# US 11,298,538 B2 · Neuromodulation calibration based on neurophysiological signals > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,538 B2 - Document ID: US11298538B2 - Status: Granted - Kind: B2 - Application number: 16/454,864 - Filed: 2019-06-27 - Published: 2020-01-02 - Granted: 2022-04-12 - Earliest claimed: 2018-06-29 - Assignees: Boston Scientific Neuromodulation Corporation - Applicants: Boston Scientific Neuromodulation Corporation - Inventors: Ismael Huertas Fernandez; Que T. Doan - Web page: https://patentgrep.com/patent/US11298538B2 ## CPC - A61B 5/6886: {Monitoring or controlling distance between sensor and tissue} - A61N 1/36062: {Spinal stimulation} - A61B 5/395: Details of stimulation, e.g. nerve stimulation to elicit EMG response - A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/36139: {with automatic adjustment} - A61N 1/36146: {specified by the stimulation parameters} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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 system may include at least one sensor configured to bilaterally sense neurophysiological signals from the patient to provide bilateral sensing data, and at least one processor configured to calibrate at least a first electrode contact and a second electrode contact on the least one neuromodulation lead, including: instruct the neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and at least the second electrode contact to cause a second neurophysiological response; receive from the at least one sensor first bilateral sensed data corresponding to the first neurophysiological response and second bilateral sensed data corresponding to the second neurophysiological response; and determine based on the first and second neurophysiological responses at least one of: physiological midline information or electrode-tissue coupling information. ## Claims ### Claim 1 A method performed using a neuromodulation device connected to at least one neuromodulation lead and configured to deliver neuromodulation energy to spinal cord tissue in a patient using the at least one neuromodulation lead, at least one processor, and at least one bilateral sensor having bilaterally-positioned neurophysiological sensors, the at least one bilateral sensor being configured to sense at least one neurophysiological signal on a right side of the patient and sense at least one neurophysiological signal of a left side of the patient to provide bilateral sensing data, wherein the method comprises automatically performing an objective calibration of at least a first electrode contact and a second electrode contact on the least one neuromodulation lead, wherein the automatically performing the objective calibration includes using the at least one processor to: instruct the neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and using at least the second electrode contact of the lead to cause a second neurophysiological response; receive from the at least one bilateral sensor first bilateral sensed data corresponding to the first neurophysiological response and second bilateral sensed data corresponding to the sensed neurophysiological response; determine first neurophysiological response data based on the received first bilateral sensed data and determine second neurophysiological response data based on the received second bilateral sensed data, wherein the first and second neurophysiological response data include onset and amplitude; and determine 3D-related information, for input into a 3D programming algorithm, based on the first and second neurophysiological response data, wherein the 3D-related information include both: physiological midline information indicative of a medial-lateral position of the at least first electrode contact to the physiological midline and the at least second electrode contact to the physiological midline; and electrode-tissue coupling information indicative of a distance between the at least first electrode contact to the spinal cord tissue and a distance between the at least second electrode contact to the spinal cord tissue. ### Claim 2 (depends on 1) The method of claim 1, wherein the at least one bilateral sensor includes at least one bilateral sensor configured to bilaterally sense electromyograms (EMGs). ### Claim 3 (depends on 2) The method of claim 2, wherein the at least one bilateral sensor includes a plurality of EMG patches bilaterally positioned on the patient. ### Claim 4 (depends on 1) The method of claim 1, wherein the at least one bilateral sensor includes at least one bilateral sensor configured to bilaterally sense evoked compound action potentials (ECAPs). ### Claim 5 (depends on 4) The method of claim 4, wherein the at least one bilateral sensor includes an electrode contact on the neurostimulation lead other than an electrode contact being used to concurrently deliver neural modulation energy. ### Claim 6 (depends on 1) The method of claim 1, wherein the at least one bilateral sensor includes at least one bilateral sensor configured to bilaterally sense electroencephalograms (EEGs). ### Claim 7 (depends on 1) The method of claim 1, wherein the at least one bilateral sensor includes at least one bilateral sensor configured to bilaterally sense physiological signals indicative of changes in muscle tissue when the neural modulation energy is being delivered to provide bilateral sensing data. ### Claim 8 (depends on 1) The method of claim 1, wherein the method further comprises using the at least one processor to program the neuromodulator device using the 3D-programming algorithm and the physiological midline information and the electrode-tissue coupling information. ### Claim 9 (depends on 1) The method of claim 1, further comprising using the at least one processor to communicate the physiological midline information to a user interface to display a position of the at least one lead along with a representation of the physiological midline. ### Claim 10 (depends on 1) The method of claim 1, wherein the 3D-programming algorithm is configured use the physiological midline information and the electrode-tissue coupling information to determine fractionalized energy contribution of active electrodes on the at least one lead to create a stimulation field for a three-dimensional environment, wherein the determined fractionalized energy contribution includes a polarity for each of the active electrodes and a percentage of the energy contribution at the polarity for each of the active electrodes. ### Claim 11 (depends on 1) The method of claim 1, wherein performing the objective calibration of the at least the first electrode contact and the second electrode contact on the least one neuromodulation lead includes calibrating a plurality of electrode contacts on the neuromodulation lead, the method further including using the at least one processor to determine physiological midline information and electrode-tissue coupling information for each of the plurality of electrode contacts by instructing the neuromodulation device to step through a routine to deliver neuromodulation energy to cause a plurality of neurophysiological responses such that each of the plurality of electrode contacts is associated with at least one of the neurophysiological responses. ### Claim 12 (depends on 1) The method of