# US 11,026,622 B2 · State change indication by matching instantaneous heart rate shape to shape change template

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- Number: US 11,026,622 B2
- Document ID: US11026622B2
- Status: Granted
- Kind: B2
- Application number: 15/009,568
- Filed: 2016-01-28
- Published: 2016-07-28
- Granted: 2021-06-08
- Earliest claimed: 2010-09-16
- Assignees: Flint Hills Scientific, L.L.C.
- Applicants: Flint Hills Scientific, L.L.C.
- Inventors: Ivan Osorio; Mark G. Frei
- Web page: https://patentgrep.com/patent/US11026622B2

## 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 detecting an occurrence of a seizure, the method comprising:
obtaining via one or more medical devices a time series of cardiac data from a patient;
selecting via the one or more medical devices at least one parameter from the cardiac data time series;
selecting a time period;
selecting a time scale for the selected time period where the selected time scale is one of a macroscopic time scale, a mesoscopic time scale, or a microscopic time scale;
determining via the one or more medical devices a rate of change of a heart rate volatility;
comparing a value relating to heart rate volatility to a reference state value for the selected time period; and
indicating the occurrence of the seizure when the value relating to the heart rate volatility is different than the reference state value for the selected time period;
wherein the value includes an inflection point.

### Claim 2 (depends on 1)

The method of claim 1, wherein the time series of cardiac data comprises at least 300 seconds of data.

### Claim 3 (depends on 1)

The method of claim 1, wherein the time series of cardiac data comprises from about 10 seconds to about 300 seconds of data.

### Claim 4

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 seizure, the non-transitory computer readable program unit being part of a medical device, the method comprising:
obtaining via the medical device a time series of cardiac data from a patient;
selecting via the medical device at least one parameter from the cardiac data time series;
determining via the medical device a rate of change of a heart rate volatility;
comparing a value relating to heart rate volatility to a reference state value for the selected time period; and
indicating the occurrence of the seizure when the value relating to the heart rate volatility is different than the reference state value for a selected time period;
wherein the value includes an inflection point.

### Claim 5 (depends on 4)

The non-transitory computer readable program storage unit of claim 4, wherein the time series of cardiac data comprises at least 300 seconds of data.

### Claim 6 (depends on 4)

The non-transitory computer readable program storage unit of claim 4, wherein the time series of cardiac data comprises from about 10 seconds to about 300 seconds of data.