# US 12,213,812 B2 · Monitoring physiological status based on bio- vibrational and radio frequency data analysis

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- Number: US 12,213,812 B2
- Document ID: US12213812B2
- Status: Granted
- Kind: B2
- Application number: 18/494,359
- Filed: 2023-10-25
- Published: 2024-03-07
- Granted: 2025-02-04
- Earliest claimed: 2018-03-16
- Assignees: ZOLL Medical Corporation
- Applicants: ZOLL Medical Corporation
- Inventors: Kent Volosin; Gary A. Freeman
- Web page: https://patentgrep.com/patent/US12213812B2

## CPC

- 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}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/02125: {of pulse wave propagation time}
- A61B 5/02405: {Determining heart rate variability}
- A61B 5/05: Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24)
- A61B 5/0535: Impedance plethysmography (for measuring blood flow A61B5/0295)
- A61B 5/1102: {Ballistocardiography}
- A61B 5/112: {Gait analysis}
- A61B 5/1135: {by monitoring thoracic expansion}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/282: Holders for multiple electrodes (for introduction into the body A61B5/287)
- A61B 5/366: Detecting abnormal QRS complex, e.g. widening
- A61B 5/6805: {Vests, e.g. shirts or gowns}
- A61B 5/7257: {using Fourier transforms}
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61B 5/7465: {Arrangements for interactive communication between patient and care services, e.g. by using a telephone network (telemetry of measured physiological signal A61B5/0002)}
- A61N 1/3904: {External heart defibrillators [EHD]}
- G16H 40/67: for remote operation
- G16H 80/00: ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
- H04Q 9/00: Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
- A61B 2560/0214: of power generation or supply
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B 2562/0204: Acoustic sensors
- A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
- A61N 1/046: {Specially adapted for shock therapy, e.g. defibrillation}
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- H04Q 2209/823: where the data is sent when the measured values exceed a threshold, e.g. sending an alarm
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H04Q: SELECTING (switches, relays, selectors H01H; wireless communication networks H04W)

## Abstract

A patient monitoring device includes an ECG sensor coupled to a patient, a sensor coupled to the patient and configured to detect bio-vibrational signals, and a radiofrequency monitoring device configured to produce information responsive to electromagnetic energy reflected from the patient's thoracic cavity. A processor processes the ECG signals, the bio-vibrational signals, and the radio frequency information to generate a plurality of physiological parameters of the patient. The processor also performs at least one of a predictive analysis and a trend analysis of the plurality of physiological parameters to determine a current clinical condition of the patient. The trend analysis includes determining a substantial relationship between changes in the plurality of physiological parameters. The processor can also compare the current clinical condition of the patient to predetermined clinically actionable criteria to determine one or more clinically actionable events and provide an output relating to one or more clinically actionable events.

## Claims

### Claim 1

An externally worn cardiac monitoring and treatment system comprising:
an ECG sensor coupled to a patient and configured to detect one or more ECG signals of the patient;
a therapy electrode configured to deliver a therapeutic shock to the patient;
a vibrational sensor coupled to the patient and configured to detect one or more cardio-vibrational signals of the patient;
a radiofrequency transceiver circuit comprising one or more radiofrequency antennas, the radiofrequency transceiver circuit configured to
cause the one or more radiofrequency antennas to direct radiofrequency energy into at least a portion of the patient, and
produce radiofrequency information responsive to reflected radiofrequency energy that is received through the one or more radiofrequency antennas and that is reflected from within the patient; and
one or more processors configured to
process the one or more ECG signals and the one or more cardio-vibrational signals to generate a combinational parameter,
process the radiofrequency information to generate a thoracic fluid content measurement of the patient,
perform a correlation analysis on the combinational parameter and the thoracic fluid content measurement to determine a current clinical condition of the patient, wherein the current clinical condition of the patient indicates a possible occurrence of a cardiac arrhythmia,
compare the current clinical condition of the patient to predetermined clinically actionable criteria to identify one or more clinically actionable events, and
cause an output device to provide an output relating to the one or more clinically actionable events; and
therapy delivery circuitry that is operably connected to the therapy electrode and that is configured to treat the cardiac arrhythmia by providing a therapeutic shock to the patient using the therapy electrode.

### Claim 2 (depends on 1)

The system of claim 1, wherein the correlation analysis is performed on the combinational parameter and the thoracic fluid content measurement over a prior period of time including one or more of: at least 24 hours, at least 48 hours, at least one week, at least two weeks, at least one month, at least 6 weeks, at least two months, at least 4 months, at least 6 months, at least 1 year, or at least 2 years.

