# US 10,499,946 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 10,499,946 B2 - Document ID: US10499946B2 - Status: Granted - Kind: B2 - Application number: 16/150,711 - Filed: 2018-10-03 - Published: 2019-01-31 - Granted: 2019-12-10 - 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/US10499946B2 ## 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 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, each abrasive element 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; wherein the drive shaft, the spherical eccentric abrasive elements, and the metallic stability element rotate together about the longitudinal axis, wherein the stability element being distally spaced apart from a distal-most abrasive element of the spherical eccentric abrasive elements by a distal separation distance, and wherein the distal separation distance being greater than the element spacing distance. ### Claim 2 (depends on 1) The system of claim 1, wherein the at least three spherical eccentric abrasive elements are positioned adjacent to one another along the coil. ### Claim 3 (depends on 1) The system of claim 1, further comprising a guidewire configured to be slidably disposed within a fluid-impermeable lumen of the drive shaft. ### Claim 4 (depends on 1) 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, and wherein the coil formed by the helically wound metallic filars has a constant outer coil diameter. ### Claim 5 (depends on 1) The system 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 the inner diameter that is fixed to an outer diameter of the torque-transmitting coil. ### Claim 6 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 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, 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; wherein the drive shaft, the spherical eccentric abrasive elements, and the metallic stability element rotate together about the longitudinal axis, the system further comprising a second stability element fixed to the drive shaft. ### Claim 7 (depends on 6) The system of claim 6, 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 8 (depends on 6) The system of claim 6, wherein the second stability element is located proximally of the abrasive elements. ### Claim 9 (depends on 6) The system of claim 6, further comprising a guidewire configured to be slidably disposed within a fluid-impermeable lumen of the drive shaft. ### Claim 10 (depends on 6) The system of claim 6, wherein the spherical eccentric abrasive elements are positioned adjacent to one another along the drive shaft. ### Claim 11 (depends on 6) The system of claim 6, wherein the abrasive elements comprises five spherical eccentric abrasive elements positioned along the drive shaft. ### Claim 12 (depends on 6) The system of claim 6, wherein the drive shaft has a central lumen extending along the longitudinal axis that is configured to receive a guidewire, and wherein the coil formed by the helically wound metallic filars has a constant outer coil diameter. ### Claim 13 (depends on 6) The system of claim 6, 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 that is fixed to an outer diameter of the torque-transmitting coil. ### Claim 14 (depends on 13) The system of claim 13, wherein the hollow metallic cylinder has an axial length that is greater than a maximum exterior diameter of the hollow metallic cylinder. ### Claim 15 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 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, each abrasive element 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; wherein the drive shaft, the spherical eccentric 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 element is smaller than an outer diameter of the at least one inner spherical eccentric abrasive element. ### Claim 16 (depends on 15) The system of claim 15, wherein the drive shaft has a central lumen extending along the longitudinal axis that is configured to receive a guidewire, and wherein the coil formed by the helically wound metallic filars has a constant outer coil diameter. ### Claim 17 (depends on 15) The system of claim 15, further comprising a guidewire configured to be slidably disposed within a fluid-impermeable lumen of the drive shaft. ### Claim 18 (depends on 15) The system of claim 15, wherein the spherical eccentric abrasive elements are positioned adjacent to one another along the drive shaft. ### Claim 19 (depends on 15) The system of claim 15, wherein the metallic stability element comprises a hollow metallic cylinder with an exterior cylindrical surface. ### Claim 20 (depends on 15) The system of claim 15, 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 21 (depends on 20) The system of claim 20, wherein the hollow metallic cylinder has an axial length that is greater than a maximum exterior diameter of the hollow metallic cylinder. ### Claim 22 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 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, 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; wherein the drive shaft, the spherical eccentric 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, and wherein a middle spherical eccentric abrasive element of the at least three spherical eccentric abrasive elements has a larger outer diameter than a proximal spherical eccentric abrasive element of the at least three spherical eccentric abrasive elements and a larger outer diameter than a distal spherical eccentric abrasive element of the at least three spherical abrasive elements. ### Claim 23 (depends on 22) The system of claim 22, wherein the metallic stability element comprises a hollow metallic cylinder with an exterior cylindrical surface. ### Claim 24 (depends on 22) The system of claim 22, wherein the system includes a means for stabilizing a portion of the drive shaft that is proximal of the abrasive elements. ### Claim 25 (depends on 22) The system of claim 22, wherein the drive shaft has a central lumen extending along the longitudinal axis that is configured to receive a guidewire, and wherein the coil formed by the helically wound metallic filars has a constant outer coil diameter. ### Claim 26 (depends on 22) The system of claim 22, 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 that is fixed to an outer diameter of the torque-transmitting coil. ### Claim 27 (depends on 22) The system of claim 22, wherein the spherical eccentric abrasive elements are positioned adjacent to one another along the drive shaft. ### Claim 28 (depends on 22) The system of claim 22, wherein the system includes an inflatable balloon member attached to and surrounding an outer diameter of a distal end portion of the elongate tube, the balloon member is in fluid communication with the lumen, and the balloon member is configured to contact a blood vessel wall when the balloon member is in an inflated configuration. ### Claim 29 (depends on 28) The system of claim 28, 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. ### Claim 30 (depends on 22) The system of claim 22, wherein the drive shaft has an outer diameter covered by a flexible polymer coating. ### Claim 31 (depends on 30) The system of claim 30, wherein the flexible polymer coating comprises a fluid-impermeable material that provides a fluid-impermeable lumen along the drive shaft.