Abstract: Fluid delivery devices, systems and methods. The fluid delivery devices may be used to delivery fluid (e.g., insulin) to a user. The devices may have one or more inlets, and may be configured for use with an injection device, such as a syringe, and/or with a pump.

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: Disclosed herein are techniques related to device performance mode adjustment based on activity detection. In some embodiments, the techniques involve detecting, based on processing sensor data obtained from one or more gesture sensors, an activity in which a user of the one or more gesture sensors is engaged. The techniques further involve generating information corresponding to the detected activity in which the user of the one or more gesture sensors is engaged. The techniques also involve controlling, based on providing the generated information to a device for monitoring a physiological characteristic of the user, adjustment of a performance mode of the device for monitoring the physiological characteristic of the user.

Abstract: Systems and methods for forming probes for a biosensor. In the systems and methods disclosed herein, a base substrate is provided; and a platinum layer is formed on the base substrate by sputtering platinum in the absence of oxygen. The platinum layer is formed using a sputtering pressure of at least 30 mtorr.

Abstract: Disclosed herein are techniques related to safeguards against separation from portable medicine delivery devices. In some embodiments, the techniques may involve monitoring a wireless connection established between a portable computing device and a portable medicine delivery device. The techniques may also involve making a determination, based on the result of the monitoring, that the portable medicine delivery device is outside a predetermined range of the portable computing device. The techniques may further involve generating a notification based on the determination. The notification may be indicative of a user of the portable computing device being unaccompanied by the portable medicine delivery device.

Abstract: Techniques related to automatically generating a super bolus may include determining an amount of an augmented meal bolus to be delivered to a patient for regulating the patient's glycemic response to a meal. The amount of the augmented meal bolus may exceed a sufficient amount for counteracting a glucose level increase caused by the meal. In some embodiments, the techniques may further include determining a duration of a postprandial reduction period during which basal dosage deliveries to the patient are to be reduced. In some other embodiments, the techniques may further include delivering the augmented meal bolus to the patient prior to determining whether or not to cause reduction of basal dosage deliveries. More specifically, a glucose level of the patient may be obtained after delivery of the augmented meal bolus, and the obtained glucose level may be used to determine whether to reduce basal dosage deliveries.

Abstract: A method for insulin therapy includes obtaining a current glucose measurement value of a user from a sensing arrangement, obtaining a determination of a current amount of active insulin in the body of the user, identifying an amount of future insulin deliveries to be delivered by an infusion device, determining a homeostasis metric based at least in part on the current glucose measurement value, the current amount of active insulin in the body of the user, and the amount of future insulin deliveries, wherein determining the homeostasis metric comprises predicting a change in the current glucose measurement value based on accounting for metabolism of the current amount of active insulin and the amount of future insulin deliveries, and generating an alert based at least in part on the homeostasis metric.

Abstract: A disposable medical introduction system including a medical device and a disposable inserter. The disposable inserter includes a carrier to receive the medical device. The carrier includes at least one annular projection. The disposable inserter includes a retractor received within the at least one annular projection and movable relative to the at least one annular projection. The retractor has at least one retaining arm. The disposable inserter includes a needle cartridge coupled to the retractor that includes an insertion needle. The at least one retaining arm cooperates with the needle cartridge to maintain the insertion needle in a first, extended state. A movement of the retractor relative to the at least one annular projection releases the at least one retaining arm to move the insertion needle from the first, extended state to a second, retracted state.

Abstract: An insertion device configured to implant a first medical device and a second medical device in a user. The first medical device may be a fluid delivery cannula configured to deliver a fluid (e.g., insulin) to the user. The second medical device may be an analyte sensor (e.g., a glucose sensor) configured to detect a physiological characteristic of the user (e.g., a glucose level). The insertion device may be configured to be worn by the user. The insertion device includes a first linkage assembly configured to extend and retract a first insertion needle to implant the first medical device and a second linkage assembly configured to extend and retract a second insertion needle to implant the second medical device. The insertion device includes a user input device configured to cause the insertion device to initiate the implantation when activated by the user.

Abstract: Embodiments are provided for dynamic management of charge. A method involves obtaining an estimated readiness time for an energy storage element, obtaining a target state of charge for the energy storage element, calculating an estimated charging time based at least in part on a difference between the target state of charge and a current state of charge, using a first charging rate to charge the energy storage element to an intermediate state of charge responsive to determining a time difference between the estimated readiness time and a first time is greater than the estimated charging time, maintaining the energy storage element at the intermediate state of charge, and responsive to determining a time difference between the estimated readiness time and a second time is less than the estimated charging time, using a second charging rate to charge the energy storage element to the target state of charge.

