Neural stimulation system providing auto adjustment of stimulus output as a function of sensed impedance

• US 7,742,823 B2
• Filed: 05/10/2007
• Issued: 06/22/2010
• Est. Priority Date: 02/12/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: King, John D. H., Thacker, James R.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): LEE, YUN H
• Application Number:
  US11/746,748
• Publication Number:
  US 20070208394A1
• Time in Patent Office: 1,139 Days
• Field of Search: 607/43, 607/46, 607/62, 600/547, 600/594
• US Class Current: 607/62
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity

Abstract

A neural stimulation system automatically corrects or adjusts the stimulus magnitude (stimulation energy) in order to maintain a comfortable and effective stimulation therapy. Because the changes in impedance associated with the electrode-tissue interface can indicate obstruction of current flow and positional lead displacement, lead impedance can indicate the quantity of electrical stimulation energy that should be delivered to the target neural tissue to provide corrective adjustment. Hence, a change in impedance or morphology of an impedance curve may be used in a feedback loop to indicate that the stimulation energy needs to be adjusted and the system can effectively auto correct the magnitude of stimulation energy to maintain a desired therapeutic effect.

Claims

1. A method of neural stimulation using a neurostimulator, the method comprising:

correlating impedance changes with predicted stimulation energy adjustments;

initially storing the correlated measured impedance changes and predicted stimulation energy adjustments in a look-up table;

measuring a change in impedance indicative of variations in the coupling efficiency between stimulation energy output from the neurostimulator and neural tissue;

subsequently analyzing the stored correlated measured impedance changes and predicted stimulation energy adjustments to determine the predicted stimulation energy adjustment correlated to the measured impedance change; and

automatically adjusting the stimulation energy output from the neurostimulator accordance with the determined stimulation energy adjustment to compensate for the variations in the coupling efficiency by maintaining the stimulation energy delivered to the neural tissue at a set level.

2. The method of claim 1, wherein the stimulation energy output from the neurostimulator is automatically adjusted by varying pulse amplitude, pulsewidth, frequency of pulses or some combination of these three stimulus parameters.

3. The method of claim 1, further comprising cross-referencing the measured impedance change with the correlated impedance changes to determine the adjustment of the stimulation energy output from the neurostimulator.

4. The method of claim 1, wherein the impedance changes are correlated with the predicted stimulation energy adjustments by having a patient implanted with the neurostimulator make positional movements to induce changes in measured impedance and recording impedance measurements as a function of the positional movements.

5. The method of claim 4, wherein the positional movements comprise sitting to lying, standing to lying, sitting to standing, twisting the torso to one or the other side, standing to sitting, and running.

6. The method of claim 4, wherein the impedance changes are correlated with the predicted stimulation energy adjustments further by recording associated changes in sensation reported by the patient.

7. The method of claim 4, wherein the impedance changes are correlated with the predicted stimulation energy adjustments further by varying the stimulation energy output from the neurostimulator at each particular patient position and determining the perception threshold at the particular patient position and the maximum comfort level at the particular patient position.

8. The method of claim 1, wherein the correlated impedance changes are characteristic impedance waveform morphologies, the impedance change measurement comprises measuring a characteristic impedance waveform morphology, and the stimulation energy output from the neurostimulator is automatically adjusted based on the predicted stimulation energy adjustments and the measured characteristic impedance waveform morphology.

9. A method of neural stimulation using a neurostimulator, the method comprising:

correlating impedance changes with predicted stimulation energy adjustments;

measuring a change in impedance indicative of variations in the coupling efficiency between stimulation energy output from the neurostimulator and neural tissue, wherein the change in impedance is measured by taking at least two impedance samples over time and comparing the at least two impedance measurements to each other;

cross-referencing the measured impedance change with the correlated impedance changes to determine the adjustment of the stimulation energy output from the neurostimulator; and

automatically adjusting the stimulation energy output from the neurostimulator in accordance with the determined adjustment of the stimulation energy output in order to compensate for the variations in the coupling efficiency.

10. The method of claim 9, wherein the stimulation energy output from the neurostimulator is automatically by varying pulse amplitude, pulsewidth, frequency of pulses or some combination of these three stimulus parameters.

11. The method of claim 9, further comprising initially storing the correlated measured impedance changes and predicted stimulation energy adjustments.

12. The method of claim 11, wherein the correlated measured impedance changes and predicted stimulation energy adjustments are stored in a look-up table.

13. The method of claim 9, wherein the impedance changes are correlated with the predicted stimulation energy adjustments by having a patient implanted with the neurostimulator make positional movements to induce changes in measured impedance and recording impedance measurements as a function of the positional movements.

