Atherectomy devices and methods

• US 10,639,063 B2
• Filed: 11/20/2018
• Issued: 05/05/2020
• Est. Priority Date: 04/06/2016
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Piippo Svendsen, Cassandra Ann, Plowe, Charles Anthony, Benjamin, Albert Selden, Robinson, Paul Joseph, Leingang, Evan
• Primary Examiner(s): Schwiker, Katherine H
• Application Number:
  US16/197,125
• Publication Number:
  US 20190083127A1
• Time in Patent Office: 532 Days
• Field of Search: 606159, 606180
• 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 2017/00057 Light
• CPC Class Codes: A61B 2017/00075 Motion
• CPC Class Codes: A61B 2017/00553 using a turbine
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2017/320766 eccentric

Abstract

Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating an abrasive element within the vessel. The abrasive element can be attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly. In particular embodiments, the handle assembly includes a compressed gas driven turbine member that drives rotation of the drive shaft. The turbine member can be rotatably attached to a carriage that is longitudinally translatable in relation to a housing of the handle assembly. The handle assembly can include a latch mechanism that when actuated allows the carriage to translate to a proximal-most position. While the carriage is in the proximal-most position, an open pathway is created so that a guidewire can be slidably passed through the handle assembly and a lumen of the drive shaft.

Claims

1. A rotational atherectomy system comprising:

a rotational atherectomy device comprising;

a handle assembly including a housing, a rotatable member disposed within the housing, and a carriage to which the rotatable member is rotatably attached, wherein the carriage is longitudinally translatable in relation to the housing;

an elongate flexible drive shaft comprising a torque-transmitting coil extending from the housing, the drive shaft defining a central lumen and a longitudinal axis, and the drive shaft being coupled to the rotatable member such that rotation of the rotatable member rotates the drive shaft about the longitudinal axis;

a combination of multiple ellipsoid eccentric abrasive elements and a concentric distal stability element attached to the drive shaft, each of the multiple ellipsoid eccentric abrasive elements being longitudinally spaced apart from one another and having a respective center of mass offset from the longitudinal axis while the concentric distal stability element is spaced distally from the multiple ellipsoid eccentric abrasive elements and has a respective center of mass aligned with the longitudinal axis, wherein the multiple ellipsoid eccentric abrasive elements comprise a distal-most eccentric abrasive element, a proximal-most eccentric abrasive element, and at least one ellipsoid eccentric abrasive element positioned between the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element, wherein the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element of the combination of multiple ellipsoid eccentric abrasive elements are both smaller in maximum outer diameter than the at least one ellipsoid eccentric abrasive element positioned between the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element;

a sheath having a proximal end attached to the housing, the sheath defining a longitudinal sheath lumen therethrough in which the drive shaft is slidably disposed; and

a controller operatively connected with the rotational atherectomy device and configured to control rotation of the rotatable member.

2. The rotational atherectomy system of claim 1, wherein the controller is configured for supplying a pressurized gas for rotating the rotatable member.

3. The rotational atherectomy system of claim 2, wherein the controller will not supply the pressurized gas unless a detected pressure of a flush fluid supplied to the sheath lumen is above a threshold limit value.

4. The rotational atherectomy system of claim 1, wherein the controller comprises electronic controls that are in electrical communication with a RPM sensor located on the carriage.

5. The rotational atherectomy system of claim 4, wherein the controller is configured to convert a signal from the RPM sensor into a corresponding RPM quantity and display the RPM quantity on a user interface.

6. The rotational atherectomy system of claim 4, wherein the controller is configured to increase or decrease the rotational speed of the drive shaft.

7. The rotational atherectomy system of claim 4, wherein the controller is configured to modulate a supply a flow or pressure of compressed gas supplied from the controller to the handle assembly.

8. The rotational atherectomy system of claim 1, wherein the controller is configured to discontinue the supply of compressed gas when a detected pressure of a flush liquid supplied to the sheath is below a threshold pressure value.

9. The rotational atherectomy system of claim 1, wherein the controller is configured to discontinue rotation of the rotatable member when a detected pressure of a flush liquid supplied to the sheath is below a threshold pressure value.

10. The rotational atherectomy system of claim 1, further comprising an optical sensor configured for detecting rotation of the rotatable member.

11. The rotational atherectomy system of claim 10, wherein the controller prevents rotation of the rotatable member until the optical sensor is in electrical communication with the controller.

12. The rotational atherectomy system of claim 1, wherein the respective centers of mass of the multiple ellipsoid eccentric abrasive elements are offset in the same radial direction from the longitudinal axis.

13. The rotational atherectomy system of claim 1, wherein the combination of multiple ellipsoid eccentric abrasive elements and the concentric distal stability element consists of five ellipsoid eccentric abrasive elements and one concentric distal stability element.

14. The rotational atherectomy system of claim 1, wherein, when the drive shaft is rotated about its longitudinal axis, the multiple ellipsoid eccentric abrasive elements follow a transverse circular orbit around the longitudinal axis.

15. The rotational atherectomy system of claim 1, wherein the concentric distal stability element comprises a cylindrical member mounted to the torque-transmitting coil.

16. The rotational atherectomy system of claim 15, wherein a distal end portion of the torque-transmitting coil is exposed distally of the cylindrical member.

17. A rotational atherectomy system comprising:

a rotational atherectomy device comprising;

a handle assembly including a housing, a rotatable member disposed within the housing, and a carriage to which the rotatable member is rotatably attached, wherein the carriage is longitudinally translatable in relation to the housing;

an elongate flexible drive shaft comprising a torque-transmitting coil extending from the housing, the drive shaft defining a central lumen and a longitudinal axis, and the drive shaft being coupled to the rotatable member such that rotation of the rotatable member rotates the drive shaft about the longitudinal axis;

a combination of multiple ellipsoid eccentric abrasive elements and a concentric distal stability element attached to the drive shaft, each of the multiple ellipsoid eccentric abrasive elements being longitudinally spaced apart from one another and having a respective center of mass offset from the longitudinal axis while the concentric distal stability element is spaced distally from the multiple ellipsoid eccentric abrasive elements and has a respective center of mass aligned with the longitudinal axis, wherein the multiple ellipsoid eccentric abrasive elements comprise a distal-most eccentric abrasive element, a proximal-most eccentric abrasive element, and at least one intermediate eccentric abrasive element, wherein the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element are smaller in maximum diameter than a maximum diameter of the at least one intermediate eccentric abrasive element;

a sheath having a proximal end attached to the housing, the sheath defining a longitudinal sheath lumen therethrough in which the drive shaft is slidably disposed; and

a controller operatively connected with the rotational atherectomy device and configured to control rotation of the rotatable member, wherein the controller is configured to compute, display, and adjust the rotational speed of the drive shaft.