Ambulatory extended-wear electrocardiography and syncope sensor monitor

• US 9,642,537 B2
• Filed: 04/10/2015
• Issued: 05/09/2017
• 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, Bishay, Jon Mikalson, Bardy, Gust H.
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): STEINBERG, AMANDA L
• Application Number:
  US14/684,260
• Publication Number:
  US 20160213263A1
• Time in Patent Office: 760 Days
• 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 syncope sensor imbedded into an electrocardiography monitor, which correlates syncope events and electrocardiographic data. Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended-wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally on the patient'"'"'s chest at the sternal midline and includes a unique narrow “hourglass”-like shape, significantly improving the ability of the monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and QRS interval signals, which indicate ventricular activity in electrocardiographic waveforms. The electrocardiographic electrodes on the electrode patch are tailored for axial positioning along the midline of the sternum to capture action potential propagation in an orientation that corresponds to the aVF lead in a conventional 12-lead electrocardiogram, which senses positive P-waves.

Claims

1. An electrocardiography and syncope monitoring system, comprising:

an ambulatory, extended-wear electrocardiography and syncope 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, low-power microcontroller that is operable to execute under microprogrammable control as specified in a firmware;

an electrocardiographic front end circuit electrically interfaced to the microcontroller 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 a midline of a sternum for capturing action potential propagation, the electrocardiographic front end circuit further operable to process the sensed electrocardiographic signals prior to storing samples of the processed signals, the processing comprising;

amplifying, via a unity gain amplifier comprised in the electrocardiographic front end circuit, current of the electrocardiographic signals; and

after the amplification of the current, amplifying voltage of the electrocardiographic signals while conditioning the electrocardiographic signals;

a reference generator comprising a pair of resistors configured to receive power supply noise and system noise and to inject a driven reference containing the power supply noise and the system noise into a patient;

a syncope sensor electrically interfaced with the microcontroller and operable to sense syncope events; and

an externally-powered flash memory electrically interfaced with the microcontroller and operable to store the samples of the processed electrocardiographic signals the syncope events.

2. A system according to claim 1, wherein:

the syncope sensor comprises an actigraphy-based syncope sensor assembly sensing actigraphy data, applying actigraphy filtering criteria to the sensed actigraphy data, identifying a portion of the actigraphy data indicative of the syncope events based on the actigraphy filtering criteria application and detecting the syncope events based on the portion of the data, providing the detected syncope event to the microcontroller, wherein the microcontroller stores the syncope events into the memory.

3. A system according to claim 2, wherein the syncope events comprise at least one of a falling event and a postural change and the syncope sensor further comprises a patient-mediated tactile feedback syncope button.

4. A system according to claim 2, wherein the actigraphy filtering criteria comprise a threshold of acceleration or deceleration of the sealed housing.

5. A system according to claim 2, further comprising:

a three-axis accelerometer comprised in the actigraphy-based syncope sensor assembly.

6. A system according to claim 1, further comprising:

a server computer system centrally accessible over a data communications network and comprising a processor configured to execute program code stored in a memory, the server computer system configured to;

retrieve the samples of the electrocardiographic signals and the syncope event data from the flash memory of the electronic circuitry;

identify those samples of the electrocardiographic signals that were sensed substantially concurrent to one of the sensed syncope events; and

output the samples of the syncope event data and the identified electrocardiographic signals.

7. A system according to claim 6, the server computer system further configured to:

detect whether an abnormal electrocardiography baseline is associated with a syncope event based on the electrocardiographic signals; and

determine that the syncope event is indicative of one of a cardiac-based syncope type and a non-cardiac-based syncope type based on whether the abnormal baseline is associated with detection of at least one syncope event.

8. A system according to claim 6, further comprising at least one additional sensor located at least one in the monitor recorder and the disposable patch and configured to collect physiological data comprising one or more of SpO₂, blood pressure, temperature, glucose level, air flow, and volumetric pressure, wherein the server computer system further configured to:

retrieve at least one of a physiological sample selected from the group comprising the SpO₂, the blood pressure, the temperature, the glucose level, the air flow, and the volumetric pressure;

identify those physiological samples that were sensed substantially concurrent to a time of a syncope event; and

output the syncope events and the physiological samples that were identified.

