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 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: 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: 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 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: 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: 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.

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: 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: Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch with sewn electrodes and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The 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 method for constructing physiological electrode assembly with integrated flexile wire components is provided. An electrode backing is formed from a stretchable woven textile material, the electrode backing having a proximal electrode backing end and a distal electrode backing end. A set of flexile wires is integrated into the proximal electrode 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 electrode backing end. An electrocardiographic electrode is positioned on the contact side of the distal electrode backing end. A further electrocardiographic electrode is positioned on the contact side of the proximal electrode backing end. One of the electrical contact surfaces is connected to the electrocardiographic electrode. Another one of the electrical contact surfaces is connected to the further electrocardiographic electrode.

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

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 computer-implemented system and method for providing a personal mobile device-triggered medical intervention is provided. An activity monitor is associated with a patient and is configured to sense cardiac activity data, including heart rate and heart rhythm. A mobile device is paired with the activity monitor to execute an application for detecting a potentially medically significant cardiac event based on the cardiac activity data. An electrocardiography and physiological sensor monitor is fitted to a sternal region of the patient to sense electrocardiographic signals that the activity monitor is not capable of obtaining. The patient's access to the electrocardiography and physiological sensor monitor is triggered upon detection of the potentially medically significant cardiac event and the electrocardiographic signals are directly uploaded into an electronic medical record for the patient for review by a medical professional.

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.