Extended wear ambulatory electrocardiography and physiological sensor monitor

• US 10,806,360 B2
• Filed: 12/03/2018
• Issued: 10/20/2020
• 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: Felix, Jason, Bardy, Gust H., Bishay, Jon Mikalson, Green, Joshua Djon
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US16/208,468
• Publication Number:
  US 20190104961A1
• Time in Patent Office: 687 Days
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• 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 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/087 Measuring breath flow
• 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 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

An extended wear electrocardiography patch is provided. A flexible backing includes an elongated strip of stretchable material. An electrocardiographic electrode is respectively affixed to and conductively exposed on each end of the elongated strip. A flexible circuit is affixed on each end to the elongated strip and includes a pair of circuit traces each originating within one of the ends of the elongated strip and coupled to one of the electrocardiographic electrodes. A non-conductive receptacle securely adhered on the one end of the elongated strip and includes electrode terminals aligned to interface the pair of circuit traces to an electrocardiography monitor to obtain electrocardiographic signals through the electrocardiographic electrodes. A crypto circuit includes memory programed with a sampling rate for at least one physiological sensor provided at least one of with the electrocardiography monitor and on the flexible backing to instruct the physiological sensor to obtain readings of physiological data.

Claims

1. An electrocardiography monitoring system, comprising:

a flexible backing formed of an elongated strip of stretchable material;

an electrocardiographic electrode respectively affixed to and conductively exposed on a contact surface of each end of the elongated strip;

a flexible circuit affixed on each end to the elongated strip and comprising a pair of circuit traces each originating within one of the ends of the elongated strip and electrically coupled to one of the electrocardiographic electrodes;

a non-conductive receptacle securely adhered on one of the ends of the elongated strip on a surface opposite the contact surface and formed to removably receive an electrocardiography monitor operable to obtain electrocardiographic signals through the electrocardiographic electrodes, wherein the non-conductive receptacle comprises electrode terminals aligned to electrically interface the pair of circuit traces to the electrocardiography monitor;

a crypto circuit comprising memory on the flexible backing; and

a battery to provide power to at least one physiological sensor provided with the electrocardiography monitor or on the flexible backing to obtain readings of physiological data, wherein the battery is positioned on one end of the flexible backing underneath the non-conductive receptacle and the electrocardiography monitor when received by the non-conductive receptacle and further wherein the flexible backing reduces shear forces by comprising a low center of gravity.

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

the electrocardiography monitor; and

a download station to retrieve the electrocardiographic signals from the electrocardiography monitor.

3. A system according to claim 2, wherein the electrocardiographic signals are converted into a different format via middlewear on the download station.

4. A system according to claim 3, wherein the electrocardiographic signals are retrieved from the download station by a server that remotely interfaces with the download station.

5. A system according to claim 1, wherein the physiological sensor comprises one of a SpO2 sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, or volumetric pressure sensor.

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

the electrocardiography monitor, comprising;

a sealed housing adapted to be removably secured into the non-conductive receptacle; and

electronic circuitry comprised within the sealed housing, comprising;

an electrocardiographic front end circuit configured to sense the electrocardiographic signals through the electrocardiographic electrodes provided on the flexible backing; and

flash memory to record the electrocardiographic signals.

7. A system according to claim 6, wherein the electronic circuitry of the electrocardiography monitor is configured to embed the physiological data into a stream of the electrocardiographic signals.

8. A system to claim 6, wherein the electronic circuitry of the electrocardiography monitor is configured to match the electrocardiographic signals to the physiological data.

9. An electrocardiography monitoring system according to claim 1, wherein the memory is programed with a sampling rate for the physiological sensor to obtain the readings of physiological data.

10. A system according to claim 9, wherein the physiological sensor is configured to record the physiological data based on the sampling rate.

11. An extended wear electrocardiography and physiological sensor monitor, comprising:

an electrocardiography monitor, comprising;

a sealed housing; and

electronic circuitry comprised within the sealed housing, comprising;

an externally-powered micro-controller; and

an electrocardiographic front end circuit electrically interfaced to the micro-controller and operable to sense electrocardiographic signals; and

an electrocardiography patch, comprising;

a flexible backing formed of an elongated strip of stretchable material;

an electrocardiographic electrode affixed to and conductively exposed on a contact surface of each end of the elongated strip;

a flexible circuit affixed on each end to the elongated strip and comprising a pair of circuit traces each originating within one of the ends of the elongated strip and electrically coupled to one of the electrocardiographic electrodes;

a non-conductive receptacle securely adhered on one of the ends of the elongated strip opposite the contact surface and formed to removably receive the electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of circuit traces to the electrocardiography monitor;

a crypto circuit comprising memory on the flexible backing; and

a battery to provide power to at least one physiological sensor provided with the electrocardiography monitor or on the flexible backing to obtain readings of physiological data, wherein the physiological sensor is electrically interfaced with the micro-controller over an expansion bus and the battery is positioned on one end of the flexible backing underneath the non-conductive receptacle and the electrocardiography monitor when received by the non-conductive receptacle and further wherein the electrocardiography patch reduces shear forces by comprising a low center of gravity.

12. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a download station to retrieve the electrocardiographic signals from the from the electrocardiography monitor.

13. An extended wear electrocardiography and physiological sensor monitor according to claim 12, wherein the electrocardiographic signals are converted into a different format via middlewear on the download station.

14. An extended wear electrocardiography and physiological sensor monitor according to claim 13, further comprising:

a server to remotely interface with the download station and configured to retrieve the differently formatted electrocardiographic signals.

15. An extended wear electrocardiography and physiological sensor monitor according to claim 11, wherein each physiological sensor comprises one of a SpO2 sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, or volumetric pressure sensor.

16. An extended wear electrocardiography and physiological sensor monitor according to claim 11, wherein the electronic circuitry is configured to embed the physiological data into a stream of the electrocardiographic signals.

17. An extended wear electrocardiography and physiological sensor monitor according to claim 11, wherein the electronic circuitry is configured to match the physiological data to the electrocardiographic signals.

18. An extended wear electrocardiography and physiological sensor monitor according to claim 11, wherein the memory is programed with a sampling rate for the physiological sensor to obtain the readings of physiological data and samples of the physiological data are stored in a flash memory of the electrocardiography monitor operable through the expansion bus.

19. An extended wear electrocardiography and physiological sensor monitor according to claim 18, further comprising:

at least one other electrocardiography patch with a flexible backing electrocardiography electrodes, flexible circuit, non-conductive receptacle, crypto circuit and battery to replace the electrocardiography patch, wherein each electrocardiography patch comprises memory with a different sampling rate for different physiological data stored in the memory.

20. An extended wear electrocardiography and physiological sensor monitor according to claim 18, wherein the physiological sensor is configured to record the physiological data based on the sampling rate.