Seizure detection based on work level excursion

• US 9,788,779 B2
• Filed: 01/30/2014
• Issued: 10/17/2017
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/169,006
• Publication Number:
  US 20140275831A1
• Time in Patent Office: 1,356 Days
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence

Abstract

We report a method of determining an occurrence of an epileptic convulsive seizure in a patient, comprising: receiving body data from a patient during a first time period, determining a work level relating to said first time period at least based partially upon said body data; determining whether said work level exceeds an extreme work level threshold; performing a responsive action, in response to a determination that said work level exceeds said extreme work level threshold. We also report a medical device system configured to implement the method. We also report a non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform the method.

Claims

1. A medical device, comprising:

a body data module configured to receive body data from a patient;

a work level data module configured to determine a first work level for the patient during a first time period, and a second work level for the patient during a second time period;

a work level excursion module configured to;

determine whether the second work level exceeds the first work level by an amount greater than a first work level excursion threshold which indicates that the second work level has a current body signal value which is incommensurate to an expected body signal value range for the second work level; and

detect a work level excursion based upon the determination that the current body signal value for the second work level is incommensurate to the expected body signal value range for the second work level which indicates an epileptic seizure event; and

a controller configured to perform at least one of generating a warning of the epileptic seizure event, providing a therapy for the epileptic seizure event, or logging an occurrence of the epileptic seizure event, in response to detecting the work level excursion.

2. The medical device of claim 1, wherein the first time period is at a first time of day on a current day and the second time period is at the first time of day on at least one prior day.

3. The medical device of claim 1, wherein the first time period and the second time period are contiguous, partially overlapping, or fully overlapping.

4. The medical device of claim 1, wherein the first work level and the second work level are each a work level magnitude or a work level rate of change.

5. The medical device of claim 1, further comprising:

at least one sensor, each configured to collect at least one body signal from the patient relating to a work level of the patient.

6. The medical device of claim 5, wherein the at least one sensor comprises at least one of:

an autonomic data acquisition unit configured to acquire at least one of heart beat data, blood pressure data, respiration data, or blood gas data;

a neurological data acquisition unit configured to acquire kinetic data selected from the group consisting of accelerometer data and inclinometer data;

an endocrine data acquisition unit configured to acquire endocrine data,

a metabolic data acquisition unit configured to acquire metabolic data;

a tissue stress marker data acquisition unit configured to acquire tissue stress marker data;

or

a physical fitness data acquisition unit configured to acquire data relating to the patient'"'"'s physical fitness.

7. The medical device of claim 1, further comprising a patient state data unit configured to determine the patient state based upon the body data.

8. The medical device of claim 1, wherein the medical device is configured to confirm the pathological state based on at least one of cardiac data of the patient, kinetic data of the patient, the patient'"'"'s responsiveness, or a patient'"'"'s awareness.

9. The medical device of claim 1, wherein the work level excursion threshold is based at least in part on one or more of a time of day, an environmental condition, an indicator of the patient'"'"'s overall health, an indicator of the patient'"'"'s hydration status, an indicator of the patient'"'"'s overall fitness, the patient'"'"'s body weight and height, the patient'"'"'s body mass index, the patient'"'"'s gender, or the patient'"'"'s age.

10. The medical device of claim 1, wherein the work level data module comprises:

a body data analysis module to determine a value relating to at least one of a cardiac data, a blood pressure data, a respiration data, a blood gas data, a patient kinetic data, a responsiveness data, an endocrine data, a metabolic data, or a tissue stress marker data; and

a work level determination unit to determine the first work level and the second work level based upon at least one of the cardiac data, the blood pressure data, the respiration data, the blood gas data, the patient kinetic data, the responsiveness data, endocrine data, the metabolic data, or the tissue stress marker data.

11. The medical device of claim 10, wherein the work level excursion module is further configured to determine the first work level excursion threshold based on at least one of the body data, a time of day, or a patient state.

