Abstract: The present invention is directed toward a detection architecture for use in implantable cardiac rhythm devices. The detection architecture of the present invention provides methods and devices for discriminating between arrhythmias. Moreover, by exploiting the enhanced specificity in the origin of the identified arrhythmia, the detection architecture can better discriminate between rhythms appropriate for device therapy and those that are not.

Abstract: An insertable physiological monitor injector tool is provided. An elongated handle includes a recess formed along a longitudinal axis and has an opening on a distal end. An insertion tube has a hollow elongated shape that is movably positioned within the elongated handle, in the recess. A stationary arbor is affixed on a proximal end to a proximal end of the elongated handle and extends through the insertion tube when the insertion tube is in a retracted position. A tab is affixed to the insertion tube, wherein the tab can lock the insertion tube in an extended position.

Abstract: A system for secure physiological data acquisition and delivery is provided. The system includes a monitoring patch that includes a flexible backing; a pair of electrocardiographic electrodes included on a contact surface of each end of the flexible backing; a receptacle affixed to a non-contacting surface of the flexible backing and including an electro-mechanical docking interface for interfacing with a monitor recorder; a pair of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to the electro-mechanical docking interface; and a circuit operable to store an identifier associated with the patch and an encrypted password necessary to access physiological monitoring data obtained using the patch identified by that identifier, the circuit configured to provide via the electro-mechanical docking interface the password and the identifier to the monitor recorder.

Abstract: An extended wear electrocardiography and physiological sensor monitor is provided. An electrode patch includes an integrated flexible circuit having a single piece of material that includes a longitudinal midsection between upper and lower ends and a mirror image shape of the upper end extending from at least a portion of one side of the upper end that runs substantially parallel to the midsection and folds over the upper end. A receptacle is adhered on an outward surface of the mirror image when the integrated circuit is folded over the upper end. One electrode is positioned on a contact surface of the integrated circuit on the upper end and another electrode is positioned on the contact surface on the lower end. A battery is directly adhered to the outward surface of the mirror image and positioned under the receptacle. A monitor is configured to be removably secured in the receptacle.

Abstract: An implantable medical device is disclosed. A housing includes a hollow body forming a first electrode on an outer surface with end caps affixed to opposite ends, one end cap forming a second electrode. A microcontroller circuit is provided and includes a microcontroller operable under program instructions stored within a non-volatile memory device. An analog front end is interfaced to the electrodes to sense electrocardiographic signals. A transceiver circuit is operable to wirelessly communicate with an external data device. The program instructions define instructions to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory device to the external data device. A diagnostic overread of the samples can be performed using medical diagnostic criteria and medical care initiated with one of pre-identified care providers based on the overread.

Abstract: An electrocardiography patch is provided. A backing includes an elongated strip with a midsection connecting two rounded ends. The midsection tapers in from each end and is narrower than each of the two ends. An electrode is positioned on each end of the backing on a contact surface to capture electrocardiographic signals. A circuit trace electrically is coupled to each of the electrodes in the pair. A battery is provided on an outer surface of the backing opposite the contact surface. Memory is provided on the outer surface of the backing to store data regarding the electrocardiographic signals. A processor is powered by the battery to write the data into the memory.

Abstract: An electrocardiography patch is provided. A backing forms an elongated strip with a mid-section connecting two ends of the backing. The mid-section is narrower than the two ends of the backing. An electrocardiographic electrode is provided on each end of the backing to capture electrocardiographic signals. A flexible circuit includes a pair of circuit traces electrically coupled to the electrocardiographic electrodes. A wireless transceiver communicates at least a portion of the electrocardiographic signals.

Abstract: A system and method for physiological data classification for use in facilitating diagnosis is provided. A physiological monitor includes a feedback button and physiological data obtained via the physiological monitor is stored in a database. The physiological data is divided into segments and one or more data segments are classified as noise. A determination is made that at least one of the data segments classified as noise includes a marker indicating a press of the feedback button on the physiological monitor. A set of the physiological data including and surrounding the physiological data occurring during the press of the feedback button is identified within the data segment classified as noise. The identified set of physiological data is provided with the data segments classified as valid for analysis.

Abstract: A wearable electrocardiography monitoring ensemble is provided. A first receptacle is defined in a wearable garment by two horizontal bands placed across the wearable garment. A second receptacle is defined by two further horizontal bands positioned across the wearable garment under the first receptacle. A first electrode assembly is positioned within the first receptacle and includes a backing with an electrical connection having an electrode on one end of the electrical connection and terminated at the other end of the electrical connection to connect with a monitor recorder. A second electrode assembly is positioned within the second receptacle and includes a backing with an electrical connection having an electrode on one end of the electrical connection and terminated at the other end of the electrical connection to connect with a further monitor recorder, wherein the first and second electrodes are aligned longitudinally in the wearable garment.

Abstract: A subcutaneous electrocardiography monitor configured for self-optimizing ECG data compression is provided. ECG waveform characteristics are rarely identical in patients with cardiac disease making this innovation crucial for the long-term data storage and analysis of complex cardiac rhythm disorders. The monitor includes a memory and a micro-controller operable to execute under a micro-programmable control and configured to: obtain a series of electrode voltage values; select one or more of a plurality of compression algorithms for compressing the electrode voltage series; apply one or more of the selected compression algorithms to the electrode voltage series; evaluate a degree of compression of the electrode voltage series achieved using the application of the selected algorithms; apply one or more of the compression algorithms to the compressed electrode voltage series upon the degree of compression not meeting a predefined threshold; and store the compressed electrode voltage series within the memory.

