Method for addressing medical conditions through a wearable health monitor with the aid of a digital computer

• US 9,788,722 B2
• Filed: 11/28/2016
• Issued: 10/17/2017
• 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:
  US15/362,743
• Publication Number:
  US 20170095153A1
• Time in Patent Office: 323 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 5/33 specially adapted for cooperation with other devices
• 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 method for addressing medical conditions through a wearable health monitor with the aid of a digital computer, comprising the steps of:

providing a patient with a wearable health monitor comprising a disposable extended wear electrode patch and a monitor recorder, the electrode patch comprising a flexible backing and a plurality of electrocardiographic electrodes comprised on the contact surface of each end of the flexible backing, 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, the monitor recorder comprising a sealed housing adapted to be removably secured into the non-conductive receptacle and electronic circuitry comprising a memory and comprised within the sealed housing including an external interface configured to be removably connected to the electrocardiographic electrodes via the electro mechanical docking interface;

sensing the patient'"'"'s physiology through the disposable extended wear electrode patch over a monitoring period and recording the physiology throughout the monitoring period into the memory onboard the wearable health monitor;

downloading the physiology into a computer upon completion of the monitoring period and comparing the physiology to a medical diagnostic criteria;

generating with the computer a diagnostic overread that comprises one or more diagnostic findings;

determining with the computer the severity of any medical condition indicated by the diagnostic findings; and

referring the patient to one or more pre-identified care providers via the computer for facilitated diagnosis as conditioned upon the severity of each such medical condition that exceeds a threshold tolerance level.

2. A method according to claim 1, wherein the physiology is selected from the group comprising heart rate, blood pressure, respiratory rate, temperature, oxygen saturation, and blood glucose.

3. A method according to claim 1, wherein the diagnostic criteria are selected from the group comprising lightheadedness, fainting, chest pain, hypoxia, syncope, palpitations, and congestive heart failure.

4. A method according to claim 1, further comprising at least one of the steps of:

notifying a general practice physician upon a diagnostic finding comprising normal physiological data;

notifying a cardiologist upon a diagnostic finding comprising one or more of atrial fibrillation, ectopy, palpitations, and supraventricular tachycardia; and

notifying an electrophysiologist upon a diagnostic finding comprising ventricular tachycardia, bradycardia, and heart blockage.

5. A method according to claim 1, further comprising the steps of:

maintaining a database on the computer of the pre-identified care providers ordered by medical specialty and paired with one or more of the diagnostic criteria.

6. A method according to claim 1, further comprising the steps of:

retrieving a medical history for the patient; and

incorporating the medical history into the comparison against the diagnostic criteria.

7. A method according to claim 6, further comprising at least one of the steps of:

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

engaging proactive health care management if the diagnostic findings comprises a medical condition found in the patient'"'"'s medical history.

8. A method according to claim 1, further comprising at least one of the steps of:

structuring the diagnostic criteria along a temporal spectrum comprising changes in the physiology for at least one of the diagnostic findings over time; and

structuring the diagnostic criteria on a per event basis comprising a change in the physiology for at least one of the diagnostic findings.

9. A method according to claim 1, further comprising the step of:

generating performance of health care parameters comprising one or more of quality, efficiency, and expediency for the one or more care providers.

10. A method according to claim 1, further comprising the step of:

performing quality assurance testing on the diagnostic findings.

11. A method according to claim 1, further comprising the step of:

providing the notification through social media.

12. A method according to claim 1, further comprising the step of:

positioning each of the electrocardiographic electrodes comprised in the disposable extended wear electrode patch axially along the midline of the sternum for capturing action potential propagation.

13. A method according to claim 1, further comprising the step of:

wirelessly interfacing the monitor recorder through an integral wireless transceiver adapted to be electrically interfaced with one or more external wireless-enabled devices.

14. A method for addressing cardiac rhythm disorders through a wearable health monitor with the aid of a digital computer, comprising the steps of:

obtaining a wearable health monitor comprising a disposable extended wear electrode patch and a removable reusable monitor recorder comprising a memory, the electrode patch comprising a flexible backing defined as an elongated strip with a narrow longitudinal midsection and a plurality of electrocardiographic electrodes comprised on the contact surface of each end of the flexible backing, the electrode patch further comprising a non-conductive receptacle affixed to a non-contacting surface of the flexible backing into which the monitor recorder is adapted to dock;

positioning each of the electrocardiographic electrodes comprised in the disposable extended wear electrode patch axially along the midline of the sternum of a patient for capturing action potential propagation;

sensing the patient'"'"'s cardiac-related physiology, including action potential propagation, through the disposable extended wear electrode patch over a monitoring period and recording the physiology throughout the monitoring period into the memory onboard the wearable health monitor;

downloading the cardiac-related physiology into a computer upon completion of the monitoring period and comparing the cardiac-related physiology to a cardiac rhythm disorder diagnostic criteria;

generating with the computer a diagnostic overread that comprises one or more diagnostic findings and determining the severity of any cardiac rhythm disorder condition indicated by the diagnostic findings with the computer; and

initiating medical care of the patient with one or more pre-identified care providers via the computer as conditioned upon the severity of each such cardiac rhythm disorder condition that exceeds a threshold tolerance level.

15. A method according to claim 14, further comprising at least one of the steps of:

setting the severity to general concern upon a diagnostic finding comprising normal physiological data;

setting the severity to cardiac specialist concern upon a diagnostic finding comprising one or more of atrial fibrillation, ectopy, palpitations, and supraventricular tachycardia; and

setting the severity to cardiac subspecialist concern upon a diagnostic finding comprising ventricular tachycardia, bradycardia, and heart blockage.

16. A method according to claim 15, further comprising at least one of the steps of:

conditioning the tolerance level comprised in the normal physiological data comprised upon complaints by the patient of light headedness or syncope;

conditioning the tolerance level comprised in the atrial fibrillation comprising at least one-minute durations;

conditioning the tolerance level comprised in the ectopy comprising more than three premature ventricular contractions per minute;

conditioning the tolerance level comprised in the palpitations comprising fluttering of the chest;

conditioning the tolerance level comprised in the supraventricular tachycardia comprising heart rates over 180 bpm;

conditioning the tolerance level comprised in the ventricular tachycardia comprising three or more consecutive abnormal ventricular beats;

conditioning the bradycardia comprised in the diagnostic findings comprising pauses greater than three seconds; and

conditioning the tolerance level comprised in the heart blockage comprising the non-conduction of any normal sinus beat.

17. A method according to claim 15, further comprising the steps of:

supplementing the diagnostic findings with one or more of the patient'"'"'s medical history and testing results; and

structuring the medical care to comprise one of the steps of;

generating a referral to one such care provider if the diagnostic findings comprise a medical condition not found in the patient'"'"'s medical history or testing results; and

engaging in proactive health care management if the diagnostic findings comprise a medical condition found in the patient'"'"'s medical history or testing results.

18. A method according to claim 15, further comprising the step of:

managing a subscription service that authorizes the monitor recorder to operate for a set period of time or under pre-defined operational parameters.

19. A method according to claim 15, further comprising the step of:

wirelessly interoperating the monitor recorder with at least one of a wearable physiology monitor, a wearable activity sensor, and a mobile device.