# US 8,644,947 B2 · Neurostimulation system for estimating desired stimulation amplitude for electrode configuration > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,644,947 B2 - Document ID: US8644947B2 - Status: Granted - Kind: B2 - Application number: 13/335,924 - Filed: 2011-12-22 - Published: 2012-06-28 - Granted: 2014-02-04 - Earliest claimed: 2010-12-23 - Assignees: Boston Scientific Neuromodulation Corporation - Applicants: Changfang Zhu; Dongchul Lee - Inventors: Changfang Zhu; Dongchul Lee - Web page: https://patentgrep.com/patent/US8644947B2 ## CPC - A61N 1/36128: {Control systems} - A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves - A61N 1/36071: {Pain} - A61N 1/3616: {Voltage density or current density} - A61N 1/36185: {Selection of the electrode configuration} - A61N 1/36192: {Amplitude modulation} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - A61B 5/407: {Evaluating the spinal cord (for locating the epidural space A61B5/4896)} - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A neurostimulation system comprises a user input device configured for receiving input from a user, and processing circuitry configured for (a) selecting a first electrode configuration in response to receiving the user input, (b) predicting a neural response induced by electrical energy theoretically conveyed by the first electrode configuration at a specified amplitude, (c) deriving a metric value from the predicted neural response, (d) comparing the metric value to a reference threshold value, (e) adjusting the specified amplitude of the electrical energy if the metric value is not in a specified range relative to the reference threshold value, (f) repeating steps (b)-(e) using the adjusted amplitude as the specified amplitude until the metric value is in the specific range relative to the reference threshold value, and (g) instructing a neurostimulation device to deliver the electrical energy at the adjusted amplitude via the first electrode configuration to stimulate the patient. ## Claims ### Claim 1 A neurostimulation system for use in providing therapy to a patient, comprising: a user input device configured for receiving input from a user; and processing circuitry configured for (a) selecting a first electrode configuration in response to receiving the input from the user via the user input device, (b) predicting a neural response in the patient induced by electrical energy theoretically conveyed by the first electrode configuration at a specified amplitude, (c) deriving a metric value from the predicted neural response, (d) comparing the metric value to a reference threshold value, (e) adjusting the specified amplitude of the electrical energy if the metric value is not in a specified range relative to the reference threshold value, (f) repeating steps (b)-(e) using the adjusted amplitude as the specified amplitude until the metric value is in the specific range relative to the reference threshold value, and (g) instructing a neurostimulation device to deliver the electrical energy at the adjusted amplitude via the first electrode configuration to stimulate the patient. ### Claim 2 (depends on 1) The neurostimulation system of claim 1, wherein the first electrode configuration is a fractionalized electrode configuration. ### Claim 3 (depends on 1) The neurostimulation system of claim 1, wherein the specified amplitude of the electrical energy theoretically conveyed by the first electrode configuration is adjusted in uniform increments. ### Claim 4 (depends on 1) The neurostimulation system of claim 1, wherein the specified amplitude of the electrical energy theoretically conveyed by the first electrode configuration is increased if the metric value is below the reference threshold value. ### Claim 5 (depends on 1) The neurostimulation system of claim 1, wherein the specified amplitude of the electrical energy theoretically conveyed by the first electrode configuration is decreased if the metric value exceeds the reference threshold value by more than a specific difference value. ### Claim 6 (depends on 1) The neurostimulation system of claim 1, wherein the metric value is an estimated transmembrane potential of at least one neuronal element, and the reference threshold value is a threshold transmembrane potential. ### Claim 7 (depends on 1) The neurostimulation system of claim 1, wherein the metric value is an estimated volume of activation, and the reference threshold value is a threshold volume of activation. ### Claim 8 (depends on 1) The neurostimulation system of claim 1, wherein the processing circuitry is configured for predicting the neural response in the patient by estimating a spatial distribution of electrical parameter values induced by electrical energy theoretically conveyed by the first electrode configuration at a unit amplitude value, multiplying the electrical parameters by the specified amplitude to obtain a spatial distribution of scaled electrical parameter values, and estimating a transmembrane potential of at least one neuronal element in the patient in response to the scaled electrical parameters. ### Claim 9 (depends on 8) The neurostimulation system of claim 8, wherein the electrical parameter values are in a linear relationship with the specified amplitude of the electrical energy theoretically conveyed by the first electrode configuration. ### Claim 10 (depends on 8) The neurostimulation system of claim 8, wherein each of the electrical parameter values is selected from one of a field potential value, an electrical field value, and a current density value. ### Claim 11 (depends on 8) The neurostimulation system of claim 8, wherein the processing circuitry is configured for predicting the neural response by generating an electric field model of the first electrode configuration, and generating an electrical model of the at least one neuronal element, wherein the electrical parameter values are estimated based on