Systems and Method for Recording Clinical Manifestations of a Seizure

• US 20090171168A1
• Filed: 12/23/2008
• Published: 07/02/2009
• Est. Priority Date: 12/28/2007
• Status: Abandoned Application

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Leyde, Kent W., Bland, Michael
• Application Number:
  US12/343,376
• Publication Number:
  US 20090171168A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• 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 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• 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

Abstract

A method of comparing a patient'"'"'s neurological data to data that is indicative of the patient'"'"'s clinical manifestation of a seizure. In some embodiments, the method includes the steps of monitoring neurological data from a patient indicative of the patient'"'"'s propensity for having a seizure; automatically recording clinical manifestation data from the patient that may be indicative of the occurrence of a clinical seizure; and analyzing the automatically recorded clinical manifestation data and the monitored neurological data to determine if one of the clinical manifestation data and the neurological data indicates the occurrence of a seizure while the other does not. Systems are described including a monitoring device having a communication assembly for receiving neurological data transmitted external to a patient from a transmitter implanted in a patient; a processor that processes the neurological data to estimate the patient'"'"'s brain state; and an assembly for automatically recording clinical manifestation data in response to a brain state estimate by the processor.

Claims

1. A method of comparing a patient'"'"'s neurological data to data that is indicative of the patient'"'"'s clinical manifestation of a seizure, comprising:

monitoring neurological data from a patient that is indicative of the patient'"'"'s propensity for having a seizure;

automatically recording clinical manifestation data from the patient that is indicative of the occurrence of a clinical seizure; and

analyzing the automatically recorded clinical manifestation data and the monitored neurological data to determine if one of the clinical manifestation data and the monitored neurological data indicates the occurrence of a seizure while the other does not.

2. The method of claim 1 wherein monitoring neurological data from the patient comprises monitoring EEG data, and wherein analyzing the automatically recorded clinical manifestation data and the monitored neurological data comprises analyzing the automatically recorded clinical manifestation data and the EEG data to determine if one of the clinical manifestation data and the EEG data indicates the occurrence of a seizure while the other does not.

3. The method of claim 1 wherein monitoring neurological data from the patient comprises determining the patient'"'"'s brain state, and wherein analyzing the automatically recorded clinical manifestation data and the monitored neurological data comprises analyzing the automatically recorded clinical manifestation data and the patient'"'"'s brain state to determine if one of the clinical manifestation data and the brain state indicates the occurrence of a seizure while the other does not.

4. The method of claim 3 wherein determining the patient'"'"'s brain state comprises continuously determining the patient'"'"'s brain state, and wherein automatically recording clinical manifestation data from the patient comprises automatically recording clinical manifestation data when the patient'"'"'s brain state changes from one state to another.

5. The method of claim 3 wherein determining the patient'"'"'s brain state comprises determining if the patient is in at least one of a pro-ictal state and an ictal state.

6. The method of claim 5 wherein automatically recording clinical manifestation data comprises automatically recording clinical manifestation data when the patient'"'"'s brain state enters into the pro-ictal or the ictal state.

7. The method of claim 3 further comprising retraining an algorithm used in determining the patient'"'"'s brain state if one of the clinical manifestation data and the determined brain state indicates seizure activity while the other does not.

8. The method of claim 1 wherein automatically recording clinical manifestation data comprises substantially continuously buffering clinical manifestation data while monitoring the neurological data from the patient.

9. The method of claim 8 further comprising determining the patient'"'"'s brain state using the neurological data, and further comprising permanently storing in memory the recorded clinical manifestation data when the brain state indicates at least an increased likelihood of having a seizure.

10. The method of claim 1 wherein automatically recording clinical manifestation data from the patient comprises annotating the monitored neurological data from a patient with an indication of the occurrence of the clinical manifestation of the seizure.

11. The method of claim 10 wherein the neurological data comprises an EEG recording, and annotating the neurological data comprises annotating the EEG data with an indication of the occurrence of the clinical manifestation of the seizure.

