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

Abstract: An extended wear electrocardiography and physiological sensor monitor recorder is provided. A set of electrical contacts extend from a bottom surface of a proximal end of a sealed housing. The sealed housing includes electronic circuitry, including an electrographic front end circuit to sense electrocardiographic signals and a micro-controller interfaced to the electrocardiographic front end circuit to sample the electrocardiographic signals. A patient feedback button located is on a top surface of the proximal end of the sealed housing and positioned above the feedback bottom on the distal end.

Abstract: A system and method for classifier-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. 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. An action is taken based on one or more of the determinations.

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: 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: 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: 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 electrocardiography and actigraphy data processing with the aid of a digital computer are provided. Samples of actigraphy event occurrences and samples of electrocardiographic signals are retrieved from a memory of a physiological monitor, wherein the samples of the actigraphy event occurrences are embedded among the samples of the electrocardiographic signals based on a time associated each of the samples of the actigraphy event occurrences and a time associated with each of the samples of the electrocardiographic signals. An actionable actigraphy event occurrence is identified from the samples of the actigraphy event occurrences. Those samples of the electrocardiographic signals that were sensed substantially concurrent to a time of the occurrence of the actionable actigraphy event are identified based on the embedding. The actionable event occurrence and the samples of the electrocardiographic signals that were identified are output.

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 self-authenticating electrocardiography and physiological sensor monitor is provided. An electrode patch includes an elongated strip and electrodes exposed on each end. A receptacle is adhered to the elongated strip and includes electrical pads. Circuit traces are electrically coupled to the electrocardiographic electrodes and the electrical pads. A monitor recorder having a sealed housing is adapted to be secured into the receptacle. Circuitry within the housing includes a microcontroller with a private key. A copy of the private key is stored on the patch. Self-authentication is performed each time the monitor recorder is inserted into a new patch by challenging the patch using a code hashed with the private key and by receiving a response from the patch in reply to the challenge. A front end circuit senses electrocardiographic signals via electrodes on the patch when the response received by the microcontroller is positive, until the electrode patch expires.

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: 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: 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 online opinion sharing about proximate motor vehicles with the aid of a digital computer. Motor vehicle identifying indicia uniquely identifying a motor vehicle about which an opinion can be shared is received from a voter who accessed a voter entry page of an online motor vehicle voting service via a user interface. The identifying indicia can be obtained using a computing device executing a mobile application, which can interface with a variety of devices to obtain the indicia. The voter is redirected from the voter entry page to a voting page of a social networking site for sharing the opinion. Then, a plurality of opinions about the motor vehicle is tallied. The voter and the driver of the vehicle can exchange messages.

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: 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.