Remote Interfacing of Extended Wear Electrocardiography and Physiological Sensor Monitor

• US 20160367164A1
• Filed: 09/02/2016
• Published: 12/22/2016
• 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, Bishay, Jon Mikalson, Bardy, Gust H.
• Granted Patent: US 9,820,665 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 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 5/1118 Determining activity level
• 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 5/14551 for measuring blood gases
• 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 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• 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

A remotely-interfaceable extended wear electrocardiography and physiological sensor monitor recorder is provided. A sealed housing forms on a bottom surface a cavity shaped to accommodate an upward projection of a battery compartment formed on a non-conductive receptacle of a disposable extended wear electrode patch and includes a set of electrical contacts that protrude from the bottom surface and are arranged in alignment with electrical pads provided on the non-conductive receptacle. Electronic circuitry is provided within the sealed housing and includes an externally-powered micro-controller operable to execute under micro programmable control. An electrocardiographic front end circuit is electrically interfaced to the micro-controller. A wireless transceiver electrically interfaces with the micro-controller and externally-powered flash memory is electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals.

Claims

1. A remotely-interfaceable extended wear electrocardiography and physiological sensor monitor recorder, comprising:

a sealed housing forming on a bottom surface a cavity shaped to accommodate an upward projection of a battery compartment formed on a non-conductive receptacle of a disposable extended wear electrode patch and comprising a set of electrical contacts that protrude from the bottom surface and are arranged in alignment with electrical pads provided on the non-conductive receptacle; 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;

a wireless transceiver electrically interfaced with the micro-controller and operable to wirelessly interface with an external wireless-enabled device to communicate samples of the electrocardiographic signals; and

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

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

a seal coupling circumferentially surrounding the set of electrical contacts.

3. An electrocardiography and physiological sensor monitor recorder according to claim 2, wherein the seal coupling securely mates with a moisture-resistant seal formed on the non-conductive receptacle.

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

a patient-operable tactile-feedback button provided on a top surface of the sealed housing.

5. An electrocardiography and physiological sensor monitor recorder according to claim 1, wherein a battery is provided in the battery compartment of the non-conductive receptacle of the extended wear electrode patch and powers the electronic circuitry.

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

a feedback buzzer utilized by the microcontroller.

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

an external physiological sensor provided with the circuitry and comprising at least one of an SpO₂ sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, and volumetric pressure sensor.

8. An electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the sealed housing comprises a rounded isosceles trapezoidal-like shape.

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

a least one of a retention detent and a tension detent each molded along a top edge of a top surface of the sealed housing.

10. An electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the retention detent and tension detent are shaped to engage respectively with a retention catch and a tension clip molded into the non-conductive receptacle.

11. A remotely-interfaceable extended wear electrocardiography and physiological sensor monitor, 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; 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, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection to serve as the strain relief; and

a resusable electrocardiography monitor having a sealed housing forming on a bottom surface a cavity shaped to accommodate an upward projection of a battery compartment formed on a non-conductive receptacle of a disposable extended wear electrode patch and comprising a set of electrical contacts that protrude from the bottom surface and are arranged in alignment with the electrical pads provided on the non-conductive receptacle, wherein the reusable electrocardiography monitor comprises electronic circuitry, 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;

a wireless transceiver electrically interfaced with the micro-controller and operable to wirelessly interface with an external wireless-enabled device to communicate samples of the electrocardiographic signals; and

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

12. An electrocardiography and physiological sensor monitor according to claim 11, further comprising at least one of:

a seal coupling circumferentially surrounding the set of electrical contacts.

13. An electrocardiography and physiological sensor monitor according to claim 12, wherein the seal coupling securely mates with a moisture-resistant seal formed on the non-conductive receptacle.

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

a patient-operable tactile-feedback button provided on a top surface of the sealed housing.

15. An electrocardiography and physiological sensor monitor according to claim 11, wherein a battery is provided in the battery compartment of the non-conductive receptacle of the extended wear electrode patch and powers the electronic circuitry.

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

a feedback buzzer utilized by the microcontroller.

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

an external physiological sensor provided with the circuitry and comprising at least one of an SpO₂ sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, and volumetric pressure sensor.

18. An electrocardiography and physiological sensor monitor according to claim 11, wherein the sealed housing comprises a rounded isosceles trapezoidal-like shape.

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

a least one of a retention detent and a tension detent each molded along a top edge of a top surface of the sealed housing.

20. An electrocardiography and physiological sensor monitor according to claim 11, wherein the retention detent and tension detent are shaped to engage respectively with a retention catch and a tension clip molded into the non-conductive receptacle.