9. A system according to claim 1, the processing further comprising:

reducing high frequency noise in the electrocardiographic signals prior to the amplification of the current;

applying a high pass filter to the electrocardiographic signals with the amplified current prior to the amplification of the voltage; and

applying an anti-aliasing low-pass filter to the electrocardiographic signals with the amplified voltage,

wherein the conditioning comprises applying a low-pass filter.

10. A system according to claim 1, further comprising:

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of cardiac activation wave front amplitudes;

at least one low-pass filter comprised in the firmware; and

at least one high-pass filter comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through at least one low-pass filter and at least one high-pass filter following conversion into the digital representations.

11. A system according to claim 10, the microcontroller further comprising:

a compression algorithm comprised in the firmware,

wherein the cardiac activation wave front amplitudes are compressed with the compression algorithm into compressed digital representations prior to being stored in the flash memory of the electronic circuitry.

12. An electrocardiography and syncope monitoring system optimized for capturing low amplitude cardiac action potential propagation, comprising:

an ambulatory, extended-wear electrocardiography and syncope sensor monitor optimized for capturing low amplitude cardiac action potential propagation, 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, the elongated strip being narrower at the longitudinal midsection than at the ends;

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

a battery electrically interfaced to a different pair of the pads; and

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;

a low-power microcontroller that is operable to draw power from the battery via the different pair of the electrical pads and that is operable to execute under microprogrammable control as specified in a firmware;

an electrocardiographic front end circuit electrically interfaced to the microcontroller 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 a midline of a sternum for capturing action potential propagation; and

a syncope sensor electrically interfaced with the microcontroller and operable to sense syncope events, the syncope sensor comprising an actigraphy-based syncope sensor sensing actigraphy data, applying actigraphy filtering criteria to the sensed actigraphy data, identifying a portion of the actigraphy data indicative of the syncope events based on the actigraphy filtering criteria application and detecting the syncope events based on the portion of the data, providing the detected syncope event to the microcontroller, wherein the microcontroller stores the syncope events into the memory; and

a flash memory electrically interfaced with the microcontroller and operable to store samples of the electrocardiographic signals and the syncope events, the memory further operable to draw power from the battery via the different pair of the electrical pads.

13. A system according to claim 12, wherein the syncope sensor further comprises a patient-mediated tactile feedback syncope button.

14. A system according to claim 12, wherein the syncope events comprise at least one of a falling event and a postural change event.

15. A system according to claim 12, wherein the actigraphy filtering criteria comprise a threshold of acceleration or deceleration of the sealed housing.

16. A system according to claim 12, further comprising:

a server computer system centrally accessible over a data communications network and comprising a processor configured to execute program code stored in a memory, the server configured to;

retrieve the samples of the electrocardiographic signals and the syncope event data from the flash memory of the electronic circuitry;

identify those samples of the electrocardiographic signals that were sensed substantially concurrent to one of the syncope events; and

output the samples of the syncope event data and the identified electrocardiographic signals.

17. A system according to claim 16, the server computer system further configured to:

detect whether an abnormal electrocardiography baseline is associated with a syncope event based on the electrocardiographic signals; and

determine that the syncope event is indicative of one of a cardiac-based syncope type and a non-cardiac-based syncope type based on whether the abnormal baseline is associated with detection of at least one syncope event.

18. A system according to claim 12, wherein the electrocardiographic front end circuit is further operable to:

reduce high frequency noise in the sensed electrocardiographic signals;

amplify current of the sensed electrocardiographic signals in which the high-frequency noise is reduced;

apply a high pass filter to the sensed electrocardiographic signals with the amplified current;

amplify voltage of the filtered electrocardiographic signals while applying a low-pass filter to the filtered electrocardiographic signals; and

apply an anti-aliasing low-pass filter to the electrocardiographic signals with the amplified voltage.

19. A system according to claim 12, further comprising:

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of cardiac activation wave front amplitudes;

at least one low-pass filter comprised in the firmware; and

at least one high-pass filter comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through at least one low-pass filter and at least one high-pass filter following conversion into the digital representations.

20. A system according to claim 19, the microcontroller further comprising:

a compression algorithm comprised in the firmware,

wherein the cardiac activation wave front amplitudes are compressed with the compression algorithm into compressed digital representations prior to being stored in the flash memory of the electronic circuitry.