Patent Issued for Health Monitoring Apparatus For Initiating A Treatment Of A Patient Based On Physiological Data With The Aid Of A Digital Computer (USPTO 10,390,700)

2019 SEP 10 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Bardy Diagnostics Inc. (Seattle, Washington, United States) has been issued patent number 10,390,700, according to news reporting originating out of Alexandria, Virginia, by NewsRx editors.

The patent’s inventors are Bardy, Gust H. (Carnation, WA); Bishay, Jon Mikalson (Lexington, KY).

This patent was filed on November 9, 2018 and was published online on September 9, 2019.

From the background information supplied by the inventors, news correspondents obtained the following quote: “Ensuring ready access to health care remains a pressing concern in our increasingly fast-paced society, but the ever climbing costs of health care makes having health insurance or similar financial arrangements all but essential for practically everyone except the wealthy or destitute. For the insured, the average health insurance carrier effectively serves as the gatekeeper that controls entry into the health care system and who manages the provisioning or denial of health care by stipulating the terms under which benefits will be paid. Thusly, health insurance subscribers (or enrollees) are at times caught in the middle between the dictates of their insurer and their ability to readily address their health concerns. On the one hand, a subscriber who bypasses his primary care provider, as typically required by an insurer as a first contact, and instead seeks out a medical specialist on his own may be taking a financial risk, as a health insurer could deny coverage. On the other hand, the primary care provider may not always offer a satisfactory or practicable solution, particularly in situations where a condition has symptoms that are transient or infrequent, or which underlies a disorder with a long incubatory or onset period, as can happen with certain chronic conditions.

“For instance, cardiac rhythm disorders may present with lightheadedness, fainting, chest pain, hypoxia, syncope, palpitations, and congestive heart failure (CHF), yet cardiac rhythm disorders are often sporadic in occurrence and may not show up in-clinic during a conventional 12-second electrocardiogram (ECG). Moreover, some types of cardiac rhythm disorders may warrant immediate subspecialist care, such as heart blockage, tachycardia and bradycardia, which require the attention of an electrophysiologist. Continuous ambulatory ECG monitoring over an extended period is more apt to capture sporadic cardiac events, yet health insurers often require a primary care referral to a monitoring laboratory before underwriting long-term ECG monitoring and access to a specialist may be delayed or denied, depending upon the ECG monitoring results.

“Notwithstanding, if a subscriber’s ECG could be recorded in an ambulatory setting over a prolonged time period, particularly for as long as seven days or more, thereby allowing the subscriber to engage in activities of daily living, the chances of acquiring meaningful medical information and capturing an abnormal event while the subscriber is engaged in normal activities are vastly improved. Unfortunately, few, if any, options for long-term ambulatory ECG monitoring that a subscriber could undertake on his own are available, and existing ECG monitoring solutions require physician involvement with tacit insurer approval. For instance, Holter monitors are widely used for extended ECG monitoring, typically for 24-48 hour time periods. A typical Holter monitor is a wearable and portable version of an ECG and, as such, is cumbersome, expensive and typically available for use only through a prescription, which limits their usability, and the discretion to refer the subscriber still remains with the attending physician.

“Similarly, the ZIO XT Patch and ZIO Event Card devices, manufactured by iRhythm Tech., Inc., San Francisco, Calif., are wearable monitoring devices that are typically worn on the upper left pectoral region to respectively provide continuous and looping ECG recording. The location is used to simulate surgically implanted monitors. The ZIO XT Patch device is limited to a 14-day period, while just the electrodes of the ZIO Event Card device can be worn for up to 30 days. Both devices represent compromises between length of wear and quality of ECG monitoring. Moreover, both of these devices are also prescription-only, which limits their usability and, the same as a Holter monitor, the discretion to refer the subscriber remains with the attending physician.

“Therefore, a need remains for a low cost monitor for recording an ECG and other physiology that can be used by an individual on their own, without health insurance pre-authorization, yet which can identify and generate an actionable, health condition-specific (and ideally health insurance-payable) referral to a medical specialist when medically appropriate.”

