ROTATIONAL ATHERECTOMY DEVICE WITH COUNTERWEIGHTING

• US 20090105736A1
• Filed: 10/23/2007
• Published: 04/23/2009
• Est. Priority Date: 10/23/2007
• Status: Active Grant

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Inventors: Prudnikov, Dmitriy, Walter, Larry A., McBroom, Jeffrey A.
• Granted Patent: US 8,348,965 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320766 eccentric

Abstract

The invention provides a rotational atherectomy device having a flexible, elongated, rotatable drive shaft with an abrasive section comprising an enlarged diameter section of the drive shaft or, alternatively, a solid abrasive crown which may be attached to the drive shaft. The device further comprises a proximal and/or a distal counterweight attached to the drive shaft, spaced from the abrasive section wherein each counterweight has its center of mass offset from the longitudinal axis of the drive shaft to stimulate orbital motion by the abrasive section. When placed within an artery against stenotic tissue and rotated at sufficiently high speeds (e.g., in the range of about 20,000 rpm to about 200,000 rpm) the orbiting nature of the abrasive section causes such section to rotate as to open the stenotic lesion to a diameter substantially larger than the resting outer diameter of the abrasive section.

Claims

1. A high-speed rotational atherectomy device for opening a stenosis in an artery having a given diameter, comprising:

a guide wire having a maximum diameter less than the diameter of the artery;

a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a rotational axis and an abrasive section; and

at least one counterweight on the drive shaft.

2. The high-speed rotational atherectomy device of claim 1, wherein the at least one counterweight further comprises:

a proximal counterweight spaced a distance proximally from the abrasive section; and

a distal counterweight spaced a distance distally from the abrasive section.

3. The high-speed rotational atherectomy device of claim 1, wherein the abrasive section is eccentric.

4. The high-speed rotational atherectomy device of claim 1, wherein the at least one counterweight is eccentric.

5. The high-speed rotational atherectomy device of claim 2, wherein at least one of the proximal and distal counterweights is eccentric.

6. The high-speed rotational atherectomy device of claim 1, wherein the abrasive section is concentric.

7. The high-speed rotational atherectomy device of claim 1, wherein at least one counterweight is concentric.

8. The high-speed rotational atherectomy device of claim 2, wherein at least one of the proximal and distal counterweights is concentric.

9. The high-speed rotational atherectomy device of claim 1, wherein the at least one counterweight is solid and fixedly attached to the drive shaft.

10. The high-speed rotational atherectomy device of claim 1, wherein the wherein the abrasive section is solid and fixedly attached to the drive shaft.

11. The high-speed rotational atherectomy device of claim 1, wherein the abrasive section comprises an enlarged section of the drive shaft.

12. The high-speed rotational atherectomy device of claim 1, wherein the at least one counterweight comprises an enlarged section of the drive shaft.

13. The high-speed rotational atherectomy device of claim 1, wherein the abrasive section is partially hollow.

14. The high-speed rotational atherectomy device of claim 1, wherein the at least one counterweight is partially hollow.

15. The high-speed rotational atherectomy device of claim 1, further comprising the abrasive section being eccentric and the at least one counterweight being solid.

16. The high-speed rotational atherectomy device of claim 2, further comprising the distance spaced proximally between the proximal counterweight and the abrasive section is substantially equal to the distance spaced distally between the distal counterweight and the abrasive section.

17. The rotational atherectomy device of claim 2, wherein the abrasive section, proximal counterweight and distal counterweight each comprise a center of mass, the abrasive section center of mass and the proximal and distal counterweight centers of mass being aligned in substantially the same longitudinal plane.

18. The rotational atherectomy device of claim 17, further comprising the centers of mass of the proximal counterweight and distal counterweights are each separated from the center of mass of the abrasive section by an angle of 180 degrees around the rotational axis of the drive shaft.

19. The rotational atherectomy device of claim 18, further comprising the mass of the proximal and the distal counterweights each being approximately one-half the mass of the abrasive section.

20. A high-speed rotational atherectomy device for opening a stenosis in an artery having a given diameter, comprising:

a guide wire having a maximum diameter less than the diameter of the artery;

a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a rotational axis and an eccentric abrasive section;

an eccentric proximal counterweight spaced a distance proximally from the abrasive section; and

an eccentric distal counterweight spaced a distance distally from the abrasive section.

21. The rotational atherectomy device of claim 20, wherein the eccentric abrasive section, proximal and distal counterweights are enlarged sections of the drive shaft.

22. The rotational atherectomy device of claim 20, wherein the eccentric abrasive section, proximal and distal counterweights are solid.

23. The rotational atherectomy device of claim 20, wherein the eccentric abrasive section is at least partially hollow.

24. A method for generating a rotating diameter within a lumen with an abrasive section of a flexible drive shaft wherein the rotating diameter is larger than the resting diameter of the abrasive section, comprising:

providing a guide wire with a diameter less than the diameter of the lumen;

providing a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a rotational axis and an eccentric abrasive section;

providing an eccentric proximal counterweight spaced a distance proximally from the abrasive section;

providing an eccentric distal counterweight spaced a distance distally from the abrasive section; and

rotating the drive shaft at high speed.

25. A method for clearing an obstruction from a lumen, comprising:

providing a guide wire having a maximum diameter less than the diameter of the lumen;

providing a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a rotational axis and an eccentric abrasive section;

providing at least one counterweight on the drive shaft; and

rotating the drive shaft at high speed.