12. The method of claim 10 wherein monitoring neurological data from a patient comprises determining the patient'"'"'s brain state, and wherein annotating the monitored neurological data from a patient comprises annotating the patient'"'"'s brain state with an indication of the occurrence of the clinical manifestation of the seizure.

13. The method of claim 1 wherein automatically recording clinical manifestation data comprises automatically recording convulsion activity in the patient.

14. The method of claim 1 wherein automatically recording clinical manifestation data comprises automatically recording audio data from the patient.

15. The method of claim 1 wherein automatically recording clinical manifestation data comprises automatically recording heart rate data from the patient.

16. The method of claim 1 wherein automatically recording clinical manifestation data comprises automatically recording video data of the patient.

17. The method of claim 1 further comprising transmitting in substantially real-time the neurological data from an implanted device to a device external to the patient, wherein automatically recording clinical manifestation data is initiated in the external device when monitoring the neurological data indicates a change from a first brain state to a second brain state.

18. The method of claim 1 wherein automatically recording clinical manifestation data comprises automatically recording clinical manifestation data in response to the occurrence of an event in the patient'"'"'s condition.

19. The method of claim 1 wherein the monitoring, automatically recording, and analyzing steps are performed with an ambulatory patient monitoring device.

20. A method of comparing a patient'"'"'s estimated brain state to data that is indicative of clinical manifestation of a seizure, comprising:

monitoring neurological data from a patient;

determining the patient'"'"'s brain state based on the monitored neurological data, wherein the brain state indicates the patient'"'"'s propensity for having a seizure;

monitoring clinical manifestation data from the patient that is indicative of the occurrence of a clinical seizure; and

comparing the monitored clinical manifestation data with the patient'"'"'s determined brain state to determine if one of the brain state and the clinical manifestation data indicates the occurrence of a seizure while the other does not.

21. The method of claim 20 wherein monitoring clinical manifestation data from the patient comprises recording clinical manifestation upon the occurrence of a change in the patient'"'"'s brain state from a first brain state to a second brain state.

22. The method of claim 20 wherein determining the brain state comprises determining if the patient is in at least one of a pro-ictal state and an ictal state.

25. The method of claim 20 further comprising retraining an algorithm used in determining the patient'"'"'s brain state if one of the brain state and the clinical manifestation data indicates seizure activity while the other does not.

26. The method of claim 20 wherein monitoring clinical manifestation data comprises substantially continuously buffering clinical manifestation data while monitoring the neurological data from the patient.

27. The method of claim 26 further comprising permanently storing in memory the monitored clinical manifestation data when the brain state indicates at least an increased likelihood of having a seizure.

28. The method of claim 20 wherein monitoring clinical manifestation data from the patient comprises annotating the monitored neurological data from a patient with an indication of the occurrence of the clinical manifestation of the seizure.

29. The method of claim 28 wherein monitoring the neurological data comprises monitoring EEG data from the patient, and annotating the neurological data comprises annotating the EEG data with an indication of the occurrence of the clinical manifestation of the seizure.

30. The method of claim 20 comprising annotating the patient'"'"'s brain state with an indication of the occurrence of the clinical manifestation of the seizure.

31. The method of claim 20 wherein recording clinical manifestation data comprises recording convulsion activity in the patient.

32. The method of claim 20 wherein recording clinical manifestation data comprises recording audio data from the patient.

33. The method of claim 20 wherein recording clinical manifestation data comprises recording heart rate data from the patient.

34. The method of claim 20 wherein recording clinical manifestation data comprises recording video data of the patient.

35. The method of claim 20 further comprising transmitting in substantially real-time the neurological data from an implanted device to an external device, wherein monitoring clinical manifestation data is initiated in the external device when monitoring the neurological data indicates a change from a first brain state to a second brain state.

