ROTATIONAL ATHERECTOMY DEVICE WITH A SYSTEM OF ECCENTRIC ABRADING HEADS

• US 20160199093A1
• Filed: 03/21/2016
• Published: 07/14/2016
• Est. Priority Date: 09/17/2012
• Status: Active Grant

• Current Assignee: Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Cambronne, Matthew D., Kohler, Robert E.
• Granted Patent: US 10,517,631 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip

Abstract

The invention provides a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with a system of eccentric abrading heads attached thereto. At least part of the eccentric enlarged abrading heads in the system have a tissue removing surface—typically an abrasive surface. In certain embodiments, the abrading heads may be at least partially hollow. Preferably the eccentric enlarged abrading heads have centers of mass spaced radially from the rotational axis of the drive shaft, facilitating the ability of the system of eccentric abrading heads to work together to open the stenotic lesion to a diameter substantially larger than the outer resting diameter of the enlarged abrading heads when operated at high speeds. Therefore, certain embodiments comprise a system having unbalanced centers of mass to not only stimulate greater rotational diameters but also arranged in a manner whereby a debris-removing augering effect occurs. Alternatively, other embodiments may comprise systems having abrading heads with balanced centers of mass.

Claims

1. A high-speed rotational atherectomy device, comprising:

a guide wire;

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

an eccentric abrasive element disposed on the drive shaft and comprising a mass and a center of mass that is spaced a distance radially away from the rotational axis of the drive shaft in a direction along a longitudinal plane;

an eccentric proximal abrasive counterweight disposed on the drive shaft and comprising a mass and a center of mass that is spaced a distance radially away from the rotational axis along the longitudinal plane and in the opposite direction as the eccentric abrasive element'"'"'s center of mass spacing center of mass spaced radially away from the rotational axis along the longitudinal plane and in the opposite direction as the eccentric abrasive element'"'"'s center of mass spacing, and the center of mass of the eccentric proximal abrasive counterweight is spaced a distance from the center of mass of the eccentric abrasive element; and

an eccentric distal abrasive counterweight disposed on the drive shaft and having a mass and a center of mass spaced radially away from the rotational axis of the drive shaft along the longitudinal plane, and the center of mass of the eccentric distal abrasive counterweight is spaced a distance from the center of mass of the eccentric abrasive element.

2. The device of claim 1, further comprising the center of mass of the eccentric distal abrasive counterweight spaced radially away from the rotational axis in the same direction as the radial spacing of the eccentric abrasive element and the eccentric proximal abrasive counterweight centers of mass.

3. The device of claim 1, further comprising the center of mass of the eccentric distal abrasive counterweight spaced radially away from the rotational axis of the drive shaft in the opposite direction of the eccentric proximal abrasive element.

4. The device of claim 1, the abrasive element further comprising an enlarged eccentric abrading head.

5. The device of claim 1, further comprising the masses of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight being equal, each mass comprising ½

the mass of the eccentric abrasive element.

6. The device of claim 1, further comprising the masses of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight being unequal to each other.

7. The device of claim 6, further comprising a summation of the masses of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight equaling the mass of the eccentric abrasive element.

8. The device of claim 6, further comprising a summation of the masses of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight differing from the mass of the eccentric abrasive element.

9. The device of claim 1, further comprising the radial spacing distances of the centers of mass of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight being equal and comprising a radial distance for each abrasive counterweight that is ½

the radial spacing distance of the eccentric abrading head.

10. The device of claim 1, further comprising the radial spacing distances of the centers of mass of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight being unequal to each other.

11. The device of claim 1, further comprising a summation of the radial spacing distances of the centers of mass of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight radial spacing of the center of mass of the eccentric equaling the radial spacing distance of the center of mass of the eccentric abrasive element.

12. The device of claim 1, further comprising a summation of the radial spacing distances of the centers of mass of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight radial spacing of the center of mass of the eccentric equaling the radial spacing distance of the center of mass of the eccentric abrasive element.

13. The device of claim 1, further comprising the spacing of the center of mass of the eccentric proximal abrasive counterweight from the center of mass of the eccentric abrasive element being equal to the spacing of the center of mass of the eccentric distal counterweight from the center of mass of the eccentric abrasive element.

14. The device of claim 1, further comprising the spacing of the center of mass of the eccentric proximal abrasive counterweight from the center of mass of the eccentric abrasive element being unequal to the spacing of the center of mass of the eccentric distal abrasive counterweight from the center of mass of the eccentric abrasive element.

15. The device of claim 1, further comprising at least one of the proximal and distal abrasive counterweights being at least partially hollow.

