# US 12,214,144 B2 · Endovascular 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 12,214,144 B2 - Document ID: US12214144B2 - Status: Granted - Kind: B2 - Application number: 18/370,453 - Filed: 2023-09-20 - Published: 2024-01-04 - Granted: 2025-02-04 - Earliest claimed: 2005-09-12 - Assignees: Boston Scientific Scimed, Inc. - Applicants: Boston Scientific Scimed, Inc. - Inventors: Chad J. Kugler; Robert E. Atkinson - Web page: https://patentgrep.com/patent/US12214144B2 ## CPC - A61M 25/09: Guide wires - A61B 2017/22095: {accessing a blood vessel true lumen from the sub-intimal space} - A61M 25/104: {used for angioplasty} - A61M 2025/09083: {having a coil around a core} - A61M 2025/09133: {having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque} - A61M 2025/09175: {having specific characteristics at the distal tip} - A61M 2025/09191: {made of twisted wires} - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion with a lumen extending therein; inserting the device into the vascular lumen; positioning the distal portion in the vascular wall; and directing the distal portion within the vascular wall. ## Claims ### Claim 1 A method of treating an occlusion of a blood vessel, comprising: advancing an intravascular device within a lumen of the blood vessel to a position adjacent the occlusion, wherein the intravascular device comprises: an elongate shaft defining a central longitudinal axis; a first lumen extending to a distal opening at a distal end of the elongate shaft; a second lumen extending to a distal opening located proximal of the distal end of the elongate shaft; and an inflatable balloon secured to the elongate shaft, the inflatable balloon including an expandable portion; inflating the inflatable balloon to orient the distal opening of the second lumen toward an intimal layer of a wall of the blood vessel; and thereafter, advancing a subintimal device through the second lumen and into a subintimal space of the blood vessel proximal of the distal end of the elongate shaft. ### Claim 2 (depends on 1) The method of claim 1, further comprising: advancing the subintimal device distally within the subintimal space of the blood vessel to a position distal of the intravascular device. ### Claim 3 (depends on 2) The method of claim 2, wherein the subintimal space is disposed outside of the intimal layer of the wall of the blood vessel and inside of a medial layer of the wall of the blood vessel. ### Claim 4 (depends on 1) The method of claim 1, further comprising: advancing the subintimal device helically around the occlusion of the blood vessel. ### Claim 5 (depends on 1) The method of claim 1, wherein the distal opening of the first lumen is centered on the central longitudinal axis. ### Claim 6 (depends on 1) The method of claim 1, wherein advancing the intravascular device within the lumen of the blood vessel further comprises advancing the intravascular device over a guidewire disposed within the first lumen. ### Claim 7 (depends on 1) The method of claim 1, wherein the subintimal device comprises a device body having a corkscrew member extending radially outward from an outer surface of the device body. ### Claim 8 (depends on 7) The method of claim 7, wherein the corkscrew member is configured to rotationally engage tissue to drive the subintimal device through the subintimal space. ### Claim 9 A method of treating an occlusion of a blood vessel, comprising: advancing an intravascular device within a lumen of the blood vessel to a position adjacent the occlusion, wherein the intravascular device comprises: an elongate shaft defining a central longitudinal axis; a first lumen extending to a distal opening at a distal end of the elongate shaft; and a second lumen extending to a distal opening located along a distal end region of the intravascular device proximal of the distal end of the elongate shaft; urging the distal end region of the intravascular device toward an intimal layer of a wall of the blood vessel to position the distal opening of the second lumen against the intimal layer of the wall of the blood vessel; and thereafter, advancing a subintimal device through the second lumen and into a subintimal space of the blood vessel proximal of the distal end of the elongate shaft. ### Claim 10 (depends on 9) The method of claim 9, further comprising: advancing the subintimal device distally within the subintimal space of the blood vessel to a position distal of the intravascular device. ### Claim 11 (depends on 9) The method of claim 9, further comprising: advancing the subintimal device helically around the occlusion of the blood vessel. ### Claim 12 (depends on 9) The method of claim 9, wherein the distal opening of the first lumen is centered on the central longitudinal axis. ### Claim 13 (depends on 12) The method of claim 12, wherein advancing the intravascular device within the lumen of the blood vessel further comprises advancing the intravascular device over a guidewire disposed within the first lumen. ### Claim 14 A method of treating an occlusion of a blood vessel, comprising: advancing an intravascular device within a lumen of the blood vessel to a position adjacent the occlusion, wherein the intravascular device comprises: an elongate shaft defining a central longitudinal axis; an inflatable balloon secured to the elongate shaft, the inflatable balloon including an expandable portion; a first lumen extending coaxially with the central longitudinal axis to a distal opening positioned distal of the expandable portion of the inflatable balloon; a second lumen extending along an exterior of the expandable portion of the inflatable balloon to a distal opening positioned intermediate a proximal end of the expandable portion and a distal end of the expandable portion; and inflating the inflatable balloon to expand the expandable portion and orient the distal opening of the second lumen toward an intimal layer of a wall of the blood vessel; after expanding the expandable portion, advancing a subintimal device through the second lumen and into a subintimal space within the wall of the blood vessel. ### Claim 15 (depends on 14) The method of claim 14, wherein advancing the intravascular device within the lumen of the blood vessel further comprises advancing the intravascular device over a guidewire disposed within the second lumen. ### Claim 16 (depends on 14) The method of claim 14, wherein the second lumen extends axially along an outer surface of the elongate shaft. ### Claim 17 (depends on 14) The method of claim 14, wherein the second lumen extends helically around the expandable portion of the inflatable balloon. ### Claim 18 (depends on 14) The method of claim 14, further comprising: advancing the subintimal device helically around the occlusion of the blood vessel within the subintimal space. ### Claim 19 (depends on 18) The method of claim 18, wherein advancing the subintimal device helically around the occlusion of the blood vessel within the subintimal space includes positioning the subintimal device concentrically around the occlusion of the blood vessel within the subintimal space. ### Claim 20 (depends on 14) The method of claim 14, wherein the subintimal device comprises a device body having a corkscrew member extending radially outward from an outer surface of the device body.