Methods and systems for recommending an appropriate action to a patient for managing epilepsy and other neurological disorders

• US 8,868,172 B2
• Filed: 12/28/2005
• Issued: 10/21/2014
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Leyde, Kent W., Dilorenzo, Daniel J.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US11/321,897
• Publication Number:
  US 20070150024A1
• Time in Patent Office: 3,219 Days
• Field of Search: 607 45- 46, 607115-116, 600/300, 600/378, 600544-545
• US Class Current: 600/544
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

The present invention provides methods and system for managing neurological disorders such as epilepsy. In one embodiment, the method comprises measuring one or more signals from a patient and processing the one or more signals to characterize a patient'"'"'s propensity for a future seizure. The characterized propensity for the seizure is thereafter used to determine an appropriate action for managing or treating the predicted seizure; and a recommendation is communicated to the patient that is indicative of the appropriate action.

Claims

1. A system for monitoring a patient, the system comprising:

a device assembly that is configured to;

process one or more patient parameters to characterize the patient'"'"'s propensity for an onset of a first neurological event,

provide a first output that is indicative of a first appropriate action for responding to the first neurological event, wherein the first appropriate action is selected from a plurality of appropriate actions based on the patient'"'"'s propensity for the onset of the first neurological event,

process the one or more patient parameters to characterize the patient'"'"'s propensity for an onset of a second neurological event occurring subsequent to the first neurological event, and

provide a second output that is indicative of a second appropriate action for responding to the second neurological event, wherein the second appropriate action is different from the first appropriate action and is selected from the plurality of appropriate actions based on the patient'"'"'s propensity for the onset of the second neurological event; and

a communication assembly in communication with the device assembly, wherein the communication assembly communicates to the patient and/or a health care provider a first signal that is indicative of the first appropriate action for responding to the first neurological event and communicates to the patient and/or the health care provider a second signal that is indicative of the second appropriate action for responding to the second neurological event.

2. The system of claim 1 wherein at least one of the first and second neurological events comprises a seizure.

3. The system of claim 1 wherein the device assembly characterizes the patient'"'"'s propensity for the onset of the second neurological event by calculating a patient neural state and processing the patient neural state to generate the second output that is indicative of the second appropriate action.

4. The system of claim 3 wherein the device assembly provides the second output when the calculated patient neural state is indicative of the onset of the second neurological event within a prediction time horizon of at least one of 30 seconds, 1 minute, 5 minutes, 10 minutes, 30 minutes, and 60 minutes.

5. The system of claim 1 wherein the one or more patient parameters comprise one or more physiological signals from the patient, a patient history, and patient feedback.

6. The system of claim 5 wherein the device assembly characterizes the patient'"'"'s propensity for the onset of at least one of the first and second neurological events by extracting one or more features from the one or more physiological signals and classifying the extracted features.

7. The system of claim 1 wherein at least one of the first and second signals indicates that the patient take at least one type of pharmacological agent.

8. The system of claim 7 wherein at least one of the first and second signals indicates that the patient take a specified dosage of the at least one type of pharmacological agent, wherein the specified dosage is based on the patient'"'"'s propensity for the onset of the at least one of the first and second neurological events.

9. The system of claim 8 wherein at least one of the first and second signals indicates that the patient take at least one of a reduction of a normal dosage of the at least one type of pharmacological agent and an increase of the normal dosage of the at least one type of pharmacological agent.

10. The system of claim 1 wherein at least one of the first and second signals indicates a recommendation to the patient to make a behavioral modification.

11. The system of claim 10 wherein the behavioral modification comprises at least one of lying down, turning off lights, interrupting working, touching the face, hyperventilating, hypoventilating, holding breath, performing a valsalva maneuver, applying an external stimulator, applying transcutaneous electrical neural stimulation, and cessation of an activity.

12. The system of claim 1 further comprising:

a patient interface assembly for delivering a therapy to the patient when the one or more patient parameters reaches a threshold.

13. The system of claim 12 wherein the patient interface assembly comprises one or more electrodes and the therapy comprises electrical stimulation,

wherein the electrical stimulation is delivered to the patient through the one or more electrodes and one or more stimulation parameters of the electrical stimulation are dependent on the one or more patient parameters.

14. The system of claim 13 wherein the one or more electrodes are configured to deliver the electrical stimulation to a vagus nerve.

15. The system of claim 12 wherein the patient interface assembly comprises an implantable medication dispenser.

16. The system of claim 1 wherein at least a portion of the device assembly is adapted to be implanted within the patient'"'"'s body and the communication assembly is adapted to be disposed external to the patient'"'"'s body.

17. The system of claim 1 wherein the communication assembly comprises at least one of a visual device, a tactile device, and an audio device.

18. The system of claim 3 wherein the device assembly is configured to transmit the calculated neural state to the communication assembly and the communication assembly is adapted to communicate the neural state to the patient.

19. The system of claim 18 wherein the device assembly is configured to transmit the calculated neural state to the patient substantially in real-time.

20. The system of claim 1 further comprising:

a clinician communication assembly that is in communication with at least one of the communication assembly and the device assembly.

21. The system of claim 1 wherein the system does not deliver a therapy to the patient.

22. The system of claim 1 wherein the device assembly is configured to select at least one of the first and second appropriate actions from the plurality of appropriate actions by selecting a dosage from a plurality of dosages for one or more pharmacological agents based on at least one of the first and second neurological events.

23. The system of claim 1 wherein the device assembly is configured to select at least one of the first and second appropriate actions from the plurality of appropriate actions by selecting a pharmacological agent from a plurality of pharmacological agents based on at least one of the first and second neurological events.

24. The system of claim 1 wherein the device assembly is configured to select at least one of the first and second appropriate actions from the plurality of appropriate actions by selecting an electrical stimulation parameter from a plurality of electrical stimulation parameters based on at least one of the first and second neurological events.

25. The system of claim 1 wherein at least one of the first and second appropriate actions is at least one of vagus nerve stimulation, intracranial stimulation, tactile stimulation, and pharmacological intervention.