Supplementing the background information on this patent, NewsRx reporters also obtained the inventors’ summary information for this patent: “Certain kinds of medical conditions, particularly conditions that only sporadically exhibit measurable symptoms, defy conventional forms of medical diagnosis centered on in-clinic testing. Individuals who suffer from such conditions 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. Moreover, such individuals may present to a physician or other health care provider unable to provide state-of-the-art care for cardiac conditions, especially cardiac rhythm disorders. 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 expeditiously. 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 scheduled for a consultation, thereby removing delays and bypassing intermediaries who will not provide definitive interventions for the patient.

“In one embodiment, a health monitoring apparatus for initiating a patient treatment based on physiological data with the aid of a digital computer is provided. The apparatus includes a wearable health monitor, a download station configured to receive the physiology sensed by the wearable health monitor, and an at least one computer interfaced to the download station. The wearable health monitor includes a flexible backing; a plurality of electrocardiographic electrodes included on the flexible backing and provided to sense a patient’s physiology over a monitoring period; 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 and via which the sensed physiology is recorded by the wearable health monitor. The at least one computer includes a database configured to store the physiology and medical diagnostic criteria; and a processor and a memory configured to store code executable by the processor and including: 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.

“In a further embodiment, a health monitoring apparatus for initiating a patient treatment based on physiological data with the aid of a digital computer is provided. The apparatus includes a wearable health monitor, a download station configured to receive the physiology sensed by the wearable health monitor, and an at least one computer interfaced to the download station. The wearable health monitor includes a sealed housing; and an electronic circuitry included within the sealed housing and including an external interface configured to be connected to a pair of electrocardiographic electrodes configured to sense physiology of a patient throughout an extended period and an onboard memory configured to store the recorded physiology. The at least one computer includes a database configured to store the physiology and medical diagnostic criteria; and a processor and a memory configured to store code executable by the processor and including: 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.

“Still other embodiments will become readily apparent to those skilled in the art from the following detailed description, wherein are described embodiments by way of illustrating the best mode contemplated. As will be realized, other and different embodiments are possible and the embodiments’ several details are capable of modifications in various obvious respects, all without departing from their spirit and the scope. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.”

The claims supplied by the inventors are:

“What is claimed is:

“1. A health monitoring apparatus for initiating a patient treatment based on physiological data with the aid of a digital computer, comprising: a wearable health monitor 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; 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 and via which the sensed physiology is recorded by the wearable health monitor; a download station configured to receive the physiology sensed by the wearable health monitor; at least one computer interfaced to the download station, comprising: a database configured to store the 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, further comprising: the database further comprising the patient’s electronic medical records, wherein the diagnostic overread is generated further based on the electronic medical records.

“3. A health monitoring apparatus according to claim 1, wherein the electronic medical records comprise the patient’s medical history and testing results.

“4. A health monitoring apparatus according to claim 1, the wearable health monitor further comprising: a wireless transceiver operable to wirelessly interface with one or more external wireless-enabled devices.

“5. A health monitoring apparatus according to claim 4, wherein one of the wireless-enabled devices comprises a mobile device configured to receive the physiology recorded by the wearable physiology monitor and to transmit the physiology to the download station.

“6. A health monitoring apparatus according to claim 1, the wearable health monitor comprising an additional physiological sensor configured to collect additional physiological data, wherein the diagnostic overread is further based on the additional physiological data.

“7. A health monitoring apparatus according to claim 6, wherein the additional physiological data comprises blood pressure, respiratory rate, temperature, and blood glucose.

“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.”

For the URL and additional information on this patent, see: Bardy, Gust H.; Bishay, Jon Mikalson. Health Monitoring Apparatus For Initiating A Treatment Of A Patient Based On Physiological Data With The Aid Of A Digital Computer. U.S. Patent Number 10,390,700, filed November 9, 2018, and published online on September 9, 2019. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10,390,700.PN.&OS=PN/10,390,700RS=PN/10,390,700

(Our reports deliver fact-based news of research and discoveries from around the world.)