Abstract: Embodiments of the invention provide compositions useful in analyte sensors as well as methods for making and using such compositions and sensors. In typical embodiments of the invention, the sensor is a glucose sensor comprising an analyte modulating membrane formed from a polymeric reaction mixture formed to include limiting amounts of catalyst and/or polycarbonate compounds so as to provide such membranes with improved material properties such as enhanced thermal and hydrolytic stability.

Abstract: A method for automatically configuring a medical device with user-specific configuration data includes determining, by a first medical device, that the first medical device is being placed into service to provide medical therapy to a patient, wherein the first medical device is a replacement medical device for a second medical device that was previously placed into service to provide medical therapy to the patient in accordance with user-specific configuration data stored on the second medical device, communicating, by the first medical device, data indicative of the first medical device being placed into service, after communicating the data indicative of the first medical device being placed into service, obtaining, by the first medical device, the user-specific configuration data stored on the second medical device, and configuring, by the first medical device, the first medical device to provide therapy in accordance with the obtained user-specific configuration data.

Abstract: A sensing device monitors and tracks food intake events and details. A processor, appropriately programmed, controls aspects of the sensing device to capture data, store data, analyze data and provide suitable feedback related to food intake. More generally, the methods might include detecting, identifying, analyzing, quantifying, tracking, processing and/or influencing, related to the intake of food, eating habits, eating patterns, and/or triggers for food intake events, eating habits, or eating patterns. Feedback might be targeted for influencing the intake of food, eating habits, or eating patterns, and/or triggers for those. The sensing device can also be used to track and provide feedback beyond food-related behaviors and more generally track behavior events, detect behavior event triggers and behavior event patterns and provide suitable feedback.

Abstract: A device for delivering fluid to a user includes a fluid reservoir for holding the fluid, the fluid reservoir defining an internal volume and a stopper positioned in the internal volume of the fluid reservoir, wherein the stopper is formed with a cavity. The device further includes a piston having a distal end received within the cavity of the stopper and an actuator coupled to the piston for driving the piston into the internal volume of the fluid reservoir. Also, the device includes a coupling device for engaging the piston in the cavity of the stopper at a desired position and a sensor for determining whether the piston is engaged in the cavity of the stopper at the desired position.

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: Electrochemical Impedance Spectroscopy (EIS) is used in conjunction with continuous glucose monitors and continuous glucose monitoring (CGM) to enable in-vivo sensor calibration, gross (sensor) failure analysis, and intelligent sensor diagnostics and fault detection. An equivalent circuit model is defined, and circuit elements are used to characterize sensor behavior.

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: Embodiments of the invention provide amperometric analyte sensors having optimized elements such as interference rejection membranes as well as methods for making and using such sensors. The amperometric analyte sensor apparatus comprises: a base layer; a conductive layer disposed on the base layer and comprising a working electrode; an interference rejection membrane disposed on an electroactive surface of the working electrode, wherein the interference rejection membrane comprises silicon-oxygen polymers; and an analyte sensing layer. While embodiments of the innovation can be used in a variety of contexts, typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: Medical devices and related systems and operating methods are provided. A method of operating an infusion device capable of delivering fluid influencing a physiological condition to a patient involves obtaining an event indication, such as a meal indication, determining an initial bolus amount based on the event indication, and determining predicted values for the physiological condition of the patient during a time window into the future based at least in part on the initial bolus amount. When the predicted values violate a threshold during the time window, the control system identifies an adjusted bolus amount that results in the predicted values for the physiological condition satisfying the threshold during the time window from within a search space defined by the initial bolus amount and operates an actuation arrangement of the infusion device to deliver the adjusted bolus amount of the fluid to the patient.

Abstract: Devices, systems, and techniques for controlling delivery of therapy for diabetes are described. In one example, a system includes a wearable device configured to generate user activity data associated with an arm of a user; and one or more processors configured to: identify at least one gesture indicative of utilization of an injection device for preparation of an insulin injection based on the user activity data; based on the at least one identified gesture, generate information indicative of at least one of an amount or type of insulin dosage in the insulin injection by the injection device; compare the generated information to a criteria of a proper insulin injection; and output information indicative of whether the criteria is satisfied based on the comparison.