# US 2021/0275022 A1 · Wearable ambulatory medical device with multiple sensing electrodes

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- Number: US 2021/0275022 A1
- Document ID: US20210275022A1
- Status: Published application
- Kind: A1
- Application number: 17/207,005
- Filed: 2021-03-19
- Published: 2021-09-09
- Earliest claimed: 2010-05-18
- Assignees: ZOLL Medical Corporation
- Applicants: ZOLL Medical Corporation
- Inventors: Thomas E. Kaib; Shane S. Volpe; John D. Macho
- Web page: https://patentgrep.com/patent/US20210275022A1

## CPC

- A61B 5/0006: {ECG or EEG signals}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/0245: by using sensing means generating electric signals, {i.e. ECG signals}
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)}
- A61B 5/1118: {Determining activity level}
- 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 5/349: Detecting specific parameters of the electrocardiograph cycle
- A61B 5/35: by template matching
- A61B 5/364: Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/6804: {Garments; Clothes}
- A61B 5/6805: {Vests, e.g. shirts or gowns}
- A61B 5/6823: {Trunk, e.g., chest, back, abdomen, hip}
- A61B 5/7207: {of noise induced by motion artifacts}
- A61B 5/7221: {Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217)}
- A61N 1/046: {Specially adapted for shock therapy, e.g. defibrillation}
- A61N 1/0484: {Garment electrodes worn by the patient}
- A61N 1/3987: {characterised by the timing or triggering of the shock}
- A61B 2562/04: Arrangements of multiple sensors of the same type
- A61N 1/3904: {External heart defibrillators [EHD]}
- 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

A wearable arrhythmia monitoring and treatment device for improving confidence in determined arrhythmias prior to treatment includes a plurality of sensing electrodes, one or more therapy electrodes, and an electrode signal acquisition circuit having a plurality of inputs. The electrode signal acquisition circuit is configured to sense a respective signal provided by each of a plurality of different pairings of the plurality of sensing electrodes. The wearable arrhythmia monitoring and treatment device includes a monitoring and detection circuit including at least one processor configured to analyze the respective signals provided by each of the plurality of different pairings of the plurality of sensing electrodes, change a confidence level in a determined arrhythmia condition based on the respective signals provided by the plurality of different pairings of the plurality of sensing electrodes, and initiate a therapy to the patient via the one or more therapy electrodes based on the confidence level.

## Claims

### Claim at position 1

1-43. (canceled)

### Claim 44

A wearable arrhythmia monitoring and treatment device for improving confidence in determined arrhythmias prior to treatment, comprising:
a plurality of sensing electrodes configured to be disposed at spaced apart positions about a body of a patient;
one or more therapy electrodes configured to be disposed about the body of the patient;
an electrode signal acquisition circuit having a plurality of inputs, each respective input of the plurality of inputs being electrically coupled to a respective sensing electrode of the plurality of sensing electrodes, the electrode signal acquisition circuit being configured to sense a respective signal provided by each of a plurality of different pairings of the plurality of sensing electrodes; and
a monitoring and detection circuit, electrically coupled to an output of the electrode signal acquisition circuit, the monitoring and detection circuit including at least one processor configured to
analyze the respective signals provided by each of the plurality of different pairings of the plurality of sensing electrodes,
change a confidence level in a determined arrhythmia condition based on the respective signals provided by the plurality of different pairings of the plurality of sensing electrodes, and
initiate a therapy to the patient via the one or more therapy electrodes based on the confidence level.

### Claim 45 (depends on 44)

The wearable arrhythmia monitoring and treatment device of claim 44, further comprising at least one activity sensor configured to monitor a physical activity of the patient.

### Claim 46 (depends on 45)

The wearable arrhythmia monitoring and treatment device of claim 45, wherein the at least one processor is configured to determine whether the physical activity of the patient is strenuous physical activity of the patient.

### Claim 47 (depends on 45)

The wearable arrhythmia monitoring and treatment device of claim 45, wherein the at least one processor is configured to determine an optimal pairing of the plurality of sensing electrodes based on the physical activity of the patient.

### Claim 48 (depends on 44)

The wearable arrhythmia monitoring and treatment device of claim 44, wherein the at least one processor is configured to increase the confidence level based on a quality metric of the respective signals provided by the plurality of different pairings of the plurality of sensing electrodes.

### Claim 49 (depends on 48)

The wearable arrhythmia monitoring and treatment device of claim 48, wherein the quality metric comprises a signal-to-noise ratio of the respective signals provided by the plurality of different pairings of the plurality of sensing electrodes.

