# US 12,179,023 B2 · Systems and methods to place one or more leads in tissue for providing functional and/or therapeutic stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,179,023 B2 - Document ID: US12179023B2 - Status: Granted - Kind: B2 - Application number: 17/885,799 - Filed: 2022-08-11 - Published: 2022-12-22 - Granted: 2024-12-31 - Earliest claimed: 2008-12-05 - Assignees: Spr Therapeutics, Inc. - Applicants: SPR Therapeutics, Inc. - Inventors: Joseph W. Boggs - Web page: https://patentgrep.com/patent/US12179023B2 ## CPC - A61N 1/36071: {Pain} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/0558: {Anchoring or fixation means therefor} - A61N 1/36017: {with leads or electrodes penetrating the skin} - A61N 1/36021: {for treatment of pain} - 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 Systems and methods make possible the placement of one or more electrode leads in a tissue region for providing functional and/or therapeutic stimulation to tissue. The systems and methods are adapted to provide the relief of pain. ## Claims ### Claim 1 A method comprising: inserting a coiled lead into a tissue until an electrode on the lead is in electrical proximity to a peripheral nerve innervating a painful region and wherein the electrode is outside of the painful region; activating the peripheral nerve through application of electrical stimulation to the peripheral nerve via an electrical stimulation device; and evoking a tingling sensation over at least a portion of the painful region without damaging the peripheral nerve. ### Claim 2 (depends on 1) The method according to claim 1, wherein the activation of the peripheral nerve occurs without functional nerve stimulation at a motor point. ### Claim 3 (depends on 1) The method according to claim 1 further comprising removing the lead from the tissue by pulling the coiled lead from the tissue. ### Claim 4 (depends on 1) The method according to claim 1, wherein the electrical stimulation comprises a frequency of between 1 and 300 Hz. ### Claim 5 (depends on 4) The method according to claim 4, wherein the frequency is between 4 and 20 Hz. ### Claim 6 (depends on 4) The method according to claim 4, wherein the frequency is between 1 and 12 Hz. ### Claim 7 (depends on 1) The method according to claim 1, wherein a surface electrode is operatively coupled to the electrical stimulation device. ### Claim 8 (depends on 1) The method according to claim 1, wherein the electrical stimulation device is fixed to the coiled lead. ### Claim 9 (depends on 1) The method according to claim 1, wherein the coiled lead is insulated with a plurality of de-insulated portions along a length of the coiled lead. ### Claim 10 (depends on 1) The method according to claim 1, wherein the coiled lead comprises a plurality of anchors along a length of the coiled lead. ### Claim 11 (depends on 1) The method according to claim 1, wherein the electrical stimulation comprises an intensity of between 0.1 and 40 mA. ### Claim 12 (depends on 11) The method according to claim 11, wherein coiled lead comprises an electrode and an anchoring element, wherein the anchoring element is prevented from fully engaging bodily tissue until the electrode has been fully deployed. ### Claim 13 (depends on 1) The method of claim 1 further comprising placing a surface electrode and operatively coupling the surface electrode to the electrical stimulation device. ### Claim 14 (depends on 1) The method of claim 1, wherein the coiled lead comprises one or more coiled metal wires with in an open core and is insulated and coated with a material stabilizing the coiled lead while permitting tension to remove the coiled lead. ### Claim 15 (depends on 14) The method of claim 14, wherein the insulation comprises a biocompatible film. ### Claim 16 (depends on 14) The method of claim 14, wherein the insulation comprises a biocompatible polymer film. ### Claim 17 A method comprising: identifying a skeletal muscle innervated by a peripheral nerve innervating a targeted painful region; placing an electrode within a tissue region in electrical proximity to the peripheral nerve outside of the targeted painful region; applying electrical stimulation to the peripheral nerve according to predefined therapeutic stimulation parameters to activate the peripheral nerve through the electrode; and providing therapeutic nerve stimulation that evokes a tingling sensation to alleviate pain in the targeted painful region without functional nerve stimulation at a motor point and without damaging the peripheral nerve. ### Claim 18 (depends on 17) The method according to claim 17, wherein the electrical stimulation comprises a frequency of between 1 and 300 Hz. ### Claim 19 (depends on 18) The method according to claim 18, wherein the frequency is between 4 and 20 Hz. ### Claim 20 (depends on 18) The method according to claim 18, wherein the frequency is between 1 and 12 Hz. ### Claim 21 (depends on 18) The method according to claim 18, wherein the frequency is 12 Hz. ### Claim 22 (depends on 18) The method according to claim 18, wherein the frequency is 100 Hz. ### Claim 23 (depends on 18) The method according to claim 18, wherein the electrical stimulation comprises a pulse duration of between 1 and 200 μs. ### Claim 24 (depends on 23) The method according to claim 23, wherein the pulse duration is between 5 and 100 μs. ### Claim 25 (depends on 24) The method according to claim 24, wherein the electrical stimulation comprises an intensity of between 0.1 and 40 mA. ### Claim 26 (depends on 25) The method according to claim 25, wherein the intensity comprises 30 mA. ### Claim 27 (depends on 17) The method according to claim 17, wherein the electrical stimulation comprises a frequency of 12 Hz or 100 Hz, a pulse duration of between 5 and 100 μs and an intensity of between 0.1 and 40 mA. ### Claim 28 (depends on 17) The method of claim 17, wherein the electrode is a unipolar contact electrode. ### Claim 29 A method to alleviate pain comprising: placing