Eccentric system of abrasive elements with equal mass for rotational atherectomy

• US 10,064,646 B2
• Filed: 02/27/2018
• Issued: 09/04/2018
• 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.
• Primary Examiner(s): Lynch, Robert
• Application Number:
  US15/906,067
• Publication Number:
  US 20180185057A1
• Time in Patent Office: 189 Days
• 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 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• 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
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The invention provides a rotational atherectomy device having, in various embodiments, a flexible, elongated, rotatable drive shaft with a plurality of eccentric abrading heads attached thereto. At least part of the eccentric enlarged abrading heads in the system have a tissue removing surface such as an abrasive surface. In certain embodiments, the plurality of abrasive elements may be connected to the drive shaft, with adjacent abrasive elements spaced apart from each other, wherein each of the plurality of abrasive elements comprises a center of mass that is radially offset from the rotational axis of the drive shaft and wherein the centers of mass for adjacent abrasive elements are rotationally spaced apart from each other at a rotational angle within the range of between 0 degrees to 90 degrees.

Claims

1. A rotational atherectomy device, comprising:

a flexible, elongated and rotatable drive shaft, the drive shaft comprising a rotational axis;

an eccentric system of abrasive elements comprising;

a first abrasive element fixedly disposed along on the drive shaft and comprising a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a first longitudinal plane located at a first rotational angle position;

a second abrasive element fixedly disposed along on the drive shaft and spaced proximally from the first abrasive element and comprising a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a second longitudinal plane that is spaced rotationally a distance from the first longitudinal plane; and

a third abrasive element fixedly disposed along on the drive shaft and spaced distally from the first abrasive element and comprising a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a third longitudinal plane that is rotationally spaced a distance from the second longitudinal plane,

wherein the mass of the first abrasive element, the mass of the second abrasive element and the mass of the third abrasive element are substantially equivalent.

2. The device of claim 1, wherein the drive shaft comprises a distal portion extending beyond a distal end of the third abrasive element.

3. The device of claim 1, wherein the second longitudinal plane is located between the first longitudinal plane and the third longitudinal plane.

4. The device of claim 1, wherein the rotational spacing distance between the first longitudinal plane and the second longitudinal plane is within a rotational angle range of between 0 degrees to 90 degrees, and wherein the rotational spacing distance between the second longitudinal plane and the third longitudinal plane is within a rotational angle range of between 0 degrees to 180 degrees.

5. The device of claim 1, further comprising the rotational spacing distance between the third longitudinal plane and the first longitudinal place being within a rotational angle range of between 0 degrees to 45 degrees and the rotational spacing distance between the first longitudinal plane and the second longitudinal plane being within a rotational angle range of between 0 degrees to 45 degrees.

6. The device of claim 1, further comprising the rotational spacing distance between the first longitudinal plane and the third longitudinal plane being within a rotational angle range of between 0 degrees and 90 degrees.

7. The device of claim 1, wherein the system of eccentric heads further comprises:

a fourth abrasive element fixedly disposed along the drive shaft and spaced proximally from the second abrasive element and comprising a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a fourth longitudinal plane that is spaced rotationally a distance from the second longitudinal plane; and

a fifth abrasive element fixedly disposed along on the drive shaft and spaced distally from the third abrasive element and comprising a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a fifth longitudinal plane that is spaced rotationally a distance from the third longitudinal plane,

wherein the mass of the first abrasive element, the second abrasive element, the third abrasive element, the fourth abrasive element and the fifth abrasive element are substantially equivalent.

8. The device of claim 7, wherein the drive shaft comprises a distal portion extending beyond a distal end of the fifth abrasive element.

9. The device of claim 7, further comprising the rotational spacing distance between the fourth longitudinal plane and the second longitudinal plane being within a rotational angle range between 0 and 90 degrees and the rotational spacing distance between the fifth longitudinal plane and the third longitudinal plane being within a rotational angle range of between 0 degrees and 90 degrees.

10. The device of claim 7, further comprising the rotational spacing distance between the fourth longitudinal plane and the second longitudinal plane being within a rotational angle range between 0 and 45 degrees and the rotational spacing distance between the fifth longitudinal plane and the third longitudinal plane being within a rotational angle range of between 0 degrees and 45 degrees.

11. The device of claim 7, wherein the second longitudinal plane is located between the first longitudinal plane and the fourth longitudinal plane.

12. The device of claim 7, wherein the third longitudinal plane is located between the first longitudinal plane and the fifth longitudinal plane.

13. The device of claim 7, wherein the second longitudinal plane is located between the first longitudinal plane and the third longitudinal plane.

14. The device of claim 7, further comprising the fourth longitudinal plane being rotationally spaced away from the first longitudinal plane, the third longitudinal plane, and the fifth longitudinal plane.

15. The device of claim 7, further comprising the fifth longitudinal plane being rotationally spaced a distance away from the first longitudinal plane and rotationally spaced a distance away from the second longitudinal plane.

16. The device of claim 7, further comprising a lumen through each of the first, second, third, fourth and fifth abrasive elements, wherein each of the lumens are adapted to receive the drive shaft.

