Detecting or validating a detection of a state change from a template of heart rate derivative shape or heart beat wave complex

• US 8,452,387 B2
• Filed: 09/20/2010
• Issued: 05/28/2013
• Est. Priority Date: 09/16/2010
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan, Frei, Mark G.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US12/886,419
• Publication Number:
  US 20120071775A1
• Time in Patent Office: 981 Days
• Field of Search: 600508-509
• US Class Current: 600/509
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• 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: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36064 Epilepsy

Abstract

Methods, systems, and apparatus for detecting and/or validating a detection of a state change by matching the shape of one or more of a cardiac data series, a heart rate variability data series, or at least a portion of a heart beat complex, derived from cardiac data, to an appropriate template.

Claims

1. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for confirming an occurrence of a brain state change, comprising:

obtaining data relating to at least a portion of a heart beat complex shape from a patient;

identifying an occurrence of a brain state change based upon a first body parameter, wherein said first body parameter is not a parameter relating to at least a portion of said first heart beat complex shape;

comparing said at least said portion of said heart beat complex shape with a corresponding portion of a first reference heart beat complex shape template of said patient; and

,

confirming an occurrence of a brain state change based upon a determination that said heart beat complex shape fails to match said first reference heart beat complex shape template;

wherein said comparing and said confirming are performed in response to said identifying, to validate said identifying.

2. The non-transitory computer readable program storage unit of claim 1, wherein said identifying comprises:

obtaining a time series of cardiac data from a patient;

determining a reference heart rate parameter from said cardiac data;

determining a heart rate derivative shape from said time series of cardiac data, wherein said heart rate derivative shape comprises at least one characteristic selected from a number of phases relative to said reference heart rate parameter, a number of extrema of said heart rate derivative, a number of directions of change of said heart rate derivative, an area under the curve of at least one phase, a number of positive phases, or a number of negative phases; and

,

identifying said occurrence of said brain state change based upon a determination that said heart rate derivative shape matches a brain state change template in said at least one characteristic.

3. The non-transitory computer readable program storage unit of claim 2, wherein said heart rate derivative is selected from heart rate or heart rate variability.

4. The non-transitory computer readable program storage unit of claim 2, wherein said identifying further comprises:

determining a second reference heart rate parameter; and

determining a second heart rate derivative shape from said time series of cardiac data, wherein said second heart rate derivative shape comprises at least one second characteristic selected from a number of phases relative to said reference heart rate parameter, a number of positive phases relative to said reference heart rate parameter, a number of negative phases relative to said reference heart rate parameter, a number of extrema of said second heart rate derivative, an area under the curve of at least one phase, or a number of directions of change of said second heart rate derivative;

wherein said identifying said occurrence of said state change is further based upon a determination that said second heart rate derivative shape matches a second brain state change template in said at least one second characteristic.

5. The non-transitory computer readable program storage unit of claim 1, wherein said portion of said heart beat complex shape comprises at least one of an amplitude of a P wave, a polarity of a P wave, an amplitude of an R wave, a polarity of a Q wave, a polarity of an R wave, an amplitude of an S wave, a polarity of an S wave, an amplitude of a T wave, a polarity of a T wave, an area under the curve of a P wave, an area under the curve of a Q wave, an area under the curve of an R wave, an area under the curve of an S wave, an area under the curve of a T wave, a width of a P wave, a width of a Q wave, a width of an R wave, a width of an S wave, a width of a T wave, a morphology of a P wave, a morphology of a Q wave, a morphology of an R wave, a morphology of a T wave, a magnitude of a change in the distance from a P wave to a Q wave, a magnitude of a change in the distance from a P wave to an R wave, a magnitude of a change in the distance from a Q wave to an R wave, a magnitude of a change in the distance from an R wave to an S wave, a magnitude of a change in the distance from an R wave to a T wave, a magnitude of a change in the distance from an S wave to a T wave, a magnitude of an S-T segment elevation, a magnitude of an S-T segment depression, a magnitude of a Q-T segment elevation, a magnitude of a Q-T segment depression, a P-R interval, an R-S interval, an S-T interval, an R-T interval, and a Q-T interval.

