# US 12,594,427 B2 · Programming closed-loop neural stimulation therapy

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- Number: US 12,594,427 B2
- Document ID: US12594427B2
- Status: Granted
- Kind: B2
- Application number: 18/178,444
- Filed: 2023-03-03
- Published: 2023-09-07
- Granted: 2026-04-07
- Earliest claimed: 2022-03-03
- Assignees: Saluda Medical Pty Ltd
- Applicants: Saluda Medical Pty Ltd
- Inventors: Daniel John Parker; James Hamilton Wah; Samuel Nicholas Gilbert; Dean Michael Karantonis; Matthew Marlon Williams; John Louis Parker
- Web page: https://patentgrep.com/patent/US12594427B2

## CPC

- A61N 1/36139: {with automatic adjustment}
- 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 1/3615: {Intensity}
- A61N 1/37252: {Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data}
- 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 neuromodulation device comprises stimulus electrodes and sense electrodes. A stimulus source provides stimuli to evoke a neural response on a neural pathway. A signal sensed at the sense electrodes includes an evoked neural response. A control unit controls the stimulus source to provide the neural stimulus according to a stimulus intensity parameter; measures an intensity of the evoked response; and completes a feedback loop using the measured intensity and controller parameters to control the stimulus intensity parameter to maintain the measured intensity at a target value. Optimal values of the controller parameters are determined from a representative value of a characteristic of the feedback loop, the representative value having been derived from data of previously programmed patients, and/or the processor is configured to determine optimal values of the one or more controller parameters from a predetermined value of an amplification parameter of the feedback loop.

## Claims

### Claim 1

A neuromodulation system comprising:
a neuromodulation device for controllably delivering a neural stimulus, the neuromodulation device comprising:
a plurality of implantable electrodes including one or more stimulus electrodes and one or more sense electrodes;
a stimulus source configured to provide a neural stimulus to be delivered via the one or more stimulus electrodes to a neural pathway of a patient in order to evoke a neural response on the neural pathway;
measurement circuitry configured to process a signal sensed at the one or more sense electrodes subsequent to the delivered neural stimulus, the sensed signal including an evoked neural response; and
a control unit configured to:
control the stimulus source to provide the neural stimulus according to a stimulus intensity parameter;
measure an intensity of the evoked neural response in the sensed signal; and
implement a feedback controller which completes a feedback loop, the feedback controller configured to complete the feedback loop by using the measured intensity and one or more controller parameters to adjust the stimulus intensity parameter so as to maintain the measured intensity at a target value; and
a processor configured to:
determine optimal values of the one or more controller parameters from a predetermined representative value of a variable that characterises performance of the feedback loop, the predetermined representative value having been derived from data of previously programmed patients.

### Claim 2 (depends on 1)

The neuromodulation system of claim 1, wherein the processor is further configured to measure a sensitivity of the neural pathway based on the values of the stimulus intensity parameter and the corresponding measured neural response intensities.

### Claim 3 (depends on 2)

The neuromodulation system of claim 2, wherein the one or more controller parameters comprises a controller gain, and the processor is configured to determine the optimal value of the controller gain using the measured sensitivity as well as the predetermined representative value of the variable.

### Claim 4 (depends on 3)

The neuromodulation system of claim 3, wherein the variable is a loop gain, and the processor is configured to determine the optimal value of the controller gain by dividing the predetermined representative value of the loop gain by the measured sensitivity.

### Claim 5 (depends on 3)

The neuromodulation system of claim 3, wherein the processor is configured to determine the optimal value of the controller gain by:
determining an optimal value of loop gain of the feedback loop from the predetermined representative value of the variable, and
dividing the optimal value of the loop gain by the measured sensitivity.

### Claim 6 (depends on 5)

The neuromodulation system of claim 5, wherein the predetermined representative value of the variable is a cutoff frequency of the feedback loop.

### Claim 7 (depends on 5)

The neuromodulation system of claim 5, wherein the predetermined representative value of the variable is a time constant of the feedback loop.

### Claim 8 (depends on 5)

The neuromodulation system of claim 5, wherein the predetermined representative value of the variable is a noise amplification ratio of the feedback loop.

