Abstract: A test system for measuring a volume of fluid dispensed by a fluid infusion device includes a test housing. The test housing includes an inlet and an internal channel. The inlet is to be coupled to the fluid infusion device to receive the volume of fluid, and the internal channel is in fluid communication with the inlet. The test system includes an input electrode coupled to the internal channel to be in fluid communication with the volume of fluid, and an output electrode coupled to the internal channel to be in fluid communication with the volume of fluid. The test system includes a power source configured to create a voltage potential between the input electrode and the output electrode. The volume of fluid in the internal channel conducts current between the input electrode and the output electrode to facilitate measurement of the volume of fluid dispensed.

Abstract: Ambulatory infusion pumps, durable assemblies, and disposable assemblies, including energy sources, reservoirs, baseplates, and related components therefor, as well as component combinations and related methods.

Abstract: Ambulatory infusion pumps, medicament reservoirs, and medicament sealing assemblies, including a variety of trocar seal assemblies and fill plug seal assemblies, plus related components, as well as component combinations and related methods.

Abstract: A method and system are provided for controlling which communication interface of a plurality of communication interfaces is used for communication between a plurality of devices that can be part of a wireless body area network for a medical device system. The communication interfaces can include a body area network communication interface and a far field communication interface. A controller can determine whether a first device is able to establish a communication link with a second device that is located in a coverage region of the wireless body area network using a first body area network communication interface. If so, the controller can determine whether a quality of service over the communication link is greater than or equal to a first threshold, and if so, the first body area network communication interface can be used to communicate data from the first device to the second device via magnetic signals.

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.

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: Embodiments of the invention provide multilayer analyte sensors having elements and/or architectures that function to improve oxygen delivery to sensor enzymes in manner that enhances sensor function, as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: A method of controlling an insulin infusion device involves controlling the device to operate in an automatic basal insulin delivery mode, obtaining a blood glucose measurement for the user, and initiating a correction bolus procedure when: the measurement exceeds a correction bolus threshold value; and a maximum basal insulin infusion rate is reached during the automatic basal insulin delivery mode. The correction bolus procedure calculates an initial correction bolus amount, and scales the initial amount to obtain a final correction bolus amount, such that a predicted future blood glucose level resulting from simulated delivery of the final correction bolus amount exceeds a low blood glucose threshold level. The final amount is delivered to the user during operation in the automatic basal insulin delivery mode.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves obtaining measurement values for a physiological condition influenced by the fluid, autonomously operating the infusion device to deliver the fluid based at least in part on the measurement values, and detecting a nonactionable condition based on the measurement values. In response to detecting the nonactionable condition, delivery of the fluid is limited while maintaining autonomous operation of the infusion device. In one exemplary embodiment, the nonactionable condition is a rescue condition indicative of the user having consumed fast-acting carbohydrates, and thus insulin delivery may be automatically limited in response to detecting the rescue carbohydrate consumption.

Abstract: An embodiment of a sensor device includes a base substrate, a circuit pattern formed overlying the interior surface of the substrate, a physiological characteristic sensor element on the exterior surface of the substrate, conductive plug elements located in vias formed through the substrate, each conductive plug element having one end coupled to a sensor electrode, and having another end coupled to the circuit pattern, a multilayer component stack carried on the substrate and connected to the circuit pattern, the stack including features and components to provide processing and wireless communication functionality for sensor data obtained in association with operation of the sensor device, and an enclosure structure coupled to the substrate to enclose the interior surface of the substrate, the circuit pattern, and the stack.

Abstract: The invention is directed to a competitive glucose binding affinity assay comprising a glucose receptor (typically mannan binding lectin) labeled with an assay fluorophore and a modified glucose analog (typically dextran) labeled with a reference fluorophore. In certain embodiments, the glucose analog is dextran and is coupled to both a reference fluorophore and a quencher dye (e.g. hexamethoxy crystalviolet-1). Optionally the reference fluorophore is blue shifted relative to the assay fluorophore.