the electric field model of the first electrode configuration, wherein the transmembrane potential is estimated based on the electrical model of the at least one neuronal element. ### Claim 12 (depends on 11) The neurostimulation system of claim 11, wherein the electric field model is one of an analytical model and a numerical model, and the electrical model of the at least one neuronal element is one of a passive neuron model, an active neuron model, and an analog chip based circuit model. ### Claim 13 (depends on 11) The neurostimulation system of claim 11, wherein the induced transmembrane potential is estimated using one of an activating function and a total driving function of the electrical model of the at least one neuronal element. ### Claim 14 (depends on 1) The neurostimulation system of claim 1, wherein the amplitude of the electrical energy theoretically conveyed by the first electrode configuration is an amperage value. ### Claim 15 (depends on 1) The neurostimulation system of claim 1, wherein the amplitude of the electrical energy theoretically conveyed by the first electrode configuration is a voltage value. ### Claim 16 (depends on 1) The neurostimulation system of claim 1, wherein the processing circuitry is configured for instructing the neurostimulation device to deliver reference electrical energy at a known amplitude to a reference electrode configuration, adjusting the reference amplitude of the reference electrical energy until a perception threshold of the patient is met or exceeded, and estimating a transmembrane potential of at least one reference neuron of the patient that would be induced by the reference electrical energy of the reference amplitude by the reference electrode configuration, and deriving the reference threshold value based on the estimated transmembrane potential of the at least one reference neuron. ### Claim 17 (depends on 1) The neurostimulation system of claim 1, wherein the processing circuitry is further configured for (h) selecting a second different electrode configuration in response to receiving the input from the user, and (i) repeating steps (b)-(g) for the second electrode configuration. ### Claim 18 (depends on 17) The neurostimulation system of claim 17, wherein the user input device has a directional programming device for receiving the input from the user. ### Claim 19 (depends on 1) The neurostimulation system of claim 1, wherein the processing circuitry is configured for (h) determining a first scaling factor for the first electrode configuration, (i) instructing the neurostimulation device to deliver the electrical energy at a known amplitude via the first electrode configuration to stimulate the patient; (j) selecting another different electrode configuration in response to receiving the input from the user, (k) repeating steps (b)-(f) for the second electrode configuration, (l) determining a second scaling factor for the second electrode configuration (m) computing a boosting factor based on the first and second scaling factors, (n) applying the boosting factor to the known amplitude to generate an estimated amplitude, and (o) instructing the neurostimulation device to deliver the electrical energy at the estimated amplitude via the second electrode configuration to stimulate the patient. ### Claim 20 (depends on 19) The neurostimulation system of claim 19, wherein the first scaling factor is between the adjusted amplitude for the first electrode configuration and a reference amplitude, and the second scaling factor is between the adjusted amplitude for the second electrode configuration and the reference amplitude. ### Claim 21 (depends on 19) The neurostimulation system of claim 19, wherein the first scaling factor is between the metric value for the first electrode configuration and a reference metric value at a reference amplitude, and the second scaling factor is between the metric value for the second electrode configuration and the reference metric value at the reference amplitude. ### Claim 22 (depends on 19) The neurostimulation system of claim 19, wherein the known amplitude is the adjusted amplitude. ### Claim 23 (depends on 19) The neurostimulation system of claim 19, wherein the known amplitude is different from the adjusted amplitude. ### Claim 24 (depends on 19) The neurostimulation system of claim 19, wherein the boosting factor is computed in accordance with the equation BF=(SFB−SFA)/SFA, wherein BF is the boosting factor, SFA is the first scaling factor, and SFB is the second scaling factor. ### Claim 25 (depends on 19) The neurostimulation system of claim 19, wherein the boosting factor is applied to the known amplitude in accordance with the equation AEST=AKNOWN ×(1+BV), where AEST is the estimated amplitude, and AKNOWN is the known amplitude. ### Claim 26 (depends on 1) The neurostimulation system of claim 1, further comprising output circuitry configured via which the processing circuitry instructs the neurostimulation device to actually deliver the electrical energy at the adjustable amplitude to the first electrode configuration. ### Claim 27 (depends on 1) The neurostimulation system of claim 1, further comprising a housing containing the user interface device and the processing circuitry. ### Claim 28 (depends on 27) The neurostimulation system of claim 27, further comprising an external control device comprising the housing, user interface, device, and the processing circuitry. ### Claim 29 (depends on 1) The neurostimulation system of claim 1, wherein the processing circuitry is configured for automatically performing step (e). ### Claim 30 (depends on 1) The neurostimulation system of claim 1, wherein the processing circuitry is configured for instructing the neurostimulation device to deliver electrical energy via the first electrode configuration to stimulate the patient only until the metric value is in the specific range relative to the reference threshold value.