# US 8,571,643 B2 · Detecting or validating a detection of a state change from a template of heart rate derivative shape or heart beat wave complex

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- Number: US 8,571,643 B2
- Document ID: US8571643B2
- Status: Granted
- Kind: B2
- Application number: 12/884,051
- Filed: 2010-09-16
- Published: 2012-03-22
- Granted: 2013-10-29
- Earliest claimed: 2010-09-16
- Assignees: Flint Hills Scientific, L.L.C.
- Applicants: Ivan Osorio; Mark Frei
- Inventors: Ivan Osorio; Mark Frei
- Web page: https://patentgrep.com/patent/US8571643B2

## CPC

- A61B 5/4094: {Diagnosing or monitoring seizure diseases, e.g. epilepsy}
- A61B 5/02405: {Determining heart rate variability}
- A61B 5/0245: by using sensing means generating electric signals, {i.e. ECG signals}
- A61B 5/33: specially adapted for cooperation with other devices
- A61B 5/349: Detecting specific parameters of the electrocardiograph cycle
- A61B 5/35: by template matching
- A61B 5/352: Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
- A61B 5/364: Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
- A61B 5/7246: {using correlation, e.g. template matching or determination of similarity}
- 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}
- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)}
- A61N 1/36064: {Epilepsy}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## 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

### Claim 1

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.

### Claim 2 (depends on 1)

The method 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.

### Claim 3 (depends on 1)

The method of claim 1, wherein said state change template comprises at least one matched filter.

### Claim 4 (depends on 3)

The method 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.

### Claim 5 (depends on 3)

The method 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.

### Claim 6 (depends on 1)

The method 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.

### Claim 7 (depends on 1)

The method 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.

### Claim 8 (depends on 1)

The method 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.

### Claim 9 (depends on 1)

The method of claim 1, wherein said state change template comprises at least two extrema of said heart rate derivative.

### Claim 10 (depends on 9)

The method of claim 9, wherein said state change template further comprises at least two phases.

### Claim 11 (depends on 1)

The method 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.

### Claim 12 (depends on 1)

The method 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.

### Claim 13 (depends on 1)

The method of claim 1, wherein said heart rate derivative is selected from heart rate, heart rate variability, or heart rate volatility.

### Claim 14 (depends on 1)

The method 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.

### Claim 15 (depends on 14)

The method 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.

### Claim 16 (depends on 1)

The method 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.

### Claim 17 (depends on 16)

The method of claim 16, wherein said reference heart beat complex template is selected from a normal template or an abnormal template.

### Claim 18 (depends on 1)

The method 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.

### Claim 19 (depends on 1)

The method 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.

### Claim 20 (depends on 1)

The method 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.

### Claim 21 (depends on 1)

The method 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.

### Claim 22 (depends on 1)

The method 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.

### Claim 23 (depends on 1)

The method of claim 1, wherein the heart rate derivative shape occurs before said state change.

### Claim 24

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.
