Abstract: A system for facilitating a cardiac rhythm disorder diagnosis with the aid of a digital computer is provided. A download station retrieves cutaneous action potentials of a patient recorded over a time by an ECG device as ECG data. An R-R interval plot of the ECG data includes R-R intervals plotted along an x-axis of the plot and heart rates associated with the R-R intervals plotted along a y-axis. The R-R intervals are calculated as a difference between recording times of successive pairs of R-wave peaks. Each heart rate is associated with each time difference. One or more portions of the R-R intervals are identified in the plot. Each portion of the R-R intervals includes a cardiac event. Report strips are generated and each includes one portion of the R-R intervals and a portion of the ECG data. The report strips are included in a cardiac report for the patient.

Abstract: Long-term electrocardiographic and physiological monitoring over a period lasting up to several years in duration can be provided through a continuously-recording subcutaneous insertable cardiac monitor (ICM). The sensing circuitry and the physical layout of the electrodes are specifically optimized to capture electrical signals from the propagation of low amplitude, relatively low frequency content cardiac action potentials, particularly the P-waves that are generated during atrial activation. The ICM is intended to be implanted centrally and positioned axially and slightly to either the left or right of the sternal midline in the parasternal region of the chest, with at least one of the ECG sensing electrodes of the ICM being disposed for being positioned in a region overlying the sternum or adjacent to the sternum and the other of the electrodes also being disposed for being positioned over the sternum or adjacent to the sternum of on the patient's chest.

Abstract: Long-term electrocardiographic and physiological monitoring over a period lasting up to several years in duration can be provided through a continuously-recording subcutaneous insertable cardiac monitor (ICM). The sensing circuitry and the physical layout of the electrodes are specifically optimized to capture electrical signals from the propagation of low amplitude, relatively low frequency content cardiac action potentials, particularly the P-waves that are generated during atrial activation. In general, the ICM is intended to be implanted centrally and positioned axially and slightly to either the left or right of the sternal midline in the parasternal region of the chest. Additionally, the ICM includes an ECG sensing circuit that measures raw cutaneous electrical signals and performs signal processing prior to outputting the processed signals for sampling and storage.

Abstract: A monitor recorder-implemented method for electrocardiography data compression and an electrocardiography monitor recorder with integral data compression are provided. A series of data items are obtained, each of the data items associated with a magnitude of an ECG signal sensed by a monitor recorder. A range is set for an initial one of the data items in the series. Each of the data items remaining in the series is processed, including: obtaining an estimation of probabilities of the data items appearing next to that data item in the series; dividing the further range into sub-ranges, each sub-range representing a fraction of the further range proportional to the probabilities of the next data items; selecting the sub-range corresponding to the data item next to that data item in the series; and representing the next data item by the selected sub-range in a non-volatile memory.

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 devices, and can include cellular phone capabilities. The power usage of the wireless communication can be reduced by using a low energy wireless transceiver in the monitor. The monitor detects that the monitor has been adhered to the patient and begin collecting physiological data after such detection, preserving battery power.

Abstract: An extended wear electrocardiography patch with wire interconnects is provided. The patch includes a flexible backing formed of an elongated strip of stretchable material with narrow longitudinal midsection evenly tapering inward from a distal end and a proximal end, the elongated strip adherable only at a contact surface defined on each of the ends; a pair of electrocardiographic electrodes interfaced to one or more of a set of electrode pads, each of the electrodes including an electrically conductive surface only exposed on the contact surface; a battery connected to one or more of the pads of the set via at least one flexile wire interconnect, the battery secured in place via a flexile wire; and the set of electrical contact pads included on the flexible backing and formed by a set of further flexile wires, the set configured to interface the electrodes and the battery with an electrocardiography monitor recorder.

Abstract: Long-term electrocardiographic and physiological monitoring over a period lasting up to several years in duration can be provided through a continuously-recording subcutaneous insertable cardiac monitor (ICM). The sensing circuitry and the physical layout of the electrodes are specifically optimized to capture electrical signals from the propagation of low amplitude, relatively low frequency content cardiac action potentials, particularly the P-waves that are generated during atrial activation and storing samples of captured signals. In general, the ICM is intended to be implanted centrally and positioned axially and either over the sternum or slightly to either the left or right of the sternal midline in the parasternal region of the chest.

Abstract: A method for constructing physiological electrode assembly with integrated flexile wire components is provided. A flexible backing is formed from a stretchable woven textile material, the flexible backing having a proximal flexible backing end and a distal flexible backing end. A set of flexile wires is integrated into the proximal flexible backing end to form a set of electrical contact surfaces shaped to interface with a monitor recorder on a side of proximal electrical backing end opposite the contact side of the proximal flexible backing end. An electrocardiographic electrode is positioned on the contact side of the distal flexible backing end. A further electrocardiographic electrode is positioned on the contact side of the proximal flexible backing end. One of the electrical contact surface of the set of electrical surfaces is connected to the electrocardiographic electrode.

