# US 12,178,594 B2 · Detecting or validating a detection of a state change from a template of heart rate derivative shape or heat beat wave complex

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- Number: US 12,178,594 B2
- Document ID: US12178594B2
- Status: Granted
- Kind: B2
- Application number: 16/996,335
- Filed: 2020-08-18
- Published: 2020-12-03
- Granted: 2024-12-31
- 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/US12178594B2

## 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 medical device system, comprising:
a cardiac data collection module configured to obtain a time series of cardiac data from a patient;
a parameter selection module configured to select at least one parameter from the cardiac data time series;
a reference parameter value determination module configured to determine a magnitude, a duration, a direction and a rate of change of a characteristic of the heart's beat contractility during a reference state;
a state change determination module configured to indicate an occurrence of a brain state change when at least one value relating to the characteristic of the heart's beat contractility is different than at least one reference value for a selected time period; and
a therapy device configured to initiate an electrical stimulation based on the occurrence of the brain state change.

### Claim 2 (depends on 1)

The medical device system of claim 1, wherein the cardiac data collection module is configured to collect at least 300 seconds of cardiac data.

### Claim 3 (depends on 1)

The medical device system of claim 1, wherein the cardiac data collection module is configured to collect from about 10 seconds to about 300 seconds of cardiac data.

### Claim 4 (depends on 1)

The medical device system of claim 1, wherein the cardiac data collection module is configured to collect cardiac data from no more than one heart beat based on at least one of the characteristic of the heart's beat contractility.

### Claim 5 (depends on 1)

The medical device system of claim 1, wherein the selected time period utilizes a microscopic time scale.

### Claim 6 (depends on 5)

The medical device system of claim 5, wherein the brain state change determination is based off of the microscopic time scale utilization.

### Claim 7 (depends on 1)

The medical device system of claim 1, wherein the selected time period utilizes a mesoscopic time scale.

### Claim 8 (depends on 7)

The medical device system of claim 7, wherein the brain state change determination is based off of the mesoscopic time scale utilization.

### Claim 9 (depends on 1)

The medical device system of claim 1, wherein the selected time period utilizes a macroscopic time scale.

### Claim 10 (depends on 9)

The medical device system of claim 9, wherein the brain state change determination is based off of the macroscopic time scale utilization.
