Abstract: Described here are patches and methods for measuring glucose in sweat (and tears and the like). In general, the patches comprise an adhesive layer adapted to bond to skin of an individual, a substrate layer disposed over the adhesive layer and comprising a glucose sensing complex including a chromogen that changes color in the presence of certain concentrations of glucose, and a cover. In typical embodiments, the substrate layer has elements formed to direct and accumulate sweat that migrates from the skin of the individual to the glucose sensing complex. Methods of using the invention can comprise cleaning the skin surface, collecting sweat in a patch comprising this microfluidic constellation of elements, and observing concentrations of glucose collected in the sweat, for example either visually, or by using a smartphone or other computer processing device.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves determining a current value for a physiological condition of the user influenced by the fluid violates a first threshold value, determining a predicted value for the physiological condition of the user violates a second threshold value, and automatically altering operation of the infusion device to modify delivery of the fluid to the user after determining the predicted value violates the second threshold value when the current value violates the first threshold value.

Abstract: A fluid infusion device is provided. The fluid infusion device includes a housing that includes a lock and a set connector assembly removably coupled to the housing to define a fluid flow path from the fluid infusion device. The set connector assembly includes a connector having a body that defines a graspable portion and a coupling portion. The coupling portion is receivable within the housing, and the graspable portion has at least one wing that defines a locking tab for engaging the lock. The at least one wing is movable relative to the body to disengage the locking tab with the lock.

Abstract: A set connector assembly for a fluid infusion device is provided. The set connector assembly includes a connector having a body. The body defines a graspable portion and a coupling portion, and the coupling portion is to be received within a portion of the fluid infusion device. The graspable portion has at least one locking tab to lock the connector to the fluid infusion device, and the graspable portion is movable relative to the body to move the connector between a first, locked position and a second, unlocked position relative to the fluid infusion device.

Abstract: Apparatuses and methods for medical monitoring physiological characteristics values such as blood glucose levels for the treatment of diabetes, are presented. The apparatuses and methods provide dynamic glucose monitoring functions that perform predictive analysis to anticipate harmful conditions, such as glucose crash and hyperglycemic incidents for a patient. The dynamic functions can also be used to maximize athletic performance and warn of inadequate nocturnal basal rate. Other aspects include advanced alarm and reminder functions, as well as advanced data presentation tools to further facilitate convenient and efficient management of various physiological conditions.

Abstract: Insertion devices for installing insertion sets to a user, insertion needles, methods for loading insertion devices with insertion sets, methods for installing insertion sets, methods for instructing others how to load and/or install insertion sets, and certain aspects of insertion sets, including insertion needle hubs.

Abstract: A fluid infusion device including a housing that receives a sealed fluid reservoir is presented here. The fluid infusion device includes a drive motor assembly, an actuation mechanism, a force sensor, and at least one processor in the housing. The processor detects insertion of the fluid reservoir and incrementally rewinds the drive motor assembly to achieve an equilibrium state. The processor advances the drive motor assembly and obtains at least one measure of force using the force sensor until the at least one measure of force indicates that the fluid reservoir has reached an initial seated state. The processor performs a stabilizing cycle with the drive motor assembly. The processor advances the drive motor assembly and obtains at least one subsequent measure of force using the force sensor until the at least one subsequent measure of force indicates that the fluid reservoir has reached a subsequent sealed state.

Abstract: Systems and processes for managing data relating to one or more medical or biological conditions of a plurality of subjects (such as patients) over a wide area network, such as the Internet, may be employed for diabetes subjects or subjects with other medical conditions requiring monitoring and/or treatment over time. Such systems and processes provide various functions for several types of users, including patients or subject-users, healthcare provider-users and payor entity-users and combinations thereof, which allow for improved treatment and medical data management of individual subjects and groups of subjects and which allow collection and analysis of aggregate data from many subject sources, for improving overall healthcare practices of providers and subjects (e.g., patients).

Abstract: Described here are patches and methods for measuring glucose in sweat (and tears and the like). In general, the patches comprise an adhesive layer adapted to bond to skin of an individual, a substrate layer disposed over the adhesive layer and comprising a glucose sensing complex including a chromogen that changes color in the presence of certain concentrations of glucose, and a cover. In typical embodiments, the substrate layer has elements formed to direct and accumulate sweat that migrates from the skin of the individual to the glucose sensing complex. Methods of using the invention can comprise cleaning the skin surface, collecting sweat in a patch comprising this microfluidic constellation of elements, and observing concentrations of glucose collected in the sweat, for example either visually, or by using a smartphone or other computer processing device.

Abstract: Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration.

