Atherectomy devices and methods

• US 9,788,853 B2
• Filed: 01/15/2014
• Issued: 10/17/2017
• 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
• Primary Examiner(s): Miles, Jonathan
• Assistant Examiner(s): Rwego, Kankindi
• Application Number:
  US14/155,549
• Publication Number:
  US 20150196320A1
• Time in Patent Office: 1,371 Days
• Field of Search: 606159
• 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 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; and

a rotational atherectomy device comprising;

an elongate flexible drive shaft comprising helically wound metallic filars that form a coil having a constant outer diameter, the 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 array of at least three spherical abrasive elements positioned adjacent to one another along the coil, the spherical abrasive elements being fixed to the drive shaft such that a center of mass of each abrasive element is offset from the longitudinal axis, each abrasive elements being spaced apart from an adjacent abrasive element by an element spacing distance; and

a metallic stability element having a cylindrical shape defining an inner diameter, the metallic stability element being fixed along the inner diameter to the helically wound metallic filars of the drive shaft, the metallic stability element having a center of mass aligned with the longitudinal axis, the stability element being distally spaced apart from a distal-most abrasive element of the spherical abrasive elements by a distal separation distance, the distal separation distance being greater than the element spacing distance;

wherein the drive shaft includes a distal extension portion extending distally beyond a distal end of the metallic stability element; and

wherein the drive shaft, the abrasive elements, and the metallic stability element rotate together about the longitudinal axis.

2. The system of claim 1, further comprising a second stability element fixed to the drive shaft and located proximally of the abrasive elements.

3. The system of claim 1, further comprising a guidewire configured to be slidably disposed within a fluid-impermeable lumen of the drive shaft.

4. The system of claim 1, wherein the abrasive elements comprise five spherical abrasive elements positioned adjacent to one another along the drive shaft.

5. The system of claim 4, wherein the array comprises outer spherical abrasive elements and at least one inner spherical abrasive element, wherein an outer diameter of the outer spherical abrasive element is smaller than an outer diameter of the at least one inner spherical abrasive element.

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

7. The system of claim 1, wherein the drive shaft comprises a torque-transmitting coil and wherein the stability element comprises a hollow metallic cylinder with an inner diameter that is fixed along the inner diameter to an outer diameter of the torque-transmitting coil.

8. The system of claim 7, wherein the hollow metallic cylinder has an axial length that is greater than a maximum exterior diameter of the hollow metallic cylinder.

9. The system of claim 1, wherein each spherical abrasive element of the at least three spherical abrasive elements has an abrasive outer surface, and wherein a middle spherical abrasive element of the at least three spherical abrasive elements has a larger outer diameter than a proximal spherical abrasive element of the at least three spherical abrasive elements and a larger outer diameter than a distal spherical abrasive element of the at least three spherical abrasive elements.

10. The system of claim 1, wherein the metallic stability element comprises a hollow metallic cylinder with an exterior cylindrical surface.

11. The system of claim 1, wherein an outer surface of the balloon member defines channel spaces configured to allow blood flow past the balloon member when the balloon member is in the inflated configuration and in contact with the blood vessel wall.

12. The system of claim 1, wherein the flush tube includes an inflatable balloon member attached to and surrounding an outer diameter of a distal end portion of the flush tube, the balloon member is in fluid communication with the first lumen, and the balloon member is configured to contact a blood vessel wall when the balloon member is in an inflated configuration.

13. The system of claim 1, wherein the device further comprises a flexible polymer coating covering an outer diameter of the metallic stability element and an outer diameter of at least a portion of the drive shaft, and wherein the drive shaft has an outer diameter covered by the flexible polymer coating.

14. The system of claim 13, wherein the flexible polymer coating comprises a fluid-impermeable material that provides a fluid-impermeable lumen along the drive shaft.

15. The system of claim 13, wherein the flexible polymer coating has a different durometer at different locations on the drive shaft.