### Claim 9 (depends on 5)

The neuromodulation system of claim 5, wherein the predetermined representative value of the variable is a posture wave amplification ratio of the feedback loop.

### Claim 10 (depends on 5)

The neuromodulation system of claim 5, wherein the predetermined representative value of the variable is a total amplification of the feedback loop, the total amplification comprising a noise amplification ratio of the feedback loop and a posture wave amplification ratio of the feedback loop.

### Claim 11 (depends on 9)

The neuromodulation system of claim 9, further comprising an external sensor configured to measure a frequency of the posture wave.

### Claim 12 (depends on 1)

The neuromodulation system of claim 1, wherein one or more controller parameters comprises a controller gain, and the processor is configured to determine the optimal value of the controller gain by:
determining a value of the variable that characterises performance of the feedback loop;
adjusting the controller gain based on the determined value and the predetermined representative value of the variable; and
repeating the determining and adjusting until the determined value of the variable is within a predetermined distance from the predetermined representative value of the variable.

### Claim 13 (depends on 12)

The neuromodulation system of claim 12, wherein the processor is configured to determine the value of the variable by measuring a loop gain of the feedback loop from a response of the neural response intensity to a step change in the target value.

### Claim 14 (depends on 13)

The neuromodulation system of claim 13, wherein the predetermined representative value of the variable is a loop gain of the feedback loop, and the determined value of the variable is the measured loop gain.

### Claim 15 (depends on 13)

The neuromodulation system of claim 13, wherein the predetermined representative value of the variable is a cutoff frequency of the feedback loop, and the processor is configured to determine the value of the variable from the measured loop gain.

### Claim 16 (depends on 13)

The neuromodulation system of claim 13, wherein the predetermined representative value of the variable is a time constant of the feedback loop, and the processor is configured to determine the value of the variable from the measured loop gain.

### Claim 17 (depends on 13)

The neuromodulation system of claim 13, wherein the predetermined representative value of the variable is a noise amplification ratio of the feedback loop, and the processor is configured to determine the value of the variable from the measured loop gain.

### Claim 18 (depends on 13)

The neuromodulation system of claim 13, wherein the predetermined representative value of the variable is a posture wave amplification ratio of the feedback loop, and the processor is configured to determine the value of the variable from the measured loop gain.

### Claim 19 (depends on 13)

The neuromodulation system of claim 13, wherein the predetermined representative value of the variable is a total amplification of the feedback loop, the total amplification comprising a noise amplification ratio of the feedback loop and a posture wave amplification ratio of the feedback loop, and the processor is configured to determine the value of the variable from the measured loop gain.

### Claim 20 (depends on 18)

The neuromodulation system of claim 18, further comprising an external sensor configured to measure a frequency of the posture wave.

### Claim 21 (depends on 1)

The neuromodulation system of claim 1, further comprising an external computing device in communication with the neuromodulation device.

### Claim 22 (depends on 21)

The neuromodulation system of claim 21, wherein the processor forms part of the external computing device.

### Claim 23 (depends on 1)

The neuromodulation system of claim 1, wherein the processor forms part of the neuromodulation device.

### Claim 24

An automated method of controlling a neuromodulation device to deliver a neural stimulus to neural tissue of a patient, the method comprising:
delivering the neural stimulus to the neural tissue according to a value of a stimulus intensity parameter;
measuring an intensity of a neural response evoked by the stimulus, completing a feedback loop by using the measured intensity and one or more controller parameters to adjust the stimulus intensity parameter so as to maintain the measured intensity at a target value; and
determining optimal values of the one or more controller parameters from a predetermined representative value of a variable that characterises performance of the feedback loop, the predetermined representative value having been derived from data of previously programmed patients.

### Claim 25 (depends on 24)

The method of claim 24, further comprising measuring a sensitivity of the neural tissue based on the values of the stimulus intensity parameter and the corresponding measured neural response intensities.

### Claim 26 (depends on 25)

The method of claim 25, wherein the one or more controller parameters comprises a controller gain, and determining the optimal value of the controller gain uses the measured sensitivity as well as the predetermined representative value of the variable.

