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

• US 10,029,102 B2
• Filed: 06/04/2014
• Issued: 07/24/2018
• 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., Parramon, Jordi, Kothandaraman, Sridhar, Gillespie, Christopher Ewan, Grandhe, Sarvani
• Primary Examiner(s): KOHARSKI, CHRISTOPHER
• Assistant Examiner(s): Bays, Pamela M
• Application Number:
  US14/296,056
• Publication Number:
  US 20140364920A1
• Time in Patent Office: 1,511 Days
• Field of Search: 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 for delivering a therapy to a patient, comprising:

modulation output circuitry and a plurality of electrical terminals, the 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 electrical energy to specified groups of electrodes for delivering the therapy to the patient, the modulation output circuitry configured to deliver electrical energy in accordance with sub-threshold programs, wherein each of the sub-threshold programs includes a set of modulation parameters for delivering the electrical energy below a patient-perception threshold, and the sub-threshold programs provide electrode fractionalization values that vary from one another; and

control circuitry configured to automatically control the modulation output circuitry to cycle through the sub-threshold programs that provide electrode fractionalization values that vary from one another over a period of time to continually maintain the delivered electrical energy below the patient-perception threshold over the period of time, the patient-perception threshold being a boundary below which the 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, wherein the set of modulation parameters includes an electrode combination.

4. The neuromodulation system of claim 3, wherein the control circuitry is configured to automatically control the modulation output circuitry to cycle through the sub-threshold programs to gradually displace a locus of the delivered electrical energy relative to the plurality of electrodes.

5. The neuromodulation system of claim 1, wherein the set of modulation parameters includes a pulse amplitude, a pulse duration, and a pulse rate.

6. The neuromodulation system of claim 1, wherein the different sub threshold programs include different values for at least one of the pulse amplitude, the pulse duration or the pulse rate.

7. The neuromodulation system of claim 6, wherein at least one of the sub-threshold programs is configured to vary a value of at least one modulation parameter in the set of modulation parameters, and the modulation output circuitry is configured to vary the at least one modulation parameter.

8. The neuromodulation system of claim 7, further comprising memory configured to store a limited range, wherein the control circuitry is configured to automatically control the modulation output circuitry to vary the value of the at least one modulation parameter in the set of modulation parameters within the limited range.

9. The neuromodulation system of claim 8, wherein the at least one modulation parameter in the set of modulation parameters is a pulse rate or a pulse duration, 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.

10. The neuromodulation system of claim 8, further comprising a user interface configured to receive input from a user defining the limited range.

11. The neuromodulation system of claim 7, 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.

12. The neuromodulation system of claim 7, 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.

13. The neuromodulation system of claim 7, 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.

14. The neuromodulation system of claim 7, wherein the control circuitry is configured to cycle through the sub-threshold programs to cycle through the different electrode fractionalization values to avoid neurological accommodation during delivery of a sub-threshold modulation therapy to alleviate pain without paresthesia.

15. The neuromodulation system of claim 7, 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.

16. The neuromodulation system of claim 7, 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.

17. The neuromodulation system of claim 16, 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.

18. The neuromodulation system of claim 16, 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.

19. The neuromodulation system of claim 16, 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.

20. The neuromodulation system of claim 16, 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.

21. The neuromodulation system of claim 1, wherein the system includes a spinal cord modulation (SCM) system and the patient-perception threshold is a boundary below which a patient does not sense paresthesia.

22. An implantable neuromodulation device for delivering a therapy to a patient, comprising:

implantable modulation output circuitry and a plurality of electrical terminals, the 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 electrical energy to specified groups of electrodes for delivering the therapy to the patient, the modulation output circuitry configured to deliver the electrical energy in accordance with sub-threshold programs, wherein each of the sub-threshold programs includes a set of modulation parameters for delivering the electrical energy below a patient-perception threshold, and the sub-threshold programs provide electrode fractionalization values that vary from one another; and

implantable control circuitry configured to automatically control the implantable modulation output circuitry to cycle through the sub-threshold programs that provide electrode fractionalization values that vary from one another over a period of time to continually maintain the delivered electrical energy below a patient-perception threshold over the period of time, the patient-perception threshold being a boundary below which a patient does not sense delivery of the electrical energy.

23. The implantable neuromodulation device of claim 22, wherein the sub-threshold programs include different values for at least one of the pulse amplitude, the pulse duration or the pulse rate.

24. A non-transitory machine-readable medium including instructions, which when executed by a neuromodulation system having modulation output circuitry, a plurality of electrical terminals configured to be respectively coupled to a plurality of electrodes, and control circuitry, cause the neuromodulation system to:

deliver electrical energy from the modulation output circuitry to specified groups of electrodes for delivering a therapy to a patient in accordance with sub-threshold programs, wherein each of the sub-threshold programs includes a set of modulation parameters for delivering the electrical energy below a patient-perception threshold, and the sub-threshold programs provide electrode fractionalization values that vary from one another; and

control the modulation output circuitry, using the control circuitry, to automatically cycle through the sub-threshold programs that provide electrode fractionalization values that vary from one another over a period of time to continually maintain the delivered electrical energy below a patient-perception threshold over the period of time, the patient-perception threshold being a boundary below which a patient does not sense delivery of the electrical energy.