# US 10,869,601 B2 · System and method for patient medical care initiation based on physiological monitoring data with the aid of a digital computer

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- Number: US 10,869,601 B2
- Document ID: US10869601B2
- Status: Granted
- Kind: B2
- Application number: 16/551,213
- Filed: 2019-08-26
- Published: 2019-12-19
- Granted: 2020-12-22
- Earliest claimed: 2015-10-05
- Assignees: Bardy Diagnostics, Inc.
- Applicants: Bardy Diagnostics, Inc.
- Inventors: Gust H. Bardy; Jon Mikalson Bishay
- Web page: https://patentgrep.com/patent/US10869601B2

## CPC

- A61B 5/0006: {ECG or EEG signals}
- 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 5/021: Measuring pressure in heart or blood vessels
- A61B 5/0245: by using sensing means generating electric signals, {i.e. ECG signals}
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/1477: non-invasive
- A61B 5/33: specially adapted for cooperation with other devices
- A61B 5/332: Portable devices specially adapted therefor
- A61B 5/361: Detecting fibrillation
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/364: Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
- A61B 5/6823: {Trunk, e.g., chest, back, abdomen, hip}
- A61B 5/7246: {using correlation, e.g. template matching or determination of similarity}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- G16H 40/67: for remote operation
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 2560/0475: Special features of memory means, e.g. removable memory cards
- A61B 2562/04: Arrangements of multiple sensors of the same type
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

Individuals who suffer from certain kinds of medical conditions, particularly conditions that only sporadically exhibit measurable symptoms, can feel helpless in their attempts to secure access to medical care because, at least in part, they are left to the mercy of their condition to present symptoms at the right time to allow diagnosis and treatment. Providing these individuals with ambulatory extended-wear health monitors that record ECG and physiology, preferably available over-the-counter and without health insurance preauthorization, is a first step towards addressing their needs. In addition, these individuals need a way to gain entry into the health care system once a medically-actionable medical condition has been identified. Here, the ECG and physiology is downloaded and evaluated post-monitoring against medical diagnostic criteria. Medical specialists are pre-identified and paired up with key diagnostic findings, such that an individual whose monitoring data indicates a medical concern will be automatically referred and treated.

## Claims

### Claim 1

A system for patient medical care initiation based on physiological monitoring data with the aid of a digital computer, comprising:
a physiological monitor, comprising:
a sealed housing shaped to insert into a receptacle on an extended wear electrode patch; and
an electronic circuitry comprised within the sealed housing and configured to sense via at least a pair of electrocardiographic electrodes provided on the extended wear electrode patch physiology of a patient, the electronic circuitry comprising an onboard memory configured to store the sensed physiology; and
a download station configured to receive the physiology sensed by the physiological monitor;
at least one computer, comprising:
a database configured to store the received physiology and medical diagnostic criteria; and
a processor and a memory configured to store code executable by the processor, the processor configured to:
generate a diagnostic overread of the physiology using the medical diagnostic criteria; and
initiate medical care of the patient with one or more pre-identified care providers based on the overread.

### Claim 2 (depends on 1)

A system according to claim 1, wherein the diagnostic overread comprises one or more diagnostic findings that are rated by degrees of severity.

### Claim 3 (depends on 2)

A system according to claim 2, the processor further configured to:
compare the ratings of the diagnostic findings to a threshold, wherein the initiation of the diagnostic treatment comprises generating orders to seek immediate treatment based on the comparison.

### Claim 4 (depends on 2)

A system according to claim 2, wherein the diagnostic findings are associated with a treatment, the processor further configured to:
select the one or more pre-identified health care providers based on the treatments associated with the one or more diagnostic findings.

### Claim 5 (depends on 1)

A system according to claim 1, the processor further configured to:
obtain physiological data associated with a population of individuals similar to the patient, wherein the diagnostic overread is further generated based on the physiological data associated with the population of individuals similar to the patient.

### Claim 6 (depends on 1)

A system according to claim 1, wherein at one of:
the received physiology is structured along a temporal spectrum that reflects a change in the received physiology over time; and
the received physiology is structured on a per event basis.

### Claim 7 (depends on 6)

A system according to claim 6, wherein the classes of medical conditions comprise cardiac disorder, respiratory distress, hypoglycemia, and hypoxia.

### Claim 8 (depends on 1)

A system according to claim 1, wherein each of the medical diagnostic criteria are associated with at least one of a class of health conditions and a specific medical condition.

### Claim 9 (depends on 1)

A system according to claim 1, the physiological monitor further comprising one or more of a blood pressure sensor, respiratory rate sensor, a temperature sensor, and a blood glucose sensor.

### Claim 10

A method for patient medical care initiation based on physiological monitoring data with the aid of a digital computer, comprising:
sensing physiology of a patient by a physiological monitor that comprises a sealed housing shaped to insert into a receptacle on an extended wear electrode patch and an electronic circuitry comprised within the sealed housing, the electronic circuitry configured to sense via at least a pair of electrocardiographic electrodes provided on the extended wear electrode patch the physiology of the patient, the electronic circuitry comprising an onboard memory configured to store the sensed physiology; and
receiving by a download station the physiology sensed by the physiological monitor; and
processing the received physiology by an at least one computer, comprising:
storing the received physiology and medical diagnostic criteria in a database;
generating a diagnostic overread of the physiology using the medical diagnostic criteria; and
initiating medical care of the patient with one or more pre-identified care providers based on the overread.

### Claim 11 (depends on 10)

A method according to claim 10, wherein the diagnostic overread comprises one or more diagnostic findings that are rated by degrees of severity.

### Claim 12 (depends on 11)

A method according to claim 11, further comprising:
comparing by the at least one computer the ratings of the diagnostic findings to a threshold, wherein the initiation of the diagnostic treatment comprises generating orders to seek immediate treatment based on the comparison.

### Claim 13 (depends on 11)

A method according to claim 11, wherein the diagnostic findings are associated with a treatment, further comprising
selecting the one or more pre-identified health care providers based on the treatments associated with the one or more diagnostic findings.

### Claim 14 (depends on 10)

A method according to claim 10, the processor further configured to:
obtaining physiological data associated with a population of individuals similar to the patient, wherein the diagnostic overread is further generated based on the physiological data associated with the population of individuals similar to the patient.

### Claim 15 (depends on 10)

A method according to claim 10, wherein at one of:
the received physiology is structured along a temporal spectrum that reflects a change in the received physiology over time; and
the received physiology is structured on a per event basis.

### Claim 16 (depends on 15)

A method according to claim 15, wherein the classes of medical conditions comprise cardiac disorder, respiratory distress, hypoglycemia, and hypoxia.

### Claim 17 (depends on 10)

A method according to claim 10, wherein each of the medical diagnostic criteria are associated with at least one of a class of health conditions and a specific medical condition.

### Claim 18 (depends on 10)

A method according to claim 10, the physiological monitor further comprising one or more of a blood pressure sensor, respiratory rate sensor, a temperature sensor, and a blood glucose sensor.

### Claim 19 (depends on 10)

A method according to claim 10, further comprising:
generating a referral to the one or more pre-identified care providers; and
notifying the patient of the referral.
