Self-authenticating electrocardiography monitoring circuit

• US 10,398,334 B2
• Filed: 05/22/2017
• Issued: 09/03/2019
• 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: Felix, Jason, Bardy, Gust H., Bishay, Jon Mikalson
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US15/602,007
• Publication Number:
  US 20170251948A1
• Time in Patent Office: 834 Days
• 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 5/259 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

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 (in the midline) 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. Instead, the patient can place an electrode patch anywhere within the general region of the sternum. Ensuring that the quality level of ECG recording remains constant over an extended period of time is provided through self-authentication of electrode patches. The monitor recorder implements a challenge response scheme upon being connected to an electrode patch. Failing self-authentication, the monitor recorder signals an error condition.

Claims

1. An extended wear electrocardiography and physiological sensor monitor recorder with self-authenticating electrocardiography monitoring circuit, comprising:

a sealed housing adapted to be removably secured into a non-conductive receptacle on an electrode patch; and

electronic circuitry comprised within the sealed housing, comprising;

an electrocardiographic front end circuit operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the electrode patch;

flash memory to record the electrocardiographic signals; and

a micro-controller to periodically write data into a memory of the electrode patch on which the sealed housing is removably secured via the non-conductive receptacle during continuous recording of the electrocardiographic signals via the electrocardiographic front end circuit, to determine an expiration of the electrode patch based on an amount of the data stored in the memory of the electrode patch, and to turn off the micro-controller upon the expiration of the electrode patch.

2. An electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the recorded electrocardiographic signals are retrieved via a download station.

3. An electrocardiography and physiological sensor monitor recorder according to claim 2, further comprising:

a set of electrical contacts formed on a surface of the sealed housing; and

a set of terminals on a paired receptacle of the download station and configured to interface with the set of electrical contacts on the sealed housing.

4. An electrocardiography and physiological sensor monitor recorder according to claim 1, further comprising:

middlewear operable to convert the sensed or recorded elctrocardiographic signals into a different format as formatted electrocardiography data.

5. An electrocardiography and physiological sensor monitor recorder according to claim 4, wherein the formatted electrocardiography data is retrieved via a server remotely interfaced with a download station.

6. An electrocardiography and physiological sensor monitor recorder according to claim 4, wherein a gain of at least a portion of the formatted electrocardiography data is adjusted to compensate for relocation or replacement of the sealed housing on a wearer.

7. An electrocardiography and physiological sensor monitor recorder according to claim 1, further comprising:

one or more sensors configured to record physiological data in response to a sensed event; and

the electronic circuitry configured to embed the physiological data into a stream of the sensed or recorded electrocardiographic signals.

8. An electrocardiography and physiological sensor monitor recorder according to claim 1, further comprising:

one or more sensors within the sealed housing or the electrode patch, and configured to record physiological data in response to a sensed event, wherein the physiological data is matched to the sensed or recorded electrocardiographic signals.

9. An electrocardiography and physiological sensor monitor recorder according to claim 1, further comprising:

a feedback button formed on a surface of the sealed housing and configured to mark events identified by a wearer.

10. An electrocardiography and physiological sensor monitor recorder according to claim 1, further comprising:

located within the sealed housing, a buzzer comprising a speaker, magnetic resonator or piezoelectric buzzer and configured to output feedback to a wearer.

11. An extended wear electrocardiography and physiological sensor monitor with self-authenticating electrocardiography monitoring circuit, comprising:

an electrode patch, comprising;

an elongated strip of stretchable material;

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

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

a circuit affixed on each end of the elongated strip and comprising a pair of circuit traces electrically coupled to the pair of the electrocardiographic electrodes and a pair of the electrical pads; and

an electrocardiography monitor having a sealed housing adapted to be removably secured into the non-conductive receptacle on the electrode patch and electronic circuitry comprised within the sealed housing, comprising;

an electrocardiographic front end circuit operable to sense electrocardiographic signals through the electrocardiographic electrodes provided on the electrode patch;

flash memory to record the electrocardiographic signals; and

an externally-powered micro-controller to periodically write data into a memory of the electrode patch on which the electrocardiography monitor is removably secured via the non-conductive receptacle during continuous recording of the electrocardiographic signals via the front end circuit, to determine an expiration of the electrode patch based on an amount of the data stored in the memory of the electrode patch, and to turn off the micro-controller upon the expiration of the electrode patch.

12. An electrocardiography and physiological sensor monitor according to claim 11, wherein the recorded electrocardiographic signals are retrieved via a download station.

13. An electrocardiography and physiological sensor monitor according to claim 12, further comprising:

a set of electrical contacts formed on a surface of the sealed housing; and

a set of terminals on a paired receptacle of the download station and configured to interface with the set of electrical contacts on the sealed housing.

14. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

middlewear operable to convert the sensed or recorded lectrocardiographic signals into a different format as formatted electrocardiography data.

15. An electrocardiography and physiological sensor monitor according to claim 14, wherein the formatted electrocardiography data is retrieved via a server remotely interfaced with a download station.

16. An electrocardiography and physiological sensor monitor according to claim 14, wherein a gain of at least a portion of the formatted electrocardiography data is adjusted to compensate for relocation or replacement of the sealed housing on a wearer.

17. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

one or more sensors configured to record physiological data in response to a sensed event; and

the electronic circuitry configured to embed the physiological data into a stream of the sensed or recorded electrocardiographic signals.

18. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

one or more sensors within the sealed housing or the electrode patch, and configured to record physiological data in response to a sensed event, wherein the physiological data is matched to the sensed or recorded electrocardiographic signals.

19. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a feedback button formed on a surface of the sealed housing and configured to mark events identified by a wearer.

20. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

located within the sealed housing, a buzzer comprising a speaker, magnetic resonator or piezoelectric buzzer and configured to output feedback to a wearer.