# US 10,478,216 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 10,478,216 B2 - Document ID: US10478216B2 - Status: Granted - Kind: B2 - Application number: 16/151,531 - Filed: 2018-10-04 - 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/US10478216B2 ## 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 method for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the method comprising: navigating a rotational atherectomy device within the blood vessel, the rotational atherectomy device comprising an elongate flexible drive shaft defining a longitudinal axis and including helically wound metallic filars that form a coil having an outer diameter; advancing a distal tip portion of the drive shaft past stenotic lesion material within the blood vessel; after advancing the distal tip portion past the stenotic lesion material, advancing a concentric metallic stability element affixed to the coil of the drive shaft past the stenotic lesion material, the concentric metallic stability element having a center of mass aligned with the longitudinal axis; after advancing the concentric metallic stability element past the stenotic lesion material, advancing a distal-most eccentric abrasive element of an array of at least three eccentric abrasive elements past the stenotic lesion material while causing a rotary actuator coupled to the drive shaft to rotate the drive shaft about the longitudinal axis, the eccentric abrasive elements affixed to the drive shaft such that a center of mass of each eccentric abrasive element is offset from the longitudinal axis, each eccentric abrasive element being spaced apart from an adjacent eccentric abrasive element, wherein said causing the rotary actuator to rotate the drive shaft about the longitudinal axis causes the distal-most eccentric abrasive element to move in an orbital path to abrade the stenotic lesion material. ### Claim 2 (depends on 1) The method of claim 1, further comprising: delivering an elongate guide tube into the blood vessel, the guide tube defining a lumen, at least a portion of the drive shaft being disposed within the lumen during said rotating the drive shaft about the longitudinal axis. ### Claim 3 (depends on 1) The method of claim 1, wherein the distal tip portion of the drive shaft defines a central lumen that slidably receives a guidewire to facilitate the delivering the rotational atherectomy device through the blood vessel. ### Claim 4 (depends on 1) The method of claim 1, further comprising means for supporting a portion of the drive shaft proximal of the eccentric abrasive elements during the rotating the drive shaft. ### Claim 5 (depends on 1) The method of claim 1, wherein the drive shaft comprises a means for enhancing column strength to facilitate pushing the drive shaft through the stenotic lesion material. ### Claim 6 (depends on 1) The method of claim 1, further comprising aspirating particulate abraded from the stenotic lesion material during the rotating the drive shaft. ### Claim 7 (depends on 1) The method of claim 1, further comprising conveying a flush fluid during the rotating the drive shaft. ### Claim 8 (depends on 1) The method of claim 1, wherein the concentric metallic stability element includes cylindrical structure having a coating on an exterior thereof. ### Claim 9 (depends on 8) The method of claim 8, further comprising rotating the drive shaft to facilitate the concentric metallic stability element to bore through and past the stenotic lesion material. ### Claim 10 (depends on 1) The method of claim 1, wherein during the rotating, each eccentric abrasive element in said array of at least three eccentric abrasive elements has a respective orbital path about an axis of rotation, wherein each of the respective orbital paths has a substantially greater diameter than a travel path of the concentric metallic stability element. ### Claim 11 (depends on 10) The method of claim 10, further comprising translating the drive shaft proximally and distally while rotating the drive shaft so that said array of at least three eccentric abrasive elements abrades the stenotic lesion material. ### Claim 12 (depends on 11) The method of claim 11, further comprising, after the advancing the concentric metallic stability element past the stenotic lesion material and prior to the advancing the distal-most eccentric abrasive element past the stenotic lesion material, advancing a second portion of the drive shaft past the stenotic lesion material. ### Claim 13 (depends on 1) The method of claim 1, further comprising, prior to the advancing the distal tip portion of the drive shaft past the stenotic lesion material, navigating a guidewire within the patient's vasculature to a target location within the blood vessel. ### Claim 14 (depends on 13) The method of claim 13, wherein a distal end