6. The non-transitory computer readable program storage unit of claim 1, wherein said comparing further comprises comparing said at least a portion of said first heart beat complex shape with a corresponding portion of a second reference heart beat complex shape template of said patient, and wherein said confirming is based upon a determination that said first heart beat complex shape fails to match at least one of said first reference heart beat complex shape template and said second reference heart beat complex shape template.

7. The non-transitory computer readable program storage unit of claim 1, wherein said method further comprises:

obtaining a time series of data relating to a plurality of heart beat complex shapes from said patient, said obtaining occurring after said confirming;

comparing at least a portion of each of a sequential plurality of heart beat complex shapes with a corresponding portion of said first reference heart beat complex shape template; and

,

indicating a termination of said brain state change based upon a determination that at least one heart beat complex shape of said sequential plurality of heart beat complex shapes matches said first reference heart beat complex shape template, after said confirming an occurrence of a brain state change.

8. The non-transitory computer readable program storage unit of claim 1, wherein said method further comprises taking an action in response to said confirming, wherein said action is providing a warning of said brain state change, logging a time of said brain state change, computing one or more brain state change indices, logging one or more computed brain state change indices, providing at least one treatment of said brain state change, or two or more thereof.

9. The non-transitory computer readable program storage unit of claim 1, further comprising a second reference heart beat complex shape template, wherein said confirming said occurrence of said brain state change is based upon both said determination that said heart beat complex shape fails to match said first reference heart beat complex shape template and a second determination that said heart beat complex shape fails to match said second reference heart beat complex shape template.

10. The non-transitory computer readable program storage unit of claim 1, wherein said obtaining further comprises obtaining data relating to at least a portion of a plurality of heart beat complex shapes;

and said confirming is based upon a determination that at least one said heart beat complex shape of said plurality of heart beat complex shapes fails to match said first reference heart beat complex shape template.

11. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for indicating an occurrence of a brain state change, comprising:

obtaining data relating to at least a portion of a heart beat complex shape from a patient;

comparing said at least said portion of said heart beat complex shape with a corresponding portion of a first reference heart beat complex shape template of said patient; and

,

indicating an occurrence of a brain state change based upon a determination that said heart beat complex shape fails to match said first reference heart beat complex shape template

validating an occurrence of a brain state change in response to said indicating, wherein said validating is not based upon a determination that at least a portion of a heart beat complex shape fails to match a first reference heart beat complex shape template.

12. The non-transitory computer readable program storage unit of claim 11, wherein said validating comprises:

obtaining a time series of cardiac data from a patient;

determining a reference heart rate parameter from said cardiac data;

determining a heart rate derivative shape from said time series of cardiac data, wherein said heart rate derivative shape comprises at least one characteristic selected from a number of phases relative to said reference heart rate parameter, a number of extrema of said heart rate derivative, a number of directions of change of said heart rate derivative, a number of positive phases, or a number of negative phases; and

,

identifying said occurrence of said brain state change based upon a determination that said heart rate derivative shape matches a brain state change template in said at least one characteristic.

13. The non-transitory computer readable program storage unit of claim 11, wherein said portion of said heart beat complex shape comprises at least one of an amplitude of a P wave, a polarity of a P wave, an amplitude of an R wave, a polarity of a Q wave, a polarity of an R wave, an amplitude of an S wave, a polarity of an S wave, an amplitude of a T wave, a polarity of a T wave, an area under the curve of a P wave, an area under the curve of a Q wave, an area under the curve of an R wave, an area under the curve of an S wave, an area under the curve of a T wave, a width of a P wave, a width of a Q wave, a width of an R wave, a width of an S wave, a width of a T wave, a morphology of a P wave, a morphology of a Q wave, a morphology of an R wave, a morphology of a T wave, a magnitude of a change in the distance from a P wave to a Q wave, a magnitude of a change in the distance from a P wave to an R wave, a magnitude of a change in the distance from a Q wave to an R wave, a magnitude of a change in the distance from an R wave to an S wave, a magnitude of a change in the distance from an R wave to a T wave, a magnitude of a change in the distance from an S wave to a T wave, a magnitude of an S-T segment elevation, a magnitude of an S-T segment depression, a magnitude of a Q-T segment elevation, a magnitude of a Q-T segment depression, a P-R interval, an R-S interval, an S-T interval, an R-T interval, and a Q-T interval.

