Abstract: The present invention relates to the analysis apparatus capable of collecting the body fluid such as urine or blood, for embodiment urination and measuring or calculating the specific constituent from the collected body urine, and the apparatus for collecting body fluid capable of using by connecting to the analysis apparatus and its related article, in which the apparatus for collecting and analyzing for the body fluid of a patient consists of the body fluid collecting part and the collecting part case, the apparatus for collecting body fluid consists of the body fluid collecting part, the total tube and adapter, the collecting part is constructed with the absorbing tube, the sensor tube, the cleansing tube and the passage and is attachable/detachable connected to the collecting part, a diaper and pants exclusive for a patient are provided as the related article such that it is convenient to possess and has effects in the urination having no relations to the intention of a patient or in case of unable to use

Abstract: A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry; and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: A sensor system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes a connection detection device, a power source, and a delay circuit. The connection detection device determines if the sensor electronics device is connected to the sensor and transmits a connection signal. The delay circuit receives the connection signal, waits a preset hydration time, and couples the regulated voltage from the power source to an electrode in the sensor after the preset hydration time has elapsed. Alternatively, the sensor electronics device may include an electrical detection circuit and a microcontroller. The electrical detection circuit determines if the plurality of electrodes are hydrated and generates an interrupt if the electrodes are hydrated. A microcontroller receives the interrupt and transmits a signal representative of a voltage to an electrode of the plurality of electrodes.

Abstract: Method and apparatus for providing calibration of analyte sensor including applying a control signal, detecting a measured response to the control signal, determining a variance in the detected measured response, and estimating a sensor sensitivity based on the variance in the detected measured response is provided

Abstract: Method and apparatus for providing calibration of analyte sensor including applying a control signal, detecting a measured response to the control signal, determining a variance in the detected measured response, and estimating a sensor sensitivity based on the variance in the detected measured response is provided

Abstract: Method and apparatus for providing calibration of analyte sensor including applying a control signal, detecting a measured response to the control signal, determining a variance in the detected measured response, and estimating a sensor sensitivity based on the variance in the detected measured response is provided

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: Electrochemical sensor devices are provided, in various amperometric, potentiometric, and conductometric sensor device configurations. An amperometric sensor device may include a structural body which has at least one reservoir that has at least one opening; a working electrode located within the reservoir; analyte sensor chemistry located within the reservoir and deposited on at least the working electrode; an auxiliary electrode located outside of the reservoir; a reference electrode; at least one reservoir cap closing the opening to isolate the working electrode and analyte sensor chemistry within the reservoir and to prevent an analyte outside of the reservoir from contacting the analyte sensor chemistry; and means for rupturing or displacing the reservoir cap to permit the analyte from outside of the reservoir to contact the analyte sensor chemistry.

Abstract: A sensor module is disclosed herein. The sensor module includes a main housing defining an analysis zone within the housing. The sensor module also includes a skin piercing member mounted within the main housing. The skin piercing member is movable relative to the main housing between a retracted position and an extended position. The main housing of the sensor module defines a fluid sample flow passage that extends from a sampling end of the main housing to the analysis zone. The fluid sample flow passage includes a funnel structure through which the skin piecing member extends when in the extended position. The fluid sample flow passage also includes capillary flow enhancing slots that extend outwardly from opposite sides of the funnel structure.

Abstract: Method and apparatus for providing multiple data receiver units in a data monitoring and management system such as analyte monitoring system where a first data receiver includes all of the functionalities for the data monitoring and management system receiver unit, and a second data receiver unit is configured with limited functions to provide application specific convenience to the user or patient is disclosed.

Abstract: An apparatus comprising a substrate, the substrate having supported thereon: plural collectors each for collecting a bodily fluid from the surface of a body part placed adjacent thereto; an analyser for analysing each collected bodily fluid; and a display for displaying an indication of a result of each analysis.

Abstract: An interventional device (12) is configured to be positioned in a body and includes an electrically operable unit (E1, E2) configured to carry out an interaction with the body upon a receipt of electric power. The device further includes a sensor (2) configured for wirelessly receiving electromagnetic energy from a remote source. The sensor is configured as a resonant circuit (2a, 2b) which converts the received electromagnetic energy into the electric power. The electrically operable device may include a diagnostic and/or therapeutic module.

Abstract: The present invention is directed to an integrated system and a method for utilizing the system to detect and remove blood-borne factors of interest, such as pathogens and/or toxins and/or cytokines, from blood or serum (blood) by contacting the blood with a solid, essentially nonporous substrate which has been surface treated with molecules or chemical groups (the adsorbent media or media) having a binding affinity for the pathogens and/or toxins to be removed (the adsorbents). The invention can be used to remove virulence factors, e.g. toxins, that are released from various pathogens. In one aspect, the invention is for the treatment of sepsis and infection, such as infections associated with battle field trauma.

