Systems and methods for characterizing a patient's propensity for a neurological event and for communicating with a pharmacological agent dispenser

• US 20070149952A1
• Filed: 12/28/2005
• Published: 06/28/2007
• Est. Priority Date: 12/28/2005
• Status: Abandoned Application

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Snyder, David, Leyde, Kent, Dilorenzo, Daniel, Bland, Mike
• Application Number:
  US11/322,150
• Publication Number:
  US 20070149952A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The present invention provides systems and methods for managing intake of a pharmacological agent. In one method of the present invention, the systems and methods are for controlling intake of an anti-epileptic drug. In such embodiments, one or more signals from a patient are processed to predict an onset of a seizure. Upon the prediction of the seizure, the patient is allowed to access the pharmacological agent in a pharmacological agent dispenser.

Claims

1. A method for controlling administration of a pharmacological agent for treating epilepsy, the method comprising processing one or more signals from a patient to characterize a patient'"'"'s propensity for a future seizure, and based upon measuring an increased propensity for the future seizure, allowing the patient to access the pharmacological agent from a dispenser.

2. The method of claim 1 wherein processing the one or more signals comprises:

extracting features from the one or more signals with a feature extractor;

transmitting at least some of the extracted features to a classifier; and

classifying at least some of the transmitted features to characterize the patient'"'"'s propensity for the future seizure.

3. The method of claim 2 wherein the features comprise a mathematical feature derived from a physiological signal from the patient.

4. The method of claim 2 wherein the patient'"'"'s propensity for a future seizure is indicated by a prediction interval, wherein the prediction interval is at least about 30 seconds.

5. The method of claim 2 wherein the feature extractor is embodied within a device that is implanted in the patient'"'"'s body and the classifier is embodied in a device that is external to the patient'"'"'s body.

6. The method of claim 2 wherein the feature extractor and classifier are embodied within a device that is implanted in the patient'"'"'s body.

7. The method of claim 2 wherein the feature extractor and the classifier are embodied in a device that is external to the patient'"'"'s body.

8. The method of claim 2 wherein the classifier is embodied within a device that is implanted in the patient'"'"'s body and the feature extractors are embodied in a device that is external to the patient'"'"'s body.

9. The method of claim 2 further comprising transmitting selected signals to the classifier, wherein classifying comprises classifying at least some of the transmitted features and the selected signals to characterize the patient'"'"'s propensity for the future seizure.

10. The method of claim 1 wherein processing the one or more signals to characterize the patient'"'"'s propensity for the future seizure comprises characterizing a patient'"'"'s neural state.

11. The method of claim 10 wherein allowing the patient to access the pharmacological agent from the dispenser comprises allowing administration of only an amount of pharmacological agent that is a function of the patient'"'"'s characterized neural state.

12. The method of claim 1 wherein allowing the patient to access the pharmacological agent comprises unlocking the dispenser.

13. The method of claim 1 further comprising monitoring the patient'"'"'s access to the pharmacological agent from the dispenser.

14. The method of claim 13 further comprising limiting the patient'"'"'s access to the pharmacological agent when the access to the pharmacological agent reaches a threshold.

15. The method of claim 13 wherein monitoring the patient'"'"'s access to the pharmacological agent comprises measuring a number of times the pharmacological agent was made accessible over a time period.

16. The method of claim 13 wherein monitoring the patient'"'"'s access to the pharmacological agent comprises measuring a number of times the pharmacological agent dispenser was activated.

17. The method of claim 13 wherein monitoring the patient'"'"'s access to the pharmacological agent comprises a number of times the patient affirmed that the pharmacological agent was taken.

18. The method of claim 13 wherein monitoring the patient'"'"'s access to the pharmacological agent comprises monitoring the one or more signals from the patient for an expected response to the pharmacological agent.

19. The method of claim 1 further comprising delivering a communication to the patient that is indicative of the patient'"'"'s increased propensity for the future seizure.

20. The method of claim 19 wherein the communication to the patient comprises a recommendation to take the pharmacological agent.

21. The method of claim 20 wherein the recommendation to take the pharmacological agent is indicative of at least one of a dosage, form, formulation, and route of administration of the pharmacological agent.

22. The method of claim 1 wherein the one or more signals comprises an input from the patient.

23. The method of claim 22 wherein the input from the patient comprises an affirmation from the patient that the pharmacological agent has been taken.

24. The method of claim 23 comprising using the affirmation from the patient that the pharmacological agent has been take in future characterizations of the patient'"'"'s propensity for seizures.

25. A method for controlling administration of an anti-epileptic drug, the method comprising:

measuring one or more signals from a patient;

extracting one or more features from the one or more signals;

classifying at least some of the extracted features to characterize the patient'"'"'s propensity for a future seizure; and

based upon the patient'"'"'s increased propensity for the future seizure, transmitting a signal to a drug dispenser that enables the patient to dispense the pharmacological agent from the pharmacological agent dispenser.

