Detecting, assessing and managing a risk of death in epilepsy

• US 9,504,390 B2
• Filed: 09/13/2013
• Issued: 11/29/2016
• Est. Priority Date: 03/04/2011
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: GlobalFoundries, Inc.
• Inventors: Osorio, Ivan
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/026,998
• Publication Number:
  US 20150080670A1
• Time in Patent Office: 1,173 Days
• Field of Search: None
• US Class Current: 1/1
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/162 Testing reaction times
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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: A61F 7/00 Heating or cooling appliances for medical or therapeutic treatment of the human body heating or cooling means in connection with bedsteads or mattresses A47C21/00 ; massage, therapeutic baths A61H; hyperthermia using electric or magnetic fields or ultrasound A61N; electric heating elements H05B
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/208 pH-value
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• 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 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/36142 : for improving safety
• CPC Class Codes: A61N 1/36514 : controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36585 : controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 : Alerting the patient
• CPC Class Codes: A61N 1/3987 : characterised by the timing or triggering of the shock
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

A method includes receiving cardiac data and determining a cardiac index based upon the cardiac data; determining an increased risk of death associated with epilepsy if the indices are extreme, issuing a warning of the increased risk of death and logging information related to the increased risk of death. A second method comprises receiving at least one of arousal data, responsiveness data or awareness data and determining an arousal index, a responsiveness index or an awareness index, where the indices are based on arousal data, responsiveness data or awareness data respectively; determining an increased risk of death related to epilepsy if indices are extreme values, issuing a warning of the increased risk of death and logging information related to the increased risk of death. A non-transitory computer readable program storage device encoded with instructions that, when executed by a computer, perform a method is also provided.

Claims

1. A method for determining and responding in real-time to an increased risk of death relating to a patient with epilepsy, comprising:

receiving cardiac data into a medical device;

determining, using the medical device, at least one cardiac index, the at least one cardiac index being based upon the cardiac data;

determining, using the medical device, an increased risk of death associated with epilepsy if the at least one cardiac index is an extreme value;

issuing automatically a warning of the occurrence of the increased risk of death; and

logging automatically information related to the increased risk of death,

further comprising at least one of;

automatically performing at least one of determining, classifying, ranking, reporting or logging an autonomic index;

automatically performing at least one of reporting or logging at least one autonomic index over a predetermined time period before the increased risk of death is determined;

or

determining a time when the increased risk of death returns to a baseline value.

2. The method of claim 1 wherein the autonomic index comprises:

a respiratory rate;

a respiratory rhythm;

a respiratory pattern;

a cardiac rate;

or

a cardiac rhythm over a predetermined period of time related to the increased risk of death.

3. A method for determining in real-time an increased risk of death relating to a patient with epilepsy, comprising:

receiving at least one of cardiac data, arousal data or responsiveness data into a processing device;

determining at least one of a cardiac index or an arousal index or a responsiveness index, the at least one of a cardiac index, an arousal index or a responsiveness index being based upon cardiac data or arousal data or responsiveness data respectively;

determining an increased risk of death associated with epilepsy if at least one of the cardiac index, the arousal index or the responsiveness index is an extreme value;

issuing, automatically, a warning of the occurrence of the increased risk of death; and

logging, automatically, information related to the increased risk of death.

4. The method of claim 3, wherein determining the increased risk of death associated with epilepsy comprises at least one of:

reaching or crossing an extreme threshold by at least one of the cardiac index, the arousal index or the responsiveness index;

or

determining at least one of a time at which at least one of the cardiac index, the arousal index or the responsiveness index becomes extreme or if there is a likelihood of at least one of the cardiac index, the arousal index or the responsiveness index becoming extreme.

5. The method of claim 3, further comprising identifying a further increase in the risk of death comprises utilizing at least one of:

a time when the increased risk of death is identified;

a time when the warning is issued;

a type of warning issued;

a body organ index related to the determined at least one index and associated with the increased risk of death;

a classification of the increased risk of death;

one or more environmental factors;

one or more patient conditions;

one or more patient activity factors;

or

one or more patient circumstances associated with the increased risk of death.

