Self-authenticating electrocardiography monitoring circuit

• US 9,655,538 B2
• Filed: 11/15/2013
• Issued: 05/23/2017
• 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:
  US14/082,066
• Publication Number:
  US 20150087950A1
• Time in Patent Office: 1,285 Days
• Field of Search: 600382, 600393, 600391-392, 600509
• 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 a disposable extended wear electrode patch; and

an electronic circuitry comprised within the sealed housing, comprising;

an externally-powered micro-controller operable to execute under micro programmable control and to write use data comprising ECG data into a memory provided on the disposable extended wear electrode patch, to measure an amount of the use data written into the memory, and to determine an expiration of the disposable extended wear electrode patch once the amount reaches a predetermined threshold;

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

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

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

the disposable extended wear electrode patch;

a pair of electrical contacts external to the sealed housing and electrically connected to the micro-controller;

a cryptographic circuit comprising the memory and provided on the disposable extended wear electrode patch; and

a 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 circuit traces to the cryptographic circuit, wherein the micro-controller issues a challenge to the cryptographic circuit to which the cryptographic circuit is operable to provide a response, wherein the micro-controller is operable to authenticate the patch based on the response.

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

at least one of a private key stored by the cryptographic circuit of the disposable electrode wear patch and a precomputed challenge-response pair securely stored by the micro-controller and by the disposable extended wear electrode patch, which is exchanged as part of the challenge and the response.

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

a download station comprising;

a non-conductive receptacle adapted to removably receive the sealed housing; and

a download station controller operable to interface with the micro-controller of the electronic circuitry;

a computer system operatively coupled to the download station controller and centrally accessible over a data communications network and operable to interact with the micro-controller; and

a server computer system centrally accessible over the data communications network and operable to interface with the computer system to authorize additional functionality in the electronic circuitry.

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

a user interface provided by the computer system centrally accessible over the data communications network through which a patient can select the additional functionality in the electronic circuitry.

6. An electrocardiography and physiological sensor monitor recorder according to claim 5, further comprising:

a subscription service implemented by a server that controls purchasing of the additional functionality in the electronic circuitry by the patient.

7. An electrocardiography and physiological sensor monitor recorder according to claim 1 further comprising the disposable extended wear electrode patch, 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 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 surface of the elongated strip and comprising a plurality of 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 the electrocardiographic electrodes and a pair of the electrical pads.

8. An electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the micro-controller is operable to turn-off upon determining the expiration of the patch.

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

a disposable extended wear electrode patch 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, respectively;

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

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 the electrocardiographic electrodes and a pair of the electrical pads; and

a cryptographic circuit electrically coupled to another pair of the electrical pads; and

a reusable electrocardiography monitor having a sealed housing adapted to be removably secured into the non-conductive receptacle and comprising;

a micro-controller operable to execute under micro programmable control and electrically interfaced to an electrocardiographic front end circuit that is operable to sense electrocardiographic signals through the electrocardiographic electrodes via the pair of the electrical pads, the micro-controller further operable to authenticate the disposable extended wear electrode patch through the cryptographic circuit via the another pair of the electrical pads, to write use data comprising the electrocardiographic signals into memory of the cryptographic circuit of the disposable extended wear patch, and to determine an expiration of the disposable extended wear electrode patch once an amount of the use data reaches a predetermined threshold; and

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

10. An electrocardiography and physiological sensor monitor according to claim 9, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

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

a battery comprised on the disposable extended wear electrode patch and electrically interfaced via battery leads to a different pair of the electrical pads; and

at least one of;

the micro-controller operable to draw power from the battery via the different pair of the electrical pads; and

the flash memory operable to draw power from the battery via the different pair of the electrical pads.

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

a battery comprised on the disposable extended wear electrode patch and electrically interfaced via battery leads to a different pair of the electrical pads, the capacity of the battery being selected to support additional electrical components without affecting operation of the reusable electrocardiography monitor.

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

a download station comprising;

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

a download station controller operable to interface with the micro-controller of the reusable electrocardiography monitor;

a computer system operatively coupled to the download station controller and centrally accessible over a data communications network and operable to interact with the micro-controller; and

a server computer system centrally accessible over the data communications network and operable to interface with the computer system to authorize additional functionality in the reusable electrocardiography monitor.

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

a user interface provided by the computer system centrally accessible over the data communications network through which a patient can select the additional functionality in the reusable electrocardiography monitor.

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

a subscription service implemented by a server that controls purchasing of the additional functionality in the reusable electrocardiography monitor by the patient.

16. An electrocardiography and physiological sensor monitor according to claim 9, further comprising at least one of:

a feedback output component comprised in the reusable electrocardiography monitor and electrically interfaced with the micro-controller; and

a feedback input component comprised in the reusable electrocardiography monitor and externally wearer-operable from outside the sealed housing, the feedback input further electrically interfaced with the micro-controller.

17. An electrocardiography and physiological sensor monitor according to claim 9, wherein the micro-controller is operable to turn-off upon determining the expiration of the patch.

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

at least one of a private key stored by the cryptographic circuit of the disposable electrode wear patch and a precomputed challenge-response pair securely stored by the micro-controller and by the disposable extended wear electrode patch, which is exchanged as part of the challenge and the response.