Extended Wear Ambulatory Electrocardiography And Physiological Sensor Monitor

• US 20150087949A1
• Filed: 11/14/2013
• Published: 03/26/2015
• 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 9,730,593 B2
• Time in Patent Office: Days
• US Class Current: 600/382
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/02055 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 5/0816 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 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1117 Fall detection
• 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 5/316 : Modalities, i.e. specific diagnostic methods
• 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 5/35 : by template matching
• CPC Class Codes: A61B 5/4809 : Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/7455 : characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: G01N 27/307 : Disposable laminated or multilayered electrodes G01N27/3272 takes precedence

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. Power is provided through a battery provided on the electrode patch, which avoids having to open the monitor recorder'"'"'s housing for battery replacement.

Claims

1. An 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; and

an electronic circuitry comprised within the sealed housing, comprising;

an externally-powered micro-controller operable to execute under micro programmable control through firmware that is stored in a program memory unit of the micro-controller;

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; 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, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

3. An electrocardiography and physiological sensor monitor recorder according to claim 1, wherein the disposable extended wear electrode patch is disposed for being adhered to a patient'"'"'s chest with a narrow longitudinal midsection oriented centrally (in the midline) along the sternum with one of the electrocardiographic electrodes overlying a region of the lower sternum and an other of the electrocardiographic electrodes in a region of the manubrium.

4. 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 and the flash memory;

a battery 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 the electrical contacts, the electrical pads further electrically interfaced via battery leads to the battery.

5. An electrocardiography and physiological sensor monitor recorder according to claim 4, wherein the capacity of the battery is selected to support additional electrical components without affecting Operation of either of the micro-controller and the flash memory.

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

one of the electrocardiographic electrodes on the disposable extended wear electrode patch being disposed for being adhered to a region overlying the lower sternum on a patient'"'"'s chest; and

an other of the electrocardiographic electrodes on the disposable extended wear electrode patch being disposed for being adhered to a region near the manubrium on the patient'"'"'s chest oriented centrally (in the midline) along the sternum upwards from the one electrocardiographic electrode.

7. 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 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 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.

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

a power up sequence stored as part of the firmware in the program memory unit, wherein the micro-controller is operable to execute the power up sequence upon the pair of the electrical pads being operatively coupled to the pair of the electrical contacts.

22. An electrocardiography and physiological sensor monitor recorder according to claim 21, further comprising:

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

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

a further pair of electrical pads external to the disposable extended wear electrode patch and disposed to operatively couple with the further pair of the electrical contacts; and

an authentication procedure stored as part of the firmware in the program memory unit, wherein the micro-controller is operable to securely authenticate and validate the disposable extended wear electrode patch through the cryptographic circuit upon the further pair of the electrical pads being operatively coupled to the further pair of the electrical contacts, the micro-controller further operable to cease execution upon failure of the authentication procedure.

23. An electrocardiography and physiological sensor monitor recorder according to claim 21, the power up sequence comprising one or more of a battery voltage checking procedure, a flash memory state checking procedure, and a micro-controller diagnostic procedure.

8. An 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 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 through firmware that is stored in a program memory unit of the micro-controller, the micro-controller 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; and

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

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

10. An electrocardiography and physiological sensor monitor according to claim 8, wherein the disposable extended wear electrode patch is disposed for being adhered to a patient'"'"'s chest with the narrow longitudinal midsection oriented centrally (in the midline) along the sternum with one of the electrocardiographic electrodes overlying a region of the lower sternum and an other of the electrocardiographic electrodes in a region of the manubrium.

11. An electrocardiography and physiological sensor monitor according to claim 8, wherein orientation of the monitor is compensated if installed upside down.

12. An electrocardiography and physiological sensor monitor according to claim 8, 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, and 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.

13. An electrocardiography and physiological sensor monitor according to claim 8, 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.

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

one of the electrocardiographic electrodes on the disposable extended wear electrode patch being disposed for being adhered to a region overlying the lower sternum on a patient'"'"'s chest; and

an other of the electrocardiographic electrodes on the disposable extended wear electrode patch being disposed for being adhered to a region near the manubrium on the patient'"'"'s chest oriented centrally (in the midline) along the sternum upwards from the one electrocardiographic electrode.

15. An electrocardiography and physiological sensor monitor according to claim 8, 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 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 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 8, 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 a battery via a 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 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 8, 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 8, 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.

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

a power up sequence stored as part of the firmware in the program memory unit, wherein the micro-controller is operable to execute the power up sequence upon the pair of the electrical pads being electrically interfaced to the micro-controller.

25. An electrocardiography and physiological sensor monitor according to claim 24, further comprising:

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

a further pair of electrical pads external to the disposable extended wear electrode patch and disposed to operatively couple with the micro-controller; and

an authentication procedure stored as part of the firmware in the program memory unit, wherein the micro-controller is operable to securely authenticate and validate the disposable extended wear electrode patch through the cryptographic circuit upon the further pair of the electrical pads being electrically interfaced to the micro-controller, the micro-controller further operable to cease execution upon failure of the authentication procedure.

26. An electrocardiography and physiological sensor monitor according to claim 24, the power up sequence comprising one or more of a battery voltage checking procedure, a flash memory state checking procedure, and a micro-controller diagnostic procedure.