# US 12,594,426 B2 · Systems and methods for detecting evoked compound action potential (ECAP) features in response to neurostimulation

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- Number: US 12,594,426 B2
- Document ID: US12594426B2
- Status: Granted
- Kind: B2
- Application number: 18/074,449
- Filed: 2022-12-02
- Published: 2023-06-08
- Granted: 2026-04-07
- Earliest claimed: 2021-12-03
- Assignees: Advanced Neuromodulation Systems, Inc.
- Applicants: Advanced Neuromodulation Systems, Inc.
- Inventors: Mingming Zhang; Erika Ross; Yagna Pathak; Kyuwan Choi; Hyun-Joo Park; Nishant Verma
- Web page: https://patentgrep.com/patent/US12594426B2

## CPC

- A61N 1/36139: {with automatic adjustment}
- A61B 5/1116: {Determining posture transitions}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61B 5/389: Electromyography [EMG]
- A61B 5/4041: {Evaluating nerves condition}
- A61B 5/407: {Evaluating the spinal cord (for locating the epidural space A61B5/4896)}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/7257: {using Fourier transforms}
- A61B 5/726: {using Wavelet transforms}
- A61N 1/025: {Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36071: {Pain}
- A61N 1/36178: {Burst or pulse train parameters}
- A61N 1/36192: {Amplitude modulation}
- A61N 1/37223: {Circuits for electromagnetic coupling}
- A61N 1/0558: {Anchoring or fixation means therefor}
- A61N 1/36062: {Spinal stimulation}
- A61N 1/36171: {Frequency}
- A61N 1/36175: {Pulse width or duty cycle}
- A61N 1/36185: {Selection of the electrode configuration}
- A61N 1/37241: {providing test stimulations}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- 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)

## Abstract

Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient and/or guide an implant procedure.

## Claims

### Claim 1

A method of providing a neurostimulation therapy to a patient using an implantable pulse generator (IPG), comprising:
generating electrical pulses by the IPG;
applying the generated electrical pulses to neural tissue of the patient using one or more electrodes of one or more stimulation leads;
measuring neural response to the applied electrical pulses through one or more electrodes of one or more stimulation leads using sensing circuitry of the IPG; and
processing the measured neural response according to wavelet analysis to isolate evoked compound action potential (ECAP) features in the neural response, wherein the wavelet analysis comprises,
converting the measured neural response from a time domain into a temporal-frequency domain,
extracting temporal and frequency-based features to conduct signal denoising,
reconstructing a time-domain signal representing ECAP features.

### Claim 2 (depends on 1)

The method of claim 1 further comprising:
displaying a graph of ECAP features to a clinician on a display of a clinician programmer device.

### Claim 3 (depends on 1)

The method of claim 1 further comprising:
processing data representative of the ECAP features to detect a change in posture by the patient based on one or more ECAP features.

### Claim 4 (depends on 3)

The method of claim 3 further comprising:
automatically modifying at least one stimulation parameter for patient therapy in response to detecting a change in posture by the patient.

### Claim 5 (depends on 4)

The method of claim 4 further comprising:
stimulation parameter comprising modifying a stimulation amplitude to maintain stimulation by the IPG below a level that generates paresthesia in the patient.

### Claim 6 (depends on 1)

The method of claim 1 further comprising:
detecting a change in relative position of a first electrode of a first stimulation lead to position of a second electrode of a second stimulation lead by processing data representative of the ECAP features.

### Claim 7 (depends on 1)

The method of claim 1 wherein the processing the measured neural response comprises:
isolating discrete phases of ECAP features in the neural response.

### Claim 8 (depends on 1)

The method of claim 1 further comprising:
detecting a shape of ECAP features that differs from an expected shape to detect an undesired patient response to application of the generated electrical pulses.

### Claim 9 (depends on 8)

The method of claim 8 further comprising:
detecting muscle activation in response to the application of the generated electrical pulses according to the shape of the ECAP features.

### Claim 10 (depends on 1)

The method of claim 1 further comprising:
after isolating ECAP features in a frequency and time domain representation, transforming data indicative of the ECAP features into a one-dimensional time domain to form a reconstructed signal of ECAP values.

### Claim 11

A neurostimulation system for providing a neurostimulation therapy to a patient, comprising:
an implantable pulse generator (IPG) for generating electrical pulses, wherein the IPG comprises sensing circuitry for sensing neural activity of the patient in response to electrical pulses;
one or more stimulation leads with multiple electrodes for applying electrical pulses to neural tissue of the patient; and
an external device adapted to wirelessly communicate with the IPG when the IPG is implanted in the patient, wherein the IPG is adapted to communicated data to the external device indicative of neural activity of the patient in response to one or more electrical pulses; and
wherein the external device is adapted to process the measured neural response according to a wavelet analysis to isolate evoked compound action potential (ECAP) features in the neural activity in response to one or more electrical pulses, wherein the wavelet analysis comprises,
converting the measured neural response from a time domain into a temporal-frequency domain,
extracting temporal and frequency-based features to conduct signal denoising, reconstructing a time-domain signal representing ECAP features.

### Claim 12 (depends on 11)

The neurostimulation system of claim 11 wherein the external device is adapted to provide a display of ECAP features to a user of the external device.

### Claim 13 (depends on 11)

The neurostimulation system of claim 11 wherein the external device is adapted to detect a change in posture by the patient based on one or more ECAP features.

### Claim 14 (depends on 13)

The neurostimulation system of claim 13 wherein the external device is adapted to automatically modify at least one stimulation parameter for patient therapy in response to detecting a change in posture by the patient by communicating one or more control signals to the IPG.

### Claim 15 (depends on 14)

The neurostimulation system of claim 14 wherein modification of the at least one stimulation parameter maintains stimulation of the patient by the IPG below a level that generates paresthesia in the patient.

### Claim 16 (depends on 11)

The neurostimulation system of claim 11 wherein the external device is adapted to detect a change in relative position of a first electrode of a first stimulation lead to position of a second electrode of a second stimulation lead by processing data representative of the ECAP features.

### Claim 17 (depends on 11)

The neurostimulation system of claim 11 wherein the external device is adapted to isolate discrete phases of ECAP features.

### Claim 18 (depends on 11)

The neurostimulation system of claim 11 wherein the external device is adapted to detect a shape of the neural response that differs from an expected shape to detect an undesired patient response to application of the generated electrical pulses.

### Claim 19 (depends on 11)

The neurostimulation system of claim 11 wherein the external device is adapted to, after isolating ECAP features in a frequency and time domain representation, transform data indicative of the ECAP features into a one-dimensional time domain to form a reconstructed signal of ECAP values.

### Claim 20 (depends on 11)

The neurostimulation system of claim 11 wherein the IPG is adapted to provided burst stimulation to the patient for neurostimulation therapy and to provide pinging pulses between therapeutic pulses of the burst stimulation to sense of responsive neural activity of the patient.