6. The method of claim 5, wherein the one or more environmental factors, the one or more patient conditions, the one or more patient activity factors, and the one or more patient circumstances are based upon at least one of:

a level of consciousness of the patient;

a level, type and duration of the activity of the patient;

a patient body posture;

a time of day;

a type of seizure activity

a site of origin of the seizure activity;

a frequency of seizure activity;

an intensity of seizure activity;

a duration of seizure activity;

an extent of spread of seizure activity;

one or more brain regions engaged in seizure activity involved by severity of seizure activity;

a time spent in seizure;

a seizure burden on the patient;

a seizure density;

age of the patient;

physical fitness/integrity of the patient;

an impact of seizure activity on the patient;

or

types of medications the patient takes.

7. The method of claim 3, further comprising automatically delivering a therapy to the patient, wherein the therapy comprises at least one of:

an electrical therapy;

a chemical therapy;

a thermal therapy;

cardiac defibrillation;

cardiac pacing;

or

a supportive treatment.

8. The method of claim 3, further comprising automatically performing at least one of determining, classifying, ranking, reporting or logging at least one of an autonomic index from the group comprising:

a respiratory rate;

a respiratory rhythm;

a respiratory pattern;

a cardiac rate; and

a cardiac rhythm over a predetermined period of time.

9. The method of claim 8, further comprising automatically performing at least one of reporting or logging to a memory the at least one determined autonomic index over a predetermined time period before the increased risk of death is determined.

10. The method of claim 3, further comprising determining a time when the increased risk of death returns to a baseline value.

11. The method of claim 3, wherein the cardiac index is selected from the group consisting of heart rate, heart rhythm, EKG complex morphology and blood pressure.

12. The method of claim 3, wherein the at least one of an arousal index, a responsiveness index or an awareness index is selected from the group comprising:

an increase in muscle activity;

heart rate;

blood pressure;

respiratory rate;

eye opening;

eyelid blinking associated with arousal stimulus; and

an ability of a patient to;

react to a simple stimulus, wherein the simple stimulus is at least one of a sensory stimuli, noxious or non-noxious;

react to a complex stimulus, wherein the complex stimulus is at least one of cognitive stimuli;

comprehend or memorize symbols, wherein the symbol is at least one of a verbal, geometric, graphic or visuo-spatial symbol; and

behave adaptively, wherein adaptive behavior is motor or cognitive.

13. The method of claim 3, wherein the at least one of the arousal index, the cardiac index or the responsiveness index becomes extreme based at least upon one of the following:

at least one of the arousal index, the cardiac index or the responsiveness index is above the eightieth percentile of a plurality of reference arousal index values, cardiac index values or responsiveness index values respectively;

at least one of the arousal index, the cardiac index or the responsiveness index is below the twentieth percentile of the plurality of reference arousal index values, cardiac index values or responsiveness index values respectively;

or

at least one of the arousal index, the cardiac index or the responsiveness index is beyond two standard deviations to the right or left of the mean for a normal or a normalized distribution of reference arousal index values, cardiac index values or responsiveness index values respectively, for the patient, a portion of a patient population or a population of patients.

14. The method of claim 3, wherein automatically issuing a warning comprises indicating a severity indication commensurate with the increased risk of death;

and

wherein automatically logging information comprises logging information indicative of the severity indication commensurate with the increased risk of death.

15. An apparatus for determining in real-time an increased risk of death relating to a patient with epilepsy, comprising:

a determination component adapted to;

receive at least one of cardiac data, arousal data or responsiveness data into a processing device;

determine at least one of a cardiac index or an arousal index or a responsiveness index, the at least one of a cardiac index, an arousal index or a responsiveness index being based upon cardiac data or arousal data or responsiveness data respectively;

determine an increased risk of death associated with epilepsy if at least one of the cardiac index, the arousal index or the responsiveness index is an extreme value;

issue, automatically, a warning of the occurrence of the increased risk of death; and

log, automatically, information related to the increased risk of death.