Abstract: A monitor recorder optimized for electrocardiography and respiratory data acquisition and processing is provided.

Abstract: 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 (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, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and, to a lesser extent, the QRS interval signals indicating ventricular activity in the ECG waveforms. Additionally, the monitor recorder includes an ECG sensing circuit that measures raw cutaneous electrical signals and performs signal processing prior to outputting the processed signals for sampling and storage.

Abstract: 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 along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.

Abstract: A system and method for applying a uniform dynamic gain over cardiac data with the aid of a digital computer is provided. A time series of a plurality of voltage values that comprises a digital representation of a raw electrocardiography (“ECG”) signal recorded by an ambulatory monitor recorder is obtained by an least one computer processor, the time series including segments of noise and segments of non-noise. The segments of non-noise are analyzed by the at least one computer processor and a single gain factor for all of the values in the analyzed non-noise segments is determined by the at least one computer processor based on the analysis. The single gain factor to all of the values in the non-noise segments is applied by the at least one computer processor.

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.

Abstract: A system and method for machine-learning based atrial fibrillation detection are provided. A database is maintained that is operable to maintain a plurality of ECG features and annotated patterns of the features. At least one server is configured to: train a classifier based on the annotated patterns in the database; receive a representation of an ECG signal recorded by an ambulatory monitor recorder during a plurality of temporal windows; detect a plurality of the ECG features in at least some of the portions of the representation falling within each of the temporal windows; use the trained classifier to identify patterns of the ECG features within one or more of the portions of the ECG signal; for each of the portions, calculate a score indicative of whether the portion of the representation within that ECG signal is associated the patient experiencing atrial fibrillation; and take an action based on the score.

Abstract: A system and method for facilitating a cardiac rhythm disorder diagnosis based on subcutaneous cardiac monitoring data with the aid of a digital computer are provided. Cutaneous action potentials of a patient are recorded as electrocardiogram (EGC) data over a set time period using a subcutaneous insertable cardiac monitor. A set of R-wave peaks is identified within the ECG data and an R-R interval plot is constructed. A difference between recording times of successive pairs of the R-wave peaks in the set is determined. A heart rate associated with each difference is also determined. The pairs of the R-wave peaks and associated heart rate are plotted as the R-R interval plot. A diagnosis of cardiac disorder is facilitated based on patterns of the plotted pairs of the R-wave peaks and the associated heart rates in the R-R interval plot.

Abstract: An extended wear electrocardiography patch is provided. An integrated flexible circuit includes a pair of circuit traces that each originate within one end. A pair of electrocardiographic electrodes are each electrically coupled to one of the circuit traces. A layer of adhesive is applied on a contact surface of the flexible circuit and includes an opening on each end. Conductive gel is provided in each of the openings of the adhesive layer and is in electrical contact with the electrocardiographic electrodes. A non-conductive receptacle is adhered on one end of an outward surface of the flexible circuit and is operable to removably receive an electrocardiography monitor. The non-conductive receptacle includes electrode terminals aligned to electrically interface the circuit traces to the electrocardiography monitor. A battery is affixed to the outward surface of the flexible circuit and electrically interfaced via battery leads to a pair of electrical pads.

Abstract: A method for secure physiological data acquisition and storage is provided. An identifier of a physiological monitoring device that is configured to store the identifier within a cryptographic circuit is obtained by a programming wand. A password for accessing physiological monitoring data collected using that device is generated based on at least a portion of the identifier. The password is encrypted using a secret key, and password is loaded into the cryptographic circuit. The secret key is loaded into a monitor recorder, wherein the monitor recorder retrieves the identifier and the password from the device, decodes the password, and offloads the physiological monitoring data together with the identifier and the decoded password. The identifier and the password are reported to at least one server. The offloaded physiological monitoring data is stored using the identifier. Access to the data is granted upon receipt of the decoded password from a user.

Abstract: Physiological monitoring can be provided through an actigraphy sensor imbedded into an electrocardiography monitor, which correlates movement and electrocardiographic data. 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. The patient can place an electrode patch anywhere within the general region of the sternum. The occurrence of actigraphy events are monitored by the monitor recorder through an actigraphy sensor. Actigraphy becomes a recordable actigraphy event occurrence when the movement of the wearable monitor and, therefore, the patient, exceeds a certain criteria threshold of acceleration or deceleration as detected by the actigraphy sensor.

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. Ensuring that the quality level of ECG recording remains constant over an extended period of time is provided through self-authentication of electrode patches. The monitor recorder implements a challenge response scheme upon being connected to an electrode patch. Failing self-authentication, the monitor recorder signals an error condition.