Abstract: Medical devices and related systems and methods are provided. A method of calibrating an instance of a sensing element involves obtaining fabrication process measurement data from a substrate having the instance of the sensing element fabricated thereon, obtaining a calibration model associated with the sensing element, determining calibration data associated with the instance of the sensing element for converting the electrical signals into a calibrated measurement parameter based on the fabrication process measurement data using the calibration model, and storing the calibration data in a data storage element associated with the instance of the sensing element.

Abstract: An insertion set system includes a base configured to be secured to a patient, and a flexible tubing on the base. The flexible tubing has a distal end portion forming a cannula to be inserted into the patient. An inserter having a needle is received by the base. The needle has a channel in which the distal end portion of the flexible tubing is received. The needle is able to slide relative to the flexible tubing, to selectively withdraw the needle off of the distal end portion of the flexible tubing. The base may include a passage for fluid flow arranged transverse to the axial dimension of the distal end portion of the flexible tubing.

Abstract: A test system for measuring electrical current consumption of a device under test (DUT) includes a capacitor with power and ground terminals; a voltage regulator with input and output terminals; first and second switching elements; and a controller. The voltage regulator generates a DUT operating voltage based on its input voltage. The first switching element is arranged between a direct current (DC) voltage source and the regulator input, and the second switching element is arranged between the DC voltage source and the capacitor. The controller operates the switching elements to charge the capacitor, and to configure the test system for measuring operating current of the DUT using the capacitor as the power source.

Abstract: A fluid infusion system includes a housing configured to be adhesively coupled to an anatomy of the user. The housing comprises a communication device configured to wirelessly communicate a physiological characteristic to a communication component of a fluid infusion device. The fluid infusion system includes a fluid flow path from the fluid infusion device into the anatomy of the user, and the fluid flow path is configured to extend from the housing for insertion into the anatomy of the user.

Abstract: An actuation device includes a lancing device held by and moveable relative to a distal end portion of a housing. A drive member is supported by the housing and arranged to engage the lancing device to move the lancing device in the first direction from a retracted position to an extended position upon movement of the drive member in a first direction. A piercing member of the lancing device is arranged to extend from the distal end portion of the housing by a first distance when the lancing device is moved to the extended position, the first distance being adjustable by adjusting the retracted position of the lancing device relative to the distal end portion of the housing.

Abstract: Embodiments of the invention provide optimized sputtered metallic surfaces adapted for use with implantable medical devices as well as methods for making and using such polymeric surfaces. These sputtered metallic surfaces have features that function to inhibit or avoid an inflammatory immune response generated by implantable medical devices. Typical embodiments of the invention include an implantable glucose sensor used in the management of diabetes having a sputtered metallic surface adapted to contact an in vivo environment.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method involves operating an infusion device to deliver fluid to a user in accordance with a first operating mode of a plurality of operating modes, obtaining operational information pertaining to the first operating mode, and obtaining clinical information pertaining to the user. A destination operating mode of the plurality of operating modes is determined based at least in part on the operational information and the clinical information, and the infusion device is operated to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by at least a portion of the operational information pertaining to the first operating mode.

Abstract: Techniques related to advance diagnosis of operating mode viability are disclosed. The techniques may involve obtaining status information pertaining to operation of a fluid delivery device. The status information may include at least one of a group comprising recent sensor measurement data, sensor calibration data, blood glucose reference measurement data, fluid delivery data, a current battery level of the fluid delivery device, and a current amount of fluid remaining in the fluid delivery device. The techniques may further involve determining, based on the status information, viability of transitioning to a destination operating mode of the fluid delivery device. Additionally, the techniques may involve causing generation of one or more user notifications of recommended remedial actions to improve the viability of transitioning to the destination operating mode when transitioning into the destination operating mode is determined not to be viable.

Abstract: The invention provides amperometric analyte sensor systems comprising one or more electrodes designed to monitor in vivo levels of 3-hydroxybutyrate (and optionally glucose as well) in order to facilitate the management of diabetic ketoacidosis. The invention further includes compositions, elements and methods useful with such amperometric analyte sensor systems.

Abstract: Techniques related to temporary setpoint values are disclosed. The techniques may involve causing operation of a fluid delivery device in a first mode for automatically delivering fluid to a patient based on a first target glucose value. Additionally, the techniques may involve obtaining a second target glucose value. The second target glucose value may be a temporary target glucose value to be used for a specified period of time to regulate fluid delivery to the patient, and the second target glucose value may be greater than the first target glucose value. The techniques may further involve causing, based on obtaining the second target glucose value, operation of the fluid delivery device in a second mode for automatically delivering fluid to the patient. The second mode may be for reduced fluid delivery during the specified period of time.