26. The method of claim 25 further comprising determining an appropriate pharmacological agent therapy for managing the predicted seizure based on the patient'"'"'s propensity for the future seizure.

27. The method of claim 26 comprising transmitting a communication to the patient that is indicative of at least one of the patient'"'"'s increased propensity for the future seizure and the appropriate pharmacological agent therapy.

28. The method of claim 26 wherein the communication to the patient is indicative of a suggested dosage of the pharmacological agent, wherein the suggested dosage is a function of the patient'"'"'s propensity for the future seizure.

29. The method of claim 26 wherein the patient'"'"'s propensity for the future seizure is a function of at least one of an estimated probability of the future seizure an estimated time horizon to the future seizure.

30. The method of claim 26 wherein the patient'"'"'s propensity for the future seizure is a function of a patient'"'"'s neural state.

31. The method of claim 25 wherein the features comprise mathematical features that are derived from a physiological signal from the patient.

32. The method of claim 25 wherein enabling the patient to dispense the pharmacological agent from the dispenser further comprises limiting the amount of pharmacological agent that is dispensed to an amount that corresponds to the patient'"'"'s propensity for the future seizure.

33. The method of claim 25 wherein enabling the patient to dispense the pharmacological agent from the pharmacological agent dispenser comprises unlocking the dispenser.

34. The method of claim 25 further comprising monitoring the patient'"'"'s dispensing of the pharmacological agent from the dispenser.

35. The method of claim 34 further comprising limiting the patient'"'"'s dispensing of the pharmacological agent when the amount of pharmacological agent dispensed reaches a threshold.

36. The method of claim 25 further comprising transmitting selected signals directly to the classifier, wherein classifying comprises classifying at least some of the transmitted features and the selected signals to characterize the patient'"'"'s propensity for the future seizure.

37. A method for controlling administration of a pharmacological agent for managing a predicted seizure, the method comprising:

characterizing a patient'"'"'s neural state to estimate a patient'"'"'s propensity for a future seizure;

wherein if the patient'"'"'s neural state is indicative of an increased propensity for a future seizure;

processing the neural state to determine an appropriate acute pharmacological treatment for managing the future seizure;

providing an output to the patient; and

transmitting a signal to a pharmacological agent dispenser that permits the use of the pharmacological agent dispenser and administration of the appropriate pharmacological treatment to the patient.

38. The method of claim 37 wherein the output to the patient is indicative of the appropriate pharmacological treatment.

39. The method of claim 37 wherein the pharmacological agent dispenser is configured to limit administration to only the amount of pharmacological agent that corresponds to the patient'"'"'s characterized neural state.

40. The method of claim 37 wherein parameters of the appropriate pharmacological treatment are a function of at least one of the patient'"'"'s neural state and the patient'"'"'s propensity for a future seizure.

41. The method of claim 40 wherein the parameters comprise at least one of dosage, form, formulation, and route of administration.

42. A method of communicating with a drug delivery assembly that is external to a patient'"'"'s body, the method comprising:

measuring one or more physiological parameters with one or more implanted sensors;

transcutaneously transmitting one or more signals from the implanted sensors that are reflective of the measured physiological parameters to a predictive algorithm that is external to the patient'"'"'s body; and

analyzing the one or more signals with the predictive algorithm to measure a patient'"'"'s neural state that is indicative of a patient'"'"'s propensity for an onset of a future seizure,

wherein if the patient'"'"'s neural state indicates an increased propensity for the onset of a future seizure, transmitting a signal to a manually activatable drug delivery device that is external to the patient'"'"'s body.

43. A method of predicting an onset of a seizure, the method comprising:

monitoring one or more signals from the patient;

extracting features from the one or more signals in a device that is implanted in the patient'"'"'s body;

transmitting at least some of the extracted features transcutaneously to a device that is external to the patient'"'"'s body; and

classifying at least some of the transmitted features to characterize the patient'"'"'s propensity for a future seizure in the device that is external to the patient'"'"'s body.

44. The method of claim 43 wherein upon the characterization of an increased propensity for the future seizure, the method comprises enabling access to a pharmacological agent in a dispenser that is external to a patient'"'"'s body.

45. The method of claim 44 wherein enabling access comprises transmitting a signal to the pharmacological agent dispenser that enables the patient to dispense a pharmacological agent from the dispenser.

46. The method of claim 45 wherein the signal to the pharmacological agent dispenser unlocks the pharmacological agent dispenser.

47. The method of claim 45 wherein the signal unlocks the pharmacological agent dispenser for a finite period of time.

48. The method of claim 45 further comprising transmitting a second signal to the pharmacological agent that locks the pharmacological agent dispenser.

49. The method of claim 43 further comprising providing a communication output to a patient.

50. The method of claim 43 further comprising allowing the patient to input a communication with at least one of the device implanted in the patient'"'"'s body and the device external to the patient'"'"'s body.

51. The method of claim 50 wherein the communication may be used by the classifier for subsequent characterizations of the patient'"'"'s propensity for future seizures.