# US 2021/0275079 A1 · Ambulatory electrocardiography monitor

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- Number: US 2021/0275079 A1
- Document ID: US20210275079A1
- Status: Published application
- Kind: A1
- Application number: 17/328,696
- Filed: 2021-05-24
- Published: 2021-09-09
- Earliest claimed: 2013-09-25
- Assignees: Bardy Diagnostics, Inc.
- Applicants: Bardy Diagnostics, Inc.
- Inventors: Jason Felix; Ezra M. Dreisbach; Jon Mikalson Bishay; Corey Bailey Williamson; Gust H. Bardy
- Web page: https://patentgrep.com/patent/US20210275079A1

## CPC

- A61B 5/333: Recording apparatus specially adapted therefor
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/282: Holders for multiple electrodes (for introduction into the body A61B5/287)
- A61B 5/33: specially adapted for cooperation with other devices
- A61B 5/339: Displays specially adapted therefor
- A61B 5/353: Detecting P-waves
- A61B 5/361: Detecting fibrillation
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/366: Detecting abnormal QRS complex, e.g. widening
- A61B 5/6823: {Trunk, e.g., chest, back, abdomen, hip}
- A61B 5/6832: {using adhesives (conductive adhesive for bioelectric electrodes A61B5/259)}
- A61B 5/6833: {Adhesive patches}
- A61B 5/7203: {for noise prevention, reduction or removal}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/748: {Selection of a region of interest, e.g. using a graphics tablet}
- A61B 90/90: Identification means for patients or instruments, e.g. tags
- A61B 90/96: using barcodes
- G06F 21/604: {Tools and structures for managing or administering access control systems}
- G06F 21/6218: {to a system of files or objects, e.g. local or distributed file system or database}
- G16H 40/63: for local operation
- A61B 2560/0487: Special user inputs or interfaces
- A61B 2562/08: Sensors provided with means for identification, e.g. barcodes or memory chips
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

An ambulatory electrocardiography monitor is provided. The monitor includes a housing adapted to couple to a monitoring patch that includes electrocardiographic electrodes; and electronic circuitry provided within the housing. The electronic circuitry includes an electrocardiographic front end circuit; the microcontroller configured to: execute a power up sequence upon the housing coupling to the patch; after the execution of the power-up sequence, retrieve from the monitoring patch an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch; read samples of the electrocardiographic signals, buffer the samples of the electrocardiographic signals, compress the buffered samples of the electrocardiographic signals, buffer the compressed samples of the electrocardiographic signals, and write-the buffered samples into a memory in association with the password and the identifier; and the memory electrically interfaced with the microcontroller.

## Claims

### Claim 1

An ambulatory electrocardiography monitor, comprising:
a housing adapted to couple to a monitoring patch that comprises electrocardiographic electrodes; and
electronic circuitry provided within the housing, comprising:
an electrocardiographic front end circuit under a control of a microcontroller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the microcontroller as electrocardiographic signals representative of amplitudes of the action potential propagation;
the microcontroller operable to execute over an extended period under modular micro program control as specified in firmware, the microcontroller configured to:
execute a power up sequence upon the housing coupling to the patch;
after the execution of the power-up sequence, retrieve from the monitoring patch an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch;
read samples of the electrocardiographic signals, buffer the samples of the electrocardiographic signals, compress the buffered samples of the electrocardiographic signals, buffer the compressed samples of the electrocardiographic signals, and write-the buffered samples into a memory in association with the password and the identifier; and
the memory electrically interfaced with the microcontroller and operable to store the samples of the electrocardiographic signals in association with the identifier and the password.

### Claim 2 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, the microcontroller further configured to offload the stored samples together with the identifier and the password.

### Claim 3 (depends on 2)

An ambulatory electrocardiography monitor according to claim 2, the electronic circuitry further comprising:
a wireless transceiver interfaced to the microcontroller and configured to wirelessly offload the stored samples together with the identifier and the password.

### Claim 4 (depends on 2)

An ambulatory electrocardiography monitor according to claim 2, further comprising:
a set of electrical contacts through which the microcontroller offloads the stored samples together with the identifier and the password.

### Claim 5 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, wherein the password is based on the identifier.

### Claim 6 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, wherein the password comprises a cryptographic hash of at least a portion of the identifier.

### Claim 7 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, further comprising:
a key stored in the memory,
wherein the password is encrypted when retrieved from the monitoring patch and the microcontroller uses the key to decode the password.

### Claim 8 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, the microcontroller further configured to perform an authentication procedure with the patch.

### Claim 9 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, further comprising:
a physiological sensor interfaced to the microcontroller, the microcontroller configured to store data collected by the physiological monitor in the memory in association the password and the identifier.

### Claim 10 (depends on 9)

An ambulatory electrocardiography monitor according to claim 9, wherein the physiological sensor comprises one or more of an SpO2 sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, and volumetric pressure sensor.

### Claim 11 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, wherein the microcontroller is configured to interface to a physiological sensor provided on the patch when the housing is coupled to the patch, the microcontroller configured to store data collected by the physiological monitor in the memory in association the password and the identifier.

### Claim 12 (depends on 11)

An ambulatory electrocardiography monitor according to claim 11, wherein the physiological sensor comprises one or more of an SpO2 sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, and volumetric pressure sensor.

### Claim 13 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, further comprising:
the monitoring patch, comprising:
a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection;
the electrocardiographic electrodes comprised on a contact surface of each end of the flexible backing, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along a midline of a sternum for capturing action potential propagation;
a receptacle affixed to a non-contacting surface of the flexible backing and comprising an electro-mechanical docking interface for interfacing with the housing;
a pair of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to the electro-mechanical docking interface; and
a circuit operable to store the identifier the patch, the circuit configured to provide via the electro-mechanical docking interface the password and the identifier to the monitor recorder.

### Claim 14 (depends on 13)

An ambulatory electrocardiography monitor according to claim 13, the monitoring patch further comprising:
a battery interfaced to the electro mechanical docking interface and configured to power the electronic circuitry via the docking interface.

### Claim 15 (depends on 14)

An ambulatory electrocardiography monitor according to claim 14, wherein the battery is a rechargeable battery.

### Claim 16 (depends on 13)

An ambulatory electrocardiography monitor according to claim 13, the monitoring patch further comprising a wireless transceiver.

### Claim 17 (depends on 16)

An ambulatory electrocardiography monitor according to claim 16, wherein the identifier and the password are loaded into the circuit via the wireless transceiver.

### Claim 18 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, the electronic circuitry further comprising a buzzer configured to output feedback after a completion of the power up sequence.

### Claim 19 (depends on 18)

An ambulatory electrocardiography monitor according to claim 18, wherein the buzzer comprises at least one of a speaker, a magnetic resonator, and a piezoelectric buzzer.

### Claim 20 (depends on 1)

An ambulatory electrocardiography monitor according to claim 1, wherein the power up sequence comprises one or more of checking a voltage of a battery powering the electronic circuitry, checking a state of the memory, and diagnostically confirming the microcontroller's operation.
