# US 12,214,200 B2 · Sensing reference electrode for percutaneous neuromodulation trials > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,214,200 B2 - Document ID: US12214200B2 - Status: Granted - Kind: B2 - Application number: 18/195,690 - Filed: 2023-05-10 - Published: 2023-09-07 - Granted: 2025-02-04 - Earliest claimed: 2019-06-10 - Assignees: Boston Scientific Neuromodulation Corporation - Applicants: Boston Scientific Neuromodulation Corporation - Inventors: Joseph M. Bocek; Michael X. Govea; Rosana Esteller - Web page: https://patentgrep.com/patent/US12214200B2 ## CPC - A61N 1/36132: {using patient feedback} - A61N 1/372: Arrangements in connection with the implantation of stimulators - A61N 1/0502: {Skin piercing electrodes} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/36017: {with leads or electrodes penetrating the skin} - A61N 1/37241: {providing test stimulations} - 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 An example of an apparatus for percutaneously delivering neurostimulation energy to a patient and sensing from the patient using a test device placed externally to the patient is provided. The apparatus may include a stimulation lead, a sensing reference electrode, a sensing wire, and a connection system. The stimulation lead may be configured to be percutaneously introduced into the patient to place the one or more electrodes in the patient. The sensing reference electrode may be configured to be placed in the patient. The sensing wire may be connected to the sensing reference electrode and configured to be percutaneously introduced into the patient to place the sensing reference electrode in the patient. The connection system may be configured to mate the lead connector and the wire connector and to provide electrical connections between the lead connector and the test device and between the wire connector and the test device. ## Claims ### Claim 1 A method for sensing a signal from a patient, the method comprising: delivering neurostimulation energy to the patient from an external test device via a percutaneous stimulation lead having a lead proximal end and a lead distal end, the external test device placed externally to the patient, the lead proximal end including a lead connector connected to the external test device, the lead distal end including one or more electrodes placed in the patient; and sensing the signal from the patient using the external test device via the percutaneous stimulation lead and a percutaneous sensing wire being at least partially separated from the percutaneous stimulation lead and having a wire proximal end and a wire distal end, the wire proximal end including a wire connector connected to the external test device, the wire distal end connected to a sensing reference electrode placed in the patient. ### Claim 2 (depends on 1) The method of claim 1, further comprising connecting each of the lead connector and the wire connector to the external test device using a cable assembly including: a cable connector configured to mate each of the lead connector and the wire connector; and a cable connected to the cable connector and providing electrical connections between the cable connector and the external test device. ### Claim 3 (depends on 1) The method of claim 1, further comprising attaching the sensing reference electrode to the percutaneous stimulation lead. ### Claim 4 (depends on 1) The method of claim 1, further comprising integrating the sensing reference electrode into the percutaneous stimulation lead. ### Claim 5 (depends on 1) The method of claim 1, further comprising partially introducing the percutaneous stimulation lead into the patient to place the one or more electrodes in the patient using a lead introducer including an introducer distal end configured to enter the patient, an introducer proximal end, an elongate introducer body coupled between the introducer distal end and the introducer proximal end, and a lumen extending within the introducer body from an introducer distal opening at or near the introducer distal end and an introducer proximal opening at or near the introducer proximal end, the lumen configured to accommodate a portion of the percutaneous stimulation lead and to allow the lead distal end to enter the introducer primary opening and exit from the introducer distal opening. ### Claim 6 (depends on 5) The method of claim 5, further comprising detachably attaching the sensing reference electrode to the lead introducer. ### Claim 7 (depends on 6) The method of claim 6, further comprising detaching the sensing reference electrode from the lead introducer after the one or more electrodes are placed in the patient. ### Claim 8 (depends on 7) The method of claim 7, wherein detachably attaching the sensing reference electrode to the lead introducer comprises detachably attaching the sensing reference electrode to the lead introducer using a releasable clip, and detaching the sensing reference electrode from the lead introducer comprises releasing the releasable clip using a release handle coupled to the releasable clip. ### Claim 9 (depends on 1) The method of claim 1, wherein delivering neurostimulation energy to the patient comprises delivering spinal cord stimulation to the patient. ### Claim 10 (depends on 1) The method of claim 1, wherein delivering neurostimulation energy to the patient comprises delivering deep brain stimulation to the patient. ### Claim 11 An apparatus for sensing a signal from a patient, the apparatus comprising: a percutaneous stimulation lead having a lead proximal end and a lead distal end, the lead proximal end including a lead connector, the lead distal end including one or more electrodes configured to be placed in the patient; a percutaneous sensing wire being at least partially separated from the percutaneous stimulation lead and having a wire proximal end and a wire distal end, the wire proximal end including a wire connector, the wire distal end connected to a sensing reference electrode configured to be placed in the patient; and an external test device configured to be placed externally to the patient, to be connected to the lead connector and to the wire connector, to deliver neurostimulation energy to the patient via the percutaneous stimulation lead, and to sense the signal from the patient via percutaneous stimulation lead and the percutaneous sensing wire. ### Claim 12 (depends on 11) The apparatus of claim 11, further comprising a cable assembly including a cable connector and a cable, the cable connector configured to mate the lead connector and to mate the wire connector, the cable connected to the cable connector and configured to provide electrical connections between the cable connector and the external test device. ### Claim 13 (depends on 11) The apparatus of claim 11, wherein the sensing reference electrode is configured to be attached to the percutaneous stimulation lead. ### Claim 14 (depends on 13) The apparatus of claim 13, wherein the sensing reference electrode is configured to be detachably attached to the percutaneous stimulation lead. ### Claim 15 (depends on 13) The apparatus of claim 13, wherein the sensing reference electrode is permanently attached the percutaneous stimulation lead, and the wire distal end of the percutaneous sensing wire is configured to be detachably connected to the sensing referenced electrode. ### Claim 16 (depends on 11) The apparatus of claim 11, wherein the sensing reference electrode is integrated into the percutaneous stimulation lead. ### Claim 17 (depends on 16) The apparatus of claim 16, wherein a portion of the percutaneous sensing wire is integrated into the percutaneous stimulation lead. ### Claim 18 (depends on 11) The apparatus of claim 11, further comprising a lead introducer including an introducer distal end configured to enter the patient, an introducer proximal end, an elongate introducer body coupled between the introducer distal end and the introducer proximal end, and a lumen extending within the introducer body from an introducer distal opening at or near the introducer distal end and an introducer proximal opening at or near the introducer proximal end, the lumen configured to accommodate a portion of the percutaneous stimulation lead and to allow the lead distal end to enter the introducer primary opening and exit from the introducer distal opening. ### Claim 19 (depends on 18) The apparatus of claim 18, wherein the lead introducer is removable from the patient after the percutaneous stimulation lead is percutaneously placed, and the sensing reference electrode is configured to be detached from the lead introducer to remain in the patient after the lead introducer is removed from the patient. ### Claim 20 (depends on 19) The apparatus of claim 19, further comprising: a releasable clip configured to attach the sensing reference electrode to the lead introducer and to detach the sensing reference electrode from the lead introducer; and a release handle coupled to the releasable clip and configured to detach the sensing reference electrode from the introducer by releasing the releasable clip.