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

• US 9,020,582 B2
• Filed: 09/30/2013
• Issued: 04/28/2015
• 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:
  US14/042,557
• Publication Number:
  US 20140039331A1
• Time in Patent Office: 575 Days
• Field of Search: 600508-509, 600/515
• US Class Current: 600/515
• 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 an 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 indicating an occurrence of a state change, comprising:

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

,

indicating an occurrence of a state change based upon a determination that said heart rate derivative shape matches a state change template in said at least one characteristic,

wherein said at least one characteristic of said state change template comprises two or more phases relative to said reference heart rate parameter, two or more extrema of said heart rate derivative, three or more directions of change of said heart rate derivative, a number of positive phases, or a number of negative phases, provided the total number of positive phases and negative phases is two or more.

2. The non-transitory computer readable program storage unit of claim 1, wherein said at least one characteristic of said state change template further comprises at least one of the amplitude of at least one phase, the area under the curve of at least one phase, the duration of at least one phase, the valence (positive or negative) of at least one phase, at least one slope of at least one phase, the arc length of at least one phase, the number of extrema in at least one phase, the sharpness of the extrema of at least one phase, and the sharpness of at least one phase.

3. The non-transitory computer readable program storage unit of claim 1, wherein said state change template comprises at least one matched filter.

4. The non-transitory computer readable program storage unit of claim 3, further comprising a reference parameter filter, wherein said indicating said occurrence of said state change is based upon both said determination that said heart rate derivative shape matches said state change template in said at least one characteristic and a second determination that said heart rate derivative shape fails to match said reference parameter filter.

5. The non-transitory computer readable program storage unit of claim 3, wherein said heart rate derivative shape has a matched filter output to said state change template equal to or greater than a value threshold for at least a duration threshold.

6. The non-transitory computer readable program storage unit of claim 1, wherein said state change template comprises at least one positive phase relative to said reference heart rate parameter and at least one negative phase relative to said reference heart rate parameter.

7. The non-transitory computer readable program storage unit of claim 1, wherein the number of positive phases relative to said reference heart rate parameter in said heart rate derivative shape is at least one and said at least one positive phase relative to said reference heart rate parameter is a period of increased heart rate.

8. The non-transitory computer readable program storage unit of claim 1, wherein the number of negative phases relative to said reference heart rate parameter in said heart rate derivative shape is at least one and said at least one negative phase relative to said reference heart rate parameter is a period of decreased heart rate.

9. The non-transitory computer readable program storage unit of claim 1, wherein said state change template comprises at least two extrema of said heart rate derivative.

10. The non-transitory computer readable program storage unit of claim 9, wherein said state change template further comprises at least two phases.

11. The non-transitory computer readable program storage unit of claim 1, wherein said state change template comprises a notched triangle pattern, an M pattern, a W pattern, a fused M-W pattern, a pattern of periodic oscillations, a sawtooth pattern, a pattern of periodic oscillations overlaid on a longer-timescale triangle pattern, a comb pattern, a triphasic pattern a multiple “

M”

s and/or “

W”

s pattern, or two or more thereof.

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

identifying an occurrence of a state change prior to said determining step and said indicating step, wherein said identifying is not based upon a determination that a heart rate derivative shape matches a state change template in at least one characteristic;

and wherein said determining said heart rate derivative shape and said indicating are performed in response to said identifying, to validate said identifying.

13. The non-transitory computer readable program storage unit of claim 1, wherein said heart rate derivative is selected from heart rate, heart rate variability, or heart rate volatility.

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

validating an occurrence of a state change in response to said indicating, wherein said validating is not based upon a determination that a heart rate derivative shape matches a state change template in at least one characteristic.

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

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

comparing said at least said portion of said heart beat complex with a corresponding portion of a reference heart beat complex template of said patient, wherein said reference heart beat complex template is not indicative of a state change of interest; and

,

validating said indicating an occurrence of said state change, wherein said validating is based upon a determination that said heart beat complex fails to match said reference heart beat complex template.

16. The non-transitory computer readable program storage unit of claim 15, wherein said reference heart beat complex template is selected from a normal template or an abnormal template.

17. The non-transitory computer readable program storage unit of claim 14, wherein said method comprises:

determining a second reference heart rate parameter;

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, an area under the curve of at least one phase, a number of extrema of said second heart rate derivative, or a number of directions of change of said second heart rate derivative; and

,

validating said indicating an occurrence of a state change, wherein said validating is based upon a determination that said second heart rate derivative shape matches a second state change template in said at least one second characteristic.

18. The non-transitory computer readable program storage unit of claim 1, wherein said determination comprises using a first matched filter to yield a first output, building a second matched filter from said first output, and using said second matched filter to detect said state change.

19. The non-transitory computer readable program storage unit of claim 1, wherein said reference heart rate parameter is selected from the group consisting of a shape, a vector, a vector space, a matrix, and two or more thereof.

21. The non-transitory computer readable program storage unit of claim 1, wherein the state change template exists in a first timescale and said heart rate derivative shape is present in said first timescale.

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

23. The non-transitory computer readable program storage unit of claim 1, wherein the state change template exists in a first timescale, a second state change template exists in a second timescale other than the first timescale, said heart rate derivative shape is present in said first timescale, and a second heart rate derivative shape is present in said second timescale, wherein a state change is indicated if both said heart rate derivative shape matches said state change template in said at least one characteristic and said second heart rate derivative shape matches said second state change template in at least one said characteristic.

24. The non-transitory computer readable program storage unit of claim 1, wherein the heart rate derivative shape occurs before said state change.

20. 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 state change, comprising:

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

,

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