Systems for monitoring brain activity and patient advisory device

• US 9,788,744 B2
• Filed: 07/28/2008
• Issued: 10/17/2017
• Est. Priority Date: 07/27/2007
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Bland, Michael, Leyde, Kent W., McIlvaine, Neil G., Gaw, Shan, Weiss, Peter, Harris, John F.
• Primary Examiner(s): WANG, CHANG YU
• Application Number:
  US12/180,996
• Publication Number:
  US 20090062682A1
• Time in Patent Office: 3,368 Days
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy

Abstract

A patient advisory device (“PAD”) and its methods of use. The PAD may be configured to alert the patient about an estimated brain state of the patient. In preferred embodiments, the PAD is adapted to alert the patient of the patient'"'"'s brain state, which corresponds to the patient'"'"'s propensity of transitioning into an ictal brain state, e.g., having a seizure. Based on the specific type of alert, the patient will be made aware whether they are highly unlikely to have a seizure for a given period of time, an elevated propensity of having a seizure, a seizure is occurring or imminent, or the patient'"'"'s brain state is unknown.

Claims

1. A system for monitoring a patient'"'"'s brain activity, the system comprising:

an electrode for detecting physiological signals from the patient;

a communication assembly coupled to the electrode, the communication assembly configured to wirelessly transmit a data signal that is encoded with data that is indicative of the detected physiological signals; and

an external patient advisory device configured to receive the data signal from the communication assembly, the patient advisory device comprising;

a processing assembly comprising one or more brain state algorithms that process the data signal to estimate the patient'"'"'s brain state;

a brain state indicator configured to provide the estimated brain state, wherein the brain state indicator indicates;

when the estimated brain state is a contra-ictal brain state comprising a protected state in which the patient has a risk of transitioning from a non-ictal state to an ictal state within an upcoming time period below a first risk level; and

when the estimated brain state is a pro-ictal brain state comprising a prediction state in which the patient has a risk of transitioning from a non-ictal state to an ictal state within an upcoming time period above a second risk level, wherein the second risk level is higher than the first risk level; and

an output assembly comprising a first indicator that provides an indication of a status of the patient advisory device, a second indicator that provides an indication of a status of the communication assembly, and a failure alert indicator that provides an indication that a failure has occurred with the patient advisory device or the communication assembly.

2. The system of claim 1 wherein the output assembly further comprises a third indicator that provides an indication when there is a problem with transmission of the data signal from the communication assembly or receipt of the data signal at the patient advisory device.

3. The system of claim 1 wherein the communication assembly is programmed to substantially continuously transmit the data signal to the patient advisory device.

4. The system of claim 1 wherein the patient advisory device comprises a memory assembly for storing the data signal.

5. The system of claim 1 wherein the brain state indicator comprises a plurality of brain state indicators that differentiate between the contra-ictal state, a pro-ictal state, and an ictal state.

6. The system of claim 1, the system further comprising:

a therapy delivery device, wherein the therapy delivery device is adapted to automatically initiate therapy to the patient when the patient has an elevated propensity of seizure.

7. The system of claim 1 wherein the output assembly further comprises a communication indicator that provides an indication that the patient advisory device is out of communication range with the communication assembly.

8. The system of claim 1 wherein the output assembly further comprises a data indicator that provides an indication that data is not being received by the patient advisory device.

9. The system of claim 1 wherein the communication assembly further comprises a processor programmed to encrypt the detected physiological signals from the patient.

10. The system of claim 1 wherein the communication assembly further comprises a processor programmed to compress the detected physiological signals from the patient.

11. The system of claim 1, the system further comprising:

an electrical stimulator adapted to automatically initiate stimulation therapy to the patient when the patient has an elevated propensity of seizure.

12. A patient advisory device comprising:

a housing; and

a user interface on the housing comprising;

a first portion providing system status information including a failure alert indicator that provides an indication that a failure has occurred with the patient advisory device; and

a second portion comprising a brain state indicator that provides a substantially continuous indication of a patient'"'"'s propensity for a seizure, wherein the brain state indicator indicates;

when an estimated brain state is a contra-ictal brain state comprising a protected state in which the patient has a risk of transitioning from a non-ictal state to an ictal state within an upcoming time period below a first risk level; and

when the estimated brain state is a pro-ictal brain state comprising a prediction state in which the patient has a risk of transitioning from a non-ictal state to an ictal state within an upcoming time period above a second risk level, wherein the second risk level is higher than the first risk level.

13. The device of claim 12 wherein the brain state indicator comprises a plurality of brain state indicators that differentiate between the contra-ictal state, a pro-ictal state, and an ictal state.

14. A patient advisory device comprising:

a communication assembly configured to wirelessly receive a substantially continuously transmitted data signal that is encoded with brain activity data from a detection device disposed to detect a physiological signal from a patient;

a digital signal processor that executes a plurality of brain activity algorithms on the substantially continuously transmitted data signal to estimate the patient'"'"'s brain state;

a brain state indicator that is activated to report the estimated brain state estimated by at least one of the plurality of brain activity algorithms, wherein the brain state indicator indicates;

when the estimated brain state is a contra-ictal brain state comprising a protected state in which the patient has a low risk of transitioning from a non-ictal state to an ictal state within an upcoming time period is below a first risk level; and

when the estimated brain state is a pro-ictal brain state comprising a prediction state in which the patient has a risk of transitioning from a non-ictal state to an ictal state within an upcoming time period above a second risk level, wherein the second risk level is higher than the first risk level;

a first status indicator that indicates an operational status of the patient advisory device;

a second status indicator that indicates an operational status of the detection device; and

a failure alert indicator that provides an indication that a failure has occurred with the patient advisory device or the detection device.

15. The patient advisory device of claim 14 further comprising:

a communication indicator configured to issue an alert when the patient advisory device is out of communication range from the detection device.

16. The patient advisory device of claim 14 wherein the plurality of brain activity algorithms comprise a seizure detection algorithm, a seizure prediction algorithm, and a safety algorithm.

17. The patient advisory device of claim 14 further comprising:

a system state indicator that indicates a signal strength of the substantially continuously transmitted data signal that is encoded with the brain activity data from the detection device.

18. The patient advisory device of claim 14 wherein the brain state indicator comprises a plurality of brain state indicators that differentiate between the contra-ictal state, a pro-ictal state, and an ictal.

19. The patient advisory device of claim 16 wherein the safety algorithm is configured to report the estimated brain state to be a contra-ictal state, wherein the contra-ictal state comprises a protected state in which the patient has a low risk of transitioning from a non-ictal state to an ictal state within an upcoming time period.