System and method for patient medical care initiation based on physiological monitoring data with the aid of a digital computer

• US 10,869,601 B2
• Filed: 08/26/2019
• Issued: 12/22/2020
• 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:
  US16/551,213
• Publication Number:
  US 20190380581A1
• Time in Patent Office: 484 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 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 shaped to insert into a receptacle on an extended wear electrode patch; and

an electronic circuitry comprised within the sealed housing and configured to sense via at least a pair of electrocardiographic electrodes provided on the extended wear electrode patch physiology of a patient, the electronic circuitry comprising an onboard memory configured to store the sensed 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 6, wherein the classes of medical conditions comprise cardiac disorder, respiratory distress, hypoglycemia, and hypoxia.

8. 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.

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 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 shaped to insert into a receptacle on an extended wear electrode patch and an electronic circuitry comprised within the sealed housing, the electronic circuitry configured to sense via at least a pair of electrocardiographic electrodes provided on the extended wear electrode patch the physiology of the patient, the electronic circuitry comprising an onboard memory configured to store the sensed physiology; and

receiving by a download station the physiology sensed by the physiological monitor; and

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.

11. A method according to claim 10, wherein the diagnostic overread comprises one or more diagnostic findings that are rated by degrees of severity.

12. A method according to claim 11, 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.

13. A method according to claim 11, 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.

14. A method according to claim 10, 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.

15. A method according to claim 10, 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.

16. A method according to claim 15, wherein the classes of medical conditions comprise cardiac disorder, respiratory distress, hypoglycemia, and hypoxia.

17. A method according to claim 10, 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 10, the physiological monitor further comprising one or more of a blood pressure sensor, respiratory rate sensor, a temperature sensor, and a blood glucose sensor.

19. A method according to claim 10, further comprising:

generating a referral to the one or more pre-identified care providers; and

notifying the patient of the referral.