Algorithm for detecting a seizure from cardiac data

• US 8,562,536 B2
• Filed: 04/29/2010
• Issued: 10/22/2013
• Est. Priority Date: 04/29/2010
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan, Frei, Mark
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): BERHANU, ETSUB D
• Application Number:
  US12/770,562
• Publication Number:
  US 20110270096A1
• Time in Patent Office: 1,272 Days
• Field of Search: 600/483, 600/481, 600/544
• US Class Current: 600/483
• 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 5/02405 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 5/346 Analysis of electrocardiograms
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• 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: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61N 1/36064 Epilepsy

Abstract

Methods, systems, and apparatus for detecting the seizure in a patient using a medical device. The determination is performed by collecting cardiac data; determining valid heart beats suitable for seizure detection from the cardiac data; calculating heart rate data of interest from the valid heart beats; and identifying a seizure event from the heart rate data. The medical device may then take a responsive action, such as warning, logging the time of the seizure, computing and storing one or more seizure severity indices, and/or treating the seizure.

Claims

1. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for detecting epileptic seizures based upon a time of beat sequence of the patient'"'"'s heart comprising:

obtaining a time series of fiducial time markers for candidate heart beats;

identifying valid beats from said candidate heart beats by subjecting a plurality of candidate beats to at least one beat validity test, said at least one beat validity test comprising at least one beat interval test applied to a candidate beat interval derived from a candidate heart beat and at least one preceding heart beat; and

accepting as valid beats the candidate beats that pass said at least one beat validity test;

identifying valid beats suitable for seizure detection by forming a first window for each accepted valid beat, said first window comprising a first accepted valid beat and at least one preceding heart beat;

testing said first window with at least one window test; and

accepting as suitable for seizure detection said first accepted valid beat from each said first window that passes said at least one window test; and

detecting an epileptic seizure by;

forming a second window for each valid beat suitable for seizure detection, said second window comprising a first valid beat suitable for seizure detection and at least one prior valid beat suitable for seizure detection;

determining a foreground heart rate parameter comprising a statistical measure of central tendency of heart rate in said second window;

forming a third window for each valid beat suitable for seizure detection, said third window comprising said first valid beat suitable for seizure detection from said second window and at least two prior valid beats suitable for seizure detection;

determining a background heart rate parameter comprising a statistical measure of central tendency of heart rate in said third window;

determining a relative heart rate comprising at least one of the ratio of said foreground and said background heart rate parameters and the ratio of said background and said foreground heart rate parameters; and

comparing said relative heart rate to a first seizure threshold value associated with an epileptic seizure event.

2. The non-transitory computer readable program storage unit of claim 1 wherein identifying valid beats comprises determining if each of said plurality of candidate beats falls within a plausibly physiological interval.

3. The non-transitory computer readable program storage unit of claim 2 wherein said beat validity test comprises comparing said candidate beat interval to at least one of an upper and a lower beat interval seizure duration threshold.

4. The non-transitory computer readable program storage unit of claim 3 wherein said upper and lower beat interval seizure duration thresholds are derived from at least one of the patient'"'"'s own heart beat data, and heart beat data from a sample patient population based upon one or more of brain state, sex, age, weight, level of activity, time of day, type of epilepsy, use of drugs or substances (such as food) that affect cardiac function, ambient temperature, body temperature, respiration, and blood pressure.

5. The non-transitory computer readable program storage unit of claim 1 wherein said at least one beat interval test comprises:

a) determining that said candidate beat interval corresponds to a heart rate within a range bound by a minimum heart rate and a maximum heart rate;

b) determining that the candidate beat interval is within an acceptable percentage of at least one of the immediately preceding valid beat interval or a recent baseline heart rate in a predetermined time window; and

c) determining that the absolute slope of the current candidate beat interval does not correspond to a rate of acceleration or deceleration of heart rate that is physiologically improbable.

6. The non-transitory computer readable program storage unit of claim 5 wherein:

a) said minimum heart rate is about 35 beats per minute and said maximum heart rate is about 180 beats per minute;

b) said candidate beat interval is not more than about 115 percent of the greater of the immediately preceding valid beat interval or a recent baseline heart rate in a 30 second time window, and is at least about 65 percent of the immediately preceding valid beat interval; and

c) said absolute slope of the current candidate beat interval is ≦

0.3.

7. The non-transitory computer readable program storage unit of claim 1 wherein said first window comprises one of:

a) a time window of from 1 to 10 seconds, bounded on the most recent end by said first valid beat; and

b) a number of beats window comprising said first valid beat and a number of immediately preceding beats ranging from 1-10.

8. The non-transitory computer readable program storage unit of claim 7 wherein said at least one window test comprises:

a) determining whether the mean square error of a least squares linear fit of the beats in said first window is less than or equal to a predetermined heart rate variability threshold.

9. The non-transitory computer readable program storage unit of claim 7 wherein said first window comprises a time window and said at least one window test comprises determining that the number of valid beats in the window exceeds a lower number of beats threshold.

