Detecting, assessing and managing a risk of death in epilepsy

• US 10,226,220 B2
• Filed: 10/30/2017
• Issued: 03/12/2019
• 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:
  US15/796,887
• Publication Number:
  US 20180049704A1
• Time in Patent Office: 498 Days
• Field of Search: None
• 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 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 monitoring an increased risk of death relating to a patient with epilepsy, comprising:

receiving cardiac data into a medical device;

determining via the medical device at least one cardiac index based upon the cardiac data;

determining via the medical device the increased risk of death associated with epilepsy based on the at least one cardiac index being in an extreme state;

initiating at least one of issuing a warning of an occurrence of the increased risk of death and delivering a therapy based on the occurrence of the increased risk of death; and

logging information related to the increased risk of death.

2. The method of claim 1, wherein the extreme state relates to a respiratory dysfunction.

3. The method of claim 1, further comprising at least one of determining an autonomic index, classifying the autonomic index, ranking the autonomic index, reporting the autonomic index, and logging the autonomic index.

4. The method of claim 1, further comprising at least one of reporting and logging at least one autonomic index over a first predetermined time period before the increased risk of death is determined.

5. The method of claim 1, further comprising determining that an increased risk of death state has returned to a baseline value.

6. The method of claim 1, further comprising determining an autonomic index where the autonomic index includes at least one of a respiratory rate, a respiratory rhythm, a respiratory pattern, a cardiac rate, and a cardiac rhythm over a time period related to the increased risk of death.

7. A medical device configured to monitor for an increased risk of death to a patient with epilepsy, comprising:

one or more processors configured to receive cardiac data from one or more sensors, the one or more processors configured to determining a cardiac index based on the cardiac data, the one or more processors configured to determining the increased risk of death associated with epilepsy based on the cardiac index, the one or more processors configured to determine one or more grades associated with the determined increased risk of death, and the one or more processors configured to issue one or more warnings based on the one or more grades determinations.

8. The medical device of claim 7, wherein the one or more processors are configured to issue a first warning based on a first grade determination.

9. The medical device of claim 8, wherein the one or more processors are configured to issue a second warning based on a second grade determination.

10. The medical device of claim 7, wherein the one or more processors are configured to issue no warning based on a first grade determination and a first characteristic for a first patient determined via the one or more processors.

11. The medical device of claim 10, wherein the one or more processors are configured to issue a first warning based on the first grade determination and the first characteristic for a second patient determined via the one or more processors.

12. The medical device of claim 11, wherein the one or more processors are configured to issue a second warning based on the first grade determination and the first characteristic for a third patient determined via the one or more processors.

13. The medical device of claim 7, wherein the one or more processors are configured to issue an extreme warning based on an Nth grade determination.

14. The medical device of claim 7, wherein the one or more processors are configured to initiate an action based on at least one of a surrounding determination and a grade determination.

15. The medical device of claim 14, wherein the action is at least one of turning on a device and turning off the device.

16. A method of monitoring for an increased risk of death to a patient with epilepsy, comprising:

receiving cardiac data from one or more sensors;

determining via one or more processors a cardiac index based on the cardiac data;

determining the increased risk of death associated with epilepsy based on the cardiac index;

determining one or more grades associated with the determined increased risk of death, and issuing one or more warnings based on the one or more grades determinations.

17. The method of claim 16, further comprising issuing a first warning and delivering a first therapy based on a first grade determination.

18. The method of claim 17, further comprising issuing a second warning and delivering a second therapy based on a second grade determination.

19. The method of claim 16, further comprising issuing no warning and not delivering a therapy based on a first grade determination and a first characteristic for a first patient determined via the one or more processors.

20. The method of claim 19, further comprising issuing a first warning and delivering a first therapy based on the first grade determination and the first characteristic for a second patient determined via the one or more processors.

21. The method of claim 20, further comprising issuing a second warning and delivering a second therapy based on the first grade determination and the first characteristic for a third patient determined via the one or more processors.

22. The method of claim 16, further comprising issuing an extreme warning and delivering a therapy based on an Nth grade determination.

23. The method of claim 16, further comprising initiating an action based on at least one of a surrounding determination and a grade determination.

24. The method of claim 23, wherein the action is at least one of turning on a device and turning off the device.