16. The apparatus of claim 15, wherein determining the increased risk of death associated with epilepsy comprises at least one of:

reaching or crossing an extreme threshold by at least one of the cardiac index, the arousal index or the responsiveness index;

or

determining at least one of a time at which at least one of the cardiac index, the arousal index or the responsiveness index becomes extreme or if there is a likelihood of at least one of the cardiac index, the arousal index or the responsiveness index becoming extreme.

17. The apparatus of claim 15, wherein the determination component is further adapted to:

identify a further increase in the risk of death based upon at least one of;

a time when the increased risk of death is identified;

a time when the warning is issued;

a type of warning issued;

a body organ index related to the determined at least one index and associated with the increased risk of death;

a classification of the increased risk of death;

one or more environmental factors;

one or more patient conditions;

one or more patient activity factors;

or

one or more patient circumstances associated with the increased risk of death.

18. The apparatus of claim 17, wherein the one or more environmental factors, the one or more patient conditions, the one or more patient activity factors, and the one or more patient circumstances are based upon at least one of:

a level of consciousness of the patient;

a level, type and duration of the activity of the patient;

a patient body posture;

a time of day;

a type of seizure activity;

a site of origin of the seizure activity;

a frequency of seizure activity;

an intensity of seizure activity;

a duration of seizure activity;

an extent of spread of seizure activity;

one or more brain regions engaged in seizure activity involved by severity of seizure activity or a time spent in seizure;

a seizure burden on the patient;

a seizure density;

age of the patient;

physical fitness/integrity of the patient;

an impact of seizure activity on the patient;

or

types of medications the patient takes.

19. The apparatus of claim 15 further comprising a therapy delivery component adapted to automatically deliver a therapy to the patient.

20. The apparatus of claim 19, wherein the therapy comprises at least one of an electrical therapy, a chemical therapy, a thermal therapy, cardiac defibrillation, cardiac pacing or a supportive treatment.

21. The apparatus of claim 15, wherein the determination component is further adapted to:

automatically perform at least one of determining, classifying, ranking, reporting or logging at least one of an autonomic index from the group comprising a respiratory rate, a respiratory rhythm, a respiratory pattern, a cardiac rate, and a cardiac rhythm over a predetermined period of time;

automatically perform at least one of reporting or logging to a memory the at least one determined autonomic index over a predetermined time period before the increased risk of death is determined;

or

determine a time when the increased risk of death returns to a baseline value.

22. The apparatus of claim 15, wherein the cardiac index is selected from the group comprising:

heart rate;

heart rhythm;

EKG complex morphology; and

blood pressure.

23. The apparatus of claim 15, wherein the at least one of an arousal index, a responsiveness index or an awareness index is selected from the group comprising:

an increase in muscle activity;

heart rate;

blood pressure;

respiratory rate;

eye opening;

eyelid blinking associated with arousal stimulus;

an ability of the patient to;

reflexely react to a simple stimulus, wherein the simple stimulus is at least one of a sensory stimuli, noxious or non-noxious;

react to a complex stimulus, wherein the complex stimulus is at least one of cognitive stimuli;

comprehend or memorize a symbol, wherein the symbol is selected from the group comprising;

a verbal symbol;

geometric symbol;

graphic symbol; and

a visuo-spatial symbol;

behave adaptively, wherein the adaptive behavior is motor or cognitive.

24. The apparatus of claim 15, wherein at least one of the arousal index, the cardiac index or the responsiveness index becomes extreme based at least upon one of the following:

at least one of the arousal index, the cardiac index or the responsiveness index is above the eightieth percentile of a plurality of reference arousal index values, cardiac index values or responsiveness index values respectively;

at least one of the arousal index, the cardiac index or the responsiveness index is below the twentieth percentile of the plurality of reference arousal index values, cardiac index values or responsiveness index values respectively;

or

at least one of the arousal index, the cardiac index or the responsiveness index is beyond two standard deviations to the right or left of the mean for a normal or a normalized distribution of reference arousal index values, cardiac index values or responsiveness index values respectively, for the patient, a portion of a patient population or a population of patients.

25. The apparatus of claim 15, wherein automatically issuing a warning comprises indicating a severity indication commensurate with the increased risk of death;

and

wherein automatically logging information comprises logging information indicative of the severity indication commensurate with the increased risk of death.