Abstract: Provided is a system for delivering and recording a dose of a medicament to a patient. Also provided is a method of administering a medicament to a patient. Additionally provided is a method of tracking usage of a medicament by a patient through a pen.

Abstract: Embodiments of the invention provide compositions useful in implantable devices such as analyte sensors as well as methods for making and using such compositions and devices. In typical embodiments of the invention, the device is a glucose sensor comprising a polymeric composition disposed on a flexible assembly within the sensor that includes amounts of one or more immunosuppressant agents designed to provide such sensors with improved material properties such as enhanced biocompatibility.

Abstract: A connector interface system includes a cap to connect to a reservoir to form a reservoir/cap unit for installation into an infusion pump device. The cap has at least one receptacle for receiving one or more detectable features comprising at least one disc-shaped member, for detection by at least one sensor element on the infusion pump device when the reservoir of the reservoir/cap unit is received in a reservoir receptacle of the infusion pump device. The at least one detectable feature has at least one detectable parameter that is associated with one or more characteristics of the cap, the reservoir, the infusion pump device, a cannula associated with the cap or a tubing connected between the cap and the cannula.

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 patient involves predicting, by a control system associated with the infusion device, a future occurrence of an event based at least in part on historical data associated with the patient, and prior to the future occurrence of the event, automatically adjusting a control parameter for operating the infusion device based at least in part on the event and automatically operating an actuation arrangement of the infusion device to deliver the fluid to the patient based at least in part on a current measurement of the physiological condition and the adjusted control parameter.

Abstract: A sensor inserter for a physiological characteristic sensor includes a housing that defines a track system that extends from a bottom of the housing toward a top of the housing. The sensor inserter includes a striker assembly movable relative to the housing between a first state, a second, cocked state and a third, disposal state. The striker assembly is movable from the second, cocked state to the third, disposal state to couple the physiological characteristic sensor to an anatomy. The striker assembly includes a lock beam that engages with the track system as the striker assembly moves between the first state, the second, cocked state and the third, disposal state. In the third, disposal state the lock beam inhibits movement of the striker assembly from the third, disposal state to the first state.

Abstract: Disclosed is a medical device component for delivering medication fluid to a patient. The medical device component includes a fluid infusion device to regulate delivery of medication fluid, a body-mountable base unit, and a top cover assembly that is removably couplable to the base unit and to the fluid infusion device. The base unit includes a cannula to deliver medication fluid under the control of the fluid infusion device, and a physiological analyte sensor to measure a physiological characteristic. The base unit also includes an electronics assembly electrically connected to sensor leads to obtain measurements in the analog domain, to convert measurements into digital sensor data, and to communicate conditioned digital sensor data to the fluid infusion device. The top cover assembly is configured to provide both fluid and electrical connections for the base unit, by way of an infusion tube having sensor conductors integrated therein or otherwise associated therewith.

Abstract: Medical devices and related systems and methods are provided. A method of providing a notification pertaining to a physiological condition using a translation model involves identifying an error metric associated with an input variable associated with the translation model, determining a reference output of the translation model by providing reference values for the input variable to the translation model, generating modulated values for the input variable based on the reference values using the error metric, determining a simulated output of the translation model by providing the modulated values for the input variable to the translation model, and updating the translation model to reduce a weighting associated with the input variable when a difference between the simulated output and the reference output is greater than a threshold.

Abstract: A single flex double-sided electrode useful in a continuous glucose monitoring sensor. In one example, a counter electrode is placed on the back-side of the flex and a work electrode is placed on the top-side of the sensor flex. The electrode is fabricated on physical vapor deposited metal deposited on a base substrate. Adhesion of the electrode to the base substrate is carefully controlled so that the electrode can be processed on the substrate and subsequently removed from the substrate after processing.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining one or more measurement values of a physiological condition in the body of a user during an initial monitoring period and determining a fasting reference value for a metric based on the one or more measurement values. After the initial monitoring period, the method continues by obtaining an updated measurement value during a fasting period, determining a current value for the metric based at least in part on the updated measurement value, and generating a notification in response to a deviation between the current value and the fasting reference value exceeding a threshold indicative of insertion site loss or other loss of effectiveness.

Abstract: An electrochemical sensor including a working electrode having an arrangement of pillars defining channels between the pillars. The channels increase confinement of a byproduct produced in an electrochemical reaction used during sensing of an analyte, so as to increase interaction of the byproduct with the working electrode. A number of working embodiments of the invention are shown to be useful in amperometric glucose sensors worn by diabetic individuals.