IP Library › Granted Patent US 11,904,168
Granted Patent B2
US 11,904,168 · App. 16/569,393 · Granted Feb 20, 2024

Neuromodulation calibration based on health-related parameter

Inventors: Jordi Parramon (Valencia, CA); Bradley Lawrence Hershey (Carrollton, TX); Michael A. Moffitt (Solon, OH); Changfang Zhu (Valencia, CA)
Assignee: Boston Scientific Neuromodulation Corporation
A61N1/36071A61N1/0551A61N1/3605A61N1/3616A61N1/36128A61N1/36164A61N1/37247
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,904,168
App. No.
16/569,393
Granted
Feb 20, 2024
Kind
B2
Abstract

An example of a system may include electrodes on at least one lead configured to be operationally positioned for use in modulating a volume of neural tissue, where the neural tissue has an activation function. The system may further include a neural modulation generator configured to deliver energy using at least some electrodes to generate a modulation field within the volume of neural tissue. The neural modulation generator may be configured to use a programmed modulation parameter set to generate the modulation field. The programmed modulation parameter set having values selected to control energy delivery using the at least some electrodes to achieve an objective function specific to the activation function of the volume of neural tissue to promote uniformity of a response to the modulation field in the volume of neural tissue along a span of the at least one lead.

Claims (41)

1. A method, comprising:

delivering a spinal cord stimulation (SCS) neuromodulation therapy to a patient, including delivering neuromodulation to neural tissue;

monitoring an effectiveness of the SCS neuromodulation therapy by monitoring a health-related parameter of the patient indicative of therapeutic effectiveness during the SCS neuromodulation therapy, wherein the health-related parameter indicative of the therapeutic effectiveness of the SCS neuromodulation therapy is monitored by sensing the health-related parameter using at least one sensor or receiving patient-entered information for the health-related parameter;

determining when the monitored effectiveness indicates calibration for the neuromodulation;

automatically initiating a calibration process when the calibration for the neuromodulation is indicated by the monitored effectiveness, wherein the calibration process calibrates the neuromodulation delivered for the SCS therapy; and

delivering the SCS neuromodulation therapy using the calibrated neuromodulation.

2. 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.

3. The method of claim 2 , wherein the process includes moving a neuromodulation field through a volume of targeted tissue, 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, and using the received user input to determine a perception threshold.

4. The method of claim 1 , wherein the delivering neuromodulation includes delivering sub-perception neuromodulation.

5. The method of claim 1 , wherein the delivering neuromodulation includes delivering super-perception neuromodulation.

6. The method of claim 1 , wherein the monitoring the health-related parameter includes sensing an acceleration parameter.

7. The method of claim 1 , wherein the monitoring the health-related parameter includes sensing a posture parameter.

8. The method of claim 1 , wherein the monitoring the health-related parameter includes receiving the receiving the patient-entered information.

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 quantitative sensory testing.

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 determining an electroencephalogram (EEG).

11. 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).

12. 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.

13. 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.

14. 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).

15. 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.

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

deliver a spinal cord stimulation (SCS) neuromodulation therapy to a patient, including deliver neuromodulation to neural tissue;

monitor an effectiveness of the neuromodulation therapy by monitoring a health-related parameter of the patient indicative of therapeutic effective during the SCS neuromodulation therapy, wherein the health-related parameter indicative of the therapeutic effectiveness of the SCS neuromodulation therapy is monitored by sensing the health-related parameter using at least one sensor or receiving patient-entered information for the health-related parameter;

determine when the monitored effectiveness indicates calibration for the neuromodulation;

automatically initiate a calibration process when the calibration for the neuromodulation is indicated by the monitored effectiveness, wherein the calibration process calibrates the neuromodulation delivered for the SCS therapy; and

deliver the SCS neuromodulation therapy using the calibrated neuromodulation.

17. The non-transitory machine-readable medium of claim 16 , wherein the monitoring the health-related parameter includes monitoring an input signal derived from at least one of an activity sensor or a posture sensor.

18. The non-transitory machine-readable medium of claim 16 , 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).

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:

a neural modulation device configured to deliver a spinal cord stimulation (SCS) neuromodulation therapy using active electrodes in the array of the stimulation electrodes to generate a modulation field to deliver neuromodulation to the neural tissue; and

a controller configured to control the neural modulation device to generate the modulation field to deliver the neuromodulation for the neuromodulation therapy, monitor an effectiveness of the SCS neuromodulation therapy by monitoring a health-related parameter, wherein the health-related parameter indicative of the therapeutic effectiveness of the SCS neuromodulation therapy is monitored by sensing the health-related parameter using at least one sensor or receiving patient-entered information for the health-related parameter, automatically initiate a calibration process when the calibration for the neuromodulation is indicated by the monitored effectiveness wherein the calibration process calibrates the neuromodulation delivered for the SCS therapy, and deliver the SCS neuromodulation therapy using the calibrated neuromodulation.

20. The system of claim 19 , wherein the system comprises an implantable device including the neural modulation device and the controller, the neuromodulation includes sub-perception neuromodulation, and the calibration process includes:

a sensor-based calibration of the 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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 8, 2020
From: PARRAMON, JORDI; HERSHEY, BRADLEY LAWRENCE; MOFFITT, MICHAEL A.; ZHU, CHANGFANG
To: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Reel/Frame 052341/0496 →
Continuity (3)
Continuation 14860961 · Sep 22, 2015
Provisional Application 62054081 · Sep 23, 2014
Related Publication 20200001087A1 · Jan 2, 2020