Neuromodulation system and method for reducing energy requirements using feedback

• US 9,878,158 B2
• Filed: 10/20/2016
• Issued: 01/30/2018
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Hershey, Bradley Lawrence, Bradley, Kerry
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US15/299,142
• Publication Number:
  US 20170036024A1
• Time in Patent Office: 467 Days
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

An electrical neuromodulation system and method of meeting a therapeutic goal for a patient using a neuromodulation device. A modulation parameter value is varied by a step size. The neurostimulation device instructs the neuromodulation device to deliver electrical energy to at least one electrode in accordance with the varied modulation parameter value. A therapeutic feedback indicator is compared to a threshold in response to the delivery of the electrical energy. Whether the therapeutic goal has been met is determined based on the comparison, and the previous steps are repeated to determine the modulation parameter value at the resolution of the step size that minimizes energy consumption of the neuromodulation device required to meet the therapeutic goal when delivering the electrical energy to the electrode(s) in accordance with the varied modulation parameter value.

Claims

1. A method, comprising:

using a modulation parameter to deliver electrical energy from a neuromodulation device through at least one electrode;

using a therapeutic feedback indicator to confirm that a therapeutic goal is met by the delivered electrical energy; and

initiating an automatic process to reduce the electrical energy delivered from the neuromodulation device, wherein the automatic process includes incrementally changing the modulation parameter to reduce the electrical energy, delivering the electrical energy using the incrementally-changed modulation parameter, and using the therapeutic feedback indicator to confirm that the therapeutic goal is met.

2. The method of claim 1, wherein the automatic process further includes automatically repeating the incrementally changing, the delivering, and the using the therapeutic feedback indicator until the therapeutic goal is unmet.

3. The method of claim 1, wherein the electrical energy comprises pulsed electrical energy.

4. The method of claim 1, wherein the modulation parameter comprises a pulse rate.

5. The method of claim 1, wherein the modulation parameter comprises a pulse width.

6. The method of claim 1, wherein the modulation parameter comprises a duty cycle.

7. The method of claim 1, wherein the modulation parameter comprises an amplitude.

8. The method of claim 1, wherein the modulation parameter comprises an electrode combination.

9. The method of claim 1, wherein the using the therapeutic feedback indicator includes using conscious patient feedback.

10. The method of claim 1, wherein the using the therapeutic feedback indicator includes using a signal indicative of at least one of:

a body activity;

a body temperature;

or

a blood flow.

11. The method of claim 1, wherein the using the therapeutic feedback indicator includes using a signal indicative of at least one of:

an electrocardiogram or derived autonomic tone metrics thereof;

an electrocortigram;

or

an electroencephalogram.

12. The method of claim 1, wherein the using the therapeutic feedback indicator includes using a signal indicative of at least one of:

a tissue or transcutaneous oxygen tension;

a glucose concentration;

or

an electrode impedance.

13. The method of claim 1, wherein the using the therapeutic feedback indicator includes using a signal indicative of at least one of:

compound action potentials;

an intra- or extra-cellular potential or electrical current;

or

a chemical species concentration.

14. The method of claim 1, wherein the using the therapeutic feedback indicator comprises comparing the therapeutic feedback indicator to a threshold indicative of the therapeutic goal to confirm that the therapeutic goal is met.

15. The method of claim 1, wherein using the therapeutic feedback indicator to confirm that the therapeutic goal is met includes using the therapeutic feedback indicator to confirm alleviation of chronic pain.

16. The method of claim 1, wherein using the modulation parameter to deliver the electrical energy includes using the modulation parameter to deliver the electrical energy from the neuromodulation device through an implantable electrode.

17. A system, comprising:

delivery means for delivering electrical energy having at least one modulation parameter through at least one electrode; and

control means for automatically using a therapeutic feedback indicator to confirm that a therapeutic goal is met by the delivered electrical energy, incrementally changing the modulation parameter to reduce the electrical energy, instructing the delivery means to deliver the electrical energy in accordance with the incrementally changed modulation parameter, and using the therapeutic feedback indicator to confirm that the therapeutic goal is met.

18. The system of claim 17, wherein the control means is further configured to automatically repeat the incrementally changing, the instructing, and the using the therapeutic feedback indicator until the therapeutic goal is unmet.

19. A system, comprising:

a neuromodulation device configured to deliver electrical energy having at least one modulation parameter through at least one electrode; and

controller circuitry configured to automatically use a therapeutic feedback indicator to confirm that a therapeutic goal is met by the delivered electrical energy, incrementally change the modulation parameter to reduce the electrical energy, instruct the neuromodulation device to deliver the electrical energy in accordance with the incrementally changed modulation parameter, and use the therapeutic feedback indicator to confirm that the therapeutic goal is met.

20. The system of claim 19, wherein the controller circuitry is further configured to automatically and repeatedly incrementally change the modulation parameter to reduce the electrical energy, instruct the neuromodulation device to deliver the electrical energy in accordance with the incrementally changed modulation parameter, and use the therapeutic feedback indicator until the therapeutic goal is unmet.