Abstract: Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: Devices, systems, and methods for providing more accurate and reliable sensor data and for detecting sensor failures. Two or more electrodes can be used to generate data, and the data can be subsequently compared by a processing module. Alternatively, one sensor can be used, and the data processed by two parallel algorithms to provide redundancy. Sensor performance, including sensor failures, can be identified. The user or system can then respond appropriately to the information related to sensor performance or failure.

Abstract: A system and method for receiving and ejecting a test strip of a fluid testing device. The system includes parallel first and second guide rails defining a rail cavity between the guide rails. A sled includes a sled post and opposed first and second side leg sets each having at least one deflectable leg. Each of the deflectable legs is externally slidably engaged to one of the guide rails limiting the sled to only sliding motion in either a loading direction or an opposite ejection direction. An actuator arm is rotatably connected to a mechanism assembly. The sled post is received in an actuator arm slot. Actuator arm rotation in a loading rotational direction displaces the sled in the loading direction in a sliding motion. Subsequent opposite rotation of the actuator arm in an ejection rotational direction displaces the sled in the ejection direction and ejects the test strip.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: The present application provides Ag/AgCl based reference electrodes having an extended lifetime that are suitable for use in long term amperometric sensors. Electrochemical sensors equipped with reference electrodes described herein demonstrate considerable stability and extended lifetime in a variety of conditions.

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include enhanced analyte monitoring devices and systems.

Abstract: A biochip and nanochip device, or a system of biochips, providing diagnostic testing, sensing and therapeutic functionality useful in diagnosis and treatment of a variety of physiological maladies.

Abstract: The disclosure provides method and materials for preparing biosensors (e.g., in vitro test strips and in vivo sensors) with improved mechanical properties. In some aspects, for example, the electrochemical sensors have improved durability and are better able to withstand mechanical and electrochemical stresses such as those encountered during manufacturing, transportation, storage, and use (e.g., in vivo positioning, in vivo operation, or in vitro operation). Also for example, in some aspects the electrochemical sensors are less susceptible to pinholes and other manufacturing defects that degrade performance in traditional sensors.

Abstract: Devices and methods relating to analyte sensor insertion devices and methods are provided.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

Abstract: Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

Abstract: A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

Abstract: A disease diagnosis apparatus and a disease diagnosis method thereof, and a disease diagnosis system and a disease diagnosis method thereof are provided. The disease diagnosis apparatus includes a patch including one or more diagnosis modules collecting blood and measuring concentrations of one or more cardinal markers included in the collected blood, and a processor wirelessly transmitting measurement results to a server.

Abstract: Method and apparatus for providing an introducer for transcutaneous placement of at least a portion of an analyte sensor through the skin of a patient is provided.

Abstract: A sensor system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes a connection detection device, a power source, and a delay circuit. The connection detection device determines if the sensor electronics device is connected to the sensor and transmits a connection signal. The delay circuit receives the connection signal, waits a preset hydration time, and couples the regulated voltage from the power source to an electrode in the sensor after the preset hydration time has elapsed. Alternatively, the sensor electronics device may include an electrical detection circuit and a microcontroller. The electrical detection circuit determines if the plurality of electrodes are hydrated and generates an interrupt if the electrodes are hydrated. A microcontroller receives the interrupt and transmits a signal representative of a voltage to an electrode of the plurality of electrodes.

Abstract: A biosensor system comprises a capillary substrate, conductive electrode, and a plurality of nanoparticles having an enzyme deposited thereon formed in a cavity at one end of the capillary substrate. The substrate may have an optional reinforcing layer (which may be conductive or non-conductive) and optional insulating layer thereon. A cannula having an optional conductive layer, insulating layer, and reference electrode may also form part of the system.

Abstract: Methods and devices and systems including a data collection module for receiving and storing analyte data over a predetermined time period from a subject, a user interface unit coupled to the data collection module for providing one or more indication related to the analyte data, a control unit coupled to the data collection module and the user interface unit to control, at least in part the operation of the data collection module and the user interface unit, a communication module coupled to the control unit for communicating one or more signals associated with the analyte data to a remote location, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of the analyte level received by the data collection module, and a retrospective analysis mode including limited output of information to the subject during the predetermined time period, and further where the communication module is configured to communicate with the remote location afte

Abstract: The measuring system for in vivo monitoring of an analyte concentration with malfunction detection, comprises an electrode system, a potentiostat and an evaluation unit. The electrode system has a working electrode, a reference electrode, and a counter electrode. The potentiostat is for adjusting a difference of potential between the electric potential of the working electrode and the electric potential of the reference electrode to a specified value and for measuring an electric current flowing between the working electrode and the counter electrode. The potentiostat comprises a working electrode terminal for connection to the working electrode, a reference electrode terminal for connection to the reference electrode, and a counter electrode terminal for connection to the counter electrode. The evaluation unit monitors the electric potential of the counter electrode and generates a malfunction signal when said potential is outside a specified reference range. A method of operation is also disclosed.

Abstract: Systems and methods for continuous measurement of an analyte in a host are provided. The system generally includes a continuous analyte sensor configured to continuously measure a concentration of analyte in a host and a sensor electronics module physically connected to the continuous analyte sensor during sensor use, wherein the sensor electronics module is further configured to directly wirelessly communicate displayable sensor information to a plurality of different types of display devices.

