# US 10,478,217 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 10,478,217 B2 - Document ID: US10478217B2 - Status: Granted - Kind: B2 - Application number: 16/155,010 - Filed: 2018-10-09 - Published: 2019-02-07 - 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/US10478217B2 ## 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: 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 two spherical eccentric 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 and a center of mass aligned with the longitudinal axis; and wherein the drive shaft, the abrasive elements, and the metallic stability element rotate together about the longitudinal axis, wherein the metallic stability element being distally spaced apart from a distal-most abrasive element of the spherical eccentric abrasive elements by a distal separation distance, wherein each abrasive element is spaced apart from an adjacent abrasive element by an element spacing distance, and wherein the center of mass for each eccentric spherical abrasive element 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 the element spacing distance. ### 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 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 3 (depends on 1) The device of claim 1, wherein the drive shaft comprises a fluid-impermeable lumen. ### Claim 4 (depends on 1) The device of claim 1, wherein the coil of the drive shaft comprises a torque-transmitting coil and wherein the metallic stability element comprises a hollow metallic cylinder with an inner diameter that is fixed along the inner diameter to and outer diameter of the torque-transmitting coil. ### Claim 5 (depends on 1) The device of claim 1, wherein the device further comprises a coating covering an outer diameter of the metallic stability element. ### Claim 6 (depends on 1) The device of claim 1, wherein the drive shaft comprises a coating on the outer diameter of the drive shaft. ### Claim 7 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 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 spherical eccentric 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 and a center of mass aligned with the longitudinal axis; and wherein the drive shaft, the abrasive elements, and the metallic stability element rotate together about the longitudinal axis, and wherein each spherical eccentric abrasive element of the at least three spherical eccentric 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 element 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 8 (depends on 7) The device of claim 7, wherein the spherical eccentric abrasive elements comprises at least five spherical eccentric abrasive elements positioned along the drive shaft. ### Claim 9 (depends on 7) The device 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 an constant outer coil diameter. ### Claim 10 (depends on 7) The device of claim 7, wherein the drive shaft comprises a fluid-impermeable lumen. ### Claim 11 (depends on 7) The device 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 an inner diameter that is fixed along the inner diameter to and outer diameter of the torque-transmitting coil. ### Claim 12 (depends on 7) The device of claim 7, wherein the device further comprises a coating covering an outer diameter of the metallic stability element. ### Claim 13 (depends on 7) The device of claim 7, wherein the drive shaft comprises a coating on the outer diameter of the drive shaft. ### Claim 14 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 helically wound metallic filars that form a coil having an outer diameter, the drive shaft defining a longitudinal axis; an array of at least five spherical eccentric 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 and a center of mass aligned with the longitudinal axis; and 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 eccentric abrasive elements and at least one inner spherical eccentric abrasive element, wherein an outer diameter of each of the outer spherical eccentric abrasive elements is smaller than an outer diameter of the at least one inner spherical eccentric abrasive element. ### Claim 15 (depends on 14) The device of claim 14, wherein the metallic stability element defines an inner diameter and the metallic stability element is fixed along the inner diameter to the helically wound metallic filars of the drive shaft. ### Claim 16 (depends on 14) The device of claim 14, wherein the at least five spherical eccentric abrasive elements are positioned adjacent to one another along the coil. ### Claim 17 (depends on 14) The device of claim 14, wherein the spherical eccentric abrasive elements are positioned adjacent to one another along the drive shaft. ### Claim 18 (depends on 14) The device of claim 14, 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 19 (depends on 14) The device of claim 14, wherein the drive shaft comprises a fluid-impermeable lumen. ### Claim 20 (depends on 14) The device of claim 14, wherein the drive shaft comprises a torque-transmitting coil and wherein the metallic 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. ### Claim 21 (depends on 14) The device of claim 14, wherein the device further comprises a coating covering an outer diameter of the metallic stability element. ### Claim 22 (depends on 14) The device of claim 14, wherein the drive shaft comprises a means for surrounding an outer diameter of at least a portion of the drive shaft. ### Claim 23 (depends on 14) The device of claim 14, wherein the drive shaft comprises a coating on the outer diameter of the drive shaft. ### Claim 24 (depends on 14) The device of claim 14, wherein the metallic stability element being distally spaced apart from a distal-most abrasive element of the spherical eccentric abrasive elements by a distal separation distance. ### Claim 25 (depends on 24) The device of claim 24, wherein each abrasive element is spaced apart from an adjacent abrasive element by an element spacing distance, and wherein the center of mass for each eccentric spherical abrasive element 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 26 (depends on 14) The device of claim 14, wherein the device further comprises a means for extending the device distally from the metallic stability element by a distal extension distance. ### Claim 27 (depends on 26) The device of claim 26, wherein the device comprises a distal-most extension portion that extends distally of the metallic stability element for the distal extension distance. ### Claim 28 (depends on 27) The system of claim 27, wherein at least a portion of the distal-most extension portion is defined by the helically wound metallic filars of the drive shaft.