Sub-perception modulation responsive to patient input

• US 9,993,646 B2
• Filed: 09/22/2015
• Issued: 06/12/2018
• 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 AHMAD
• Application Number:
  US14/861,261
• Publication Number:
  US 20160082262A1
• Time in Patent Office: 994 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 neural modulation to neural tissue using an implantable device and electrodes, wherein the neural tissue includes at least one of dorsal horn tissue, dorsal root tissue or dorsal column tissue, and the sub-perception modulation has an intensity below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense generation a modulation field;

receiving from an external device a patient input signal indicative of a patient input received by the external device using a user interface of the external device; and

automatically implementing a programmed response in response to receiving the patient input signal to automatically adjust the sub-perception neural modulation to an adjusted sub-perception neural modulation.

2. The method of claim 1, wherein receiving the patient input includes receiving a patient command from an external device to implement a calibration routine to obtain calibration information, and automatically implementing the programmed response includes automatically adjusting the sub-perception neural modulation to the adjusted sub-perception neural modulation based on the calibration information.

3. The method of claim 1, wherein the patient input includes a dose adjustment, and implementing the programmed response includes adjusting a dose of the sub-perception neural modulation, wherein the programmed response includes limiting dose adjustments using stimulation limits for the neural modulation.

4. The method of claim 1, further comprising receiving feedback to assess therapeutic effectiveness of the sub-perception neural modulation, wherein automatically implementing the programmed response in response to receiving the patient input signal includes automatically self-calibrating the sub-perception neural modulation using the received feedback input.

5. The method of claim 4, wherein receiving the feedback includes receiving a patient-provided indication of pain relief using the user interface of the external device.

6. The method of claim 4, wherein receiving the feedback includes receiving a signal from a sensor to assess therapeutic effectiveness of the sub-perception neural modulation.

7. The method of claim 1, wherein the patient input signal is indicative of a patient activity level input, and automatically implementing the programmed response in response to patient input includes:

automatically assessing a quality of patient health using the patient activity level input; and

triggering the adjustment to the sub-perception neural modulation when indicated by the assessed quality of health, wherein triggering the adjustment when indicated by the assessed quality of health includes automatically triggering a calibration routine to calibrate the sub-perception neural modulation.

8. A system for use with electrodes on at least one lead that are configured to be operationally positioned for use in modulating neural tissue where the neural tissue includes at least one of dorsal horn tissue, dorsal root tissue or dorsal column 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 modulation to the neural tissue, the sub-perception modulation 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, and automatically adjust the modulation field, in response to a patient input signal received from an external device and indicative of a patient input signal received by the eternal device using a user interface of the external device, to adjust the sub-perception modulation delivered to the neural tissue to an adjusted sub-perception neural modulation.

9. The system of claim 8, further comprising:

the external device, wherein the external device is configured to communicate with the implantable device and includes;

the user interface to receive the patient input; and

a controller configured to respond to the patient input and automatically initiate communication to send a patient-initiated control signal to the implantable device,

wherein the controller of the implantable device is configured to control the neural modulation device to generate the modulation field, and automatically adjust the modulation field in response to receiving the patient-initiated control signal to automatically provide the adjusted sub-perception modulation.

10. The system of claim 9, wherein the patient input includes a dose adjustment, and the controller of the implantable device is configured to automatically adjust a dose of the sub-perception modulation in response to receiving the patient-initiated control signal to adjust the sub-perception modulation delivered to the neural tissue.

11. The system of claim 10, wherein the system is configured to implement stimulation limits for the neural stimulation to limit the automatic adjustment of the dose in response to the patient-initiated control signal.

12. The system of claim 9, further comprising a feedback input to assess therapeutic effectiveness of the sub-perception modulation, the controller configured to automatically self-calibrate the sub-perception modulation using feedback received at the feedback input.

13. The system of claim 12, wherein the user interface is configured to provide the feedback input, the feedback input including a patient-provided indication of pain relief using the user interface of the external device.

14. The system of claim 12, further comprising a sensor, wherein the feedback input includes the sensor.

15. The system of claim 9, wherein the user interface is configured to receive a patient activity input, and the controller is configured to automatically trigger a calibration routine when indicated by a quality of patient health that is assessed using the patient activity input.

16. The system of claim 9, wherein the user interface is configured to receive a patient activity input, and the controller is configured to implement a calibration routine to generate calibration data for a detected patient activity level, and to adjust the sub-perception modulation to provide the adjusted sub-perception modulation using the generated calibration data for the detected patient activity level when the patient activity input is at the detected patient activity level.

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

deliver sub-perception neural modulation to neural tissue using an implantable device and electrodes, wherein the neural tissue includes at least one of dorsal horn tissue, dorsal root tissue or dorsal column tissue, and the sub-perception modulation has an intensity below a patient-perception threshold, the patient-perception threshold being a boundary below which a patient does not sense generation a modulation field;

receive from an external device a patient input signal indicative of a patient input received by the external device using a user interface of the external device; and

automatically implement a programmed response in response to receiving the patient input signal to automatically adjust the sub-perception neural modulation to an adjusted sub-perception neural modulation.

18. The non-transitory machine-readable medium of claim 17, wherein the patient input signal includes a patient command from the external device to implement a calibration routine to obtain calibration information, and the programmed response includes automatically adjust the sub-perception neural modulation to the adjusted sub-perception neural modulation based on the calibration information.

19. The non-transitory machine-readable medium of claim 17, wherein the patient input signal includes a dose adjustment, and the programmed response includes adjust a dose of the sub-perception neural modulation including limit dose adjustments using stimulation limits for the neural modulation.

20. The non-transitory machine-readable medium of claim 17, wherein the patient input includes feedback assessing therapeutic effectiveness of the sub-perception neural modulation and the programmed response includes automatically self-calibrate the sub-perception neural modulation using the received feedback input.