the operator control comprises heating and/or cooling the pre-curved section.

30. A method of directionally clearing target tissue comprising a stenosis within a lumen using the present invention may comprise:

providing an outer catheter having an outer diameter smaller than the lumen

providing a flexible elongated, rotatable drive shaft with a pre-curved section comprising at least one abrasive section thereon;

advancing the drive shaft through the lumen of the outer catheter;

deforming the pre-curved section of the drive shaft into a substantially linear profile;

advancing the drive shaft into the lumen to a position proximal the target tissue;

retracting the catheter proximally;

allowing the pre-curved section to move back into its undeformed and curvilinear profile form;

rotating the drive shaft wherein the abrasive section is applied directly to the target tissue;

directionally ablating the target tissue while avoiding other non-target tissue within the lumen;

deforming the pre-curved section by reinserting the pre-curved section within the catheter, and substantially straightening the pre-curved section in preparation for withdrawal from the lumen; and

withdrawing the substantially straightened drive shaft from the lumen.

31. The method of claim 30, further comprising:

providing a pre-curved section comprising a shape memory alloy; and

providing dynamic adaptable operator control of the curvilinear profile of the pre-curved section.

32. The method of claim 31, further comprising thermodynamically controlling the pre-curved section to provide dynamic adaptable control of the curvilinear profile of the pre-curved section.

33. The method of claim 32, further comprising flushing the pre-curved section with a temperature controlled biocompatible solution to provide the dynamic adaptable operator control.

34. The method of claim 33, further comprising modifying the temperature of the biocompatible solution to provide the dynamic adaptable operator control.

35. The method of claim 32, further comprising using electrical current to provide the dynamic adaptable operator control.

36. The method of claim 35, further comprising applying electrical current to the guide wire to increase or decrease the temperature of the pre-curved section and to provide the dynamic adaptable operator control.

37. The method of claim 36, further comprising using a Peltier device to allow cooling of the pre-curved section and to provide the dynamic adaptable operator control.

38. A method of manufacturing a drive shaft having a pre-curved section for directional ablation, comprising:

winding the drive shaft using a coil winder as is well known in the art.

heat setting the entire length of the wound drive shaft to pre-relax the drive shaft coils;

inserting a mandrel shaped in the curvilinear profile desired for pre-curved section into the drive shaft lumen near the distal end of the pre-relaxed drive shaft;

performing a local heat treatment is performed on the curved portion of the drive shaft 20 with the mandrel in place;

removing the mandrel; and

operatively connecting at least one abrasive section to the pre-curved section.

39. The method of claim 38, further comprising using a shape memory alloy to comprise the pre-curved section.