at least one electrode in electrical proximity to a peripheral nerve innervating a painful region, the at least one electrode positioned outside of the painful region; applying stimulation through the at least one electrode via an electrical stimulation device; and activating the peripheral nerve to alleviate pain in the painful region without functional nerve stimulation at a motor point and without damaging the peripheral nerve. ### Claim 30 (depends on 29) The method of claim 29 further comprising evoking a tingling sensation over at least a portion of the painful region. ### Claim 31 (depends on 29) The method of claim 29, wherein the stimulation is configured to be scaled to account for variations in a geometry of the at least one electrode. ### Claim 32 (depends on 29) The method of claim 29, wherein the electrical stimulation device is configured to account for variations in current density resulting from variations in a geometry of the at least one electrode. ### Claim 33 A method comprising: percutaneously inserting a coiled lead through skin of a patient; positioning an electrode extending from the coiled lead into adipose or connective tissue outside of a painful region and in electrical proximity to a peripheral nerve; electrically stimulating the peripheral nerve innervating the painful region with an electrical stimulation device through the electrode; and evoking a tingling sensation over at least a portion of the painful region without damaging the peripheral nerve. ### Claim 34 (depends on 33) The method according to claim 33, wherein the electrical stimulation comprises a frequency of between 1 and 300 Hz. ### Claim 35 (depends on 33) The method according to claim 33, wherein the electrical stimulation comprises a frequency between 4 and 20 Hz. ### Claim 36 (depends on 33) The method according to claim 33, wherein the electrical stimulation comprises a frequency between 1 and 12 Hz. ### Claim 37 (depends on 33) The method according to claim 33, wherein the electrical stimulation comprises a frequency of 12 Hz. ### Claim 38 (depends on 33) The method according to claim 33, wherein the electrical stimulation comprises a frequency of 100 Hz. ### Claim 39 (depends on 33) The method according to claim 33, wherein the electrical stimulation comprises a pulse duration of between 1 and 200 μs. ### Claim 40 (depends on 39) The method according to claim 39, wherein the pulse duration is between 5 and 100 μs. ### Claim 41 (depends on 40) The method according to claim 40, wherein the electrical stimulation comprises an intensity of between 0.1 and 40 mA. ### Claim 42 (depends on 33) The method according to claim 33, wherein the electrical stimulation comprises an intensity of 30 mA. ### Claim 43 (depends on 33) The method of claim 33, wherein the electrical stimulation is conducted a therapeutic time and the therapeutic time ranges from approximately one to twelve weeks. ### Claim 44 (depends on 33) The method according to claim 33, wherein the electrical stimulation comprises a frequency of 12 Hz or 100 Hz, a pulse duration of between 5 and 100 μs and an intensity of between 0.1 and 40 mA. ### Claim 45 (depends on 33) The method of claim 33, wherein the electrical stimulation device is connected with the lead. ### Claim 46 A method comprising: inserting a lead having an electrode through skin of a patient; positioning the electrode in electrical proximity to but spaced from a peripheral nerve innervating a painful region, the electrode positioned outside of the painful region; applying electrical stimulation through the electrode; and electrically stimulating the peripheral nerve to alleviate pain in the painful region without functional nerve stimulation at a motor point and without damaging the peripheral nerve. ### Claim 47 (depends on 46) The method according to claim 46, wherein the electrical stimulation comprises a frequency of between 1 and 300 Hz. ### Claim 48 (depends on 46) The method according to claim 46, wherein the electrical stimulation comprises a frequency between 4 and 20 Hz. ### Claim 49 (depends on 46) The method according to claim 46, wherein the electrical stimulation comprises a frequency between 1 and 12 Hz. ### Claim 50 (depends on 46) The method according to claim 46, wherein the electrical stimulation comprises a frequency of 12 Hz. ### Claim 51 (depends on 46) The method according to claim 46, wherein the electrical stimulation comprises a frequency of 100 Hz. ### Claim 52 (depends on 46) The method according to claim 46, wherein the electrical stimulation comprises a pulse duration of between 1 and 200 μs. ### Claim 53 (depends on 52) The method according to claim 52, wherein the pulse duration is between 5 and 100 μs. ### Claim 54 (depends on 53) The method according to claim 53, wherein the electrical stimulation comprises an intensity of between 0.1 and 40 mA. ### Claim 55 (depends on 46) The method according to claim 46, wherein the electrical stimulation comprises an intensity of 30 mA. ### Claim 56 (depends on 46) The method of claim 46, wherein electrically stimulating the peripheral nerve is done through an electrical stimulation device that is connected with the lead. ### Claim 57 (depends on 46) The method of claim 46, wherein the electrode comprises a spherical, raised, and depressed characteristics and contours that are undulating. ### Claim 58 (depends on 46) The method of claim 46, wherein the electrode comprises hemispherical, raised, and depressed characteristics and contours that are undulating. ### Claim 59 (depends on 46) The method of claim 46, wherein the electrode comprises elevated and recessed characteristics and contours that are continuous and undulating. ### Claim 60 (depends on 46) The method of claim 46, wherein electrode comprises a contact configuration that is intermittent. ### Claim 61 (depends on 46) The method of claim 46, wherein the lead is configured to withstand mechanical forces and resist migration when inserted into the skin during a home trial.