System and method for delivering modulated sub-threshold therapy to a patient

• US 9,381,360 B2
• Filed: 01/20/2015
• Issued: 07/05/2016
• Est. Priority Date: 02/05/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Hershey, Bradley L.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/600,649
• Publication Number:
  US 20150217117A1
• Time in Patent Office: 532 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A neuromodulation system configured for providing sub-threshold neuromodulation therapy to a patient. The neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes, modulation output circuitry configured for delivering electrical energy to the electrical terminals in accordance with at least one modulation parameter, thereby providing therapy to the patient at a sub-threshold level and control circuitry configured for controlling the modulation output circuitry in a manner that pseudo-randomly varies a value of the at least one modulation parameter based on a previous value of the at least one modulation parameter, such that the delivered electrical energy is continually maintained at the sub-threshold level.

Claims

1. A method of providing therapy to a patient, comprising:

providing a sub-threshold therapy to the patient, including delivering electrical energy to tissue of the patient in accordance with at least one modulation parameter at a sub-threshold level such that the delivered electrical energy is not perceived by the patient but is therapeutically effective for the sub-threshold therapy; and

pseudo-randomly varying a value of the at least one modulation parameter based on a previous value of the at least one modulation parameter, wherein the at least one modulation parameter is pseudo-randomly varied within a limited range to continually maintain the delivered electrical energy at the sub-threshold level in which the delivered electrical energy is therapeutically effective for the sub-threshold therapy and is not perceived by the patient.

2. The method of claim 1, further comprising calculating the pseudo-randomly varied value of the at least one modulation parameter based on a function of the previous value and a pseudo-randomly generated number;

and

delivering electrical energy having the pseudo-randomly varied value of the at least one modulation parameter.

3. The method of claim 1, wherein the at least one modulation parameter is pseudo-randomly varied by both increasing and decreasing the value around a mean value of the at least one modulation parameter.

4. The method of claim 1, receiving user-input defining the limited range.

5. The method of claim 1, wherein the modulation parameter comprises at least one of a pulse amplitude, a pulse duration, and a pulse rate.

6. The method of claim 1, wherein the pseudo-random variance of the at least one modulation parameter mimics a physiologically relevant signal.

7. The method of claim 1, wherein the at least one varied modulation parameter is a pulse rate greater than 1500 Hz or a pulse width less than 100 μ

s.

8. The method of claim 1, wherein the delivered electrical energy is an electrical pulse train.

9. The method of claim 1, further comprising delivering electrical energy in accordance with a plurality of pseudo-randomly varied values of the at least one modulation parameter, such that neural tissue is stimulated without undergoing neurological accommodation that would otherwise occur if the at least one modulation parameter was not pseudo-randomly varied.

10. The method of claim 1, wherein pseudo-randomly varying the value of the at least one modulation parameter includes varying temporal and spatial firing patterns in the tissue of the patient, including varying the pattern around a mean volume of activation (VOA).

11. A neuromodulation system, comprising:

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

modulation output circuitry configured for delivering electrical energy to the electrical terminals in accordance with at least one modulation parameter; and

control circuitry configured for controlling the modulation output circuitry to provide a sub-threshold therapy to a patient, including delivering the electrical energy at a sub-threshold level such that the delivered electrical energy is not perceived by the patient but is therapeutically effective for the sub-threshold therapy, wherein the control circuitry is configured to pseudo-randomly vary a value of the at least one modulation parameter based on a previous value of the at least one modulation parameter, wherein the at least one modulation parameter is pseudo-randomly varied within a limited range to continually maintain the delivered electrical energy at the sub-threshold level in which the delivered electrical energy is therapeutically effective for the sub-threshold therapy and is not perceived by the patient.

12. The neuromodulation system of claim 11, where in the control circuitry is further configured for calculating the pseudo-randomly varied value of the at least one modulation parameter based on a function of the first value and a pseudo-randomly generated number, and controlling the modulation output circuitry to deliver electrical energy having the pseud-randomly varied value of the at least one modulation parameter.

13. The neuromodulation system of claim 11, wherein the control circuitry is further configured for pseudo-randomly varying the at least one modulation parameter by both increasing and decreasing the value around a mean value of the at least one modulation parameter.

14. The neuromodulation system of claim 11, wherein the control circuitry is further configured for defining the limited range.

15. The neuromodulation system of claim 11, further comprising a user interface configured for receiving user input defining the limited range.

16. The neuromodulation system of claim 11, wherein the pseudo-random variance of the at least one modulation parameter mimics a physiologically relevant signal.

17. The neuromodulation system of claim 11, wherein the modulation parameter comprises at least one of a pulse amplitude, a pulse duration, and a pulse rate.

18. The neuromodulation system of claim 11, wherein the at least one varied modulation parameter is a pulse rate greater than 1500 Hz or a pulse width less than 100 μ

s.

19. The neuromodulation system of claim 11, wherein the at least one modulation parameter is pseudo-randomly varied in order to avoid neurological accommodation over time.

20. The neuromodulation system of claim 11, wherein the control circuitry is configured to pseudo-randomly vary the value of the at least one modulation parameter to vary temporal and spatial firing patterns in the tissue of the patient, including varying the pattern around a mean volume of activation (VOA).