Abstract: A sensor system includes a sensor and a sensor electronics device. The sensor includes a plurality of electrodes. The sensor electronics device includes a connection detection device, a power source, and a delay circuit. The connection detection device determines if the sensor electronics device is connected to the sensor and transmits a connection signal. The delay circuit receives the connection signal, waits a preset hydration time, and couples the regulated voltage from the power source to an electrode in the sensor after the preset hydration time has elapsed. Alternatively, the sensor electronics device may include an electrical detection circuit and a microcontroller. The electrical detection circuit determines if the plurality of electrodes are hydrated and generates an interrupt if the electrodes are hydrated. A microcontroller receives the interrupt and transmits a signal representative of a voltage to an electrode of the plurality of electrodes.

Abstract: Method and system for providing basal profile modification in insulin therapy for use with infusion devices includes periodically monitoring the analyte levels of a patient for a predetermined period of time in order to determine, based on the monitored analyte levels, an appropriate modification factor to be incorporated into the underlying basal profile which was running at the time the periodic monitoring of the analyte levels were performed.

Abstract: A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucose is described. The electrode is designed to allow “one-point” in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably three or four-layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer is overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited (third layer). An outer (fourth) layer is biocompatible.

Abstract: Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.

Abstract: A method, system, and computer program product related to the detection of physical activity using changes in heart rate. The method, system, and computer program product evaluates short term glucose demand and long term insulin action due to physical activity. The method, system, and computer program product is further related to the improvement of open and closed loop control of diabetes by accounting for the metabolic changes due to physical activity. The method, system, and computer program product is directed to detecting in real time the short and long term effects of physical activity on insulin action via heart rate analysis, and recommending changes in insulin dosing to compensate for the effects of physical activity. With these recommendations, the open and closed loop control of diabetes can be improved and steps can be taken to prevent hypoglycemia that may result from increased insulin sensitivity due to physical activity.

Abstract: An absorbent article for absorbing liquid discharge when worn on the crotch region of the body of a user includes a plurality of detection zones for detecting the liquid discharge. Each detection zone is provided by first and second electrically conductive paths that are electrically isolated from one another and arranged so that a liquid discharge between the first and second conductive paths allows electrical current to flow between the first and second conductive paths which is able to be detected to detect the presence of liquid discharge in the respective zone. The plurality of zones are longitudinally distributed with respect to the absorbent article along an absorbent core of the absorbent article, to allow the longitudinal extent of the discharge to be ascertained. The first and second conductive paths are longitudinally spaced from one another. The first and second conductive paths are elongate and are laterally aligned.

Abstract: Methods, devices, and systems for calibrating an analyte sensor are provided. Embodiments include determining a sensitivity value associated with an analyte sensor, retrieving a prior sensitivity value associated with the analyte sensor, determining whether a variance between the determined sensitivity value and the retrieved prior sensitivity value is within a predetermined sensitivity range, determining a composite sensitivity value based on the determined sensitivity value and the retrieved prior sensitivity value, and assigning a successful calibration sensitivity value based on the retrieved prior sensitivity value when the variance is within the predetermined sensitivity range.

Abstract: Devices and methods are described for providing continuous measurement of an analyte concentration. In some embodiments, the device has a sensing mechanism and a sensing membrane that includes at least one surface-active group-containing polymer and that is located over the sensing mechanism. The sensing membrane may have a bioprotective layer configured to substantially block the effect and/or influence of non-constant noise-causing species.

Abstract: Human or animal body fluids can be measured in-vivo to determine analyte concentrations, such as glucose. The measurement system comprises an exchangeable sensor for in-vivo placement, a data carrier with calibration data for the sensor, a housing having a first chamber for receiving a sterile sensor and a second chamber for receiving a data carrier, and a base station that couples to the housing for transmitting measurement signals to an evaluation unit. Replacement sterile sensors can be packaged in a sterile package and the data carrier associated with the replacement sensor can be packaged in a non-sterile package.

Abstract: A device contains individually controllable sites for electrochemically monitoring an analyte in interstitial fluid of a user. The sites include a conductive pattern attached at a first and second ends thereof to electrode material in a closed-circuit configuration for receiving a first predetermined voltage applied thereto in order to thermally ablate a stratum corneum of a user's skin to access the interstitial fluid and form an open-circuit configuration including first and second portions of the electrode material that are electrically isolated from each other; a sensing area deposited on at least one of the first and second portions of the electrode material; and a measuring component for receiving individual measurement data from the sensing area in response to a second predetermined voltage applied to the open circuit configuration. The individual measurement data is indicative of an amount of the analyte in the interstitial fluid.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: Methods and devices and systems for determining an analyte value are disclosed.

Abstract: Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: Disclosed herein are systems and methods for a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes first and second working electrodes to measure analyte or non-analyte related signal, both of which electrode include an interference domain.