Atherectomy devices and methods

• US 10,335,187 B2
• Filed: 10/23/2018
• Issued: 07/02/2019
• Est. Priority Date: 02/23/2017
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Benjamin, Albert Selden, Svendsen, Cassandra Ann Piippo, Plowe, Charles Anthony, Robinson, Paul Joseph
• Primary Examiner(s): Severson, Ryan J.
• Application Number:
  US16/168,087
• Publication Number:
  US 20190053823A1
• Time in Patent Office: 252 Days
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320766 eccentric

Abstract

Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating one or more abrasive elements within the vessel. The abrasive elements can be attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly that includes a driver for rotating the drive shaft. In particular implementations, individual abrasive elements are attached to the drive shaft at differing radial angles in comparison to each other (e.g., configured in a helical array). The centers of mass of the abrasive elements can define a path that fully or partially spirals around the drive shaft. In some embodiments, a distal stability element with a center of mass aligned with the longitudinal axis is fixedly mounted to the drive shaft.

Claims

1. A rotational atherectomy device for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the device comprising:

an elongate flexible drive shaft defining a longitudinal axis;

an array of at least three spherical abrasive elements fixed to the drive shaft and spaced apart from one another by a first separation distance, the spherical abrasive elements fixed to the drive shaft such that a center of mass of each abrasive element is offset from the longitudinal axis, the center of mass of a first spherical abrasive element of the spherical abrasive elements being offset from the longitudinal axis at a first radial angle, the center of mass of a second spherical abrasive element of the spherical abrasive elements being offset from the longitudinal axis at a second radial angle that differs from the first radial angle, the center of mass of a third spherical abrasive element of the spherical abrasive elements being offset from the longitudinal axis at a third radial angle that differs from the first radial angle and the second radial angle; and

a metallic concentric abrasive element having a cylindrical shape with an abrasive exterior coating and a center of mass aligned with the longitudinal axis, the metallic concentric abrasive element fixed to the drive shaft and distally spaced apart from a distal-most spherical abrasive element of the spherical abrasive elements by a distal separation distance.

2. The device of claim 1, wherein a proximal-most spherical abrasive element in the array has an outer diameter that is no greater than an outer diameter of an adjacent spherical abrasive element in the array and that is greater than an outer diameter of the metallic concentric abrasive element.

3. The device of claim 2, further comprising:

a fourth spherical abrasive element attached to the drive shaft, wherein the center of mass of the fourth spherical abrasive element is offset from the longitudinal axis along a fourth radial angle that differs from the first radial angle, the second radial angle, and the third radial angle; and

a fifth spherical abrasive element attached to the drive shaft, wherein the center of mass of the fifth spherical abrasive element is offset from the longitudinal axis along a fifth radial angle that differs from the first radial angle, the second radial angle, the third radial angle, and the fourth radial angle.

4. The device of claim 3, wherein:

the second radial angle differs from the first radial angle by at least 15 degrees,

the third radial angle differs from the each of first radial angle and the second radial angle by at least 15 degrees,

the fourth radial angle differs from each of the first radial angle, the second radial angle, and the third radial angle by at least 15 degrees, and

the fifth radial angle differs from each of the first radial angle, the second radial angle, the third radial angle, and the fourth radial angle by at least 15 degrees.

5. The device of claim 4, wherein the proximal-most spherical abrasive element and the distal-most spherical abrasive element are both smaller than all spherical abrasive elements positioned between the proximal-most and the distal most spherical abrasive elements.

6. The device of claim 4, where each of the spherical abrasive elements is equal in outer diameter.

7. The device of claim 6, wherein centers of mass of the spherical abrasive elements in the array define a helical path around the longitudinal axis.

8. The device of claim 1, wherein the metallic concentric abrasive element has a maximum diameter that is smaller than a maximum diameter of each of the spherical abrasive elements.

9. The device of claim 1, wherein the drive shaft comprises a distal-most extension portion that extends distally of the metallic concentric abrasive element for a distal extension distance.

10. The device of claim 9, wherein the drive shaft has a central lumen configured to receive a guidewire extending along the longitudinal axis and exiting from a distal tip of the distal-most extension portion.

11. The device of claim 9, wherein each spherical abrasive element is spaced apart from an adjacent one of the abrasive elements by the first separation distance that is less than the distal separation distance.

12. The device of claim 11, wherein the distal separation distance is greater than the distal extension distance.

13. The device of claim 12, wherein the first separation distance in ratio to an outer diameter of a largest one of the spherical abrasive elements is in a range from 1:

1 to 1.2;

1.

14. The device of claim 1, further comprising means for driving rotation of the drive shaft about the longitudinal axis.

15. The device of claim 14, further comprising means for translating the drive shaft along in a longitudinal direction while rotations of the drive shaft are driven by the means for driving.

16. The device of claim 1, further comprising an actuator handle assembly and a sheath extending from the actuator handle assembly, and wherein at least a portion of the drive shaft is slidably disposed within a lumen defined by the sheath.

17. The device of claim 16, further comprising means for controlling rotation of the drive shaft, the means for controlling being operably coupleable to the actuator handle assembly and configured to provide output to the actuator handle assembly that causes the actuator handle assembly to drive rotation of the drive shaft about the longitudinal axis.

18. The device of claim 17, wherein the means for controlling includes a user interface with a plurality of selectable inputs.

19. The device of claim 18, wherein the plurality of selectable inputs includes a low rotational speed selectable input and a high rotational speed selectable input.

20. The device of claim 19, further comprising means for providing a fluid impermeable flow path to a distal portion of the device.