SYSTEM AND METHOD FOR DELIVERING MODULATED SUB-THRESHOLD THERAPY TO A PATIENT

• US 20140364920A1
• Filed: 06/04/2014
• Published: 12/11/2014
• 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., Parramon, Jordi, Kothandaraman, Sridhar, Gillespie, Christopher Ewan, Lee, Dongchul, Grandhe, Sarvani
• Granted Patent: US 10,029,102 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• 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 1/36189 using modulation techniques
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A neuromodulation system and method of providing therapy to a patient. Electrical energy is delivered to the patient in accordance with a modulation parameter, thereby providing therapy to the patient, and the modulation parameter of the delivered electrical energy is varied over a period of time, such that the delivered electrical energy is continually maintained at a sub-threshold level throughout the period of time. The sub-threshold level may be referred to as a patient-perception threshold, which may be referred to as a boundary below which a patient does not sense delivery of the electrical energy. For example, in a spinal cord modulation system, the patient-perception threshold may be a boundary below which a patient does not experience paresthesia.

Claims

1. A neuromodulation system, comprising:

modulation output circuitry configured to deliver electrical energy in accordance with at least one modulation parameter; and

control circuitry configured to control the modulation output circuitry in an automated manner that varies the at least one modulation parameter of the delivered electrical energy over a period of time to continually maintain the delivered electrical energy below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense delivery of the electrical energy.

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.

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 at least one modulation parameter includes an electrode combination.

5. The neuromodulation system of claim 4, wherein the electrode combination includes a fractionalized electrode combination.

6. The neuromodulation system of claim 4, wherein the electrode combination is varied, such that a locus of the delivered electrical energy is gradually displaced relative to the plurality of electrodes in one direction.

7. The neuromodulation system of claim 1, wherein the at least one modulation parameter includes a pulse amplitude, or a pulse duration, or a pulse rate.

8. The neuromodulation system of claim 1, further comprising memory configured to store a predetermined tissue modulation regimen, wherein the control circuitry is configured to control the modulation output circuitry to vary the at least one modulation parameter in accordance with the predetermined tissue modulation regimen.

9. The neuromodulation system of claim 8, wherein the predetermined tissue modulation regimen defines a plurality of sub-threshold modulation programs, and the modulation output circuitry is configured to vary the at least one modulation parameter by cycling through the sub-threshold modulation programs.

10. The neuromodulation system of claim 8, wherein the predetermined tissue

modulation regimen defines a sub-threshold modulation program, and the modulation output circuitry is configured to vary the at least one modulation parameter in accordance with the sub-threshold modulation program.

11. The neuromodulation system of claim 1, further comprising memory configured to store a limited range, wherein the control circuitry is configured to control the modulation output circuitry in the automated manner that varies the at least one modulation parameter between the limited range.

12. The neuromodulation system of claim 11, wherein the modulation parameter is a pulse rate, and the limited range has a lower frequency limit greater than 1500 Hz, or the limited range has an upper pulse duration limit lower than 500 μ

s.

13. The neuromodulation system of claim 11, further comprising a user interface configured to receive input from a user defining the limited range.

14. The neuromodulation system of claim 1, wherein the delivered electrical energy comprises an electrical pulse train, wherein the electrical pulse train comprises a plurality of electrical pulse train portions respectively delivered to the electrical terminals in accordance with a plurality of modulation parameter sets that differ from each other by the varied modulation parameter.

15. The neuromodulation system of claim 1, wherein the control circuitry is configured to vary the modulation parameter to generate a plurality of different sets of modulation parameters, eliminate at least one of the plurality of different modulation parameter sets to create a reduced number of modulation parameter sets, and control the modulation output circuitry in an automated manner that serially delivers the electrical energy to the electrical terminals in accordance with the reduced number of modulation parameter sets, the system further comprising monitoring circuitry configured to detect a physiological parameter in response to the delivery of the electrical energy to the electrical terminals as the modulation parameter is varied, wherein the control circuitry is configured to eliminate the at least one modulation parameter set based on the detected physiological parameter.

16. The neuromodulation system of claim 1, wherein the control circuitry is configured to vary the modulation parameter to generate a plurality of different sets of modulation parameters, eliminate at least one of the plurality of different modulation parameter sets to create a reduced number of modulation parameter sets, and control the modulation output circuitry in an automated manner that serially delivers the electrical energy to the electrical terminals in accordance with the reduced number of modulation parameter sets, the system further comprising a user interface configured to receive input from a user in response to the delivery of the electrical energy to the electrical terminals, wherein the control circuitry is configured to eliminate the at least one modulation parameter set based on the user input.

17. The neuromodulation system of claim 1, wherein the control circuitry is configured to vary the modulation parameter in order to avoid neurological accommodation.

18. The neuromodulation system of claim 1, further comprising a user interface configured to receive at least one patient satisfaction score, wherein the control circuitry is configured for varying the at least one modulation parameter based on the at least one patient satisfaction score.

19. The neuromodulation system of claim 1, wherein the control circuitry is configured to vary the at least one modulation parameter to generate a plurality of different sets of modulation parameters, determine a therapeutic efficacy of a first one of the modulation parameter sets, and determine a second one of the modulation parameter sets based on the determined therapeutic efficacy of the first modulation parameter set.

20. The neuromodulation system of claim 19, further comprising a user interface configured for receiving input from a user in response to the delivery of the electrical energy to the electrical terminals, wherein the control circuitry is configured for determining the therapeutic efficacy of the first modulation parameter set based on the user input, wherein the user input comprises a patient satisfaction score.

21. The neuromodulation system of claim 19, further comprising monitoring circuitry configured for configured for detecting a physiological parameter in response to the delivery of the electrical energy to the electrical terminals, wherein the control circuitry is configured for determining the therapeutic efficacy of the first modulation parameter set based on detected physiological parameter.

22. The neuromodulation system of claim 19, wherein the second modulation parameter set is determined by the control circuitry by selecting the second modulation parameter sets from a plurality of pre-existing modulation parameter sets.

23. The neuromodulation system of claim 19, wherein the second modulation parameter set is determined by the control circuitry by deriving a new modulation parameter set from the first modulation parameter set.

24. A spinal cord modulation (SCM) system, comprising:

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

modulation output circuitry operably connected to the plurality of electrical terminals to deliver therapeutic electrical energy for alleviating pain to specified groups of electrodes, the modulation output circuitry configured to deliver electrical energy in accordance with a modulation parameter; and

control circuitry configured to control the modulation output circuitry in an automated manner that varies the modulation parameter of the delivered electrical energy over a period of time to continually maintain the delivered electrical energy below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense paresthesia.