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

• US 9,936,875 B2
• Filed: 10/16/2017
• Issued: 04/10/2018
• 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:
  US15/785,317
• Publication Number:
  US 20180049640A1
• Time in Patent Office: 176 Days
• Field of Search: None
• 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 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 pair 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 and an external interface configured to be removably connected to the electrocardiographic electrodes via the docking interface;

a download station comprising an interface over which the physiology can be downloaded from the onboard memory of the wearable health monitor upon completion of the monitoring period; and

a computer adapted to be interfaced to the download station, comprising;

a database, comprising;

the physiology as retrieved from the download station; and

a medical diagnostic criteria;

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

a comparison module configured to compare the physiology to the medical diagnostic criteria and to generate a diagnostic overread that comprises one or more diagnostic findings; 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 over-read.

2. A health monitoring apparatus according to claim 1, the monitor recorder further comprising:

a microcontroller operable to store the recorded physiology into the onboard memory.

3. A health monitoring apparatus according to claim 2, further comprising:

a wireless transceiver electrically interfaced with the microcontroller and operable to wirelessly interface with one or more external wireless-enabled devices.

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

a mobile device configured to create a confirmation of the patient'"'"'s receipt of the wearable health monitor and to transmit the confirmation.

5. A health monitoring apparatus according to claim 4, wherein the confirmation comprises a recording of the wearable health monitor on the patient'"'"'s chest and one or more identifying marks of at least one of the patient and the wearable health monitor.

6. A health monitoring apparatus according to claim 4, wherein the confirmation is transmitted to at least one of a physician of the patient and the wearable health monitor.

7. A health monitoring apparatus according to claim 4, wherein the confirmation comprises a biometric identifier scanned from the patient.

8. A health monitoring apparatus according to claim 1, the referral 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.

9. A health monitoring apparatus according to claim 8, the referral 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

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

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 for patient referral 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 pair 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 and an external interface configured to be removably connected to the electrocardiographic electrodes via the docking interface;

a download station comprising an interface over which the physiology can be downloaded from the onboard memory of the wearable health monitor upon completion of the monitoring period; and

a computer adapted to be interfaced to the download station, comprising;

a database, comprising;

the physiology as retrieved from the download station; and

a medical diagnostic criteria;

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

a comparison module configured to compare the physiology to the medical diagnostic criteria and to generate a diagnostic overread that comprises one or more diagnostic findings; and

a referral module configured to refer the patient to one or more pre-identified care providers for facilitated diagnosis based on the diagnostic overread.

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

a microcontroller operable to store the recorded physiology into the onboard memory.

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

a wireless transceiver electrically interfaced with the microcontroller and operable to wirelessly interface with one or more external wireless-enabled devices.

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

a mobile device configured to create a confirmation of the patient'"'"'s receipt of the wearable health monitor and to transmit the confirmation.

15. A health monitoring apparatus according to claim 14, wherein the confirmation comprises a recording of the wearable health monitor on the patient'"'"'s chest and one or more identifying marks of at least one of the patient and the wearable health monitor.

16. A health monitoring apparatus according to claim 14, wherein the confirmation is transmitted to at least one of a physician of the patient and the wearable health monitor.

17. A health monitoring apparatus according to claim 14, wherein the confirmation comprises a biometric identifier scanned from the patient.

18. A health monitoring apparatus according to claim 11, the referral 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 18, the referral 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

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

20. 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.