Systems and method of adjusting the compliance voltage in a neuromodulation device

• US 9,616,233 B2
• Filed: 08/20/2014
• Issued: 04/11/2017
• Est. Priority Date: 08/29/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Shi, Jess Weiqian, Parramon, Jordi, Marnfeldt, Goran N.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/464,557
• Publication Number:
  US 20150066108A1
• Time in Patent Office: 965 Days
• Field of Search: 607 62
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

A therapeutic neuromodulation system configured for providing therapy to a patient. The therapeutic neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes implanted within tissue, analog output circuitry configured for delivering therapeutic electrical energy between the plurality of electrical terminals in accordance with a set of modulation parameters that includes a defined current value, a voltage regulator configured for supplying an adjustable compliance voltage to the analog output circuitry, and control/processing circuitry configured for automatically performing a compliance voltage calibration process at a compliance voltage adjustment interval by periodically computing an adjusted compliance voltage value as a function of a compliance voltage margin. The control/processing circuitry may also be configured for automatically adjusting at least one of the compliance voltage adjustment interval and the compliance voltage margin during the compliance voltage calibration process.

Claims

1. A therapeutic neuromodulation system, comprising:

a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes implanted within tissue;

analog output circuitry configured for delivering therapeutic electrical energy between the plurality of electrical terminals in accordance with a set of modulation parameters that includes a defined current value;

a voltage regulator configured for supplying an adjustable compliance voltage to the analog output circuitry;

monitoring circuitry configured for measuring an electrical parameter indicative of a change of impedance in the tissue; and

control/processing circuitry configured for automatically performing a compliance voltage calibration process at a compliance voltage adjustment interval including;

periodically computing an adjusted compliance voltage value as a function of a compliance voltage margin, including;

periodically directing the monitoring circuitry to measure the electrical parameter value, determining voltage drops based on the measured electrical parameters;

computing a function of at least two of the voltage drops indicative of a rate of impedance change; and

adjusting the at least one of the compliance voltage adjustment interval and the compliance voltage margin based on the computed function; and

directing the voltage regulator to adjust the compliance voltage to the adjusted compliance voltage value,

wherein the control/processing circuitry is configured for automatically adjusting at least one of the compliance voltage adjustment interval and the compliance voltage margin during the voltage compliance calibration process.

2. The therapeutic neuromodulation system of claim 1, further comprising monitoring circuitry, wherein control/processing circuitry is configured for automatically performing the compliance voltage calibration process by further directing the monitoring circuitry to measure a voltage drop in the analog output circuitry, and computing the adjusted compliance voltage value based on the measured voltage drop.

3. The therapeutic neuromodulation system of claim 2, wherein the analog output circuitry comprises at least one of a current source and a current sink configured for delivering the therapeutic electrical energy between the electrical terminals, and the monitoring circuitry is configured for measuring the voltage drop across the at least one of the current source and the current sink.

4. The therapeutic neuromodulation system of claim 3, wherein the control/processing circuitry is configured for computing a voltage drop across the tissue based on a difference between the compliance voltage and the measured voltage drop across the at least one of the current source and the current sink.

5. The therapeutic neuromodulation system of claim 4, further comprising a plurality of coupling capacitors respectively coupled to the plurality of electrical terminals, wherein the at least one of the current source and the current sink is configured for delivering therapeutic electrical energy between the plurality of electrical terminals via the capacitors, the monitoring circuitry is configured for monitoring the voltage drops across the capacitors, and the control/processing circuitry is configured for computing the voltage drop across the tissue based on a difference between the compliance voltage and a sum of the measured voltage drop across the at least one of the current source and the current sink and the measured voltage drops across the capacitors.

6. The therapeutic neuromodulation system of claim 4, wherein the control/processing circuitry is configured for computing the adjusted compliance voltage value as a function of the voltage drop across the tissue and an operating voltage of the at least one current source and the at least one current sink.

7. The therapeutic neuromodulation system of claim 6, wherein the function is a sum of the voltage drop across the tissue, the operating voltage of the at least one current source and the at least one current sink and the compliance voltage margin.

8. The therapeutic neuromodulation system of claim 7, wherein the compliance voltage margin is a percentage of the voltage drop across the tissue.

9. The therapeutic neuromodulation system of claim 3, wherein controller/processing circuitry is configured for directing the voltage regulator to incrementally vary the compliance voltage to a baseline value that causes the voltage drop across the at least one of the current source and the current sink to meet a threshold value, and computing the adjusted compliance voltage based on the baseline value.

10. The therapeutic neuromodulation system of claim 1, wherein the at least one of the compliance voltage adjustment interval and the compliance voltage margin comprises the compliance voltage adjustment interval.

11. The therapeutic neuromodulation system of claim 10, wherein the control/processing circuitry is configured for increasing the compliance voltage adjustment interval during the compliance voltage calibration process.

12. The therapeutic neuromodulation system of claim 11, wherein the compliance voltage adjustment interval is adjusted from a value in the range of 0-20 minutes to a value in the range greater than 20 minutes.

13. The therapeutic neuromodulation system of claim 11, wherein the compliance voltage adjustment interval is adjusted from a value in the range of 20-60 minutes to a value in the range greater than 60 minutes.

14. The therapeutic neuromodulation system of claim 11, wherein the compliance voltage adjustment interval is adjusted from a value in the range of 60 minutes to 1 day to a value in the range greater than 1 day.

15. The therapeutic neuromodulation system of claim 1, wherein the at least one of the compliance voltage adjustment interval and the compliance voltage margin comprises the compliance voltage margin.

