Health monitoring apparatus with wireless capabilities for initiating a patient treatment with the aid of a digital computer

• US 10,123,703 B2
• Filed: 04/09/2018
• Issued: 11/13/2018
• Est. Priority Date: 10/05/2015
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Bardy, Gust H., Bishay, Jon Mikalson
• Primary Examiner(s): Sereboff, Neal
• Application Number:
  US15/948,915
• Publication Number:
  US 20180220890A1
• Time in Patent Office: 218 Days
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

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

1. A health monitoring apparatus with wireless capabilities for initiating a patient treatment with the aid of a digital computer, comprising:

a wearable health monitor comprising;

a disposable extended wear electrode patch comprising;

a flexible backing;

a plurality of electrocardiographic electrodes comprised on the flexible backing and provided to sense a patient'"'"'s physiology over a monitoring period;

a non-conductive receptacle affixed to a non-contacting surface of the flexible backing; and

a plurality of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to an electro-mechanical docking interface; and

a monitor recorder capable of recording the physiology throughout the monitoring period into an onboard memory, comprising;

a sealed housing adapted to be removably secured into the non-conductive receptacle; and

an electronic circuitry comprised within the sealed housing and comprising the onboard memory configured to store the recorded physiology, an external interface configured to be removably connected to the electrocardiographic electrodes via the docking interface, and a wireless transceiver configured to transmit the physiology from the onboard memory to an at least one computer;

the at least one computer, comprising;

a database, comprising the transmitted physiology and medical diagnostic criteria; and

a processor and a memory configured to store code executable by the processor and comprising;

a comparison module configured to generate a diagnostic overread of the physiology using the medical diagnostic criteria; and

an initiation module configured to initiating medical care of the patient with one or more pre-identified care providers via the computer based on the overread.

2. A health monitoring apparatus according to claim 1, wherein the wireless transceiver connects to a telecommunications network and provides the physiology to the database to via the telecommunications networks.

3. A health monitoring apparatus according to claim 2, wherein the wireless transceiver comprises a cellular chipset and the telecommunications network comprises cellular network.

4. A health monitoring apparatus according to claim 1, wherein the wireless transceiver is implemented using at least one of a Bluetooth®

4.2 standard and a Wi-Fi standard and the telecommunications network comprises the Internet.

5. A health monitoring apparatus according to claim 1, further comprising:

a mobile device configured to interface with the wireless transceiver and configured to transmit the physiology received to the database.

6. A health monitoring apparatus according to claim 5, further comprising:

a heart rate monitor configured to detect an irregularity in a heartbeat of the patient and to trigger a dispatch of the wearable health monitor to the patient upon the detection.

7. A health monitoring apparatus according to claim 1, wherein the heartrate monitor is one of wirelessly interfaced to the mobile device and comprised within the mobile device and the mobile device transmits a request for the dispatch upon the detection.

8. A health monitoring apparatus according to claim 1, further comprising:

a physiology sensor comprised in the wearable health monitor, wherein the transmitted physiology comprises data recorded by the physiology sensor.

9. A health monitoring apparatus according to claim 8, wherein the physiology sensor comprises at least one of a blood pressure sensor, respiratory rate sensor, temperature sensor, and a blood glucose sensor.

10. A health monitoring apparatus according to claim 1, the database further comprising the pre-identified care providers ordered by medical specialty and paired with one or more of the diagnostic criteria.

11. A health monitoring apparatus with mobile device capabilities for initiating a patient treatment with the aid of a digital computer, comprising:

a wearable health monitor comprising;

a disposable extended wear electrode patch comprising;

a flexible backing;

a plurality of electrocardiographic electrodes comprised on the flexible backing and provided to sense a patient'"'"'s physiology over a monitoring period;

a non-conductive receptacle affixed to a non-contacting surface of the flexible backing; and

a plurality of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to an electro-mechanical docking interface; and

a monitor recorder capable of recording the physiology throughout the monitoring period into an onboard memory, comprising;

a sealed housing adapted to be removably secured into the non-conductive receptacle; and

an electronic circuitry comprised within the sealed housing and comprising the onboard memory configured to store the recorded physiology, an external interface configured to be removably connected to the electrocardiographic electrodes via the docking interface, and a wireless transceiver configured to transmit the physiology from the onboard memory;

a mobile device configured to receive the physiology from the wireless transceiver and to transmit the physiology to an at least one computer;

the at least one computer, comprising;

a database, comprising the transmitted physiology and medical diagnostic criteria; and

a processor and a memory configured to store code executable by the processor and comprising;

a comparison module configured to generate a diagnostic overread of the physiology using the medical diagnostic criteria; and

an initiation module configured to initiating medical care of the patient with one or more pre-identified care providers via the computer based on the overread.

12. A health monitoring apparatus according to claim 11, further comprising:

a heart rate monitor configured to detect an irregularity in a heartbeat of the patient and to trigger a dispatch of the wearable health monitor to the patient upon the detection.

13. A health monitoring apparatus according to claim 12, wherein the heartrate monitor is one of wirelessly interfaced to the mobile device and comprised within the mobile device and the mobile device transmits a request for the dispatch upon the detection.

14. A health monitoring apparatus according to claim 12, wherein the triggering comprises a request that is sent to at least one of the patient'"'"'s physician, a medical service provider organization, a pharmacy, and an emergency medical service.

15. A health monitoring apparatus according to claim 11, further comprising:

a physiology sensor comprised in the wearable health monitor, wherein the transmitted physiology comprises data recorded by the physiology sensor.

16. A health monitoring apparatus according to claim 15, wherein the physiology sensor comprises at least one of a blood pressure sensor, respiratory rate sensor, temperature sensor, and a blood glucose sensor.

17. A health monitoring apparatus according to claim 11, the database further comprising the pre-identified care providers ordered by medical specialty and paired with one or more of the diagnostic criteria.

18. A health monitoring apparatus according to claim 11, the initiation module further comprising at least one of:

a notification module configured to notify a general practice physician upon a diagnostic finding comprising normal physiological data despite patient complaints of light headedness or syncope;

a notification module configured to notify a cardiologist upon a diagnostic finding comprising atrial fibrillation of over 1 minute duration, ectopy comprising more than 3 PVCs per minute, palpitations comprising fluttering of the chest, and supraventricular tachycardia comprising heart rates over 180 bpm; and

a notification module configured to notify an electrophysiologist upon a diagnostic finding comprising ventricular tachycardia comprising 3 or more consecutive abnormal ventricular beats, bradycardia comprising pauses greater than 3 seconds, and heart blockage comprising the non-conduction of any normal sinus beat.

19. A health monitoring apparatus according to claim 11, the database further comprising the pre-identified care providers ordered by medical specialty and paired with one or more of the diagnostic criteria.

20. A health monitoring apparatus according to claim 11, the initiation module further comprising:

a notification module configured to generate a referral to one such care provider if the diagnostic findings comprises a medical condition not found in the patient'"'"'s medical history; and

an engagement module configured to engage proactive health care management if the diagnostic findings comprises a medical condition found in the patient'"'"'s medical history.