### Claim 27 (depends on 24)

The method of claim 24, wherein the one or more controller parameters comprises a controller gain, and determining the optimal value of the controller gain comprises:
measuring a value of the variable;
adjusting the controller gain based on the measured value and the predetermined representative value of the variable; and
repeating the measuring and adjusting until the measured value of the variable is within a predetermined distance from the predetermined representative value of the variable.

### Claim 28 (depends on 27)

The method of claim 27, wherein measuring the value of the variable comprises measuring a loop gain of the feedback loop from a response of the neural response intensity to a step change in the target value.

### Claim 29

A neural stimulation system comprising:
a neuromodulation device for controllably delivering a neural stimulus, the neuromodulation device comprising:
a plurality of implantable electrodes including one or more stimulus electrodes and one or more sense electrodes;
a stimulus source configured to provide a neural stimulus to be delivered via the one or more stimulus electrodes to a neural pathway of a patient in order to evoke a neural response on the neural pathway;
measurement circuitry configured to process a signal sensed at the one or more sense electrodes subsequent to the delivered neural stimulus, the sensed signal including an evoked neural response; and
a control unit configured to:
control the stimulus source to provide the neural stimulus according to a stimulus intensity parameter;
measure an intensity of the evoked neural response in the sensed signal; and
implement a feedback controller which completes a feedback loop, the feedback controller configured to complete the feedback loop by using the measured intensity and one or more controller parameters to adjust the stimulus intensity parameter so as to maintain the measured intensity at a target value; and
a processor configured to:
determine optimal values of the one or more controller parameters from a predetermined value of an amplification parameter of the feedback loop.

### Claim 30 (depends on 29)

The neural stimulation system of claim 29, wherein the processor is further configured to measure a sensitivity of the neural pathway based on the values of the stimulus intensity parameter and the corresponding measured neural response intensities.

### Claim 31 (depends on 30)

The neural stimulation system of claim 30, wherein the one or more controller parameters comprises a controller gain, and the processor is configured to determine the optimal value of the controller gain using the measured sensitivity as well as the predetermined value of the amplification parameter of the feedback loop.

### Claim 32 (depends on 31)

The neural stimulation system of claim 31, wherein the processor is configured to determine the optimal value of the controller gain by:
determining an optimal value of loop gain of the feedback loop from the predetermined value, and
dividing the optimal value of the loop gain by the measured sensitivity.

### Claim 33 (depends on 32)

The neural stimulation system of claim 32, wherein predetermined value is a noise amplification ratio of the feedback loop.

### Claim 34 (depends on 32)

The neural stimulation system of claim 32, wherein the predetermined value is a posture wave amplification ratio of the feedback loop.

### Claim 35 (depends on 32)

The neural stimulation system of claim 32, wherein the predetermined value is a total amplification of the feedback loop, the total amplification comprising a noise amplification ratio of the feedback loop and a posture wave amplification ratio of the feedback loop.

### Claim 36 (depends on 34)

The neural stimulation system of claim 34, further comprising an external sensor configured to measure a frequency of the posture wave.

### Claim 37 (depends on 29)

The neural stimulation system of claim 29, wherein the one or more controller parameters comprises a controller gain, and the processor is configured to determine the optimal value of the controller gain by:
determining a value of the amplification parameter;
adjusting the controller gain based on the determined value and the predetermined value of the amplification parameter; and
repeating the determining and adjusting until the determined value of the amplification parameter is within a predetermined distance from the predetermined value of the amplification parameter.

### Claim 38 (depends on 37)

The neural stimulation system of claim 37, wherein the processor is configured to determine the value of the amplification parameter by measuring a loop gain of the feedback loop from a response of the neural response intensity to a step change in the target value.

### Claim 39 (depends on 38)

The neural stimulation system of claim 38, wherein the predetermined value of the amplification parameter is a noise amplification ratio of the feedback loop, and the processor is configured to determine the value of the amplification parameter from the measured loop gain.

### Claim 40 (depends on 38)

The neural stimulation system of claim 38, wherein the predetermined value of the amplification parameter is a posture wave amplification ratio of the feedback loop, and the processor is configured to determine the value of the amplification parameter from the measured loop gain.