16. The therapeutic neuromodulation system of claim 15, wherein the control/processing circuitry is configured for decreasing the compliance voltage margin during the compliance voltage calibration process.

17. The therapeutic neuromodulation system of claim 16, wherein the compliance voltage margin is a voltage drop percentage.

18. The therapeutic neuromodulation system of claim 17, wherein the voltage drop percentage is adjusted from a value in the range greater than 10% to a value less than 10%.

19. The therapeutic neuromodulation system of claim 17, wherein the voltage drop percentage is adjusted from a value in the range between 5%-10% to a value less than 2%.

20. The therapeutic neuromodulation system of claim 17, wherein the voltage drop percentage is adjusted from a value in the range between 1%-2% to a value less than 1%.

21. The therapeutic neuromodulation system of claim 1, wherein the control/processing circuitry is configured for adjusting the at least one of the compliance voltage adjustment interval and the compliance voltage margin in accordance with a predetermined time schedule.

22. The therapeutic neuromodulation system of claim 1, wherein the control/processing circuitry is configured for computing the adjusted compliance voltage by applying the compliance voltage margin to the determined voltage drop.

23. The therapeutic neuromodulation system of claim 1, wherein the measured electrical parameter is a voltage drop across at least one component in the analog output circuitry.

24. The therapeutic neuromodulation system of claim 1, wherein the computed function is a difference in the voltage drops determined at two consecutive compliance voltage adjustment intervals.

25. The therapeutic neuromodulation system of claim 1, wherein the computed function is an average of voltage drop differences determined between a plurality of consecutive compliance voltage adjustment intervals.

26. The therapeutic neuromodulation system of claim 1, wherein the determined voltage drop is a voltage drop across the tissue.

27. The therapeutic neuromodulation system of claim 1, wherein the determined voltage drop is the compliance voltage.

28. The therapeutic neuromodulation system of claim 1, wherein the control/processing circuitry is configured for comparing the computed function to a first threshold value, and adjusting the at least one of the compliance voltage adjustment interval and the compliance voltage margin based on the comparison.

29. The therapeutic neuromodulation system of claim 28, wherein the control/processing circuitry is configured for adjusting the at least one of the compliance voltage adjustment interval and the compliance voltage margin only if the computed function meets the first threshold value.

30. The therapeutic neuromodulation system of claim 28, wherein the control/processing circuitry is configured for computing another function of at least another two of the voltage drops, and adjusting at least one of the compliance voltage interval and the compliance voltage margin based on the other computed function.

31. The therapeutic neuromodulation system of claim 30, wherein the control/processing circuitry is configured for comparing the other computed function to a second threshold value different from the first threshold value, and readjusting the at least one of the compliance voltage adjustment interval and the compliance voltage margin based on the other comparison.

32. The therapeutic neuromodulation system of claim 31, wherein the control/processing circuitry is configured for readjusting the at least one of the compliance voltage adjustment interval and the compliance voltage margin only if the other computed function meets the second threshold value.

33. The therapeutic neuromodulation system of claim 28, wherein the control/processing circuitry is configured for increasing the at least one of the compliance voltage adjustment interval and/or decreasing the compliance voltage margin if the function is equal to or less than the first threshold value.

34. The therapeutic neuromodulation system of claim 1, wherein the analog output circuitry is configured for delivering the therapeutic electrical energy between the plurality of electrical terminals over a continuous therapeutic period without changing the set of modulation parameters, and the controller/processing circuitry is configured for performing the periodic voltage compliance calibration process during the continuous therapeutic period.

35. The therapeutic neuromodulation system of claim 34, wherein the controller/processing circuitry is configured for initiating the periodic voltage compliance calibration process each time delivery of the electrical energy by the analog output circuitry is initiated in accordance with the unchanged set of modulation parameters.

36. The therapeutic neuromodulation system of claim 1, wherein the defined current value is user programmable.

37. The therapeutic neuromodulation system of claim 1, wherein the delivered therapeutic electrical energy comprises an electrical pulse train.

38. The therapeutic neuromodulation system of claim 1, further comprising a battery to which the voltage regulator is coupled.

39. The therapeutic neuromodulation system of claim 1, further comprising a housing containing the plurality of electrical terminals, the modulation output circuitry, the voltage regulator, and the control/processing circuitry.

40. A therapeutic neuromodulation system, comprising:

a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes implanted within tissue;

analog output circuitry configured for delivering therapeutic electrical energy between the plurality of electrical terminals in accordance with a set of modulation parameters that includes a defined current value;

a voltage regulator configured for supplying an adjustable compliance voltage to the analog output circuitry;

monitoring circuitry configured for measuring an electrical parameter indicative of a change of impedance in the tissue; and

control/processing circuitry configured for automatically performing a compliance voltage calibration process at a compliance voltage adjustment interval including;

compensating for trends in tissue impedance, including computing an adjusted compliance voltage value as a function of a compliance voltage margin, including;

periodically directing the monitoring circuitry to measure the electrical parameter value, determining voltage drops based on the measured electrical parameters;

computing a function of at least two of the voltage drops indicative of a rate of impedance change; and

setting the compliance voltage adjustment interval and the compliance voltage margin based on the computed function; and

directing the voltage regulator to adjust the compliance voltage to the adjusted compliance voltage value, wherein the control/processing circuitry is configured for automatically adjusting at least one of the compliance voltage adjustment interval and the compliance voltage margin during the voltage compliance calibration process.