PATHOLOGICAL STATE DETECTION USING DYNAMICALLY DETERMINED BODY DATA VARIABILITY RANGE VALUES

• US 20140275840A1
• Filed: 03/13/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Application

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan
• Application Number:
  US14/208,952
• Publication Number:
  US 20140275840A1
• Time in Patent Office: Days
• US Class Current: 600/301
• 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 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence

Abstract

We report a method of detecting a pathological body state of a patient, comprising receiving a body signal of the patient; determining a BDV from said body signal; determining an activity level of said patient; determining a value range for said BDV for said patient, based at least in part on said activity level; comparing said BDV to said value range; and detecting a pathological state when said BDV 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 data variability (BDV) from said first body signal;

determining an activity level of said patient;

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

comparing said first BDV to said non-pathological range for said first BDV;

detecting a pathological body state when said first BDV is outside said non-pathological range; and

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

2. The method of claim 1, further comprising

determining at least a second BDV;

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

comparing said second BDV to said non-pathological range for said second BDV;

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

3. The method of claim 1, wherein said first BDV is selected from heart rhythm variability, heart rate variability, blood pressure variability, respiratory rate variability, respiratory rhythm variability, respiratory sinus arrhythmia, end tidal CO₂ concentration variability, power variability at a certain neurological index frequency band, kinetic activity variability, cognitive activity variability, skin resistivity variability, skin conductivity variability, arterial pH variability, venous pH variability, arterial-venous pH difference variability, lactic acid concentration variability, cortisol level variability, catecholamine level variability, EKG morphology variability, heart rate pattern variability, pupillary diameter variability, or blood oxygen saturation variability.

4. The method of claim 1, further comprising

determining at least a second body data index;

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

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

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

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

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

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

8. 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 BDV at a sampling rate ranging from about 100 times per second to about once every four hours.

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

10. The method of claim 9, wherein the duration of said first time window is from 1 second to 2 hours.

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

12. The method of claim 1, wherein determining said non-pathological range comprises dynamically determining said non-pathological value range.

13. The method of claim 1, wherein said first BDV is selected from:

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

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

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

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

a neurological index variability based on a brain signal or a nerve signal, wherein said neurological index variability is selected from a power variability at a certain frequency band, a kinetic activity variability, and cognitive activity variability; and

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

14. A medical device system, comprising:

at least one sensor, each said sensor configured to collect at least one body 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 body signal;

a current BDV module configured to determine at least a first BDV based on said at least one body signal;

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

a pathological state determination module, configured to determine that the patient is in a pathological state if said at least first BDV is outside said non-pathological BDV range for said at least first BDV.

15. The medical device system of claim 14, wherein said first BDV is selected from heart rhythm variability, heart rate variability, blood pressure variability, respiratory rate variability, respiratory rhythm variability, respiratory sinus arrhythmia, end tidal CO₂ concentration variability, power variability at a certain neurological index frequency band, kinetic activity variability, cognitive activity variability, skin resistivity variability, skin conductivity variability, arterial pH variability, venous pH variability, arterial-venous pH difference variability, lactic acid concentration variability, cortisol level variability, catecholamine level variability, an EKG morphology variability, a heart rate pattern variability, a pupillary diameter variability, or blood oxygen saturation variability.

16. The medical device system of claim 14, further comprising an additional factor module configured to determine one or more of a time of day, an environmental condition, an indicator of said patient'"'"'s state, an indicator of said patient'"'"'s body weight and height, an indicator of said patient'"'"'s body mass index, an indicator of said patient'"'"'s gender, an indicator of said patient'"'"'s age, 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 BDV range determination module is further configured to determine a non-pathological BDV range for said at least a first BDV based at least in part on said output of said additional factor module.

17. The medical device system of claim 14, wherein said pathological state is an epileptic event.

18. A method, comprising:

receiving a first body signal of the patient;

determining a change in a first body data variability (BDV), based on said first body signal;

determining an activity level of said patient;

determining if said change in said first BDV is commensurate with said determined activity level; and

,

taking a further action in response to determining that said change in said first BDV is incommensurate with said determined activity level.

19. The method of claim 18, wherein said further action is selected from issuing a notice of said change, delivering a therapy, issuing a warning, logging a time of occurrence of said change, logging a response to a therapy, or logging a severity of said pathological state.