claim 1, wherein: performing the objective calibration of the at least the first electrode contact and the second electrode contact on the at least one neuromodulation lead includes calibrating less than all of a plurality of contacts on the at least one neuromodulation lead, including using the at least one processor to determine physiological midline information and electrode-tissue coupling information for a first subset of the plurality of electrode contacts by instructing the neuromodulation device to step through a routine to deliver neuromodulation energy to cause a plurality of neurophysiological responses, each of the first subset of the plurality of electrode contacts being associated with at least one of the plurality of neurophysiological responses, and each of a second subset of the plurality of electrode contacts being not associated with at least one of the neurophysiological responses, and the method further comprises using the at least one processor to estimate at least one of the physiological midline information or the electrode-tissue coupling information for the second subset of the plurality of electrode contacts based on the determined physiological midline information and the electrode-tissue coupling information for the first subset of the plurality of electrode contacts. ### Claim 13 (depends on 1) The method of claim 1, wherein: performing the objective calibration of the at least a first electrode contact and the second electrode contact on the least one neuromodulation lead includes instructing the neuromodulation device to deliver neuromodulation energy using at least a first neuromodulation parameter set and a second neuromodulation parameter set; a neuromodulation parameter has a first value in the first neuromodulation parameter set and a second value in the second neuromodulation parameters set; and using the at least one processor to determine physiological midline information and electrode-tissue coupling information for the at least the first and second neuromodulation parameter sets. ### Claim 14 (depends on 13) The method of claim 13, further comprising using the at least one processor to interpolate at least one of the physiological midline information or the electrode-tissue coupling information for a neuromodulation parameter value based on at least the first value and the second value. ### Claim 15 A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to automatically perform an objective calibration of at least a first electrode contact and a second electrode contact on at least one neuromodulation lead, including: instruct a neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and using at least the second electrode contact of the lead to cause a second neurophysiological response; receive from at least one bilateral sensor first bilateral sensed data corresponding to the first neurophysiological response and second bilateral sensed data corresponding to the sensed neurophysiological response, wherein the at least one bilateral sensor has bilaterally-positioned neurophysiological sensors and is configured to sense at least one neurophysiological signal on a right side of the patient and sense at least one neurophysiological signal on a left side of the patient to provide each of the first and second bilateral sensed data; determine first neurophysiological response data based on the received first bilateral sensed data and determine second neurophysiological response data based on the received second bilateral sensed data, wherein the first and second neurophysiological response data include onset and amplitude; and determine 3D-related information, for input into a 3D programming algorithm, based on the first and second neurophysiological response data, wherein the 3D-related information include both: physiological midline information indicative of a medial-lateral position of the at least first electrode contact to the physiological midline and the at least second electrode contact to the physiological midline; and electrode-tissue coupling information indicative of a distance between the at least first electrode contact to the spinal cord tissue and a distance between the at least second electrode contact to the spinal cord tissue. ### Claim 16 (depends on 15) The non-transitory machine-readable medium of claim 15, wherein the instructions, which when executed by the machine, cause the machine to program the neuromodulator device using the physiological midline information and the electrode-tissue coupling information. ### Claim 17 (depends on 15) The non-transitory machine-readable medium of claim 15, wherein the instructions, which when executed by the machine, cause the machine to communicate the physiological midline information to a user interface to display a position of the at least one lead along with a representation of the physiological midline. ### Claim 18 (depends on 15) The non-transitory machine-readable medium of claim 15, wherein the 3D-programming algorithm is configured use the physiological midline information and the electrode-tissue coupling information to determine fractionalized energy contribution of active electrodes on the at least one lead to create a stimulation field for a three-dimensional environment, wherein the determined fractionalized energy contribution includes a polarity for each of the active electrodes and a percentage of the energy contribution at the polarity for each of the active electrodes. ### Claim 19 A system configured for use with a neuromodulation device connected to at least one neuromodulation lead, wherein the neuromodulation device is configured to deliver neuromodulation energy to spinal cord tissue in a patient using the at least one neuromodulation lead, the system including: at least one bilateral sensor, having bilaterally-positioned neurophysiological sensors, configured to sense at least one neurophysiological signal on a right side of the patient and sense at least one neurophysiological signal of a left side of the patient to provide bilateral sensing data; and at least one processor configured to automatically perform an objective calibration of at least a first electrode contact and a second electrode contact on the least one neuromodulation lead, including: instruct the neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and using at least the second electrode contact of the lead to cause a second neurophysiological response; receive from the at least one bilateral sensor first sensed data corresponding to the first neurophysiological response and second sensed data corresponding to the second neurophysiological response; and determine 3D-related information, including onset and amplitude, based on the first and second neurophysiological responses for input into a 3D-programming algorithm, physiological midline information indicative of a medial-lateral position of the at least first electrode contact to the physiological midline and the at least second electrode contact to the physiological midline. ### Claim 20 (depends on 19) The system of claim 19, wherein the at least one bilateral sensor includes bilaterally-positioned electromyogram (EMG) sensors, bilaterally-positioned evoked compound action potential (ECAP) sensors, or bilaterally-positioned electroencephalogram (EEG) sensors.