PATHOLOGICAL STATE DETECTION USING DYNAMICALLY DETERMINED BODY INDEX RANGE VALUES

• US 20140275828A1
• Filed: 11/19/2013
• Published: 09/18/2014
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan
• Granted Patent: US 11,083,407 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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 5/024 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 5/0533 Measuring galvanic skin response
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1123 Discriminating type of movement, e.g. walking or running A61B5/1116, A61B5/112 take precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• 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 5/222 combined with detection or measurement of physiological parameters, e.g. heart rate
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• 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 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/36064 : Epilepsy
• CPC Class Codes: G01N 2800/2857 : Seizure disorders; Epilepsy

Abstract

We report method of detecting a pathological body state of a patient, comprising receiving a body signal of the patient; determining a body index from said body signal; determining an activity level of said patient; determining a value range for said body index for said patient, based at least in part on said activity level; comparing said body index to said value range; and detecting a pathological state when said body index is outside said value range. 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 method for detecting a pathological body state of a patient, comprising:

receiving a first body signal of the patient;

determining a first body index from said first body signal;

determining an activity level of said patient;

determining a non-pathological range for said first body index, based at least in part on said activity level;

comparing said first body index to said non-pathological range for said first body index;

detecting a pathological body state when said first body index is outside said non-pathological range.

2. The method of claim 1, further comprising

determining at least a second body index;

determining a non-pathological range for said second body index, based at least in part on said activity level;

comparing said second body index to said non-pathological range for said second body index; and

wherein detecting said pathological state comprises detecting said pathological state when said first body index is outside said non-pathological range for said first body index and said second body index is outside said non-pathological range for said second body index.

3. The method of claim 1, further comprising:

in response to detecting said pathological state, performing at least one further action selected from issuing a notice of said detecting, delivering a therapy, issuing a warning, logging a time of occurrence of said detecting, logging a response to a therapy, and logging a severity of said pathological state.

4. The method of claim 1, wherein said first body index is selected from heart rate, heart rate rhythm, heart rate variability, blood pressure, respiratory rate, respiratory rhythm, tidal CO₂, kinetic activity, cognitive activity, dermal activity, arterial pH, cortisol level, catecholamine level, or blood oxygen saturation.

5. The method of claim 1, wherein determining said activity level comprises analyzing a body signal of said patient, wherein said analyzing is performed on sensed data from one or more of an accelerometer, an inclinometer, an electromyography (EMG) sensor, a muscle temperature sensor, an oxygen consumption sensor, a lactic acid accumulation sensor, a sweat sensor, a neurogram sensor, a force transducer, or an ergometer.

6. The method of claim 1, wherein determining said non-pathological body index range is further based at least in part on one or more of a time of day, an environmental condition, a patient'"'"'s body weight and height, a patient'"'"'s body mass index, a patient'"'"'s gender, a patient'"'"'s age, an indicator of said patient'"'"'s overall health, or an indicator of said patient'"'"'s overall fitness.

7. The method of claim 1, wherein said activity level is an activity level for a time window.

8. The method of claim 1, wherein determining said activity level occurs in real time.

9. The method of claim 1, wherein said pathological state is an epileptic event.

10. The method of claim 1, further comprising repeating said steps of determining an activity level of the patient and determining a non-pathological range for said first body index at a time interval ranging from about 100 times per second to about once every four hours.

11. The method of claim 1, wherein determining a non-pathological range for said first body index comprises determining said non-pathological range for said first body index for a first time point based on the patient'"'"'s activity in a first time window prior to said first time point.

13. The method of claim 1 wherein determining a first body index from said first body signal comprises determining a change in said first body index, and wherein detecting said pathological body state when said first body index is outside said non-pathological range comprises determining if said change in said first body index is commensurate with said determined activity level.

12. The non-transitory computer readable program storage unit of claim 12, wherein the duration of said first time window is from 1 second to 2 hours.

14. A method of determining a pathological state in a patient, comprising:

receiving data relating to an activity level of said patient;

determining an activity level of the patient based on said data relating to an activity level;

receiving at least one body signal of the patient;

determining at least a first body index based on said at least one body signal;

dynamically determining a reference value range for said at least a first body index based on said activity level;

determining that the patient is in one of a non-pathological state and a pathological state, wherein said patient is determined to be in a non-pathological state if the at least a first body index is within said reference value range for said activity level, and said patient is determined to be in a pathological state if the at least a first body index is outside said reference value range; and

taking at least one further action based on determining that the patient is in a pathological state, wherein said further action is selected from treating said pathological state, issuing a warning to the patient or a caregiver regarding said pathological state, logging the occurrence of said pathological state, logging the response to a therapy, or logging a severity of said pathological state.

15. The method of claim 14, wherein said reference value range comprises one of a non-pathological range and a pathological range.

16. The method of claim 14, wherein said pathological state is an epileptic seizure.

17. The method of claim 14, wherein said at least one body signal is selected from a cardiac signal, a respiratory signal, a blood signal, a dermal signal and an endocrine signal.

18. The method of claim 14, wherein said first body index is selected from:

a cardiac index based on said cardiac signal, wherein said cardiac index is selected from a heart rate, heart rhythm, a heart rate variability, and a blood pressure;

a respiratory index based on said respiratory signal, wherein said respiratory index is selected from a respiratory rate, respiratory rhythm, blood oxygen saturation, and an end tidal CO₂ concentration;

a dermal index based on said dermal signal, wherein said dermal index is selected from a skin resistivity and a skin conductivity;

a blood index based on said blood signal, wherein said blood index is selected from an arterial pH and a lactic acid concentration; and

an endocrine index based on said endocrine signal, wherein said endocrine signal is selected from a cortisol level and a catecholamine level.

19. A medical device system, comprising:

at least one kinetic sensor, each said sensor configured to collect at least one kinetic signal from a patient;

an activity level module configured to determine an activity level of said patient, based at least in part on said at least one kinetic signal;

at least one sensor configured to sense a body signal;

a body index determination module configured to determine at least a first body index based on said sensed body signal;

a body index range module, configured to determine a non-pathological body index range for said at least a first body index, based at least in part on said activity level; and

a pathological state determination module, configured to determine that the patient is in one of a non-pathological state and a pathological state, wherein said patient is determined to be in a non-pathological state if the at least a first body index is within said non-pathological body index range for said at least a first body index, and said patient is determined to be in a pathological state if the at least a first body index is outside said non-pathological body index range for said at least a first body index.

20. The medical device system of claim 19, wherein said body signal is selected from heart rate, heart rhythm heart rate variability, blood pressure, respiratory rate, respiratory rhythm, end tidal CO₂, dermal activity, arterial pH, cortisol level, catecholamine level, or blood oxygen saturation.

21. The medical device system of claim 19, further comprising an additional factor module configured to determine one or more of a time of day, an indicator of said patient'"'"'s overall health, an indicator of said patient'"'"'s overall fitness, or an indicator of said patient'"'"'s level of consciousness, and provide an output relating to said determination;

wherein said body index range module is further configured to determine a non-pathological body index range for said at least a first body index based at least in part on said output of said additional factor module.

22. The medical device system of claim 19, wherein said pathological state is an epileptic event.