Detecting, assessing and managing a risk of death in epilepsy

• US 8,562,524 B2
• Filed: 04/20/2011
• Issued: 10/22/2013
• Est. Priority Date: 03/04/2011
• 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:
  US13/091,033
• Publication Number:
  US 20120271372A1
• Time in Patent Office: 916 Days
• Field of Search: 600/16, 600/17, 600/300, 600/483, 600/508, 600/509, 600515-519
• US Class Current: 600/300
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1117 Fall detection
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4227 endocrine glands, i.e. thyroid, adrenals, hypothalamic, pituitary
• 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 5/4866 Evaluating metabolism A61B5/083 takes precedence
• 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 1/36064 Epilepsy
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A method for determining and responding in real-time to an increased risk of death relating to a patient with epilepsy is provided. The method includes receiving cardiac data and determining a cardiac index based upon the cardiac data. The method includes 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. Also presented is a second method for determining and responding in real-time to an increased risk of death relating to a patient with epilepsy comprising 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. The second method includes 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 computer readable program storage device is also provided. Also provided is a method for receiving body data, determining a cardiac, an arousal, a responsiveness, or a kinetic index, determining an increased or increasing risk of death over a first time window relating to a patient with epilepsy and issuing a warning and logging relevant information.

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, said 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 determining a further increase in the risk of death;

wherein logging comprises logging at least one of a time when the increased risk of death is identified, a time when the further 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 at least one of the increased risk of death or the further increased risk of death, a classification of at least one of the increased risk of death or the further 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; and

wherein the one or more environmental factors, the one or more patient activity factors, the one or more patient conditions, 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 body posture of the patient, a time of day, a type of seizure activity, a site of origin of the seizure activity, a frequency of seizure activity, an intensity, 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, the age of the patient, the physical fitness/integrity of the patient, an impact of seizure activity on the patient, or types of medications the patient takes.

2. 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, said 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 at least one of an autonomic index from the group consisting of a respiratory rate, a respiratory rhythm, a respiratory pattern, a cardiac rate, and a cardiac rhythm over a predetermined period of time related to said increased risk of death;

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 said increased risk of death returns to a baseline value.

3. 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, said 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;

determining a time scale at which said extreme autonomic index is associated with a risk of death;

determining an increased risk of sudden death if the time scale upon which the increase risk of death applies is a microscopic scale; and

issuing a warning of an elevated risk of sudden death in response to said determining that there is a an elevated risk of sudden death, wherein the warning is indicative of at least one of a minor risk, a moderate risk, a major risk or an extreme risk.

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

receiving at least one of arousal data, responsiveness data or awareness data into a medical device;

determining, at the medical device, at least one of an arousal index, a responsiveness index or an awareness index, said at least one of an arousal index, a responsive index or an awareness index being based upon said arousal data, responsiveness data or said awareness data respectively;

determining, at the medical device, an increased risk of death related to epilepsy if said at least one of an arousal index, a responsiveness index or an awareness 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.

5. The method of claim 4, wherein the responsiveness index comprises an awareness index.

6. The method of claim 4, wherein determining the increased risk of death relating to a patient with epilepsy comprises at least one of:

a reaching or a crossing of an extreme threshold by said at least one of an arousal index, a responsiveness index or an awareness index;

or

determining at least one of a time at which at least one of a responsiveness index or an awareness index becomes extreme or if there is a likelihood of said at least one of an awareness index, a responsiveness index or an awareness index becoming extreme.

7. The method of claim 4, further comprising determining a further increase in the risk of death;

and

wherein logging comprises logging 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; and

wherein the one or more environmental factors, the one or more patient activity factors, the one or more patient conditions, 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 body posture of the patient, a time of day, a type of seizure activity, a site of origin of the seizure activity, a frequency of seizure activity, an intensity, 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, the age of the patient, the physical fitness/integrity of the patient, an impact of seizure activity on the patient or types of medications the patient takes.

8. The method of claim 4, further comprising automatically delivering a therapy to the patient, wherein said therapy comprises at least one of an electrical therapy, a chemical therapy, a thermal therapy, cardiac defibrillation, cardiac pacing or a supportive treatment.

