Remote interfacing of extended wear electrocardiography and physiological sensor monitor

• US 9,433,367 B2
• Filed: 11/15/2013
• Issued: 09/06/2016
• 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.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US14/082,071
• Publication Number:
  US 20150087921A1
• Time in Patent Office: 1,026 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

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 communications devices, to download monitoring data either in real-time or in batches. The monitor recorder can provide data or other information to, or receive data or information from, an interfacing physiology or activity sensor, or mobile communications devices for relay to a further device, such as a server, analysis, or other purpose.

Claims

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

a sealed housing adapted to be removably secured into a non-conductive receptacle on a disposable extended wear electrode patch that comprises a battery electrically interfaced via battery leads to a pair of electrical pads on the non-conductive receptacle; and

an 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, each of the electrocardiographic electrodes adapted to be positioned axially along the midline of the sternum for capturing action potential propagation;

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

an 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 server computer system centrally accessible over a data communications network and operable to wirelessly interface with the wireless transceiver to receive the samples of the electrocardiographic signals;

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; and

a smart mobile device operable to wirelessly interface with the wireless transceiver to access the samples of the electrocardiographic signals.

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

a secure database interconnected to a data communications network and operable to maintain the samples of the electrocardiographic signals on behalf of one or more of the server computer system, the client computer system, and the smart mobile device.

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 monitor recorder; 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.

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

a pair of electrical contacts external to the sealed housing and electrically connected to at least one of the micro-controller, the wireless transceiver, and the flash memory, wherein the pair of electrical contacts operatively couples with the pair of electrical pads.

6. An electrocardiography and physiological sensor monitor recorder 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 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;

a non-conductive receptacle adhered to an outward-facing surface of the elongated strip and comprising the 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 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.

7. 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;

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 battery electrically interfaced via battery leads to the pair of 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;

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.

8. An electrocardiography and physiological sensor monitor according to claim 7, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

9. An electrocardiography and physiological sensor monitor according to claim 7, 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 the samples of the electrocardiographic signals;

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; and

a smart mobile device operable to wirelessly interface with the wireless transceiver to access the samples of the electrocardiographic signals.

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

a secure database interconnected to a data communications network and operable to maintain the samples of the electrocardiographic signals on behalf of one or more of the server computer system, the client computer system, and the smart mobile device.

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

a wearable physiology sensor, comprising;

a housing adapted to be removably worn by a patient along with the disposable extended wear electrode patch; and

an electronic circuitry comprised within the housing and comprising a sensor operable to sense physiology and a wireless transceiver electrically interfaced with the sensor and operable to wirelessly interface with the reusable electrocardiography monitor to communicate samples of the physiology sensed by the wearable physiology sensor.

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

a download station comprising;

a non-conductive receptacle adapted to removably receive the monitor recorder; 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.

13. An electrocardiography and physiological sensor monitor according to claim 7, wherein the battery is further electrically interfaced to at least one of:

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

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

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

a battery comprised on the disposable extended wear electrode patch and electrically interfaced via battery leads to a 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.

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

an expansion bus operatively interconnected to the micro-controller and electrically coupled to at least one of the electrical pads;

a physiology sensor comprised within the disposable extended wear electrode patch and operable to sense physiology and to draw power from the battery via the battery leads, the physiology sensor electrically interfaced with the micro-controller over the expansion bus; and

the flash memory further operable through the expansion bus to store samples of the physiology sensed detected by the physiology sensor.

16. An electrocardiography and physiological sensor monitor according to claim 15, wherein the physiology sensor is selected from the group comprising an SpO₂ sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.

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

an expansion bus operatively interconnected to the micro-controller;

a physiology sensor comprised within the reusable electrocardiography monitor and operable to sense physiology and to draw power from the battery via the pair of the electrical pads, the physiology sensor electrically interfaced with the micro-controller over the expansion bus; and

the flash memory further operable through the expansion bus to store samples of the physiology sensed detected by the physiology sensor.

18. An electrocardiography and physiological sensor monitor according to claim 17, wherein the physiology sensor is selected from the group comprising an SpO₂ sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor.

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

an actigraphy sensor comprised within the reusable electrocardiography monitor and operable to detect movement, the actigraphy sensor electrically interfaced with the micro-controller; and

the flash memory further operable to store samples of the movement detected by the actigraphy sensor.

20. An electrocardiography and physiological sensor monitor according to claim 7, 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.