### Claim 50 (depends on 44)

The wearable arrhythmia monitoring and treatment device of claim 44, wherein the at least one processor is configured to analyze the respective signal provided by a first pairing of the plurality of different pairings of the plurality of sensing electrodes to determine the arrhythmia condition, and change the confidence level in the determined arrhythmia condition based on a second pairing of the plurality of different pairings of the plurality of sensing electrodes.

### Claim 51 (depends on 50)

The wearable arrhythmia monitoring and treatment device of claim 50, wherein changing the confidence level in the determined arrhythmia condition comprises increasing the confidence level in the determined arrhythmia condition in response to determining that the arrhythmia condition is still present or is also present on the respective signal provided by the second pairing.

### Claim 52 (depends on 50)

The wearable arrhythmia monitoring and treatment device of claim 50, wherein changing the confidence level in the determined arrhythmia condition comprises decreasing the confidence level in the determined arrhythmia condition in response to determining that the arrhythmia condition is no longer present or is not also present on the respective signal provided by the second pairing.

### Claim 53

The wearable arrhythmia monitoring and treatment device of 44, further comprising a garment configured to be worn about the body of the patient, wherein the plurality of sensing electrodes are integrated into the garment.

### Claim 54 (depends on 53)

The wearable arrhythmia monitoring and treatment device of claim 53, wherein the plurality of sensing electrodes are sewn into the garment.

### Claim 55 (depends on 53)

The wearable arrhythmia monitoring and treatment device of claim 53, wherein the garment comprises an adjustable belt and adjustable shoulder straps.

### Claim 56 (depends on 44)

The wearable arrhythmia monitoring and treatment device of claim 44, wherein the one or more therapy electrodes are configured to deliver a defibrillating shock to the body of the patient.

### Claim 57

A wearable monitoring device, comprising:
at least two ECG channels corresponding to a plurality of pairings of ECG sensing electrodes disposed at different axial positions around a body of a patient and integrated into a garment such as a shirt or vest that is worn on a torso of the patient;
a signal acquisition circuit configured to be integrated into the garment, the signal acquisition circuit being configured to be electrically coupled to the ECG sensing electrodes and configured to process ECG signals; and
a processor in communication with the signal acquisition circuit, the processor being configured to
instruct the signal acquisition circuit to analyze respective signals provided by the at least two ECG channels,
determine a presence of an arrhythmia condition based on the respective signals from one or more of the at least two ECG channels,
assess a confidence level in the determined arrhythmia condition based on the respective signals from two or more of the at least two ECG channels, by
increasing the confidence level in the determined arrhythmia condition in response to determining that the arrhythmia condition is still present or is also present on an ECG channel additional to the one or more of the at least two ECG channels, or
decreasing the confidence level in the determined arrhythmia condition in response to determining that the arrhythmia condition is not present or is no longer present on an ECG channels additional to the one or more of the at least two ECG channels, and
execute one or more instructions that result in defibrillation being applied to the body of the patient in response to the confidence level being above a certain threshold.

### Claim 58 (depends on 57)

The wearable monitoring device of claim 57, further comprising at least one activity sensor configured to monitor a physical activity of the patient.

### Claim 59 (depends on 58)

The wearable monitoring device of claim 58, wherein the processor is configured to determine whether the physical activity of the patient is strenuous physical activity of the patient.

### Claim 60 (depends on 58)

The wearable monitoring device of claim 58, wherein the processor is configured to determine an optimal ECG channel of the at least two ECG channels based on the physical activity of the patient.

### Claim 61 (depends on 57)

The wearable monitoring device of claim 57, wherein the processor is configured to increase the confidence level based on a quality metric of one or more of the at least two ECG channels.

### Claim 62 (depends on 61)

The wearable monitoring device of claim 61, wherein the quality metric comprises a signal-to-noise ratio of one or more of the at least two ECG channels.

### Claim 63 (depends on 61)

The wearable monitoring device of claim 61, wherein the processor is configured to determine the presence of the arrhythmia condition based on the respective signal from a first ECG channel, and assess the confidence level in the determined arrhythmia condition based on the respective signals from the first ECG channel and a second ECG channel.

### Claim 64 (depends on 57)

The wearable monitoring device of claim 57, wherein the ECG sensing electrodes are sewn into the garment.

### Claim 65 (depends on 57)

The wearable monitoring device of claim 57, wherein the garment comprises an adjustable belt and adjustable shoulder straps.

### Claim 66 (depends on 57)

The wearable monitoring device of claim 57, further comprising one or more therapy electrodes configured to deliver a defibrillating shock to the body of the patient.