# US 10,478,215 B2 · Atherectomy devices and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,215 B2 - Document ID: US10478215B2 - Status: Granted - Kind: B2 - Application number: 16/150,003 - Filed: 2018-10-02 - Published: 2019-01-31 - Granted: 2019-11-19 - 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/US10478215B2 ## 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 system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient the system comprising: an elongate tube defining a lumen; and a rotational atherectomy device comprising: an elongate flexible drive shaft comprising helically wound metallic filars that form a coil having an outer diameter, the drive shaft defining a longitudinal axis; an array of at least three eccentric 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; and a metallic stability element having a cylindrical shape defining an inner diameter, the metallic stability element being fixed to the helically wound metallic filars of the drive shaft the metallic stability element having a center of mass aligned with the longitudinal axis; and a distal-most extension portion that extends distally of the metallic stability element to a distal free end; wherein the drive shaft, the abrasive elements, and the metallic stability element rotate together about the longitudinal axis, wherein the distal-most extension portion extends distally of the metallic stability element for a distal extension distance, wherein the distal-most extension portion is distally spaced apart from a distal-most abrasive element of the eccentric spherical abrasive elements by a distal separation distance, and wherein the center of mass for each eccentric spherical abrasive elements in said array is offset from the longitudinal axis while contemporaneously the center of mass of the metallic stability element is aligned with the longitudinal axis, and wherein the distal separation distance being greater than an element spacing distance, wherein each abrasive element is spaced apart from an adjacent abrasive element by the element spacing distance. ### Claim 2 (depends on 1) The system of claim 1, wherein a ratio of the distal extension distance relative to the distal separation distance is about 1:1. ### Claim 3 (depends on 1) The system of claim 1, wherein a ratio of the distal extension distance relative to the distal separation distance is about 2:1. ### Claim 4 (depends on 1) The system of claim 1, wherein a ratio of the distal extension distance relative to the distal separation distance is about 3:1. ### Claim 5 (depends on 1) The system of claim 1, wherein a ratio of the distal extension distance relative to the distal separation distance is higher than 3:1. ### Claim 6 (depends on 1) The system of claim 1, wherein the distal extension distance and the distal separation distance are unequal. ### Claim 7 A system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the system comprising: an elongate tube defining a lumen; and a rotational atherectomy device comprising: an elongate flexible drive shaft comprising helically wound metallic filars that form a coil having an outer diameter, the drive shaft defining a longitudinal axis; an array of at least three eccentric 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; and a metallic stability element having a cylindrical shape defining an inner diameter, the metallic stability element being fixed to the helically wound metallic filars of the drive shaft, the metallic stability element having a center of mass aligned with the longitudinal axis; and a distal-most extension portion that extends distally of the metallic stability element to a distal free end; wherein the drive shaft, the abrasive elements, and the metallic stability element rotate together about the longitudinal axis, wherein the distal-most extension portion is configured to provide a stable rotary motion during rotation of the system. ### Claim 8 (depends on 7) The system of claim 7, wherein the distal-most extension portion is a portion of the drive shaft. ### Claim 9 (depends on 7) The system of claim 7, wherein the at least three spherical abrasive elements are positioned adjacent to one another along the coil. ### Claim 10 (depends on 7) The system of claim 7, wherein at least a portion of the distal-most extension portion is defined by the helically wound metallic filars of the drive shaft that extends distally of the metallic stability element. ### Claim 11 (depends on 7) The system of claim 7, wherein the spherical abrasive elements are positioned adjacent to one another along the drive shaft. ### Claim 12 (depends on 7) The system of claim 7, wherein the spherical abrasive elements comprises five spherical abrasive elements positioned along the drive shaft. ### Claim 13 (depends on 7) The system of claim 7, wherein the drive shaft has a central lumen extending along the longitudinal axis that is configured to receive a guidewire that is fully withdrawable into the central lumen, and wherein the coil formed by the helically wound metallic filars has a constant outer coil diameter. ### Claim 14 (depends on 7) The system of claim 7, wherein the coil of the drive shaft comprises a torque-transmitting coil and wherein the metallic stability element comprises a hollow metallic cylinder with the inner diameter fixed to an outer diameter