IP Library Granted Patent US 11,191,966
Granted Patent B2
US 11,191,966 · App. 16/091,428 · Granted Dec 7, 2021

Feedback control of neuromodulation

Inventor: James Hamilton Wah (Artarmon, AU)
Assignee: Saluda Medical Pty Ltd
A61N1/36132A61B5/0031A61B5/24A61B5/4836A61N1/0551A61N1/18A61N1/36067A61N1/36071A61N1/36075A61N1/36139A61N1/3787A61N1/37264
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Quick Facts
Patent No.
US 11,191,966
App. No.
16/091,428
Granted
Dec 7, 2021
Kind
B2
Abstract

An automated method of controlling neural stimulation. A neural stimulus is applied to a neural pathway in order to give rise to an evoked action potential on the neural pathway, and the stimulus is defined by at least one stimulus parameter. A neural compound action potential response evoked by the stimulus is measured. From the measured evoked response a feedback variable such as observed ECAP voltage (V) is derived. A feedback loop is completed by using the feedback variable to control the at least one stimulus parameter value for a future stimulus. The method adaptively compensates for changes in a gain of the feedback loop caused by electrode movement relative to the neural pathway. A compensating transfer function is applied to the feedback variable, the compensating transfer function being configured to compensate for both (i) a distance-dependent transfer function of stimulation, and (ii) a distance dependent transfer function of measurement which is distinct from (i).

Claims (38)

1. An automated method of controlling a neural stimulus, the method comprising:

applying the neural stimulus to a neural pathway in order to give rise to an evoked action potential on the neural pathway, the stimulus being defined by at least one stimulus parameter;

measuring a neural compound action potential response evoked by the stimulus, and deriving from the measured evoked response (ECAP) a feedback variable;

completing a feedback loop by using the feedback variable to control the at least one stimulus parameter value; and

adaptively compensating for changes in a gain of the feedback loop caused by electrode movement relative to the neural pathway, by applying a compensating transfer function to the feedback variable, the compensating transfer function including the at least one stimulus parameter as a variable and being configured to compensate for both (i) a distance-dependent transfer function of stimulation, and (ii) a distance dependent transfer function of measurement which is distinct from the distance-dependent transfer function of stimulation;

wherein applying the compensating transfer function comprises multiplying the feedback variable with an exponentiated version (I k ) of the stimulus parameter (I) used to generate that ECAP.

2. The method of claim 1 wherein constant recruitment is effected by use of single measurement pairs of stimulus parameter (I) and observed ECAP amplitude (V).

3. The method of claim 1 wherein the parameter k reflects both a recruitment parameter n and a measurement parameter m, m≠n.

4. The method of claim 3 wherein the total number of fibres recruited N varies as N∝Ix −n −T 0 , where x is the electrode to cord distance, the measured ECAP amplitude V is approximated as ∝Nx −m , and k=m/n.

5. The method of claim 4 wherein k is selected to take a value which is based upon the stimulation and recording configurations in use.

6. The method of claim 5 wherein tripolar stimulation is delivered using first to third electrodes of a SCS lead, and recordings are taken using a sixth electrode of the same lead, and wherein k is selected to be in the range 0.1 to 0.7.

7. The method of claim 6 wherein k is selected to be in the range 0.22 to 0.53.

8. The method of claim 7 wherein k is selected to be about 0.37.

9. The method of claim 3 wherein k is determined clinically using a recruitment datum.

10. The method of claim 9 wherein the recruitment datum comprises one or more of: the patient's perceptual threshold, discomfort threshold, coverage of a certain area or body part, a qualitative characteristic of the patient's perception of a stimulation, patient's perception of optimal comfort, an electrophysiological measure, the onset of muscle response/twitching, and a measure of neural activity.

11. The method of claim 9 further comprising the patient assuming a series of postures; in each posture adjusting the stimulus parameter until the required recruitment datum is achieved; and estimating k from constant recruitment data in differing postures.

