# US 11,433,232 B2 · Devices and techniques for anchoring an implantable medical device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,433,232 B2 - Document ID: US11433232B2 - Status: Granted - Kind: B2 - Application number: 16/214,882 - Filed: 2018-12-10 - Published: 2019-04-11 - Granted: 2022-09-06 - Earliest claimed: 2013-05-06 - Assignees: Medtronic, Inc. - Applicants: Medtronic, Inc. - Inventors: Amy E. Thompson-Nauman; Melissa G. T. Christie - Web page: https://patentgrep.com/patent/US11433232B2 ## CPC - A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) - A61N 1/057: {Anchoring means; Means for fixing the head inside the heart} - A61N 1/0573: {chacterised by means penetrating the heart tissue, e.g. helix needle or hook} - A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion} - A61N 2001/0578: {having means for removal or extraction} - A61N 2001/058: {Fixing tools} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract Anchoring mechanisms for an implantable electrical medical lead that is positioned within a substernal space are disclosed. The anchoring mechanisms fixedly-position a distal portion of the lead, that is implanted in the substernal space. ## Claims ### Claim 1 A method comprising: navigating a distal portion of an implantable medical lead from an access point of a patient to an implantation site within a substernal space of the patient, wherein navigating the distal portion of the implantable medical lead comprises orienting the distal portion of the implantable medical lead within the substernal space relative to a heart of the patient; and fixedly-securing the distal portion of the implantable medical lead oriented relative to the heart at the implantation site using one or more anchoring mechanisms along a length of the implantable medical lead from the access point to a distal end of the implantable medical lead, wherein fixedly-securing comprises fixedly-securing the implantable medical lead at the access point with at least one anchoring mechanism of the one or more anchoring mechanisms configured to secure the implantable medical lead at the access point. ### Claim 2 (depends on 1) The method of claim 1, further comprising subcutaneously advancing at least some of the implantable medical lead through a subcutaneous space of the patient between a subcutaneously positioned implantable medical device and the access point. ### Claim 3 (depends on 2) The method of claim 2, further comprising conforming the at least one anchoring mechanism to a curvature of a transition from the subcutaneous space into the substernal space through the access point. ### Claim 4 (depends on 1) The method of claim 1, further comprising sliding the at least one anchoring mechanism longitudinally relative to the lead to position the at least one anchoring mechanism at the access point. ### Claim 5 (depends on 1) The method of claim 1, wherein the access point comprises an incision near a xiphoid process of the patient. ### Claim 6 (depends on 1) The method of claim 1, wherein the at least one anchoring mechanism comprises a first anchoring mechanism, and wherein fixedly-securing the distal portion of the implantable medical lead oriented relative to the heart at the implantation site using one or more anchoring mechanisms comprises fixedly-securing the distal portion of the implantable medical lead oriented relative to the heart at the implantation site using a second anchoring mechanism on the distal portion of the implantable medical lead distal of the first anchoring mechanism. ### Claim 7 (depends on 6) The method of claim 6, wherein fixedly-securing the distal portion of the implantable medical lead oriented relative to the heart at the implantation site using the second anchoring mechanism comprises suturing the distal end of the implantable medical lead to a tissue of the patient. ### Claim 8 (depends on 6) The method of claim 6, wherein fixedly-securing the distal portion of the implantable medical lead oriented relative to the heart at the implantation site using the second anchoring mechanism comprises deploying the second anchoring mechanism for coupling with a tissue of the patient. ### Claim 9 (depends on 8) The method of claim 8, wherein the second anchoring mechanism comprises at least one of a prong, barb, clip, screw, flange, disk, flap, or a porous structure. ### Claim 10 (depends on 6) The method of claim 6, wherein fixedly-securing the distal portion of the implantable medical lead oriented relative to the heart at the implantation site using the second anchoring mechanism comprises deploying the second anchoring mechanism from a first retracted configuration to a second expanded configuration in the substernal space such that the deployed second anchoring mechanism is in the second expanded configuration for coupling with a tissue of the patient when positioned in the substernal space. ### Claim 11 (depends on 10) The method of claim 10, wherein the second anchoring mechanism comprises a plurality of tines constrained against a body of the implantable medical lead in the first retracted configuration. ### Claim 12 (depends on 10) The method of claim 10, wherein the second anchoring mechanism comprises a disk. ### Claim 13 (depends on 6) The method of claim 6, wherein the second anchoring