Neuromodulation system and method for reducing energy requirements using feedback

• US 9,480,841 B2
• Filed: 07/15/2015
• Issued: 11/01/2016
• 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:
  US14/800,183
• Publication Number:
  US 20160008600A1
• Time in Patent Office: 475 Days
• US Class Current: 1/1
• 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 of meeting a therapeutic goal for a patient using a neuromodulation device, the method comprising:

(a) incrementally varying a modulation parameter value by a step size;

(b) delivering electrical energy from the neuromodulation device to at least one electrode adjacent a target tissue site in accordance with the varied modulation parameter value, thereby modulating the target tissue site;

(c) analyzing a therapeutic feedback indicator in response to the modulation of the target tissue site by the delivered electrical energy;

(d) determining whether the therapeutic goal has been met based on the analyzed therapeutic feedback indicator; and

(e) repeating steps (a)-(d) 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 at least one electrode in accordance with the varied modulation parameter value.

2. The method of claim 1, wherein the modulation parameter value is incrementally varied at step (a) to increase the energy consumption of the neuromodulation device, the therapeutic goal is initially determined to not be met at step (d), and steps (a)-(d) are repeated until the therapeutic goal has been determined to be met at step (d), such that the modulation parameter value that minimizes energy consumption of the neuromodulation device required to meet the therapeutic goal is determined to be the last modulation parameter value.

3. The method of claim 1, wherein the modulation parameter value is incrementally varied at step (a) to decrease the energy consumption of the neuromodulation device, the therapeutic goal is initially determined to be met at step (d), and steps (a)-(d) are repeated until the therapeutic goal has been determined to not be met at step (d), such that the modulation parameter value that minimizes energy consumption of the neuromodulation device required to meet the therapeutic goal is determined to be the previous modulation parameter value.

4. The method of claim 1, wherein the electrical energy is pulsed electrical energy.

5. The method of claim 4, wherein the modulation parameter is a pulse rate.

6. The method of claim 4, wherein the modulation parameter is a pulse width.

7. The method of claim 1, wherein the modulation parameter is a duty cycle.

8. The method of claim 1, wherein the modulation parameter is an amplitude.

9. The method of claim 1, wherein the modulation parameter is an electrode combination.

10. The method of claim 1, wherein therapeutic feedback indicator is conscious feedback from the patient.

11. The method of claim 1, wherein the therapeutic feedback indicator is one of a body activity, body temperature, blood flow, electrocardiogram and derived autonomic tone metrics thereof, electrocortigram, electroencephalogram, tissue or transcutaneous oxygen tension, glucose concentration, electrode impedance, compound action potentials, intra- or extra-cellular potential or electrical current, and chemical species concentration.

12. The method of claim 1, wherein the step of analyzing the therapeutic feedback indicator comprises comparing the therapeutic feedback indicator to a threshold indicative of the therapeutic goal, and wherein determining whether the therapeutic goal had been met is based on the comparison.

13. The method of claim 1, wherein the therapeutic goal is the alleviation of chronic pain.

14. The method of claim 1, wherein the electrical energy is conveyed from the neuromodulation device at a frequency in the range of 1 KHz-50 KHz.

15. The method of claim 1, wherein the at least one electrode is implanted within the patient.

16. The method of claim 1, wherein the delivery of the electrical energy from the neuromodulation device to the at least one electrode stimulates the target tissue site.

17. A method of meeting a therapeutic goal for a patient using a neuromodulation device, the method comprising:

(a) incrementally varying a modulation parameter value by a step size;

(b) delivering electrical energy from the neuromodulation device to at least one electrode adjacent a target tissue site in accordance with the varied modulation parameter value, thereby modulating the target tissue site;

(c) analyzing a therapeutic feedback indicator in response to the modulation of the target tissue site by the delivered electrical energy;

(d) determining whether the therapeutic goal has been met based on the analyzed therapeutic feedback indicator; and

(e) repeating steps (a)-(d) 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 at least one electrode in accordance with the varied modulation parameter value,

wherein the therapeutic goal is the alleviation of chronic pain and the electrical energy is conveyed from the neuromodulation device at a frequency in the range of 1 KHz-50 KHz.

18. The method of claim 17, wherein the modulation parameter includes a modulation parameter selected from the group of modulation parameters consisting of:

a pulse rate, a pulse width, a duty cycle, an amplitude, and an electrode combination.

19. The method of claim 17, wherein therapeutic feedback indicator is conscious feedback from the patient.

20. The method of claim 17, wherein the therapeutic feedback indicator is one of a body activity, body temperature, blood flow, electrocardiogram and derived autonomic tone metrics thereof, electrocortigram, electroencephalogram, tissue or transcutaneous oxygen tension, glucose concentration, electrode impedance, compound action potentials, intra- or extra-cellular potential or electrical current, and chemical species concentration.