### Claim 41 (depends on 38)

The neural stimulation system of claim 38, wherein the predetermined value of the amplification parameter is a total amplification of the feedback loop, the total amplification comprising a noise amplification ratio of the feedback loop and a posture wave amplification ratio of the feedback loop, and the processor is configured to determine the value of the amplification parameter from the measured loop gain.

### Claim 42 (depends on 40)

The neural stimulation system of claim 40, further comprising an external sensor configured to measure a frequency of the posture wave.

### Claim 43 (depends on 29)

The neural stimulation system of claim 29, further comprising an external computing device in communication with the neuromodulation device.

### Claim 44 (depends on 43)

The neural stimulation system of claim 43, wherein the processor forms part of the external computing device.

### Claim 45 (depends on 29)

The neural stimulation system of claim 29, wherein the processor forms part of the neuromodulation device.

### Claim 46

An automated method of controlling a neuromodulation device to deliver a neural stimulus to neural tissue of a patient, the method comprising:
delivering the neural stimulus to the neural tissue according to a stimulus intensity parameter;
measuring an intensity of a neural response evoked by the stimulus,
completing a feedback loop by using the measured intensity and one or more controller parameters to adjust the stimulus intensity parameter so as to maintain the measured intensity at a target value; and
determining optimal values of the one or more controller parameters from a predetermined value of an amplification parameter of the feedback loop.

### Claim 47 (depends on 46)

The method of claim 46, further comprising measuring a sensitivity of the neural tissue based on the values of the stimulus intensity parameter and the corresponding measured neural response intensities.

### Claim 48 (depends on 47)

The method of claim 47, wherein the one or more controller parameters comprises a controller gain, and the determining the optimal value of the controller gain comprises using the measured sensitivity as well as the predetermined value of the amplification parameter of the feedback loop.

### Claim 49 (depends on 48)

The method of claim 48, wherein the determining the optimal value of the controller gain comprises:
determining an optimal value of loop gain of the feedback loop from the predetermined value, and
dividing the optimal value of the loop gain by the measured sensitivity.

### Claim 50 (depends on 49)

The method of claim 49, wherein predetermined value is a noise amplification ratio of the feedback loop.

### Claim 51 (depends on 49)

The method of claim 49, wherein the predetermined value is a posture wave amplification ratio of the feedback loop.

### Claim 52 (depends on 49)

The method of claim 49, wherein the predetermined value is a total amplification of the feedback loop, the total amplification comprising a noise amplification ratio of the feedback loop and a posture wave amplification ratio of the feedback loop.

### Claim 53 (depends on 51)

The method of claim 51, further comprising an external sensor configured to measure a frequency of the posture wave.

### Claim 54 (depends on 46)

The method of claim 46, wherein the one or more controller parameters comprises a controller gain, and the determining the optimal value of the controller gain comprises:
determining a value of the amplification parameter;
adjusting the controller gain based on the determined value and the predetermined value of the amplification parameter; and
repeating the measuring and adjusting until the determined value of the amplification parameter is within a predetermined distance from the predetermined value of the amplification parameter.

### Claim 55 (depends on 54)

The method of claim 54, wherein the determining the value of the amplification parameter comprises measuring a loop gain of the feedback loop from a response of the neural response intensity to a step change in the target value.

### Claim 56 (depends on 55)

The method of claim 55, wherein the predetermined value of the amplification parameter is a noise amplification ratio of the feedback loop, and the determining the value of the amplification parameter uses the measured loop gain.

### Claim 57 (depends on 55)

The method of claim 55, wherein the predetermined value of the amplification parameter is a posture wave amplification ratio of the feedback loop, and the determining the value of the amplification parameter uses the measured loop gain.

### Claim 58 (depends on 55)

The method of claim 55, wherein the predetermined value of the amplification parameter is a total amplification of the feedback loop, the total amplification comprising a noise amplification ratio of the feedback loop and a posture wave amplification ratio of the feedback loop, and the determining the measured value of the amplification parameter uses the measured loop gain.

### Claim 59 (depends on 57)

The method of claim 57, further comprising an external sensor configured to measure a frequency of the posture wave.