Atherectomy devices and methods

• US 10,639,064 B2
• Filed: 11/21/2018
• 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:
  US16/198,425
• Publication Number:
  US 20190090901A1
• Time in Patent Office: 531 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 method of performing a rotational atherectomy, the method comprising:

advancing a drive shaft of a rotation atherectomy device along a guidewire so that a set of five ellipsoid eccentric abrasive elements mounted along a distal end portion of the drive shaft is directed toward a targeted vessel, the drive shaft comprising a torque-transmitting coil extending from a handle assembly and being configured to rotate in response to rotation of a rotatable member housed within the handle assembly, the set of five ellipsoid eccentric abrasive elements comprising a distal-most eccentric abrasive element, a proximal-most eccentric abrasive element, and three intermediate eccentric abrasive elements, and both the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element are smaller in maximum diameter than a maximum diameter of each of the three intermediate eccentric abrasive elements; and

rotating the rotatable member coupled to a proximal portion of the drive shaft to drive rotation of the drive shaft about a longitudinal axis of the drive shaft.

2. The method of claim 1, wherein the rotation atherectomy device further comprises a carriage to which the rotatable member is coupled.

3. The method of claim 2, further comprising longitudinally translating the carriage in relation to a housing of the handle assembly, and wherein longitudinal translations of the rotatable member result in corresponding longitudinal translations of the drive shaft.

4. The method of claim 3, wherein when the carriage is located in a first position, an access port defined by the housing is in fluid communication with a central lumen of the drive shaft.

5. The method of claim 4, wherein when the carriage is shifted away from the first position, the access port defined by the housing is disconnected from fluid communication with the central lumen of the drive shaft.

6. The method of claim 5, wherein the first position is a proximal-most position of the carriage, and when the carriage is located in the proximal-most position and a latch mechanism is deactivated, the carriage is detained in the proximal-most position.

7. The method of claim 2, wherein the carriage further comprises a valve coupled to the carriage.

8. The method of claim 7, further comprising directing fluid to the rotatable member for driving rotation of the rotatable member and the drive shaft by operating the valve.

9. The method of claim 1, wherein the rotatable member is a turbine member.

10. The method of claim 1, further comprising controlling rotation of the rotatable member between a rotationally stopped state and a rotationally moving state.

11. The method of claim 10, wherein the controlling rotation of the rotatable member between the rotationally stopped state and the rotationally moving state is achieved by actuating a valve coupled to the handle assembly.

12. The method of claim 11, wherein the valve is spring biased to a closed configuration resulting in the rotatable member being in the rotationally stopped state.

13. The method of claim 11, wherein the valve is manually actuatable to an open configuration resulting in the rotatable member being in the rotationally moving state.

14. The method of claim 1, wherein the handle assembly further comprises a controller and a RPM sensor, wherein the controller is in electrical communication with the RPM sensor.

15. The method of claim 14, wherein the controller convert a signal from the sensor into a corresponding RPM quantity and displays the RPM quantity on a user interface.

16. A method of performing a rotational atherectomy on a targeted lesion of a patient, the method comprising:

advancing a drive shaft assembly of a rotation atherectomy device along a guide wire disposed within a vasculature of the patient so that a distal end of the drive shaft assembly is advanced toward the targeted lesion, the drive shaft assembly comprising;

a sheath comprising an elongate tubular member defining a lumen therethrough;

a torque-transmitting coil slidably disposed within the lumen and extending distally from a handle assembly positioned at a proximal end of the torque-transmitting coil, the torque-transmitting coil configured to rotate in response to rotation of a rotatable member housed within the handle assembly; and

a set of at least three same-shaped eccentric abrasive elements attached to a distal end portion of the torque-transmitting coil, the set of at least three same-shaped eccentric abrasive elements comprising a distal-most eccentric abrasive element, a proximal-most, and one or more intermediate eccentric abrasive elements, and both the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element are smaller in maximum diameter than a maximum diameter of each of the one or more intermediate eccentric abrasive elements; and

a distal stability element fixed to the torque-transmitting coil and having a center of mass that is axially aligned with a longitudinal axis of the torque-transmitting coil; and

rotating the rotatable member to drive rotation of the torque-transmitting coil such that the set of at least three same-shaped eccentric abrasive elements contact the targeted lesion.

17. The method of claim 16, wherein the sheath comprises an inflatable member disposed about a distal end portion of the tubular member, and further comprising inflating the inflatable member while the inflatable member is positioned at the targeted lesion, wherein the inflating results in compression of the targeted lesion.

18. The method of claim 16, wherein the distal stability element includes a coating.

19. The method of claim 16, wherein the drive shaft assembly further comprises a distal drive shaft extension portion that extends distally from the distal stability element and terminates at a free end.

20. The method of claim 19, wherein the distal stability element is concentrically fixed to the torque-transmitting coil between the set of at least three same-shaped eccentric abrasive elements and the distal drive shaft extension portion.