12. The medical device of claim 11, further comprising a patient state module configured to determine the patient state based upon the body data.

13. The medical device of claim 10, further comprising:

a background activity time period module configured to provide data relating to historic patient activity in relation to time of day;

a body data activity correlation unit configured to correlate the body data to at least one of a plurality of candidate states based upon the data relating to historic patient activity; and

a patient input unit configured to receive input from the patient.

14. The medical device of claim 10, wherein the work level excursion module is further configured to determine the first work level excursion threshold based at least one on the body data, a time of day, or the patient state.

15. The medical device of claim 1, wherein the work level excursion is pathological.

16. The medical device of claim 1, further comprising:

a warning unit to provide a warning in response to a determine that the work level excursion has occurred; and

a logging unit to log at least one of an occurrence or a severity of the work level excursion, wherein logging comprises storing to memory one or more of;

a date, a time, or a severity of the epileptic seizure event;

a type of therapy delivered to treat the epileptic seizure event;

or at least one effect of a therapy delivered to treat the epileptic seizure event.

17. The medical device of claim 1, further comprising a therapy delivery source configured to deliver an electrical stimulation, a drug, or a thermal therapy to a tissue of the patient, in response to a determination that the work level excursion has occurred.

18. A medical device, comprising:

a body data module configured to receive body data from a patient;

a work level data module configured to determine a first patient work level during a first time period and a second patient work level during a second time period;

a work level excursion module configured to;

determine whether the second work level exceeds the first work level by an amount greater than a first work level excursion threshold which indicates a first state; and

determine a change in body data from the first work level to the second work level; and

a controller configured to perform at least one of generating a warning, providing a therapy, or logging data related to the first state when the change in the body data is not commensurate with the second work level, the controller further configured to suppress the warning and the therapy when the change in the body data is commensurate with the second work level, the controller further configured to log data relating to at least one of the first work level, the second work level, and the change in the body data when the change in the body data is commensurate with the second work level.

19. The medical device of claim 18, further comprising a therapy delivery source configured to deliver an electrical stimulation, a drug, or a thermal therapy to a tissue of the patient.

20. The medical device of claim 18, wherein a force sensing unit is configured to determine a change in kinetic data from the first work level to the second work level, the controller configured to perform at least one of generating the warning, providing the therapy, or logging data related to the first state when the change in the kinetic data is not commensurate with the second work level, the controller further configured to suppress the warning and the therapy when the change in the kinetic data is commensurate with the second work level, the controller further configured to log data relating to at least one of the first work level, the second work level, and the change in the kinetic data when the change in the kinetic data is commensurate with the second work level.

21. A medical device, comprising:

a body data module configured to receive body data from a patient;

a work level data module configured to determine a first work level for the patient during a first time period and a second work level for the patient during a second time period;

a work level excursion module configured to;

determine whether the second work level does not exceed the first work level by an amount greater than a first work level excursion threshold;

determine if the body signal value correlated with the second work level not exceeding the first work level by the amount greater than the first work level excursion threshold is incommensurate with the second work level; and

when the body signal value is incommensurate with the second work level not exceeding the first work level by the amount greater than the first work level excursion threshold which indicates an epileptic seizure event, perform via a controller at least one of generating a warning of the epileptic seizure event, providing a therapy for the epileptic seizure event, or logging an occurrence of the epileptic seizure event.

22. A medical device, comprising:

a body data module configured to receive body data from a patient;

a work level data module configured to determine a first work level for the patient during a first time period and a second work level for the patient during a second time period;

a work level excursion module configured to;

determine whether the second work level does not exceed the first work level by an amount greater than a first work level excursion threshold which is associated with a first body signal value;

determine if a change in the first body signal value associated with the second work level is outside of a range; and

determine an epileptic seizure when a determination that the change in the first body signal value is outside of the range and occurred during the second time period; and

a controller configured to perform at least one of generating a warning of the epileptic seizure, providing a therapy for the epileptic seizure, or logging an occurrence of the epileptic seizure.