Electrocardiography And Syncope Monitor Recorder
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.
1 . An electrocardiography and syncope 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 electrocardiographic front end circuit electrically interfaced to a 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 a midline of a sternum for capturing action potential propagation;
at least one syncope sensor electrically interfaced with the micro-controller and operable to sense syncope events and to send a signal to the micro-controller upon sensing each of the syncope events;
the micro-controller that is operable to execute under micro-programmable control as specified in a firmware and is electrically interfaced to the syncope sensor, the micro-controller further operable to sample the electrocardiographic signals, and to sample the syncope events sensed by the syncope sensor upon receiving each of the signals from the at least one syncope sensor; and
a flash memory electrically interfaced with the micro-controller and operable to store the samples of the electrocardiographic signals and the samples of the syncope events.
2 . A monitor recorder according to claim 1 , wherein the micro-controller is further configured to embed the samples of the syncope events within a data stream that is recorded to the flash memory and that also comprises the samples of the electrocardiographic signals.
3 . A monitor recorder according to claim 2 , wherein the samples of the syncope events are compressed by the micro-controller prior to being written into the flash memory.
4 . A monitor recorder according to claim 1 , wherein multiple ECG channels are recorded into the flash memory, and the samples of the electrocardiographic signals are recorded into one of the channels and the samples of the syncope events are recorded into another one of the channels.
5 . A monitor recorder according to claim 1 , wherein the signal is an interrupt signal.
6 . A monitor recorder 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 one of the syncope events based on the actigraphy filtering criteria application, wherein the one syncope event is sensed the syncope events based on the portion of the data.
7 . A monitor recorder according to claim 6 , wherein the portion of the actigraphy data is indicative of at least one of a falling event and a postural change.
8 . A monitor recorder according to claim 6 , wherein the actigraphy-based syncope sensor-assembly comprises a three-axis accelerometer.
9 . A monitor recorder according to claim 1 , wherein the syncope sensor comprises a patient-mediated tactile feedback syncope button.
10 . A monitor recorder according to claim 1 , wherein the syncope sensor comprises a patient-mediated tactile feedback syncope button.
11 . An electrocardiography and syncope data acquisition and analysis system, comprising:
at least one syncope sensor electrically interfaced with a micro-controller and operable to sense syncope events and to send a signal to the micro-controller upon sensing each of the syncope events;
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 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 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 a midline of a sternum for capturing action potential propagation;
the micro-controller that is operable to execute under micro-programmable control as specified in a firmware and is electrically interfaced to the syncope sensor, the micro-controller further operable to sample the electrocardiographic signals, and to sample the syncope events sensed by the syncope sensor upon receiving each of the signals from the at least one syncope sensor; and
a flash memory electrically interfaced with the micro-controller and operable to store the samples of the electrocardiographic signals and the samples of the syncope events.
12 . A system according to claim 11 , wherein the at least one syncope sensor is comprised within the monitor recorder.
13 . A system according to claim 11 , wherein the micro-controller is further configured to embed the samples of the syncope events within a data stream that is recorded to the flash memory and that comprises the samples of the electrocardiographic signals.
14 . A system according to claim 11 , wherein the samples of the syncope events by the micro-controller are compressed prior to being written into the flash memory.
15 . A system according to claim 11 , wherein multiple ECG channels are recorded into the flash memory, and the samples of the electrocardiographic signals are recorded into one of the channels and the samples of the syncope events are recorded into another one of the channels.
16 . A system according to claim 11 , further comprising:
at least one additional sensor interfaced to the micro-controller and comprised in at least one of the monitor recorder and the disposable patch and configured to collect physiological data, wherein the micro-controller is further configured to sample the physiological data and the flash memory is configured to store the sampled physiological data;
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, the syncope event samples, and the physiological data samples from the flash memory of the electronic circuitry;
identify those samples of the electrocardiographic signals and the physiological data that were sensed substantially concurrent to one of the sensed syncope events;
identify a type of the one syncope event; and
output data regarding the identifies syncope event.
17 . A system according to claim 16 , wherein the output data comprises one or more of a time the one syncope event occurred, a duration of the one syncope event, the type of the one syncope event, a magnitude associated with the one syncope event, and the concurrent electrocardiographic and physiological data samples.
18 . A system according to claim 16 , wherein the server computer system is further configured to:
detect whether an abnormal electrocardiography baseline is associated with the one syncope event based on the concurrent electrocardiographic signal samples; and
determine that the one 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.
19 . A system according to claim 16 , wherein the physiological data comprises a glucose level and the identified type of the one syncope event is associated with the glucose level that is low.
20 . A system according to claim 16 , wherein the physiological data comprises respiratory data and the identified type of the one syncope event is associated with metabolic hyperventilation.