IP Library Granted Patent US 11,491,334
Granted Patent B2
US 11,491,334 · App. 17/031,749 · Granted Nov 8, 2022

Method and apparatus for application of a neural stimulus

Inventors: John Louis Parker (Artarmon, AU); James Hamilton Wah (Artarmon, AU); Dean Michael Karantonis (Artarmon, AU); Milan Obradovic (Artarmon, AU); Robert Bruce Gorman (Artarmon, AU)
Assignee: Saluda Medical Pty Ltd
A61N1/36139A61N1/0551A61N1/36071A61N1/36167
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Quick Facts
Patent No.
US 11,491,334
App. No.
17/031,749
Granted
Nov 8, 2022
Kind
B2
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 (40)

1. A neuromodulation system comprising:

an implantable device for applying a neural stimulus, the 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 the 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 sensed neural responses to a corresponding stimulus to determine a characteristic of a neural response growth curve, wherein the neural response growth curve is a relation of a neural response intensity to a stimulus intensity, the processor further configured to set a value of a parameter of feedback control of the stimulus source on the basis of the determined characteristic of the growth curve,

wherein the stimulus source is configured to provide therapeutic stimuli according to the parameter of feedback control.

2. The neuromodulation system of claim 1 wherein the determined characteristic of the neural response growth curve which is used to set the value of the parameter of feedback control of the stimulus source is a slope of the growth curve.

3. The neuromodulation system of claim 2 wherein the parameter of feedback control of the stimulus source is a feedback loop gain term.

4. The neuromodulation system of claim 3 wherein the feedback loop gain term is set such that the feedback control is stable.

5. The neuromodulation system of claim 1 wherein the feedback control of the stimulus source on the basis of the determined characteristic of the growth curve is in accordance with a non-linear function relating the stimulation response and the measured neural response.

6. The neuromodulation system of claim 5 wherein the determined characteristic is a slope of the growth curve, and wherein the non-linear function effects feedback control of the stimulus source in a manner which accounts for a sensitivity of the growth curve slope to distance.

7. The neuromodulation system of claim 1 wherein the determined characteristic of the neural response growth curve which is used to set the value of the parameter of feedback control of the stimulus source is a downward trend divergence of the neural response growth curve.

8. The neuromodulation system of claim 7 wherein the processor is configured to determine a stimulation threshold by iteratively increasing the stimulus intensity until neural response intensity exhibits a downward trend divergence; and determine the stimulation threshold based on the stimulus intensity at the trend divergence.

9. The neuromodulation system of claim 8 wherein the determined stimulation threshold is a maximum comfort threshold.

10. The neuromodulation system of claim 9 wherein the processor is configured to define a therapeutic target stimulus intensity as a function of the maximum comfort threshold.

11. The neuromodulation system of claim 7 wherein the downward trend divergence is an inflection point marking decelerating growth of the neural response growth curve.

12. The neuromodulation system of claim 7 wherein the downward trend divergence is identified by finding a reducing gradient of the neural response growth curve.

13. The neuromodulation system of claim 1 wherein the processor is further configured to identify a minimum stimulus intensity threshold at which evoked neural responses occur.

14. The neuromodulation system of claim 13 wherein the processor is configured to define a therapeutic target stimulus intensity as a function of the minimum stimulus intensity threshold.

15. The neuromodulation system of claim 13 wherein the processor is configured to identify the minimum stimulus intensity threshold at which evoked neural responses occur by iteratively varying an applied stimulus intensity and monitoring measurement circuitry recordings for presence of an evoked neural response.

16. The neuromodulation system of claim 13 wherein the processor is configured to identify the minimum stimulus intensity threshold at which evoked neural responses occur by:

applying at least two stimuli of differing intensity in a linear region of the neural response growth curve;

determining a zero intercept of a line fitted to neural response recordings obtained in respect of each of the at least two stimuli; and

identifying the minimum stimulus intensity threshold from the zero intercept.

17. The neuromodulation system of claim 1 wherein the growth curve reflects a measured Aβ response intensity.

18. The neuromodulation system of claim 17 wherein the growth curve reflects a measured Aβ response amplitude.

19. The neuromodulation system of claim 1 wherein the growth curve reflects a measured 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.

20. The neuromodulation system of claim 1 wherein the stimulus intensity comprises stimulus current amplitude.

21. The neuromodulation system of claim 1 wherein the processor is further configured to set the value of the parameter of feedback control of the stimulus source on the basis of a linear region of the growth curve.

22. The neuromodulation system of claim 21 , wherein the processor is further configured to automatically set the stimulation intensity to a comfort level of the patient based on the linear region of the growth curve.

23. The neuromodulation system of claim 21 , wherein the processor is further configured to determine growth curves for different postures of the patient and set the value of the parameter of feedback control based on the linear region of the growth curve associated with each posture.

24. The neuromodulation system of claim 1 , wherein the processor is part of an external computing device in communication with the implantable device.

25. The neuromodulation system of claim 1 , wherein the setting a value forms part of an automated device fitting procedure for the implantable device.

26. A method of suppressing pain by applying a neural stimulus, the method comprising:

delivering stimuli from at least one stimulus electrode to an electrically excitable tissue in the dorsal column of a patient;

measuring neural responses sensed at least one sense electrode and evoked in response to the stimuli;

compare each of a plurality of sensed neural responses to a corresponding stimulus to determine a characteristic of a neural response growth curve, wherein the neural response growth curve is a relation of a neural response intensity to a stimulus intensity; and

set a value of a parameter of feedback control of the stimulus delivery on the basis of the determined characteristic of the growth curve, and

delivering therapeutic stimuli according to the parameter of feedback control.

Assignments (4)
SECURITY INTEREST Recorded Mar 14, 2025
From: SALUDA MEDICAL PTY LTD
To: PERCEPTIVE CREDIT HOLDINGS IV, LP
Reel/Frame 070518/0710 →
CONFIRMATORY ASSIGNMENT Recorded Apr 22, 2022
From: NATIONAL ICT AUSTRALIA LTD
To: NICTA IPR PTY LTD
Reel/Frame 059766/0109 →
CONFIRMATORY ASSIGNMENT Recorded Apr 22, 2022
From: NICTA IPR PTY LTD
To: SALUDA MEDICAL PTY LTD
Reel/Frame 059766/0301 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 22, 2022
From: PARKER, JOHN LOUIS; WAH, JAMES HAMILTON; OBRADOVIC, MILAN; GORMAN, ROBERT BRUCE; KARANTONIS, DEAN MICHAEL
To: SALUDA MEDICAL PTY LTD
Reel/Frame 059829/0048 →
Priority Claims (2)
AU 2011901828 · May 13, 2011 · national
AU 2011901829 · May 13, 2011 · national
Continuity (4)
Continuation 15846069 · Dec 18, 2017
Continuation 14844929 · Sep 3, 2015
Continuation 14117586
Related Publication 20210016091A1 · Jan 21, 2021