Electrode to nerve distance estimation

• US 10,894,158 B2
• Filed: 04/08/2016
• Issued: 01/19/2021
• Est. Priority Date: 04/09/2015
• Status: Active Grant

• Current Assignee: Saluda Medical Pty Ltd.
• Original Assignee: Saluda Medical Pty Ltd.
• Inventors: Parker, John Louis
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US15/561,960
• Publication Number:
  US 20180110987A1
• Time in Patent Office: 1,747 Days
• Field of Search: 607 42, 607 72
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Estimating a nerve-to-electrode distance involves applying a stimulus from a stimulus electrode to a nerve. Neural measurements of at least one evoked compound action potential are obtained, and processed in order to estimate an originating state of stimulation exhibiting at least one characteristic defined by a single fibre size. A single fibre model is then applied to produce a measure of the nerve-to-electrode distance. Also provided for is estimation of a distribution of recruited fibres. Measurements of a compound action potential are obtained from sense electrodes spaced apart along a neural pathway. A conduction velocity of the compound action potential is determined from the latency between the measurements. From the conduction velocity a dominant recruited fibre diameter is determined. A rate of dispersion of the compound action potential between the sense electrodes is determined. From the rate of dispersion a distribution of diameters of the recruited fibre population is determined.

Claims

1. An implantable device for estimating a nerve-to-electrode distance, the device comprising:

at least one stimulus electrode and at least one sense electrode;

measurement circuitry for obtaining a neural measurement from the at least one sense electrode; and

a processor configured to;

apply from the at least one stimulus electrode to a nerve at least one stimulus having defined stimulus parameters;

obtain from the measurement circuitry a plurality of neural measurements of at least one compound action potential evoked by the at least one stimulus;

process the plurality of neural measurements in order to estimate an originating state of stimulation, the originating state of stimulation exhibiting at least one observable characteristic defined by a single fibre size; and

apply a single fibre model to the estimated originating state of stimulation and the stimulus parameters, in order to produce a measure of the nerve-to-electrode distance.

2. The implantable device for estimating a nerve-to-electrode distance of claim 1, wherein the measure of the nerve-to electrode distance comprises an absolute measure of distance.

3. The implantable device for estimating a nerve-to-electrode distance of claim 1, wherein the measure of the nerve-to electrode distance comprises a relative measure reflecting a change in distance from a previous time.

4. The implantable device for estimating a nerve-to-electrode distance of claim 1, wherein the processor is further configured to adjust a therapeutic stimulus regime in response to an observed change in the nerve-to-electrode distance.

5. The implantable device for estimating a nerve-to-electrode distance of claim 1, wherein the single fibre model comprises a lookup table matching the observed characteristic and the stimulus parameters to a corresponding nerve-to-electrode distance.

6. The implantable device for estimating a nerve-to-electrode distance of claim 1, wherein the implantable device functions intra-operatively, as part of a surgical procedure.

7. The implantable device for estimating a nerve-to-electrode distance of claim 6, wherein the processor is configured to performed to progressively monitor a position of a structure bearing the electrodes relative to the nerve.

8. The implantable device for estimating a nerve-to-electrode distance of claim 6, wherein the processor is configured to image fibres of the nerve.

9. The implantable device for estimating nerve-to-electrode distance of claim 1, wherein the implantable device functions as part of a postoperative fitting procedure of a neurostimulator.

10. The implantable device for estimating nerve-to-electrode distance of claim 1, wherein the originating state of stimulation comprises an estimated ECAP peak width at the stimulus site.

11. The implantable device for estimating nerve-to-electrode distance of claim 10, wherein to apply a single fibre model to the estimated originating state of stimulation and the stimulus parameters, in order to produce a measure of the nerve-to-electrode distance, the processor is configured to apply a single stimulus in order to evoke a single ECAP, and wherein the plurality of neural measurements are obtained from at least two sense electrodes each at a unique distance away from the stimulus electrode.

12. The implantable device for estimating nerve-to-electrode distance of claim 10, wherein the processor is further configured to estimate an originating ECAP peak width by extrapolating a first ECAP measure obtained from a first sense electrode and a second ECAP measure obtained from a second sense electrode back to the stimulus site.

13. The implantable device for estimating nerve-to-electrode distance of claim 12, wherein the originating ECAP peak width is taken as being dominated by a single fibre of largest diameter, and the processor is further configured to determine the nerve-to-electrode distance from the relationship of the single fibre originating peak width to nerve-to-electrode distance.

14. The implantable device for estimating nerve-to-electrode distance of claim 10, wherein the measure of ECAP peak width comprises a half-height peak width, being a measure of a width of an ECAP peak as observed at an amplitude which is half the amplitude of the peak amplitude of the observed ECAP peak.

15. The implantable device for estimating nerve-to-electrode distance of claim 10, wherein the measure of ECAP peak width comprises a time between peaks of the observed response.

16. The implantable device for estimating nerve-to-electrode distance of claim 10, wherein the measure of ECAP peak width comprises a time between a first zero crossing and a second zero crossing of the neural measurement.

17. The implantable device for estimating nerve-to-electrode distance of claim 1, wherein the processor is further configured to obtain neural measurements of both orthodromic and antidromic ECAPs, to improve an estimate of the originating state of stimulation.

18. The implantable device for estimating nerve-to-electrode distance of claim 1, wherein the originating state of stimulation comprises a Rheobase.

19. The implantable device for estimating nerve-to-electrode distance of claim 18, wherein the processor is further configured to determine a stimulus threshold at at least two differing stimulus pulse widths, and wherein the Rheobase is calculated from the stimulus thresholds.

20. The implantable device for estimating nerve-to-electrode distance of claim 18, wherein a conduction velocity is measured and used to determine a fibre diameter recruited at threshold.

21. The implantable device for estimating nerve-to-electrode distance of claim 20, wherein a fitted relationship of the modelled single fibre diameter Rheobase to the electrode-to-nerve separation is used to determine the separation.