Sub-perception modulation responsive to patient input

• US 10,342,979 B2
• Filed: 05/09/2018
• Issued: 07/09/2019
• Est. Priority Date: 09/23/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Parramon, Jordi, Hershey, Bradley Lawrence, Moffitt, Michael A., Zhu, Changfang
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US15/975,542
• Publication Number:
  US 20180256897A1
• Time in Patent Office: 426 Days
• Field of Search: 607 46, 607 48
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36142 for improving safety
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

An example of a system may include electrodes on at least one lead configured to be operationally positioned for use in modulating neural tissue. The neural tissue may include at least one of dorsal horn tissue, dorsal root tissue or dorsal column tissue. The system may include an implantable device including a neural modulation device and a controller. The neural modulation device may be configured to use at least some of the electrodes to generate a modulation field to deliver sub-perception modulation to the neural tissue. The sub-perception modulation may have an intensity below a patient-perception threshold. The patient-perception threshold may be a boundary below which a patient does not sense generation of the modulation field. The controller may be configured to control the neural modulation device to generate the modulation field, and automatically adjust the modulation field in response to a patient input.

Claims

1. A method, comprising:

delivering sub-perception neuromodulation to neural tissue using an implantable device and electrodes, wherein the sub-perception neuromodulation has an intensity below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense generation of a modulation field;

receiving an input signal indicative of a quality of patient health; and

automatically initiating a calibration process to calibrate the sub-perception neuromodulation based on the input signal.

2. The method of claim 1, wherein the neural tissue includes at least one of dorsal horn tissue, dorsal root tissue or dorsal column tissue.

3. The method of claim 1, wherein the input signal indicative of the quality of patient health includes an input signal derived from a user input or at least one of an activity sensor or a posture sensor that is indicative of worsening patient health.

4. The method of claim 1, wherein the automatically initiating the calibration process includes automatically initiating a sensor-based calibration of sub-perception neuromodulation, wherein the sensor-based calibration includes quantitative sensory testing.

5. The method of claim 1, wherein the automatically initiating the calibration process includes automatically initiating a sensor-based calibration of sub-perception neuromodulation, wherein the sensor-based calibration includes determining an electroencephalogram (EEG).

6. The method of claim 1, wherein the automatically initiating the calibration process includes automatically initiating a sensor-based calibration of sub-perception neuromodulation, wherein the sensor-based calibration includes determining an electrocorticogram (ECoG).

7. The method of claim 1, wherein the automatically initiating the calibration process includes automatically initiating a sensor-based calibration of sub-perception neuromodulation, wherein the sensor-based calibration includes diffuse optical imaging.

8. The method of claim 1, wherein the automatically initiating the calibration process includes automatically initiating a sensor-based calibration of sub-perception neuromodulation, wherein the sensor-based calibration includes functional magnetic resonance imaging.

9. The method of claim 1, wherein the automatically initiating the calibration process includes automatically initiating a sensor-based calibration of sub-perception neuromodulation, wherein the sensor-based calibration includes sensing local field potentials.

10. The method of claim 1, wherein the automatically initiating the calibration process includes automatically initiating a sensor-based calibration of sub-perception neuromodulation, wherein the sensor-based calibration includes sensing evoked compound action potentials (eCAPs).

11. The method of claim 1, wherein the automatically initiating the calibration process includes automatically initiating a process to determine perceived neuromodulation using received user input indicative of perceived neuromodulation and calibrating the sub-perception neuromodulation based on the perceived neuromodulation.

12. The method of claim 11, wherein the process includes moving a neuromodulation field through a volume of targeted tissue, and receiving user input for adjusting the neuromodulation to keep the perceived neuromodulation substantially constant as the neuromodulation field is moved through the volume of tissue.

13. The method of claim 11, wherein the process includes using the received user input to determine a perception threshold.

14. A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to:

deliver sub-perception neuromodulation to neural tissue using an implantable device and electrodes, wherein the sub-perception neuromodulation has an intensity below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense generation of a modulation field;

receive an input signal indicative of a quality of patient health; and

automatically initiate a calibration process to calibrate the sub-perception neuromodulation based on the input signal.

15. The non-transitory machine-readable medium of claim 14, wherein the input signal indicative of the quality of patient health includes an input signal derived from a user input or at least one of an activity sensor or a posture sensor that is indicative of worsening patient health.

16. The non-transitory machine-readable medium of claim 14, wherein the calibration process includes a sensor-based calibration of sub-perception neuromodulation, wherein the sensor-based calibration includes at least one of:

quantitative sensory testing;

determining an electroencephalogram (EEG);

determining an electrocorticogram (ECoG);

diffuse optical imaging;

functional magnetic resonance imaging;

sensing local field potentials;

or

sensing evoked compound action potentials (eCAPs).

17. The non-transitory machine-readable medium of claim 14, wherein the calibration process includes a process to determine perceived neuromodulation using received user input indicative of perceived neuromodulation and calibrate the sub-perception neuromodulation based on the perceived neuromodulation.

18. The non-transitory machine-readable medium of claim 17, wherein the process includes moving a neuromodulation field through a volume of targeted tissue, and receiving user input for adjusting the neuromodulation to keep the perceived neuromodulation substantially constant as the neuromodulation field is moved through the volume of tissue.

19. A system for use with electrodes on at least one lead that are configured to be operationally positioned for use in modulating neural tissue, the system comprising an implantable device including:

a neural modulation device configured to use active electrodes in the array of the stimulation electrodes to generate a modulation field to deliver sub-perception neuromodulation to the neural tissue, the sub-perception neuromodulation having an intensity below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense generation of the modulation field; and

a controller configured to control the neural modulation device to generate the modulation field to deliver the sub-perception neuromodulation, and automatically initiate a calibration process to calibrate the sub-perception neuromodulation based on a received input signal indicative of a quality of patient health.

20. The system of claim 19, wherein:

the input signal indicative of the quality of patient health includes an indication of worsening patient health; and

the calibration process includes;

a sensor-based calibration of sub-perception neuromodulation;

or

a process to determine perceived neuromodulation using received user input indicative of perceived neuromodulation and calibrate the sub-perception neuromodulation based on the perceived neuromodulation.