### Claim 3 (depends on 1)

The system of claim 1, wherein the correlation analysis is performed on the combinational parameter and the thoracic fluid content measurement over a prior period of time corresponding to at least an available clinical history of the patient.

### Claim 4 (depends on 1)

The system of claim 1, wherein the one or more clinically actionable events comprise at least one of:
an automated event that is triggered without user input; or
a manual event that is triggered based upon a user response to the output and comprises one or more instructions to perform one or more actions.

### Claim 5 (depends on 4)

The system of claim 4, wherein the automated event comprises configuring the cardiac monitoring and treatment system to increase a sensitivity of an ECG signal detection process for a period of time.

### Claim 6 (depends on 1)

The system of claim 1, wherein the output relating to the one or more clinically actionable events is based on a transgression of one or more thresholds defined with respect to results of the correlation analysis.

### Claim 7 (depends on 1)

The system of claim 1, wherein the current clinical condition of the patient comprises a predictive score that indicates a likelihood of the cardiac arrhythmia.

### Claim 8 (depends on 1)

The system of claim 1, wherein performing the correlation analysis further comprises determining that at least one of:
the combinational parameter has exceeded a combinational parameter threshold; or
the thoracic fluid content measurement has exceeded a thoracic fluid content measurement threshold.

### Claim 9 (depends on 1)

The system of claim 1, wherein performing the correlation analysis further comprises calculating a correlation score that indicates a change in the current clinical condition of the patient.

### Claim 10 (depends on 1)

The system of claim 1, wherein the vibrational sensor is further configured to sense one or more lung vibrations for the patient, the one or more lung vibrations comprising at least one of bronchial vibrations, stridor, crackle, wheeze, rhonchus, pleural friction, squawk, glottal, pharyngeal, or other vibrations.

### Claim 11 (depends on 1)

The system of claim 1, wherein the one or more ECG signals comprise at least one of heart rate; heart rate variability; PVC burden or counts; atrial fibrillation burden; pauses; heart rate turbulence; QRS height; QRS width; changes in size or shape of ECG morphology; cosine R-T; artificial pacing; QT interval; QT variability; T wave width; T wave alternans; T-wave variability; or ST segment changes.

### Claim 12 (depends on 1)

The system of claim 1, wherein the one or more processors are further configured to perform a predictive analysis of a determined value of, or a trend in, the thoracic fluid content measurement.

### Claim 13 (depends on 1)

The system of claim 1, wherein the one or more processors are further configured to display, via the output device, a graphical timeline representing at least a portion of a monitoring period during which the cardiac monitoring and treatment system is worn by the patient.

### Claim 14 (depends on 13)

The system of claim 13, wherein the graphical timeline visually depicts a correlation between the combinational parameter and the thoracic fluid content measurement.

### Claim 15 (depends on 13)

The system of claim 13, wherein the monitoring period comprises one or more of at least 24 hours, at least 48 hours, at least one week, or at least two weeks.

### Claim 16 (depends on 1)

The system of claim 1, further comprising a garment, wherein the ECG sensor, the therapy electrode, and the vibrational sensor are coupled to the garment.

### Claim 17 (depends on 1)

The system of claim 1, wherein the one or more processors are further configured to perform a trend analysis on the combinational parameter to generate an overall classification score for the patient.

### Claim 18 (depends on 17)

The system of claim 17, wherein the one or more processors are further configured to update a monitoring schedule for the patient based on results of the trend analysis.

### Claim 19 (depends on 1)

The system of claim 1, wherein the combinational parameter comprises electromechanical activation time.

### Claim 20 (depends on 1)

The system of claim 1, wherein the combinational parameter comprises % LVST.

### Claim 21 (depends on 1)

The system of claim 1, wherein the one or more cardio-vibrational signals include at least one of an S1 vibration, an S2 vibration, an S3 vibration, an S4 vibration, or a heart murmur vibration.

### Claim 22 (depends on 1)

The system of claim 1, wherein the one or more processors are further configured to determine a left ventricular systolic time metric based on the one or more cardio-vibrational signals.

### Claim 23 (depends on 1)

The system of claim 1, wherein the one or more cardio-vibrational signals comprise at least one of an S1 vibration, an S2 vibration, an S3 vibration, or an S4 vibration.

### Claim 24 (depends on 1)

The system of claim 1, wherein the one or more cardio-vibrational signals comprise a heart murmur vibration.