# US 11,304,609 B2 · Body-worn sensor for characterizing patients with heart failure

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- Number: US 11,304,609 B2
- Document ID: US11304609B2
- Status: Granted
- Kind: B2
- Application number: 15/985,404
- Filed: 2018-05-21
- Published: 2018-09-20
- Granted: 2022-04-19
- Earliest claimed: 2012-12-31
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Tosense, Inc.
- Inventors: Matthew Banet; Susan Meeks Pede; Marshal Singh Dhillon; Kenneth Robert Hunt
- Web page: https://patentgrep.com/patent/US11304609B2

## CPC

- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0531: Measuring skin impedance
- A61B 5/256: Wearable electrodes, e.g. having straps or bands
- A61B 5/265: containing silver or silver chloride
- A61B 5/266: containing electrolytes, conductive gels or pastes
- A61B 5/273: Connection of cords, cables or leads to electrodes
- A61B 5/28: for electrocardiography [ECG]
- A61B 5/282: Holders for multiple electrodes (for introduction into the body A61B5/287)
- A61B 5/6822: {Neck}
- A61B 5/6823: {Trunk, e.g., chest, back, abdomen, hip}
- A61B 5/7225: {Details of analogue processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation (input circuits for detecting, measuring, or recording bioelectric or biomagnetic signals A61B5/30; specific diagnostic methods using bioelectric or biomagnetic signals A61B5/316)}
- A61B 5/1117: {Fall detection}
- A61B 5/1118: {Determining activity level}
- A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The invention provides a sensor for measuring both impedance and ECG waveforms that is configured to be worn around a patient's neck. The sensor features 1) an ECG system that includes an analog ECG circuit, in electrical contact with at least two ECG electrodes, that generates an analog ECG waveform; and 2) an impedance system that includes an analog impedance circuit, in electrical contact with at least two (and typically four) impedance electrodes, that generates an analog impedance waveform. Also included in the neck-worn system are a digital processing system featuring a microprocessor, and an analog-to-digital converter. During a measurement, the digital processing system receives and processes the analog ECG and impedance waveforms to measure physiological information from the patient. Finally, a cable that drapes around the patient's neck connects the ECG system, impedance system, and digital processing system.

## Claims

### Claim 1

A system worn entirely on a body of a patient for measuring parameters determined from heartbeat-induced impedance pulses, ECG signals, and motion signals exclusively from the patient's chest, comprising:
a monitoring housing supporting electrical circuit components, the monitoring housing configured to rest on the patient's chest and not wrap around the patient's chest;
an impedance-measuring system integrated within the monitoring housing, the impedance-measuring system comprising an impedance circuit in electrical contact with at least a first set of impedance electrodes and configured to receive a first set of electrical signals from the patient's chest and process them to determine heartbeat-induced impedance pulses exclusively from the patient's chest;
an ECG-measuring system integrated within the monitoring housing, the ECG-measuring system comprising an analog ECG circuit in electrical contact with at least an ECG electrode and configured to receive a second set of electrical signals from the patient's chest and process them to determine ECG signals, wherein the ECG electrode is disposed between the first set of impedance electrodes to ensure a gap exists between each impedance electrode and ECG electrode;
a motion-measuring system connected to the monitoring housing, the motion-measuring system comprising a motion-detecting circuit and configured to generate motion signals in response to the patient's movements; a data-processing system connected to the monitoring housing and in electrical contact with the impedance-measuring system, the ECG-measuring system, and the motion-measuring system, the data-processing system comprising a microprocessor configured to operate a set of computer algorithms configured to process the heartbeat-induced impedance pulses, the ECG signals, and the motion signals;
a wireless transmitter integrated connected to the monitoring housing and in electrical contact with the data-processing system, the wireless transmitter configured to transmit the parameters determined from the heartbeat-induced impedance pulses, the ECG signal, and the motion signal; and
a battery system comprising a battery in electrical contact with and configured to power the impedance-measuring system, the ECG-measuring system, the motion-measuring system, the data-processing system, and the wireless transmitter.

### Claim 2 (depends on 1)

The system of claim 1, wherein the monitoring housing comprises at least one rigid circuit board electrically connected to a flexible substrate comprising an electrical system including at least one of the impedance-measuring system and the ECG-measuring system.