10. The non-transitory computer readable program storage unit of claim 1, wherein said detecting an epileptic seizure comprises:

(1) forming a second window for each valid beat suitable for seizure detection, said second window comprising a first valid beat suitable for seizure detection and at least one prior valid beat suitable for seizure detection;

determining a foreground heart rate parameter comprising a statistical measure of central tendency of heart rate in said second window;

forming a third window for each valid beat suitable for seizure detection, said third window comprising said first valid beat suitable for seizure detection from said second window and at least two prior valid beats suitable for seizure detection;

determining a background heart rate parameter comprising a statistical measure of central tendency of heart rate in said third window;

determining a relative heart rate comprising at least one of the ratio of said foreground and said background heart rate parameters and the ratio of said background and said foreground heart rate parameters;

comparing said relative heart rate to a first seizure threshold value associated with an epileptic seizure event; and

indicating the occurrence of a seizure event based on whether said relative heart rate exceeds said first seizure threshold value.

11. The non-transitory computer readable program storage unit of claim 1 wherein determining a foreground heart rate parameter comprises determining, from said valid beats in said second window, a target percentile value in a uniform distribution Percentile Tracking Filter.

12. The non-transitory computer readable program storage unit of claim 11 wherein upper and lower bounds for said uniform distribution are adaptively determined for each said second window based upon the maximum and minimum beat intervals in said second window.

13. The non-transitory computer readable program storage unit of claim 11 wherein said target percent value of said Percentile Tracking Filter comprises a value in the range of 20 percent to 80 percent.

14. The non-transitory computer readable program storage unit of claim 13 wherein said Percentile Tracking Filter comprises an exponential forgetting factor applied to the interbeat intervals of the heart beats in said Percentile Tracking Filter, and said target percent value is 30 percent.

15. The non-transitory computer readable program storage unit of claim 1 wherein determining a background heart rate parameter comprises determining, from said valid beats in said third window, a target percentile value in a uniform distribution Percentile Tracking filter.

16. The non-transitory computer readable program storage unit of claim 1 further comprising the step of determining a duration of time that said relative heart rate exceeds said first seizure threshold, and wherein indicating the occurrence of a seizure event is only performed if said duration exceeds a seizure duration threshold.

17. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for detecting epileptic seizures based upon a time of beat sequence of the patient'"'"'s heart comprising:

obtaining a time series of fiducial time markers for candidate heart beats;

identifying valid beats from said candidate heart beats by subjecting a plurality of candidate beats to at least one beat validity test, said at least one beat validity test comprising at least one beat interval test applied to a candidate beat interval derived from a candidate heart beat and at least one preceding heart beat; and

accepting as valid beats the candidate beats that pass said at least one beat validity test to provide validated beats;

identifying at least one validated beat suitable for seizure detection from said validated beats, wherein identifying said validated beat suitable for seizure detection comprises forming a first window for each validated beat, said first window comprising a first validated beat and at least one preceding heart beat; and

detecting an epileptic seizure by at least one of;

(1) forming a second window for each validated beat suitable for seizure detection, said second window comprising a first validated beat suitable for seizure detection and at least one prior validated beat suitable for seizure detection;

determining a foreground heart rate parameter comprising a statistical measure of central tendency of heart rate in said second window;

forming a third window for each validated beat suitable for seizure detection, said third window comprising said first validated beat suitable for seizure detection from said second window and at least two prior validated beats suitable for seizure detection;

determining a background heart rate parameter comprising a statistical measure of central tendency of heart rate in said third window;

determining a relative heart rate comprising at least one of the ratio of said foreground and said background heart rate parameters and the ratio of said background and said foreground heart rate parameters; and

comparing said relative heart rate to a first seizure threshold value associated with an epileptic seizure event;

(2) a) determining at least one short-term heart rate comprising at least one of;

i) a first instantaneous heart rate from said first valid beat and the immediately preceding valid beat, or

ii) a fourth window heart rate comprising a statistical measure of central tendency of heart rate using said valid beats in said fourth window; and

b) comparing said at least one short-term heart rate to a short-term heart rate threshold associated with an epileptic seizure event;

or

(3) a) determining a fifth window heart rate comprising a statistical measure of central tendency of heart rate using said valid beats in said fifth window;

b) determining a slope of the least squares linear fit of the beats in said fifth window;

c) comparing said fifth window heart rate to at least one of an upper fifth window heart rate threshold and a lower fifth window heart rate threshold associated with an epileptic seizure event; and

d) comparing said slope of the least squares linear fit of said valid beats in said fifth window to at least one of a lower slope threshold and an upper slope threshold associated with an epileptic seizure event;

further comprising, if at least one of said relative heart rate exceeds said first seizure threshold value, said short-term heart rate exceeds said short-term heart rate seizure threshold value, said fifth window heart rate is below said upper fifth window heart rate threshold, said fifth window heart rate exceeds said lower fifth window heart rate threshold, said slope of said least squares linear fit is below said upper slope threshold, or said slope of said least squares linear fit exceeds said lower slope threshold, indicating the occurrence of a seizure event.

18. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for detecting epileptic seizures based upon a time of beat sequence of the patient'"'"'s heart, the method comprising:

obtaining a time series of fiducial time markers for patient heart beats; and

detecting an epileptic seizure by at least one of;

(1) forming a second window for each patient heart beat, said second window comprising a first heart beat and at least one prior heart beat;

determining a foreground heart rate parameter comprising a target percentile value in a uniform distribution Percentile Tracking Filter of heart rate in said second window;

forming a third window for each patient heart beat, said third window comprising said first heart beat from said second window and at least two prior heart beats;

determining a background heart rate parameter comprising a target percentile value in a uniform distribution Percentile Tracking Filter of heart rate in said third window;

determining a relative heart rate comprising at least one of the ratio of said foreground and said background heart rate parameters and the ratio of said background and said foreground heart rate parameters; and

comparing said relative heart rate to a first seizure threshold value associated with an epileptic seizure event;

(2) a) determining at least one short-term heart rate comprising at least one of;

i) a first instantaneous heart rate from said first heart beat and the immediately preceding heart beat, or

ii) a fourth window heart rate comprising a target percentile value in a uniform distribution Percentile Tracking Filter of heart rate using said heart beats in said fourth window; and

b) comparing said at least one short-term heart rate to a short-term heart rate threshold associated with an epileptic seizure event;

and

(3) a) determining a fifth window heart rate comprising a target percentile value in a uniform distribution Percentile Tracking Filter of heart rate using said heart beats in said fifth window;

b) determining a slope of the least squares linear fit of the beats in said fifth window;

c) comparing said fifth window heart rate to at least one of an upper fifth window heart rate threshold and a lower fifth window heart rate threshold associated with an epileptic seizure event; and

d) comparing said slope of the least squares linear fit of said heart beats in said fifth window to at least one of a lower slope threshold and an upper slope threshold associated with an epileptic seizure event;

further comprising, if at least one of said relative heart rate exceeds said first seizure threshold value, said short-term heart rate exceeds said short-term heart rate seizure threshold value, said fifth window heart rate is below said upper fifth window heart rate threshold, said fifth window heart rate exceeds said lower fifth window heart rate threshold, said slope of said least squares linear fit is below said upper slope threshold, or said slope of said least squares linear fit exceeds said lower slope threshold, indicating the occurrence of a seizure event.

19. The non-transitory computer readable program storage unit of claim 18, wherein determining a foreground heart rate parameter comprises determining, from said valid beats in said second window, a target percentile value in a uniform distribution Percentile Tracking Filter.

20. The non-transitory computer readable program storage unit of claim 18, wherein upper and lower bounds for said uniform distribution are adaptively determined for each said second window based upon the maximum and minimum beat intervals in said second window.

21. The non-transitory computer readable program storage unit of claim 18 wherein said Percentile Tracking Filter comprises an exponential forgetting factor applied to the interbeat intervals of the heart beats in said Percentile Tracking Filter, and said target percent value is 30 percent.

22. The non-transitory computer readable program storage unit of claim 18 further comprising the step of determining a duration of time that said relative heart rate exceeds said first seizure threshold, and wherein indicating the occurrence of a seizure event is only performed if said duration exceeds a seizure duration threshold.

23. A method for detecting epileptic seizures based upon a time of beat sequence of the patient'"'"'s heart comprising:

obtaining by a cardiac data collection module a time of beat sequence for a series of candidate heart beats;

identifying by a heart beat/interval determination module a series of candidate beat intervals from pairs of adjacent candidate heart beats;

testing by a heart beat validation module at least a plurality of candidate beat intervals with at least one beat interval test selected from;

a) determining that said candidate beat interval is less than a maximum beat interval and greater than a minimum beat interval;

b) determining that said candidate beat interval is within an acceptable percentage of at least one of the immediately preceding beat interval or a recent short term beat interval measure; and

c) determining that the slope of the current candidate beat interval does not correspond to a rate of change of heart rate that is physiologically improbable;

accepting by said heart beat validation module as valid beats each pair of candidate heart beats from each candidate beat interval passing said at least one beat interval test;

identifying by a window test module valid beats suitable for seizure detection by forming a first window for each accepted valid beat, said first window comprising a first accepted valid beat and at least one preceding heart beat;

forming by a foreground/background module a foreground window defined by at least one of;

a) a duration of 30 seconds or less; and

b) from 2-90 beats;

determining by said foreground/background module a foreground heart rate parameter comprising a statistical measure of central tendency in said foreground window;

forming by said foreground/background module a background window defined by at least one of;

a) a duration exceeding the duration of the foreground window; and

b) a number of valid beats suitable for seizure detection that exceeds the number of valid beats in said foreground window;

determining by said foreground/background module a background heart rate parameter comprising a statistical measure of central tendency in said background window;

determining by a seizure detection module a relative heart rate parameter comprising at least one of the ratio of said foreground and said background heart rate parameters and the ratio of said background and said foreground heart rate parameters;

comparing by said seizure detection module said relative heart rate parameter to a seizure threshold value; and

indicating by said seizure detection module the occurrence of a seizure event if said relative heart rate parameter exceeds said seizure threshold value.