Pain management based on brain activity monitoring

• US 10,675,469 B2
• Filed: 01/11/2018
• Issued: 06/09/2020
• Est. Priority Date: 01/11/2017
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Annoni, Elizabeth Mary, Gu, Jianwen, Esteller, Rosana, Clark, Bryan Allen, Thakur, Pramodsingh Hirasingh, Srivastava, Kyle Harish
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US15/867,801
• Publication Number:
  US 20180193651A1
• Time in Patent Office: 880 Days
• CPC Class Codes: A61B 5/245 specially adapted for magnetoencephalographic [MEG] signals
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

This document discusses, among other things, systems and methods for managing pain of a subject. A system includes one or more physiological sensors configured to sense a physiological signal indicative of patient brain activity. The physiological signals may include an electroencephalography signal, a magnetoencephalography signal, or a brain-evoked potential. The system may extract from the brain activity signal one or more signal metrics indicative of strength or pattern of brain electromagnetic activity associated with pain, and generate a pain score using the one or more signal metrics. The pain score can be output to a patient or a process. The system may select an electrode configuration for pain-relief electrostimulation based on the pain score, and deliver a closed-loop pain therapy according to the selected electrode configuration.

Claims

1. A system for managing pain of a patient, the system comprising:

a sensor circuit coupled to one or more physiological sensors and configured to sense from the patient at least one physiological signal indicative of patient brain activity;

a plurality of candidate electrodes configured to couple to an electrostimulator;

a pain analyzer circuit coupled to the sensor circuit, the pain analyzer circuit configured to;

generate, from each of the sensed at least one physiological signal indicative of the patient brain activity, one or more signal metrics indicative of strength or a pattern of brain electromagnetic activity associated with pain; and

generate, for each of the plurality of candidate electrodes, a pain score using the generated one or more signal metrics;

a controller circuit coupled to the pain analyzer circuit, the controller circuit configured to select, from the plurality of candidate electrodes, one or more active electrodes based on the pain scores; and

an output unit configured to output the pain scores to a user.

2. The system of claim 1, further comprising:

the electrostimulator, wherein the electrostimulator is configured to generate electrostimulation energy to treat pain; and

wherein the controller circuit is coupled to the electrostimulator, the controller circuit configured to control the electrostimulator to deliver a pain therapy and to control the electrostimulation energy generated by the electrostimulator according to the pain score.

3. The system of claim 2, wherein the controller circuit is further configured to

control the electrostimulator to deliver the pain therapy using the selected one or more active electrodes.

4. The system of claim 2, wherein:

the sensor circuit is configured to sense a brain activity signal during electrostimulation delivered to the patient using one of the plurality of candidate electrodes;

the pain analyzer circuit is configured to generate one or more brain activity signal metrics using the sensed brain activity signal, and to generate a composite pain score for the one of the plurality of candidate electrodes using metric-specific pain scores for the generated one or more brain activity signal metrics; and

the control circuit is configured to select one or more active electrodes corresponding to respective pain scores less than pain scores associated with other candidate electrodes different from the selected one or more active electrodes.

5. The system of claim 2, wherein the controller circuit is further configured to determine electrostimulation energy fractionalization for the one or more active electrodes based on the pain scores.

6. The system of claim 2, wherein the electrostimulator is further configured to deliver at least one of:

a spinal cord stimulation;

a brain stimulation;

or

a peripheral nerve stimulation.

7. The system of claim 1, wherein the at least one physiological signal includes one or more electroencephalography (EEG) signals each recorded at a brain region of interest.

8. The system of claim 7, wherein:

the one or more physiological sensors include one or more electrodes disposed on a lead configured to be implanted in a patient brain; and

the sensor circuit is configured to sense the one or more EEG signals via the one or more electrodes disposed on the lead.

9. The system of claim 8, wherein the one or more electrodes disposed on the lead are further configured to deliver electrostimulation energy to treat pain.

10. The system of claim 7, wherein:

the one or more physiological sensors include one or more wearable sensors communicatively coupled to the sensor circuit, the one or more wearable sensors configured to be removably worn on a patient head; and

the sensor circuit is configured to sense the one or more EEG signals via the one or more wearable sensors.

11. The system of claim 1, wherein the pain analyzer circuit is further configured to generate the pain score associated with a candidate electrode using a combination of a plurality of the signal metrics weighted by their respective weight factors.

12. The system of claim 2, further comprising an implantable neuromodulator device that includes one or more of the sensor circuit, the pain analyzer circuit, or the electrostimulator.

13. A method for managing pain of a patient using an implantable neuromodulator device (IND), the method comprising:

sensing at least one physiological signal from the patient via a sensor circuit, the at least one physiological signal indicative of patient brain activity;

generating, from each of the sensed at least one physiological signal indicative of the patient brain activity, one or more signal metrics indicative of strength or a pattern of brain electromagnetic activity associated with pain;

generating, for each of a plurality of candidate electrodes, a pain score based on the generated one or more signal metrics;

selecting, from the plurality of candidate electrodes, one or more active electrodes based on the pain scores; and

outputting the pain scores to a user.

14. The method of claim 13, further comprising delivering a pain therapy via the IND, the pain therapy including electrostimulation energy determined according to the pain score.

15. The method of claim 14, further comprising

delivering the pain therapy using the selected one or more active electrodes.

16. The method of claim 15, wherein:

sensing at least one physiological signal includes sensing a brain activity signal during electrostimulation delivered to the patient using one of the plurality of candidate electrodes;

generating one or more signal metrics includes generating one or more brain activity signal metrics using the sensed brain activity signal;

generating pain score includes generating a composite pain score for the one of the plurality of candidate electrodes using metric-specific pain scores for the generated one or more brain activity signal metrics; and

selecting one or more active electrodes includes one or more electrodes with respective pain scores less than pain scores associated with other candidate electrodes different from the selected one or more active electrodes.

17. The method of claim 15, further comprising determining electrostimulation energy fractionalization for the one or more active electrodes based on the pain score.

18. The method of claim 13, wherein the at least one physiological signal includes one or more electroencephalography (EEG) signals each recorded at a brain region of interest via an implantable or wearable sensor.

19. The method of claim 18, further comprising:

sensing the one or more EEG signals via one or more electrodes disposed on a lead implanted in a patient brain; and

delivering electrostimulation energy to treat pain via the one or more electrodes disposed on the lead.

20. The method of claim 13, wherein generating the pain score associated with a candidate electrode includes using a combination of a plurality of the signal metrics weighted by their respective weight factors.