Atherectomy Devices and Methods

• US 20150196320A1
• Filed: 01/15/2014
• Published: 07/16/2015
• Est. Priority Date: 01/15/2014
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Robinson, Paul Joseph, Piippo Svendsen, Cassandra Ann, Plowe, Charles Anthony, Benjamin, Albert Selden
• Granted Patent: US 9,788,853 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon

Abstract

This document describes rotational atherectomy devices and systems for removing or reducing stenotic lesions in blood vessels by rotating an abrasive element within the vessel to partially or completely remove the stenotic lesion material.

Claims

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

an elongate flexible drive shaft comprising a torque-transmitting coil and defining a longitudinal axis, the drive shaft being configured to rotate about the longitudinal axis;

an abrasive element that is attached to the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft;

a proximal stability element that is fixed to the drive shaft and that has a center of mass aligned with the longitudinal axis of the drive shaft, the proximal stability element being proximally spaced apart from the abrasive element;

a distal stability element that is fixed to the drive shaft and that has a center of mass aligned with the longitudinal axis of the drive shaft, the distal stability element being distally spaced apart from the abrasive element; and

a flexible polymer coating along the drive shaft such that the coating surrounds an outer diameter of at least a portion of drive shaft.

2. The device of claim 1, wherein the proximal and distal stability elements are equally spaced apart from the abrasive element by a stability spacing distance.

3. The device of claim 2, wherein the drive shaft comprises a distal-most extension portion that extends distally of the distal stability element for a distal extension distance.

4. The device of claim 3, wherein the distal extension distance is substantially greater than the stability spacing distance.

5. The device of claim 1, wherein the drive shaft has a central lumen extending along the longitudinal axis that is configured to receive a guidewire.

6. The device of claim 1, wherein the proximal and distal stability elements comprise hollow cylinders that surround the torque-transmitting coil of the drive shaft.

7. The device of claim 6, wherein the hollow cylinders have an exterior cylindrical surface that is smoother and different from an abrasive exterior surface of the abrasive element.

8. The device of claim 6, wherein the hollow cylinders have an axial length that is greater than a maximum exterior diameter of the hollow cylinders.

9. The device of claim 1, wherein the flexible polymer coating surrounds the torque-transmitting coil of the drive shaft extending between the first and second stability elements, and exteriors of the abrasive element and the proximal and distal stability elements are uncoated and outwardly exposed.

10. The device of claim 1, wherein the flexible polymer coating surrounds the outer diameter of the drive shaft extending between the first and second stability elements and surrounds exterior surfaces of the first and second stability elements, and an abrasive outer surface of the abrasive element is uncoated and outwardly exposed.

11. The device of claim 1, wherein the flexible polymer coating comprises a fluid-impermeable material that provides a fluid-impermeable lumen along the drive shaft.

12. The device of claim 1, wherein the flexible polymer coating has a different durometer at different locations on the drive shaft.

13. The device of claim 1, further comprising a second proximal stability element and a second distal stability element, wherein the second proximal stability element is located proximally to the abrasive element and the second distal stability element is located distally to the abrasive element.

14. The device of claim 1, wherein the abrasive element comprises two or more abrasive segments positioned adjacent to one another along the drive shaft.

15. The device of claim 15, wherein the abrasive element comprises at least three segments, and wherein a middle segment has a larger outer diameter than a proximal segment and a larger outer diameter than a distal segment.

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

an elongate flush tube defining a first lumen and a second lumen, the flush tube including an inflatable balloon member attached to and surrounding an outer diameter of a distal end portion of the flush tube, the balloon member in fluid communication with the first lumen, the balloon member configured to contact a blood vessel wall when the balloon member is in an inflated configuration; and

a rotational atherectomy device comprising;

an elongate flexible drive shaft defining a longitudinal axis, the drive shaft configured for rotation about the longitudinal axis, the drive shaft configured to be at least partially disposed within the second lumen when the system is used for performing the rotational atherectomy;

an abrasive element that is fixed to the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis; and

a stability element that is fixed to the drive shaft and that has a center of mass aligned with the longitudinal axis, the second stability element being distally spaced apart from the abrasive element.

17. The system of claim 16, wherein the balloon member defines channel spaces that are configured to allow blood flow therethrough when the balloon member is in the inflated configuration within the blood vessel.

18. The system of claim 16, further comprising a second stability element fixed to the drive shaft and located proximally of the abrasive element.

19. The system of claim 16, further comprising a guidewire configured to slidably withdrawn into a fluid-impermeable lumen of the drive shaft of rotational atherectomy device.

20. The system of claim 16, wherein the rotational atherectomy device further comprises a flexible polymer coating along the drive shaft such that the coating surrounds an outer diameter of at least a portion of drive shaft.

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

delivering a rotational atherectomy device into the blood vessel, wherein the rotational atherectomy device comprises;

an elongate flexible drive shaft defining a longitudinal axis, the drive shaft configured for rotation about the longitudinal axis;

an abrasive element that is fixed to the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis;

a first stability element that is fixed to the drive shaft and that has a center of mass aligned with the longitudinal axis, the first stability element being proximally spaced apart from the abrasive element; and

a second stability element that is fixed to the drive shaft and that has a center of mass aligned with the longitudinal axis, the second stability element being distally spaced apart from the abrasive element; and

rotating the drive shaft about the longitudinal axis such that a portion of the drive shaft extending between the first and second stability elements traces a generally bicone shape.

22. The method of claim 21, wherein during said rotation, the abrasive element has an orbital path about an axis of rotation, the orbital path having a substantially greater diameter than a travel path of each of the first and second stability elements.

23. The method of claim 21, further comprising translating the drive shaft distally during the rotating the drive shaft.

24. The method of claim 21, wherein the rotating the drive shaft causes the abrasive element to remove the stenotic lesion material from a vessel wall.

25. The method of claim 21, further comprising:

delivering an elongate flush tube into the blood vessel, the flush tube defining a first lumen and a second lumen, the flush tube including a balloon member attached to and surrounding an outer diameter of a distal end portion of the flush tube, the balloon member in fluid communication with the first lumen, at least a portion of the drive shaft being disposed within the second lumen; and

inflating the balloon member by supplying an inflation fluid through the first lumen, wherein the inflating causes the balloon member to expand into contact with the blood vessel.