# US 12,403,302 B2 · Methods and apparatus for a lead fixation device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,403,302 B2 - Document ID: US12403302B2 - Status: Granted - Kind: B2 - Application number: 18/057,320 - Filed: 2022-11-21 - Published: 2023-04-20 - Granted: 2025-09-02 - Earliest claimed: 2017-09-26 - Assignees: OsteoMed LLC - Applicants: OsteoMed LLC - Inventors: Kris A. Smith; Matthew G. Marek - Web page: https://patentgrep.com/patent/US12403302B2 ## CPC - A61N 1/0539: {Anchoring of brain electrode systems, e.g. within burr hole} - A61N 1/0534: {Electrodes for deep brain stimulation} - 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 A lead fixation device for attaching a deep brain stimulation lead within in a burr hole in a human skull. The lead fixation device may comprise a mounting plate and an insertion collar extending from a lower surface of the mounting plate and configured to be received in within the burr hole in the human skull. The mounting plate may comprise a mounting flange, a first arm and a second arm. The mounting flange and the first arm may comprise a static mounting hole while the second arm may comprise an adjustable mounting hole. The second arm may be movable to an operating position when the second arm is compressed toward the first arm, the inner walls of the first and second arms are substantially parallel, and the mounting screw is tightened within the adjustable mounting hole when the second arm is in the operating position. ## Claims ### Claim 1 A lead fixation device for attaching a deep brain stimulation (“DBS”) lead within a burr hole in a human skull, the lead fixation device being movable from an open position to an operating position, comprising: a mounting plate comprising: a mounting flange comprising a first static mounting hole configured to receive a mounting screw, a first arm comprising an inner wall and a second static mounting hole configured to receive a mounting screw, and a second arm comprising an inner wall and an adjustable mounting hole configured to receive a mounting screw, wherein the second arm is configured to rotate between the open position and the operating position when the mounting screw is received in the adjustable mounting hole, wherein the second arm is movable to an operating position when the inner walls of the first and second arms are substantially parallel, and wherein the mounting screw for the adjustable mounting hole is tightened when the second arm is moved to the operating position. ### Claim 2 (depends on 1) The lead fixation device of claim 1, wherein the inner walls of the first and second arms form a channel to receive the DBS lead when the lead fixation device is in the operating position. ### Claim 3 (depends on 2) The lead fixation device of claim 2, wherein the second static mounting hole and the adjustable mounting hole are located outwardly of the channel. ### Claim 4 (depends on 1) The lead fixation device of claim 1, wherein the adjustable mounting hole comprises an elongated hole to provide for adjustment when the second arm is compressed toward the first arm when the lead fixation device is moved from the open position to the operating position. ### Claim 5 (depends on 1) The lead fixation device of claim 1, wherein: the second static mounting hole on the first arm is located at approximately a midpoint of the first arm, and the adjustable mounting hole is located at approximately a midpoint of the second arm. ### Claim 6 (depends on 1) The lead fixation device of claim 1, wherein the first and second arms each contain a raised flange at an end opposite the mounting flange, wherein the raised flange is configured to allow a user to move the second arm toward the first arm when the second arm is moved to the operating position. ### Claim 7 (depends on 1) The lead fixation device of claim 1, further comprising an insertion collar extending from a lower surface of the mounting plate and configured to be received within the burr hole in the human skull and comprising an insertion hole configured to receive the DBSlead. ### Claim 8 (depends on 7) The lead fixation device of claim 7, wherein the insertion collar and insertion hole are located inwardly of the first and second static mounting holes and the adjustable mounting hole. ### Claim 9 (depends on 8) The lead fixation device of claim 8, wherein an outer surface of the insertion collar tapers inwardly as it depends from the lower surface of the mounting plate. ### Claim 10 (depends on 7) The lead fixation device of claim 7, wherein the insertion hole comprises a cutout area where a portion of a sidewall of the insertion hole and insertion collar is removed. ### Claim 11 (depends on 1) A method of attaching the lead fixation device of claim 1 to a deep brain stimulation (“DBS”) lead exiting a burr hole implanted in a human skull, comprising: placing the DBS lead within an insertion hole; inserting mounting screws within the first and second static mounting holes and the adjustable mounting hole to fasten the lead fixation device to the human skull; tightening the mounting screws within the first and second static mounting holes; pressing the second arm toward the first arm to form a channel while the mounting screw is inserted in the adjustable mounting hole; placing the DBS lead within the channel; and tightening the mounting screw within the adjustable mounting hole once the lead fixation device is in the operating position. ### Claim 12 (depends on 11) The method of attaching the lead fixation device of claim 11, wherein the inner walls of the first and second arms form the channel to receive the lead when the lead fixation device is in the operating position. ### Claim 13 (depends on 11) The method of attaching the lead fixation device of claim 11, wherein the adjustable mounting hole comprises an elongated hole to provide for adjustment when the second arm is compressed toward the first arm when the lead fixation device is moved from the open position to the operating position. ### Claim 14 (depends on 11) The method of attaching the lead fixation device of claim 11, wherein; the second static mounting hole on the first arm is located at approximately a midpoint of the first arm, and the adjustable mounting hole is located at approximately a midpoint of the second arm. ### Claim 15 (depends on 14) The method of attaching the lead fixation device of claim 14, wherein the second static mounting hole and the adjustable mounting hole are located outwardly of the channel. ### Claim 16 (depends on 11) The method of attaching the lead fixation device of claim 11, wherein the first and second arms each contain a raised flange at an end opposite the mounting flange, wherein the raised flange is configured to allow a user to move the second arm toward the first arm when the second arm is moved to the operating position. ### Claim 17 (depends on 11) The method of attaching the lead fixation device of claim 11, wherein the insertion hole is in an insertion collar. ### Claim 18 (depends on 17) The method of attaching the lead fixation device of claim 17, further comprising placing the insertion collar in the burr hole in the skull. ### Claim 19 (depends on 17) The method of attaching the lead fixation device of claim 17, wherein the insertion collar and insertion hole are located inwardly of the first and second static mounting holes and the adjustable mounting hole. ### Claim 20 (depends on 17) The method of attaching the lead fixation device of claim 17, wherein an outer surface of the insertion collar tapers inwardly as it depends from the lower surface of the mounting plate.