14. The method of claim 13, wherein the positional movements comprise sitting to lying, standing to lying, sitting to standing, twisting the torso to one or the other side, standing to sitting, and running.

15. The method of claim 13, wherein the impedance changes are correlated with the predicted stimulation energy adjustments further by recording associated changes in sensation reported by the patient.

16. The method of claim 13, wherein the impedance changes are correlated with the predicted stimulation energy adjustments further by varying the stimulation energy output from the neurostimulator at each particular patient position and determining the perception threshold at the particular patient position and the maximum comfort level at the particular patient position.

17. The method of claim 9, wherein the correlated impedance changes are characteristic impedance waveform morphologies, the impedance change measurement comprises measuring a characteristic impedance waveform morphology, and the measured impedance waveform morphology is cross-referenced with the correlated characteristic impedance waveform morphologies to determine the adjustment of the stimulation energy output from the neurostimulator.

18. The method of claim 9, wherein the stimulation energy output from the neurostimulator is automatically adjusted to compensate for the variations in the coupling efficiency by maintaining the stimulation energy delivered to the neural tissue at a set level.

19. A method of neural stimulation using a neurostimulator, the method comprising:

correlating impedance changes with predicted stimulation energy adjustments by having a patient implanted with the neurostimulator make positional movements to induce changes in measured impedance and recording impedance measurements as a function of the positional movements;

measuring a change in impedance indicative of variations in the coupling efficiency between stimulation energy output from the neurostimulator and neural tissue; and

automatically adjusting the stimulation energy output from the neurostimulator based on the predicted stimulation energy adjustments and the measured impedance change to compensate for the variations in the coupling efficiency by maintaining the stimulation energy delivered to the neural tissue at a set level.

20. The method of claim 19, wherein the stimulation energy output from the neurostimulator is automatically adjusted by varying pulse amplitude, pulsewidth, frequency of pulses or some combination of these three stimulus parameters.

21. The method of claim 19, further comprising:

initially storing the correlated measured impedance changes and predicted stimulation energy adjustments; and

subsequently analyzing the stored correlated measured impedance changes and predicted stimulation energy adjustments to determine the predicted stimulation energy adjustment correlated to the measured impedance change.

22. The method of claim 19, wherein the positional movements comprise sitting to lying, standing to lying, sitting to standing, twisting the torso to one or the other side, standing to sitting, and running.

23. The method of claim 19, wherein the impedance changes are correlated with the predicted stimulation energy adjustments further by recording associated changes in sensation reported by the patient.

24. The method of claim 19, wherein the impedance changes are correlated with the predicted stimulation energy adjustments further by varying the stimulation energy output from the neurostimulator at each particular patient position and determining the perception threshold at the particular patient position and the maximum comfort level at the particular patient position.

25. The method of claim 19, wherein the correlated impedance changes are characteristic impedance waveform morphologies, the impedance change measurement comprises measuring a characteristic impedance waveform morphology, and the stimulation energy output from the neurostimulator is automatically adjusted based on the predicted stimulation energy adjustments and the measured characteristic impedance waveform morphology.

26. A method of neural stimulation using a neurostimulator, the method comprising:

correlating characteristic impedance waveform morphologies with predicted stimulation energy adjustments;

measuring a characteristic impedance waveform morphology indicative of variations in the coupling efficiency between stimulation energy output from the neurostimulator and neural tissue; and

automatically adjusting the stimulation energy output from the neurostimulator based on the predicted stimulation energy adjustments and the measured characteristic impedance waveform morphology to compensate for the variations in the coupling efficiency by maintaining the stimulation energy delivered to the neural tissue at a set level.

27. The method of claim 26, wherein the stimulation energy output from the neurostimulator is automatically adjusted by varying pulse amplitude, pulsewidth, frequency of pulses or some combination of these three stimulus parameters.

28. The method of claim 26, further comprising:

initially storing the correlated measured characteristic impedance waveform morphologies and predicted stimulation energy adjustments; and

subsequently analyzing the stored correlated measured characteristic impedance waveform morphologies and predicted stimulation energy adjustments to determine the predicted stimulation energy adjustment correlated to the measured characteristic impedance waveform morphology.

29. The method of claim 26, wherein the characteristic impedance waveform morphologies are correlated with the predicted stimulation energy adjustments by having a patient implanted with the neurostimulator make positional movements to induce changes in measured characteristic impedance waveform morphologies and recording characteristic impedance waveform morphology measurements as a function of the positional movements.