Computer-Implemented System And Method For Providing A Personal Mobile Device-Triggered Medical Intervention

• US 20150088007A1
• Filed: 03/17/2014
• Published: 03/26/2015
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Bardy, Gust H., Felix, Jason, Bishay, Jon Mikalson
• Granted Patent: US 10,165,946 B2
• Time in Patent Office: Days
• US Class Current: 600/484
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• 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: G16H 40/63 for local operation
• 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

Physiological monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder. The wearable monitor sits centrally on the patient'"'"'s chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline (or immediately to either side of the sternum) benefits extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. The wearable monitor can interoperate wirelessly with other physiology and activity sensors and mobile devices. An application executed by the sensor or device can trigger the dispatch of a wearable monitor to the patient upon detecting potentially medically-significant events. The dispatched wearable monitor would then be capable of providing precise medically-actionable data, not merely an alert that some abnormality may be present. The patient can then use the sensor or device to physically record the placement and use of the medically-actionable wearable monitor, thereby facilitating the authentication of the data recorded.

Claims

1. A computer-implemented system for providing a personal mobile device-triggered medical intervention, comprising:

an activity monitor adapted to be used proximal to a patient'"'"'s body comprising a physiology sensor operable to sense physiological data of the body;

a personal mobile device, comprising;

an application executable by the mobile device and configured to detect an event of potential medical significance within the sensed physiological data; and

a wireless transceiver operable to interface the mobile device with an external system and to send notification of a detection of the event; and

an extended wear electrocardiography and physiological sensor monitor recorder dispatched by the external system upon receipt of the notification.

2. A system according to claim 1, further comprising at least one of:

the activity monitor further adapted to sense the physiological data continuously;

the activity monitor further adapted to sense the physiological data non-continuously; and

the activity monitor further adapted to sense the physiological data upon patient triggering.

3. A system according to claim 1, wherein the activity monitor is comprised in the mobile device.

4. A system according to claim 1, wherein the activity monitor is a device physically independent from the mobile device, further comprising:

the mobile device operable to be paired with the activity monitor and further comprising;

a wireless communications services transceiver operable to interface the mobile device with a telecommunications network upon which the external system is located; and

the activity monitor further comprising;

a short-range wireless transceiver operable to interface the activity monitor with the mobile device and to relay the notification to the mobile device.

5. A system according to claim 1, wherein the physiological data is selected from the group comprising heart rate, temperature, blood pressure, respiratory rate, blood pressure, blood sugar, oxygen saturation, and minute ventilation.

6. A system according to claim 1, further comprising:

the sensor monitor recorder comprising;

a sealed housing adapted to be removably secured into the non-conductive receptacle on a disposable extended wear electrode patch; and

electronic circuitry comprised within the sealed housing, comprising;

an externally-powered micro-controller operable to execute under micro programmable control;

an electrocardiographic front end circuit electrically interfaced to the micro-controller and operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the disposable extended wear electrode patch; and

externally-powered flash memory electrically interfaced with the micro-controller and operable to store the samples of the electrocardiographic signals.

7. A system according to claim 6, further comprising:

a recorder wireless transceiver electrically interfaced with the micro-controller and operable to interface the mobile device with a telecommunications network upon which electronic medical records are located; and

an upload module configured to send the samples of the electrocardiographic signals directly to the electronic medical records via the recorder wireless transceiver.

8. A system according to claim 7, further comprising:

a server coupled to the electronic medical records, further comprising;

a data retrieval module configured to retrieve the samples of the electrocardiographic signals from the electronic medical records; and

an evaluation module configured to evaluate the samples of the electrocardiographic signals and to refer the patient for medical care.

9. A system according to claim 7, further comprising:

a recording feature comprised in the mobile device operable to record physical indicia proximal to the mobile device,

wherein a recording of both the placement of the sensor monitor recorder on the patient'"'"'s body and indicia uniquely identifying the patient are provided to the electronic medical records with the samples of the electrocardiographic signals as certification.

10. A system according to claim 9, further comprising:

the sealed housing further comprising indicia uniquely identifying the sensor monitor recorder,

wherein the recording further comprises the indicia uniquely the sensor monitor recorder.

11. A system according to claim 10, wherein the indicia uniquely the sensor monitor recorder is selected from the group comprising visible indicia printed on the outside of the sealed housing, visible indicia applied to the outside of the sealed housing, and electronic indicia integrated into the sealed housing.

12. A system according to claim 7, further comprising:

a recording feature comprised in the mobile device operable to record physical indicia proximal to the mobile device,

wherein a recording of the placement of the sensor monitor recorder on the patient'"'"'s body and indicia uniquely identifying the patient are securely stored as part of the samples of the electrocardiographic signals as certification.

13. A system according to claim 12, further comprising:

the sealed housing further comprising indicia uniquely identifying the sensor monitor recorder,

wherein the recording further comprises the indicia uniquely the sensor monitor recorder.

14. A system according to claim 13, wherein the indicia uniquely the sensor monitor recorder is selected from the group comprising visible indicia printed on the outside of the sealed housing, visible indicia applied to the outside of the sealed housing, and electronic indicia integrated into the sealed housing.

15. A system according to claim 6, further comprising:

a download station comprising;

a non-conductive receptacle adapted to removably receive the monitor recorder; and

a download station controller operable to retrieve the samples of the electrocardiographic signals; and

a computer system operatively coupled to the download station controller and centrally accessible over a data communications network and operable to maintain the samples of the electrocardiographic signals upon retrieval.

16. A system according to claim 6, further comprising:

a pair of electrical contacts external to the sealed housing and electrically connected to at least one of the micro-controller, the wireless transceiver, and the flash memory;

a battery provided on the disposable extended wear electrode patch; and

an pair of electrical pads external to the disposable extended wear electrode patch and disposed to operatively couple with the pair of electrical contacts, the electrical pads further electrically interfaced via battery leads to the battery.

17. A system according to claim 6, the disposable extended wear electrode patch further comprising:

a flexible backing formed of an elongated strip of stretchable material with a narrow longitudinal midsection and, on each end, a contact surface at least partially coated with an adhesive dressing provided as a crimp relief;

a pair of electrocardiographic electrodes conductively exposed on the contact surface of each end of the elongated strip;

a non-conductive receptacle adhered to an outward-facing end of the elongated strip and comprising the electrical pads; and

a flexible circuit affixed on each end of the elongated strip as a strain relief and comprising a pair of circuit traces electrically coupled to the pair of electrocardiographic electrodes and a pair of the electrical pads.

18. A system according to claim 1, wherein the activity tracker is selected from the group comprising a wearable physiology sensor, a wearable activity sensor, a smart watch, and a smartphone.

19. A system according to claim 1, further comprising at least one of:

a server computer system centrally accessible over a data communications network and operable to wirelessly interface with the wireless transceiver to receive the samples of the electrocardiographic signals; and

a client computer system interconnected to the data communications network and operable to wirelessly interface with the wireless transceiver to access the samples of the electrocardiographic signals.

20. A system according to claim 19, further comprising:

a secure database interconnected to the data communications network and operable to maintain the samples of the electrocardiographic signals on behalf of one or more of the server computer system and the client computer system in the patient'"'"'s electronic medical records.