Method and apparatus for controlling a neural stimulus

• US 9,381,356 B2
• Filed: 05/11/2012
• Issued: 07/05/2016
• Est. Priority Date: 05/13/2011
• Status: Active Grant

• Current Assignee: Saluda Medical Pty Ltd.
• Original Assignee: Saluda Medical Pty Ltd.
• Inventors: Laird, James Hamilton, Gorman, Robert Bruce, Parker, John Louis, Karantonis, Dean Michael, Obradovic, Milan
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US14/117,149
• Publication Number:
  US 20140236257A1
• Time in Patent Office: 1,516 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity

Abstract

An implantable device applies and controls a neural stimulus. The device has a plurality of electrodes, and a stimulus source for providing a stimulus to be delivered from the electrodes to a neural pathway in order to evoke an action potential on the neural pathway, such as the spinal cord. A control unit controls application of a neural stimulus as defined by a set of parameter values and measures via measurement circuitry an evoked neural compound action potential response. The control unit determines from the measured evoked response a feedback variable, and compares it to a therapy map. The therapy map defines a therapeutic relationship of control variable to feedback variable. One or more of the stimulus parameter values are altered to effect the required change in the control variable. This process is performed iteratively to improve alignment of the feedback variable with the therapy map over time.

Claims

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 applied as defined by a set of parameter values;

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

comparing the feedback variable to a therapy map, the therapy map defining a therapeutic relationship of control variable to feedback variable, and determining from the therapy map a required change in the control variable in order to improve alignment of the feedback variable with the therapy map;

altering one or more of the stimulus parameter values to effect the required change in the control variable; and

iteratively performing the applying, measuring, comparing and altering, in order to improve alignment of the feedback variable with the therapy map over time;

wherein the feedback variable is a type of measure of evoked response strength, and the control variable is a type of stimulus intensity, and the therapeutic relationship represents a locus defining a desired output measure of evoked response strength for a given input stimulus intensity, with the desired output measure of evoked response strength being defined in a manner which varies for varying stimulus intensity.

2. The method of claim 1 wherein the therapy map defines the therapeutic relationship of control variable to feedback variable in a manner which is adaptive in response to changed recruitment sensitivity and/or measurement sensitivity.

3. The method of claim 1 wherein the locus comprises a discontinuous stepped locus.

4. The method of claim 3 wherein a hysteresis is effected by the therapy map defining partially overlapping steps in the discontinuous stepped locus.

5. The method of claim 1 wherein the locus comprises a continuous curve.

6. The method of claim 5 wherein the locus comprises a continuous monotonic curve.

7. The method of claim 6 wherein the locus comprises a continuous monotonic decreasing curve.

8. The method of claim 1 wherein the therapy map is fitted to a user by determining a plurality of preferred set points, and by fitting the therapy map to the set points.

9. The method of claim 8 wherein the preferred set points are determined in an automated manner from user control inputs for preferred stimulus intensity.

10. The method of claim 8 wherein the preferred set points are determined in an automated manner from automated estimations of a stimulus threshold at a given posture.

11. The method of claim 8 wherein the therapy map is derived from the preferred set points by linear interpolation between the preferred set points.

12. The method of claim 1 further providing differential slew rates whereby a rate of change of the control variable in response to a detected overstimulation condition is more rapid than a rate of change of the control variable in response to a detected understimulation condition.

13. The method of claim 1 wherein the therapy map is derived at least in part from a body percept map.

14. The method of claim 1 wherein the feedback variable is an estimate of an electrode-to-fibre distance d.

15. The method of claim 14 wherein the electrode to fibre distance d is estimated by obtaining neural response amplitude measurements in response to at least two stimuli of differing current level for constant d, the stimuli being within a linear range of a neural recruitment versus current curve, taking a linear extrapolation of neural response amplitude measurements to a point of zero neural response to estimate a stimulus current threshold, and estimating d from the stimulus current threshold.

16. The method of claim 14 wherein the estimate for d is obtained by measuring an amplitude (R_e1p1, R_e5p1) of the neural compound action potential response as measured at two spaced apart sense electrodes e1 and e5 for a first stimulus, and measuring an amplitude(R_e1p2, R_e5p2)of the neural response at the two sense electrodes for a second stimulus having the same parameters as the first stimulus after a change in d, and calculating the change in recruitment scaling factor A_s in response to d as:

(R_e1p2/R_e1p1)−

(R_e5p2/R_e5p1)=A_s

17. The method of claim 1 wherein the feedback variable comprises a measure of dispersion of the neural compound action potential response relative to distance from a stimulus site and wherein increased dispersion is taken to indicate increased electrode-to-fibre distance d.

18. 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 action potential on the neural pathway;

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

a control unit configured to;

control application of a neural stimulus as defined by a set of parameter values;

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

determine from the measured neural compound action potential response a feedback variable;

compare the feedback variable to a therapy map, the therapy map defining a therapeutic relationship of control variable to feedback variable;

alter one or more of the stimulus parameter values to effect a required change in the control variable, and

iteratively perform the applying, measuring, comparing and altering, in order to improve alignment of the feedback variable with the therapy map over time;

wherein the feedback variable is a type of measure of evoked response strength, and the control variable is a type of stimulus intensity, and the therapeutic relationship represents a locus defining a desired output measure of evoked response strength for a given input stimulus intensity, with the desired output measure of evoked response strength being defined in a manner which varies for varying stimulus intensity.