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

• US 9,950,173 B2
• Filed: 06/04/2014
• Issued: 04/24/2018
• Est. Priority Date: 06/06/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Doan, Que T.
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/295,735
• Publication Number:
  US 20140364919A1
• Time in Patent Office: 1,420 Days
• Field of Search: 607 46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A neuromodulation system includes modulation output circuitry and control circuitry. The modulation output circuitry may be configured to deliver therapeutic electrical energy including therapeutic sub-threshold electrical energy and therapeutic a super-threshold electrical energy. The sub-threshold electrical energy is below a patient-perception threshold and the super-threshold electrical energy is above the patient-perception threshold. The patient-perception threshold is a boundary below which a patient does not sense delivery of the electrical energy and above which the patient does sense delivery of the electrical energy. The control circuitry is configured to control the modulation output circuitry to deliver the therapeutic electrical energy using alternating cycles of the sub-threshold electrical energy below the patient-perception threshold and the super-threshold electrical energy above the patient-perception-threshold.

Claims

1. A neuromodulation system, comprising:

modulation output circuitry configured to deliver therapeutic electrical energy including therapeutic sub-threshold electrical energy and therapeutic a super-threshold electrical energy, wherein the modulation output circuitry is configured to deliver the sub-threshold electrical energy below a patient-perception threshold and is configured to deliver the super-threshold electrical energy above the patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense delivery of the electrical energy and above which the patient does sense delivery of the electrical energy; and

control circuitry configured to control the modulation output circuitry to deliver the therapeutic electrical energy using alternating cycles of high-energy consumption time periods during which the patient does not sense delivery of the electrical energy and low-energy consumption time periods during which the patient does sense delivery of the electrical energy, wherein the control circuitry is configured to control the modulation circuitry to deliver the sub-threshold electrical energy below the patient-perception threshold during the high-energy consumption periods and deliver the super-threshold electrical energy above the patient-perception threshold during the low-energy consumption periods.

2. The neuromodulation system of claim 1, wherein:

the neuromodulation system includes a spinal cord modulation (SCM) system;

the patient-perception threshold being a boundary below which the patient does not experience paresthesia and above which the patient does experience paresthesia; and

the modulation system is configured to deliver therapeutic electrical energy effective to alleviate pain, including sub-threshold electrical energy effective to alleviate pain without paresthesia and super-threshold electrical energy effective to alleviate pain with paresthesia.

3. The neuromodulation system of claim 1, further comprising a plurality of electrical terminals configured to be respectively coupled to a plurality of electrodes, the modulation output circuitry being operably connected to the plurality of electrical terminals to deliver the therapeutic electrical energy to specified groups of electrodes.

4. The neuromodulation system of claim 3, wherein the modulation system is configured to use a specified group of electrodes to deliver both the sub-threshold electrical energy and the super-threshold electrical energy.

5. The neuromodulation system of claim 3, wherein the modulation system is configured to use a specified group of electrodes to deliver the sub-threshold electrical energy and use another group of electrodes to deliver the super-threshold electrical energy.

6. The neuromodulation system of claim 3, further comprising independently-controlled current sources or independently controlled voltage sources, wherein the modulation system is configured to control a percentage of electrical energy assigned to each electrode.

7. The neuromodulation system of claim 1, wherein the therapeutic sub-threshold electrical energy includes a pulse train with a pulse rate greater than 1500 Hz, and the therapeutic super-threshold electrical energy includes a pulse train with a pulse rate less than 1500 Hz.

8. The neuromodulation system of claim 1, wherein the therapeutic sub-threshold electrical energy includes a pulse train with a pulse duration less than 500 μ

s, and the therapeutic super-threshold electrical energy includes a pulse train with a pulse duration greater than 500 μ

s.

9. The neuromodulation system of claim 1, further comprising a user interface configured to receive a user input, wherein the control circuitry is configured to modify at least one of the sub-threshold electrical energy and the super-threshold electrical pulse energy in response to the user input.

10. The neuromodulation system of claim 1, further comprising a memory to store a time schedule defining hours for operating in the high-energy consumption time periods and hours for operating in the low-energy consumption time periods, and a user interface configured to receive a user input, wherein the control circuitry is configured to store the time schedule in response to the user input, and to use the stored time schedule to control timing for cycling the sub-threshold electrical energy below the patient-perception threshold and the super-threshold electrical energy above the patient-perception threshold.

11. The neuromodulation system of claim 10, wherein the time schedule defines absolute times.

12. The neuromodulation system of claim 10, wherein the time schedule defines relative times.

13. The neuromodulation system of claim 1, further comprising a sensor configured to detect a patient activity level, wherein the control circuitry is configured to use the sensor to determine times of low patient activity to identify the high-energy consumption time periods and times of high patient activity to identify the low-energy consumption time periods, and to deliver the sub-threshold electrical energy during the times of low patient activity and deliver the super-threshold electrical energy during the times of low patient activity.

14. The neuromodulation system of claim 1, further comprising memory configured to store a programmed tissue modulation regimen, wherein the control circuitry is configured to use the programmed tissue modulation regimen to control the modulation output circuitry to automatically cycle each of the sub-threshold electrical energy and the super-threshold electrical energy on and off in accordance with the programmed tissue modulation regimen.

15. The neuromodulation system of claim 14, wherein the programmed tissue modulation regimen defines a sub-threshold modulation program and a super-threshold modulation program, and the modulation output circuitry is configured to deliver the sub-threshold electrical energy in accordance with the sub-threshold modulation program, and deliver the super-threshold electrical energy in accordance with the super-threshold modulation program.

16. The neuromodulation system of claim 1, wherein the system includes a spinal cord modulation (SCM) system, comprising:

a plurality of electrical terminals configured to be respectively coupled to a plurality of electrodes;

wherein the modulation output circuitry is operably connected to the plurality of electrical terminals to deliver therapeutic electrical energy for alleviating pain to specified groups of electrodes, the therapeutic electrical energy including the sub-threshold electrical energy and the super-threshold electrical energy; and

the SCM system including a memory with a time schedule programmed in the memory, the control circuitry configured to use the time schedule to automatically cycle the sub-threshold electrical energy and the super-threshold electrical energy.

17. The SCM system of claim 16, wherein the therapeutic sub-threshold electrical energy includes a pulse train with a pulse rate greater than 1500 Hz, the therapeutic super-threshold electrical energy includes a pulse train with a pulse rate less than 1500 Hz.

18. The SCM system of claim 16, wherein the therapeutic sub-threshold electrical energy includes a pulse train with a pulse duration less than 500 μ

s, and the therapeutic super-threshold electrical energy includes a pulse train with a pulse duration greater than 500 μ

s.

19. The SCM system of claim 16, further comprising a sensor configured to detect a patient activity level, wherein the control circuitry is configured to use the sensor to determine times of low patient activity and times of high patient activity, and to deliver the sub-threshold electrical energy during the times of low patient activity and deliver the super-threshold electrical energy during the times of low patient activity.

20. The SCM system of claim 16, further comprising a user interface configured to receive a user input, wherein the control circuitry is configured to modify at least one of the sub-threshold electrical energy and the super-threshold electrical pulse energy in response to the user input.