16. A high-speed rotational atherectomy device, comprising:

a guide wire;

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

an eccentric abrasive element disposed on the drive shaft and comprising a mass and a center of mass spaced radially away from the rotational axis of the drive shaft;

a concentric proximal abrasive counterweight disposed on the drive shaft and comprising a mass and a center of mass located on the rotational axis of the drive shaft, the center of mass spaced a distance from the center of mass of the eccentric abrasive element; and

an concentric distal abrasive counterweight disposed on the drive shaft and having a mass and a center of mass located on the rotational axis of the drive shaft, the center of mass spaced a distance from the center of mass of the eccentric abrasive element.

17. A high-speed rotational atherectomy device, comprising:

a guide wire;

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

an eccentric abrasive element disposed on the drive shaft and comprising a mass and a center of mass that is spaced radially away from the rotational axis of the drive shaft in a direction along a longitudinal plane;

an eccentric proximal abrasive counterweight disposed on the drive shaft and comprising a mass and a center of mass that is spaced radially away from the rotational axis along the longitudinal plane and in the opposite direction as the eccentric abrasive element'"'"'s center of mass spacing center of mass spaced radially away from the rotational axis along a different longitudinal plane than the radial spacing of the center of mass of the eccentric abrasive element; and

an eccentric distal abrasive counterweight disposed on the drive shaft and having a mass and a center of mass spaced radially away from the rotational axis of the drive shaft along a longitudinal plane.

18. The device of claim 17, further comprising the center of mass of the eccentric distal abrasive counterweight spaced radially away from the rotational axis in the same direction as the radial spacing of the eccentric abrasive element and the eccentric proximal abrasive counterweight centers of mass and in the same longitudinal plane.

19. The device of claim 17, further comprising the center of mass of the eccentric distal abrasive counterweight spaced radially away from the rotational axis of the drive shaft in the opposite direction of the eccentric proximal abrasive element and in the same longitudinal plane.

20. The device of claim 17, further comprising the center of mass of the eccentric distal abrasive counterweight spaced radially away from the rotational axis in a different longitudinal plane than the center of mass of the eccentric abrading head.

21. The device of claim 20, further comprising the center of mass of the eccentric distal abrasive counterweight spaced radially away from the rotational axis in a different longitudinal plane than the center of mass of the eccentric proximal abrasive counterweight.

22. The device of claim 17, the abrasive element further comprising an enlarged eccentric abrading head.

23. The device of claim 17, further comprising the masses of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight being equal, each mass comprising ½

the mass of the eccentric abrasive element.

24. The device of claim 17, further comprising the masses of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight being unequal.

25. The device of claim 23, further comprising a summation of the masses of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight equaling the mass of the eccentric abrasive element.

26. The device of claim 23 further comprising a summation of the masses of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight differing from the mass of the eccentric abrasive element.

27. The device of claim 17, further comprising the radial spacing distances of the centers of mass of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight being equal and comprising a radial distance for each abrasive counterweight that is ½

the radial spacing distance of the eccentric abrading head.

28. The device of claim 17, further comprising the radial spacing distances of the centers of mass of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight being unequal.

29. The device of claim 17, further comprising a summation of the radial spacing distances of the centers of mass of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight radial spacing of the center of mass of the eccentric equaling the radial spacing distance of the center of mass of the eccentric abrasive element.

30. The device of claim 17, further comprising a summation of the radial spacing distances of the centers of mass of the eccentric proximal abrasive counterweight and the eccentric distal abrasive counterweight radial spacing of the center of mass of the eccentric equaling the radial spacing distance of the center of mass of the eccentric abrasive element.

31. The device of claim 17, further comprising the spacing of the center of mass of the eccentric proximal abrasive counterweight from the center of mass of the eccentric abrasive element being equal to the spacing of the center of mass of the eccentric distal abrasive counterweight from the center of mass of the eccentric abrasive element.

32. The device of claim 17, further comprising the spacing of the center of mass of the eccentric proximal abrasive counterweight from the center of mass of the eccentric abrasive element being unequal to the spacing of the center of mass of the eccentric distal abrasive counterweight from the center of mass of the eccentric abrasive element.

33. The device of claim 21, further comprising the rotational separation between adjacent longitudinal planes comprising the centers of mass of the eccentric abrasive element, the eccentric proximal abrasive counterweight and the eccentric distal counterweight is between 0 degrees and 90 degrees.

34. The device of claim 33, further comprising the rotational separation between adjacent longitudinal planes comprising the centers of mass of the eccentric abrasive element, the eccentric proximal abrasive counterweight and the eccentric distal counterweight is about 45 degrees.

35. The device of claim 17, further comprising at least one of the proximal and distal abrasive counterweights being at least partially hollow.