Abstract: A computer-implemented system and related method of managing use of a diabetes management device are presented here. An embodiment of the method obtains input data for a user of the diabetes management device, and compares the input data against historical event/outcome combinations maintained for the user. Each of the event/outcome combinations includes insight event data indicative of a glycemic event and a glycemic outcome corresponding to the insight event data. The method determines, based on the comparing, a correlation between the input data and a glycemic outcome. The method continues by generating a glycemic insight message for delivery to the user, wherein the glycemic insight message includes information regarding a relationship between at least some of the input data and the glycemic outcome.

Abstract: A method of initializing a sensor with a voltage sequence including a ramped voltage combined with a biphasic voltage pulse. The initialization scheme results in faster in-vitro sensor run-in and stabilization times. In various examples, the in-vitro sensor stabilization time is reduced from 200 minutes to 40-55 minutes (a reduction by a factor of least 5 as compared to a non-initialized sensor). In addition, staircase voltage initialization is implemented adaptively so that the voltage step size and sweep rates are changed depending on the state of the sensor (characterized by ISIG magnitude). As a result, individual sensors can be initialized in a customized manner rather than by using a general hardwired and harsh initialization scheme.

Abstract: Medical devices and related augmented reality systems and methods are provided. A method of operating an infusion device involves analyzing one or more images captured by an imaging device to identify image content indicative of an activity capable of influencing the physiological condition of the patient and in response to identifying the activity based at least in part on the one or more images, automatically adjusting delivery of the fluid to the patient based at least in part on the activity. An expected nutritional characteristic for a meal is determined based at least in part on the image content, and a delivery adjustment for delivering the fluid is determined based on the expected nutritional characteristic. A graphical indication of the delivery adjustment may also be provided using augmented reality.

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 obtaining, by a control system associated with the infusion device, measurement values indicative of a condition of the patient provided by a sensing device, identifying an event pattern based at least in part on the measurement values for the condition and historical data associated with the patient, generating a notification indicative of the event pattern in response to identifying the event pattern, and adjusting operation of the infusion device to deliver the fluid to the patient in a manner that is influenced by the event pattern in response to receiving user input confirming the event pattern.

Abstract: A system and method for controlling and monitoring a diabetes-management system through the use of a model that predicts or estimates future dynamic states of glucose and insulin from variables such as insulin delivery or exogenous glucose appearance as well as inherent physiological parameters. The model predictive estimator can be used as an insulin bolus advisor to give an apriori estimate of postprandial glucose for a given insulin delivery profile administered with a known meal to optimize insulin delivery; as a supervisor to monitor the operation of the diabetes-management system; and as a model predictive controller to optimize the automated delivery of insulin into a user's body to achieve a desired blood glucose profile or concentration. Open loop, closed-loop, and semi-closed loop embodiments of the invention utilize a mathematical metabolic model that includes a Minimal Model, a Pump Delivery to Plasma Insulin Model, and a Meal Appearance Rate Model.

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: Presented here are techniques for controlling glucose levels of a patient based on predicted time to a target glucose level. One methodology predicts a trajectory of the blood glucose level based on past observations of the blood glucose level, determines a cost expression based on the trajectory, and affects a future command to an infusion pump to affect a cost value according to the cost expression. Another methodology defines a target blood glucose concentration level for the patient, observes a current blood glucose concentration for the patient based on signals received from a blood-glucose sensor, and predicts a duration of time for the patient's blood glucose concentration to reach the target blood glucose concentration level based on the observed current blood glucose concentration.

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 obtaining, by a control system associated with the infusion device, user input indicating an activity by the patient, obtaining historical data for the patient corresponding to the activity, determining a probable patient response corresponding to the activity based at least in part on the historical data for the patient, determining an adjustment for delivering the fluid by the infusion device based at least in part on the probable patient response, and operating the infusion device to deliver the fluid to the patient in accordance with the adjustment.

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 obtaining, by a control system associated with the infusion device, an input meal indication, obtaining historical data for the patient associated with the input meal indication, determining an estimated carbohydrate amount corresponding to the input meal indication based at least in part on the historical data, determining a bolus dosage of the insulin based at least in part on the estimated carbohydrate amount, and operating an actuation arrangement of the infusion device to deliver the bolus dosage of the insulin to the patient.