Abstract: A fluid infusion device and related operating methods are disclosed. The fluid infusion device has a housing, a fluid pump mechanism having an inlet and an outlet, a first flow path in fluid communication with the inlet and at least partially defined by structure compatible with fluid cartridge modules containing medication fluid, a second flow path in fluid communication with the outlet and terminating at a subcutaneous conduit for a body, and a drive motor that actuates the pump mechanism. An exemplary operating method detects a first installation of a fluid cartridge module in the housing. The detecting occurs after the housing has been affixed to the body and after the subcutaneous conduit has been inserted into the body. In response to the detecting, the operating method initiates an automatic priming operation to prepare the device for delivery of the medication fluid to the body.

Abstract: The disclosed subject matter relates to diagnostic procedures and related device architectures that check the operating health of a display element of a host electronic device. In certain embodiments, a display apparatus for an electronic device includes a display element, a display controller, a conductive trace, and a detection circuit. The display element has an array of pixel elements formed overlying a substrate and arranged to define a viewable display area. The display controller is coupled to control activation of the array of pixel elements. The conductive trace is formed overlying the substrate and is arranged to bypass the display controller in a layout that does not interfere with visibility of the pixel elements. The detection circuit is coupled to the conductive trace, and it operates to check electrical continuity of the conductive trace to obtain an indication of health of the display element.

Abstract: This invention pertains to systems and components useful for infusing medications such as insulin. Typically, the components are used to deliver insulin to a diabetic patient at a site of infusion over a period of time greater than 4 days. The system components typically comprise a cannula adapted for subcutaneous insertion into a diabetic patient. The system further comprises a fluid conduit adapted to deliver the insulin solution from a medication reservoir to the site of infusion and a depot in operable contact with the fluid conduit. The depot comprises selected materials including a site-loss mitigating agent (such as heparin) which inhibits inflammation at the site of infusion, and encapsulation of the cannula at the site of infusion. The site-loss mitigating agent is not premixed with the insulin, and instead is adapted to contact the insulin solution in the depot as the insulin solution flows from the medication reservoir to the site of infusion.

Abstract: An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.

Abstract: An embodiment of a fluid infusion device includes a fluid pump mechanism having a rotor and a stator. The rotor includes a reference surface and a cam element rising from the reference surface. The stator includes a cam element having a stator cam surface. The cam elements cooperate to axially displace the rotor as a function of rotation. A biasing element provides force to urge the cam elements together. A drive motor is coupled to actuate the rotor to pump medication fluid from a fluid cartridge module to a body, via a subcutaneous conduit. A force sensor is coupled to the rotor to generate output levels in response to force imparted thereto. The force sensor cooperates with a detection circuit that obtains and processes the output levels to detect occlusions in a fluid path downstream of the fluid pump mechanism.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining a filtered measurement indicative of a physiological condition of a user, determining a metric indicative of a characteristic of the filtered measurement based at least in part on one or more derivative metrics associated with the filtered measurement, and determining an output measurement indicative of the physiological condition of the user based at least in part on the filtered measurement, the metric, and a previous output measurement.

Abstract: An electronic controller for an insulin infusion device includes at least one processor device and at least one memory element that cooperate to provide a processor-implemented closed-loop initiation module. The initiation module is operated to obtain a most recent calibration factor for a continuous glucose sensor, the most recent calibration factor representing a first conversion value applicable to convert a first sensor value to a first blood glucose value. The initiation module also obtains a prior calibration factor for the sensor, and calibration timestamp data for the most recent calibration factor and the prior calibration factor. The initiation module regulates entry into a closed-loop operating mode of the insulin infusion device, based on the most recent calibration factor, the prior calibration factor, and the calibration timestamp data.

Abstract: A method of measuring blood glucose of a patient is presented here. In accordance with certain embodiments, the method applies a constant voltage potential to a glucose sensor and obtains a constant potential sensor current from the glucose sensor, wherein the constant potential sensor current is generated in response to applying the constant voltage potential to the glucose sensor. The method continues by performing an electrochemical impedance spectroscopy (EIS) procedure for the glucose sensor to obtain EIS output measurements. The method also performs a nonlinear mapping operation on the constant potential sensor current and the EIS output measurements to generate a blood glucose value.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary infusion device includes a motor operable to deliver fluid to a body of a user, a first control module to enable input power for the motor and provide a dosage command for operating the motor, and a second control module coupled to the first control module to receive the dosage command and operate the motor using at least a portion of the input power based at least in part on the dosage command. One of the first control module and the second control module detects an anomalous condition, and in response, disables the input power to the motor, stores diagnostic information for the anomalous condition in its internal memory, and automatically resets thereafter.

Abstract: An embodiment of a fluid infusion device includes a fluid pump mechanism having a rotor and a stator. The rotor includes a reference surface and a cam element rising from the reference surface, and the stator includes a cam element having a stator cam surface. The cam elements cooperate to axially displace the rotor as a function of angular position of the rotor. A biasing element provides force to urge the cam elements together. A drive motor actuates the rotor to pump medication fluid from a fluid cartridge module to a body, via a subcutaneous conduit. A detection circuit processes axial and angular position data of the rotor, and determines that an upstream occlusion has occurred based on detectable characteristics of the axial and angular position data.