Detecting, quantifying, and/or classifying seizures using multimodal data

• US 9,332,939 B2
• Filed: 11/17/2014
• Issued: 05/10/2016
• Est. Priority Date: 10/01/2010
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/543,734
• Publication Number:
  US 20150073237A1
• Time in Patent Office: 540 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• 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 5/1117 Fall detection
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• 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 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 7/003 : Detecting lung or respiration noise
• CPC Class Codes: A61N 1/36064 : Epilepsy
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• CPC Class Codes: A61N 1/36585 : controlled by two or more physical parameters
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Methods, systems, and apparatus for detecting an epileptic event, for example, a seizure in a patient using a medical device. The determination is performed by providing an autonomic signal indicative of the patient'"'"'s autonomic activity; providing a neurologic signal indicative of the patient'"'"'s neurological activity; and detecting an epileptic event based upon the autonomic signal and the neurologic signal.

Claims

1. A medical device system for detecting an epileptic event based upon a patient'"'"'s cardiac signal and kinetic activity, comprising:

a first sensor for detecting a cardiac signal indicative of a patient'"'"'s heart activity;

a second sensor for detecting a kinetic signal indicative of body movement of the patient; and

a medical device (MD) coupled to the patient'"'"'s body and operatively coupled to the first sensor and the second sensor;

the MD comprising;

a kinetic signal module for receiving the kinetic signal;

a cardiac signal module for receiving the cardiac signal;

a cardiac index module for determining at least one cardiac index from the cardiac signal, wherein said at least one cardiac index is selected from a heart rate, a heart rhythm, an EKG morphology feature, or an EKG wave interval;

a detection module for determining whether an epileptic event has occurred based on a change in the at least one cardiac index, wherein said change in said at least one cardiac index is selected from an increase in the patient'"'"'s heart rate;

a decrease in the patient'"'"'s heart rate;

or a change in said at least one heart rhythm, EKG morphology feature, or EKG wave interval; and

an action module for taking a further action based on said kinetic signal, wherein the further action is selected from confirming the detecting of the epileptic event, or not confirming the detecting of the epileptic event.

2. The medical device system of claim 1, further comprising:

a kinetic index module for determining at least one kinetic index from the kinetic signal, wherein the kinetic index is selected from;

a body posture,

a body position,

a fall,

a cessation of movement,

a parameter derived from an accelerometer signal selected from a movement, a frequency per unit time, a time interval between movements, a movement direction in at least one plane, an acceleration, a velocity, a force,

a parameter derived from an inclinometer signal, or

a change in one or more of the foregoing,

wherein said action module takes said further action based on the at least one kinetic index.

3. The medical device system of claim 1, wherein said action module takes said further action based upon a temporal relationship between a change in the at least one cardiac index and the kinetic signal.

4. The medical device system of claim 1, further comprising a classification module for classifying said epileptic event based upon at least one of said cardiac index, a kinetic index, a respiratory index, a skin index, a blood gases signal, a blood pH, a force index, vocal sounds, ocular activity, an EEG signal, an ECoG signal, an EMG signal, a responsiveness of the patient, an awareness of the patient, or a stress marker.

5. The medical device system of claim 4, wherein said classification module is configured to classify the event as one or more of:

an unconfirmed seizure;

a confirmed seizure;

a non-epileptic seizure;

a primarily generalized tonic-clonic seizure,

a secondarily generalized tonic-clonic seizure;

an absence seizure;

a partial seizure;

a simple partial seizure;

a complex partial seizure;

a simple partial seizure with secondary generalization;

or

a complex partial seizure with secondary generalization.

6. The medical device system of claim 4, wherein said classification module is configured to classify the event as one or more of:

a generalized seizure;

a partial seizure;

an absence seizure;

or

a non-epileptic seizure.

7. The medical device system of claim 4, further comprising at least one of

a responsiveness module for providing a signal indicative of the patient'"'"'s responsiveness following said confirming of said epileptic event, and

an awareness module for providing a signal indicative of the patient'"'"'s awareness following said confirming of said epileptic event,

wherein the classification module is configured to classify the epileptic event based upon the at least one of the responsiveness signal and the awareness signal.

8. The medical device system of claim 1, wherein said action module is configured to not confirm said detecting of said epileptic event by overriding said detecting.

9. A medical device system for detecting an epileptic event based upon a patient'"'"'s cardiac signal and kinetic activity, comprising:

a first sensor for detecting a cardiac signal indicative of a patient'"'"'s heart activity;

a second sensor for detecting a kinetic signal indicative of body movement of the patient; and

a medical device (MD) coupled to the patient'"'"'s body and operatively coupled to the first sensor and the second sensor;

the MD comprising;

a kinetic signal module for receiving the kinetic signal;

a cardiac signal module for receiving the cardiac signal;

a kinetic index module for determining at least one kinetic index from the kinetic signal, wherein said at least one kinetic index is selected from a body posture, a body position, a fall, a parameter derived from an accelerometer signal selected from a movement, a frequency per unit time, a time interval between movements, a movement direction in at least one plane, an acceleration, a velocity, a force, a parameter derived from an inclinometer signal, or a change in one or more of the foregoing;

a detection module for determining whether an epileptic event has occurred based on a change in the at least one kinetic index; and

an action module for taking a further action based on said cardiac signal, wherein the further action is selected from confirming the detecting of the epileptic event, or not confirming the detecting of the epileptic event.