mechanism comprises a single distal segment of the distal portion of the implantable medical lead, the single distal segment canted at an angle relative to a remainder of the distal portion of the implantable medical lead. ### Claim 14 (depends on 6) The method of claim 6, further comprising orienting the second anchoring mechanism to trigger a corresponding orientation of an electrode of the implantable medical lead towards a target stimulation therapy site. ### Claim 15 (depends on 1) The method of claim 1, further comprising orienting the at least one anchoring mechanism to trigger a corresponding orientation of an electrode of the implantable medical lead towards a target stimulation therapy site. ### Claim 16 (depends on 1) The method of claim 1, wherein navigating the distal portion of the implantable medical lead comprises: inserting the distal portion of the implantable medical lead into a delivery system having a distal end portion that is positioned within the substernal space, wherein the distal end portion of the delivery system comprises a sheath having a lumen into which the distal portion of the implantable medical lead is disposed; advancing the distal end of the implantable medical lead towards a distal end portion of the delivery system; and retracting the delivery system over the implantable medical lead. ### Claim 17 (depends on 1) The method of claim 1, wherein orienting the distal portion of the implantable medical lead comprises positioning an electrode disposed on the distal portion of the implantable medical lead such that a field of an electrical stimulation applied through the electrode is directed toward a target stimulation site. ### Claim 18 (depends on 1) The method of claim 1, further comprising delivering at least one of cardiac pacing or defibrillation via the implantable medical lead. ### Claim 19 (depends on 1) The method of claim 1, wherein orienting the distal portion of the implantable medical lead comprises positioning the distal portion of the implantable medical lead at a position in an inferior-superior direction, the position superior to the access point. ### Claim 20 A method comprising: navigating a distal portion of an implantable medical lead from an access point of a patient to an implantation site within a substernal space of the patient, wherein navigating the distal portion of the implantable medical lead comprises orienting the distal portion of the implantable medical lead within the substernal space relative to a heart of the patient; and fixedly-securing the distal portion of the implantable medical lead oriented relative to the heart at the implantation site using a first anchoring mechanism and a second anchoring mechanism, the first and second anchoring mechanisms along a length of the implantable medical lead from the access point to a distal end of the implantable medical lead, and the second anchoring mechanism distal of the first anchoring mechanism, wherein fixedly-securing using the first anchoring mechanism comprises: conforming the first anchoring mechanism to a curvature of a transition from a subcutaneous space into the substernal space through the access point; and fixedly-securing the implantable medical lead at the access point with the first anchoring mechanism, and wherein fixedly-securing using the second anchoring mechanism comprises deploying the second anchoring mechanism from a first retracted configuration to a second expanded configuration in the substernal space such that the deployed second anchoring mechanism is in the second expanded configuration for coupling with the subcutaneous tissue when positioned in the substernal space. ### Claim 21 (depends on 20) The method of claim 20, wherein the second anchoring mechanism comprises a plurality of tines constrained against a body of the implantable medical lead in the first retracted configuration. ### Claim 22 (depends on 20) The method of claim 20, further comprising sliding the first anchoring mechanism longitudinally relative to the implantable medical lead to position the first anchoring mechanism at the access point. ### Claim 23 (depends on 20) The method of claim 20, wherein the access point comprises an incision near a xiphoid process of the patient. ### Claim 24 (depends on 20) The method of claim 20, wherein orienting the distal portion of the implantable medical lead comprises positioning an electrode disposed on the distal portion of the implantable medical lead such that a field of an electrical stimulation applied through the electrode is directed toward a target stimulation site. ### Claim 25 (depends on 20) The method of claim 20, wherein orienting the distal portion of the implantable medical lead comprises positioning the distal portion of the implantable medical lead at a position in an inferior-superior direction, the position superior to the access point. ### Claim 26 A method comprising: navigating a distal end of an implantable medical lead from a subcutaneous space of a patient to an implantation site within a substernal space; and fixedly-securing a segment of the implantable medical lead at an access point with an anchoring mechanism, wherein the anchoring mechanism secures the implantable medical lead at an intersection between the subcutaneous space and the substernal space.