IP Library Granted Patent US 11,420,064
Granted Patent B2
US 11,420,064 · App. 17/478,793 · Granted Aug 23, 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 11,420,064
App. No.
17/478,793
Granted
Aug 23, 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 (66)

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 set a threshold for therapeutic stimuli to be provided by the stimulus source based on the measured neural responses by:

comparing each of a plurality of the measured neural responses to a corresponding stimulus intensity 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

setting the threshold for the therapeutic stimuli to be provided by the stimulus source based on the determined characteristic of the neural response growth curve,

wherein the stimulus source is configured to provide the therapeutic stimuli according to the threshold.

2. The neuromodulation system of claim 1 , wherein the threshold for the therapeutic stimuli is a maximum intensity of the therapeutic stimuli.

3. The neuromodulation system of claim 2 , wherein the implantable device further comprises a control unit configured to maintain the intensity of the therapeutic stimuli below the maximum intensity of the therapeutic stimuli.

4. The neuromodulation system of claim 1 , wherein the characteristic is a stimulus threshold at which evoked neural responses arise.

5. The neuromodulation system of claim 4 wherein the processor is configured to determine the stimulus threshold at which evoked neural responses arise by:

determining a zero intercept of a line fitted to the neural response growth curve, and

determining the stimulus threshold from the zero intercept.

6. The neuromodulation system of claim 4 wherein the processor is configured to determine the stimulus threshold at which evoked neural responses arise by iteratively varying the intensity of the provided stimuli and monitoring measured neural responses for presence of an evoked neural response.

7. 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 N 1 peak and a P 2 peak of the neural response.

8. The neuromodulation system of claim 1 , wherein the stimulus intensity is an amplitude of stimulus current.

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

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

11. 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 a dorsal column;

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

setting a threshold for therapeutic stimuli to be delivered based on the measured neural responses by:

comparing each of a plurality of the measured neural responses to a corresponding stimulus intensity 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

setting the threshold for the therapeutic stimuli based on the determined characteristic of the neural response growth curve; and

delivering the therapeutic stimuli according to the threshold.

12. The method of claim 11 , wherein the threshold for the therapeutic stimuli is a maximum intensity of the therapeutic stimuli.

13. The method of claim 12 , further comprising maintaining the intensity of the therapeutic stimuli below the maximum intensity of the therapeutic stimuli.

14. The method of claim 11 , wherein the characteristic is a stimulus threshold at which evoked neural responses arise.

15. The method of claim 14 , further comprising:

determining a zero intercept of a line fitted to the neural response growth curve, and

determining the stimulus threshold from the zero intercept.

16. The method of claim 14 , further comprising determining the stimulus threshold by iteratively varying the intensity of the delivered stimuli and monitoring measured neural responses for presence of an evoked neural response.

17. A neuromodulation system comprising:

an implantable device for suppressing pain by 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 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 set a maximum intensity of therapeutic stimuli to be provided by the stimulus source based on the measured neural responses,

wherein the processor is configured to set the maximum intensity of the therapeutic stimuli based on the measured neural responses by:

comparing each of a plurality of the measured neural responses to a corresponding stimulus intensity 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

setting the maximum intensity of the therapeutic stimuli to be provided by the stimulus source based on the determined characteristic of the neural response growth curve,

wherein the stimulus source is configured to provide therapeutic stimuli according to the maximum intensity of the delivered stimuli.

18. The neuromodulation system of claim 17 , wherein the implantable device further comprises a control unit configured to maintain the intensity of the therapeutic stimuli below the maximum intensity of the therapeutic stimuli.

19. The neuromodulation system of claim 17 , wherein the characteristic is a stimulus threshold at which evoked neural responses arise.

20. The neuromodulation system of claim 19 , wherein the processor is configured to determine the stimulus threshold at which evoked neural responses arise by:

determining a zero intercept of a line fitted to the neural response growth curve, and

determining the stimulus threshold from the zero intercept.

21. The neuromodulation system of claim 17 , wherein the neural response intensity is an amplitude of a portion of a neural response which comprises a voltage amplitude between an N 1 peak and a P 2 peak of the neural response.

22. The neuromodulation system of claim 17 , wherein the stimulus intensity is an amplitude of stimulus current.

23. The neuromodulation system of claim 17 , wherein the processor is part of an external computing device in communication with the implantable device.

24. The neuromodulation system of claim 17 , wherein the setting a value forms part of an automated device fitting procedure for the implantable device.

25. 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 a dorsal column of a patient;

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

setting a maximum intensity of therapeutic stimuli to be delivered based on the measured neural responses,

wherein setting the maximum intensity of the therapeutic stimuli based on the measured neural responses comprises:

comparing each of a plurality of the measured neural responses to a corresponding stimulus intensity 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

setting the maximum intensity of the therapeutic stimuli based on the determined characteristic of the neural response growth curve; and

delivering the therapeutic stimuli according to the maximum intensity.

26. The method of claim 25 , further comprising maintaining the intensity of the therapeutic stimuli below the maximum intensity of the therapeutic stimuli.

27. The method of claim 25 , wherein the characteristic is a stimulus threshold at which evoked neural responses arise.

28. The method of claim 27 , wherein determining the stimulus threshold at which evoked neural responses arise comprises:

determining a zero intercept of a line fitted to the neural response growth curve, and

determining the stimulus threshold from the zero intercept.

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 059772/0299 →
CONFIRMATORY ASSIGNMENT Recorded Apr 22, 2022
From: NICTA IPR PTY LTD
To: SALUDA MEDICAL PTY LTD
Reel/Frame 059772/0335 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 22, 2022
From: PARKER, JOHN LOUIS; WAH, JAMES HAMILTON; KARANTONIS, DEAN MICHAEL; OBRADOVIC, MILAN; GORMAN, ROBERT BRUCE
To: SALUDA MEDICAL PTY LTD
Reel/Frame 059787/0001 →
Priority Claims (2)
AU 2011901828 · May 13, 2011 · national
AU 2011901829 · May 13, 2011 · national
Continuity (5)
Continuation 17031749 · Sep 24, 2020
Continuation 15846069 · Dec 18, 2017
Continuation 14844929 · Sep 3, 2015
Continuation 14117586
Related Publication 20220023634A1 · Jan 27, 2022