9. The method of claim 4, further comprising at least one of:

automatically performing at least one of classifying, ranking, reporting or logging at least one of an autonomic index from the group consisting of a respiratory rate, a respiratory rhythm, a respiratory pattern, a cardiac rate, and a cardiac rhythm over a predetermined period of time related to said increased risk of death;

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

or

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

10. The method of claim 4, further comprising at least one of:

wherein a responsiveness index or an awareness index is selected from the group comprising an ability of a patient to reflexely react to a simple stimulus, to react to a complex stimulus, to comprehend symbols, to memorize symbols, to behave adaptively, and wherein the simple stimulus is at least one of a sensory stimuli, noxious or non-noxious, the complex stimulus is at least one of cognitive stimuli, the symbol is at least one of a verbal, geometric, graphic or visuo-spatial symbol and adaptive behavior is motor or cognitive, and wherein an arousal index is at least one of an increase in muscle activity, heart rate. blood pressure, respiratory rate, eye opening, eyelid blinking associated with an arousal stimulus;

wherein the at least one responsiveness index becomes an extreme value based at least upon one of the following;

the at least one responsiveness index is above the eightieth percentile of at least one of a plurality of reference responsiveness index values;

the at least one of a responsiveness index is below the twentieth percentile of the at least one of a plurality of reference responsiveness index values;

or

the at least one of a responsiveness index is beyond two standard deviations to the right or left of the mean for a normal or a normalized distribution of at least one of a responsiveness index values for the patient or a population of patients;

or

determining an additional autonomic index based upon a heart rate, a heart rhythm, a heart rate variability, a respiratory rate, a respiratory rhythm, a respiratory pattern, breath morphology, an oxygen saturation of the patient or a carbon dioxide concentration in the patient.

11. The method of claim 4, further comprising determining at least one additional index from at least one of an autonomic index, a metabolic index, an endocrine index, a tissue stress index, or a physical fitness/integrity index, said at least one additional index being based upon body data;

wherein the autonomic index is at least one of heart rate, heart rhythm, EKG complex morphology or blood pressure;

wherein the metabolic index comprises a blood index selected from the group comprising at least one of an arterial pH, a lactic acid concentration, a serum potassium concentration, a serum glucose concentration, a lactate-pyruvate ratio, at least one electrolyte concentration, and a bicarbonate concentration;

wherein the endocrine index is a concentration or level of at least one of an epinephrine or its metabolites, a norepinephrine or its metabolities, a dopamine or its metabolites, an acetyl-choline or its metabolites, a serotonin or its metabolites, a growth hormone, a cortisol, prolactin, ACTH, vasopressin, a beta-endorphin, or a lipotropin;

wherein the tissue stress index is at least one of a serum creatine kinase (CK), a troponin, a reactive oxygen species, a reactive nitrogen species, a neuroprostane, a gluthatione;

wherein the physical fitness/integrity index is at least one of one or more strength tests, one or more speed and power tests, one or more physical endurance tests, or one or more flexibility tests; and

wherein the additional index becomes extreme based at least upon one of the following;

the additional index is above the eightieth percentile of a plurality of reference index values;

the additional index is below the twentieth percentile of the plurality of reference index values;

or

the additional index is beyond two standard deviations to the right or left of the mean for a normal or a normalized distribution of index values for the patient or a population of patients.

12. The method of claim 4, wherein determining said increased risk comprises determining at least one of:

an increased risk of death associated with epilepsy over a macroscopic time scale;

an increased risk of death associated with epilepsy over a mesoscopic time scale;

or

an increased risk of death associated with epilepsy over a microscopic time scale.

13. The method of claim 4, wherein automatically issuing a warning comprises indicating a severity indication related to 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.

14. The method of claim 4, further comprising:

determining a time scale at which said a neurologic index is associated with risk of death;

upon determination that the time scale upon which the increase risk of death applies is a microscopic scale, determining an increased risk of sudden death an occurrence of said extreme seizure event; and

issuing a warning of an elevated risk of sudden death in response to said determining that there is an elevated risk of sudden death.

15. A non-transitory, computer-readable storage device for storing instructions that, when executed by a processor, perform a method for determining in real-time of 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, said 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.

16. A non-transitive, computer-readable storage device for storing instructions that, when executed by a processor, perform the method as in claim 15, wherein identifying the increased risk of death relating to a patient with epilepsy comprises at least one of:

a reaching or a crossing of 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. A non-transitive, computer-readable storage device for storing instructions that, when executed by a processor, perform the method as in claim 15, further comprising identifying a further increase in the risk of death;

wherein information comprises 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; and

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, 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, the age of the patient, the physical fitness/integrity of the patient, an impact of seizure activity on the patient, or types of medications the patient takes.