17. The device of claim 7, wherein each of the first, second, third, fourth and fifth abrasive elements comprise a geometric center, wherein the location of the center of mass of at least one of the first, second, third, fourth and fifth abrasive elements is coextensive with the geometric center of the respective abrasive element.

18. The device of claim 7, wherein each of the first abrasive element, the second abrasive element, the third abrasive element, the fourth abrasive element, and the fifth abrasive element comprise a geometric center, wherein the location of the center of mass of at least one of the first abrasive element, the second abrasive element, the third abrasive element, the fourth abrasive element and the fifth abrasive element is not coextensive with the geometric center of the respective abrasive element.

19. The device of claim 7, wherein the first abrasive element, the second abrasive element, the third abrasive element, the fourth abrasive element and the fifth abrasive element are eccentrically mounted to the drive shaft.

20. A rotational atherectomy device, comprising:

a flexible, elongated and rotatable drive shaft, the drive shaft comprising a rotational axis;

an eccentric system of abrasive elements comprising;

a first abrasive element fixedly disposed along the drive shaft and comprising a resting diameter, a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a first longitudinal plane;

a second abrasive element fixedly disposed along the drive shaft and spaced proximally from the first abrasive element and comprising a resting diameter, a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a second longitudinal plane that is spaced rotationally from the first longitudinal plane;

a third abrasive element fixedly disposed along the drive shaft and spaced distally from the first abrasive element and comprising a mass, a resting diameter and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a third longitudinal plane that is spaced rotationally from the first longitudinal plane and spaced rotationally from the second longitudinal plane;

a fourth abrasive element fixedly disposed along the drive shaft and spaced proximally from the second abrasive element and comprising a resting diameter, a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a fourth longitudinal plane that is spaced rotationally from the second longitudinal plane; and

a fifth abrasive element fixedly disposed along the drive shaft and spaced distally from the third abrasive element and comprising a resting diameter, a mass and a center of mass having a location that is spaced radially away from the rotational axis of the drive shaft in a direction along a fifth longitudinal plane that is spaced rotationally from the third longitudinal plane,

wherein the masses of the first abrasive element, the second abrasive element, the third abrasive element, the fourth abrasive element and the fifth abrasive element are substantially equivalent.

21. The device of claim 20, wherein the drive shaft comprises a distal portion extending beyond a distal end of the fifth abrasive element.

22. The rotational atherectomy system of claim 20, further comprising a working diameter for the first, second and third abrasive elements, wherein each of the working diameters are traced out during high-speed rotation of the rotational atherectomy system, and wherein the working diameter for the first abrasive element is greater than its resting diameter, the working diameter for the second abrasive element is greater than its resting diameter, and the working diameter for the third abrasive element is greater than its resting diameter.

23. The rotational atherectomy system of claim 22, further comprising a working diameter for the fourth and fifth abrasive elements, wherein each of the working diameters are traced out during high-speed rotation of the rotational atherectomy system, and wherein the working diameter for the fourth abrasive element is greater than its resting diameter and the working diameter for the fifth abrasive element is greater than its resting diameter.

24. A high-speed rotational atherectomy device for opening a stenosis in a blood vessel, comprising:

a flexible elongated, rotatable drive shaft, the drive shaft having a rotational axis; and

an eccentric system comprising a proximal abrasive element, a distal abrasive element and a plurality of abrasive elements disposed between the proximal and distal eccentric abrasive elements, each abrasive element in the eccentric system being in spaced apart longitudinal disposition along the drive shaft and comprising a mass and a center of mass that is radially offset from the rotational axis of the drive shaft, wherein the centers of mass for adjacent abrasive elements are rotationally spaced apart from each other at a rotational angle within the range of between 0 degrees to 90 degrees; and

wherein the eccentric system comprises a center of mass that is radially offset from the rotational axis of the drive shaft, and

wherein the masses of each abrasive element in the eccentric system are substantially equivalent.

25. The rotational atherectomy system of claim 24, wherein the drive shaft comprises a distal portion extending beyond a distal end of the distal abrasive element.

26. The rotational atherectomy system of claim 24, further comprising the centers of mass for adjacent abrasive elements in the eccentric system being rotationally spaced apart from each other at a rotational angle within the range of between 0 degrees and 45 degrees.

27. The rotational atherectomy system of claim 24, wherein the rotational angles between the centers of mass for adjacent abrasive elements are substantially equal such that the centers of mass for adjacent abrasive elements all comprise substantially equal rotational spacing therebetween.

28. The rotational atherectomy system of claim 26, wherein the rotational angles between the centers of mass for adjacent abrasive elements are substantially equal such that the centers of mass for adjacent abrasive elements all comprise substantially equal rotational spacing therebetween.

29. The rotational atherectomy system of claim 24, further comprising at least one of the abrasive elements in the eccentric system comprising a geometric center that is coextensive with the center of mass of the at least one abrasive element.

30. The rotational atherectomy system of claim 24, further comprising at least one of the abrasive elements in the eccentric system comprising a geometric center that is not coextensive with the center of mass of the at least one abrasive element.