Hybrid system for treating mental and emotional disorders with responsive brain stimulation

• US 10,413,235 B2
• Filed: 04/22/2015
• Issued: 09/17/2019
• Est. Priority Date: 04/25/2014
• Status: Active Grant

• Current Assignee: Massachusetts Institute of Technology, The General Hospital Corporation (Mass General Brigham, Inc.), University of Washington
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Widge, Alik S., Moritz, Chet, Dougherty, Darin
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US15/305,752
• Publication Number:
  US 20170043167A1
• Time in Patent Office: 1,609 Days
• CPC Class Codes: A61B 3/112 for measuring diameter of pupils
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/245 specially adapted for magnetoencephalographic [MEG] signals
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take 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 6/037 Emission tomography
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: G06F 3/015 : Input arrangements based on nervous system activity detection, e.g. brain waves [EEG] detection, electromyograms [EMG] detection, electrodermal response detection
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 20/70 : relating to mental therapies, e.g. psychological therapy or autogenous training

Abstract

A closed-loop brain computer interface (BCI) system for treating mental or emotional disorders with responsive brain stimulation is disclosed. The system includes an implanted module including a processor configured to process neural data acquired from one or more electrodes in communication with one or more brain regions of a patient. The implanted module is configured to deliver stimulation to electrodes in contact with the brain regions. An interface is in wireless communication with the implanted module and configured to receive the neural data from the implanted module. A controller processes the patient'"'"'s brain and body signals to provide patient intentional control over the stimulation applied to the one or more electrodes and to control the stimulation.

Claims

1. A closed-loop brain computer interface (BCI) system for treating a patient suspected of having a mental or emotional disorder with on-demand responsive brain stimulation, the system comprising:

an implanted module including a processor configured to process neural data acquired from at least one electrode in communication with at least one brain region of the patient suspected of having a mental or emotional disorder, the implanted module configured to deliver stimulation to the at least one electrode in contact with the at least one brain region, wherein the neural data comprises brain and body signals that are acquired by the implanted module;

an interface in wireless communication with the implanted module and configured to receive the neural data from the implanted module; and

a controller that processes the patient'"'"'s brain and body signals to provide the patient intentional control over the stimulation applied to the at least one electrode and to control the stimulation in concert with the patient'"'"'s intentional control to provide therapy for the mental or emotional disorder, wherein the intentional control comprises the patient being permitted to alter the provided brain and body signals if an alteration of the applied stimulation is desired by the patient.

2. The system of claim 1, wherein the neural data includes at least one of spike, local field potential, or electrocorticography data acquired from the at least one electrode.

3. The system of claim 1, wherein the implanted module includes a controlling hub and a plurality of satellite modules coupled to the controlling hub.

4. The system of claim 3, wherein the interface is a head or body mounted interface positioned between the controlling hub and a base station to provide wireless communication therebetween.

5. The system of claim 4, wherein the base station includes a hand held or wearable patient controller configured for at least one of self-reporting, triggering recordings, or monitoring at least one of heart rate or skin conductance.

6. The system of claim 3, wherein each of the plurality of satellite modules include a unique ID to enable the controlling hub to interrogate the plurality of satellite modules and configure the controlling hub based upon returned information.

7. The system of claim 1, wherein the implanted module include at least one sensor for monitoring or reporting a set of system health parameters.

8. The system of claim 7, wherein the set of system health parameters include at least one of electrode impedance, temperature, humidity, supply voltage, or a lead line integrity of the implanted module.

9. The system of claim 3, wherein the controlling hub further includes at least one current pulse generator for applying stimulation therapies through the at least one electrode.

10. The system of claim 1, wherein the implanted module includes a memory accessible by the processor for storing neural data.

11. The system of claim 1, wherein the interface includes a charger for wirelessly recharging and continuously powering the implanted module.

12. The system of claim 11, wherein the interface includes a first antenna for the charger, a second transmit antenna and a third receive antenna for high-bandwidth telemetry.

13. The system of claim 1, wherein the processor is configured to execute emotional decoding algorithms to control the implanted module to merge the neural data to estimate a psychiatric state of the patient, deliver therapeutic stimulation, or provide the patient intentional control of the stimulation.

14. The system of claim 1, wherein the processor is configured to execute at least one of a training or calibration protocol to help the patient learn to use the controller.

15. The system of claim 1, further comprising a clinician interface for adjusting at least one internal system parameter for usability of the patient.

16. A method for diagnosing a patient suspected of having a mental or emotional disorder with on-demand responsive brain stimulation using a closed-loop brain computer interface (BCI), the method comprising the steps of:

acquiring neural data from at least one electrode in communication with at least one brain region of the patient suspected of having a mental or emotional disorder, wherein the neural data comprises brain and body signals;

processing the neural data using an implanted module including a processor;

receiving the processed neural data at an interface in wireless communication with the implanted module;

delivering stimulation, using the implanted module, to the at least one electrode in contact with the at least one brain region; and

providing the patient intentional control over the applied stimulation using a controller that processes the patient'"'"'s brain and body signals initiated by the patient and in communication with the at least one electrode to control the stimulation to provide therapy for the mental or emotional disorder, wherein the intentional control comprises the patient being permitted to alter the provided brain and body signals if an alteration of the applied stimulation is selected by the patient, wherein the brain and body signals are acquired by the implanted module.

17. The method of claim 16, wherein acquiring the neural data includes acquiring at least one of spike, local field potential, electrocorticography, or bio-magnetic data from the at least one electrode.

18. The method of claim 16, wherein acquiring the neural data includes non-invasively acquiring data from at least one scalp electrode.

19. The method of claim 16, wherein the implanted module includes a controlling hub and a plurality of satellite modules coupled to the controlling hub.

20. The method of claim 19, wherein the interface is a head or body mounted interface positioned between the controlling hub and a base station to provide wireless communication therebetween.

21. The method of claim 20, wherein the base station includes a hand held patient controller configured for at least one of self-reporting, triggering recordings, or monitoring at least one of heart rate or skin conductance.

22. The method of claim 19, further comprising the step of providing a unique ID for each of the plurality of satellite modules to enable the controlling hub to interrogate the plurality of satellite modules and configure the controlling hub based upon returned information.

23. The method of claim 16, further comprising the step of monitoring, using at least one sensor coupled to the implanted module, a set of health parameters related to the BCI.

24. The method of claim 23, wherein monitoring the set of health parameters includes monitoring at least one of electrode impedance, temperature, humidity, supply voltage, or a lead line integrity of the implanted module.

25. The method of claim 19, further comprising the step of applying stimulation therapies through the at least one electrode using at least one current pulse generator coupled to the controlling hub.

26. The method of claim 16, further comprising the step of storing the neural data in a memory accessible by the processor of the implanted module.

27. The method of claim 16, further comprising the step of wirelessly recharging and continuously powering the implanted module using a charger coupled the interface.

28. The method of claim 27, wherein the interface includes a first antenna for the charger, a second transmit antenna and a third receive antenna for high-bandwidth telemetry.