of the torque-transmitting coil. ### Claim 15 (depends on 7) The system of claim 7, wherein the device further comprises a coating covering an outer diameter of the metallic stability element. ### Claim 16 A system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient the system comprising: an elongate tube defining a lumen; and a rotational atherectomy device comprising; an elongate flexible drive shaft comprising helically wound metallic filars that form a coil having an outer diameter, the drive shaft defining a longitudinal axis; an array of at five 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; and a metallic stability element having a cylindrical shape defining an inner diameter, the metallic stability element being fixed to the helically wound metallic filars of the drive shaft the metallic stability element having a center of mass aligned with the longitudinal axis; and a distal-most extension portion that extends distally of the metallic stability element to a distal free end; wherein the drive shaft, the abrasive elements, and the metallic stability element rotate together about the longitudinal axis, and 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. ### Claim 17 (depends on 16) The system of claim 16, wherein the drive shaft has a central lumen extending along the longitudinal axis that is configured to receive a guidewire that is fully withdrawable into the central lumen, and wherein the coil formed by the helically wound metallic filars has a constant outer coil diameter. ### Claim 18 (depends on 16) The system of claim 16, wherein the coil of the drive shaft comprises a torque-transmitting coil and wherein the metallic stability element comprises a hollow metallic cylinder with the inner diameter fixed to an outer diameter of the torque-transmitting coil. ### Claim 19 (depends on 16) The system of claim 16, wherein the distal-most extension portion is a portion of the drive shaft. ### Claim 20 (depends on 16) The system of claim 16, wherein the five spherical abrasive elements are positioned adjacent to one another along the coil. ### Claim 21 (depends on 16) The system of claim 16, wherein at least a portion of the distal-most extension portion is defined by the helically wound metallic filars of the drive shaft that extends distally of the metallic stability element. ### Claim 22 (depends on 16) The system of claim 16, wherein the device further comprises a coating covering an outer diameter of the metallic stability element. ### Claim 23 A system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the system comprising: an elongate tube defining a lumen; and a rotational atherectomy device comprising: an elongate flexible drive shaft comprising helically wound metallic filars that form a coil having an outer diameter, the drive shaft defining a longitudinal axis; an array of at least three eccentric 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; and a metallic stability element having a cylindrical shape defining an inner diameter, the metallic stability element being fixed to the helically wound metallic filars of the drive shaft, the metallic stability element having a center of mass aligned with the longitudinal axis; and a distal-most extension portion that extends distally of the metallic stability element to a distal free end; wherein the drive shaft, the abrasive elements, and the metallic stability element rotate together about the longitudinal axis, and wherein each spherical abrasive element of the at least three spherical abrasive elements has an abrasive outer surface, wherein a middle spherical abrasive element of the at least three spherical abrasive elements has a larger outer diameter than a proximal-most spherical abrasive element of the at least three spherical abrasive elements and a larger outer diameter than a distal-most spherical abrasive element of the at least three spherical abrasive elements, and wherein the center of mass for each eccentric spherical abrasive elements in said array is offset from the longitudinal axis while contemporaneously the center of mass of the metallic stability element is aligned with the longitudinal axis. ### Claim 24 (depends on 23) The system of claim 23, wherein the device further comprises a coating covering an outer diameter of the metallic stability element. ### Claim 25 (depends on 23) The system of claim 23, wherein the drive shaft has a central lumen extending along the longitudinal axis that is configured to receive a guidewire that is fully withdrawable into the central lumen, and wherein the coil formed by the helically wound metallic filars has a constant outer coil diameter. ### Claim 26 (depends on 23) The system of claim 23, wherein the coil of the drive shaft comprises a torque-transmitting coil and wherein the metallic stability element comprises a hollow metallic cylinder with the inner diameter fixed to an outer diameter of the torque-transmitting coil. ### Claim 27 (depends on 23) The system of claim 23, wherein the at least three spherical abrasive elements are positioned adjacent to one another along the coil. ### Claim 28 (depends on 23) The system of claim 23, wherein at least a portion of the distal-most extension portion is defined by the helically wound metallic filars of the drive shaft that extends distally of the metallic stability element.