14. The non-transitory computer readable program storage unit of claim 11, wherein said comparing further comprises comparing said at least a portion of said first heart beat complex shape with a corresponding portion of a second reference heart beat complex shape template of said patient, and wherein said indicating is based upon a determination that said first heart beat complex shape fails to match at least one of said first reference heart beat complex shape template and said second reference heart beat complex shape template.

15. The non-transitory computer readable program storage unit of claim 11, wherein said method further comprises:

obtaining a time series of data relating to a plurality of heart beat complex shapes from said patient, said obtaining occurring after said indicating;

comparing at least a portion of each of a sequential plurality of heart beat complex shapes with a corresponding portion of said first reference heart beat complex shape template; and

,

indicating a termination of said brain state change based upon a determination that at least one heart beat complex shape of said sequential plurality of heart beat complex shapes matches said first reference heart beat complex shape template, after said indicating an occurrence of a brain state change.

16. The non-transitory computer readable program storage unit of claim 11, wherein said method further comprises taking an action in response to said indicating, wherein said action is providing a warning of said brain state change, logging a time of said brain state change, computing one or more brain state change indices, logging one or more computed brain state change indices, providing at least one treatment of said brain state change, or two or more thereof.

17. The non-transitory computer readable program storage unit of claim 11, further comprising a second reference heart beat complex shape template, wherein said indicating said occurrence of said brain state change is based upon both said determination that said heart beat complex shape fails to match said first reference heart beat complex shape template and a second determination that said heart beat complex shape fails to match said second reference heart beat complex shape template.

18. The non-transitory computer readable program storage unit of claim 11, wherein said obtaining further comprises obtaining data relating to at least a portion of a plurality of heart beat complex shapes;

and said indicating is based upon a determination that at least one said heart beat complex shape of said plurality of heart beat complex shapes fails to match said first reference heart beat complex shape template.

19. The non-transitory computer readable program storage of claim 11, wherein said obtaining comprises obtaining data relation to at least a portion of a heart beat complex shape from multiple heart beats of said patient.

20. A medical device for determining an occurrence of a brain state change, comprising:

a cardiac data collection module for receiving cardiac data comprising a PQRST complex of a patient;

a heart rate derivative/complex module for determining a shape of said PQRST complex;

a template match module for comparing at least a portion of said morphology of said PQRST complex with a corresponding portion of a first reference non-seizure PQRST complex template, and for indicating an occurrence of a brain state change based upon a determination that said PQRST complex fails to match said first reference non-seizure PQRST complex template; and

a brain state change module for identifying an occurrence of a brain state change, wherein said identifying is not based upon a determination that at least a portion of said morphology of said PQRST complex fails to match said first reference non-seizure PQRST complex template.

21. The medical device of claim 20, further comprising a heart beat/interval determination module for:

determining an interbeat interval for at least two heart beats in a time series of said cardiac data;

determining at least one fiducial time marker to indicate at least one point of said PQRST complex; and

detecting said PQRST complex of said patient based upon said fiducial time marker and said interbeat interval;

wherein said cardiac data collection module comprises;

a cardiac data signal receiver for amplifying and filtering of said cardiac data; and

an analog to digital converter for converting said cardiac data to a digital signal;

and wherein said template match module comprises;

a template comparison unit for comparing said PQRST complex with a corresponding portion of said first reference non-seizure PQRST complex template; and

a state change indication unit for determining an occurrence of a brain state change based upon a determination that said morphology of said PQRST complex fails to match said first reference non-seizure PQRST complex morphology template.