Computer-implemented system and method for providing a personal mobile device-triggered medical intervention

• US 10,165,946 B2
• Filed: 03/17/2014
• Issued: 01/01/2019
• 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
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): BALDWIN, NATHAN AARON
• Application Number:
  US14/217,402
• Publication Number:
  US 20150088007A1
• Time in Patent Office: 1,751 Days
• 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:

a wearable ambulatory sensor monitor comprising;

a disposable extended wear electrode patch configured for positioning along a sternal midline of a patient, comprising;

a non-conductive receptacle comprising a first set of electrical contact mating pads and a second set of electrical contact mating pads;

a pair of electrocardiographic electrodes, a first electrocardiographic electrode configured for positioning under the non-conductive receptacle on one end of the disposable extended wear electrode patch below the manubrium of a patient and the other electrocardiographic electrode configured for positioning on the other end of the disposable extended wear electrode patch that extends over the Xiphoid process of the patient, wherein the extension over the Xiphoid process facilitates sensing of ventricular activity and provides improved recordation of QRS intervals;

a battery electrically interfaced to the first set of electrical contact mating pads and located between and in alignment with the electrodes, wherein the battery is configured for positioning in a battery compartment provided in the non-conductive receptacle on the electrode patch; and

a flexible circuit connecting each of the electrocardiographic electrodes to one of the electrical contact mating pads of the second set of electrical contact mating pads;

a reusable sealed housing adapted to be removably secured into the non-conductive receptacle and comprising electronic circuitry operable to sense electrocardiographic signals through the electrocardiographic electrodes and a set of electrical contacts protruding from a surface of the sealed housing and contacting the first set of electrical mating pads that connect the battery on the electrode patch and the second set of electrical contact mating pads that connect each of the electrocardiographic electrodes;

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

a personal mobile device, comprising;

a wireless transceiver operable to interface the mobile device with a wirelessly-interfaceable server;

a non-transitory readable storage medium comprising program code; and

a processor and memory with the processor coupled to the wireless transceiver and the storage medium, wherein the processor is configured to execute the program code to perform steps to;

detect an event of potential medical significance comprising a cardiac rhythm disorder within the physiological data as sensed by the physiology sensor comprised in the activity monitor; and

trigger dispatch of the wearable ambulatory sensor monitor with the wireless transceiver through a request sent to the server upon the detection of the event of potential medical significance based on the physiological data; and

the server operable to dispatch the wearable ambulatory sensor monitor comprising the extended wear electrode patch and the sealed housing to the patient upon receipt of the request as sent from the mobile device after obtaining the physiological data via the activity monitor, for further monitoring of the patient via the wearable ambulatory sensor monitor.

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, the mobile device further comprising:

the activity monitor.

4. A system according to claim 1, wherein the activity monitor comprises a device physically independent from the mobile device,

the activity monitor further comprising:

a short-range wireless transceiver coupled to the physiology sensor and operable to wirelessly interface the activity monitor with the wireless transceiver comprised in the mobile device and relay the physiological data as sensed by the physiology sensor comprised in the activity monitor 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, the electronic circuity further 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

the micro-controller comprising an upload module as part of the micro programmable control that is 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 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 sealed housing,

wherein the recording further comprises the indicia uniquely identifying the sealed housing.

11. A system according to claim 10, wherein the indicia uniquely identifying the sealed housing 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 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 sealed housing,

wherein the recording further comprises the indicia uniquely identifying the sealed housing.

14. A system according to claim 13, wherein the indicia uniquely identifying the sealed housing 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 sealed housing; 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, wherein a pair of the electrical contacts are connected to at least one of the micro-controller, the wireless transceiver, and the flash memory.

17. A system according to claim 1, the disposable extended wear electrode patch further comprising:

a flexible backing formed of an elongated strip of stretchable material with a narrow longitudinal midsection evenly tapering inward from both ends of the elongated strip and, on each end, a contact surface coated with an adhesive dressing only on each end provided as a crimp relief;

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

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

the flexible circuit affixed on each end of the elongated strip and comprising a pair of circuit traces electrically coupled to the electrocardiographic electrodes and 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 samples of 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.