10. The medical device system of claim 9, further comprising:

a cardiac index module for determining at least one cardiac index selected from a heart rate, an EKG morphology feature, a heart rhythm, or an EKG wave interval feature,

wherein said action module takes said further action based on the at least one cardiac index.

11. The medical device system of claim 9, wherein said action module takes said further action based upon a temporal relationship between a change in the at least one cardiac index and the kinetic signal.

12. The medical device system of claim 9, further comprising a classification module for classifying said epileptic event based upon at least one of said kinetic index, a cardiac index, a respiratory index, a skin index, a blood gases signal, a blood pH, a force index, vocal sounds, ocular activity, an EEG signal, an ECoG signal, an EMG signal, a responsiveness of the patient, an awareness of the patient, or a stress marker.

13. The medical device system of claim 12, wherein said classification module is configured to classify said event comprises classifying the event as one or more of:

an unconfirmed seizure;

a confirmed seizure;

a non-epileptic seizure;

a primarily generalized tonic-clonic seizure,

a secondarily generalized tonic-clonic seizure;

an absence seizure;

a partial seizure;

a simple partial seizure;

a complex partial seizure;

a simple partial seizure with secondary generalization;

or

a complex partial seizure with secondary generalization.

14. The medical device system of claim 12, wherein said classification module is configured to classify the event as one or more of:

a generalized seizure;

a partial seizure;

an absence seizure;

or

a non-epileptic seizure.

15. The medical device system of claim 11, further comprising at least one of

a responsiveness module for providing a signal indicative of the patient'"'"'s responsiveness following said confirming of said epileptic event, and

an awareness module for providing a signal indicative of the patient'"'"'s awareness following said confirming of said epileptic event,

wherein the classification module is configured to classify the epileptic event based upon the at least one of the responsiveness signal and the awareness signal.

16. The medical device system of claim 9, wherein said action module is configured to not confirm said detecting of said epileptic event by overriding said detecting.

17. A medical device system for detecting an epileptic event based upon a patient'"'"'s cardiac signal and kinetic activity, comprising:

a first sensor for detecting a cardiac signal indicative of a patient'"'"'s heart activity;

a second sensor for detecting a kinetic signal indicative of body movement of the patient; and

a medical device (MD) coupled to the patient'"'"'s body and operatively coupled to the first sensor and the second sensor;

the MD comprising;

a kinetic signal module for receiving the kinetic signal;

a cardiac signal module for receiving the cardiac signal;

a cardiac index module for determining at least one cardiac index from the cardiac signal, wherein said at least one cardiac index is selected from a heart rate, a heart rhythm, an EKG morphology feature, or an EKG wave interval;

a first characterization module for characterizing the at least one cardiac index as either indicative of an epileptic event or not indicative of an epileptic event;

a kinetic index module for determining at least one kinetic index from the kinetic signal, wherein said at least one kinetic index is selected from a body posture, a body position, a fall, a parameter derived from an accelerometer signal selected from a movement, a frequency per unit time, a time interval between movements, a movement direction in at least one plane, an acceleration, a velocity, a force, a parameter derived from an inclinometer signal, or a change in one or more of the foregoing;

a second characterization module for characterizing the kinetic signal as either indicative of an epileptic event or not indicative of an epileptic event; and

an epileptic event detection module for detecting an epileptic event based on both the cardiac signal and the kinetic signal being indicative of the epileptic event.

18. The medical device system of claim 17, further comprising a module for taking a further action in response to detecting an epileptic event, wherein said further action is selected from providing a therapy to the patient, providing a warning to one of a patient or a caregiver, or logging data relating to the epileptic event.

19. The medical device system of claim 17, wherein the cardiac signal module is an electrocardiogram (EKG), and the kinetic signal module is an accelerometer, an inclinometer, an actigraph, an EMG, a mechanogram, or two or more thereof.

20. The medical device system of claim 17, further comprising a classification module for classifying said epileptic event based upon at least one cardiac index and at least one kinetic index.

21. The medical device system of claim 20, wherein said classification module is configured to classify said epileptic event as one or more of:

an unconfirmed seizure;

a confirmed seizure;

a non-epileptic seizure;

a primarily generalized tonic-clonic seizure,

a secondarily generalized tonic-clonic seizure;

an absence seizure;

a partial seizure;

a simple partial seizure;

a complex partial seizure;

a simple partial seizure with secondary generalization;

a complex partial seizure with secondary generalization.

22. The medical device system of claim 20, wherein said classification module is configured to classify the epileptic event as one or more of:

a generalized seizure;

a partial seizure;

an absence seizure;

or

a non-epileptic seizure.

23. The medical device system of claim 20, further comprising at least one of

a responsiveness module for providing a signal indicative of the patient'"'"'s responsiveness following said confirming of said epileptic event, and

an awareness module for providing a signal indicative of the patient'"'"'s awareness following said confirming of said epileptic event,

wherein the classification module is configured to classify the epileptic event based upon the at least one of the responsiveness signal and the awareness signal.