Atherectomy devices and methods

• US 10,517,634 B2
• Filed: 11/15/2018
• Issued: 12/31/2019
• 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:
  US16/192,431
• Publication Number:
  US 20190083126A1
• Time in Patent Office: 411 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 system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the system comprising:

an actuator handle assembly comprising a housing and a carriage assembly that is movably coupled to the housing;

an elongate flexible drive shaft comprising a torque-transmitting coil, the drive shaft defining a longitudinal axis and a central drive shaft lumen extending along the longitudinal axis, the drive shaft rotatably coupled to the carriage assembly such that moving the carriage assembly in relation to the housing correspondingly moves the drive shaft in relation to the housing;

a set of eccentric abrasive elements fixed to a distal portion of the drive shaft and spaced apart from one another by at least 50% of an outer diameter of a largest one of the set of eccentric abrasive elements, the set of eccentric abrasive elements including at least a first, second, and third eccentric abrasive elements fixed to the drive shaft such that a center of mass of each eccentric abrasive element is offset from the longitudinal axis, the center of mass of the first eccentric abrasive element being offset from the longitudinal axis at a first radial angle, the center of mass of the second eccentric abrasive element being offset from the longitudinal axis at a second radial angle that differs from the first radial angle, the center of mass of the third eccentric abrasive element being offset from the longitudinal axis at a third radial angle that differs from the first radial angle and the second radial angle;

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

a sheath extending from the actuator handle assembly, the drive shaft slidably disposed within a lumen defined by the sheath; and

a controller operably coupleable to the actuator handle assembly by a cable, the controller configured to provide output to the actuator handle assembly that causes the actuator handle assembly to drive the rotation of the drive shaft about the longitudinal axis, the controller including a user interface with a plurality of selectable inputs corresponding to differing speeds of rotation of the drive shaft.

2. The system of claim 1, wherein the central drive shaft lumen is configured to receive a guidewire extending along the longitudinal axis.

3. The system of claim 2, further comprising means for releasably clamping the guidewire to the actuator handle assembly.

4. The system of claim 3, wherein the means for releasably clamping the guidewire to actuator handle assembly prevents the guidewire from rotating while the drive shaft is rotating and prevents the guidewire from translating while the carriage assembly is translated in relation to the housing.

5. The system of claim 1, further comprising means for selectably actuating the rotation of the drive shaft, wherein the means for selectably actuating the rotation of the drive shaft is on the carriage assembly.

6. The system of claim 5, wherein the means for selectably actuating the rotation of the drive shaft comprises an electrical switch.

7. The system of claim 1, wherein a proximal-most abrasive element of the set of eccentric abrasive elements and the distal-most abrasive element of the set of eccentric abrasive elements have outer diameters that are no greater than outer diameters of respectively adjacent abrasive elements in the set of eccentric abrasive elements and that are greater than an outer diameter of the concentric abrasive distal stability element.

8. The system of claim 7, wherein the set of eccentric abrasive elements further comprises:

a fourth abrasive element attached to the distal portion of the drive shaft, wherein the center of mass of the fourth 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 abrasive element attached to the distal portion of the drive shaft, wherein the center of mass of the fifth 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.

9. The system of claim 8, wherein:

the second radial angle differs from the first radial angle by 20 degrees to 50 degrees,

the third radial angle differs from the each of first radial angle and the second radial angle by 20 degrees to 50 degrees,

the fourth radial angle differs from each of the first radial angle, the second radial angle, and the third radial angle by 20 degrees to 50 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 20 degrees to 50 degrees.

10. The system of claim 9, wherein the proximal-most abrasive element and the distal-most abrasive element are both smaller than all abrasive elements of the set of eccentric abrasive elements positioned between the proximal-most and the distal-most abrasive elements, and wherein the centers of mass of the set of eccentric abrasive elements define a spiral path around the longitudinal axis.

11. The system of claim 9, where each of the eccentric abrasive elements of set of eccentric abrasive elements is equal in outer diameter, and wherein the centers of mass of the eccentric abrasive elements define a spiral path around the longitudinal axis.

12. The system of claim 1, wherein the torque-transmitting coil of the drive shaft comprises a distal-most extension portion that extends distally of the concentric abrasive distal stability element for a distal extension distance.

13. The system of claim 12, wherein the central drive shaft lumen extends along the distal-most extension portion such that a guidewire in the central drive shaft lumen can exit from a distal tip of the distal-most extension portion.

14. The system of claim 12, wherein each eccentric abrasive element of set of eccentric abrasive elements is spaced apart from an adjacent one of the eccentric abrasive elements by the first separation distance that is less than the distal separation distance, and wherein the distal separation distance is greater than the distal extension distance.

15. The system of claim 1, wherein the torque-transmitting coil comprises one or more helically wound filars, and wherein the filars are wound in an opposing direction to a spiral path defined by the centers of mass of the eccentric abrasive elements of set of eccentric abrasive elements.

16. The system of claim 1, further comprising means for driving rotation of the drive shaft about the longitudinal axis, wherein the means for driving rotation of the drive shaft about the longitudinal axis is controllable via the controller.

17. The system of claim 1, further comprising an RPM sensor operable for detecting a speed of the rotation of the drive shaft about the longitudinal axis.

18. The system of claim 1, further comprising means for supplying a flush liquid to the lumen defined by the sheath.

19. The system of claim 18, further comprising means for detecting a pressure of the flush liquid.

20. The system of claim 19, wherein the controller is configured to stop driving the rotation of the drive shaft in response to the pressure of the flush liquid being below a threshold pressure value.