36. The method of claim 20 wherein monitoring clinical manifestation data comprises recording clinical manifestation data in response to an occurrence of an event in the patient'"'"'s condition.

37. The method of claim 20 wherein the monitoring, determining and comparing steps are performed with an ambulatory patient monitoring device.

38. The method of claim 20 wherein the step of monitoring clinical manifestation data comprises automatically monitoring clinical manifestation data upon a change in the patient'"'"'s condition.

39. The method of claim 20 wherein the monitoring neurological data comprises monitoring EEG data.

23. The method of 22 wherein determining the brain state comprises determining if the patient is in at least one of a contra-ictal state, a pro-ictal state, and an ictal state.

24. The method of claim 23 wherein monitoring clinical manifestation data comprises recording clinical manifestation data when the patient enters the pro-ictal or the ictal state.

40. A method of automatically recording clinical manifestation data from a patient, comprising:

monitoring neurological data from a patient;

estimating the patient'"'"'s brain state based on the monitored neurological data, wherein the estimated brain state indicates the patient'"'"'s propensity for having a seizure;

determining a change in the patient'"'"'s brain state; and

automatically recording clinical manifestation data from the patient using a device worn or held by the patient.

45. The method of claim 40 further comprising comparing either the neurological data or the brain state with the recorded clinical manifestation data to determine if one of the clinical manifestation data and the neurological data or brain state indicates the occurrence of a seizure while the other does not.

41. The method of 40 wherein automatically recording clinical manifestation data occurs upon the occurrence of the change in brain state.

42. The method of 41 wherein determining a change in the patient'"'"'s brain state comprises determining that the patient has entered into either a pro-ictal state or an ictal state.

43. The method of claim 42 wherein determining a change in the patient'"'"'s brain state comprises determining that the patient has gone from a contra-ictal state to a pro-ictal state.

44. The method of claim 42 wherein determining a change in the patient'"'"'s brain state comprises determining that the patient has gone from a pro-ictal state to an ictal state.

46. A monitoring device comprising:

a communication assembly for receiving neurological data that is transmitted externally to a patient from a transmitter implanted in a patient;

a processor that processes the neurological data to determine the patient'"'"'s brain state; and

an assembly for automatically recording clinical manifestation data in response to a change in the determined brain state.

47. The device of claim 46 wherein the assembly for automatically recording clinical manifestation data comprises a data buffer configured to continuously buffer clinical manifestation data during monitoring of neurological data from the patient.

48. The device of claim 46 further comprising an annotator configured to annotate monitored neurological data with an indication of the occurrence of clinical manifestation of a seizure.

49. The device of claim 46 wherein the assembly for automatically recording clinical manifestation data comprises a convulsion detector.

50. The device of claim 46 wherein the assembly for automatically recording clinical manifestation data comprises an audio input device.

51. The device of claim 46 wherein the assembly for automatically recording clinical manifestation data comprises a heart rate detector.

52. The device of claim 46 wherein the assembly for automatically recording clinical manifestation data comprises a video camera.

53. The device of claim 46 wherein the monitoring device is adapted to be carried by an ambulatory patient.

54. A method of recording clinical manifestation data from a patient, comprising:

monitoring neurological data from a patient; and

upon detection of a predetermined event, recording clinical manifestation data from the patient that is indicative of the occurrence of a clinical seizure.

55. The method of claim 54 wherein monitoring neurological data from the patient comprises monitoring EEG data.

56. The method of claim 54 wherein recording clinical manifestation data comprises recording convulsion activity in the patient.

57. The method of claim 54 wherein recording clinical manifestation data comprises recording audio data from the patient.

58. The method of claim 54 further comprising analyzing the monitored neurological data to determine the patient'"'"'s brain state, wherein the predetermined event comprises determination that the patient has entered a predetermined brain state.

59. The method of claim 58 wherein the predetermined brain state indicates at least an increased likelihood of having a seizure.

60. The method of claim 58 wherein the predetermined brain state indicates onset of a seizure.