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

• US 8,725,243 B2
• Filed: 12/28/2005
• Issued: 05/13/2014
• 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:
  US11/321,898
• Publication Number:
  US 20070150025A1
• Time in Patent Office: 3,058 Days
• Field of Search: 607 45- 46, 607115-116, 600/300, 600/378, 600544-545
• US Class Current: 600/544
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• 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 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• 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: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• 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 systems and methods for managing epilepsy. In one embodiment, a method of the present invention characterize a patient'"'"'s propensity for a future epileptic seizure and communicates to the patient and/or a health care provider a therapy recommendation. The therapy recommendation is typically a function of the patient'"'"'s propensity for the future epileptic seizure.

Claims

1. A method of preventing an epileptic seizure comprising:

a first characterizing step, comprising characterizing a patient'"'"'s propensity for an onset of a future epileptic seizure;

communicating to the patient and/or a health care provider a first therapy recommendation, wherein the first therapy recommendation is selected from a plurality of therapy recommendations based on the patient'"'"'s propensity for the onset of the epileptic seizure characterized in the first characterizing step;

a second characterizing step after said first characterizing step, comprising characterizing the patient'"'"'s propensity for an onset of a future epileptic seizure; and

communicating to the patient and/or a health care provider a second therapy recommendation, wherein the second therapy recommendation is different than the first therapy recommendation and is selected from the plurality of therapy recommendations based on the patient'"'"'s propensity for the onset of the epileptic seizure characterized in the second characterizing step.

2. The method of claim 1 wherein the first and second characterizing steps each comprise characterizing a neural state of a patient.

3. The method of claim 2 wherein first and second characterizing steps each comprise measuring one or more patient dependent parameters.

4. The method of claim 3 wherein the patient dependent parameters comprise EEG signals.

5. The method of claim 4 wherein the measured EEG signals are measured using an intracranial electrode array.

6. The method of claim 1 wherein the first and second therapy recommendations each comprise an instruction to administer an acute dosage of an anti-epileptic agent.

7. The method of claim 6 wherein the first and second therapy recommendations each comprise dosage information for the anti-epileptic agent, wherein the dosage is selected based on the patient'"'"'s characterized propensity for the onset of the future epileptic seizure.

8. The method of claim 7 wherein the patient'"'"'s characterized propensity for the onset of the future epileptic seizure is indicative of a seizure onset time parameter, the dosage information comprising a dose inversely related to the time parameter.

9. The method of claim 7 wherein the patient'"'"'s characterized propensity for the onset of the future epileptic seizure is indicative of a probability parameter, the dosage information comprising a dose directly related to the probability parameter.

10. The method of claim 7 wherein the dosage information corresponding to at least one of the first and second therapy recommendations is a dose selected to be lower than an FDA-approved dose for the anti-epileptic agent.

11. The method of claim 7 wherein the dosage information corresponding to at least one of the first and second therapy recommendations is a dose selected to be higher than an FDA-approved dose for the anti-epileptic agent.

12. The method of claim 7 wherein the dosage information corresponding to at least one of the first and second therapy recommendations is a dose selected to be equivalent to an FDA-approved dose for the anti-epileptic agent.

13. The method of claim 6 wherein the first and second therapy recommendations each specifies a form of the anti-epileptic agent, a formulation of the anti-epileptic agent, and/or a route of administration of the anti-epileptic agent.

14. The method of claim 1 wherein the first and second therapy recommendations each comprises electrical stimulation of a vagus nerve.

15. The method of claim 1 wherein:

the first therapy recommendation comprises an instruction to administer a first dosage of an anti-epileptic agent; and

the second therapy recommendation comprises an instruction to administer a second dosage of the anti-epileptic agent, said second dosage being different than the first dosage.

16. The method of claim 1 wherein:

the first therapy recommendation comprises an instruction to administer a first dosage of an anti-epileptic agent; and

the second therapy recommendation comprises an instruction to administer a second dosage of the anti-epileptic agent greater than the first dosage, wherein the patient'"'"'s propensity for the onset of the epileptic seizure characterized in the second characterizing step is greater than the patient'"'"'s propensity for the onset of the epileptic seizure characterized in the first characterizing step.

17. The method of claim 1 wherein:

the first therapy recommendation comprises an instruction to administer a dosage of a first pharmacological agent; and

the second therapy recommendation comprises an instruction to administer a dosage of a second pharmacological agent different than the first pharmacological agent.