18. A non-transitive, computer-readable storage device for storing instructions that, when executed by a processor, perform the method as in claim 15, further comprising at least one of:

automatically delivering a therapy to the patient, wherein said therapy comprises at least one of an electrical therapy, a chemical therapy, a thermal therapy, cardiac defibrillation, cardiac pacing or a supportive treatment;

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;

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;

or

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

19. A non-transitive, computer-readable storage device for storing instructions that, when executed by a processor, perform the method as in claim 15, wherein the cardiac index is selected from the group consisting of heart rate, heart rhythm, EKG complex morphology and blood pressure;

wherein the at least one of an arousal index, a responsiveness index or an awareness index is selected from the group consisting of an increase in muscle activity, heart rate. blood pressure, respiratory rate, eye opening, eyelid blinking associated with arousal stimulus, an ability of a patient to reflexely react to a simple stimulus, to react to a complex stimulus, to comprehend symbols, to memorize symbols, to behave adaptively, and wherein the simple stimulus is at least one of a sensory stimuli, noxious or non-noxious, the complex stimulus is at least one of cognitive stimuli, the symbol is at least one of a verbal, geometric, graphic or visuo-spatial symbol and adaptive behavior is motor or cognitive; and

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.

20. A non-transitive, computer-readable storage device for storing instructions that, when executed by a processor, perform the method as in 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.

21. A method, comprising:

receiving body data into a medical device;

determining, at the medical device, at least one of a cardiac index, an arousal index, a responsiveness index, or a kinetic index based at least upon said body data;

determining, at the medical device, at least one of an increased risk of death or an increasing risk of death over a first time window relating to a patient with epilepsy based at least upon said at least one determined index, wherein said increased risk of death relating to epilepsy and said increasing risk of death relating to epilepsy comprise at least one of;

a seizure coupled with at least one of bradycardia or asystole or a lack of arousability or of responsiveness of the patient;

at least one patient condition, patient activity or environmental circumstance external to the seizure event that when coupled with a seizure cause an increased or increasing risk of death;

or

a seizure that has a higher than normal risk of death;

issuing automatically a warning in real-time of the occurrence of said identified increased risk of death or increasing risk of death over a first time window to at least one of the patient, a caregiver or emergency response personnel; and

logging automatically relevant information related to said identified increased risk of death or increasing risk of death over a first time window.

22. The method of claim 21, further comprising:

determining the at least one of an increased risk of death relating to epilepsy or an increasing risk of death relating to epilepsy based upon at least one of an oxygen saturation in the patient or a carbon dioxide build up in the patient;

identifying the at least one of an increased risk of death relating to epilepsy or an increasing risk of death relating to epilepsy based at least upon said determining at least one of an oxygen saturation in the patient or a carbon dioxide build up in the patient;

issuing, automatically, a warning of the occurrence of the at least one of an increased risk of death relating to epilepsy or an increasing risk of death relating to epilepsy to at least one of the patient, a caregiver or emergency response personnel; and

logging, automatically, information related to the at least one of an increased risk of death relating to epilepsy or an increasing risk of death relating to epilepsy.

23. The method of claim 21, further comprising at least one of:

determining an arousal or a responsiveness index associated with the patient and correlating the determined arousal level or responsiveness level with the at least one of an oxygen saturation in the patient or a carbon dioxide build up in the patient;

determining a respiratory index based upon at least one of a respiratory rate, a respiratory rhythm, a respiratory pattern, breath morphology, an oxygen saturation of the patient or a carbon dioxide concentration in the patient;

determining a physical fitness/integrity index associated with the patient;

or

wherein the cardiac index is blood pressure; and

wherein identifying said increased risk of death further comprises identifying at least one of;

an oxygen saturation decreasing to an unsafe level for a patient having a physical fitness/integrity index greater than or equal to a reference value;

an oxygen saturation decreasing by five percent for a patient having a physical fitness/integrity index less than the reference value;

a carbon dioxide build up value increasing to an unsafe level for a patient having a physical fitness/integrity index greater than or equal to the reference value; and

a carbon dioxide build up value increasing by five percent for a patient having a physical fitness/integrity index less than the normal or normalized reference value for a population or a sample of said population or the individual patient.

24. The method for warning in real-time of an increased risk of death relating to a patient with epilepsy of claim 21, wherein identifying said increased risk of death further comprises:

determining at least one of a tissue stress index or a metabolic index; and

confirming the increased risk of death based at least upon the at least one of a tissue stress index or a metabolic index.