12. The method of claim 3 wherein k is partly or wholly determined clinically by using the recording electrode to measure neural responses to peripheral stimulation in a number of postures to obtain Vi data in each posture; using the stimulus electrode to deliver stimulation in each posture adjusted to a current level Ii which yields the respective Vi, and using the set of (I i , V i ) pairs of constant recruitment to derive k.

13. The method of claim 3 wherein k is partly or wholly determined clinically by placing the patient in a range of postures i, in each posture sweeping the stimulus parameter and recording a growth curve, linearly fitting the growth curve for each respective posture to determine the respective threshold T i and growth slope M i , and comparing log T i against log T i M i ; to derive k.

14. The method of claim 1 wherein an error signal is generated from the compensated feedback variable relative to a setpoint and fed into a controller which determines the next stimulus parameter value.

15. The implantable device of claim 1 , wherein the feedback variable is an amplitude of the measured evoked response.

16. An implantable device for controllably applying a neural stimulus, the device comprising:

a plurality of electrodes including one or more nominal stimulus electrodes and one or more nominal sense electrodes;

a stimulus source for providing a stimulus to be delivered from the one or more stimulus electrodes to a neural pathway in order to give rise to an evoked compound action potential (ECAP) on the neural pathway;

measurement circuitry for recording a neural compound action potential signal sensed at the one or more sense electrodes; and

a control unit configured to:

control application of a neural stimulus as defined by at least one stimulus parameter;

measure via the measurement circuitry a neural compound action potential response evoked by the stimulus;

determine from the measured evoked response a feedback variable;

complete a feedback loop by using the feedback variable to control the at least one stimulus parameter value; and

adaptively compensate for changes in a gain of the feedback loop caused by electrode movement relative to the neural pathway, by applying a compensating transfer function to the feedback variable, the compensating transfer function include the stimulus parameter as a variable and being configured to compensate for both (i) a distance-dependent transfer function of stimulation and (ii) a distance dependent transfer function of measurement which is distinct from the distance-dependent transfer function of stimulation;

wherein applying the compensating transfer function comprises multiplying the feedback variable with an exponentiated version (I k ) of the stimulus parameter (I) used to generate the ECAP.

17. The implantable device of claim 16 , wherein the control unit is further configured to generate an error signal relative to a setpoint and feed the error signal into a controller which determines a future stimulus intensity.

18. A non-transitory computer readable medium for controllably applying a neural stimulus, comprising the following instructions for execution by one or more processors:

computer program code means for applying the neural stimulus to a neural pathway in order to give rise to an evoked compound action potential (ECAP) on the neural pathway, the stimulus being applied as defined by at least one stimulus parameter;

computer program code means for measuring a neural compound action potential response evoked by the stimulus and deriving from the measured evoked response a feedback variable;

computer program code means for completing a feedback loop by using the feedback variable to control the at least one stimulus parameter value; and

computer program code means for adaptively compensating for changes in a gain of the feedback loop caused by electrode movement relative to the neural pathway, by applying a compensating transfer function to the feedback variable, the compensating transfer function including the stimulus parameter as a variable and being configured to compensate for both (i) a distance-dependent transfer function of stimulation and (ii) a distance dependent transfer function of measurement which is distinct from the distance-dependent transfer function of stimulation;

wherein applying the compensating transfer function comprises multiplying the feedback variable with an exponentiated version (Ik) of the stimulus parameter (I) used to generate that ECAP.

Assignments (2)
SECURITY INTEREST Recorded Mar 14, 2025
From: SALUDA MEDICAL PTY LTD
To: PERCEPTIVE CREDIT HOLDINGS IV, LP
Reel/Frame 070518/0710 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 4, 2018
From: LAIRD-WAH, JAMES HAMILTON
To: SALUDA MEDICAL PTY LTD
Reel/Frame 047072/0956 →
Priority Claims (1)
AU 2016901264 · Apr 5, 2016 · national
Continuity (1)
Related Publication 20190168000A1 · Jun 6, 2019
Cited By (4)
US 12,285,263 US 12,329,527 US 12,376,780 US 12,569,680