# US 11,439,828 B2 · Method and apparatus for application of a neural stimulus

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- Number: US 11,439,828 B2
- Document ID: US11439828B2
- Status: Granted
- Kind: B2
- Application number: 17/501,823
- Filed: 2021-10-14
- Published: 2022-02-03
- Granted: 2022-09-13
- Earliest claimed: 2011-05-13
- Assignees: Saluda Medical Pty Ltd
- Applicants: Saluda Medical Pty Ltd
- Inventors: John Louis Parker; James Hamilton Laird-Wah; Dean Michael Karantonis; Milan Obradovic; Robert Bruce Gorman
- Web page: https://patentgrep.com/patent/US11439828B2

## CPC

- A61N 1/36139: {with automatic adjustment}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36071: {Pain}
- A61N 1/36167: {Timing, e.g. stimulation onset}
- 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 method of applying a neural stimulus with an implanted electrode array involves applying a sequence of stimuli configured to yield a therapeutic effect while suppressing psychophysical side effects. The stimuli sequence is configured such that a first stimulus recruits a portion of the fibre population, and a second stimulus is delivered within the refractory period following the first stimulus and the second stimulus being configured to recruit a further portion of the fibre population. Using an electrode array and suitable relative timing of the stimuli, ascending or descending volleys of evoked responses can be selectively synchronised or desynchronised to give directional control over responses evoked.

## Claims

### Claim 1

A neuromodulation system comprising:
an implantable device for suppressing pain by applying a neural stimulus, the implantable device comprising:
a plurality of electrodes including at least one stimulus electrode and at least one sense electrode;
a stimulus source for providing stimuli to be delivered from the at least one stimulus electrode to an electrically excitable tissue in a dorsal column of a patient; and
measurement circuitry for measuring neural responses sensed at the at least one sense electrode and evoked in response to the stimuli; and
a processor configured to:
compare each of a plurality of the measured neural responses to a respective stimulus intensity to determine a characteristic of a neural response growth curve,
wherein the neural response growth curve is a relation of neural response intensity to stimulus intensity,
wherein the determined characteristic of the growth curve is a minimum stimulus intensity at which evoked neural responses arise,
and wherein the stimulus source is configured to provide therapeutic stimuli according to the determined characteristic of the growth curve.

### Claim 2 (depends on 1)

The neuromodulation system of claim 1 wherein the processor is configured to determine the minimum stimulus intensity at which evoked neural responses arise by:
determining a zero intercept of a line fitted to the neural response growth curve, and
determining the minimum stimulus intensity from the zero intercept.

### Claim 3 (depends on 1)

The neuromodulation system of claim 1, wherein the implantable device further comprises a control unit configured to effect feedback control of delivery of the therapeutic stimuli based on the determined characteristic of the growth curve.

### Claim 4 (depends on 3)

The neuromodulation system of claim 3, wherein feedback control of delivery of the therapeutic stimuli comprises:
controlling the stimulus source to provide a therapeutic stimulus according to a stimulus parameter;
measuring an intensity of the neural response evoked in response to the therapeutic stimulus;
altering the stimulus parameter based on the measured neural response intensity and a target neural response intensity; and
iteratively performing the controlling, measuring, and altering.

### Claim 5 (depends on 4)

The neuromodulation system of claim 4, wherein the processor is configured to determine the target neural response intensity based on the minimum stimulus intensity.

### Claim 6 (depends on 5)

The neuromodulation system of claim 5, wherein the processor is configured to determine the target neural response intensity as the neural response intensity at a stimulus intensity whose value is at a predetermined ratio above the minimum stimulus intensity.

### Claim 7 (depends on 1)

The neuromodulation system of claim 1, wherein the implantable device further comprises a control unit configured to effect control of delivery of the therapeutic stimuli based on the minimum stimulus intensity.

### Claim 8 (depends on 7)

The neuromodulation system of claim 7, wherein the control of delivery the therapeutic stimuli comprises controlling the stimulus source to provide the therapeutic stimuli at a therapeutic stimulus intensity.

### Claim 9 (depends on 8)

The neuromodulation system of claim 8, wherein the processor is configured to calculate the therapeutic stimulus intensity by multiplying the minimum stimulus intensity by a scaling factor.

### Claim 10 (depends on 1)

The neuromodulation system of claim 1, wherein the neural response intensity is an amplitude of a portion of a neural response which comprises a voltage amplitude between an N1 peak and a P2 peak of the neural response.

### Claim 11 (depends on 1)

The neuromodulation system of claim 1, wherein the processor is part of an external computing device in communication with the implantable device at least during a device fitting procedure for the implantable device.

### Claim 12 (depends on 1)

The neuromodulation system of claim 1, wherein the determining the characteristic of the growth curve forms part of an automated device fitting procedure for the implantable device.

### Claim 13 (depends on 1)

The neuromodulation system of claim 1, wherein the determined characteristic of the growth curve is a minimum stimulus intensity at which evoked neural responses of at least a minimum response intensity arise.

### Claim 14

A method of suppressing pain by applying a neural stimulus, the method comprising:
delivering therapeutic stimuli from at least one stimulus electrode to an electrically excitable tissue in a dorsal column of a patient;
measuring neural response sensed at at least one sense electrode and evoked in response to the therapeutic stimuli;
comparing each of a plurality of the measured neural responses to a respective stimulus intensity to determine a characteristic of a neural response growth curve, wherein the neural response growth curve is a relation of neural response intensity to stimulus intensity,
wherein the determined characteristic of the growth curve is a minimum stimulus intensity at which evoked neural responses arise; and
delivering the therapeutic stimuli according to the determined characteristic of the growth curve.

### Claim 15 (depends on 14)

The method of claim 14, wherein determining the minimum stimulus intensity at which evoked neural responses arise comprises:
determining a zero intercept of a line fitted to the neural response growth curve, and
determining the minimum stimulus intensity from the zero intercept.

### Claim 16 (depends on 14)

The method of claim 14, further comprising effecting feedback control of delivery of the therapeutic stimuli based on the determined characteristic of the growth curve.

### Claim 17 (depends on 16)

The method of claim 16, wherein effecting feedback control comprises:
delivering the therapeutic stimuli according to a stimulus parameter;
measuring an intensity of the neural response evoked in response to the therapeutic stimuli;
altering the stimulus parameter based on the measured neural response intensity and a target neural response intensity; and
iteratively performing the delivering, measuring, and altering.

### Claim 18 (depends on 17)

The method of claim 17, further comprising determining the target neural response intensity based on the minimum stimulus intensity.

### Claim 19 (depends on 18)

The method of claim 18, wherein determining the target neural response intensity as the neural response intensity at a stimulus intensity whose value is at a predetermined ratio above the minimum stimulus intensity.

### Claim 20 (depends on 14)

The method of claim 14, further comprising effecting control of delivery of the therapeutic stimuli based on the minimum stimulus intensity.

### Claim 21 (depends on 20)

The method of claim 20, wherein effecting control of delivery of the therapeutic stimuli comprises delivering the therapeutic stimuli at a therapeutic stimulus intensity.

### Claim 22 (depends on 21)

The method of claim 21, further comprising calculating the therapeutic stimulus intensity by multiplying the minimum stimulus intensity by a scaling factor.

### Claim 23 (depends on 14)

The method of claim 14, wherein the determined characteristic of the growth curve is a minimum stimulus intensity at which evoked neural responses of at least a minimum response intensity arise.
