Patient Advisory Device

• US 20090062682A1
• Filed: 07/28/2008
• Published: 03/05/2009
• Est. Priority Date: 07/27/2007
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Weiss, Peter, McIlvaine, Neil G., Leyde, Kent W., Harris, John F., Bland, Michael, Gaw, Shan
• Granted Patent: US 9,788,744 B2
• Time in Patent Office: Days
• US Class Current: 600/545
• 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 method of monitoring a patient'"'"'s brain activity, the method comprising:

sampling a brain activity signal from the patient;

wirelessly transmitting a substantially real-time data signal from a device implanted in the patient'"'"'s body to a patient advisory device external to the patient'"'"'s body, wherein the data signal is encoded with data that is indicative of the sampled brain activity signal;

processing the sampled brain activity signal to assess the patient'"'"'s propensity for a seizure;

providing a first indication with the patient advisory device that is indicative of the patient'"'"'s propensity for the seizure; and

providing a second indication with the patient advisory device of a status of at least one of the patient advisory device and implanted device.

2. The method of claim 1 wherein the second indication indicates that the patient advisory device is out of communication range with a device implanted in the patient'"'"'s body.

3. The method of claim 1 wherein the second indication indicates that the substantially real-time data signal is not being received by the patient advisory device.

4. The method of claim 1 wherein at least one of the first and second indication is delivered by an output assembly in the patient advisory device.

5. The method of claim 1 wherein the wirelessly transmitting of the substantially real-time data signal is performed substantially continuously, wherein the second indication is provided when there is an unexpected discontinuity in the substantially continuous receipt of the data signal in the patient advisory device.

6. The method of claim 1 wherein the first indication is provided by a plurality of discrete brain state indicators on the patient advisory device, wherein the plurality of brain state indicators indicate a contra-ictal state, a pro-ictal state, and an ictal state.

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

an electrode configured to sample brain activity signals from the patient;

an implanted communication assembly coupled to the electrode, the implanted communication assembly configured to wirelessly transmit a data signal that is encoded with data that is indicative of the sampled brain activity signals; and

a portable patient advisory device configured to receive the wireless data signal from the implanted communication assembly, the portable 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 plurality of brain state indicators, wherein the brain state indicator that is reflective of the patient'"'"'s estimated brain state is activated to inform the patient of the estimated brain state; and

an output assembly that is adapted to provide an indication of a status of the patient advisory device and implanted communication assembly.

8. The system of claim 7 wherein the output assembly provides an output when there is a problem with the transmission of the data signal from the implanted communication assembly or receipt of the data signal in the patient advisory device.

9. The system of claim 7 wherein the implanted communication assembly is programmed to substantially continuously transmit the data signal to the patient advisory device.

10. The system of claim 7 wherein the patient advisory device comprises a memory assembly for storing the data signal.

11. The system of claim 7 wherein the patient'"'"'s brain state is indicative of the patient'"'"'s propensity for a seizure.

12. The system of claim 11 wherein the implanted communication assembly comprises a therapy assembly, wherein the therapy assembly is adapted to automatically initiate therapy to the patient when the patient has an elevated propensity to the seizure.

13. The system of claim 7 wherein the output from the output assembly indicates that the patient advisory device is out of communication range with the implanted communication assembly.

14. The system of claim 7 wherein the output from the output assembly indicates that data is not being received by the patient advisory device.

15. The system of claim 7 wherein the communication assembly comprises an encryption assembly that is adapted to encrypt the brain activity signals from the patient.

16. The system of claim 7 wherein the communication assembly comprises a compression assembly that is adapted to compress the brain activity signals from the patient.

17. A patient advisory device comprising:

a housing; and

a user interface on the housing comprising;

a first portion configured to provide system status information; and

a second portion that comprises at least one brain state indicator that is configured to provide a substantially continuous indication of a patient'"'"'s propensity for a seizure.

18. The device of claim 17 wherein the second portion comprises a plurality of brain state indicators that differentiate between a contra-ictal state, a pro-ictal state, and an ictal state.

19. 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 an implanted device in a patient;

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

a plurality of different brain state indicators, wherein the brain state indicator that is reflective of the patient'"'"'s estimated brain state is activated to inform the patient of the estimated brain state from the plurality of brain activity algorithms.

20. The patient advisory device of claim 19 wherein the signal processor is configured to issue an alert when the patient advisory device is out of communication range from the implanted device in the patient.

21. The patient advisory device of claim 19 wherein the brain state indicators comprise a plurality of different colored light emitting diodes.

22. The patient advisory device of claim 21 wherein the different colored lights comprise a first colored light emitting diode that indicates that the patient is in a brain state that has a low propensity to having a seizure, a second colored light emitting diode that indicates that the patient is in a brain state that has an increased propensity to having a seizure or that the patient is in an ictal state, and a third colored light emitting diode that indicates that the patient is neither in a low propensity to having a seizure brain state or the increased propensity to having the seizure or that the patient is in the ictal state.

23. The patient advisory device of claim 21 wherein the plurality of brain activity algorithms comprise a seizure detection algorithm, a seizure prediction algorithm, and a safety algorithm.

24. The patient advisory device of claim 21 further comprising a system state indicator that indicates a signal strength of the transmitted data signal that is encoded with the brain activity data from the implanted device in the patient.