# US 10,368,901 B2 · Atherectomy devices and methods

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- Number: US 10,368,901 B2
- Document ID: US10368901B2
- Status: Granted
- Kind: B2
- Application number: 15/707,690
- Filed: 2017-09-18
- Published: 2018-03-08
- Granted: 2019-08-06
- Earliest claimed: 2014-01-15
- Assignees: Cardio Flow, Inc.
- Applicants: Cardio Flow, Inc.
- Inventors: Paul Joseph Robinson; Cassandra Ann Piippo Svendsen; Charles Anthony Plowe; Albert Selden Benjamin
- Web page: https://patentgrep.com/patent/US10368901B2

## CPC

- 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)}
- A61B 2017/22038: {with a guide wire}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61B 2017/320004: {abrasive}
- A61B 2017/320766: {eccentric}
- A61M 2025/1047: {having centering means, e.g. balloons having an appropriate shape}
- 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}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 1

A rotational atherectomy device for removing stenotic lesion material from a blood vessel of a patient, the device comprising:
a rotary actuator:
an elongate flexible drive shaft comprising a torque-transmitting coil having a constant outer diameter and defining a longitudinal axis, the coil configured to transmit a torque from the rotary actuator, the drive shaft being configured to rotate about the longitudinal axis;
multiple spherical abrasive elements that are attached to the drive shaft such that a center of mass of each abrasive element is offset from the longitudinal axis of the drive shaft and that each abrasive element is spaced apart from an adjacent one of the spherical abrasive elements by an element separation distance;
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 a distal-most element of the spherical abrasive elements by a distal separation distance, the distal separation distance being greater than the element separation distance; and
a coating along the drive shaft and the distal stability element such that the coating surrounds an outer diameter of at least a portion of drive shaft.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

The device of claim 1, wherein the coating surrounds the exterior surfaces of the distal stability element, and an abrasive outer surface of the abrasive element is uncoated and outwardly exposed.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

The device of claim 1, wherein the multiple abrasive elements comprise three abrasive elements positioned adjacent to one another along the drive shaft.

### Claim 8 (depends on 1)

The device of claim 1, wherein the multiple abrasive elements comprises at least three abrasive elements, and wherein a middle abrasive element has a larger outer diameter than a proximal abrasive element and a larger outer diameter than a distal abrasive element.

### Claim 9 (depends on 1)

The device of claim 1, wherein the distal stability element is spaced apart from the abrasive element by a stability spacing distance.

### Claim 10 (depends on 9)

The device of claim 9, wherein the drive shaft comprises a distal-most extension portion that extends distally of the distal stability element for a distal extension distance.

### Claim 11 (depends on 10)

The device of claim 10, wherein the distal extension distance is substantially greater than the stability spacing distance.

### Claim 12 (depends on 1)

The device of claim 1, wherein the distal stability element comprises a hollow cylinder that surrounds the torque-transmitting coil of the drive shaft.

### Claim 13 (depends on 12)

The device of claim 12, wherein the hollow cylinder has an exterior cylindrical surface that is smoother and different from an abrasive exterior surface of the abrasive element.

### Claim 14 (depends on 12)

The device of claim 12, wherein the hollow cylinder has an axial length that is greater than a maximum exterior diameter of the hollow cylinder.

### Claim 15

A rotational atherectomy device for removing stenotic lesion material from a blood vessel of a patient, the device comprising:
a rotary actuator;
an elongate flexible drive shaft comprising a torque-transmitting coil having a constant outer diameter and defining a longitudinal axis, the coil configured to transmit a torque from the rotary actuator, the drive shaft being configured to rotate about the longitudinal axis;
multiple abrasive elements 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, each abrasive element having a spherical shape;
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 a distal-most abrasive element by a distal separation distance that is greater than a longitudinal spacing between adjacent spherical abrasive elements of the multiple abrasive elements.

### Claim 16 (depends on 15)

The device of claim 15, further comprising a coating that surrounds the distal stability element.

### Claim 17 (depends on 15)

The device of claim 15, wherein the distal stability element is a hollow cylindrical member having an inner diameter that surrounds a portion of an outer diameter of the drive shaft.

### Claim 18 (depends on 15)

The device of claim 15, wherein the multiple abrasive elements comprises at least three abrasive elements positioned adjacent to one another along the drive shaft.

### Claim 19 (depends on 15)

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