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: A system and method for neural-network-based atrial fibrillation detection with the aid of a digital computer are provided. Electrocardiography (ECG) features and annotated patterns of the features are maintained in a database, at least some of the patterns associated with atrial fibrillation. A classifier is trained based on the annotated patterns, the classifier implemented by a convolutional neural network. A representation of an ECG signal recorded by one or more ambulatory monitors is received. ECG features in the representation falling within each of the temporal windows are detected. The trained classifier is used to identify patterns of the ECG features. At least one matrix with weights for the patterns are generated. A value indicative of whether portions of the representation are associated the patient experiencing atrial fibrillation is calculated. That one or more of the portions are associated with the patient experiencing atrial fibrillation is determined.

Abstract: An extended wear electrocardiography patch is provided. A flexible backing is formed of an elongated strip of stretchable material. An electrocardiographic electrode is affixed to and conductively exposed on a contact surface of each end of the elongated strip. A flexible circuit is affixed on each end of the elongated strip. A non-conductive receptacle is adhered on one of the ends of the elongated strip on a surface opposite the contact surface and removably receives an electrocardiography monitor operable to obtain electrocardiographic signals. A physiological sensor is provided with the electrocardiography monitor or on the flexible backing. Memory is provided on the flexible backing and is programmed with a sampling rate to instruct the physiological sensor to obtain readings of physiological data. A battery is positioned on one end of the flexible backing to provide power to one or more of the physiological sensors and the electrocardiography monitor.

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 by an ECG monitoring and recording 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 of the plot. The R-R intervals are calculated as a difference between recording times of successive pairs of R-wave peaks and each heart rate is associated with each time difference. Runs of the R-R intervals in the plot are identified and each run represents a cardiac event. Cardiac rhythm measurements are automatically calculated and occurrences of different types of the cardiac events are tracked. One or more of the cardiac events and the cardiac rhythm measurements are reported.

Abstract: A remotely-interfaceable electrocardiography patch is provided. The remotely-interfaceable electrocardiography patch includes a backing formed of a strip of material and an electrocardiographic electrode on each end of the backing to capture electrocardiographic signals. A flexible circuit includes a pair of circuit traces electrically coupled to the electrocardiographic electrodes. A wireless transceiver communicates at least one of the electrocardiographic signals and other physiological measures with one or more of a physiology and activity sensor, communication device, server, and personal computer.

Abstract: A P-wave centric subcutaneous insertable cardiac monitor (ICM) for use in performing long term electrocardiographic (ECG) monitoring is disclosed. The length of the monitoring performed by the ICM is extended, potentially for a life time of the patient, and the functionality of the ICM is enhanced, by including an internal energy harvesting module in the ICM. The energy harvesting module harvests energy from outside the ICM, and provides the harvested energy for powering the circuitry of the ICM, either directly or by recharging a power cell within the ICM. As the circuitry of the ICM requires a low amount of electrical power, the harvested energy can be sufficient to support the functioning of the ICM even when the electrical power stored on the ICM at the time of implantation runs out.

Abstract: An implantable medical device is disclosed. A housing includes a hollow body forming a first electrode on an outer surface with end caps affixed to opposite ends, one end cap forming a second electrode. A microcontroller circuit is provided and includes a microcontroller operable under program instructions stored within a non-volatile memory device. An analog front end is interfaced to the electrodes to sense electrocardiographic signals. A transceiver circuit is operable to wirelessly communicate with an external data device. The program instructions define instructions to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory device to the external data device. A receiving coil and a charging circuit are operable to charge an onboard power source for the microcontroller circuit.

Abstract: A system and method for remote ECG data streaming in real-time is provided. ECG data is encrypted on a physiological monitor placed on a patient via a near-field communication chip on the physiological monitor. A continuous connection is established between the physiological monitor and a cloud-based server via a wireless transceiver on the physiological monitor. The encrypted ECG data is transmitted from the physiological monitor to the cloud-based server. The ECG data is then transmitted from the cloud-based server to a device associated with a medical professional in real-time.

Abstract: Individuals who suffer from certain kinds of medical conditions, particularly conditions that only sporadically exhibit measurable symptoms, can feel helpless in their attempts to secure access to medical care because, at least in part, they are left to the mercy of their condition to present symptoms at the right time to allow diagnosis and treatment. Providing these individuals with ambulatory extended-wear health monitors that record ECG and physiology, preferably available over-the-counter and without health insurance preauthorization, is a first step towards addressing their needs. In addition, these individuals need a way to gain entry into the health care system once a medically-actionable medical condition has been identified. Here, the ECG and physiology is downloaded and evaluated post-monitoring against medical diagnostic criteria.

Abstract: A system and method for ECG data classification for use in facilitating diagnosis of cardiac rhythm disorders is provided. ECG data is obtained via an electrocardiography monitor shaped for placement on a patient's chest. The ECG data is divided into segments and noise detection analysis is applied to the ECG data segments. A noise classification or a valid classification is assigned to each segment of the ECG data. At least one ECG data segment assigned the noise classification and that includes ECG data that corresponds with feedback from the patient via the electrocardiography monitor is identified. The ECG data that corresponds with the patient feedback is removed from the identified ECG data segment with the noise classification. The ECG data segments assigned the noise classification are removed from further analysis.