Researchers Submit Patent Application, “System And Method For Patient Medical Care Initiation Based On Physiological Monitoring Data With The Aid Of A Digital Computer”, for Approval (USPTO 20190380581)

2020 JAN 07 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors Bardy, Gust H. (Carnation, WA); Bishay, Jon Mikalson (Lexington, KY), filed on August 26, 2019, was made available online on December 19, 2019.

The patent’s assignee is Bardy Diagnostics Inc. (Seattle, Washington, United States).

News editors obtained the following quote from the background information supplied by the inventors: “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.”

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors’ summary information for this patent application: “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 system and method for patient medical care initiation based on physiological monitoring data with the aid of a digital computer are provided. Physiology of a patient is sensed by a physiological monitor that includes a sealed housing and an electronic circuitry included within the sealed housing, the electronic circuitry configured to sense via at least a pair of electrocardiographic electrodes the physiology of the patient, the electronic circuitry including an onboard memory configured to store the recorded physiology. The physiology sensed by the physiological monitor is received by a download station. The received physiology is processed by an at least one computer, including: 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.

“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:

“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; and an electronic circuitry comprised within the sealed housing and configured to sense via at least a pair of electrocardiographic electrodes physiology of a patient, the electronic circuitry comprising an onboard memory configured to store the recorded 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.

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

“3. 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.

“4. 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.

“5. 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.

“6. 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.

“7. 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.

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

“9. 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.

“10. A system according to claim 1, wherein the pair of electrocardiographic electrodes are provided on an extended wear electrode patch.

“11. 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 and an electronic circuitry comprised within the sealed housing, the electronic circuitry configured to sense via at least a pair of electrocardiographic electrodes the physiology of the patient, the electronic circuitry comprising an onboard memory configured to store the recorded physiology; and receiving by a download station the physiology sensed by the physiological monitor; 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.

“12. A method according to claim 11, wherein the diagnostic overread comprises one or more diagnostic findings that are rated by degrees of severity.

“13. A method according to claim 12, 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.

“14. A method according to claim 12, 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.

“15. A method according to claim 11, 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.

“16. A method according to claim 11, 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.

“17. A method according to claim 11, wherein each of the medical diagnostic criteria are associated with at least one of a class of health conditions and a specific medical condition.

“18. A method according to claim 16, wherein the classes of medical conditions comprise cardiac disorder, respiratory distress, hypoglycemia, and hypoxia.

“19. A method according to claim 11, the physiological monitor further comprising one or more of a blood pressure sensor, respiratory rate sensor, a temperature sensor, and a blood glucose sensor.

“20. A method according to claim 11, further comprising: generating a referral to the one or more pre-identified care providers; and notifying the patient of the referral.”

For additional information on this patent application, see: Bardy, Gust H.; Bishay, Jon Mikalson. System And Method For Patient Medical Care Initiation Based On Physiological Monitoring Data With The Aid Of A Digital Computer. Filed August 26, 2019 and posted December 19, 2019. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220190380581%22.PGNR.&OS=DN/20190380581&RS=DN/20190380581

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