portion of the guidewire is navigated past the stenotic lesion material. ### Claim 15 (depends on 14) The method of claim 14, wherein the navigating the rotational atherectomy device within the blood vessel comprises advancing the drive shaft over the guidewire. ### Claim 16 (depends on 15) The method of claim 15, wherein at least a portion of the drive shaft remains over the guidewire during said rotating the drive shaft about the longitudinal axis. ### Claim 17 (depends on 1) The method of claim 1, wherein said array of at least three eccentric abrasive elements comprises five spherical eccentric abrasive elements. ### Claim 18 (depends on 17) The method of claim 17, wherein the five spherical eccentric abrasive elements include: (i) a proximal-most spherical eccentric abrasive element, (ii) the distal-most spherical eccentric abrasive element, and (iii) three middle spherical eccentric abrasive elements located between the proximal-most and distal most spherical eccentric abrasive elements. ### Claim 19 (depends on 18) The method of claim 18, wherein the five spherical eccentric abrasive elements all have equal outer diameters. ### Claim 20 A method for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient the method comprising; navigating a rotational atherectomy device within the blood vessel, the rotational atherectomy device comprising an elongate flexible drive shaft defining a longitudinal axis and including helically wound metallic filars that form a coil having an outer diameter; advancing a distal tip portion of the drive shaft past stenotic lesion material within the blood vessel; after advancing the distal tip portion past the stenotic lesion material, advancing a concentric metallic stability element affixed to the coil of the drive shaft past the stenotic lesion material, the concentric metallic stability element having a center of mass aligned with the longitudinal axis; after advancing the concentric metallic stability element past the stenotic lesion material, advancing a distal-most eccentric abrasive element of an array of five eccentric abrasive elements past the stenotic lesion material while rotating the drive shaft about the longitudinal axis, the eccentric abrasive elements affixed to the drive shaft such that a center of mass of each eccentric abrasive element is offset from the longitudinal axis, each eccentric abrasive element being spaced apart from an adjacent eccentric abrasive element, wherein said rotating the drive shaft about the longitudinal axis causes the distal-most eccentric abrasive element to move in an orbital path to abrade the stenotic lesion material, wherein the five spherical eccentric abrasive elements include: (i) a proximal-most spherical eccentric abrasive element (ii) the distal-most spherical eccentric abrasive element and (iii) three middle spherical eccentric abrasive elements located between the proximal-most and distal most spherical eccentric abrasive elements, and wherein the three middle spherical eccentric abrasive element have larger outer diameters than the proximal-most and distal-most spherical eccentric abrasive elements. ### Claim 21 (depends on 20) The method of claim 20, wherein during rotation of the drive shaft, each eccentric abrasive element in said array of five eccentric abrasive elements has a respective orbital path about an axis of rotation, wherein each of the respective orbital paths has a substantially greater diameter than a travel path of the concentric metallic stability element. ### Claim 22 (depends on 20) The method of claim 20, further comprising translating the drive shaft proximally and distally during rotation of the drive shaft. ### Claim 23 (depends on 20) The method of claim 20, further comprising, after the advancing the concentric metallic stability element past the stenotic lesion material and prior to the advancing the distal-most eccentric abrasive element past the stenotic lesion material, advancing a second portion of the drive shaft past the stenotic lesion material. ### Claim 24 (depends on 20) The method of claim 20, further comprising, prior to the advancing the distal tip portion of the drive shaft past the stenotic lesion material, navigating a guidewire within the patient's vasculature to a target location within the blood vessel. ### Claim 25 (depends on 24) The method of claim 24, wherein a distal end portion of the guidewire is navigated past the stenotic lesion material. ### Claim 26 (depends on 24) The method of claim 24, wherein the navigating the rotational atherectomy device within the blood vessel comprises advancing the drive shaft over the guidewire. ### Claim 27 (depends on 26) The method of claim 26, wherein at least a portion of the drive shaft remains over the guidewire during said rotating the drive shaft about the longitudinal axis.