### Claim 3 (depends on 2)

The system of claim 2, wherein the flexible substrate comprises Kapton®.

### Claim 4 (depends on 1)

The system of claim 1, wherein the monitoring housing comprises at least two rigid circuit boards connected by a flexible substrate.

### Claim 5 (depends on 4)

The system of claim 4, wherein the flexible substrate supports an electrical system including at least one of the impedance-measuring system and the ECG-measuring system.

### Claim 6 (depends on 5)

The system of claim 5, wherein the flexible substrate comprises Kapton®.

### Claim 7 (depends on 5)

The system of claim 5, wherein the flexible substrate further includes a cable.

### Claim 8

A system worn entirely on a body of a patient for measuring heartbeat-induced impedance pulses, ECG signals, and motion signals from the patient, comprising:
a monitoring housing supporting electrical circuit components, the monitoring housing configured to rest on the patient's chest but not wrap around the patient's chest;
an impedance-measuring system integrated within the monitoring housing, the impedance-measuring system comprising an impedance circuit in electrical contact with at least a first set of impedance electrodes and configured to receive a first set of electrical signals from the patient's chest and process them to determine heartbeat-induced impedance pulses exclusively from the patient's chest;
an ECG-measuring system integrated within the monitoring housing, the ECG-measuring system comprising an analog ECG circuit in electrical contact with at least an ECG electrode and configured to receive a second set of electrical signals from the patient's chest and process them to determine ECG signals, wherein the ECG electrode is disposed between the first set of impedance electrodes to ensure a gap exists between each impedance electrode and ECG electrode;
a motion-measuring system integrated within the monitoring housing, the motion-measuring system comprising a motion-detecting circuit and configured to generate motion signals in response to the patient's movements; and
a data-processing system connected to the monitoring housing and in electrical contact with the impedance-measuring system, the ECG-measuring system, and the motion-measuring system, the data-processing system comprising a microprocessor configured to operate a set of computer algorithms configured to process the impedance signals, the ECG signals, and the motion signals.

### Claim 9 (depends on 8)

The system of claim 8, wherein the monitoring housing comprises at least one rigid circuit board electrically connected to a flexible substrate.

### Claim 10 (depends on 9)

The system of claim 9, wherein the flexible substrate comprises Kapton®.

### Claim 11 (depends on 9)

The system of claim 9, wherein the flexible substrate further includes a cable.

### Claim 12

A system worn entirely on a body of a patient for measuring parameters determined from heartbeat-induced impedance pulses, ECG signals, and motion signals from the patient, comprising:
a monitoring housing supporting electrical circuit components, the monitoring housing configured to rest on the patient's chest but not wrap around the patient's chest;
an impedance-measuring system integrated within the monitoring housing, the impedance-measuring system comprising an analog impedance circuit in electrical contact with at least a first set of electrodes and configured to receive a first set of electrical signals from the patient's chest and process them to determine heartbeat-induced impedance pulses;
an ECG-measuring system integrated within the monitoring housing, the ECG-measuring system comprising an analog ECG circuit in electrical contact with at least an ECG electrode and configured to receive a second set of electrical signals from the patient's chest and process them to determine ECG signals, wherein the ECG electrode is disposed between the first set of impedance electrodes to ensure a gap exists between each impedance electrode and ECG electrode;
a motion-measuring system integrated within the monitoring housing, the motion-measuring system comprising a motion-detecting circuit and configured to generate a set of motion signals in response to the patient's movements;
a location-measuring system integrated within the monitoring housing, the location-measuring system configured to wirelessly receive signals and, in response, determine a set of location coordinates describing the patient's geographic location; a data-processing system integrated within the monitoring housing and in electrical contact with the impedance-measuring system, the ECG-measuring system, the motion-measuring system, and the location-measuring system, the data-processing system comprising a microprocessor configured to operate a set of computer algorithms configured to process the heartbeat-induced impedance pulses, the ECG signals, the set of location coordinates, and the motion signals;
a wireless transmitter integrated within the monitoring housing and in electrical contact with the data-processing system, the wireless transmitter configured to transmit the parameters determined from the impedance signals, the ECG signals, the set of location coordinates, and the motion signals; and
a battery system comprising a battery in electrical contact with and configured to power the impedance-measuring system, the ECG-measuring system, the motion-measuring system, the data-processing system, and the wireless transmitter.